What changed in this filing

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Item 1. Business

2024-11-13 compared with 2023-10-30 · 86 added, 166 removed, 150 unchanged (63% of the section changed)

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for marketing approval.

Our business model is to develop or acquire unique

medical-related products, engage third parties to assist in the development and manufacturing of such products, and then distribute the

products through various distribution channels, including third parties.

We own potentially life-saving technologies:

the CardioMap®

heart monitoring and screening device;

the Save A Life choking rescue device;

and ONP-002 which is a unique neurosteroid drug compound

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

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

intended to treat rare brain disorders.

To date, none of our product candidates has received regulatory clearance or approval for commercial

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

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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 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

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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.

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

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

Agreement on October 4, 2023, and received the additional $500,000 on December 11, 2023, upon our stockholder approval for the sale of

Following the closing of the Agreement on December 28, 2023, we received 8,000,000 shares of Series F preferred stock.

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

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.

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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 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

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.

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:

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.

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.

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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 ONP-001 and ONP-002.

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 either the United States, Europe or any other country.

We have development programs for devices and pharmaceutical drugs,

which are in various stages of development.

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

to sell in the United States.

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

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”).

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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

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.

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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.

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.

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

To market the ONP-001 neurosteroid, further development

and clinical studies are required.

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 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.

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.

The drug candidate is spray-dry manufactured into a powder and filled into the intranasal device.

The device is lightweight and easy to use in the field.

Odyssey’s novel intranasal device is breath-propelled causing the soft palate

to close in the back of the nasopharynx.

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.

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

was created and approved by the Alfred Ethics Committee by Odyssey Health’s CRO in Australia.

Phase 1 was designed to determine

the safety profile of the drug in healthy human subjects.

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.

The SAD component was a 1X treatment (low, medium,

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.

Standard safety monitoring was provided for each body system.

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, 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 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 ONP-002

Product Development Plan:

Pre-clinical Animal Studies

FDA Submission

December 2025

February 2026

This product development plan is an estimate and

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

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.

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

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 is designed with a valve to prevent any

air from exiting through the mask.

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 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.

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CardioMap® Competitive Analysis

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.

It 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

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.

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

QardioCore is a wireless medical grade ambulatory

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No wires, gels or patches are required.

No in-clinic fitting

nor technician needed - QardioCore is 100% deployed remotely.

fitting nor technician needed - QardioCore is 100% deployed remotely.

Governmental Regulation

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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 six employees and

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

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

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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