What changed in this filing

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Item 1. Business

2023-10-30 compared with 2022-10-31 · 115 added, 100 removed, 201 unchanged (52% of the section changed)

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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 OTCPink

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.

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.

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the Save A Life choking rescue device;

and PRV-002 which is a unique neurosteroid drug compound

and ONP-002 which is a unique neurosteroid drug compound

intended to treat mild traumatic brain injuries also known as concussions.

We on fifty percent of another unique neuro-steroid, PRV-001,

We own fifty percent of another unique neuro-steroid, ONP-001,

intended to treat rare brain disorders.

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we develop proprietary products.

Asset Purchase Agreement with Oragenics, Inc.

On October 4, 2023, we entered into an Asset Purchase

Agreement (the “Purchase Agreement”) with Oragenics, Inc.

(“Oragenics” the “Purchaser”).

to the Purchase Agreement, the we have agreed to sell and assign, certain assets and certain liabilities related to a segment of Odyssey’s business

focused on developing medical products that treat brain related illnesses and diseases (the “Purchased Assets”) to Oragenics

in exchange for (i) $1,000,000 in cash and 8,000,000 shares of convertible Series F Preferred Stock (“Series F Preferred Stock”),

on and subject to the terms and conditions set forth therein (such transaction, the “Odyssey Asset Purchase”).

The Purchased

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

Purchase Agreement on October 4, 2023 and will receive the additional $500,000 upon the earlier of (a) the closing of the Purchase Agreement

(the “Closing”), (b) within three (3) business days after the date that the Company has obtained the its stockholders’

approval approving the Odyssey Asset Purchase and (c) immediately upon the Purchasers’ wrongful termination of the Purchase Agreement

in breach of the Purchase Agreement.

The closing of the Asset Purchase is expected

to be at the end of the fourth calendar quarter of 2023.

See Note 13 of Notes to Consolidated Financial

Statements for additional information.

Financial Information about Industry Segments

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If the FDA clears or approves our product candidates

to be marketed commercially, 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, and the two neuro-steroids, PRV-002 and PRV-001 if they gain

regulatory approvals.

to be marketed commercially, we intend to enter into agreements with industry partners or qualified distributors throughout the United

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.

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

Our objective is to eventually grow revenue through

marketing and sales of each of our product candidates, CardioMap® and Save a Life, and the two neuro-steroids, ONP-002 and ONP-001

if they gain regulatory approvals.

Although no assurances can be given, management anticipates company growth from the following areas:

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.

Generate revenues from sales of CardioMap® and Save a Life.

When approved for sale by regulatory agencies we intend to market our products through third party distributors and through our own efforts.

Identify and develop our products for additional proprietary uses.

When funding allows, w e 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.

Distribution or License

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

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.

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 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.

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.

We intend to seek partners to assist with the further development and clinical trials of both ONP-001 and ONP-002.

Partnerships could be in the form of government grants or from industry pharmaceutical companies who have an interest in brain related drug therapies.

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which are in various stages of development.

Currently we are only funding the development of PRV-002 intended to treat concussion.

to funding constraints and market conditions the CardiMap ® and the 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.

Currently we are only funding the development of ONP-002 intended to treat concussion.

to funding constraints and market conditions, the CardioMap ® and the 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

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We have exclusive, royalty free rights to USPTO patent number 7,519,416 B2 related to the CardioMap technology.

FDA cleared or approved, CardioMap® could

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

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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.

About Save-a-Life®

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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.

FDA clearance or approval has not been obtained at this time.

The product development plan for the Save-a-Life

Product Development Plan::

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and is subject to change based on funding, technical risks, the clinical pathway and regulatory approvals.

About the neurosteroid PRV-001

The neurosteroid, PRV-001, is intended to improve

This project is not currently

being funded.

About the neurosteroid ONP-001

The neurosteroid, ONP-001, is intended to improve

function and lifespan in pediatric disorders where Central Nervous System (CNS) de-myelination and cell death is widespread in the cortex,

subcortical nuclei, brainstem, and cerebellar regions.

PRV-001, a new chemical entity, is designed to work through gene amplification

ONP-001, a 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.

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Results of preclinical studies

suggest that PRV-001 may improve neuromotor, cognitive and mental performance.

To market the PRV-001 neurosteroid, further development

suggest that ONP-001 may improve neuromotor, cognitive and mental performance.

To market the ONP-001 neurosteroid, further development

and clinical studies are required.

PRV-001 will also require approval by the FDA to be sold in the United States.

ONP-001 will also require approval by the FDA to be sold in the United States.

Per our agreement with Prevacus, Inc.

a Tallahassee,

Florida based biotech company, we have fifty percent (50%) ownership in the drug compound and associated intellectual property.

agreement also called for a joint venture to be created by the two companies.

The term to create the joint venture has expired and a joint

venture is no longer planned.

The United States Patent and Trademark Office issued patents covering methods of PRV-001 synthesis.

Product Development Plan for PRV-001:

Pre-clinical Animal Studies

FDA Submission

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

Florida based biotech company, we have 50% ownership in the drug compound and associated intellectual property.

The original agreement

also called for a joint venture to be created by the two companies.

The term to create the joint venture has expired and a joint venture

is no longer planned.

The United States Patent and Trademark Office issued patents covering methods of ONP-001 synthesis.

The product development plan for ONP-001 has been

suspended and the project is not currently being funded.

About the neurosteroid ONP-002

On March 1, 2021, Odyssey Health, Inc.

one hundred percent (100%) 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 an equivalent, and potentially

superior, neuroprotective effects compared to related neurosteroids.

In animal models of mild brain injury 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

Studies show that PRV-002 has a safety margin over 200X its predicted efficacious dose.

PRV-002 to date has been shown to be

Odyssey has changed the name of the drug to ONP-002.

is a fully synthetic, non-naturally occurring neurosteroid being developed for the treatment of mTBI (concussion).

Results of preclinical

studies suggest that ONP-002 has an equivalent, and potentially superior, neuroprotective effect compared to related neurosteroids.

animal models of mild brain injury ONP-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

ONP-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 rats

Studies show that ONP-002 has a safety margin over 200X its predicted efficacious dose.

ONP-002 to date has been shown to be

stable up to 104 degrees for 18-months.

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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

This mechanism traps ONP-002 in the nasal cavity allowing for more abundant and faster drug

availability in the traumatized brain.

Safety studies have established a dosing regimen of 2X/day for fourteen days.

clinical trial was performed in Melbourne, Australia with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus

Network Pty Ltd.

The country of Australia provides a greater than twenty six percent (26%) currency exchange advantage and a forty-three

and one half percent (43.5%) rebate at the end of our fiscal year from the Australian government on all Research and Development performed

in Australia.

The Phase I clinical

trial was performed in Melbourne, Australia with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty

The country of Australia provides a greater than 26% 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.

A comprehensive Investigator’s Brochure

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the safety profile of the drug in healthy human subjects.

It was double-blinded, randomized and placebo controlled (3:1, drug:

It was double-blinded, randomized and placebo controlled (3:1, drug:placebo).

Phase 1 used a Single Ascending/Multiple Ascending (SAD/MAD) drug administration design.

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or high dose) and the MAD component was a 1X/day treatment for five consecutive days (low and medium dose).

Blood and urine samples

were collected at multiple time points for safety pharmacokinetics.

Blood and urine samples were

collected at multiple time points for safety pharmacokinetics.

Standard safety monitoring was provided for each body system.

Forty (40) human subjects (31 males, 9 females)

were successfully enrolled in Phase I.

Forty human subjects (31 males, 9 females) were

successfully enrolled in Phase I.

The Safety Review Board, made up of medical doctors, has reviewed the trial data and has determined

the drug is safe and well tolerated at all dosing levels.

In Phase II clinical trial, PRV-002 will be administered

In Phase II clinical trial, ONP-002 will be administered

to acutely concussed patients, 2x a day for fourteen days.

Based on the Phase I data, we plan to apply for an Investigational New

Drug application with the FDA and conduct a Phase II trial in the United States.

Patents on PRV-002 have been filed and/or issued

and a patent has been filed on the nasal delivery device:

Composition of matter for PRV-002 and analogs

Based on the Phase I data, we plan to apply for an Investigational New Drug

application with the FDA and conduct a Phase II trial in the United States.

Patents on ONP-002 have been filed and/or issued

and a patent has been filed on the nasal delivery device as follows:

Composition of matter for ONP-002 and analogs

Use for treating traumatic brain injury

Synthetic methods for PRV-002

Synthetic methods for ONP-002

Product Development Plan:

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CardioMap® Competitive Analysis

Note, none of the current rapid EKG devices have

the ability to digitally map the heart.

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 CardioResting ECG is the first complete

and full-featured 12 lead PC based cardiology system.

The ECG is durable, reliable and easy to learn.

Performs and manages tests while saving

money and working with your existing equipment.

It performs and manages tests

while saving money and working with your existing equipment.

Our system is EMR compatible with an unlimited database.

Welch Allyn PC Based Electrocardiograph

Automatically transfer patient information and

test data into most EMRs without redundant work steps, misidentified patients, or delays from copying, scanning and shredding ECG reports.

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 is a wireless medical grade ambulatory

ECG monitor system that can identify atrial fibrillation and other arrhythmias.

ECG monitoring system that can identify atrial fibrillation and other arrhythmias.

No wires, gels or patches are required.

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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,

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

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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,

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.

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in foreign countries may prevent or delay the introduction, or require the reformulation, of some of our products.

At the date hereof, we have four employees and

At the date hereof, we have six employees and

do not intend to hire additional employees in the foreseeable future.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business