UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF(Mark one)

THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended August 31, 20192022

or

For the transition period from _______________ to ________________________ 

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

40 Wall Street, Suite 2701 Northgate Lane., Ste. 1G

Carson City, Nevada 89706New 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,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 x☒

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 x☒

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 x ☒     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 x ☒     No o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ¨☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company” and “smaller reporting“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 x☒

At February 28, 2019,2022, the last business day of the Registrant’sregistrant’s most recently completed second fiscal quarter, the aggregate market value of the voting common stock held by non-affiliates of the Registrantregistrant (without admitting that any person whose shares are not included in such calculation is an affiliate) was $1,228,814. $6,243,650.

At December 12, 2019,14, 2022, there were 135,509,22020,020,239 shares of the Registrant’sregistrant’s common stock, par value $0.001 per share, and 8,480,000 shares of Series A Preferred 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

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FORWARD-LOOKINGCAUTIONARY NOTE REGARDING FORWARDING LOOKING STATEMENTS

This Annual Report on Form 10-K of GridIron BioNutrients, Inc., a Nevada corporation,report contains “forward-looking statements,” as defined in the United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “could”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”that relate to future events or “continue” or the negative of such termsour future financial performance and involve known and unknown risks, uncertainties and other comparable terminology. These forward-looking statements include, without limitation, statements aboutfactors that may cause our market opportunity, our strategies, competition, expected activities and expenditures as we pursue our business plan, and the adequacyactual results, levels of our available cash resources. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guaranteeactivity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements. Actualachievements 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 this 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 the predictions discussedthose contained in theseany forward-looking statements. The economic environment within whichExcept for our ongoing obligations to disclose material information under the Federal securities laws, we operate could materially affect our actual results.

Our management has included projections and estimates in this Form 10-K, which are based primarily on management’s experience in the industry, assessments of our results of operations, discussions and negotiations with third parties and a review of information filed by our competitors with the SEC or otherwiseundertake no obligation to release publicly available. We caution readers notany revisions to place undue reliance on any such forward-looking statements, whichto report events or to report the occurrence of unanticipated events. These forward-looking statements speak only as of the date made. We disclaim any obligation subsequently to revise any forward-lookingof this report, and you should not rely on these statements to reflect events or circumstances afterwithout also considering the date of suchrisks and uncertainties associated with these statements or to reflect the occurrence of anticipated or unanticipated events.and our business.

All references in this Form 10-K to the “Company”, “GridIron BioNutrients”“Innovation1 Biotech Inc.,” “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, 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

PART I

Our Corporate History and BackgroundITEM 1.BUSINESS

GridIron BioNutients,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 take 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 “Company”“Acquisition”) was incorporated on July 31, 2014of 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 Stateterms of Nevada. From our formation on July 31, 2014 until October 9, 2017, we were engagedthe Amended and Restated Asset Purchase Agreement dated November 5, 2021 (the “Asset Purchase Agreement”) described in the business of cloud storage services. Sommay Vongsa served as President, Secretary, Treasurer and sole director from July 31, 2014, until his resignationCompany’s Current Report on October 9, 2017. Concurrent with his resignation, Mr. Vongsa appointed Darren Long, as the Company’s new Chief Executive Officer, Secretary, Chairman of the board of directors, and Secretary; Timothy Orr, as the Company’s new President and a director; and Brian Martinho, as the Company’s new Treasurer and a director. Effective February 26, 2018, Darren Long resigned as a member and Chairman of the Board of Directors, and as Chief Executive Officer, of the Company. Effective February 26, 2018, Brian Martinho resigned as a member of the Board of Directors, and as Treasurer, of the Company. Effective, February 27, 2018, Timothy Orr, as the sole member of the Board of Directors, appointed himself as Secretary and Treasurer of the Company. Mr. Orr is also presently the Company’s President.

Effective November 28, 2017, the board of directors and the stockholders of the majority of voting power of the Company approved an amendment to the Company’s Articles of Incorporation to change the name of the Company from “My Cloudz, Inc.” to “GridIron BioNutrients, Inc.” A Certificate of Amendment to the Articles of Incorporation effecting the change of name of the Company wasForm 8-K, filed with the SecretarySecurities 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 StateCommon Stock to STB, which at the closing of the State of Nevada effective November 27, 2017. The Financial Industry Regulatory Authority, Inc. recognized the name change effective December 18, 2017. Under Rule 14c-2, promulgated pursuant to the Securities Exchange Act of 1934, as amended, the name change became effective February 21, 2018.

From inception until we completed our reverse acquisition of GridIron BioNutrients, our principal business was cloud storage services.

Reverse Acquisition of GridIron BioNutrients

On October 9, 2017, the Company entered into a Share Exchange Agreement (the “Share Exchange Agreement”), by and among the Company, GridIron BioNutrients, Inc., then a privately-held Nevada corporation since renamed GridIron Ventures, Inc. (“GridIron Ventures”), and the holders of common stock of GridIron Ventures. The holdersrepresented approximately 70% of the common stock of GridIron Ventures consisted of 3 stockholders.

Under the terms and conditions of the Share Exchange Agreement, the Company offered, sold and issued 70,000,000 shares of common stock in consideration for all the issued and outstanding shares in GridIron Ventures. The effect of the issuance was that GridIron Ventures shareholders held approximately 57.0% of the issued andCompany’s outstanding shares of common stockCommon Stock on a fully-diluted basis. The closing of the Company, giving effectAcquisition contemplated by the Share Exchange Agreement.

Darren Long, the founderAsset Purchase Agreement on November 5, 2021, resulted in a change of GridIron Ventures, became the Company’s new Chief Executive Officer, Chairman of the board of directors, and Secretary, was then the holder of 35,000,000 shares of common stock of the Company. Timothy Orr, became the Company’s new President, a director of the Company, and the holder of 17,500,000 shares of common stock of the Company. Brian Martinho, became the Company’s new Treasurer, a director, and the holder of 17,500,000 shares of common stock of the Company. The Company’s new officers and sole director, therefore, control an aggregate of 70,000,000, or 57.0%, of the outstanding common stock of the Company, on a fully diluted basis, giving effect to the Share Exchange Agreement.

As a result of the Share Exchange Agreement, GridIron Ventures became a wholly-owned subsidiary of the Company.

The share exchange transaction with GridIron VenturesCommon Stock issued to STB was treated as a reverse acquisition, with GridIron Ventures as the acquiror andvalued at approximately $40,495,000 or $2.05 per share.

On November 7, 2022, the Company ascompleted the acquired party. Unless the context suggests otherwise, when we refer in this Form 10-K to business and financial information for periods prior to the consummationdisposition of all of the reverse acquisition,intellectual property assets and associated liabilities relating to Mioxal^®. See Subsequent Events.

Our Pipeline

At Innovation1 Biotech, we are referring todelivering innovative change in the businesspsychedelic and financial informationcannabinoid space through the development of GridIron Ventures.a portfolio that addresses five independent clinical indications with fully synthetic prodrugs, wherein the current therapeutic armamentarium is inadequate or non-existent.

Organization & Subsidiaries

	•	The first agent is a novel prodrug of psilocin, a molecule naturally found in certain mushroom species that has been shown to interact with hydroxytryptamine receptors in the limbic system of the central nervous system. Preclinical and human data support its use as a long-effecting agent for reduction of clinical depression. Our prodrug allows for a smooth pharmacokinetic profile, and avoids peak toxicologic side-effects, by blunting the maximal peak concentration.
	•	The second agent is a novel prodrug of synthetic tetrahydrocannobivarin, a molecule naturally found in Cannabis that modulates the two principal cannabinoid receptors: CBR1 and CBR2. Preclinical data support its use in the treatment of drug addiction. Our prodrug, which is manufactured chemically without any connection to the Cannabis plant, allows for improved bioavailability and hence more stable and reliable concentrations of the drug in the central nervous system.
	•	The third agent is a novel prodrug of synthetic cannabidophorol, a molecule naturally found in Cannabis, closely related to cannabidiol (CBD), that desensitizes several membrane-bound receptors in the brain (TRPV1, TRPA1, GPR55) that impact neuronal excitability and seizures. The FDA has already approved Epidiolex (CBD) for treatment of a childhood seizure disorder (Dravet syndrome). Our prodrug, which is manufactured chemically without any connection to the Cannabis plant, is expected to have improved bioavailability in comparison to CBD and its payload, cannabidophorol, is anticipated to be more potent than CBD in suppressing seizures due to its greater affinity for its biological targets.

We have one operating subsidiary, GridIron Ventures, Inc., a Nevada corporation.

Overview of GridIron BioNutrients

Our wholly owned subsidiary, GridIron Ventures was incorporated on July 20, 2017, in Nevada.

The business of GridIron BioNutrients is now the principal business of the Company. GridIron BioNutrients is in the business of marketing and selling cannabidiol products line of capsules, oil, ointments, concentrates and water.

GridIron BioNutrients principal administrative offices are located at 2701 Northgate Lane, Suite 1G, Carson City, Nevada 89706. Our website is www.gridirionbionutrients.com.

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Summary Financial Information

The tablesResearch and information below are derived from our audited financial statements as of August 31, 2019.

GridIron BioNutrients is in the business of marketing and selling cannabidiol products line of capsules, oil, ointments, concentrates and water. GridIron BioNutrients is the owner and has right to intellectual property, including trademark, trade names, images, likenesses and other associated intellectual property, such as the name “Gridion BioNutrients”.Clinical Development Strategy

We intend to:

Principal Products

Gridiron BioNutrients principal productsare currently include:

Gridiron MVP™ Water Beverage (16.9oz)

Gridiron MVP™ Concentrate (2oz / 4oz)

These products containin the pre-clinical development stage for our five pharmaceutical candidates. Our goal is to become a proprietary blendleader in the development of humic and fulvic acid, trace minerals, probiotics, electrolytes, cannabidiol (CBD) within an alkalinemodified Schedule 1 molecules of pH10.

Gridiron has securedbotanical origin where there is the rightsopportunity to this proprietary formulation through its CEO, Timothy Orr. (VERBAL AGREEMENT). Timothy Orr provided the formulationeffect breakthrough advances in connection with his receiptdiseases of 32,500,000 shares of common stock from the Company on October 9, 2017.

Gridiron has the exclusive right(s) to develop CBD products with this formulation. However, Gridiron is limited to developing only CBD products with this formulation and as such does not have any rights to develop products that do not contain CBD with this formulation.unmet medical need.

In additionorder 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 Gridiron MVP™ beverage and concentrate Gridiron currently has the following products available to market:business.

Gridiron Salve

Gridiron Premium Hemp Oil Drops (1oz /2oz)

Gridiron Premium Hemp Oil Capsules

	·	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). At the initial closing, the Company issued 673,628 shares of Series B-1 Preferred to LPC and received $500,000 in gross proceeds. 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. The aggregate gross proceeds of $2,000,000 will be used by the Company as working capital
	·	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. Pursuant to the terms of the respective purchase agreements with LPC and L1 Capital, each of LPC and L1 Capital agreed, for a period of 180 days following the final closing of such transaction, not to offer, sell, contract to sell, pledge, hypothecate, grant any option, right or warrant for the sale of, purchase any option or contract to sell, sell any option or contract to purchase, or otherwise encumber, dispose of or transfer, or grant any rights with respect to, directly or indirectly, any shares of Series B-1 Preferred or any shares of the Company’s common stock issuable upon conversion of the Series B-1 Preferred. In addition, each of LPC and L1 Capital, along with the holders of the Company’s Series B Preferred Stock has been granted the right (until the earlier of (i) the sixteen (16) month anniversary of the Closing Date or (ii) the listing of the Common Stock on a national securities exchange) to participate in up to 10% of the Company’s future equity or equity-linked financings. Furthermore, the Company granted these stockholders certain piggyback registration rights with respect to the Common Stock issuable upon conversion of the Series B-1 Preferred and Series B Preferred issued to such stockholder.

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The above reflects 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.

Distribution of ProductsProduct Marketing

Gridiron’s products areWe currently availablehave no marketing agreement(s) with third party marketing groups.

Product Development

Innovation1 Biotech has engaged with Salzman Group, a US-Israeli pharmaceutical firm that according to Salzman Group has designed and developed of novel small molecules for sale on its website http://gridironbionutrients.com. The Company intendsa number of clinical applications. According to retainSalzman Group, it has invented novel, proprietary, water-soluble, and fully 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 consultant(s) to provide avenues to distribution its products withinpsychedelic molecule for treatment of 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 after burn wound injury, and ocular inflammation of the next twelve months. However, in order to retain any consultant(s)cornea and anterior uvea.

See Subsequent Events below concerning the Company will require fundingresignation of Dr. Salzman and currently thehis related groups, Salzman Group and Herring Creek Pharmaceuticals.

Competition

Direct Competitors:

The Company does not have the required funding to accomplish this task. If the Company is unable to secure financing; it would likely result incurrently face direct competition for its portfolio technologies, but has a material lossnumber of any investment made into the Company.indirect competitors as listed below.

Competition within the cannabidiol (CBD)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, within the marketacademic institutions and numerous start-up companies entering the market. Gridiron intends to brandgovernmental agencies and market high quality CBD products through both exclusivepublic and non-exclusive strategic alliances that will serve to make the Company a market leader.

In addition to the products described herein the Company intends to add an additional CBD water beverage to itsprivate research institutions. Any product line within the next 4-5 months. The Company can provide no assurance or guarantee that it will be able to develop and/or maintain any strategic alliances now or in the future or that its anticipatedcandidates for which we complete clinical development successfully and for which we receive marketing approval may compete with existing therapies and new CBD beverage will be accepted by the market if and when developed. If the Company cannot develop and maintain strategic alliances or be successful with the offer of its CBD products and proposed CBD products it would be a significant material negative impact on the business that could result in a significant loss to any investment made into the Company.

Sources of Raw Materials

Gridiron MVP™ product(s) contain proprietary blend of nutrients that are sourced from various third parties and formulated into the water beverage and concentrate. If for any reason any of these sources are disrupted and the Company is unable to obtain the raw materials necessary to formulate the Gridiron MVP™ product(s) it would materially impact the businesstherapies that may result in significant losses. Moreover, the Company will be dependent upon third party bottling facilities for its Gridiron MVP™ product; currently the Company has no arrangements or otherwise with any bottling facility and cannot provide any assurance that a suitable bottling facility can be retained or maintainedbecome available in the future.

Many of our competitors have far greater marketing and research capabilities than us. We also face potential competition from academic institutions, government agencies and private and public research institutions, among others, which may in the future develop products to treat those diseases that we currently or, in the future, seek to treat. The Company currently has a Distribution placecurrent market for the Gridiron Salve, Gridiron Premium Hemp Oil Drops (1oz /2oz)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 Gridiron Premium Hemp Oil Capsules. If therecommercialize products that are safer, more effective, more convenient, have fewer side effects or are less expensive than our product candidates.

Indirect Competitors:

Posttraumatic stress disorder is a disruptiontreated with the manufacturer of these productsselective serotonin reuptake inhibitor antidepressant medications sertraline and paroxetine, both approved by the FDA for any reasonPTSD 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 the Company, it could result in significant delays and/or the inability to deliver the products to customers which would negatively impact the Company’s business.PTSD, a more recent study showed no benefit over placebo.

Strategic PartnersAddiction symptoms and signs of drug withdrawal and detox are currently managed with (1) anxiolytic agents that reduce anxiety and irritability, such as benzodiazepines, (2) antidepressants such as sertraline and fluoxetine, and (3) clonidine to reduce sweating, cramps, muscle aches, anxiety, tremors, and seizures. Alcohol addiction is treated with (1) naltrexone to block receptors in the brain that produce alcohol’s pleasurable effects, (2) acamprosate to relieve emotional and physical distress and depression, and (3) disulfiram to induce nausea and vomiting when alcohol is ingested. Heroin and opiate addiction are currently treated with methadone, buprenorphine, and naltrexone.

Childhood epilepsy, manifesting as partial or tonic-clonic seizures, is currently treated with carbamazepine, phenytoin, and valproic acid, as well as ACTH, clobazam, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, tiagabine hydrochloride, topiramate, vigabatrin, and zonisamide. The medications Diastat rectal gel, Epidiolex (made from cannabidiol), and fenfluramine have been approved for treatment of refractory childhood epilepsy (Dravet’s syndrome).

Uveitis is treated with (1) corticosteroids, (2) immunosuppressants such as azathioprine, cyclosporin, methotrexate, and mycophenolate, and (3) targeted immunomodulating biologic agents, including Abatacept, Adalimumab, Daclizumab, Infliximab, and Rituximab.

Wound care is currently treated with topical antibiotics and disinfectants, and supportive surgical debridement and skin grafting.

Intellectual Property

The Company intendsfiled provisional patent applications protecting composition of matter and method of use of all the technologies described below. All of these applications are assigned to develop both exclusive and non-exclusive strategic alliances that promote the Company’s products.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.

Intellectual Property

* 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.

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

87594229 - GRIDIRON BIONUTRIENTS in international class 005 (supplements)

87594267 - GRIDIRON MVP in international class 005 (supplements)

87594303 - GRIDIRON BIONUTRIENTS in international class 032 (beverages)

87594316 - GRIDIRON MVP in international class 032 (beverages)

	·	INNOVATION1 BIOTECH – U.S. Trademark SN 97195093
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Timothy Orr, the Chief Executive Officer and Chairman of the Board of Directors of the Company, is providing the Gridiron MVP™ formulation(s) to the Company at no charge to the Company. Gridiron has the exclusive right(s) to develop CBD products with this formulation. However, Gridiron is limited to developing only CBD products with this formulation and as such does not have any rights to develop products that do not contain CBD with this formulation.

The Company does not believe that there is any legal limitation on its ability to enforce the protection of its intellectual property due to federal and state laws prohibiting the production and sale of CBD.

Government Regulation and Approvals

We are not aware of any governmental regulations or approvals needed for any ofreliant on our domain name, www.innovation1bio.com, to market our products. WeHowever, as with phone numbers, we do not believe that we are subject tohave and cannot acquire any government regulations relating to the ownership and licensingproperty rights in an Internet address. The regulation of our intellectual property.

Cannabis Regulation

Although a number of states ofdomain names in the United States have legalized medical marijuana, recreational marijuana,and in other countries is subject to change. Regulatory bodies could establish additional top-level domains, appoint additional domain name registrars or both, it remains illegal undermodify 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

Initially, we intend to obtain approvals for our pharmaceutical candidates from the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA) in Australia, and other countries’ governmental regulatory agencies approvals for our product candidates.

Regulation of Psilocin and Ibogaine analog

In the United States, federal law. Cannabis currently remainspsychedelics, such as psilocin and ibogaine, are listed by the DEA as a Schedule I drugsubstance under the Controlled Substances ActCSA. The Company is developing a prodrug of 1970. Under United States federal law,psilocin and an analog of ibogaine, entitled 18-methylaminocoronaridine, which might be considered as a Schedule I drugsubstance under the Federal Analog Act. The DEA regulates chemical compounds as Schedule I, II, III, IV or substance hasV 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 abuse 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 the United States classify psilocin as a Schedule I controlled substance. For any product containing a prodrug of psilocin or an analog of ibogaine to be available for commercial marketing in the United States, these prodrugs and analogs must be rescheduled, or the product 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.

Human Capital

Timothy S. Orr was the sole officer, director and 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.

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 and Operations

We have a history of 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 $40,877,813 and $258,441, respectively, for the years ended August 31, 2022 and 2021. At August 31, 2022 we had an accumulated deficit of $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.

We have experienced recurring operating losses over the last two years and have a significant accumulated deficit. We expect to continue to generate operating losses and consume significant cash resources for the foreseeable future. Without additional financing, these conditions raise substantial doubt about our ability to continue as a going concern, meaning that we may be unable to continue operations for the foreseeable future or realize assets and discharge liabilities in the ordinary course of operations. If we seek additional financing to fund our business activities in the future and there remains doubt about our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all. If we are unable to obtain sufficient funding, our business, prospects, financial condition and results of operations will be materially and adversely affected, and we may be unable to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements, and it is likely that investors will lose all or a part of their investment.

We have a working capital deficit at August 31, 2022 and 2021. We need to raise additional capital to continue our business model.

At August 31, 2022, we had a cash balance of $156,486 and a working capital deficit of $29,525,460 compare to a cash balance of $137,476 and a working capital deficit of $238,249 at August 31, 2021. We used $3,127,852 in net cash in our operations in the year ended August 31, 2022 as compared to $30,405 in net cash used in our operations in the year ended August 31, 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 intend to raise additional capital in the next 12 months in order to continue to implement our business model. We do not have any firm commitments to raise additional working capital. As we are a small company whose 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, 2022 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, 2022 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.

If we fail to 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 required to further implement expensive 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.

Failure to comply with federal, state and foreign laws and regulations relating to 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 extent possible, our practices may not have complied or may not 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 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 do 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 the numerous and varying regulatory requirements of 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 obtain approval in any other jurisdictions. If we are unable to obtain approval for our product candidates in multiple jurisdictions, our revenue and results of operations would be negatively affected.

The Company previously sold products infused with CBD, and the negative publicity from previously being involved in the hemp and CBD space could have a material adverse effect on our business, financial condition, and results of operations.

The Company was previously involved in the sale of a health water infused with CBD. However, the Company has since ceased the sale of this product and has 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 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 but 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 clinical study process. The results of pre-clinical studies and early clinical studies, if any are commenced, of our product candidates may not be predictive of the results 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 high failure rate for drugs proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show 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 adverse 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 the sale of our product candidates, we must conduct extensive clinical studies to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time consuming and uncertain as to outcome. We cannot guarantee that any clinical studies will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical studies can occur at any stage of testing, and our future clinical studies may not be successful. Events that may prevent successful or timely completion of clinical development include but are not limited to:

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue. We may also be required to conduct additional safety, efficacy and comparability studies before we will be allowed to start clinical studies with our repurposed 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 impair our ability to obtain orphan exclusivity and successfully commercialize our product candidates and may harm our business and results of operations.

Any therapeutic candidates we may develop in the future may be subject to controlled substance laws and regulations in the territories where the product will be marketed, and failure to comply with these laws and regulations, or 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 abuse 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 the 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 the product 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 in 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 lackschedule 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 whether, or to what extent, the substance has abuse potential. This may introduce a delay into the approval and any potential rescheduling process. That delay would be dependent on the quantity of accepted safetyadditional data required by the FDA. This scheduling determination will require DEA to conduct notice and comment rule making including issuing an interim final rule. Such action will be subject to public comment and requests for hearing which could affect the usescheduling of these substances. There can be no assurance that the drugDEA will make a favorable scheduling decision. Even assuming categorization as a Schedule II or lower controlled substance (i.e., Schedule III, IV or V), at the federal level, such substances would also require scheduling determinations under medical supervision. state laws and regulations.

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

As such, cannabis related practicesour 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, including without limitation,or the manufacture, importation, possession, use,activities of our employees, contractors or distribution of cannabis, remain illegal under United States federal law.

Although federally illegal, the U.S. federal government’s approach to enforcement of such laws has of least until recently trended toward non-enforcement. On August 29, 2013, the U.S. Department of Justice (“DOJ”) issued a memorandum known as the “Cole Memorandum” to all U.S. Attorneys’ offices (federal prosecutors). The Cole Memorandum generally directed U.S. Attorneysagents, are not to prioritize the enforcement of federal cannabis laws against individuals and businesses that rigorously comply with state regulatory provisions in states with strictly regulated medical or recreational cannabis programs. While not legally binding, and merely prosecutorial guidance, the Cole Memorandum laid a framework for managing the tension between state and federal laws concerning state regulated cannabis businesses.

However, on January 4, 2018 the Cole Memorandum was revoked by Attorney General Jeff Sessions, a long-time opponent of state-regulated medical and recreational cannabis. While this did not create a change in federal law, as the Cole Memorandum was not itself law, the revocation removed the DOJ’s guidance to U.S. Attorneys that state regulated cannabis industries substantively 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 Cole Memorandum’s guidelines shouldimposition 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 Inflation 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 planned 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 currently limited. In these marketplaces, our stockholders may find it difficult to obtain 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 a prosecutorial priority. In additionsufficiently widely held; we may not be able to his revocationsecure 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 Cole Memorandum, Attorney General Sessions also issuednational exchanges, or our common stock is otherwise rejected for listing, and remains listed on the OTC Markets or is suspended from the OTC Markets, the trading price of our common stock could suffer and the trading 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 public price of our common stock and/or result in significant volatility, which could affect your ability to sell your common stock. Even if an active trading market develops for our common stock, the market price of our common 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 one-page memorandum knownsignificant impact on the future market price of our common stock.

Because our common stock is a penny stock, stockholders may be further limited in their ability to sell their shares.

The SEC has adopted Rule 3a51-1, which establishes the definition of a “penny stock” as any equity security that has 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 “Sessions Memorandum”. The Sessions Memorandum confirmedSecurities Exchange Act of 1934, as amended (the “Exchange Act”) and are expected to remain classified as a penny stock for the rescissionforeseeable future. Classification as a penny stock makes it more difficult for a broker-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 Cole Memorandum and explained the rationale of the DOJ in doing so: the Cole Memorandum, accordingExchange 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 Sessions Memorandum, was “unnecessary” due to existing general enforcement guidance adopted inrules of a national securities exchange requiring the 1980s, as set forth in the U.S. Attorney’s Manual (the “USAM”). The USAM enforcement priorities, like thoseadoption of the Cole Memorandum, are also based on the federal government’s limited resources,certain corporate governance measures and, include “law enforcement priorities set by the Attorney General,” the “seriousness” of the alleged crimes, the “deterrent effect of criminal prosecution,” and “the cumulative impact of particular crimes on the community.”

While the Sessions Memorandum emphasizes that cannabis is a Schedule I controlled substance, and reiterates the statutory view that cannabis is a “dangerous drug and that marijuana activity is a serious crime,” it does not otherwise indicate that the prosecution of cannabis-related offenses is now a DOJ priority. Furthermore, the Sessions Memorandum explicitly describes itself as a guide to prosecutorial discretion. Such discretion is firmly in the hands of U.S. Attorneys in deciding whether or not to prosecute cannabis-related offenses. Our outside U.S. counsel continuously monitors all U.S. Attorney comments related to regulated medical and adult-use cannabis laws to assess various risks and enforcement priorities within each jurisdiction. Dozens of U.S. Attorneys across the country have affirmed that their view of federal enforcement priorities has not changed, although a few have displayed greater ambivalence.

On January 15, 2019, U.S. Attorney General nominee William P. Barr intimated a markedly different approach to cannabis regulation than his predecessor during his confirmation hearing before the Senate Judiciary Committee. Mr. Barr stated that his approach to cannabis regulation would be not to upset settled expectations that have arisen 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 of the Cole Memorandum, that it would be inappropriateOTCQB 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 upset the current situation as there has been reliance on the Cole Memorandumdirector independence, stockholder approval rights and that he wouldgovernance measures designed to provide board oversight of management.

Because we are a “smaller reporting company,” we will not be targetingrequired to comply with certain disclosure requirements that are applicable to other public companies that have relied onand we cannot be certain if the Cole Memorandum and are complying with state laws with respectreduced disclosure requirements applicable to the distribution and production of cannabis. While he did not offer support for cannabis legalization, Mr. Barr did emphasize the need for the U.S. Congresssmaller reporting companies will make our common stock less attractive to clarify federal laws to address the untenable current situation which has resulted in a backdoor nullification of federal law.investors.

Additionally, under U.S. federal law it may, under certain circumstances, be a violation of federal money laundering statutes for financial institutions to accept any proceeds from cannabis sales or any other Schedule I controlled substances. Banks and other financial institutions could be prosecuted and possibly convicted of money laundering for providing services to U.S. cannabis businesses. Under U.S. federal law, banks or other financial institutions that provide a cannabis business with a checking account, debit or credit card, small business loan or any other service could be found guilty of money laundering or conspiracy. Despite these laws, in February 2014, the Financial Crimes Enforcement Network (“FCEN”) of the Treasury Department issued a memorandum (the “FCEN Memorandum”) providing instructions to banks seeking to provide services to cannabis-related businesses. The FCEN Memorandum states that in some circumstances, it is permissible for banks to provide services to cannabis-related businesses without risking prosecution for violation of federal money laundering laws. It refers to supplementary guidance that Deputy Attorney General Cole issued to federal prosecutors relating to the prosecution of money laundering offenses predicated on cannabis-related violations of the CSA. It is unclear at this time whether the current administration will follow the guidelines of the FCEN Memorandum.

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Table of Contents

Although we do not produces, handle or sell cannabis, and the possession, cultivation and distribution of marijuana for medical use is permitted in Nevada, and medical and recreational use is permitted in the State of Washington, where our administrative offices are located, provided compliance with applicable state and local laws, rules, and regulations, marijuana is illegal under federal law. We believe we operate our business in compliance with applicable Nevada and Washington law and regulations. Any changes in federal, state or local law enforcement regarding marijuana may affect our ability to operate our business. Strict enforcement of federal law regarding marijuana would likely result in the inability to proceed with our business plans, could expose us to potential criminal liability and could subject our properties to civil forfeiture. Any changes in banking, insurance or other business services may also affect our ability to operate our business.

Employees

As of the date hereof, we have 2 employees who operate our company. Timothy Orr, our sole officer and director, works full-time on Company operations.

DESCRIPTION OF PROPERTIES

Our executive offices are located at 2701 Northgate Lane, Suite 1G, Carson City, Nevada 89706. Tim Orr holds the lease, which is month-to-month, under his personal name.

We do not own any real estate or other physical properties.

Asare a “smaller reporting company,” as defined in Rule 12b-2Item 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 our 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 our 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 us to obtain director and officer liability insurance.

We will continue to incur 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 internal audit group may result in material misstatements to our financial statements and ability to provide accurate financial information to our shareholders.

Our management and 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 may eventually need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge to have effective internal controls for financial reporting.

Moreover, if we are not requiredable to providecomply with the information called forrequirements or regulations as a public reporting company in any regard, we could be subject to sanctions or investigations by this Item.the SEC or other regulatory authorities, which would require additional financial and management resources.

None.Not applicable.

Our current business address is 40 Wall Street Suite 2701, Northgate Lane, Suite 1G, Carson City,New York, NY 10005. We rent these facilities on a month-to-month basis for a monthly rental of approximately $20,000. 

ITEM 3.LEGAL PROCEEDINGS

The 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 pending legal proceedings to which the Company is a party or of which any of their property is the subject, nor are there any such proceedings known to be contemplated by governmental authorities.

On September 30, 2022, a party identified as New You Inc. filed a complaint with the District Court of Clark County, Nevada 89706. We believeagainst Innovation 1 Biotech, Inc, ST Biosciences LTD, Jeffrey Kraws and Jason Frankovich. The complaint alleges that these spaces are adequateduring 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 our current needs. Our telephone number is (800) 570-0438.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. 

We are not currently involved in any legal proceedings and we are not aware of any pending or potential legal actions.

None.

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PART II

PART II

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

Since September 7, 2018, our shares ofMarket Information 

Our common stock have beenis quoted on the OTCQB tierTier of the OTC Markets Group, Inc. (the “OTC Markets Group”) under the stock symbol “GMVP.“IVBT.” From December 18, 2017 until September 6, 2018, our shares of common stock were quoted on the OTCPink tier of the OTC Markets Group. From February 6, 2017, until December 17, 2018, our shares of common stock were quoted on the OTCPink tier of the OTC Markets under the stock symbol “MYYZ”. The following table shows the reported high and low closing bid prices per share for our common stock based on information provided by the OTC Markets Group. The over-the-counter market quotations set forth for our common stock reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not necessarily represent actual transactions.

HOLDERS

As of December 8, 2019, the Company had approximately 135,509,220 shares of common stock issued and outstanding held by approximately 85 holders of record.

During the year endedOn August 31, 2018,2022, the Company also has issued and outstanding 8,480,000 shares of Series A Preferred Stock, held collectively by two holders of record. Each share of Series A Preferred Stock has a dividend of 5% per annum, has a liquidation preference senior to all other capital stock of the Company, and is convertible at any time, at the election of the holder of the Series A Preferred Stock, into one share of common stock at a conversionlast reported sale price of $0.125 per share, which conversion price is subject to adjustment for a term of two (2) years for stock splits, stock dividends, combinations, or similar events, and has full ratchet anti-dilution protection. Additionally, each holder of Series A Preferred Stock and has voting rights equal to that number of shares of common stock into which such holder’s shares of Series A Preferred Stock would be convertible on the record date for the vote or consent of stockholders, and shall otherwise have voting rights and powers equal to the voting rights and powers of the common stock. The Company has a right to purchase any outstanding shares of Series A Preferred Stock, with 20 days’ notice, at (i) a 115% premium before 180 days after the closing, and (ii) a 125% premium following the 181st day after closing. The holders of shares of Series A Preferred Stock have a right to participate in 50% of all financings of the Company, except for certain exempt offers and sales, for a period of two (2) years following the closing or if there are no shares of Series A Preferred Stock outstanding.

The Company also has issued and outstanding two warrants to purchase 8,480,000 shares of common stock, held collectively by two holders of record. Each warrant is convertible into one share of common stock at a conversion price of $0.165 per share, for a term of three years, and contains a cashless exercise feature, if such warrant not registered in a registration statement. The conversion price of $0.165 is subject to adjustment for (i) stock splits, stock dividends, combinations, or similar events and (ii) full ratchet anti-dilution protection. The Company may call the warrants if shares of the Company’s common stock trades at a volume weighted average price of not less than $0.30 for ten (10) consecutive trading days and are covered by an effective registration statement, where the average daily volume of the common stock for the previous ten trading days has been greater than $75,000.

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DIVIDENDS

Historically, we have not paid any dividends to the holders of our common stock on the OTCQB was $0.154 per share. As of August 31, 2022, there were 131 holders of record of our common stock. 

Reverse Stock Split

On December 22, 2020, the Company filed Articles of Amendment to its Articles of Incorporation, as amended, which were effective on January 8, 2021 (the “Effective Date”), which effected a three hundred eight for one (308:1) reverse stock split of its outstanding common 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 we doour financial condition, as well as other relevant factors. We have not expect to paydeclared any suchcash dividends since our inception and have no present intention of paying any cash dividends on our common stock in the foreseeable future as we expect to retain our future earnings for use in the operation and expansion of our business. The Company's shares of Series A Preferred Stock has a dividend which has been accrued as a dividend payable in the amount of $23,695.future.

TRANSFER AGENTTransfer 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 SECURITIESRecent Sales of Unregistered Securities

None.

SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS

We have not established any compensation plans under which equity securities are authorized for issuance.

PURCHASES OF EQUITY SECURITIES BY THE REGISTRANT AND AFFILIATED PURCHASERSPurchases of Equity Securities by the Issuer and Affiliated Purchasers

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 discussion 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 anticipated 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. In 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 be affected by the uncertainties and risk factors described throughout this annual report on Form 10-K.

As a “smaller reporting company,”Overview

Effective March 31, 2022, as defined in Rule 12b-2approved by the shareholders, the name of the Exchange Act, weCompany was changed from Gridiron BioNutrients, Inc. (trading symbol GVMP) to Innovation1 Biotech Inc. (trading symbol IVBT).

Innovation1 Biotech Inc. (“IVBT”) believes it will be among the first companies to harness the raw power of botanical therapeutics by transforming them into fully synthetic drugs that are not required to provide the information called for by this Item.safely, reliably and consistently delivered. There are two fundamental limitations in exploiting botanical Schedule 1 molecules:

OVERVIEWTo 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. The Company had no revenue and a net operating loss of $40,877,813 for the fiscal year ended August 31, 2022. The Company has working capital deficit of $29,525,460 and an accumulated deficit of $44,551,043 as of August 31, 2022. We do not have sufficient funds to support our daily operations for the next twelve (12) months. 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 was incorporatedis 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 Stateviability of Nevada on July 31, 2014its strategy to commence operations and establishedgenerate 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 fiscal year endgoing 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 August 31.a public or private offering.

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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

CRITICAL ACCOUNTING POLICIESWe 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

INNOVATION1 BIOTECH INC.

Financial Statements

August 31, 2022

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders of Innovation1 Biotech, Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheets of Innovation1 Biotech, Inc. (“the Company”) as of August 31, 2022 and 2021, and the related 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, 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, 2022 and 2021 and the results of its operations and its cash flows for each of the years in the two-year period ended August 31, 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 1 to the financial statements, the Company has a net operating loss, working capital deficit, and an accumulated deficit 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 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 audit 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