Odyssey Health, Inc. 10-K

Item 1. Business This Annual Report on Form 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing. Actual results may differ materially from those expressed in forward-looking statements. See Item 1A of Part I—“Risk Factors.” Odyssey Group International, Inc. was formed as a Nevada corporation in March 2014. Our principal executive offices are located at 2372 Morse Ave., Irvine, CA 92614. The registration statement effectuating our initial public offering became effective in July 2015. Our shares of common stock are listed on the OTCPink Marketplace (“OTC”) and there is currently very little public market for our common stock. As used herein, when we refer to “Odyssey”, “ODYY,” the “Company,” “our Company,” “we,” “us” and “our,” we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates otherwise. General Odyssey is a publicly held holding company with an emphasis on the development and acquisition of medical products and health related technologies. We are focused on developing and acquiring technologies that have a technological advantage and a substantial market opportunity within significant target markets across the globe. The corporate mission is to create or acquire distinct technologies and intellectual property with an emphasis on acquisition targets that will generate positive cash flow. Our strategic mission is to deliver financial results, which yield high rates of returns for our shareholders and partners. Our leadership team has significant experience and capabilities to commercialize our technologies and submit to the appropriate regulatory agencies for marketing approval. Our business model is to develop or acquire unique medical related products, engage third parties to manufacture such products and then distribute the products through various distribution channels, including third parties. We are developing potentially life-saving technologies: the CardioMap® heart monitoring and screening device; the Save A Life choking rescue device; PRV-001 and PRV-002 which are unique neurosteroid drug compounds intended to treat concussions and rare brain disorders. To date, none of our product candidates has received regulatory clearance or approval for commercial sale. We intend to acquire other technologies and assets and plan to be a trans-disciplinary product development company involved in the development and commercialization of products and technologies that may be applied over various medical markets. We intend to license, improve and/or develop our products and identify and select distribution channels. We plan to establish agreements with distributors to get products to market quickly as well as to undertake and engage in our own direct marketing efforts. We will determine the most effective method of distribution for each unique product that we include in our portfolio. We intend to engage third party research and development firms who specialize in the creation of medical products to assist us in the development. We will apply for trademarks and patents as we develop proprietary products. 1 Financial Information about Industry Segments We do not report our financial results by segment. See financial statements. Our Growth Strategy If the FDA clears or approves our product candidates, we intend to enter into agreements with qualified distributors throughout the United States. A similar approach will be pursued if our product candidates are cleared or approved for marketing outside of the United States. We intend to require such distributors to pay us an initial license fee, as well as royalties based on gross sales. Retaining exclusivity, will be based on a mutually agreeable semi-annual or quarterly sales minimum. We have determined to focus on international growth because, generally, such international license agreements provide a stronger path to revenue and earnings than purely domestic products. Our objective is to grow revenue through marketing and sales of each of our product candidates, CardioMap® and Save a Life, if they gain regulatory approvals. Although no assurances can be given, management anticipates company growth from the following areas: 1) Distribution or License Agreements. In most cases, we will enter into distribution agreements with companies who have sales professionals with experience selling through a variety of sales methods. These distribution agreements will allow us to more quickly achieve sales and revenue in the health products industries. 2) Generate revenues from sales of CardioMap® and Save a Life. We intend to market CardioMap® and Save a Life through third party distributors and through our own efforts. 3) Identify and develop CardioMap® for additional proprietary uses of the product. We intend to pursue development of CardioMap® technology for use in other areas of the human body, such as the brain, liver and kidney. 4) The development and acquisition of new products. We intend to pursue development and acquisition of other product candidates and market any new products, if cleared or approved. We intend, as capital resources permit, to develop such opportunities if and when they present themselves. 5) Seek partners to assist in the further development of our drug device combination products. We intend to seek partners to assist with the further development and clinical trials of both PRV-001 and PRV-002. Partnerships could be in the form of government grants or from industry pharmaceutical companies who have an interest in brain related drug therapies. We currently have no products authorized for commercial distribution in either the United States, Europe or any other country. We are developing devices and pharmaceutical drugs, which are in various stages of development, and which will require regulatory clearance or approvals and we cannot begin marketing and selling our product candidates until we obtain applicable authorizations from the respective regulatory agency. FDA clearance or approval to market the products will be required to sell in the United States. About CardioMap® The CardioMap® System is intended to be a heart monitoring and screening device based on a novel method of Dispersion Mapping in ECG analysis for the early, non-invasive testing for coronary heart disease (“CHD”). The heart monitoring system is intended to provide high quality 3-D visualization and diagnosis of the heart using advanced signal analysis. The product is being designed for use in a professional setting or in remote settings including in-home use. We have exclusive, royalty free rights to USPTO patent number 7,519,416 B2 related to the CardioMap technology. 2 FDA cleared or approved, CardioMap® could provide a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally be invisible with standard ECG devices. The system can dramatically cut the costs associated with the detection of ischemic heart disease and will prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports teams, emergency facilities and general public. CardioMap® was developed by VE Science Technology LLC, from whom we have purchased the product rights. We have a working model of the device and associated software and plan to further develop the technology for clinical trials and a 510K FDA submission. To sell, market and distribute the CardioMap® product, clearance or approval from the FDA is required. Such clearance or approval has not been obtained at this time. Product Development Plan: Concept Engineering Model Prototype Clinical Trial FDA Submission Complete Complete In Process; Testing Q2 2022 Q2 2022 This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals. About Save-a-Life® In July of 2019 we purchased all intellectual property including two patents for the choking rescue device: patent Number RE45, 535 E and patent Number 8,454,624 B2. The Save a Life® (“SAL”) choking rescue device is currently in development and being designed to be a safe, and easy to use device for removing a lodged mass from the throat of a choking victim. The device includes a pump for creating a vacuum chamber, which is connected seamlessly with a replaceable/disposable mouthpiece. In an emergency the SAL may be easily inserted into the victim’s mouth, which depresses the tongue providing a clear application. By pressing an activation button on the device, the internal pump is intended to deliver the appropriate amount of instantaneous vacuum to dislodge the mass without harm or damage to the person. The application is intended to be instantly effective as the device will be operational and effective in a matter of seconds. To sell, market and distribute the Save-a-Life product, clearance or approval from the FDA is required. Clinical trials for the device will be conducted on anatomically correct models to demonstrate device performance. The regulatory pathway is expected to be a 510k submission to the FDA once successful clinical data is obtained. FDA clearance or approval has not been obtained at this time. The Development Plan for the Save-a-Life is below. Product Development Plan Concept Engineering Model Prototype Clinical Trial FDA Submission Complete Complete Q1 2022 Q2 2022 Q3 2022 Product Development Plan is an estimate only and is subject to change based on funding, technical risks and regulatory approvals. About the neurosteroid PRV-001 The neurosteroid, PRV-001, is intended to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in the cortex, subcortical nuclei, brainstem and cerebellum regions of the brain. The new chemical entity is designed to work through gene amplification to simultaneously remove intra-neuronal debris while promoting antioxidant capacity and myelin repair/cell proliferation. Disorders like Nieman Pick Type C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression. The chemical compound for the neurosteroid being developed has completed an initial safety study in rats. Results of preclinical studies suggest that PRV-001 may improve neuromotor, cognitive and mental performance. To sell the PRV-001 neurosteroid, further development and clinical studies are required. PRV-001 will also require approval by the FDA in order to be sold in the United States. Per our agreement with Prevacus, Inc. a Tallahassee, Florida based biotech company, we have fifty percent ownership in the drug compound and associated intellectual property. There are issued patents covering methods of PRV-001 synthesis. 3 Product Development Plan for PRV-001: Pre-clinical Animal Studies Phase 1a Phase 1b Phase 2 Phase 3 FDA Submission Q1 2022 Q3 2022 Q1 2023 Q3 2023 Q3 2024 Q3 2025 This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals. About the neurosteroid PRV-002 On March 1, 2021, we purchased one hundred percent of the drug compound PRV-002 from Prevacus, Inc. PRV-002 is a fully synthetic, non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion). Results of preclinical studies suggest that PRV-002 has equivalent, and potentially superior, neuroprotective effects compared to related neurosteroids. In animal models of concussion PRV-002 reduced the behavioral pathology associated with brain injury symptoms such as short-term memory loss, depression/anxiety-like behavior and motor-sensory impairment. The drug is administered through the nasal passage from a novel device. PRV-002 is lipophilic and can cross the blood-brain barrier thus supporting its potential to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow through gene amplification. The drug has completed toxicology studies in rat and dog. Studies show that PRV-002 has a safety margin over 200X it’s predicted efficacious dose. PRV-002 to date has been shown to be stable up to 104 degrees for 6-months. The drug candidate is currently being spray-dry manufactured into a powder that will be filled into the novel breath-propelled nasal device developed by Odyssey. The device is light weight and easy to use in the field. Odyssey’s novel nasal device is breath-propelled causing the soft palate to close in the back of the nasopharynx. This mechanism traps PRV-002 in the nasal cavity allowing for a more abundant and faster drug availability in the traumatized brain. Safety studies have established a dosing regimen of 2X/day for fourteen (14) days. Clinical Trial Phase I is site-set in Melbourne, Australia with a Contract Research Organization (CRO), Nucleus Network Inc. The country of Australia provides a twenty percent (20%) currency exchange advantage and a 43.5% rebate at the end of our fiscal year from the Australian government on all Research and Development performed in Australia. The trial is expected to begin in November 2021. A comprehensive Investigator’s Brochure has been created and submitted to the Alfred Ethics Committee by our CRO in Australia. Approval has been granted to initiate the phase 1 human trial and subjects have been enrolled. The phase 1 trial will have two components to it, phase 1a and 1b. Phase 1a is designed to determine the safety profile of the drug in healthy human subjects. Phase 1a will have forty-eight subjects using a Single Ascending/Multiple Ascending (SAD/MAD) drug administration design. For both the SAD and MAD portions there will be 4 groups, placebo, low dose, middle dose and high dose. All dosages are within the animal preclinical efficacy and safety range. The SAD component is a 1X treatment and the MAD component is a 1X/day treatment for 5-days. Blood and urine samples will be collected at multiple time points for safety pharmacokinetics. Standard safety monitoring will be provided for each bodily system. Phase 1b will begin following the completion of the final safety report from Phase 1a establishing no safety concerns. In Phase 1b PRV-002 will be administered to 24 acutely-concussed patients, 2x a day for 14-days. The trial will be low powered and evaluate safety as well as efficacy measurements to be used in Phase 2/3 clinical trials. Based on the Phase 1a and 1b data we plan to submit an application for an Investigational New Drug with the FDA and conduct a phase 2 trial in the United States. Patents on PRV-002 have been filed and/or issued: · Composition of matter for PRV-002 and analogs · Use for treating traumatic brain injury · Synthetic methods for PRV-002 4 Product Development Plan Pre-clinical Animal Studies Phase 1a (start date) Phase 1b (start date) Phase 2 (start date) Phase 3 (start date) U.S. Food and Drug Administration Submission Complete September 2021 January 2022 August 2022 January 2024 April 2025 This product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals. Competition We believe that the primary competition for our products and services is from existing companies offering EKG equipment and anti-choking devices, as well as other pharmaceutical companies engaged in the development of Orphan drugs. Governmental Regulation Product Regulation Domestic. The processing, formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject to certain regulation by one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States Department of Agriculture (the “USDA”) and the Environmental Protection Agency (the “EPA”), and by various agencies of the states and localities in which our products are sold. To sell, market and distribute the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required. Such clearance or approval has not been obtained at this time and our products are not currently available for commercial sale. Foreign. Any products we eventually sell in foreign countries are also subject to regulation under various national, local and international laws that include provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs and medical products. Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation, of some of our products. Employees At the date hereof, we have four employees and intend to hire additional employees in the foreseeable future. Where you can find more information Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), are filed with the U.S. Securities and Exchange Commission (the “SEC”). Such reports and other information filed by us with the SEC are available free of charge on our website at http://www.odysseygi.com when such reports are available on the SEC website. The public may read and copy any materials filed by us with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. The contents of these websites are not incorporated into this filing. Further, our references to the URLs for these websites are intended to be inactive textual references only. 5