Item 1. Business
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 Health, Inc. was formed as a Nevada corporation
in March 2014. Our principal executive offices are located at 2300 West Sahara Avenue, Suite 800 - #4012, Las Vegas, Nevada, 89102. The
registration statement effectuating our initial public offering became effective in July 2015.
Our shares of common stock are listed on the OTCQB
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 Health, Inc., a Nevada corporation, unless the context indicates otherwise.
General
Odyssey is a publicly held holding company focused
on acquiring and developing medical products. We are developing technologies that have a technological advantage, superior clinical utility,
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 leadership
team has significant experience and capabilities to commercialize our technologies and submit them to the appropriate regulatory agencies
for marketing approval.
Our business model is to develop or acquire medical
related products, engage third parties to develop and manufacture such products and then distribute the products through various distribution
channels, including third parties. We have two different technologies in research and development stage; the CardioMap® heart monitoring
and screening device, and the Save a Life choking rescue device.
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.
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Asset Purchase Agreement with Oragenics, Inc.
On October 4, 2023, we entered into an Asset Sale
Agreement (the “Agreement”) with Oragenics, which closed on December 28, 2023. Pursuant to the Agreement, we sold certain
assets related to the treatment of brain related illnesses and diseases (the “Assets”) with a total carrying value of $48,367
to Oragenics in exchange for (i) $1,000,000 in cash; (ii) 8,000,000 shares of convertible Series F preferred stock; and (iii) the assumption
of $325,672 of our accounts payable. The total value of consideration received was $16,449,054, which resulted in a gain of $16,400,687.
The Assets include drug candidates for treating mild
traumatic brain injury (“mTBI”), also known as concussion, and for treating Niemann Pick Disease Type C (“NPC”),
as well as our proprietary powder formulation and its nasal delivery device.
We received $500,000 upon the execution of the
Agreement on October 4, 2023, and received the additional $500,000 on December 11, 2023, upon our stockholder approval for the sale of
the Assets. Following the closing of the Agreement on December 28, 2023, we received 8,000,000 shares of Series F preferred stock. Upon
receipt, 511,308 shares of the Series F preferred stock, which represented 19.9% of the then outstanding shares of Oragenics common stock,
converted into 511,308 shares of Oragenics restricted common stock. The Oragenics restricted common stock became freely tradeable on June
28, 2024, subject to Rule 144 restrictions and limitations that limit us from selling no more than an amount equal to the greater of (i)
1% of the total shares of Oragenics common stock outstanding or (ii) the average of the previous four-week trading volume during each
quarterly period.
Prior to closing, we were required to obtain the consent
of Mast Hill Fund, L.P (“Mast Hill”) to consummate the closing of the Agreement. As part of the consent, we entered into a
pledge agreement with Mast Hill granting a security interest in 154,545 of the total preferred shares, and collectively with all of the
common shares or other securities into which the preferred shares are converted or exchanged into common shares, until the Mast Hill debt
is paid.
The remaining shares of convertible Series F preferred
stock will convert upon Oragenics shareholder approval and upon certain listing and change in control criteria being achieved.
See Notes 4 and 6 of Notes to Consolidated Financial
Statements for additional information.
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
to be marketed commercially, we intend to enter into agreements with industry partners or 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 partners or 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 also decided to focus on international
growth because, generally, such international license agreements provide a stronger path to revenue and earnings than purely domestic
products.
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Our objective is to eventually grow revenue through
marketing and sales of each of our product candidates, CardioMap® and Save a Life and our 50% ownership 50% ownership in unique neurosteroid
drug compound intended to treat rare brain disorders. Although no assurances can be given, management anticipates company growth from
the following areas:
1)
Distribution or License Agreements. Once any of our products in development are approved by the appropriate regulatory agency 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 achieve sales and revenue more quickly in the medical products industries.
2)
Identify and develop our products for additional proprietary uses. When funding allows, we intend to pursue development of CardioMap® technology for use in other areas of the human body, such as the brain, liver and kidney. We also intend to utilize our proprietary nasal delivery system to deliver other drugs to the brain to treat brain related medical issues.
3)
The development and acquisition of new products. We intend to pursue the 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.
4)
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 our technologies. 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 the United States, Europe or any other country. We have development programs for our devices, which are in various stages
of development. Due to funding constraints and market conditions, the CardioMap and the Save-a-Life choking rescue device programs have
been suspended. All of our products 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.
If 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 could 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 when funding is secured. 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
Complete
TBD
TBD
This product development plan is an estimate only.
The product development plan is subject to change based on our ability to fund the program, technical risks and regulatory approvals.
This project is not currently being funded.
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About Save-a-Life
In July 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 is 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. FDA clearance or approval has not been obtained at this time. The product development plan for the Save-a-Life
is below.
Product Development Plan::
Concept
Engineering Model
Prototype
Clinical Trial
FDA Submission
Complete
Complete
Complete
TBD
TBD
This product development plan is an estimate only
and is subject to change based on funding, technical risks, the clinical pathway and regulatory approvals. This project is not currently
being funded.
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.
SAL Competitive Analysis
Dechoker
The Dechoker is a device that can be used for choking
first aid on anyone 12 months or older, regardless of illness, disorder or other health-related condition. It utilizes a hand powered
pump system to extract blockages.
LifeVac
LifeVac is designed with a valve to prevent any air
from exiting through the mask. This designed valve prevents air from pushing food or objects downward. This creates a one-way suction
to remove the lodged food or object.
Act+Fast Heimlich maneuver training vests
Act+Fast™ Anti-Choking Trainer, Blue (AHA),
4-Pack. This device enables students to develop confidence in their ability to perform the Abdominal Thrust (Heimlich) Maneuver as recommended
by the American Heart Association (AHA). It has been designed to be realistic and easy to use.
CardioMap® Competitive Analysis
None of the current rapid EKG devices have the ability
to digitally map the heart. Each of the below competitors give EKG read outs only.
CardioResting (Nasiff)
The CardioResting ECG is the first complete and full-featured
12 lead PC based cardiology system. The ECG is durable, reliable and easy to learn. It performs and manages tests while saving money and
working with your existing equipment. Our system is EMR compatible with an unlimited database.
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Welch Allyn PC Based Electrocardiograph
The Welch Allyn device automatically transfers patient
information and test data into most EMRs without redundant work steps, misidentified patients, or delays from copying, scanning and shredding
ECG reports.
QardioCore
QardioCore is a wireless medical grade ambulatory
ECG monitoring system that can identify atrial fibrillation and other arrhythmias. No wires, gels or patches are required. No in-clinic
fitting nor technician needed - QardioCore is 100% deployed remotely.
Governmental Regulation
Product Regulation
Domestic
The processing, formulation, safety, manufacturing,
packaging, labeling, advertising and distribution of our products may be subject to certain regulations 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 regulations under various local, national, 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 do
not 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.odysseyhealthinc.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.
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