What changed in this filing

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Item 1A. Risk Factors

2021-06-14 compared with 2020-12-15 · 86 added, 41 removed, 25 unchanged (84% of the section changed)

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.

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 risks set forth below are not the only risks facing us.

Additional risks and uncertainties may exist

that could also adversely affect our business, prospects or operations.

If any of the following risks actually occurs, our business,

financial condition or results of operations could be harmed.

In that case, the trading price of our common stock could decline,

and you may lose all or a significant part of your investment.

Because of a lack of funds, we have

suspended our product development operations.

Our business is the development of transdermal systems for the

delivery of pharmaceuticals.

The development of pharmaceutical products is highly cash intensive, and many early stage drug development

companies are unable to raise sufficient cash to complete the development and testing of their products and obtain regulatory approval,

with the result that they either obtain funding on very unfavorable terms, cease to conduct business or sell or license their intellectual

property on unfavorable terms.

As of October 31, 2020, we had $193,392 in cash and cash equivalents and a working capital deficiency

of $2,230,240, as compared with cash and cash equivalents of $10,181 and working capital deficiency of $1,979,141 as of January

Because of the absence of any significant financing, we have suspended our development activities relating to our transdermal

pharmaceutical products.

Because of the anticipated lack of revenues until we have an approved product that we can market and the

time required to obtain FDA approval, which can take many years, we must rely on our ability to raise money in the private or public

equity market or enter into a joint venture relationship with a company that has the funds, the willingness and the ability to

fund or obtain funds for the project that is the subject of the joint venture.

In March 2020, we withdrew a registration statement

relating to a proposed public offering.

If we are able to raise funds or enter into a joint venture, it is likely that the term

will not be favorable to us.

We cannot assure you that we will be able to raise funds in a public or private financing or a joint

venture, and, if we are unable to do so, we may cease operations.

Additional risks and uncertainties may exist that could also adversely affect

our business, prospects or operations.

If any of the following risks actually occurs, our business, financial condition or results of

operations could be harmed.

In that case, the trading price of our common stock could decline, and you may lose all or a significant part

of your investment.

Because of a lack of funds, we have suspended

our pharmaceutical product development operations.

Our business is the development of transdermal

systems for the delivery of pharmaceuticals.

The development of pharmaceutical products is highly cash intensive, and many early-stage

drug development companies are unable to raise sufficient cash to complete the development and testing of their products and obtain regulatory

approval, with the result that they either obtain funding on very unfavorable terms, cease to conduct business or sell or license their

intellectual property on unfavorable terms.

Because of our lack of cash and the absence of any significant financing, we have suspended

our development activities relating to our transdermal pharmaceutical products.

Because of the anticipated lack of revenues until we have

an approved product that we can market and the time required to obtain FDA approval, which can take many years, we must rely on our ability

to raise money in the private or public equity market or enter into a joint venture relationship with a company that has the funds, the

willingness and the ability to fund or obtain funds for the project that is the subject of the joint venture.

In March 2020, we withdrew

a registration statement relating to a proposed public offering.

If we are able to raise funds or enter into a joint venture, it is likely

that the term will not be favorable to us.

We cannot assure you that we will be able to raise funds in a public or private financing or

a joint venture, and, if we are unable to do so, we may cease operations.

Because we are an early-stage company with

minimal revenue and a history of losses and we expect to continue to incur substantial losses for the foreseeable future, we cannot assure

you that we can or will be able to operate profitably.

We did not generate any revenue prior to the quarter

ended October 31, 2018 and since then, we have incurred losses as, 4P Therapeutics generated only modest revenue from contract research

and development services which are not related to our pharmaceutical transdermal patch business.

Although we anticipate that, for the

near term, we will continue to perform research and development services for third parties, we do not expect to generate significant revenue

from performing contract research and development services for our clients and we have generated losses from operations from this business.

During the year ended January 31, 2021, we experienced a significant decline in revenue from 4P Therapeutics’

largest customer.

We generated negative cash flow from operations for the years ended January 31, 2021 and 2020.

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.

Because we do not have a product we can

market in the United States, we cannot predict when or whether we will operate profitably.

We have not completed the development of our lead

product, which is our abuse deterrent fentanyl transdermal system, and we do not have any product that we can market in the United States.

Because of the numerous risks and uncertainties associated with product development, we cannot assure you that we will be able to develop

and market any products or achieve or attain profitability.

If we are able to obtain financing for our operations, we expect that we will

incur substantial expenses as we continue with our product development and clinical trials.

Further, if we are required by applicable

regulatory authorities, including the FDA as well as the comparable regulatory agencies in other countries in which we may seek to market

product, to perform studies in addition to those we currently anticipate, our expenses will increase beyond expectations and the timing

of any potential product approval may be delayed.

As a result, we expect to continue to incur substantial losses and negative cash flow

for the foreseeable future.

A number of factors, including, but not limited

to the following, may affect our ability to develop our business and operate profitably:

our ability to obtain necessary funding to develop our proposed products;

the success of clinical trials for our products;

our ability to obtain FDA approval for us to market any proposed product in our pipeline in the United States;

any delays in regulatory review and approval of product in development;

if we obtain FDA approval to market our product, our ability to establish manufacturing and distribution operations or entering into manufacturing and distribution agreements with qualified third parties;

market acceptance of our products;

our ability to establish an effective sales and marketing infrastructure;

our ability to protect our intellectual property;

competition from existing products or new products that may emerge;

the ability to commercialize our products;

potential product liability claims and adverse events;

our ability to adequately support future growth;

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

We are dependent on obtaining additional

financing to enable us to pay off debt and to resume our product development operations.

Our continued operations are substantially

dependent on our ability to obtain additional financing to pay off substantial debt incurred in our August 31, 2020 acquisition

of Pocono Coated Products, LLC and to provide us with the ability to resume product development operations and continue to finance

our current operations and generate growth in our revenues.

Our business is impacted by the following

additional key risks :

Our continued operations are substantially dependent

on our ability to obtain additional financing to pay off substantial debt incurred in our August 31, 2020 acquisition of Pocono Coated

Products, LLC and to provide us with the ability to resume product development operations and continue to finance our current operations

and generate growth in our revenues.

Our business is impacted by the following additional

Our business could be adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel.

20 unchanged sentences

We may be unable to accurately estimate anticipated expenses, capital requirements and needs for additional financing;

Best Choice or any other international distributor of our products may fail to comply with applicable laws;

Best Choice or any other international distributor of our products may not be able to obtain any necessary regulatory approval necessary to market our product or, if they are able to obtain regulatory approval, they may not be successful in marketing our products;

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

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-Q

Item 1A. Risk Factors