What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2026-04-29 compared with 2025-04-28 · 40 added, 303 removed, 423 unchanged (45% of the section changed)

2 unchanged sentences

You should carefully consider the risks described below together with all of the other information included in

this prospectus before making an investment decision with regard to our securities.

The statements contained in this prospectus include

this report before making an investment decision with regard to our securities.

The statements contained in this report include

forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those

8 unchanged sentences

Risks Concerning our Business

There is economic

uncertainty concerning economic policies being pursued by the new administration in the United States that may affect the costs and timing

of the process of bringing our products to market through approvals with the FDA.

Our operating results

are affected by the current political and economic uncertainties related to the economy of the United States, the domestic pharmaceutical

industry and world economies.

Future conditions may also adversely affect our pricing strategy, promotional activities and our profitability

The United States at

the time of this filing is involved with a war with Iran, the outcome of which could result in changes adverse to us in domestic and international

markets, including on tariffs and health care and medical products.

These changes could affect our promotional activities and our profitability

Additionally, many of the effects and consequences of U.S.

and global financial and economic conditions could potentially

have a material adverse effect on our liquidity and capital resources, including the ability to raise additional capital, if needed, or

could otherwise negatively affect our business and financial results.

Market instability could make it more difficult for us and our suppliers

to accurately forecast future product demand trends.

Additionally, inflationary factors such as increases in the costs to purchase products,

acquire product rights and overhead costs may adversely affect our operating results.

We are subject to the

risks common to start-up, pre-revenue enterprises, including, among other factors, undercapitalization, cash shortages, limitations with

respect to personnel, financial and other resources and lack of revenues.

Drug development companies typically incur substantial losses

during the product development and FDA testing phase of the business and do not generate revenues until after the drug has received FDA

approval, which cannot be assured, and until the company has started to sell the product.

We can give no assurance that we can or will

ever be successful in achieving profitability and the likelihood of our success must be considered in light of our early stage of operations.

We cannot assure you that we will be able to operate profitably or generate positive cash flow.

If we cannot achieve profitability, we

may be forced to cease operations and you may suffer a total loss of your investment.

and global financial and economic conditions and current stock

market trends, which are concentrating on companies in the artificial intelligence development market, could potentially have a material

adverse effect on our liquidity and capital resources, including the ability to raise additional capital, if needed, or could otherwise

negatively affect our business and financial results.

We are subject to

the risks common to start-up, pre-revenue medical delivery device enterprises, including, among other factors, undercapitalization,

cash shortages, limitations with respect to personnel, financial and other resources and lack of revenues.

Drug development

companies typically incur substantial losses during the product development and FDA testing phase of the business and do not

generate revenues until after the drug has received FDA approval, which cannot be assured, and until the company has started to sell

We can give no assurance that we can or will ever be successful in achieving profitability and the likelihood of our

success must be considered in light of our early stage of operations.

We cannot assure you that we will be able to operate

profitably or generate positive cash flow.

If we cannot achieve profitability, we may be forced to cease operations and you may

suffer a total loss of your investment.

While cybersecurity events have not had a material

impact on us, we can provide no assurance that we will not experience any such impact or additional interruptions to our operations in

Given the unpredictability of the timing and the evolving nature and scope oft information and operational technology system

disruptions, the various procedures and controls we use to monitor and protect against cybersecurity threats and to mitigate potential

risks arising from such threats have not been effective in some instances and may not be sufficient in preventing future cybersecurity

Further, as cybersecurity threats continue to evolve, we may be required to expend significant additional resources to continue

to modify or enhance our protective measures or to investigate and remediate vulnerabilities to cybersecurity threats.

A number of factors, including, but not limited to the following, may

13 unchanged sentences

our ability to attract and retain key personnel to manage our business effectively.

Our failure to develop our abuse deterrent

fentanyl transdermal system will impair our ability to continue in business.

Our lead product is our abuse deterrent

fentanyl transdermal system, and we are devoting our resources primarily to developing this product to enable us to obtain FDA

approval so as to be able to market the product.

If we are not able to obtain necessary financing to develop our product, obtain FDA marketing

approval and market this product successfully, we may not have the resources to develop additional products, and we may not be able

to continue in business.

Before we can market in the United States

11 unchanged sentences

the manufacturing process and the manufacturing facility.

Risk of delays at FDA due to restructuring

Changes at the Food and Drug Administration

(FDA) and other federal agencies under the incoming Trump administration include implementing a hiring freeze and employee layoffs

by executive orders and other measures implemented by the Department of Government Efficiency, may lead to new policies, changes in

the regulations, and disruption of normal operations of the FDA and other agencies, any of which may adversely impact our clinical

development plans and business operations.

Disruptions at the FDA may lead to slower response times and longer review periods,

potentially affecting our ability to progress with development of our product candidates or obtain timely regulatory approval for

our product candidates.

Changes in regulations may result in unexpected delays, increased costs, or other negative impacts on our

business that are difficult to predict.

Risk of increased tariffs on foreign goods.

7 unchanged sentences

existing products marketed in the United States.

We may encounter delays in completing clinical

trials, which would increase our costs and delay market entry.

We may experience delays in completing the clinical

trials necessary for FDA approval.

These delays may result from a number of factors which could prevent us from starting the trial on

time or completing the study in a timely manner, which may include factors out of our control.

Since we may need to rely on third parties

for supplying us with the drug and transdermal patches used in the trials, there may be various reasons for us to experience a delay in

obtaining the clinical materials required to start each clinical trial, which may include factors out of our control.

Clinical trials

can be delayed or terminated for a number of reasons, including delay or failure to:

obtain necessary financing;

obtain regulatory approval to commence a trial;

reach agreement on acceptable terms with prospective contract research organizations, investigators and clinical trial sites, the terms of which may be subject to extensive negotiation and vary significantly among different research organizations and trial sites;

obtain institutional review board approval at each site;

enlist suitable patients to participate in a trial;

have patients complete a trial or return for post-treatment follow-up;

ensure clinical sites observe trial protocol or continue to participate in a trial;

address any patient safety concerns that arise during the course of a trial;

address any conflicts with new or existing laws or regulations;

add a sufficient number of clinical trial sites;

manufacture sufficient quantities of the product candidate for use in clinical trials.

Patient enrollment is also a significant factor

in the timely completion of clinical trials and is affected by many factors, including the size and nature of the patient population,

the proximity of patients to clinical sites, the eligibility criteria for the trial, the design of the clinical trial, competing clinical

trials and clinicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to available

alternatives, including any new drugs or treatments that may be approved for the indications we are investigating.

We may also encounter delays if a clinical

trial is suspended or terminated by us or our CDMO, by the independent review boards of the institutions in which such trials are being

conducted, by the trial’s data safety monitoring board, or by the FDA.

Such authorities may suspend or terminate one or more

of our clinical trials due to a number of factors, including our failure to conduct the clinical trial in accordance with relevant

regulatory requirements or clinical protocols, inspection of the clinical trial operations or trial site by the FDA resulting in the

imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug,

changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

If we experience delays in carrying out or completing

clinical trials for any product candidates, the commercial prospects of our product candidates may be harmed, and our ability to generate

revenues from any of these product candidates will be delayed.

In addition, any delays in completing our clinical trials will increase

our costs, slow down the product development and approval process and jeopardize our ability to commence product sales and generate revenues.

Any of these occurrences may significantly harm our business and financial condition.

In addition, many of the factors that cause, or

lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of

our product candidates.

Our ability to finance our operations and

28 unchanged sentences

may not be able to generate sufficient revenues through the sale of our products to enable us to continue our business.

Since we do not have commercial manufacturing

capability, if we are unable to establish manufacturing facilities, we may have to enter into a manufacturing agreement with a manufacturer

that has been approved by the FDA.

Any commercial manufacturer of our products and

the manufacturing facilities where we make our commercial products will be subject to FDA inspection.

Part of the process of seeking FDA

approval to market our products is the FDA’s approval of the manufacturing process and facility.

Although we may establish our own

manufacturing facilities, the establishment of a manufacturing facility is very costly, and, unless we obtain funding for that purpose,

it would be necessary for us to engage a contract manufacturer who has experience is manufacturing FDA-approved transdermal products.

By relying on a contract manufacturer, we will be dependent upon the manufacturer, whose interests may be different from ours.

manufacturer will be responsible for product quality and for meeting regulatory requirements.

If the manufacturer does not meet our quality

standards and delivers products that do not meet our specifications, we may both incur liability for breach of our warranty to our customer,

as well as liability for any adverse events, including death, that may result from the use, abuse or accidental misuse of the product.

Regardless of whether we are able to make a claim against the contract manufacturer, our reputation may be harmed and we may lose business

Further, the contract manufacturer may have other customers and may allocate its resources based on the contract manufacturer’s

interest rather than our interest.

Furthermore, we may not be able to assure ourselves that we will get favorable pricing.

If we or any third-party

27 unchanged sentences

Furthermore, risks that are not adequately addressed through the proposed REMS program may also prevent or delay its approval for commercialization.

Our products will continue to be subject to FDA review after

FDA approval is given.

Discovery of previously unknown problems with

our products or unanticipated problems with the manufacturing processes and facilities, even after FDA and other regulatory approvals

of the product for commercial sale, may result in the imposition of significant restrictions, including withdrawal of the product from

The FDA and other regulatory agencies continue

to review products even after the products receive agency approval.

If and when the FDA approves one of our products, its manufacture

and marketing will be subject to ongoing regulation, which could include compliance with current good manufacturing practices, adverse

event reporting requirements and general prohibitions against promoting products for unapproved or “off-label” uses.

also subject to inspection and market surveillance by the FDA for compliance with these and other requirements.

Any enforcement action

resulting from the failure, even by inadvertence, to comply with these requirements could affect the manufacture and marketing of our

In addition, the FDA or other regulatory agencies could withdraw a previously approved product from the market upon receipt

of newly discovered information.

The FDA or another regulatory agency could also require us to conduct additional, and potentially expensive,

studies in areas outside our approved indicated uses.

We must continually monitor the safety of

88 unchanged sentences

We cannot assure you that we will

not face liability arising out of the use of our products which is significantly in excess of the limits of our product liability insurance.

In such event, if we do not have the funds or access to the funds necessary to satisfy such liability, we may be unable to continue in

not face one or more claims alleging liabilities arising out of the use of our products which is significantly in excess of the limits

of our product liability insurance.

In such event, if we do not have the funds or access to the funds necessary to satisfy such liability,

we may be unable to continue in business.

Because some of the patches we are developing,

17 unchanged sentences

assessed against us.

We may decide not to continue developing

or commercializing any products at any time during development or after approval, which would reduce or eliminate our potential return

on investment for those product candidates.

We may decide to discontinue the development of

our abuse deterrent fentanyl transdermal system or any other product in our pipeline or not to continue to commercialize any potential

product for a variety of reasons, such as the appearance of new technologies that make our product less commercially viable, an increase

in competition, changes in or failure to comply with applicable regulatory requirements, changes in the regulatory or public policy environment,

the discovery of unforeseen side effects during clinical development or after the approved product has been marketed or the occurrence

of adverse events at a rate or severity level that is greater than experienced in prior clinical trials.

If we discontinue a program in

which we have invested significant resources, we will not receive any return on our investment.

If any of our potential products are approved

for marketing but fail to achieve the broad degree of physician or market acceptance necessary for commercial success, our operating results

and financial condition will be adversely affected.

If any of the products in our pipeline

receives FDA approval thereby allowing us to market the product in the United States, it will be necessary for us to generate

acceptance of our product for the indications covered by the FDA approval.

Since we do not presently have the resources necessary to

develop or implement an in-house marketing program and we may not have the funds to do so if and when we obtain FDA approval to

market our product, we will need to establish a distribution network though license and distribution agreements with third parties

who have the capability to market our product to physicians, and we will be dependent upon the ability of these third parties to

market our products effectively.

We cannot assure you that we will be able to negotiate license and distribution agreements with

terms that are acceptable to us.

Since we do not have an established track record and our product pipeline is relatively small, we

may be at a disadvantage in negotiating the terms of license and distribution agreements.

Further, we may have little control over

the development and implementation of our licensee’s marketing program, and our licensees may have interests that are

inconsistent with ours with respect to the allocation of resources and implementation of the marketing program.

We cannot assure you

that a marketing program for any of our products can or will be implemented effectively or that we will be successful in developing

physician and emergency service acceptance of our products.

The drug delivery industry is subject to

8 unchanged sentences

would result in our having to cease its operations.

If we obtain FDA approval, we will face

significant competition from better known and better capitalized companies.

If we obtain FDA approval, we may face significant

competition from better known and better capitalized companies.

If we obtain FDA approval for any of our products,

27 unchanged sentences

the price and examining the cost effectiveness of medical products and services.

Increasing expenditures for healthcare have been

the subject of considerable public attention in the United States.

Both private and government entities are seeking ways to reduce or

contain healthcare costs.

Numerous proposals that would effect changes in the United States healthcare system have been introduced or

proposed in Congress and in some state legislatures, including reducing reimbursement for prescription products and reducing the levels

at which consumers and healthcare providers are reimbursed for purchases of pharmaceutical products.

Cost reduction initiatives and changes in coverage

implemented through legislation or regulation could decrease utilization of and reimbursement for any approved products, which in turn

would affect the price we can receive for those products.

Any reduction in reimbursement that results from federal legislation or regulation

may also result in a similar reduction in payments from private payors, since private payors often follow Medicare coverage policy and

payment limitations in setting their own reimbursement rates.

Significant developments that may adversely affect

62 unchanged sentences

our failure to develop additional proprietary technologies that are patentable.

If we seek to expand our business through

acquisition, we may not be successful in identifying acquisition targets or integrating their businesses with our existing business.

We have expanded

our business by acquisition, and we may make acquisitions in the future.

Acquisitions may lead to our acquiring assets the value of

which is not commensurate with the purchase price we paid.

For example, in 2017, we issued 1,458,333 shares of common stock,

valued at $2,500,000, in connection with our proposed acquisition of Advanced Health Brands, Inc., but the stock of Advanced Health

Brands was never transferred to us and the value of the intellectual property we were to have acquired did not have the value we

anticipated, with the result that we incurred a $2,500,000 impairment loss in the year ended January 31, 2018.

In September 2018, we

entered into an agreement to acquire Carmel Biosciences Inc., and in November 2018, we terminated the agreement.

We previously

entered into another acquisition agreement which was rescinded shortly after the agreement was executed.

We cannot assure you that

any acquisition we complete will be successful or that any acquisition agreement we may enter into will result in an acquisition.

acquisition can be unsuccessful for a number of reasons, including the following:

We may incur significant expenses and devote significant management time to the acquisition and we may be unable to consummate the acquisition on acceptable terms.

The integration of any acquisition with our existing business may be difficult and, if we are not able to integrate the business successfully, we may not only be unable to operate the business profitably, but management may be unable to devote the necessary time to the development of our existing business;

The key employees who operated the acquired business successfully prior to the acquisition may not be happy working for us and may resign, thus leaving the business without the necessary continuity of management.

If the business does not operate as we expect, we may incur an impairment charge based on the value of the assets acquired.

The products or proposed products of the acquired company may have regulatory problems with the FDA or any other regulatory agency, including the need for additional and unanticipated testing or the need for a recall or a change in labeling.

We may have difficulty maintaining the necessary quality control over the acquired business and its products and services.

To the extent that an acquired company operates at a loss prior to our acquisition, we may not be able to develop profitable operations following the acquisition.

The acquired company may have liabilities or obligations which were not disclosed to us, or the acquired assets, including any intellectual property, may not have the value we anticipated.

The assets, including intellectual property, of the acquired company may not have the value that we anticipated.

We may require significant capital both to acquire and to operate the business, and the capital requirements of the business may be greater than we anticipated.

Our failure to obtain funds on reasonable terms may impair the value of the acquisition.

The acquired company may not operate at the revenue level or with the gross margin shown in the financial statements or projections.

Patents may not be granted for patent applications which the acquired company filed or patents may be successfully challenged.

There may be conflicts in management styles that prevent us from integrating the acquired company with us.

The business of the acquired company may have problems of which management was unaware and which do not become evident until after the acquisition and we may require significant funding to remedy the problem.

The indemnification obligations of the seller under the purchase agreement, if any, may be inadequate to compensate us for any loss, damage or expense which we may sustain, including undisclosed claims or liabilities.

To the extent that the acquired company is dependent upon its management to maintain relationships with existing customers, we may have difficulty in retaining the business of these customers if there is a change in management.

Government agencies may seek damages after we make the acquisition for conduct which occurred prior to the acquisition and we may not have adequate recourse against the seller.

If any of the foregoing or any other events which

we do not contemplate happen, we may incur significant expenses, which we may not be able to cover, and the development of our business

can be impaired.

We cannot assure you that any acquisition we will make will be successful.

We are dependent on third party distributors

for the international marketing of our consumer products and complying with applicable laws.

We do not currently sell or market our consumer

transdermal products domestically, or for our international sales, directly to international consumers, and we rely on distributors to

sell and market these products.

We cannot market our consumer transdermal patch products in the United States without first obtaining

FDA approval.

We do not plan to seek FDA approval or market these products in the United States at this time.

We plan to sell our transdermal

consumer products to distributors in those countries in which the products can be sold in compliance with all applicable regulations without

our spending significant monies for preclinical and clinical studies to obtain regulatory approval.

We are dependent upon our chief executive

4 unchanged sentences

of 4P Therapeutics.

Although these officers have employment agreements with us, the employment agreements do not guarantee

that the officer will continue with us.

Although these officers have employment agreements with us, the employment agreements do not guarantee that the officer

will continue with us.

The loss of Mr.

Sheridan, Mr.

Melnik or Dr.

Smith would materially impair our ability to conduct our business.

27 unchanged sentences

in developing or maintaining internal control.

The market price for our common stock may

be volatile and your investment in our common stock could suffer a decline in value.

The trading volume in our stock is low, which

may result in volatility in our stock price.

As a result, any reported prices may not reflect the price at which you would be able to

sell shares of common stock if you want to sell any shares you own or buy if you wish to buy shares.

Further, stocks with a low trading

volume may be more subject to manipulation than a stock that has a significant public float and is actively traded.

The price of our stock

may fluctuate significantly in response to a number of factors, many of which are beyond our control.

These factors include, but are not

limited to, the following, in addition to the risks described above and general market and economic conditions:

the market’s perception as to our ability to generate positive cash flow or earnings;

changes in our or any securities analysts’ estimate of our financial performance;

the perception of our ability to raise the necessary financing to complete the product development activities including preclinical and clinical testing required for FDA approval and our ability to generate revenue and cash flow from our products;

the anticipated or actual results of our operations;

changes in market valuations of other companies in our industry;

litigation or changes in regulations and insurance company reimbursement policies affecting prescription drugs;

concern that our internal controls are ineffective;

any discrepancy between anticipated or projected results and actual results of our operations;

actions by third parties to either sell or purchase stock in quantities which would have a significant effect on our stock price;

other factors not within our control.

Raising funds by issuing equity or convertible

debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital.

We anticipate that we

will require funds for our business.

If we were to raise capital by issuing equity securities, either alone or in connection with a non-equity

financing, the net tangible book value of the then outstanding common stock could decline.

If the additional equity securities were issued

at a per share price less than the market price, which is customary in the private placement of equity securities, the holders of the

outstanding shares would suffer dilution, which could be significant.

Further, if we are able to raise funds from the sale of debt securities,

the lenders may impose restrictions on our operations and may impair our working capital as we service any such debt obligations.

Stockholders may experience significant

45 unchanged sentences

The settlement may affect the market for and the market price of our common stock.

The market price for our common stock may

be volatile and your investment in our common stock could suffer a decline in value.

The trading volume in our stock is low, which

may result in volatility in our stock price.

As a result, any reported prices may not reflect the price at which you would be able to

sell shares of common stock if you want to sell any shares you own or buy if you wish to buy shares.

Further, stocks with a low trading

volume may be more subject to manipulation than a stock that has a significant public float and is actively traded.

The price of our stock

may fluctuate significantly in response to a number of factors, many of which are beyond our control.

These factors include, but are not

limited to, the following, in addition to the risks described above and general market and economic conditions:

the market’s reaction to our financial condition and its perception of our ability to raise necessary funding or enter into a joint venture, as well as its perception of the possible terms of any financing or joint venture;

the market’s perception as to our ability to generate positive cash flow or earnings;

changes in our or any securities analysts’ estimate of our financial performance;

the anticipated or actual results of our operations;

changes in market valuations of other companies in our industry;

litigation or changes in regulations and insurance company reimbursement policies affecting prescription drugs;

concern that our internal controls are ineffective;

any discrepancy between anticipated or projected results and actual results of our operations;

actions by third parties to either sell or purchase stock in quantities which would have a significant effect on our stock price;

other factors not within our control.

Because of our executive officers’

3 unchanged sentences

as a group beneficially own approximately 49.88% of our common stock as of April 28, 2026.

As a result, they have the effective power using

their contacts with a limited number of other shareholders to elect all of our directors and to approve any action requiring stockholder

As a result, they have the effective power

using their contacts with a limited number of other shareholders to elect all of our directors and to approve any action requiring stockholder

Raising funds by

10 unchanged sentences

the lenders may impose restrictions on our operations and may impair our working capital as we service any such debt obligations.

We may issue preferred

stock whose terms could adversely affect the voting power or value of our common stock.

Our articles of incorporation

authorize us to issue, without the approval of our stockholders, one or more classes or series of preferred stock having such designations,

preferences, limitations and relative rights, including preferences over our common stock respecting dividends and distributions, as our

board of directors may determine.

The terms of one or more classes or series of preferred stock could adversely impact the voting power

or value of our common stock.

For example, we might grant holders of preferred stock the right to elect a number of our directors in all

events or on the happening of specified events or the right to veto specified transactions.

Similarly, the repurchase or redemption rights

or liquidation preferences we might assign to holders of preferred stock could affect the residual value of the common stock.

We do not intend

to pay any cash dividends in the foreseeable future.

We have not paid any

cash dividends on our common stock and do not intend to pay cash dividends on our common stock in the foreseeable future.

UNRESOLVED STAFF COMMENTS.

Not Applicable.

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