UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

(Mark one)

For the fiscal year ended August 31, 20202022

or

For the transition period from _______________ to ________________________ 

Commission File No. 000-55852No.000-55852

6991 East Camelback Road 40 Wall Street, Suite D-3002701

Scottsdale, AZ 85251New York, New York 10005

(Address of principal executive offices, zip code)

(800) 570-0438(646) 380-1923

(Registrant’s telephone number, including area code)

 _____________________________________________________________

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

Securities registered pursuant to Section 12(b) of the Act:

Securities registered pursuant to section 12(g) of the Act:

common stock, $.001 par value

(Title of class)

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐     No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐     No ☒

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 and post such files). Yes ☒     No o☐

Indicate by 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. (Check one):

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 check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

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

At February 28, 2020,2022, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the voting common stock held by non-affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) was $538,190.$6,243,650.

At December 14, 2020,2022, there were 57,636,72020,020,239 shares of the registrant’s common stock, par value $0.001 per share outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

List hereunder the following documents if incorporated by reference and the Part of the Form 10-K (e.g., Part I, Part II, etc.) into which the document is incorporated: (1) Any annual report to security holders; (2) Any proxy or information statement; and (3) Any prospectus filed pursuant to Rule 424(b) or (c) under the Securities Act of 1933. The listed documents should be clearly described for identification purposes (e.g., annual report to security holders for fiscal year ended December 24, 1980). None.

GRIDIRON BIONUTRIENTS,INNOVATION1 BIOTECH INC.

TABLE OF CONTENTS

CAUTIONARY NOTE REGARDING FORWARDING LOOKING STATEMENTS

This report includescontains forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,” “aim,” “will,” “would,” “could,” and similar expressions or phrases identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and future events and financial trends that we believe may affect our financial condition, results of operation, business strategy and financial needs. Forward-looking statements include, but are not limited to, statements about risks associated with:

You should read thoroughly this report and the documents that we refer to herein with the understanding that our actual future results may be materially different from and/or worse than what we expect. We qualify all of our forward-looking statements by these cautionary statements including those made in Part I. Item 1A. Risk Factors appearing elsewhere in this report.  Other sections of this report include additional factors, which could adversely impact our business and financial performance.Annual Report on Form 10-K. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Except for our ongoing obligations to disclose material information under the Federal securities laws, we undertake no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events. These forward-looking statements speak only as of the date of this report, and you should not rely on these statements without also considering the risks and uncertainties associated with these statements and our business.

All references in this Form 10-K to the “Company”, “Gridiron,“Innovation1 Biotech Inc.,” “GridIron BioNutrients”“Innovation1”, “we”, “us,” or “our” are to GridironInnovation1 Biotech Inc. (formerly “Gridiron BioNutrients, Inc.”), a Nevada corporation and our former wholly-owned subsidiary Gridiron Ventures, Inc., a Nevada corporation.corporation, which was dissolved in April 2022.

All share and per share information gives proforma effect to the 308:1 reverse stock split of our common stock effective January 8, 2021.

PART I

ITEM 1. BUSINESS 

Corporate Overview 

Established in 2014, Innovation1 Biotech Inc. (OTCQB: IVBT) is headquartered in New York, NY. Innovation1 Biotech is a pharmaceutical company focused on the discovery and clinical development of novel synthetic analogs of botanical Schedule 1 molecules addressing major unmet medical needs. We aretake already validated technologies and identify opportunities to refine and reengineer them, eliminating deficiencies and creating products with more desirable performance attributes. The candidate molecules in our portfolio have their genesis in natural product botanical chemistry but have been subsequently modified via synthetic chemistry to endow them with more favorable pharmaceutical characteristics.

On November 9, 2021, the Company completed its acquisition (the “Acquisition”) of all of the assets, including intellectual property assets, relating to Mioxal^®, a nutraceutical complex composed of essential amino acids, natural coenzymes and minerals, held by ST Biosciences, Ltd., a company organized under the laws of England and Wales (“STB”). The Acquisition was completed pursuant to the terms of the Amended and Restated Asset Purchase Agreement dated November 5, 2021 (the “Asset Purchase Agreement”) described in the businessCompany’s Current Report on Form 8-K, filed with the Securities and Exchange Commission (the “SEC”) on November 8, 2021 (the “November 8th Current Report”). As consideration for the Acquisition, the Company issued 19,831,623 shares of marketing and selling consumer cannabidiol product line including, capsules, oil, gummies, concentrates and CBD infused water. We are currently limitedCommon Stock to distributionSTB, which at the closing of the products through our online platform, www.GridironMVP.com; we currently have no other distribution channels or partners.Acquisition represented approximately 70% of the Company’s outstanding shares of Common Stock on a fully-diluted basis. The closing of the Acquisition contemplated by the Asset Purchase Agreement on November 5, 2021, resulted in a change of control of the Company.

In December 2019, we initiated expanding our businessThe Common Stock issued to pursue opportunities withinSTB was valued at approximately $40,495,000 or $2.05 per share.

On November 7, 2022, the cannabidiol (CBD) bulk oilspace by securing industrial hemp biomass processed by a third party into CBD Oil.Company completed the disposition of all of the intellectual property assets and associated liabilities relating to Mioxal^®. See Subsequent Events.

Our productsPipeline

Our products are marketed under the trademark Gridiron BioNutrients™ and Gridiron MVP™ including:

GridironMVP Alkaline Nutrition with Probiotics.- 16.9oz beverage with 20mg of CBD with humic/fulvic trace minerals, vitamins and probiotics with an alkaline base;

GridironMVP Concentrate.- 1oz, 2oz, 4oz sizes, alkaline nutrition with probiotics in concentrate form;

Gridiron CBD Premium Hemp Tinctures in 1oz and 2oz sizes ranging from 500mg to 750mg of CBD in natural and peppermint flavors;

Gridiron CBD Gummies-come in various sizes from a 3pack to a 30-count bottle, offered in both a daytime and nighttime version with each gummy having 5mg of CBD;

Gridiron CBD Salve.- 1.7oz salve containing 50mg of CBD

Operating Strategy and Goals

In order for us to continue to implement our model, we have identified the following milestones thatAt Innovation1 Biotech, we are seeking to achieve:delivering innovative change in the psychedelic and cannabinoid space through the development of a portfolio that addresses five independent clinical indications with fully synthetic prodrugs, wherein the current therapeutic armamentarium is inadequate or non-existent.

Research and Clinical Development Strategy

We are currently in the pre-clinical development stage for our five pharmaceutical candidates. Our goal is to become a leader in the development of modified Schedule 1 molecules of botanical origin where there is the opportunity to effect breakthrough advances in diseases of unmet medical need.

In order to achieve our goal, we plan to build an experienced team of senior executives and board members, along with a team of scientists accomplished in all facets of pharmaceutical research and development, drug formulation, clinical trial execution, and regulatory submissions. We intend to leverage the knowledge of our team in order to complete the clinical trials needed to receive approvals of our product candidates from applicable regulatory authorities.

Capital Considerations 

Our business plan can be adjusted based on the available capital to the business.

The milestones set forth above reflectreflects our current judgment and belief regarding the direction of our business. Actual events, expenditures and results will almost always vary, sometimes materially, from any estimates, predictions, projections or assumptions suggested herein.

In order to satisfy our capital requirements and needs, we require additional working capital and may seek to sell additional equity or debt securities. The sale of additional equity securities will result in dilution to our stockholders. The incurrence of indebtedness will result in increased debt service obligations and could require us to agree to operating and financial covenants that could restrict our operations or modify our plans to grow the business. Financing may not be available in amounts or on terms acceptable to us, if at all. Any failure by us to raise additional funds on terms favorable to us, or at all, will limit our ability to expand our business operations and could harm our overall business prospects.

Product Marketing

Our products are currently marketed through our online website www.gridironmvp.com.  We currently have no marketing agreement(s) with third party marketing groups.

Product Manufacturing and FulfillmentDevelopment

We currently rely on third party manufacturersInnovation1 Biotech has engaged with Salzman Group, a US-Israeli pharmaceutical firm that according to Salzman Group has designed and fulfillment.  We currently have no contract or agreement with manufacturers or fulfillment centers.  We plandeveloped of novel small molecules for a number of clinical applications. According to identify manufacturesSalzman Group, it has invented novel, proprietary, water-soluble, and fulfillment centers that can provide qualityfully synthetic prodrugs of the most promising botanical molecules existing today. It is the stated goal of Salzman Group to exploit the vast intrinsic therapeutic power of botanical Schedule 1 molecules. Innovation1 Biotech has acquired five proprietary preclinical prodrugs, all fully synthetic without connection to botanical sourcing: a psychedelic molecule for treatment of post-traumatic stress disorder and efficiency indepression, a novel cannabinoid and tree bark derived psychedelic for treatment of addiction, and three additional novel cannabinoid prodrugs addressing clinical indications of refractory pediatric epilepsy, hypertrophic scarring after burn wound injury, and ocular inflammation of the developmentcornea and delivery of our products. We currently store our inventory in a temperature-controlled facility in central California our orders are fulfilled out of this facility.anterior uvea.

In February 2020, we entered into a Stock Purchase Agreement with Notis Global, Inc. whereby we purchased 2,500,000,000 sharesSee Subsequent Events below concerning the resignation of common stock Company that included a Collaboration Agreement, dated January 24, 2020. Under the Collaboration Agreement, the CompanyDr. Salzman and Notis Global “will collaboratively explorehis related groups, Salzman Group and consider potential business opportunities for the parties within various segments of the hemp CBD supply chain including cultivation, extraction and purification and retail products.” To date, there have been no opportunities identified through this collaboration with Notis Global.Herring Creek Pharmaceuticals.

In connection with the Collaboration Agreement, the Company and Shi Farms entered into a Supply Agreement, dated January 27, 2020, pursuant to which Shi Farms agreed to sell the Company 30,000 pounds of hemp biomass at a purchase price of $5.00 per pound. The hemp biomass must contain a minimum of 6% total Cannabidiol (CBD/and or CBDA) and all hemp biomass must have less than 3% total TCH content. The hemp biomass must contain no contaminates that are above acceptable industry standards for processing hemp biomass including but not limited to: mold and mildew, non-hemp plant material, soil, insects, rodent droppings, wet or rotting material, heavy metals, residual pesticides or herbicides, or bacteria. Either party may terminate the Supply Agreement prior to delivery of the hemp biomass. The collaboration and supply agreement(s) have produced no revenues to the company this year. We have on inventory approximately 77 liters of THC-Free CBD Distillate as a result of the collaboration agreement.

Competition

Competition within the CBDDirect Competitors:

The Company does not currently face direct competition for its portfolio technologies, but has a number of indirect competitors as listed below.

The pharmaceutical industry is characterized by rapidly advancing technologies and intense competition. While we believe that our knowledge, experience, and scientific resources provide us with competitive advantages, we face potential competition from many well-establisheddifferent sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, withinacademic institutions and governmental agencies and public and private research institutions. Any product candidates for which we complete clinical development successfully and for which we receive marketing approval may compete with existing therapies and new therapies that may become available in the market, such as Charlotte's Web Holdings Inc., PureKana, cbdMD, Inc., Tilray and Hexo Corp., and numerous start-up companies entering the market.  Substantially allfuture.

Many of the Company’sour competitors are established companies with brand name recognition andhave far greater resourcesmarketing and research capabilities than Gridiron.  Whileus. We also face potential competition from academic institutions, government agencies and private and public research institutions, among others, which may in the Company is not presently ablefuture develop products to effectively compete with these larger, more established companies as a result of its limited resources and lack of brand name recognition by consumers, subject to the availability of sufficient funds Gridiron seeks to brand and market high quality CBD products through both exclusive and non-exclusive strategic alliancestreat those diseases that will serve to make the Company a market leader, which will be in direct competition with the above companies. However, the Company can provide no assurance or guarantee that it will be able to develop and/or maintain any strategic alliances nowwe currently or, in the future, seek to treat. The current market for treatments that assist in novel therapeutics for major unmet medical needs, is highly unknown. Our commercial opportunity would be reduced significantly if our competitors develop and commercialize products that are safer, more effective, more convenient, have fewer side effects or that its products will be acceptedare less expensive than our product candidates.

Indirect Competitors:

Posttraumatic stress disorder is treated with the selective serotonin reuptake inhibitor antidepressant medications sertraline and paroxetine, both approved by the market.FDA for PTSD treatment. Antianxiety medications are commonly prescribed to relieve severe anxiety despite their potential for abuse. While several studies indicated that the antihypertensive medication prazosin (Minipress) may reduce or suppress nightmares in some people with PTSD, a more recent study showed no benefit over placebo.

Intellectual Property

The Company filed provisional patent applications protecting composition of matter and method of use of all the technologies described below. All of these applications are assigned to the Company. The Company will have the option to convert its provisional applications to full published patent applications in 2023. Within 30-31 months of the publication of the full patent applications, the Company will have the opportunity to file national phase applications in up to 154 countries.

* See the risk factor related to the Inflation Reduction Act in the Risk Factors section

We rely on a combination of trademark laws, trade secrets, confidentiality provisions and other contractual provisions to protect our proprietary rights, which are primarily our brand names, product designs and marks. We do not own any patents nor do we have any patents pending

The Company has filed fourthe following approved trademark applicationsapplication with the U.S. Patent & Trademark Office (USPTO) as follows::

There are no assurances that these trademarks will be granted or that we will be able to effectively protect any of our intellectual property. 

We are reliant on our domain name, www.GridironMVP,www.innovation1bio.com, to market our products. However, as with phone numbers, we do not have and cannot acquire any property rights in an Internet address. The regulation of domain names in the United States and in other countries is subject to change. Regulatory bodies could establish additional top-level domains, appoint additional domain name registrars or modify the requirements for holding domain names. As a result, we might not be able to maintain our domain name or obtain comparable domain names, which could harm our business.

Subsequent to August 31, 2022, we sold the Mioxal product intellectual property and intangible assets as described in Note 12 to the financial statements and in the Subsequent Events disclosed elsewhere in this document.

Government Regulation

The production ofInitially, we intend to obtain approvals for our hemp extract products is contingent onpharmaceutical candidates from the U.S. Food and Drug Administration, or FDA, the FDA,European Medicines Agency, or EMA, the Japanese Pharmaceuticals and state laws, regulations,Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA) in Australia, and guidance. Whileother countries’ governmental regulatory agencies approvals for our product candidates.

Regulation of Psilocin and Ibogaine analog

In the Agriculture Improvement Act of 2018 removed hemp fromUnited States, psychedelics, such as psilocin and ibogaine, are listed by the DEA as a Schedule I substance under the CSA. The Company is developing a prodrug of psilocin and an analog of ibogaine, entitled 18-methylaminocoronaridine, which might be considered as a Schedule I substance under the Controlled Substances Act, the law did not change the FDA's authorities with respect to foodFederal Analog Act. The DEA regulates chemical compounds as Schedule I, II, III, IV or drugs. As of the date of this annual report, the FDA has not madeV substances. Schedule I substances by definition have a determination that the use of hemp extract in food is safe. The FDA has evaluated Generally Recognized as Safe (GRAS) noticeshigh potential for four hemp seed-derived food ingredients and determined that the agency hasabuse, have no questions that those ingredients are GRAS under their intended conditions of use.  In the event the FDA issues appropriate regulations or guidance or determines that it has no questions that hemp extract is GRAS under intended conditions of use that would permit us to market hemp extract in water without food additive approval. We may decide to market Gridiron BioNutrients™ and GridironMVP™ in any states, districts or territories if applicable laws allow for such sale or if a supplier meets and complies with the FDA's GRAS regulations with respect to a self-certification regarding the safety and GRAS status of the use of hemp extract. We may change the composition of our planned hemp-extract-infused product as necessary to comply with federal, state or local laws, regulations or guidance.

The advertising, distribution, labeling, production, safety, sale, and transportationcurrently “accepted medical use” in the United States, of ourlack accepted safety for use under medical supervision, and may not be prescribed marketed or sold in the United States. Pharmaceutical products will be subject to the Federal Food, Drug, and Cosmetic Act; the Federal Trade Commission Act; the Lanham Act; state consumer protection laws; competition laws; federal, state and local workplace health and safety laws; various federal, state and local environmental protection laws; and various other federal, state and local statutes and regulations.

Legal requirements apply in many jurisdictionsapproved for use in the United States requiring that deposits or certain ecotaxes or fees be charged for the sale, marketing, and use of certain non-refillable beverage containers. The precise requirements imposed by these measures vary and are constantly evolving. Other types of statutes and regulations relating to beverage container deposits, recycling, ecotaxes and/or product stewardship also apply in various jurisdictions in the United States. We anticipate that additional, similar legal requirements may be proposedlisted as Schedule II, III, IV or enacted inV, with Schedule II substances considered to present the future athighest potential for abuse or dependence and Schedule V substances the local, statelowest relative risk of abuse among such substances. Schedule I and federal levels in the United States.

Any third-party bottling facility that we may choose to utilize in the future and any other such operations will beII substances are subject to various environmental protection statutesthe strictest controls under the CSA, including manufacturing and regulations, including those relating to the useprocurement quotas, security requirements and criteria for importation. In addition, dispensing of water resourcesSchedule II substances is further restricted. For example, they may not be refilled without a new prescription and the discharge of wastewater. It will be our policy to comply with any andmay have a black box warning. Further, most, if not all, such legal requirements. Compliance with these provisions has not had, and we do not expect such compliance to have, any material adverse effect on our capital expenditures, net income or competitive position.

The advertising, distribution, labeling, production, safety, sale, and transportationstate laws in the United States classify psilocin as a Schedule I controlled substance. For any product containing a prodrug of our products willpsilocin or an analog of ibogaine to be subject to the Federal Food, Drug, and Cosmetic Act; the Federal Trade Commission Act; the Lanham Act; state consumer protection laws; competition laws; federal, state and local workplace health and safety laws; various federal, state and local environmental protection laws; and various other federal, state and local statutes and regulations.

Legal requirements apply in many jurisdictionsavailable for commercial marketing in the United States, requiring that depositsthese prodrugs and analogs must be rescheduled, or certain ecotaxesthe product itself must be scheduled, by the DEA to Schedule II, III, IV or fees be charged for the sale,V. Commercial marketing and use of certain non-refillable beverage containers. The precise requirements imposed by these measures vary and are constantly evolving. Other types of statutes and regulations relating to beverage container deposits, recycling, ecotaxes and/or product stewardship also apply in various jurisdictions in the United States. We anticipate that additional, similar legal requirements may be proposedStates will also require scheduling-related legislative or enacted in the future at the local, state, and federal levels in the United States.administrative action.

Human Capital

Timothy S. Orr is ourwas the sole officer, and director and employee.employee of the Company during the fiscal year ended August 31, 2021. On November 9, 2021, the Company completed the asset acquisition of ST Biosciences, Ltd., consisting substantially all of intellectual property assets relating to Mioxal. The closing of the acquisition resulted in a change of control of the Company. As part of the acquisition, Mr. Orr stepped down as the Company’s Chief Executive Officer and assumed the role of the Company’s Interim Chief Financial Officer. Mr. Orr has since resigned from his position and as a director.

Pursuant to the terms of the Asset Purchase Agreement, Jeffrey J. Kraws was appointed as the Company’s Chief Executive Officer and a director of the Company. Subsequent to the fiscal year ended August 31, 2022 and prior to the filing of this report, Mr. Kraws resigned as CEO, but remains a director of the Company. Also pursuant to the terms of the Asset Purchase Agreement, the Company agreed to appoint Jason Frankovich as a director of the Company subject to the Company’s compliance with Rule 14f-1 of the Exchange Act. Mr. Frankovich has since resigned from his position as a director. On April 1, 2022, the Board appointed Patrick R. Morris, Esq. as a member of the Board to fill that vacancy. During the fiscal year ended August 31, 2022, Andrew L. Salzman M.D. was appointed as the Company’s Chief Scientific Officer and a director of the Company. Subsequent to the fiscal year ended August 31, 2022 and prior to filing this report, Dr. Salzman resigned as a director and as the Company’s CSO. Subsequent to the fiscal year ended August 31, 2022 and prior to the filing of this report, Frederick E. Pierce, II was appointed as Chairman of the Board and Interim Acting Chief Executive Officer. On December 5, 2022, Charles W. Allen and Dr. Shahin Gharakhanian were appointed directors. Provided we have the resources, we intend to expand our current management to attract and retain skilled directors, officers, and employees with experience relevant to our business focus. We believe that the skill set of our current management is adequate for the current and short-term development of our brands and trademarks.

Additional information

Information on the history of our company can be found in Note 1 to the notes to our consolidated financial statements appearing later in this report. We file annual, quarterly and other reports, proxy statements and other information with the SEC. The SEC maintains a website at www.sec.gov that contains reports, proxy and information statements, and other information regarding issuers such as our company that file electronically with the SEC.

ITEM 1A. RISK FACTORS

An investment in our common stock involves several significant risks. You should carefully consider the following risks and uncertainties in addition to other information in this report in evaluating our company and its business before purchasing our securities. Our business, operating results and financial condition could be seriously harmed because of the occurrence of any of the following risks. You could lose all or part of your investment due to any of these risks.

Risks Related to Our Business

We are currently in default convertible promissory notes in the aggregate principal amount of $831,170 (net of debt discounts).

Between August 2019 and April 2020, we issued a lender four convertible promissory notes in the principal amount of $831,170 (net of debt discounts).  At November 30, 2020, the principal and interest due under these notes is approximately $1,373,000.  In addition to events of default related to our failure to maintain sufficient authorized but unissued and unreserved shares of common stock to provide for the possible future conversion of these notes, we failed to repay each of these notes on their respective maturity dates.  We do not have sufficient funds to satisfy these obligations.  While we are engaged in preliminary discussions with the noteholder for the possible exchange of these obligations for a new series of preferred stock, there are no assurances we will reach an agreement with the noteholder. 

We do not have sufficient authorized but unissued and unreserved shares of common stock to permit the conversion and/or exercise of outstanding convertible notes, shares of Series A Convertible Preferred Stock (‘Series A Preferred”), or outstanding warrants.Operations

We currently have outstanding (i) 8,480,000 shares of Series A Preferred and warrants which are presently convertible into approximately 51,393,939 shares of common stock at the holders’ option and (ii) convertible promissory notes in the aggregate principal amount of $831,170 (net of debt discounts) which are presently convertible into approximately 358,326,000 shares of our common stock. The terms of these securities contain “blockers” which limit the holders’ rights to convert or exercise these securities if such conversion or exercise would make the holder the beneficial owner of threshold amounts of our common stock ranging from 4.99% to 9.99%.  The holders’ have the right to waive the limitation upon 61 day’s prior notice to us.  We do not presently have sufficient authorized but unissued and unreserved shares of common stock to permit the conversion of all of the Series A Preferred, the exercise of all of the warrants or the conversion of all the convertible notes, should the holders of such securities determine to convert or exercise such securities.  This lack of sufficient available shares of common stock has resulted both an event of default under each of these instruments.  While there is a pending reverse stock split of our common stock which, when effective, should adjust our capital structure to provide for sufficient authorized but unissued shares of common stock for these conversions and/or exercises, our board of directors has not fixed a final ratio for the split nor the effective date.

We have a history of losses.losses, we expect to incur losses in the future and we may not be able to achieve or maintain profitability.

We incurred net operating losses of $2,580,068$40,877,813 and $170,067,$258,441, respectively, for the years ended August 31, 20202022 and 2019.2021. At August 31, 20202022 we had an accumulated deficit of $3,843,927.$44,551,043. We do not generate sufficient revenues to provide funds to pay our operating expenses, satisfy our obligations or continue to implement our business model. Unless we are able to raise sufficient working capital to continue to implement our business model, will have no ability to increase our revenues to a level which supports our operations. In that event, we will continue to report net losses in future periods and our ability to continue our operations as they are presently conducted will be in jeopardy.

Our auditors have raised substantial doubts as to our ability to continue as a going concern. 

Our consolidated financial statements appearing later in this report have been prepared assuming we will continue as a going concern. We have sustained recurring losses from operations and have a net capital deficiency. These factors, among others, raise substantial doubt about our ability to continue as a going concern. Our consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

OurWe have a working capital deficit has increased substantially at August 31, 2020 as compared to August 31, 2019.2022 and 2021. We need to raise additional capital to continue our business model.

At August 31, 2020,2022, we had a cash balance of approximately $18,000$156,486 and a working capital deficit of approximately $2.7 million as compared$29,525,460 compare to a cash balance of approximately $19,000$137,476 and a working capital deficit of approximately $24,000$238,249 at August 31, 2019.2021. We used approximately $410,000$3,127,852 in net cash in our operations in the year ended August 31, 20202022 as compared to approximately $775,000 of$30,405 in net cash used in our operations in the year ended August 31, 2019.2021. The decrease in working capital from August 31, 2021 resulted from our acquisition of the Mioxal asset which is a long-term asset and the associated current Mioxal liability, an increase in our accounts payable, accrued expenses, dividends payable, and the current portion of our lease liability. Our principal sources of liquidity are sales of equity and debt securities. We indentintend to raise additional capital in the next 12 months in order to continue to implement our business model, in addition to funds necessary to satisfy our outstanding convertible note obligations.model. We do not have any firm commitments to raise additional working capital. As we are a small company whowhose stock is quoted on the OTC Markets, we expect to encounter difficulty in raising working capital upon terms and conditions satisfactory to us, if at all. There is no assurance that we will be successful in obtaining funding to continue operations. In that event, we may be unable to continue as a going concern.

We may have difficulties managing our anticipated growth, or we may not grow at all.

If we succeed in growing our business, such growth could strain our management team and capital resources. Our ability to manage operations and control growth will be dependent on our ability to raise and spend capital to successfully attract, train, motivate, retain, and manage new members of senior management and other key personnel and continue to update and improve our management and operational systems, infrastructure and other resources, financial and management controls, and reporting systems and procedures. Failure to manage our growth effectively could cause us to misallocate management or financial resources, and result in additional expenditures and inefficient use of existing human and capital resources or we otherwise may be forced to grow at a slower pace that could impair or eliminate our ability to achieve and sustain profitability. Such slower than expected growth may require us to restrict or cease our operations and go out of business.

Our disclosure controls and procedures and internal control over financial reporting are not effective, which may cause our financial reporting to be unreliable and lead to misinformation being disseminated to the public.

Our management evaluated our disclosure controls and procedures as of August 31, 20202022 and concluded that as of that date, our disclosure controls and procedures were not effective. In addition, our management evaluated our internal control over financial reporting as of August 31, 20202022 and concluded that that there were material weaknesses in our internal control over financial reporting as of that date and that our internal control over financial reporting was not effective as of that date. A material weakness is a control deficiency, or combination of control deficiencies, such that there is a reasonable possibility that a material misstatement of the financial statements will not be prevented or detected on a timely basis.

We have not yet remediated these material weaknesses and we believe that our disclosure controls and procedures and internal control over financial reporting continue to be ineffective. Until these issues are corrected, our ability to report financial results or other information required to be disclosed on a timely and accurate basis may be adversely affected and our financial reporting may continue to be unreliable, which could result in additional misinformation being disseminated to the public. Investors relying upon this misinformation may make an uninformed investment decision.

Our growth and profitability depend on the performance of third-party brokers and distributors and maintaining a ongoing relationships with them.

We currently have no distribution partners, and our success will depend on obtaining a sufficient distribution partners and the overall performance that these third parties provide. If we are unable to secure proper a proper distribution network or if and when we do, the third parties are do not perform or have deficient performance by such parties it may significantly undermine our operations, profitability, and result in total loss of your investment.

We rely on third parties to produce and bottle our products, which creates additional risk.

We do not own or operate co-packing facilities used to produce the various products in our portfolio. We rely on those third parties to ensure the quality, safety and integrity of our products. If the third parties that we engage to produce our products fail to meet our demands or are found by government agencies to be out of compliance with applicable regulatory requirements, our supplies of those products and our future profit margins could be adversely affected.

We rely on Timothy Orr, our sole executive officers who has extensive knowledge of our business and has provided our company with rights to our propriety blend under an oral agreement; the loss of Mr. Orr or the termination of the oral agreement may adversely affect our business.

We are highly dependent on one executive officer, Timothy Orr, who has extensive knowledge of our business and has provided our company with our propriety blend under an oral agreement. We do not have "key person" life insurance policies for Mr. Orr. The loss of Timothy Orr could result in delays in product development, loss of our propriety blend, any future customers and sales and diversion of management resources, which could adversely affect our operating results.

Risks Related to Regulations Applicable to Our Industry

Significant additional labeling or warning requirements or limitations on the availability of our products may inhibit sales of affected products.

Various jurisdictions may seek to adopt significant additional product labeling or warning requirements or limitations on the availability of our products relating to the content or perceived adverse health consequences of our products. Federal laws may preempt some or all of these attempts by state or localities to impose additional labeling or warning requirements. If these types of requirements become applicable to our products under current or future environmental or health laws or regulations, they may inhibit sales of our products. Moreover, if we fail to meet compliance deadlines for any such new requirements, our products may be deemed misbranded or mislabeled and could be subject to enforcement action, or we could be exposed to private lawsuits alleging misleading labels or product promotion.

Changes in, or failure to comply with, the laws and regulations applicable to our products or our business operations could increase our costs or reduce our net operating revenues.

The advertising, distribution, labeling, production, safety, sale, and transportation in the United States of our currently marketed products are subject to: the Federal Food, Drug, and Cosmetic Act; the Federal Trade Commission Act; the Lanham Act; state food and drug laws; state consumer protection laws; competition laws; federal, state, and local workplace health and safety laws, such as the Occupational Safety and Health Act; various federal, state and local environmental protection laws; and various other federal, state, and local statutes and regulations. Changes to such laws and regulations could increase our costs or reduce our net operating revenues.

In addition, failure to comply with environmental, health or safety requirements and other applicable laws or regulations could result in the assessment of damages, the imposition of penalties, suspension of production, changes to equipment or processes, or a cessation of operations at our or our bottlers' facilities, as well as damage to our image and reputation, all of which could harm our profitability.

If we fail to comply with personal data protection laws,maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results. As a result, current and potential shareholders could lose confidence in our financial reporting, which would harm our business and the trading price of our stock.

Our management has previously determined that we did not maintain effective internal controls over financial reporting. For a detailed description of these material weaknesses and our remediation efforts and plans, see “Controls and Procedures”. If the result of our remediation of the identified material weaknesses is not successful, or if additional material weaknesses are identified in our internal control over financial reporting, our management will be unable to report favorably as to the effectiveness of our internal control over financial reporting and/or our disclosure controls and procedures, and we could be subjectrequired to adverse publicity, government enforcement actions and/or private litigation,further implement expensive and time-consuming remedial measures and potentially lose investor confidence in the accuracy and completeness of our financial reports which could negatively affecthave an adverse effect on our businessstock price and operating results.potentially subject us to litigation.

In the ordinary course of our business, we may receive, process, transmit and store information relatingFailure to identifiable individuals ("personal data"), primarily employees and former employees. As a result, we are subject to various U.S.comply with federal, and state and foreign laws and regulations relating to personal data. These laws have been subject to frequent changes, and new legislation in this area may be enacted in other jurisdictions at any time. There is no assurance that our security controls over personal data, the training of employees and vendors on data privacy and security, data protection and consumer protection, or the expansion of current or the enactment of new laws or regulations relating to data privacy and security, data protection and consumer protection, could adversely affect our business and our financial condition.

We may receive, collect, store, process, transfer, and use personal information and other data relating to our customers, website visitors, employees, vendors’ and contractors’ employees, and other persons, and we rely in part on third parties that are not directly under our control to manage certain of these operations and to collect, store, process and use payment information. Due to the volume and sensitivity of the personal information and other data that we and these third parties manage and expect to manage in the future, as well as the nature of our customer base, the security features of our information systems are critical. A variety of federal, state and foreign laws and regulations govern the collection, use, retention, sharing and security of this information. Laws and regulations relating to data privacy and security, data protection and consumer protection are evolving and subject to potentially differing interpretations. Given the uncertainty and complexity of the regulatory framework for data privacy and security, data protection and consumer protection worldwide, there is the potential that these or other actual or alleged obligations may not be harmonized, may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another, or may be interpreted and applied in such a way as to conflict with our other legal obligations or practices. In addition, we are also subject to certain contractual obligations to third parties related to data privacy and security and data protection. As a result, while we strive to comply with applicable laws and regulations, our applicable policies and contractual obligations, and all other applicable legal obligations relating to data privacy and security, data protection and consumer protection to the policies, procedures andextent possible, our practices we implementedmay not have complied or may implementnot comply in the future with all such laws, regulations, requirements and obligations.

We are dependent on our key personnel.

Our success depends in a large part on our key executives. The loss or absence of their services could have a material adverse effect on us. We will need to fill positions such as Chief Financial Officer, Chief Science Officer and possibly others. Our ability to execute the Company’s strategic goals will depend in large part on the efforts of these individuals. We may face competition for qualified personnel, and we may not be able to attract and retain such personnel.

Risks Related to Regulation of Our Business and Products

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA and comparable foreign authorities is unpredictable, typically takes many years following the commencement of clinical studies and depends upon numerous factors. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. We have not obtained regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will prevent the improper disclosure of personal data. Improper disclosure of personal data in violation of applicable personal data protection laws could harm our reputation, cause loss of consumer confidence, subject us to government enforcement actions (including fines), or result in private litigation against us, which could result in loss of revenue, increased costs, liability for monetary damages, fines and/or criminal prosecution, all of which could negatively affect our business and operating results.ever obtain regulatory approval.

Applications for our product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following:

We are heavily dependent on the success of our product candidates, which are in the pre-clinical stage of development. We cannot give any assurance that any of our product candidates will proceed to clinical development or that they will receive regulatory approval, which is necessary before they can be commercialized.

We as a company have not submitted marketing applications to the FDA or comparable foreign regulatory authorities. We cannot be certain that any of our product candidates will be successful in clinical studies or receive regulatory approval or what regulatory pathway the regulatory authorities shall designate for our product candidates. Further, our product candidates may not receive regulatory approval even if they are successful in clinical studies. If we produce, market and/or sell products infuseddo not receive regulatory approvals for our product candidates, we may not be able to continue our operations.

We generally plan to seek regulatory approval to commercialize our product candidates in the United States, the European Union, Japan, Australia and other foreign countries. To obtain regulatory approvals we must comply with hemp, as defined under the Agriculture Improvement Actnumerous and varying regulatory requirements of 2018,such countries regarding safety, efficacy, chemistry, manufacturing and controls, clinical studies, commercial sales, pricing and distribution of our product candidates. Even if we are successful in obtaining approval in one jurisdiction, we cannot ensure that we will be subject to a myriad of different laws and regulations governing the use of hempobtain approval in food and beverages and ifany other jurisdictions. If we are unable to comply with such lawsobtain approval for our product candidates in a cost-effective manner,multiple jurisdictions, our business couldrevenue and results of operations would be adverselynegatively affected.

The production of a food or beverage infused with hemp, as "hemp" is defined in the Agriculture Improvement Act of 2018 (also known as the 2018 Farm Bill, Public Law 115-334), is contingent on U.S. Food and Drug Administration, or the FDA, and state laws, regulations, and guidance. While the Agriculture Improvement Act of 2018 removed hemp from Schedule I of the Controlled Substances Act, the law did not change the FDA's authorities with respect to food or drugs. As of the date of this annual report, the FDA has not made a determination that the use of hemp in food is safe. The FDA has evaluated Generally Recognized as Safe or GRAS notices for three hemp seed-derived food ingredients and determined that the agency has no questions that those ingredients are GRAS under their intended conditions of use. We intend to comply in full with all federal, state, and local laws, rules and regulations as we develop our hemp product lines. We will not pursue the production or sale of hemp-infused products until legally permitted.

LawsThe Company previously sold products infused with CBD, and regulations governing the use of hemp in food and beveragesnegative publicity from previously being involved in the United States are broad in scope; subject to evolving interpretations;hemp and subject to enforcement by a myriad of regulatory agencies and law enforcement entities. Under the Agriculture Improvement Act of 2018, a state or Indian tribe that desires toCBD space could have primary regulatory authority over the production of hemp in the state or territory of the Indian tribe must submit a plan to monitor and regulate hemp production to the Secretary of the United States Department of Agriculture or USDA. The Secretary must then approve the state or tribal plan after determining if the plan complies with the requirements set forth in the Agriculture Improvement Act of 2018. The Secretary may also audit the state or Indian tribe's compliance with the federally-approved plan. If the Secretary does not approve the state or Indian tribe's plan, then the production of hemp in that state or territory of that Indian tribe will be subject to a plan established by USDA. USDA has not yet established such a plan. We anticipate that many states will seek to have primary regulatory authority over the production of hemp. States that seek such authority may create new laws and regulations that permit the use of hemp in food and beverages.

Federal and state laws and regulations on hemp may address production, monitoring, manufacturing, distribution, and laboratory testing to ensure that that the hemp has a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis. Federal laws and regulations may also address the transportation or shipment of hemp or hemp products, as the Agriculture Improvement Act of 2018 prohibits states and Indian tribes from prohibiting the transportation or shipment of hemp or hemp products produced in accordance with that law through the state or territory of the Indian tribe, as applicable. Because we rely on a nationwide broker-distributor-retailer network whereby brokers represent our products to distributors and retailers in turn sell our product to consumers in the fifty states and the District of Columbia, we may be subject to many different state-based regulatory regimens for hemp, all of which could require us to incur substantial costs associated with compliance requirements. In addition, violations of these laws, or allegations of such violations, could disrupt our business and result in a material adverse effect on our operations, as well as adverse publicitybusiness, financial condition, and potential harm to our reputation. We and our suppliers and vendors must take significant enterprise risk management steps to ensure that there is no comminglingresults of hemp and marihuana, as "marihuana" is defined in the federal Controlled Substances Act. Marihuana remains subject to the Controlled Substances Act and related regulations.

Furthermore, if we decide to produce, market and sell products infused with hemp outside of the United States, we will be subject to applicable laws and regulations in those non-U.S. jurisdictions, which would require us to expend significant costs associated with compliance.

In addition, it is possible that additional regulations may be enacted in the future in the United States and globally that will be directly applicable to our current and proposed product offerings infused with hemp. We cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can we determine what effect additional governmental regulations or administrative policies and procedures, when and if promulgated, could have on our business.

FDA's current position is that the sale of food and beverages that contain hemp-derived cannabidiol or CBD is prohibited under the Federal Food, Drug, and Cosmetic Act; therefore, if we decide to produce, market and/or sell beverages infused with hemp-derived cannabidiol, we may be subject to federal enforcement actions which could adversely affect our business and harm our reputation and brandoperations.

The FDACompany was previously involved in the sale of a health water infused with CBD. However, the Company has jurisdiction over drugssince ceased the sale of this product and foodshas fully transitioned into a pharmaceutical, small molecule, research and development company, involved in the development of fully synthetic prodrugs without connection to botanical sourcing. The Company’s use of these synthetic prodrugs, which do not contain any botanical sourcing of cannabis, hemp or CBD, may still result in confusion given the Company’s previous business selling health water infused with CBD. Any negative publicity resulting from an incorrect perception that contain CBD,we operate in the cannabis space could result in a loss of current or future business. It could also adversely affect the public’s perception of us or our common stock and lead to reluctance by new parties to do business with or invest in us. We cannot assure you that additional business partners, including CBD derived from hemp. Underbut not limited to financial institutions and customers, will not attempt to end or curtail their relationships with us. Any such negative press or impacts to business relationships could have a material adverse effect on our business, financial condition, and results of operations.

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies may not be predictive of future study results.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the Federal Food, Drugclinical study process. The results of pre-clinical studies and Cosmetic Act orearly clinical studies, if any are commenced, of our product candidates may not be predictive of the FDCA, itresults of later-stage clinical studies. Product candidates that have shown promising results in early-stage clinical studies may still suffer significant setbacks in subsequent advanced clinical studies. There is a prohibited acthigh failure rate for drugs proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to introduceshow the desired safety and efficacy traits despite having progressed satisfactorily through preclinical studies and initial clinical studies. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical studies due to lack of efficacy or deliveradverse safety profiles, notwithstanding promising results in earlier studies. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. We do not know whether any Phase 1, Phase 2, Phase 3 (if any) or other clinical studies we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates.

We may encounter substantial delays in our clinical studies, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining marketing approval from regulatory authorities for introduction into interstate commerce any food (which the FDCA definessale of our product candidates, we must conduct extensive clinical studies to include beverages) that is adulterated. The FDCA therefore prohibitsdemonstrate the introduction or delivery for introduction of a food that contains CBD, because the FDCA deems a food to be adulterated if it bears or contains any food additive that is unsafesafety and CBD is presently an unsafe food additive under the FDCA and FDA regulations. The FDCA also states that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food to which an FDA-approved drug has been added, unless certain exceptions are met. The FDA has approved a drug in which CBD is an active ingredient, and the agency has stated that based on available evidence, noneefficacy of the exceptions applyproduct candidates in humans. Clinical testing is expensive, time consuming and uncertain as to CBD. Oneoutcome. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of the exceptions addresses whether the drug was marketed in food before the FDA approved the drugone or more clinical studies can occur at any stage of testing, and before the institutionour future clinical studies may not be successful. Events that may prevent successful or timely completion of any substantial clinical investigations involving the drug. The FDA has stated that interested parties may present the agency with evidence that has bearing on the issue of whether CBD was marketed in food before the FDA approved the CBD drug in 2018 or before the institution of substantial clinical investigations involving the CBD drug. FDA's current position is that this provision of the FDCA also prohibits the introduction or delivery for introduction into interstate commerce of a food to which CBD has been added.development include but are not limited to:

CongressAny inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. We may decide to amend the FDCA to permit the use of hemp-derived CBD in food. The FDA may also decide to issue regulations or guidance that address the use of hemp-derived CBD in food or use its enforcement discretion with respect to hemp-derived CBD products. On May 31, 2019, the FDA held a public hearing, as well as providing a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with CBD products, including information and views related to product safety. Based on this hearing, any legislative or regulatory action could take years to implement or finalize and may not include provisions that would enable our company to produce, market and/or sell hemp products or beverages that contain hemp-derived CBD. We risk becoming subject to adverse publicity and costly federal enforcement actions should we decide to produce, market and/or sell products infused with hemp-derived CBD in the United States. We may be required to expend significant resources in defendingconduct additional safety, efficacy and comparability studies before we will be allowed to start clinical studies with our company from such actionsrepurposed drugs. Clinical study delays could also shorten any periods during which our product candidates have patent protection and may allow our competitors to bring product candidates to market before we do, which could adversely affectimpair our ability to obtain orphan exclusivity and successfully commercialize our product candidates and may harm our business and results of operations and divert the attention of management. We may also incur the risk of sustaining considerable damage to our reputation and brand should we become party to federal enforcement actions resulting from the production, marketing or sale of hemp-derived CBD infused products.operations.

Accordingly, if Congress amended federalAny therapeutic candidates we may develop in the future may be subject to controlled substance laws or FDA issuedand regulations in the territories where the product will be marketed, and failure to comply with these laws and regulations, or guidance permitting the cost of compliance with these laws and regulations, may adversely affect the results of our business operations and our financial condition.

In the United States, psychedelics such as psilocin and ibogaine, are generally listed by the DEA as a Schedule I substance under the CSA. The Company is developing a prodrug of psilocin and an analog of ibogaine, entitled 18-methylaminocoronaridine, which might be considered as a Schedule I substance under the Federal Analog Act. The DEA regulates chemical compounds as Schedule I, II, III, IV or V substances. Schedule I substances by definition have a high potential for abuse, have no currently “accepted medical use” in the United States, lack accepted safety for use under medical supervision, and may not be prescribed marketed or sold in the United States. Pharmaceutical products approved for use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of hemp-derived CBDabuse among such substances. Schedule I and II substances are subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for importation. In addition, dispensing of Schedule II substances is further restricted. For example, they may not be refilled without a new prescription and may have a black box warning. Further, most, if not all, state laws in foodthe United States classify psilocin as a Schedule I controlled substance. For any product containing psilocin to be available for commercial marketing in the United States, psilocin must be rescheduled, or announcing the agency's decisionproduct itself must be scheduled by the DEA to Schedule II, III, IV or V. Commercial marketing in the United States will also require scheduling-related legislative or administrative action.

Scheduling determinations by the DEA are dependent on FDA approval of a substance or a specific formulation of a substance. Therefore, while psilocin is a Schedule I controlled substance, products approved by the FDA for medical use its enforcement discretionin the United States that contain psilocin should be placed in Schedules II-V, since approval by the FDA satisfies the “accepted medical use” requirement. If one of our product candidates receives FDA approval, we anticipate that the DEA will make a scheduling determination and place it in a schedule other than Schedule I in order for it to be prescribed to patients in the United States. This scheduling determination will be dependent on FDA approval and the FDA’s recommendation as to the appropriate schedule. During the review process, and prior to approval, the FDA may determine that it requires additional data, either from non-clinical or clinical studies, including with respect to hemp-derived CBD products, wewhether, or to what extent, the substance has abuse potential. This may introduce a delay into the approval and our suppliers and vendorsany potential rescheduling process. That delay would be dependent on the quantity of additional data required by the FDA. This scheduling determination will require DEA to implement significant enterprise risk management measuresconduct notice and comment rule making including issuing an interim final rule. Such action will be subject to ensurepublic comment and requests for hearing which could affect the scheduling of these substances. There can be no assurance that there is no commingling of CBD derived from marihuana,the DEA will make a favorable scheduling decision. Even assuming categorization as "marihuana" is defined ina Schedule II or lower controlled substance (i.e., Schedule III, IV or V), at the federal Controlled Substances Act, with any future commercial supply of hemp-derived CBD that is used to produce our products.

level, such substances would also require scheduling determinations under state laws and regulations.

The FDA could force the removal of our products from the U.S. market.

Government reviews, inquiries, investigations, and actions could harm our business or reputation.

As our product portfolio evolves, the regulatory environment with regard to our business is also evolving. Government officials often exercise broad discretion in deciding how to interpret and apply applicable laws or regulations. We may in the future receive formal and informal inquiries from various governmental regulatory authorities, as well as self-regulatory organizations or consumer protection watchdog groups, about our business and compliance with local laws, regulations, or standards. Any determination that our products, operations or activities, or the activities of our employees, contractors or agents, are not in compliance with existing laws, regulations or standards, could adversely affect our business in a number of ways. Even if such an inquiry does not result in the imposition of fines, interruptions to our business, loss of suppliers or other third-party relationships, terminations of necessary licenses and permits, or similar direct results, the existence of the inquiry alone could potentially create negative publicity that could harm our business and/or reputation.

Risks Related to the OwnershipInflation Reduction Act

The recently-passed Inflation Reduction Act may impact, either positively or negatively, our future strategies and results of operations as it pertains to our Securitiesplanned product offerings.

Passed by the 117^th United States Congress and signed into law by President Joe Biden on August 16, 2022, the Inflation Reduction Act of 2022 is landmark legislation which may significantly impact the pharmaceutical industry. The health care provisions contain significant changes to prescription drug pricing that could have far-reaching, rippling effects on the health care industry and its stakeholders. The Company has not had adequate time to fully evaluate this complex legislation. In recent months, publicly available information published on the internet by many reliable sources can be obtained for credible information, The Company cannot at this time determine the potential effects this legislation may have on its future operations.

Risks Related to an Investment in Our Common Stock 

There is currently a limited public market for our common stock, a trading market for our common stock may never develop, and our common stock prices may be volatile and could decline substantially.

Our shares are currently traded on the over-the-counter market, with quotations entered for our common stock on the OTCQB under the symbol “IVBT.” However, the volume of trading in our common stock is subjectcurrently limited. In these marketplaces, our stockholders may find it difficult to removalobtain accurate quotations as to the market value of their shares of our common stock and may find few buyers to purchase their stock and few market makers to support its price. As a result of these and other factors, investors may be unable to resell shares of our common stock at or above the price for which they purchased them, at or near quoted bid prices, or at all. Further, an inactive market may also impair our ability to raise capital by selling additional equity in the future and may impair our ability to enter into strategic partnerships or acquire companies or products by using shares of our common stock as consideration. Some, but not all, of the factors which may delay or prevent the listing of our common stock on a more widely-traded and liquid market include the following: our stockholders’ equity may be insufficient; the market value of our outstanding securities may be too low; our net income from operations may be too low; our common stock may not be sufficiently widely held; we may not be able to secure market makers for our common stock; and we may fail to meet the rules and requirements mandated by the several exchanges and markets to have our common stock listed. Should we fail to satisfy the initial listing standards of the national exchanges, or our common stock is otherwise rejected for listing, and remains listed on the OTC Markets or is suspended from the OTC Markets, if we do not implement the reverse stock split by December 31, 2020.

Our common stock is currently quoted on the OTCQB Tier of the OTC Markets. The last reported closingtrading price of our common stock on December 1, 2020 was $0.008 per share. On September 4, 2020 we received notice fromcould suffer and the OTC Markets that astrading market for our common stock may be less liquid and our common stock price may be subject to increased volatility.

Therefore, an active, liquid, and orderly trading market for our common stock may not initially develop or be sustained, which could significantly depress the bidpublic price of our common stock had closed below $0.01 for more than 30 consecutive calendar days, we no longer met the Standards for Continued Eligibility for OTCQB pursuant to the OTCQB Standards, Section 2.3(2),and/or result in significant volatility, which states that the company must “maintain proprietary priced quotations published by a Market Maker in OTC Link with a minimum closing bid price of $0.01 per share on at least one of the prior 30 consecutive calendar days.” The OTC Markets granted us a cure period of 90 calendar days during which the minimum closing bid price for our common stock must be $0.01 or greater for 10 consecutive trading days in order to continue trading on the OTCQB marketplace. If this requirement is not met by December 31, 2020, as extended, we will be removed from the OTCQB marketplace. While our board of directors and majority stockholders have approved a reverse stock split of our common stock in a range of 1:300 to 1:310, the final ratio has not been determined and we have recently begun the process to effect the reverse stock split which we estimate will conclude by mid-January 2021. On the effective date of the reverse stock split, the bid price of our common stock will be increased in the same ratio has the reverse stock split, thereby bringing us back into compliance with the Standards for Continued Eligibility of the OTC Markets. If we are unable to obtain further extensions from the OTC Markets, it is possible our common stock will no longer be quoted on the OTCQB.  In that event,could affect your ability to sell your common stock may be adversely impacted.

The reverse stock split will not change our authorized capital.  Following the reverse stock split our management may issue significant numbers of additional shares ofstock. Even if an active trading market develops for our common stock, thereby diluting the ownership interests of our current stockholders.

Our authorized but unissued common stock may be issued at the direction of our board of directors at such times, in such amounts and upon such terms as our board of directors may determine, without further approval of our stockholders unless, in any instance, such approval is expressly required by law. In addition to providing sufficient authorized but unissued and unreserved shares of common stock to permit the full conversion of the Series A Preferred, the exercise of the warrants and/or the conversion of the convertible notes should the holders so elect to convert or exercise such securities, the reverse stock split will provide us with the ability to issue such additional shares of common stock for a variety of corporate purposes, including acquisitions involving the issuance of securities, capital raising transactions, business development efforts, or other proper corporate purposes. Our board of directors reviews and evaluates potential business combination transactions and other corporate actions on an ongoing basis to determine if such actions would be in the best interests of our company and our stockholders. The resulting increase in the number of authorized common shares as a result of the reverse stock split may affect the rights of existing holders of common shares to the extent that future issuances of common shares reduce each existing stockholder’s proportionate ownership and voting rights in our company. In addition, possible dilution caused by future issuances of common shares could be accompanied by a decline in the market price of our shares, assumingcommon stock may be highly volatile and subject to wide fluctuations. Our financial performance, government regulatory action, tax laws, interest rates and market conditions in general could have a significant impact on the future market forprice of our common stock.

Because our common stock continues, of which there is no assurance.

Our commona penny stock, is deemed tostockholders may be “penny stock,” which may make it more difficult for investorsfurther limited in their ability to sell their shares due to suitability requirements.shares.

Our common stock is deemed to beThe SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock” as any equity security that term is definedhas a market price of less than $5.00 per share or with an exercise price of less than $5.00 per share, subject to certain exceptions. Our shares constitute a penny stock under the Securities Exchange Act of 1934, as amended. Penny stocks generallyamended (the “Exchange Act”) and are equity securities with a price of less than $5.00 (other than securities registered on certain national securities exchanges. Our common stock is covered by an SEC rule that imposes additional sales practice requirements on broker-dealers who sell such securitiesexpected to persons other than established customers and accredited investors, which are generally institutions with assets in excess of $5,000,000, or individuals with net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouse.  Broker/dealers dealing in penny stocks are required to provide potential investors with a document disclosing the risks of penny stocks. Moreover, broker/dealers are required to determine whether an investment inremain classified as a penny stock isfor the foreseeable future. Classification as a suitable investmentpenny stock makes it more difficult for a prospective investor. Thesebroker-dealer to sell the stock into a secondary market, which makes it more difficult for a purchaser to liquidate his or her investment. Any broker-dealer engaged by the purchaser for the purpose of selling his or her shares will be subject to Rules 15g-2 through 15g-9 of the Exchange Act. Rather than having to comply with these rules, some broker-dealers will refuse to attempt to sell a penny stock.

We are not subject to the rules of a national securities exchange requiring the adoption of certain corporate governance measures and, as a result, our stockholders do not have the same protections.

We are quoted on the OTCQB marketplace and are not subject to the rules of a national securities exchange, such as the New York Stock Exchange or the Nasdaq Stock Market. National securities exchanges generally require more rigorous measures relating to corporate governance designed to enhance the integrity of corporate management. The requirements may reduceof the potential market forOTCQB afford our stockholders fewer corporate governance protections than those of a national securities exchange. Until we comply with such greater corporate governance measures, regardless of whether such compliance is required, our stockholders will have fewer protections such as those related to director independence, stockholder approval rights and governance measures designed to provide board oversight of management.

Because we are a “smaller reporting company,” we will not be required to comply with certain disclosure requirements that are applicable to other public companies and we cannot be certain if the reduced disclosure requirements applicable to smaller reporting companies will make our common stock less attractive to investors.

We are a “smaller reporting company,” as defined in Item 10(f)(1) of Regulation S-K. As a smaller reporting company, we are eligible for exemptions from various reporting requirements applicable to other public companies that are not smaller reporting companies, including, but not limited to:

We will remain a smaller reporting company until the end of the fiscal year in which (1) we have a public common equity float of more than $250 million, or (2) we have annual revenues for the most recently completed fiscal year of more than $100 million plus we have any public common equity float or public float of more than $700 million. We also would not be eligible for status as smaller reporting company if we become an investment company, an asset-backed issuer or a majority-owned subsidiary of a parent company that is not a smaller reporting company.

We do not expect to pay any cash dividends to the holders of the common stock in the foreseeable future and the availability and timing of future cash dividends, if any, is uncertain.

We expect to use cash flow from future operations to repay debt and support the growth of our business and do not expect to declare or pay any cash dividends on our common stock in the foreseeable future. Subject to such restrictions, our board of directors will determine the amount and timing of stockholder dividends, if any, that we may pay in future periods. In making this determination, our directors will consider all relevant factors, including the amount of cash available for dividends, capital expenditures, covenants, prohibitions or limitations with respect to dividends, applicable law, general operational requirements and other variables. We cannot predict the amount or timing of any future dividends you may receive, and if we do commence the payment of dividends, we may be unable to pay, maintain or increase dividends over time. Therefore, you may not be able to realize any return on your investment in our common stock for an extended period of time, if at all.

Future sales of our common stock, or the perception that such sales may occur, may depress our share price, and any additional capital through the sale of equity or convertible securities may dilute your ownership in us.

We may in the future issue our previously authorized and unissued securities. We are authorized to issue 200,000,000 shares of common stock and 25,000,000 shares of blank check preferred stock with such designations, preferences and rights as determined by reducingour board of directors. The potential issuance of such additional shares of common stock will result in the dilution of the ownership interests of the holders of our common stock and may create downward pressure on the trading price, if any, of our common stock. The registration rights of certain stockholders and the sales of substantial amounts of our common stock following the effectiveness of the registration statement of which this prospectus is a part or other effective registration statements of the Company, or the perception that these sales may occur, could cause the market price of our common stock to decline and impair our ability to raise capital. These shares also may be sold pursuant to Rule 144 under the Securities Act, depending on their holding period and subject to restrictions in the case of shares held by persons deemed to be our affiliates. 

We may grant additional registration rights in connection with any future issuance of our capital stock.

In April 2021, the Company entered into an Exchange Agreement pursuant to which we agreed to issue 2,694,514 shares of our newly designated Series B Convertible Preferred Stock (“Series B Preferred”) in exchange for (i) 8,480,000 shares of our Series A Convertible Preferred Stock, (ii) outstanding common stock purchase warrants, and (iii) all principal and accrued interest due under outstanding convertible promissory notes.

On September 7, 2021, the Company consummated the initial tranche of its $2 million financing contemplated by that certain Series B-1 Purchase Agreement between the Company and Lincoln Park Capital Fund, LLC (“LPC”) pursuant to which the Company agreed to issue and sell to LPC up to 2,694,514 shares of its newly designated Series B-1 Convertible Preferred Stock (the “Series B-1 Preferred”) at a Stated Value per share price of $0.742245 (or $2,000,000 in the aggregate). On October 28, 2021, the Company consummated the second tranche of the Series B-1 Preferred Stock investment, issuing an additional 637,628 shares of its Series B-1 Preferred Stock to LPC at a price per share of $0.742245 or $500,000.00 in the aggregate. On November 9, 2021, the Company consummated the third and final tranche of the Series B-1 Preferred Stock investment, issuing an additional 1,347,256 shares of its Series B-1 Preferred Stock to LPC at a price per share of $0.742245 or $1,000,000.00 in the aggregate. On November 24, 2021, the Company entered into, and consummated the financing contemplated by, that certain Series B-1 Purchase Agreement between the Company and L1 Capital Opportunities Master Fund Ltd. (“L1 Capital”), pursuant to which the Company issued and sold to L1 Capital 2,694,514 shares of its Series B-1 Preferred at a per share price of $0.742245, or $2,000,000 in the aggregate. 

We may issue preferred stock whose terms could adversely affect the voting power or value of our common stock.

Our certificate of incorporation authorizes us to issue, without the approval of our stockholders, one or more classes or series of preferred stock having such designations, preferences, limitations and relative rights, including preferences over our common stock with respect to dividends and distributions, as our board of directors may determine. The terms of one or more classes or series of preferred stock could adversely impact the voting power or value of our common stock. For example, we might grant holders of preferred stock the right to elect some number of potential investors. Thisour directors in all events or on the happening of specified events, or the right to veto specified transactions. Similarly, the repurchase or redemption rights or liquidation preferences we might grant to holders of preferred stock could affect the value of the common stock.

We will continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act of 2002 and rules subsequently implemented by the SEC, impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly, particularly after we are no longer a smaller reporting company. For example, we expect that these rules and regulations may make it more difficult and more expensive for investors in our common stockus to sell shares to third parties or to otherwise dispose of themobtain director and could cause our stock price to decline.officer liability insurance.

If we failWe will continue to maintainincur significant costs in staying current with reporting requirements. Our management will be required to devote substantial time to compliance initiatives. Additionally, the lack of an effective system of internal control over financial reporting, weaudit group may not be ableresult in material misstatements to accurately report our financial results. As a result, currentstatements and potential shareholders could lose confidence inability to provide accurate financial information to our financial reporting, which would harm our business and the trading price of our stock.shareholders.

Our management has previously determined thatand other personnel will need to devote a substantial amount of time to compliance initiatives to maintain reporting status. Moreover, these rules and regulations, which are necessary to remain as a public reporting company, will be costly because external third-party consultant(s), attorneys, or other firms may have to assist us in following the applicable rules and regulations for each filing on behalf of the Company.

We currently do not have an internal audit group, and we did not maintainmay eventually need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge to have effective internal controls overfor financial reporting. For

Moreover, if we are not able to comply with the requirements or regulations as a detailed description of these material weaknesses and our remediation efforts and plans, see “Part II — Item 9A — Controls and Procedures.” If the result of our remediation of the identified material weaknesses is not successful, or if additional material weaknesses are identifiedpublic reporting company in our internal control over financial reporting, our management will be unable to report favorably as to the effectiveness of our internal control over financial reporting and/or our disclosure controls and procedures, andany regard, we could be requiredsubject to further implement expensivesanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and time-consuming remedial measures and potentially lose investor confidence in the accuracy and completeness of our financial reports which could have an adverse effect on our stock price and potentially subject us to litigation.management resources.

ITEM 1B. UNRESOLVED STAFF COMMENTS

Not applicable.

ITEM 2. PROPERTIES 

Our current business address is 6991 East Camelback Road40 Wall Street Suite D-300 Scottsdale, AZ  85251.2701, New York, NY 10005. We rent these facilities on a month-to-month basis for a monthly rental of $200.approximately $20,000. 

ITEM 3. LEGAL PROCEEDINGS 

We knowThe Company could become a party to various legal actions arising in the ordinary course of business. Matters that are probable of unfavorable outcomes to the Company and which can be reasonably estimated are accrued. Such accruals are based on information known about the matters, the Company’s estimates of the outcomes of such matters and its experience in contesting, litigating and settling similar matters. With the exception of the following, as of the date of this report, there are no material pending legal proceedings to which our companythe Company is a party. In addition, we do not knowparty or of which any of their property is the subject, nor are there any such proceedings known to be contemplated by any governmental authorities.

On September 30, 2022, a party identified as New You Inc. filed a complaint with the District Court of Clark County, Nevada against Innovation 1 Biotech, Inc, ST Biosciences LTD, Jeffrey Kraws and Jason Frankovich. The complaint alleges that during Mr. Frankovich’s service to New You Inc. as Chairman of the Board of Directors, concurrent with Mr. Frankovich’s and Mr. Kraws’s services as executives of ST Biosciences LTD, Mr. Frankovich converted funds away from New You Inc. to satisfy obligations of ST Biosciences LTD and/or Innovation1 and/or to enrich Frankovich and Kraws. The amount of the claim is a total of $249,020 plus damages in excess of $30,000 and includes a claim for legal fees. The Company’s legal firm has evaluated the claims of the complaint and together with Innovation1 management believes the claims to be without merit. The Company intends to defend against the complaint and believes any potential liability to be $0.  

ITEM 4. MINE SAFETY DISCLOSURES. 

None. 

PART II

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES.

Market Information 

Our shares of common stock areis quoted on the OTCQB Tier of the OTC Markets Group, Inc. under the stock symbol “GMVP.“IVBT.” On December 10, 2020,August 31, 2022, the last reported sale price of our common stock on the OTCQB was $0.0094$0.154 per share, which such price did not give effect to the pending reverse stock split of our common stock described below.share. As of December 14, 2020,August 31, 2022, there were 84131 holders of record holders of our common stock. 

Pending Reverse Stock Split

On December 4,22, 2020, the Company filed a definitive Information Statement on Schedule 14C (the “Information Statement”) with the SEC and mailed sameArticles of Amendment to its stockholders immediately thereafter.  The Information Statement provided notice that on December 2, 2020 the Company’s board of directors and majority stockholders approved a proposal to amend (the “Amendment”) the Company’s Articles of Incorporation, as amended, to authorize the board to effectwhich were effective on January 8, 2021 (the “Effective Date”), which effected a three hundred eight for one (308:1) reverse stock split of all of our issued andits outstanding common stock at a ratio of not less than 1-for-300 and not more than 1-for-310, with the board having the discretion as to when such reverse stock split would be effected (at any time on or prior to December 2, 2021) and the exact ratio of the reverse stock split to be set at a whole number within the above range as determined by the board of directors in its sole discretion.  As of the date of this report, the board has not fixed a ratio for the pending reverse stock split.  The principal reasons for the reverse stock split are set forth in the Information Statement and including our need to regain compliance with OTC Markets, Inc. Standards for Continued Eligibility and an insufficient number of shares of authorized, but unissued and unreserved shares of common stock to provide for full conversion of outstanding shares of our Series A Preferred and outstanding convertible promissory notes.  See Item 1A. Risk Factors appearing earlier in this report.stock.

Dividends

The payment of dividends, if any, in the future, rests within the sole discretion of our board of directors. The payment of dividends will depend upon our earnings, our capital requirements and our financial condition, as well as other relevant factors. We have not declared any cash dividends since our inception and have no present intention of paying any cash dividends on our common stock in the foreseeable future.

Transfer Agent

Our transfer agent is Empire Stock Transfer, Inc. (“Empire Stock Transfer”), whose address 1859 Whitney Mesa Dr., Henderson, Nevada 89014. Empire Stock Transfer’s telephone number is (702) 818-5898.

Recent Sales of Unregistered Securities

None.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

On, January 28, 2020, the Company entered into an agreement to repurchase 77,872,500 restricted shares of the Company’s common stock from an investor. The Company paid $80,000 or $.00103 per share and immediately retired the shares.None.

ITEM 6. SELECTED FINANCIAL DATA 

Not Applicable

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 

The following discussion should be read in conjunction with our financial statements and the related notes that appear elsewhere in this annual report. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actualdiscussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations, and intentions. Actual results and the timing of events could differ materially from those discussedanticipated in these forward-looking statements because of several factors, including those set forth under the Part I, Item 1A, Risk Factors and Business sections in this Annual Report. We use words such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions to identify forward-looking statements. FactorsIn addition, any statements that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, and other characterizations of future events or circumstances are forward-looking statements. Such statements are based on our current expectations and could cause or contribute to such differences include those discussed belowbe affected by the uncertainties and elsewhere inrisk factors described throughout this annual report on Form 10-K.

Overview

Our products are marketed and available through our website www.gridironMVP.com. We intendEffective March 31, 2022, as approved by the shareholders, the name of the Company was changed from Gridiron BioNutrients, Inc. (trading symbol GVMP) to engage a distribution partner that has a sufficient broker network and co-packer/manufacturer in order distribute our products through several channels. We believe thereInnovation1 Biotech Inc. (trading symbol IVBT).

Innovation1 Biotech Inc. (“IVBT”) believes it will be an increasing demand for enhancedamong the first companies to harness the raw power of botanical therapeutics by transforming them into fully synthetic drugs that are safely, reliably and functional productsconsistently delivered. There are two fundamental limitations in 2021 as consumers look for healthy alternatives to enhance their lifestyle. We expect our brand to capitalize on this and potential consumer demand.  We plan to continue to look for opportunities with industrial hemp growers, processors that we can engage in a tolling and/or collaboration agreement.  We believe these types of relationships could assist in stabilizing our raw material supply chain as well as give us positive exposure within the marketplace. 

To date we have:exploiting botanical Schedule 1 molecules:

To address these limitations, ST Biosciences, Ltd. engaged with Salzman Group, and Innovation1 later assumed the contractual obligations subsequent to the Asset Purchase Agreement completed on November 9, 2021 in order to gain access to a broader portfolio of intellectual property. According to Dr. Andrew Salzman, the Salzman Group, has pioneered the design and development of novel small molecules in the fields of cancer, heart disease, lung injury, intermediary metabolism and ophthalmology. The firm is currently regarded as a world leader in the design and optimization of rare cannabinoids.

IVBT has acquired five proprietary preclinical prodrugs, all fully synthetic without connection to botanical sourcing: a mushroom-derived psychedelic molecule for treatment post-traumatic stress disorder and depression, a novel cannabinoid and tree bark derived psychedelic for treatment of addiction and three additional novel cannabinoid prodrugs addressing clinical indications of refractory pediatric epilepsy, hypertrophic scarring from burn wound injury and ocular inflammation of the cornea and anterior uvea. IVBT’s drug portfolio uniquely positions IVBT to capitalize on the growing global demand for pharmaceutical Schedule 1 drugs.

Going Concern and Cash Flows

Our financial statements are prepared using generally accepted accounting principles in the United States of America applicable to a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. We have not yet established an ongoing sourceThe Company had no revenue and a net operating loss of revenues sufficient to cover our operating costs. Our ability to continue as a going concern is dependent on our company obtaining additional capital to fund operating losses until we become profitable. If we are unable to obtain additional capital, we could be forced to significantly curtail or cease operations.

We have only realized nominal revenues from our business. In the next 12 months, we plan to identify business to whom we can license and/or distribute our brand and product(s) as well as seek additional opportunities to continue as a going concern.

COVID-19

In December 2019, a novel strain of COVID-19 was reported in China. Since then, the COVID-19 has spread globally including across North America and the United States. The spread of COVID-19 from China to other countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,” or a worldwide spread of a new disease, on March 11, 2020.

Specifically, we caution that our business could be materially and adversely affected by the risks, or the public perception of the risks, related to the outbreak of COVID-19. To date, COVID has directly impacted the ability we have to participate in trade show events and other in-person marketing.  Although retailers which may carry our products may be considered essential businesses and therefore be allowed to remain operational, they may experience significantly reduced demand. The risk of a pandemic, or public perception of the risk, could cause customers to avoid public places, including retail properties, and could cause temporary or long-term disruptions in our supply chains and/or delays in the delivery of our inventory to our customers. Further, such risks could also adversely affect retail customers’ financial condition, resulting in reduced spending on our products, which are marketed as premium products. “Shelter-in-place” or other such orders by governmental entities could also disrupt our operations, if our employees or the employees of our sourcing partners who cannot perform their responsibilities from home, are not able to report to work. Risks related to an epidemic, pandemic or other health crisis, such as COVID-19, could also lead to the complete or partial closure of one or more of our co-packing facilities or operations of our sourcing partners.

Critical Accounting Policies

Please refer to Note 2 - Summary of Significant Accounting Policies in the accompanying Notes to the Consolidated Financial Statements.

Results of Operations

Overview. We had revenues of $1,181 and $79,246$40,877,813 for the years ended August 31, 2020 and 2019, respectively. We incurred a net loss of $2,580,068 and $170,067 for the years ended August 31, 2020 and 2019, respectively. The increase in net loss of $2,410,001 is attributable to the factors discussed below.

Revenues. We had revenues from operations of $1,181 and $79,246 for thefiscal year ended August 31, 20202022. The Company has working capital deficit of $29,525,460 and 2019, respectively. Our 2020 and 2019 revenues consisted primarilyan accumulated deficit of our retail line of health water infused with probiotics and minerals. The decrease of $78,065 of revenues resulted from the Company moving away from the retail line of health water infused with probiotics and minerals. The extent to which, and the amount of, revenues which may be generated from our future business operations and activities is unknown.

Gross Margin. Once cost of revenue and other expenses to generate revenue are considered, we had negative gross margins of $1,783 and $9,955 from our operations for the years ended August 31, 2020 and 2019, respectively. The decrease of $8,172 was a result of the small revenues during the year ended August 31, 2020 compared to the year ended December 31, 2019.

Expenses. Our operating expenses were $215,095 and $616,776for the years ended August 31, 2020 and 2019, respectively. The decrease of $401,681 was primarily attributable to the Company moving away from the retail line of health water infused with probiotics and minerals. As a result, professional fees decreased approximately $208,000, advertising decreased approximately $92,000, general and administrative expenses decreased approximately $77,000, stock-based compensation decreased approximately $19,000 and consulting fees decreased approximately $6,000.

Other (Income) Expense. Our total other (income) expense was $2,363,190 and ($456,664) for the years ended August 31, 2020 and 2019, respectively. The $2,819,854 increase in expenses was attributable to a $1,090,121 increase in expenses related to our convertible notes payable and preferred stock warrants for the change in fair value of the derivative liability and interest accretion, a $838,403 increase in debt/equity issuance costs on our three new convertible notes payables,  a $385,502 increase in net interest expense on our notes payable, notes receivable, convertible notes payable for our 3 new convertible notes payable, a $546,366 increase in impairment expense as we impaired an uncollectible notes receivable and inventory write-offs, offset by $40,538 other income from the write-off of various payables and other items.

Liquidity and Capital Resources

For the year ended August 31, 2020, we used net cash of $410,248 for operating activities.  We used $300,000 from investing activities for two notes receivable investments of $300,000 (see Note 4 (Notes Receivable) in the accompanying Item 8: Financial Statements).  Net cash of $709,154 was provided by financing activities from proceeds of convertible notes payable $828,000 from an investor less repayments of principal and interest of $38,846 and for a repurchase and retirement of common stock of $80,000 from an investor.  We will require additional capital to continue as a going concern.  As set forth in Note 5 to the notes to consolidated financial statements appearing earlier in this report, we are currently in default under the repayment terms of convertible promissory notes in the aggregate amount of $831,170 (net of debt discounts). 

Current Assets

We had total assets of $208,603$44,551,043 as of August 31, 2020, which consisted of $17,881 cash, inventory of 37,450, prepaid expenses of $13,945, notes receivable (net of discount) of $132,852 from our Participation Agreement with Libertas Funding, LLC (see Note 4 (Notes Receivable) in the accompanying Item 8: Financial Statements), equity investment (net of discount) of $2,783, equipment of $2,012, (net of accumulated depreciation) and trademarks of $1,680.

Current Liabilities

We had total liabilities of $2,886,610 as of August 31, 2020 consisting of accounts payable and accrued expenses of $443,496, related party payable of $73,469 due our CEO, derivative liability of $1,454,480, note payable, current portion of $10,0000, note payable, convertible notes payable net of discount of $831,170 (for further information and details on convertible notes which have been issued, see Note 5 (Convertible Notes Payable) in the accompanying Item 8: Financial Statements) and dividends payable of $73,995.

The Company is currently in default representing $831,170 (net of debt discounts); this debt can be converted into common stock at the discretion of the lender.  If the lender decides to convert to common stock it would be a significant dilutive event to holders of the common stock.  Although we are currently working to refinance and/or restructure the notes with the lender(s) we can provide no guarantee or assurance that we will be able to negotiate favorable terms, if we are unable to refinance or restructure the notes under favorable terms it could result in a complete loss of any investment made into the Company and we may have to cease operations.

The conversion of preferred shares, warrants and convertible debt to common shares could potentially bring the number of common shares to a total of approximately 467,357,000 shares, which would exceed the authorized shares by approximately 267,357,000 shares. Due to existing restrictions limiting the holder of a convertible note to receive, upon conversion, shares of common stock which will not exceed 4.9% of our issued and outstanding common stock, there is no imminent requirement that the number of our authorized capital stock be increased. At an appropriate time, the Company envisions seeking shareholder approval of an increase in the Company’s authorized capitalization to some greater number of authorized shares, but the Company cannot provide any assurance that the Company will be able to obtain the necessary shareholder approval. If the Company fails to obtain shareholder approval for the increase in authorized capitalization, the Company may be in default under the terms of the preferred conversion and warrants and convertible promissory notes payable.

Cash Requirements

August 31, 2020, we had a cash balance of $17,881, total current liabilities of $2,886,610. Such cash amount of $17,881 is not sufficient to continue our 12-month plan of operation. We will need to raise capital to realize our 12-month plan of operation and fund our ongoing operational expenses. Additional funding will likely come from equity financing from the sale of our common stock. If we are successful in completing equity financing, existing shareholders will experience dilution of their interest in our Company. We do not have any financing arranged and we cannot provide investors with any assurance that we will be able to raise sufficient funding from the sale of our common stock to fund our 12-month plan of operation and ongoing operational expenses. In the absence of such financing, our business will likely fail. There are no assurances that we will be able to achieve further sales of our common stock or any other form of additional financing. If we are unable to achieve the financing necessary to continue our plan of operations, then we will not be able to continue our 12-month plan of operation and our business will fail.

Going Concern

To date the Company only generated nominal revenues and consequently has incurred recurring losses from operations.2022. We do not have sufficient funds to support our daily operations for the next twelve (12) months. The ability of the Company to continue as a going concern is dependent on raising capital to fund our business model and ultimately to attain profitable operations. Accordingly, these factors raise substantial doubt as to the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The ability of the Company to fully commence its operations is dependent upon, among other things, obtaining additional financing to continue operations and execution of its business plan. In response to these concerns, management plans to fund operations through additional debt and equity financing. Debt instruments may be convertible or non-convertible and will vary based on the Company’s needs and financing options available at such times. There can be no assurance that management’s plan will be successful. 

The Company is attempting to commence operations and generate sufficient revenue; however, the Company’s cash position may not be sufficient to support its daily operations. While the Company believes in the viability of its strategy to commence operations and generate sufficient revenue and in its ability to raise additional funds, there can be no assurances to that effect. The ability of the Company to continue as a going concern is dependent upon its ability to further implement its business model and generate sufficient revenue and its ability to raise additional funds by way of a public or private offering.

COVID-19

In December 2019, a novel strain of COVID-19 was reported in China. Subsequently, the COVID-19 spread globally including across North America and the United States. The spread of COVID-19 from China to other countries has resulted in the World Health Organization (WHO) declaring the outbreak of COVID-19 as a “pandemic,” or a worldwide spread of a new disease, on March 11, 2020. While the threat of continued or resurgent lockdowns or containment efforts have abated, we caution that our business could be materially and adversely affected by the risks, or the public perception of the risks, related to additional outbreaks of COVID-19.

Critical Accounting Policies

Please refer to Note 2 - Summary of Significant Accounting Policies in the accompanying Notes to the Consolidated Financial Statements.

Results of Operations

Overview. We had revenues of $0 and $3,080 for the years ended August 31, 2022 and 2021, respectively. We incurred a net income (loss) of ($40,690,155) and $1,039,932 for the years ended August 31, 2022 and 2021, respectively. The decrease in net income is attributable to the factors discussed below.

Revenues. We had revenues from operations of $0 and $3,080 for the years ended August 31, 2022 and 2021, respectively. Our revenues for the year ended August 31, 2021 consisted primarily of our retail line of health water infused with probiotics and minerals and the sale of one liter of T-free distillate. The extent to which, and the amount of revenues which may be generated from our future business operations and activities is unknown.

Gross Margin. Once cost of revenue and other expenses to generate revenue are considered, we had gross margins of $0 and $1,659 from our operations for the years ended August 31, 2022 and 2021, respectively.

Expenses. Our operating expenses were $40,877,813 and $260,100 for the years ended August 31, 2022 and 2021, respectively. The increase was primarily attributable to increased impairment expense of $35,780,148 of the Mioxal intangible assets, as well as increases of $4,237 in advertising, $324,658 in consulting fees, $125,518 in general and administrative expenses, $359,978 in professional fees, $201,165 in research and development, $1,259,519 in salaries, and $2,546,362 in depreciation and amortization expenses.

Other (Income) Expense. Our total other (income) expense was ($152,080) and ($1,298,373) for the years ended August 31, 2022 and 2021, respectively. The decrease in other expenses was attributable to a decrease of $99,910 in interest expense, a decrease of $41,929 in interest income, a decrease $1,454,480 in gain on change in fair value of a derivative liability, a decrease of $8,349 in other income, and an increase of $143,956 in gain on extinguishment of debt.

Liquidity and Capital Resources

For the year ended August 31, 2022, we used net cash of $3,127,852 for operating activities, primarily attributable to our aforementioned operating expenses. We used $853,138 in investing activities primarily attributable to our purchase the Mioxal asset. For the year ended August 31, 2022, we were provided $4,000,000 from financing activities for proceeds from our series B-1 preferred stock purchase agreements. We will require additional working capital to continue.

Assets

We had total assets of $43,963,413 as of August 31, 2022, which consisted of $156,486 cash, other receivable of $56,421, prepaid expenses of $74,049, equipment of $2,615 (net of accumulated depreciation), trademarks of $1,680, intangibles of $42,980,076, ROU asset of $482,086 and security deposits of $210,000 ($150,000 paid to Herring Creek Pharmaceuticals and $60,000 as part of a lease agreement).

Liabilities

We had total liabilities of $41,110,839 as of August 31, 2022 consisting of accounts payable and accrued expenses of $265,415, lease liability of $497,626, note payable of $10,000, dividends payable of $837,798, and the Mioxal liability of $39,500,000.

Cash Requirements

At August 31, 2022, we had a cash balance of $156,486. Such cash amount of $156,486 is not sufficient to continue our 12-month plan of operation. We will need to raise capital to realize our 12-month plan of operation and fund our ongoing operational expenses. Additional funding will likely come from equity financing from the sale of our common stock or from entering into notes payable. If we are successful in completing equity financing, existing shareholders will experience dilution of their interest in our Company. In the absence of such financing, our business will likely fail. There are no assurances that we will be able to achieve further sales of our common stock or any other form of additional financing.

Subsequent Events

Departure of Directors or Certain Officers; Election of Directors

On September 9, 2022, the Board of Directors of Innovation1 Biotech Inc. appointed Frederick E. Pierce, II as a member of the Board. On December 6, 2022, Mr. Pierce was appointed Chairman of the Board, President and Interim Acting Chief Executive Officer.

On December 6, 2022, Jeffrey Kraws resigned as the Company’s Chief Executive Officer. He remains a member of the Board.

On October 19, 2022, Dr. Andrew Salzman resigned from the Board. On November 10, 2022, Dr. Salzman resigned as Chief Science Officer of the Company.

On December 5, 2022, the Board appointed Charles W. Allen and Dr. Shahin Gharakhanian as members of the Board. On December 6, 2022, Mr. Allen was appointed Treasurer and Secretary, replacing Jamie Lynn Coulter as Secretary.

Completion of Acquisition or Disposition of Assets

On November 7, 2022, Innovation1 Biotech Inc completed the disposition of all of the assets, including intellectual property assets and associated debt, relating to Mioxal® to Ingenius Biotech S.L. The disposition was completed pursuant to the terms of certain Agreements Relating to the Transfer of the Mioxal Product, dated as of November 7, 2022. 

As part of the disposition, certain shareholders of the Company transferred an aggregate of 350,000 shares of the Company’s currently outstanding common stock, par value $0.001 per share, to Ingenius and Ingenius agreed to pay the Company (i) $100,000 upon the first to occur of Ingenius’ first sale or commercialization of the Mioxal product or Ingenius’ sale, license, transfer or other disposition of the Mioxal Product to a third party, and (ii) a 5% royalty on worldwide net sales of the Mioxal product by Ingenius or a third party commencing on the date of the first sale of Mioxal products and ending on the 18-month anniversary of the last to expire of any patent covering the Mioxal products. Additionally, Ingenius agreed to release the Company from all of its liabilities and obligations relating to the Mioxal products and indemnify the Company from all claims relating to the Mioxal Product following the date of the Disposition.

Amendments to Articles of Incorporation or Bylaws

On November 18, 2022, the Board of Directors of the Company (“Board”) approved and adopted a second amendment and restatement of the Company’s bylaws (the “Amended and Restated Bylaws”), effective as of such date. The amendments set forth in the Amended and Restated Bylaws include among other things, (1) revisions to the procedures for calling special meetings, allowing for special meetings to be called by the President, Chief Executive Officer, Company shareholders entitled to cast not less than a majority in interest of the number of shares entitled to be cast a meeting, and a majority of the Board, compared to the previous Bylaws of the Company (“Bylaws”) which only allowed for a special meeting to be called by the Board, (2) revisions to the provision for the election of directors by stockholders, which now provides that the directors shall be elected by a plurality of the votes cast, compared to the previous Bylaws which provided that the directors were to be elected by affirmative vote of a majority of the directors, (3) revisions to the provision calling for the frequency of board meetings, now providing that Board meetings are to be held no less than quarterly, compared to the previous Bylaws which provided that the meetings of the Board were to be held at such time and place as the Board shall fix.

The amendments set forth in the Amended and Restated Bylaws also include additional provisions, which were not contemplated in the previous Bylaws, these amendments include among other things, (1) the inclusion of an additional provision which provides that shareholder behavior which demonstrates a lack of due care for regulatory agencies, may cause the ownership and title of shares to be clouded, and shall prevent such shareholder from voting such shares at a meeting, until a court or administrative agency approves in writing the shareholders authority to vote, (2) the inclusion of an additional provision which provides that the Board members shall hold office for a period of 2 years or until their successors are duly elected and qualified or until their removal or resignation, (3) the inclusion of an additional provision which provides that officers of the Company may be removed by the Board by a vote of a majority of the entire number of directors then in office, (4) the inclusion of an additional provision which provides that each member of the Board acknowledges that they have fiduciary duties on behalf of the Company and may receive confidential information regarding the Company, and the executive officers or Board may limit or restrict the confidential information provided to the Board in order to protect sensitive or competitive information, (5) the inclusion of an additional section (Section 6) which provides for the indemnification of officers and directors in the event of a proceeding and allows for advancements to be made to such directors and officers, and (6) certain other language and conforming changes and other technical edits and updates.

These actions were taken pursuant to NRS 78.120 and in accordance with Article IX of the Company’s prior bylaws.

Entry into a Material Definitive Agreement

Subsequent to the year ended August 31, 2022, the Company has entered into a private placement to receive net cash proceeds up to $300,000, after the original issue discount, from secured convertible promissory notes with attached $0.08 warrants to purchase up to 4,411,764 shares of common stock. Each note is discounted 15% with a maturity date of 18 months from original issuance. The notes bear interest of 8% per annum to be paid monthly. Each note is convertible into common shares by dividing the outstanding principal on the note by the conversion price of $0.08. The warrants are exercisable for a period of seven years at an exercise price of $0.08 per share.

OFF-BALANCE SHEET ARRANGEMENTS

Not Applicable.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 

Not Applicable 

ITEM 8. FINANCIAL STATEMENTS 

GRIDIRON BIONUTRIENTS,INNOVATION1 BIOTECH INC.

Financial Statements

August 31, 20202022

Table of Contents

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and StockholdersShareholders of Gridiron BioNutrients,Innovation1 Biotech, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Gridiron BioNutrients,Innovation1 Biotech, Inc. (“the Company”) as of August 31, 20202022 and 2019,2021, and the related consolidated statements of operations, statements of stockholders’ equity (deficit), and statements of cash flows for each of the years in the two-year period ended August 31, 2020,2022, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of August 31, 20202022 and 2019,2021 and the results of its operations and its cash flows for each of the years in the two-year period ended August 31, 2020,2022, in conformity with accounting principles generally accepted in the United States of America.

Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 31 to the financial statements, the Company has a net operating loss, working capital deficit, and an accumulated deficit and net losses from operations.as of yearend. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 3.1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the auditsaudit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.

Impairment of Intangible Assets — Refer to Note 3 to the financial statements

Critical Audit Matter Description

The Company acquired and held significant intangible assets for which potential impairment of the assets was required to be considered by the Company. Given the lack of activity surrounding these intangible assets, the material nature of the related accounts, and the degree of judgment and subjectivity in evaluating management’s estimates and assumptions included in its impairment analysis, we assessed valuation and allocation of the impairment of intangible assets as a critical audit matter.

How the Critical Audit Matter Was Addressed in the Audit

Our audit procedures related to evaluating the Company’s impairment of intangible assets included the following, among others:

Fruci & Associates II, PLLC