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Item 1A. Risk Factors

2023-10-30 compared with 2022-10-31 · 413 added, 279 removed, 1184 unchanged (37% of the section changed)

Our business is subject to a number of risks that

you should be aware of before making a decision to invest in our securities, as fully described under “Risk Factors” in this

The principal factors and uncertainties that make investing in our securities risky include, among others:

An investment in our securities has a high

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As a result, you could lose all or part of your investment.

We are a development stage company with little operating history, a history of losses and we cannot assure profitability and there is substantial doubt about our ability to continue as a going concern.

Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements.

We may be unable to continue to operate without the threat of liquidation for the foreseeable future.

Raising additional capital by issuing securities or through debt financings or licensing arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidate on terms unfavorable to us.

There are substantial inherent risks in attempting to commercialize newly developed products, and, as a result, we may not be able to successfully develop new products.

We will need to achieve commercial acceptance of our products, if cleared or approved, to generate revenues and achieve profitability.

We currently only have four product candidates, which are still in development, and we have not obtained authorization from any regulatory agency to commercially distribute the products in any country and we may never obtain such authorizations.

We will depend on third parties for the manufacture and distribution of our product candidates and products, if cleared or approved, and the loss of our third-party manufacturer and distributor could harm our business.

We may be forced to litigate to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of other parties’ proprietary rights.

If our intellectual property protection is inadequate, competitors may gain access to our technology and undermine our competitive position.

We have and may continue to encounter substantial delays in planned clinical trials, or our planned clinical trials for other indications may fail to demonstrate the safety and efficacy of our product candidates to the satisfaction of applicable regulatory authorities.

We may be substantially dependent on third parties to conduct our clinical trials.

We may be required to suspend or discontinue clinical trials due to side effects or other safety risks that could preclude approval of our products.

legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after marketing authorization is obtained.

Conducting any future clinical trials of our product candidates and any future commercial sales of a product candidate may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all and may be required to limit commercialization of our product candidates.

We participate in transactions and make tax calculations for which the ultimate tax determination may be uncertain.

If we fail to develop or maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent financial fraud.

As a result, current and potential stockholders could lose confidence in our financial reporting.

If our expenses are greater than anticipated, then we will have fewer funds with which to pursue our plan of operations and our financing requirements will be greater than anticipated.

We are heavily dependent upon the ability and expertise of our management team and a very limited number of employees and the loss of such individuals could have a material adverse effect on our business, operating results or financial condition.

Investors could lose confidence in our financial reports, and the value of our common stock may be adversely affected, if our internal controls over financial reporting are found not to be effective by management or by our independent registered public accounting firm.

Challenges to our tax positions in U.S.

jurisdictions, the interpretation and application of recent U.S.

tax legislation or other changes in U.S.

taxation of our operations could harm our business, revenue and financial results.

If our business is unsuccessful, our stockholders may lose their entire investment.

The sale or issuance of our common stock to Lincoln Park may cause dilution and the sale of the shares of common stock acquired by Lincoln Park, or the perception that such sales may occur, could cause the price of our common stock to fall.

A limited public trading market exists for our common stock, which makes it difficult for our stockholders to sell their common stock on the public markets.

Any trading in our shares may have a significant effect on our stock prices.

The sale of shares of our common stock could cause the price of our common stock to decline.

A limited number of stockholders collectively own a significant portion of our common shares and may act, or prevent corporate actions, to the detriment of other stockholders.

The reverse split of our common stock could decrease our total market capitalization and increase, and may continue to increase, the volatility of our stock price.

The reverse stock split could increase our authorized but unissued shares of common stock, which could negatively impact a potential investor.

Trading of our common stock could be sporadic, and the price of our common stock may be volatile;

we caution you as to the highly illiquid nature of an investment in our shares.

An investment in our securities has a high

degree of risk.

Before you invest you should carefully consider the risks and uncertainties described below and the other information

in this prospectus.

Any of the risks and uncertainties set forth herein could materially and adversely affect our business, results of

operations and financial condition, which in turn could materially and adversely affect the trading price or value of our securities.

Additional risks not currently known to us or which we consider immaterial based on information currently available to us may also materially

adversely affect us.

As a result, you could lose all or part of your investment.

Risks Related to Our Financial Position and

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difficulties we might encounter, especially given our lack of an operating history or historical pro forma combined financial information.

There is no assurance that we will be successful, and the likelihood of success must be considered in light of its relatively early stage

There is no assurance that we will be successful, and the likelihood of success must be considered in light of our relatively early stage

of operations.

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offerings and generate revenue.

Our ability to continue as a going concern is dependent upon our ability in the future to generate revenue

and achieve profitable operations and, in the meantime, to obtain the necessary financing to meet our obligations and repay our liabilities

Our ability to continue as a going concern is dependent upon our future ability to generate revenue and

achieve profitable operations and, in the meantime, to obtain the necessary financing to meet our obligations and repay our liabilities

when they become due.

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In addition, the assumptions used

in planning may not prove to be accurate, and other factors may affect our financial condition or results of operations.

in planning may prove to be inaccurate, and other factors may affect our financial condition or results of operations.

We expect to incur significant ongoing costs and

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Our success is significantly dependent on uncertain events, including

successful developing our products, establishing satisfactory manufacturing arrangements and processes, and distributing and selling our

If we are unable to generate significant revenues from sales of our products, we will not be able to earn profits or continue

successful development of our products, establishing satisfactory manufacturing arrangements and processes, and the sale and distribution

of our products.

If we are unable to generate significant revenues from sales of our products, we will not be able to earn profits or

continue operations.

We can provide no assurance that we will generate any revenues or ever achieve profitability.

If we are unsuccessful in addressing

these risks, our business will fail, and investors may lose all of their investment in our Company.

If we are unsuccessful

in addressing these risks, our business will fail, and investors may lose all of their investment in our Company.

Our ability to generate positive cash flows

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firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial

Our independent registered public accounting firm has issued its audit

opinion on our consolidated financial statements appearing in our Annual Report on Form 10-K for the fiscal year ended July 31, 2022,

including an explanatory paragraph as to substantial doubt with respect to our ability to continue as a going concern.

The accompanying

consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States

of America, assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities

in the normal course of business.

For the fiscal year ended July 31, 2022, our net loss was $8,444,131, and we had an accumulated deficit

of $54,177,954 at July 31, 2022.

As of July 31, 2022, we had current liabilities of $5,213,294, current assets of $526,417 and a working

capital deficit of $4,686,877.

These factors raise substantial doubt about our ability to continue as a going concern which is dependent

on our ability to raise the required additional capital or debt financing to meet short- and long-term operating requirements.

also encounter business endeavors that require significant cash commitments or unanticipated problems or expenses that could result in

a need for additional cash.

Our independent registered public accounting firm

has issued its audit opinion on our consolidated financial statements appearing in our Annual Report on Form 10-K for the fiscal year

ended July 31, 2023, including an explanatory paragraph as to substantial doubt with respect to our ability to continue as a going concern.

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the

United States of America, assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction

of liabilities in the normal course of business.

For the fiscal year ended July 31, 2023, our net loss was $5,919,421, and we had an accumulated

deficit of $60,097,375 at July 31, 2023.

As of July 31, 2023, we had current liabilities of $6,611,722, current assets of $405,888 and

a working capital deficit of $6,205,834.

These factors raise substantial doubt about our ability to continue as a going concern which

is dependent on our ability to raise the required additional capital or debt financing to meet short- and long-term operating requirements.

We may also encounter business endeavors that require significant cash commitments or unanticipated problems or expenses that could result

in a need for additional cash.

Our ability to continue as a going concern is dependent upon raising capital from financing transactions.

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goals and have a material adverse effect on our business, financial condition and results of operations.

Risks Related to the Sale of the Purchased Assets

We may not be able to successfully consummate

the Odyssey Asset Purchase Agreement with Oragenics.

The closing of the Odyssey Asset Purchase Agreement

is subject to various closing conditions, including without limitation the following:

(1) Odyssey shall have obtained all required consents

to the Odyssey Asset Purchase;

(2) Odyssey shall have obtained its shareholders’ approval to the Odyssey Asset Purchase;

(3) Oragenics

shareholders shall have approved (a) the increase in the its authorized Common Stock from Four Million One Hundred Sixty Six Thousand

Six Hundred Sixty Six (4,166,666) shares to Three Hundred Fifty Million (350,000,000) and (b) the conversion of Nineteen and Nine Tenths

Percent (19.9%) of the Series F Preferred Stock into Common Stock;

(4) no material adverse change shall have occurred to the Purchased

(5) Oragenics must have at least Five Million dollars ($5,000,000) in cash at Closing;

and (6) the Oragenics must have completed

its due diligence of the Purchased Assets to its satisfaction.

There can be no assurances that such conditions will be satisfied.

Oragenics may have difficulty raising additional

capital, which could deprive them of the resources necessary to implement our business plan, which would adversely affect the equity position

in Oragenics.

Whether or not we successfully consummate the

Asset Purchase, Oragenics will need to raise additional capital to fund the development and commercialization of our product candidates

and to operate their business.

The Oragenics’ need to raise additional capital is expected to increase if we successfully consummate

the Oragenics Asset Purchase.

If Oragenics consummates the Asset Purchase, Oragenics expect their operating expenses to increase, both

due to additional employment costs and operating costs required to pursue the development of the Odyssey’s assets.

In order to support

the initiatives envisioned in the business plan, Oragenics will need to raise additional funds through the sale of assets, public or private

debt or equity financing, collaborative relationships or other arrangements.

If Oragenics operations expand faster or at a higher rate

than currently anticipated, Oragenics may require additional capital sooner than they expect.

We are unable to provide any assurance or

guarantee that additional capital will be available when needed by Oragenics or that such capital will be available under terms acceptable

to Oragenics or on a timely basis.

Oragenics’ ability to raise additional financing

depends on many factors beyond our control, including the state of capital markets, the market price of their common stock and the development

or prospects for development of competitive products by others.

If additional funds are raised through the issuance of equity, convertible

debt or similar securities of their company, the percentage of ownership in Oragenics by Odyssey stockholders will be reduced, our stockholders

may experience additional dilution upon conversion, and such securities may have rights or preferences senior to those of Oragenics’

common stock.

The preferential rights granted to the providers of such additional financing may include preferential rights to payments

of dividends, super voting rights, a liquidation preference, protective provisions preventing certain corporate actions without the consent

of the fund providers, or a combination thereof.

We are unable to provide any assurance that additional financing will be available on

terms favorable to Oragenics or at all.

If adequate funds are not available or are not

available on acceptable terms, Oragenics’ ability to take advantage of the potential of assets acquired from us will be limited

significantly.

With limited capital, Oragenics expects to continue to scale back or delay implementation of research and development of

all protocols.

By implication, the unavailability of capital could substantially harm our investment in Oragenics.

Oragenics’ success with regard to

the Purchased Assets depends on the viability of Oragenics business strategy with regard to those assets, which is unproven and may be

Oragenics revenue and income potential with regard

to the Purchased Assets, in particular the concussion asset, are unproven, and Oragenics continues to develop our strategy for such assets.

Oragenics’ anticipated business model is based on a variety of assumptions based on a growing trend in the healthcare systems in

the United States and many other countries.

These assumptions may not reflect the business and market conditions Oragenics actually faces.

As a result, Oragenics’ operating results could differ materially from those projected under Oragenics’ business model, and

Oragenics’ business model may prove to be unprofitable.

The product candidate ONP-002 (the concussion

asset) being developed by us, which development under Oragenics will continue if we successfully consummate the Asset Purchase, is in

its early stages and will require extensive testing and clinical trials before it is commercialized.

There is no guarantee that ONP-002

will be approved for commercial use.

The product candidate ONP-001 (the potential treatment for Niemann Pick Disease Type C) Oragenics

is acquiring from us, is in its early stages and will require extensive testing and clinical trials before it is commercialized.

is no guarantee that ONP-001 will be approved for commercial use.

We currently own only 50% of the intellectual property related thereto.

The other 50% is owned by Prevacus.

The joint venture with that third party has not been finalized.

If we fail to obtain marketing authorization for

these product candidates, our business, financial condition, and results of operations will be materially adversely affected.

There are substantial inherent risks in

attempting to commercialize newly developed products, and, as a result, we may not be able to successfully develop the new products acquired

from Odyssey.

If we successfully consummate the Asset Purchase,

Oragenics hopes to conduct research and development of the purchased technologies.

However, commercial feasibility and acceptance of such

product candidates are unknown.

Scientific research and development require significant amounts of capital and takes an extremely long

time to reach commercial viability, if at all.

During the research and development process, we may experience technological barriers that

we may be unable to overcome.

Because of these uncertainties, it is possible that some of Oragenics’ future product candidates will

never be successfully developed.

If Oragenics is unable to successfully develop new products, Oragenics may be unable to generate new

revenue sources or build a sustainable or profitable business.

Additionally, if we successfully consummate the

Asset Purchase, since Oragenics operates with limited resources and staff, Oragenics’ attention and resources will be diverted away

from other protocols which may result in further delays in the development and commercialization of such programs and the diminution of

our investment.

We will need to achieve commercial acceptance

of our products, if cleared or approved, to generate revenues and achieve profitability.

If we successfully consummate the Asset Purchase,

superior products may be introduced that compete with the Purchased Assets, which would diminish or extinguish the uses for the products

candidates acquired by Oragenics, if cleared or approved.

We cannot predict when significant commercial market acceptance for such products,

if cleared or approved, will develop, if at all, and we cannot reliably estimate the projected size of any such potential market.

fail to accept such products, then Oragenics may not be able to generate revenue from them.

Oragenics revenue growth and achievement of

profitability will depend substantially on Oragenics ability to introduce new products that are accepted by customers.

Oragenics competitors

in the industry are predominantly large companies with longer operating histories, with significantly easier access to capital and other

resources and an established product pipeline than Oragenics.

There can be no assurance that Oragenics will be able to establish ourselves

in their targeted markets, or, if established, that Oragenics will be able to maintain market position, if any.

Oragenics’ commercial

opportunity may be reduced if their competitors develop new or improved products that are more convenient, more effective or less expensive

than our product candidates are.

Competitors may also obtain FDA or other regulatory marketing authorization for their products more rapidly

or earlier than Oragenics may obtain marketing authorization, which could result in their competitors establishing a strong market position

before Oragenics is able to enter the market.

If Oragenics is unable to cost-effectively achieve acceptance of their products by customers,

or if Oragenics products do not achieve wide market acceptance, then their business, and consequently our investment in Oragenics’

business will be materially and adversely affected.

The products candidates Oragenics hopes

to acquire from Odyssey are still in development, and Odyssey has not obtained authorization from any regulatory agency to commercially

distribute such products in any country and we may never obtain such authorizations.

Oragenics currently has no products authorized

for commercial distribution in either the United States, Europe, or any other country.

Similarly, the products candidates Oragenics hopes

to acquire from us are still in development.

Like the product candidates Oragenics is developing, the Purchased Assets require regulatory

clearance or approvals.

Oragenics cannot begin marketing and selling product candidates until they obtain applicable authorizations from

the applicable regulatory agencies.

The process of obtaining regulatory authorization is expensive and time-consuming and can vary substantially

based upon, among other things, the type, complexity, and novelty of a product candidate.

Changes in regulatory policy, changes in or

the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application may cause

delays in the authorization of a product candidate or rejection of a regulatory application altogether.

The FDA has substantial discretion in the review

process and may refuse to accept Oragenics’ application or may decide that data are insufficient to grant the request and require

additional pre-clinical, clinical, or other studies.

In addition, varying interpretations of the data obtained from pre-clinical and clinical

testing could delay, limit, or prevent marketing authorization from the FDA or other regulatory authorities.

Any marketing authorization

from the FDA Oragenics ultimately obtains may be limited or subject to restrictions or post-market commitments that render the product

candidate not commercially viable.

If Oragenics attempts to obtain marketing authorization are unsuccessful, Oragenics may be unable to

generate sufficient revenue to sustain and grow their business, and Oragenics business, financial condition, and results of operations,

and consequently, the value of our equity will be materially adversely affected.

Oragenics is, and will continue to be,

dependent in significant part on outside scientists and third-party research institutions for research and development in order to be

able to commercialize product candidates.

Oragenics currently has a limited number of employees

and resources available to perform the research and development necessary to commercialize their product candidates and potential future

product candidates.

Oragenics therefore relies, and will continue to rely, on third-party research institutions, collaborators and consultants

for this capability.

This will remain the case if we successfully consummate the Asset Purchase.

Oragenics is heavily dependent upon the

ability and expertise of our management team and a very limited number of employees, and the loss of such individuals could have a material

adverse effect on Oragenics’ business, operating results or financial condition.

Oragenics currently has a very small management

Oragenics’ success is dependent upon the ability, expertise, and judgment of Oragenics’ senior management.

While employment

agreements are customarily used as a primary method of retaining the services of key employees, these agreements cannot assure the continued

services of such employees.

Any loss of the services of such individuals could have a material adverse effect on Oragenics business, operating

results or financial condition.

The loss of the services of any of these individuals

could harm Oragenics’ ability to successfully pursue the development of the Purchased Assets.

If any of Oragenics’ executive

officers or key employees left or seriously injured and unable to work and they were unable to find a qualified replacement and/or

to obtain adequate compensation for such loss, Oragenics may be unable to manage our business, which could harm their operating results

and financial condition.

If we successfully consummate the Asset Purchase,

Oragenics’ anticipates growth in their business and increased costs, and any inability to manage such growth could harm Oragenics’

Oragenics’ success will depend, in part, on their ability to effectively manage their growth and expansion.

Any growth in, or

expansion of, Oragenics’ business is likely to continue to place a significant strain on their management and administrative resources,

infrastructure, and systems.

In order to succeed, Oragenics will need to continue to implement management information systems and improve

our operating, administrative, financial and accounting systems and controls.

Oragenics will also need to train new employees and maintain

close coordination among our executive, accounting, finance, and operations organizations.

These processes are time-consuming and expensive,

will increase management responsibilities and will divert management attention.

Their inability or failure to manage such growth and expansion

effectively could substantially harm their business and adversely affect their operating results and financial condition, and, consequently,

the value of our equity in Oragenics.

Risks Related to Our Technology, Development

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There is no guarantee that the device will be approved or cleared for commercial use.

The product candidate PRV-001, for which we own

fifty percent (50%) of the intellectual property, will be developed by Prevacus.

PRV-001 is in its early stages and will require extensive

testing and clinical trials before it is commercialized.

There is no guarantee that PRV-001 will be approved for commercial use.

Venture contemplated in the agreement has not been formed.

The product candidate PRV-002 being developed

The product candidate ONP-001, for which we own

50% of the intellectual property, is in its early stages and will require extensive testing and clinical trials before it is commercialized.

There is no guarantee that ONP-001 will be approved for commercial use.

The Joint Venture contemplated in the agreement has not been formed.

The product candidate ONP-002 being developed

by us and is in its early stages and will require extensive testing and clinical trials before it is commercialized.

There is no guarantee

that PRV-002 will be approved for commercial use.

that ONP-002 will be approved for commercial use.

If we fail to obtain marketing authorization for

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If markets fail to accept our products, then we may not be able to generate

revenues from them.

revenue from them.

Our revenue growth and achievement of profitability will depend substantially on our ability to introduce new products

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our sales and revenues will decline.

We are, and will continue to be, dependent

in significant part on outside scientists and third-party research institutions for our research and development in order to be able to

commercialize our product candidates.

We are, and will continue to be, significantly

dependent, in-part, on outside scientists and third-party research institutions for our research and development in order to be able

to commercialize our product candidates.

We currently have a limited number of employees

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our product candidates and products that meet our specifications and quality standards, it will be difficult for us to compete effectively.

We may not be able to build an effective

We may be unable to build an effective

distribution network for our products, if cleared or approved.

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Our efforts to protect our intellectual property rights may not be effective in preventing misappropriation of any of our products or intellectual property.

Our efforts may not prevent the development and design by others of products similar to, competitive with, or superior to, those we develop.

Our efforts may not prevent others from the development and design of products similar to, competitive with, or superior to, those we develop.

Another party may obtain a blocking patent and we would need to either obtain a license or design around the patent in order to continue to offer the contested feature or service in our products.

The expiration of patent or other intellectual property protections for any assets owned by us could result in significant competition, potentially at any time and without notice, resulting in a significant reduction in sales.

The effect of the loss of these protections on us and our financial results will depend, among other things, upon the nature of the market and the position of our products in the market from time to time, the growth of the market, the complexities and economics of manufacturing a competitive product and regulatory approval requirements but the impact could be material and adverse.

The effect we will experience from the loss of these protections on us and our financial results will depend, among other things, upon the nature of the market and the position of our products in the market from time to time, the growth of the market, the complexities and economics of manufacturing a competitive product and regulatory approval requirements, which could cause a material and adverse impact on our business.

We may be forced to litigate to defend our intellectual property rights, or to defend against claims by third parties against us relating to intellectual property rights.

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names and domain names.

We may not be able to protect our trade names

and domain names against all infringers, which could decrease the value of our brand name and proprietary rights.

We currently hold the

Internet domain name Odyssey Health, Inc.

Domain names are generally regulated by Internet regulatory bodies, are subject to change, and,

in some cases, may be superseded, in some cases by-laws, rules and regulations governing the registration of trade names and trademarks

with the United States Patent and Trademark Office as well as ascertain other common law rights.

If the domain registrars are changed,

if new ones are created, or if we are deemed to be infringing upon another’s trade name or trademark, we may be unable to prevent

third parties from acquiring or using, as the case may be, our domain name, trade names or trademarks, which could adversely affect our

brand name and other proprietary rights.

We may not be able to protect our trade

names and domain names against all infringers, which could decrease the value of our brand name and proprietary rights.

hold the Internet domain name Odyssey Health, Inc.

Domain names are generally regulated by Internet regulatory bodies, are subject

to change, and, in some cases, may be superseded, in some cases by by-laws, rules and regulations governing the registration of

trade names and trademarks with the United States Patent and Trademark Office as well as ascertain other common law rights.

domain registrars are changed, if new ones are created, or if we are deemed to be infringing upon another’s trade name or

trademark, we may be unable to prevent third parties from acquiring or using, as the case may be, our domain name, trade names or

trademarks, which could adversely affect our brand name and other proprietary rights.

We may be forced to litigate to enforce

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our business.

We, as well as certain of our directors and officers,

may be subject to claims or lawsuits.

We, as well as, our directors and officers, may

be subject to claims or lawsuits.

These lawsuits may result in significant legal fees and expenses and could divert management’s

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If the claims contained in these lawsuits are successfully asserted against us, we could be liable for damages

and be required to alter or cease certain of our business practices or product lines.

and be required to alter or cease portions of our business practices or product lines.

Any of these outcomes could cause our business,

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of a device or drug for many reasons, including:

we may not be able to demonstrate to the FDA’s satisfaction that our product candidate is safe and effective for its intended users;

the data from our pre-clinical studies and clinical trials may be insufficient to support authorization, where required;

our inability to demonstrate to the FDA’s satisfaction that our product candidate is safe and effective for its intended

the data from our

pre-clinical studies and clinical trials may be insufficient to support authorization, where required;

the manufacturing process or facilities we use may not meet applicable requirements.

In addition, the FDA may change its authorization

policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or delay marketing authorization

of our product candidates under development.

Any delay in, or failure to receive or maintain clearance or approval for our product candidates

could prevent us from generating revenue from our products, if cleared or approved, and adversely affect our business operations and financial

In addition, the FDA may change its

authorization policies, adopt additional regulations or revise existing regulations, or take other actions, which may prevent or

delay marketing authorization of our product candidates under development.

Any delay in, or failure to receive or maintain clearance

or approval for our product candidates, could prevent us from generating revenue from our products, if cleared or approved, and

could adversely affect our business operations and financial results.

Even if granted, a 510(k) clearance, de novo

classification and clearance, or pre-market approval for any future product may place substantial restrictions on how our

device or drug is marketed or sold, and FDA will continue to place considerable restrictions on our products and operations.

manufacture, distribution and sale of medical devices and drugs must comply with extensive laws and regulations, including those

relating to registration and listing, labeling, marketing, complaint handling, adverse event and medical device reporting, reporting

of corrections and removals, and import and export.

If we or our facilities or those of our manufacturers or suppliers are found to

be in violation of applicable laws and regulations, or if we or our manufacturers or suppliers fail to take satisfactory corrective

classification and clearance, or pre-market approval for any future product may place substantial restrictions on how our device or

drug is marketed or sold, and FDA will continue to place considerable restrictions on our products and operations.

The manufacture,

distribution and sale of medical devices and drugs must comply with extensive laws and regulations, including those relating to

registration and listing, labeling, marketing, complaint handling, adverse event and medical device reporting, reporting of

corrections and removals, and import and export.

If we or our facilities or those of our manufacturers or suppliers are found to be

in violation of applicable laws and regulations, or if we or our manufacturers or suppliers fail to take satisfactory corrective

action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following

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product recalls;

operating restrictions or partial suspension or total shutdown of production;

operating restrictions, partial suspension or total shutdown of production;

refusing or delaying requests for marketing authorization of new products or modified products;

withdrawing marketing authorizations that have already been granted;

refusing to provide Certificates for Foreign Government;

refusing to provide Certificates for Foreign Governments;

refusing to grant export approval for our products;

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For our pharmaceutical product candidates, we

are required to submit an Investigational New Drug Application, or IND, the contents of which are subject to discussions with FDA and

include, among other things, results of preclinical studies and other testing, manufacturing information, proposed clinical trial protocols

and general investigational plan.

We cannot begin any clinical trials in the United States until thirty (30) days after the IND has been

accepted by FDA.

Clinical trials involve the administration of the investigational product to human subjects under the supervision of

qualified investigators in accordance with current Good Clinical Practices, or cGCPs, which include the requirement that all research

are required to submit an Investigational New Drug Application, or IND, the contents of which are subject to discussions with the FDA

and include, among other things, results of preclinical studies and other testing, manufacturing information, proposed clinical trial

protocols and a general investigational plan.

We cannot begin any clinical trials in the United States until 30 days after the IND has

been accepted by FDA.

Clinical trials involve the administration of the investigational product to human subjects under the supervision

of qualified investigators in accordance with current Good Clinical Practices, or cGCPs, which include the requirement that all research

subjects provide their informed consent for their participation in any clinical study.

Clinical trials are conducted under protocols detailing,

among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated.

A separate submission to the existing IND must be made for each successive clinical trial conducted during product development and for

any subsequent protocol amendments.

Furthermore, an independent Investigational Review Board, or IRB, for each site proposing to conduct

the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical trial begins

at that site and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at

any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the clinical

trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts organized

by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check points,

make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or other grounds,

such as no demonstration of efficacy.

There are also requirements governing the reporting of ongoing clinical studies and clinical study

results to public registries.

among other things, the objectives of the study, the parameters to be used in monitoring the safety and the effectiveness, of criteria

to be evaluated.

A separate submission to the existing IND must be made for each successive clinical trial conducted during product development

and for any subsequent protocol amendments.

Furthermore, an independent Investigational Review Board, or IRB, for each site proposing

to conduct the clinical trial must review and approve the plan for any clinical trial and its informed consent form before the clinical

trial begins at that site and must monitor the study until completed.

Regulatory authorities, the IRB or the sponsor may suspend a clinical

trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the

clinical trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts

organized by the clinical study sponsor, known as a data safety monitoring board, which may review data and endpoints at designated check

points, make recommendations and/or halt the clinical trial if it determines that there is an unacceptable safety risk for subjects or

other grounds, with respect to the foregoing, such as an inadequate demonstration of efficacy.

There are also requirements governing the

reporting of ongoing clinical studies and clinical study results to public registries.

Human clinical trials are typically conducted

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These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness;

In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing;

The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks.

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third parties or us.

We cannot guarantee that clinical trials will

be conducted as planned or completed on schedule, if at all.

A failure of one or more clinical trials can occur at any stage of testing.

Delays, including, but not limited those caused by the COVID-19 pandemic, can be costly and could negatively affect our ability

to complete a clinical trial and may allow our competitors to bring products to market before we do, which could impair our ability to

receive marketing authorization and successfully commercialize our products.

If we are unable to complete such planned clinical trials,

or are unsuccessful in doing so, we may be unable to advance our product candidates to regulatory authorization and commercialization,

which would harm our business, financial condition, results of operations.

We cannot guarantee that clinical trials

will be conducted as planned or completed on schedule, if at all.

A failure of one or more clinical trials can occur at any stage of

Delays, including, but not limited to those caused by the COVID-19 pandemic, can be costly and could negatively affect

our ability to complete a clinical trial and may allow our competitors to bring products to market before we do, which could impair

our ability to receive marketing authorization and successfully commercialize our products.

If we are unable to complete such

planned clinical trials, or are unsuccessful in doing so, we may be unable to advance our product candidates to regulatory

authorization and commercialization, which would harm our business, financial condition, and results of operations.

We may be substantially dependent on third

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and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.

These third parties

and we are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA

and comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these cGCPs

through periodic inspections of trial sponsors, principal investigators, and trial sites.

If we or any of these third parties fail to

comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable

foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving our marketing applications

or may subject them or us to regulatory enforcement actions.

We cannot be certain that, upon inspection, such regulatory authorities will

determine that any of our clinical trials comply with the cGCP regulations.

In addition, our clinical trials may be required to be conducted

with a large number of test patients.

Our failure or any failure by these third parties to comply with these regulations or to recruit

a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory marketing authorization process.

Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws

and regulations or healthcare privacy and security laws.

We and the foregoing

third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by

the FDA and comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these

cGCPs through periodic inspections of trial sponsors, principal investigators, and trial sites.

If we or any of these third parties fail

to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or

comparable foreign regulatory authorities may require us to perform additional nonclinical or clinical trials before approving our marketing

applications or may subject them or us to regulatory enforcement actions.

We cannot be certain that, upon inspection, such regulatory

authorities will determine that any of our clinical trials comply with the cGCP regulations.

In addition, our clinical trials may be required

to be conducted with a large number of test patients.

Our failure or any failure by these third parties to comply with these regulations,

or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory marketing authorization

Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims

laws and regulations or healthcare privacy and security laws.

Any third parties conducting our clinical trials

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Department of Health and Human Services so that our devices or drugs, following receipt of marketing authorization

is covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect

are covered under Medicare and Medicaid, this could have a negative impact on our intended sales and would have a material adverse effect

on our business, financial condition and operating results.

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to obtain a reimbursement code in a timely manner.

In the event that we do not obtain a reimbursement, our customers may be unable to

obtain reimbursement for their purchases under private or government-sponsored insurance plans, which could have a negative impact on

our sales and have a material adverse effect on our business, financial condition and operating results.

In the event that we do not obtain a reimbursement code, our customers may be unable

to obtain reimbursement for their purchases under private or government-sponsored insurance plans, which could have a negative impact

on our sales and have a material adverse effect on our business, financial condition and operating results.

If we fail to comply with healthcare laws,

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which could have a significant negative effect on our business.

We are subject to governmental oversight and associated

civil and criminal enforcement relating to advertising, promotion, and marketing, and such enforcement is evolving and intensifying.

Communications

regarding our products in development and regarding our clinical trials may subject us to enforcement if they do not comply with applicable

laws and regulations.

In the United States, we are potentially subject to enforcement from the FDA, other divisions of the Department

of Health and Human Services, the U.S.

Federal Trade Commission, or the FTC, the Department of Justice, and state and local governments.

parties, including private plaintiffs, also are commonly bringing suit against pharmaceutical and medical device companies.

be subject to liability based on the actions of individual employees and third-party contractors carrying out activities on our behalf.

We are subject to governmental oversight and

associated civil and criminal enforcement relating to advertising, promotion, and marketing, and such enforcement is evolving and

intensifying.

Communications regarding our products in development and regarding our clinical trials may subject us to enforcement

if they do not comply with applicable laws and regulations.

In the United States, we are potentially subject to enforcement from the

FDA, other divisions of the Department of Health and Human Services, the U.S.

Federal Trade Commission (the “FTC”), the

Department of Justice, and state and local governments.

Other parties, including private plaintiffs, are also commonly bringing

suit against pharmaceutical and medical device companies.

We may be subject to liability based on the actions of individual

employees and third-party contractors carrying out activities on our behalf.

legislative or FDA regulatory reforms

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It is impossible to predict

whether legislative changes will be enacted, or FDA regulations, guidance or interpretations changed, and what the impact of such changes,

if any, may be.

whether legislative or FDA regulation changes will be enacted, or whether guidance or interpretations will change, and what the impact

of such changes, if any, may be.

Risks Related to our Business Operations

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additional qualified personnel may harm our business and impede the implementation of our business strategy.

We will need to attract, integrate, motivate and

retain a significant number personnel in the future.

Competition for these individuals in our industry and geographic region is intense,

and we may be unable to attract, assimilate or retain such highly qualified personnel in the future.

Our business cannot continue to grow

if we are unable to attract such qualified personnel.

Our failure to attract and retain highly trained personnel that are essential to

our business may limit our growth rate, which would harm our business and impede the implementation of our business strategy.

We may need to attract,

integrate, motivate and retain personnel with specific qualifications in the future .

Competition for these individuals in our industry

and geographic region is intense, and we may be unable to attract, assimilate or retain such highly qualified personnel in the future.

Our business cannot continue to grow if we are unable to attract such qualified personnel.

Our failure to attract and retain highly trained

personnel that are essential to our business may limit our growth rate, which would harm our business and impede the implementation of

our business strategy.

We may be unable to maintain sufficient

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Our inability to retain and properly insure

against the loss of the services of our executive officer and other key personnel may harm our business and impede the implementation

against the loss of the services of our chief executive officer and other key personnel may harm our business and impede the implementation

of our business strategy.

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our key employees.

If any of our executive officers or key employees left or was seriously injured and unable to work and we were unable

If any of our executive officers or key employees left or were seriously injured and unable to work and we were unable

to find a qualified replacement and/or to obtain adequate compensation for such loss, we may be unable to manage our business, which could

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in dilution to our existing stockholders.

Our financial and operating performance

is adversely affected by the coronavirus pandemic.

The outbreak of a strain of coronavirus (COVID-19)

has had an unfavorable impact on our business operations.

Mandatory closures of businesses imposed by the federal, state

and local governments to control the spread of the virus is disrupting the operations of our management, business and finance teams.

addition, the COVID-19 outbreak has adversely affected the U.S.

economy and financial markets, which may result in a long-term economic

downturn that could negatively affect future performance.

The extent to which COVID-19 and the efforts to mitigate the effects will impact

our business and our consolidated financial results will depend on future developments which are highly uncertain and cannot be predicted

at the time of the filing, but could be expected to result in a material adverse impact on our business, results of operations and financial

If our expenses are greater than anticipated,

then we will have fewer funds with which to pursue our plan of operations and our financing requirements will be greater than anticipated.

We may find that the costs of carrying out our

plan of operations are greater than we anticipate.

We expect our expenses to increase over time in connection with our ongoing activities,

particularly if and as we:

invest in marketing and distribution capabilities in support of developing and potentially commercializing

our products in the U.S., if cleared or approved;

make improvements product design;

launch the PRV-002 trial or conduct other

trials of the products, subject to discussion with FDA;

We may find that the costs of carrying out

our plan of operations are greater than we anticipate.

We expect our expenses to increase over time in connection with our ongoing

activities, particularly if and as we:

invest in marketing and distribution capabilities in support of developing and potentially

commercializing our products in the U.S., if cleared or approved;

make improvements to product design;

launch the ONP-002 trial

or conduct other trials of the products, subject to discussion with the FDA;

pursue regulatory clearances and approvals;

maintain, expand and protect our intellectual

property portfolio;

expand and protect our intellectual property portfolio;

engage third party manufacturers;

and add additional personnel.

Increased operating costs may cause the amount of

financing that we require to increase.

Investors may be more reluctant to provide additional financing if we cannot demonstrate that we

can control our operating costs.

There is no assurance that additional financing required as a result of our operating costs being greater

than anticipated will be available to us.

If we do not control our operating expenses, then we will have fewer funds with which to carry

out our plan of operations with the result that our business may fail.

operating costs may cause the amount of financing that we require to increase.

Investors may be more reluctant to provide additional

financing if we cannot demonstrate that we can control our operating costs.

There is no assurance that additional financing required

as a result of our operating costs being greater than anticipated will be available to us.

If we do not control our operating

expenses, then we will have fewer funds with which to carry out our plan of operations, which could result in the failure of our

We are heavily dependent upon the ability

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No network or system can ever be completely secure, and the risk of a security breach or disruption, particularly through cyber-attacks

or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity

and sophistication of attempted attacks and intrusions from around the world have increased.

If such an event were to occur and cause

interruptions in our operations, it could result in operations, reputation, or a material disruption of our development programs for an

indeterminate period of time.

For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could

result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

In some cases,

data cannot be reproduced.

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications,

or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, damage to

our reputation, and the further development of our devices and drugs or any future product candidate could be delayed.

If a security breach

results in the exposure or unauthorized disclosure of personal information, we could incur additional costs associated with data breach

notification and remediation expenses, investigation costs, regulatory penalties and fines, and legal proceedings.

Our insurance coverage

may not be adequate to cover all the costs related to such breaches or attacks.

Challenges to our tax positions in U.S.

or cyber intrusion, including, but not limited to,by computer hackers, foreign governments, and cyber terrorists, have generally increased

as the number, intensity and sophistication of attempted attacks, and intrusions from around the world have increased.

If such an event

were to occur and cause interruptions in our operations, it could result in operations, reputation, or a material disruption of our development

programs for an indeterminate period of time.

For example, the loss of clinical trial data from completed or ongoing or planned clinical

trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

In some cases, data cannot be reproduced.

To the extent that any disruption or security breach was to result in a loss of or damage to

our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims

and liability, damage to our reputation, and the further development of our devices and drugs or any future product candidate could be

If a security breach results in the exposure or unauthorized disclosure of personal information, we could incur additional costs

associated with data breach notification and remediation expenses, investigation costs, regulatory penalties and fines, and legal proceedings.

Our insurance coverage may not be adequate to cover all the costs related to such breaches or attacks.

Challenges to our tax positions in

jurisdictions, the interpretation and application of recent U.S.

tax legislation or other changes in U.S.

of our operations could harm our business, revenue and financial results.

taxation of our operations could harm our business, revenue and financial results.

We operate, or intend to operate, in a number

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Significant judgment is required in determining

our worldwide provision for income taxes and other tax liabilities, and tax authorities may disagree with tax positions we take and challenge

our worldwide provision for income taxes and other tax liabilities.

Tax authorities may disagree with tax positions we take and challenge

our tax positions.

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Although our stockholders will not be bound by

or be personally liable for our expenses, liabilities or obligations beyond their total original investments in our common stock, if we

suffer a deficiency in funds with which to satisfy our obligations, our stockholders as a whole may lose their entire investment in our

or held personally liable for our expenses, liabilities or obligations beyond their total original investments in our common stock, if

we suffer a deficiency in funds with which to satisfy our obligations, our stockholders as a whole may lose their entire investment in

The sale or issuance of our common stock

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the related registration statement and that such registration statement remains effective.

The purchase price for the shares that we

may sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock.

The purchase price for the shares that we may

sell to Lincoln Park under the Purchase Agreement will fluctuate based on the price of our common stock.

Depending on market liquidity

at the time, sales of such shares may cause the trading price of our common stock to fall.

Subject to the terms of the Purchase Agreement, we

generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park.

Additional sales of our common

stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us.

We may ultimately decide to

sell to Lincoln Park all, some, or none of the additional shares of our common stock that may be available for us to sell pursuant to

the Purchase Agreement.

If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park may resell

all or some of those shares at any time or from time to time in its discretion.

Therefore, sales to Lincoln Park by us could result in

substantial dilution to the interests of other holders of our common stock.

Additionally, the sale of a substantial number of shares of

our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related

Subject to the terms of the Purchase Agreement,

we generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park.

Additional sales of our

common stock, if any, to Lincoln Park will depend upon market conditions and other factors to be determined by us.

We may ultimately decide

to sell to Lincoln Park all, some, or none of the additional shares of our common stock that may be available for us to sell pursuant

to the Purchase Agreement.

If and when we do sell shares to Lincoln Park, after Lincoln Park has acquired the shares, Lincoln Park may

resell all or some of those shares at any time or from time to time in its discretion.

Therefore, sales to Lincoln Park by us could result

in substantial dilution to the interests of other holders of our common stock.

Additionally, the sale of a substantial number of shares

of our common stock to Lincoln Park, or the anticipation of such sales, could make it more difficult for us to sell equity or equity-related

securities in the future at a time and at a price that we might otherwise wish to effect sales.

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purchased a total of 7,382,518 shares of our common stock at a weighted average price of $0.35 per share for total proceeds of $2,600,487.

Subsequent to July 31, 2022 and through October 31, 2022, we sold an additional 1,133,591 shares of our common stock to LPC for total

proceeds $240,710 and, as of October 31, 2022, remaining purchase availability was $7,989,024 and remaining shares available were 14,388,846.

Subsequent to July 31, 2023 and through October 30, 2023, we sold 500,000 shares of our common stock to LPC for total proceeds of $45,820.

As of October 30, 2023, LPC had purchased a total of 7,882,518 shares of our common stock for total proceeds of $2,646,306 and the remaining

purchase availability was $7,603,694 and the remaining shares available were 11,388,846.

A limited public trading market exists for our

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Our common stock is quoted for trading on the

OTC PINK Marketplace.

We still will be unable to list our stock on the OTC PINK.

Should we fail to satisfy the eligibility standards of

OTC Markets for the OTC Markets Fully Reporting, the trading price of our common stock could continue to suffer and the trading market

for our common stock may be less liquid and our common stock price may be subject to increased volatility.

OTCQB Marketplace.

Should we fail to satisfy the fully reporting eligibility standards of OTC Markets for the OTC Markets, the trading

price of our common stock could continue to suffer, and the trading market for our common stock may become less liquid and our common

stock price may be subject to increased volatility.

Our common stock is deemed to be a “penny

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penny stocks and the nature and level of risks in the penny stock market.

The broker-dealer also must provide the customer with current

The broker-dealer must also provide the customer with current

bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly

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to the transaction before the sale.

The broker-dealer also must disclose the commissions payable to the broker-dealer, current bid and

The broker-dealer must also disclose the commissions payable to the broker-dealer, current bid and

offer quotations for the penny stock, and, if the broker-dealer is the sole market maker, the broker-dealer must disclose this fact and

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decrease our total market capitalization and increase, and may continue to increase, the volatility of our stock price.

At our 2021 annual stockholder meeting, which

was held on September 14, 2021, the stockholders approved the proposal that granted the Board discretionary authority to amend our Certificate

of Incorporation to effect a reverse stock split of the issued and outstanding shares of our Common Stock, par value $0.001 per share,

such split to combine a whole number of outstanding shares of our Common Stock in a range of not less than two shares and not more than

30 shares, into one share of Common Stock at any time prior to January 31, 2022.

The amendments will not change the number of authorized

shares of Common Stock or Preferred Stock or the relative voting power of our stockholders.

At our annual stockholder meeting held on January

12, 2023, the stockholders approved the proposal that granted the Board discretionary authority to amend our Certificate of Incorporation

to effect a reverse stock split of the issued and outstanding shares of our common stock in a range of not less than two shares and not

more than 200 shares at any time on or before December 31, 2023.

As determined by our Board, such stock split could be effected at a time

and choosing of the Board.

The amendment did not change the number of authorized shares of common stock or preferred stock or the relative

voting power of our stockholders.

The number of authorized shares will not be reduced.

The number of authorized but unissued shares of

our common stock will materially increase and will be available for re-issuance.

We reserve the right not to effect any reverse stock

split if the Board does not deem it to be in the best interests of our stockholders and the Board's decision as to whether and when to

effect the reverse stock split will be based on a number of factors, including prevailing market conditions, existing and expected trading

prices for our common stock, actual or forecasted results of operations, and the likely effect of such results on the market price of

our common stock.

There can be no assurance that the total market

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we caution you as to the highly illiquid nature of an investment in our shares.

Our common stock is listed on the OTC PINK.

Our common stock is listed on the OTCQB.

of microcap and small-cap companies have experienced substantial volatility in the past, often based on factors unrelated to

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common stock.

These factors, or any of them, may materially adversely affect the prices of our common shares regardless of our operating

Any of these factors, may materially adversely affect the prices of our common shares regardless of our operating performance.

The market price of our common stock is affected

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influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors.

If any of the analysts who may cover us change their recommendation regarding our stock adversely, or provide more favorable relative

If any of the analysts who may cover us, adversely change their recommendation regarding our stock, or provide more favorable relative

recommendations about our competitors, our stock price would likely decline.

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Legal Proceedings

As of the date of this filing, we are not a party

to any legal proceeding.

As of the date of this filing, we are currently

not a party to any legal proceedings.

Mine Safety Disclosures

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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 1A. Risk Factors