What changed in this filing

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Item 1A. Risk Factors

2023-07-31 compared with 2022-07-28 · 202 added, 351 removed, 1906 unchanged (22% of the section changed)

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should consider before investing in our company.

These risks are described more in more detail in the section titled “Risk Factors”

These risks are described in more detail in the section titled “Risk Factors”

in Item 1A of this Report.

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Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties on which we rely, including Austrianova.

Our business could be impacted as a result of actions by activist shareholders, including as a result of a potential proxy contest for the election of directors at our 2022 annual meeting.

The recent and ongoing COVID-19 pandemic has affected and could continue to affect our operations, as well as the business or operations of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely have significant business operations.

If we are unable to successfully raise additional capital in addition to our recent completed public offering, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

If we are unable to successfully raise sufficient capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

Due to the significant resources required for the development of our programs, and depending on our ability to access capital, we must prioritize development of certain product candidates.

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We may not be able to protect our intellectual property rights throughout the world.

We rely and expect to continue to rely heavily on third parties to

conduct our preclinical studies, plan to rely on third parties to conduct our and clinical trials, assuming they are allowed to proceed,

and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such studies and trials.

We rely and expect to continue to rely heavily

on third parties to conduct our preclinical studies, plan to rely on third parties to conduct our and clinical trials, assuming they are

allowed to proceed, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of

such studies and trials.

Our business could be impacted as a result of actions by activist shareholders, including as a result of a potential proxy contest for the election of directors at our annual meeting.

You may experience future dilution as a result of future equity offerings.

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We may experience volatility in our stock price, which may adversely affect the trading price of our common stock.

A large number of shares may be issued and subsequently sold upon the exercise of existing options and warrants.

A large number of shares may be issued and subsequently sold upon the exercise of existing options and warrants and the conversion of preferred shares.

We are a “smaller reporting company” under the SEC’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller reporting companies.

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On October 1, 2020, we received notice from the

FDA that it had placed our IND for a planned Phase 2b clinical trial in LAPC on clinical hold.

As part of the clinical hold process, the

FDA has asked for additional information, tasks to be performed by us and new preclinical studies and assays.

It has taken and may continue

to take a considerable period of time, the length of which is not certain at this time, for us to conduct such tasks and preclinical studies

FDA that it had placed our IND for a planned clinical trial in LAPC on clinical hold.

As part of the clinical hold process, the FDA has

asked for additional information, tasks to be performed by us and new preclinical studies and assays.

It has taken and may continue to

take a considerable period of time, the length of which is not certain at this time, for us to conduct such tasks and preclinical studies

and to generate and prepare the requested information.

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on which we rely, including Austrianova.

The disruptions to the global economy in 2020, 2021 and into 2022 have

impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses.

a third-party supplier on whom we rely, from time to time has experienced significant supply chain disruptions, some of which may be related

to COVID-19, and we believe it may be experiencing liquidity issues.

Despite any actions we have undertaken to minimize the impacts from

disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain, inflationary pressures,

and delays our third parties face will not have a material adverse effect on our business, financial condition and results of operations.

Our business could be impacted as a result of actions by activist

shareholders, including as a result of a potential proxy contest for the election of directors at our annual meeting.

We recently received notice from Iroquois Capital

Management, LLC and certain of its affiliates nominating a slate of eight individuals for election to our Board of Directors for the 2022

annual meeting.

If a proxy contest or consent solicitation results from this notice, our business could be adversely affected because:

(i) responding to proxy contests and other actions by activist shareholders can be costly and time-consuming, which could disrupt our

operations and divert the attention of management and our employees;

(ii) perceived uncertainties as to our future direction could adversely

affect our relationships with customers, suppliers, investors, prospective and current team members and others, resulting in the loss

of potential business opportunities, or making it more difficult to attract and retain qualified personnel;

and (iii) if individuals are

elected to our board of directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our

strategic plan.

These actions could also cause our stock price to experience periods of volatility.

In addition, future proxy contests

and other actions by activist shareholders could require us to incur significant legal fees and solicitation expenses and require significant

time and attention by management and the Board of Directors and could materially and adversely affect our business and operating results.

We may also be subject, from time to time, to other legal and business challenges in the operation of our company due to actions instituted

by activist shareholders.

Responding to such actions could be costly and time-consuming.

The disruptions to the global economy in recent

years have impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses.

Austrianova, a third-party supplier on whom we rely, from time to time has experienced significant supply chain disruptions, some of which

may be related to COVID-19, and we believe it may be experiencing liquidity issues.

Despite any actions we have undertaken to minimize

the impacts from disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain,

inflationary pressures, and delays our third parties face will not have a material adverse effect on our business, financial condition

and results of operations.

The recent and ongoing COVID-19

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we rely have significant business operations.

Our business and its operations, including, but

not limited to, our proposed clinical development program, supply chain operations, research and development activities and fundraising

activities, has been and could continue to be adversely affected by the COVID-19 pandemic in areas where we have business operations,

including the U.S., India, Europe, Singapore and Thailand.

Also, this pandemic could cause significant disruption in the operations of

third parties upon whom we rely on to conduct the Company’s business.

In March 2020, the World Health Organization declared the

COVID-19 outbreak a pandemic.

Shortly thereafter, the U.S.

government-imposed restrictions on travel between the U.S., Europe, and certain

other countries.

The President of the U.S.

declared the COVID-19 pandemic a national emergency.

Since March 2020, numerous state, regional

and local jurisdictions, including the jurisdictions where our headquarters are located, as well as foreign jurisdictions, have imposed,

and others in the future may impose, quarantines, shelter-in-place orders, executive, and similar government orders for their residents

to control the spread of COVID-19.

The COVID-19 pandemic has had an impact upon our operations.

The effects of the executive orders, the shelter-in-place

orders and our work-from-home policies has and may continue to negatively impact productivity, disrupt our business, and delay our proposed

clinical development program and timeline, the magnitude of which will depend, in part, on the length and severity of the restrictions

and other limitations on our ability to conduct our business in the ordinary course.

These and similar, and perhaps more severe, disruptions

in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place, executive, and

similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could

occur, related to COVID-19, could impact personnel at our third-party manufacturing facilities in Thailand, or the availability or cost

of materials we use or require to conduct our business, including product development, which would disrupt our supply chain.

suppliers and vendors of certain materials used in our operations and research and development activities are located in areas that are

subject to executive orders and shelter-in-place orders.

While many of these materials may be obtained from more than one supplier, port

closures and other restrictions resulting from the COVID-19 pandemic may disrupt our supply chain or limit our ability to obtain sufficient

materials to operate our business.

To date, we are aware of certain suppliers for our research and development activities that have experienced

operational delays related to the COVID-19 pandemic.

Depending upon the length of COVID-19 and whether

the FDA lifts the clinical hold on our IND, we anticipate our planned clinical trial in LAPC may be affected by COVID-19.

continues to spread in the U.S.

and elsewhere, we may experience additional disruptions that could adversely impact our business and proposed

clinical trial, including:

(i) delays or difficulties in enrolling patients in our Phase 2b clinical trial if the FDA allows us to go

forward with such trial;

(ii) delays or difficulties in clinical site activation, including difficulties in recruiting clinical site investigators

and clinical site personnel;

(iii) delays in clinical sites receiving the supplies and materials needed to conduct our clinical trial,

including interruption in global shipping that may affect the transport of our clinical trial product;

(iv) changes in local regulations

as part of a response to COVID-19 which may require us to change the ways in which our clinical trial is to be conducted, which may result

in unexpected costs, or to discontinue the clinical trial altogether, if allowed to proceed;

(v) diversion of healthcare resources away

from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting

the conduct of our clinical trial;

(vi) interruption of key clinical trial activities, such as clinical trial site monitoring, due to

limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial

subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data;

(vii) risk that participants

enrolled in our proposed clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of

the clinical trial, including by increasing the number of observed adverse events;

(viii) delays in necessary interactions with local

regulators, ethics committees, and other important agencies and contractors due to limitations in employee resources or forced furlough

of government employees;

(ix) limitations in employee resources that would otherwise be focused on the conduct of our clinical trial because

of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;

(x) refusal of the

FDA to accept data from clinical trials in affected geographies;

and (xi) interruption or delays to our clinical trial activities.

The spread of COVID-19, which has caused a widespread

impact throughout the world, may materially affect us economically.

The potential economic impact brought about COVID-19, and the duration

of such impact, is difficult to assess or predict.

The pandemic has resulted in significant disruption of global financial markets, which

could reduce our ability to access capital and negatively affect our future liquidity.

Also, a recession or market correction resulting

from the spread of COVID-19 and related government orders and restrictions could materially affect our business and the value of our common

COVID-19 continues to evolve.

The ultimate impact of COVID-19 and the mitigation efforts to address it is highly uncertain and

subject to change.

We do not yet know the full extent of potential delays or impacts on our business, our proposed clinical trial, healthcare

systems or the global economy.

We face the ongoing risk that the coronavirus

pandemic may slow our operations, our preclinical studies or the eventual enrollment of our planned clinical trial.

In order to prioritize

patient health and that of the investigators at clinical trial sites, we may need monitor enrollment of patients in our clinical study.

In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines

or travel restrictions impede patient movement or interrupt healthcare services.

These and other factors outside of our control could

delay our ability to conduct clinical trials or release clinical trial results.

In addition, the effects of the ongoing coronavirus pandemic

may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time

from key personnel, and negatively impact our key clinical trial vendors.

We cannot guarantee that COVID-19 or any other public health

crisis will not cause delays or impact on our business or proposed clinical trial.

If we are unable to successfully

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and resource allocation to maintain an optimal balance between aggressively advancing lead programs and ensuring replenishment of our

Until such time, if ever, as the FDA lifts its clinical hold on our IND related to our planned Phase 2b clinical trial in LAPC,

our Cell-in-a-Box ® encapsulation technology is validated in our planned Phase 2b clinical trial, and sufficient additional

funding is available, we have halted spending on behalf of our development program with respect to cannabinoids.

Until such time, if ever, as the FDA lifts its clinical hold on our IND related to our planned clinical trial in LAPC, our

Cell-in-a-Box ® encapsulation technology is validated in our planned clinical trial, and sufficient additional funding is

available, we have halted spending on behalf of our development program with respect to cannabinoids.

Due to the significant resources required for

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delays or disruptions in our supply chain;

and (x) the adverse impacts caused by COVID-19 discussed in more detail below.

Additional Risks Related to Regulatory Matters

If we are unable to obtain, or if there are delays in obtaining,

required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates and our ability

to generate revenue will be materially impaired.

and (x) the adverse impacts caused by COVID-19.

Risks Related to Regulatory Matters

If we are unable to obtain, or if there

are delays in obtaining, required approval from the applicable regulatory agencies, we will not be able to commercialize our product candidates

and our ability to generate revenue will be materially impaired.

Our product candidates must obtain marketing approval

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Diminished protection of intellectual property in some countries.

Our plan to first pursue a Phase 2b clinical

trial before a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any

future commercialization and marketing if regulatory approval is obtained.

Our plan to first pursue a clinical trial

before a pivotal Phase 3 trial will likely result in additional costs to us and resultant delays in the FDA review process and any future

commercialization and marketing if regulatory approval is obtained.

If the FDA allows us to begin a clinical trial

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Therefore, we are designing a

Phase 2b clinical trial that, if successful, we believe will provide the information necessary to plan a Phase 3 pivotal trial.

clinical trial that, if successful, we believe will provide the information necessary to plan a Phase 3 pivotal trial.

Our determination

to first conduct a Phase 2b clinical trial before conducting a pivotal Phase 3 clinical trial will likely result in additional costs to

us and resultant delays in the regulatory review process and any future commercialization and marketing if regulatory approval is obtained.

The same is true to a greater extent if the FDA requires us to commence a Phase 1 or other Phase 2 clinical trial instead of the planned

Phase 2b clinical trial currently under clinical hold.

to first conduct a clinical trial before conducting a pivotal Phase 3 clinical trial will likely result in additional costs to us and

resultant delays in the regulatory review process and any future commercialization and marketing if regulatory approval is obtained.

same is true to a greater extent if the FDA requires us to commence a Phase 1 or other Phase 2 clinical trial instead of the planned Phase

2b clinical trial currently under clinical hold.

If we are unable to obtain, or if there

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In support of our IND application to commence

a Phase 2b clinical trial in LAPC using genetically -engineered live human cells encapsulated using our Cell-in-a-Box ® technology

in combination with ifosfamide we are relying on a Phase 1/2 clinical trial and a Phase 2 clinical trial previously conducted using the

same technology in combination with ifosfamide between 1998 and 1999 and between 1999 and 2000, respectively.

The Phase 1/2 clinical trial

was carried out at the Division of Gastroenterology, University of Rostock, Germany, and the Phase 2 clinical trial was carried out at

four centers in two countries in Europe:

a clinical trial in LAPC using genetically engineered live human cells encapsulated using our Cell-in-a-Box ® technology

in combination with ifosfamide we are relying on a Phase 1/2 clinical trial and a clinical trial previously conducted using the same technology

in combination with ifosfamide between 1998 and 1999 and between 1999 and 2000, respectively.

The Phase 1/2 clinical trial was carried

out at the Division of Gastroenterology, University of Rostock, Germany, and the Phase 2 clinical trial was carried out at four centers

in two countries in Europe:

Berne, Switzerland, and in Rostock, Munich and Berlin, Germany.

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It is not known whether the FDA would be likely to reject the use of such clinical data due to the significant time that has elapsed since

the earlier clinical trials were conducted or because the clinical trial material for our proposed Phase 2b clinical trial is different

from that used in the earlier clinical trials because of cloning the cells used in the earlier trials and certain other modifications

and improvements that have been made to the Cell-in-a-Box ® technology since the time of the earlier trials.

the earlier clinical trials were conducted or because the clinical trial material for our proposed clinical trial is different from that

used in the earlier clinical trials because of cloning the cells used in the earlier trials and certain other modifications and improvements

that have been made to the Cell-in-a-Box ® technology since the time of the earlier trials.

We intend to conduct clinical trials for

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clinical trials of the encapsulated live cell and ifosfamide combination product may not be predictive of similar results in future clinical

trials such as our planned Phase 2b clinical trial in LAPC, if allowed to proceed.

The previous Phase 1/2 and Phase 2 clinical trials

had a relatively limited number of patients in each trial.

These trials resulted in outcomes that were not statistically significant and

may not be representative of future results.

In addition, interim results obtained after a clinical trial has commenced do not necessarily

predict results in future clinical trials.

Numerous companies in the pharmaceutical and biotechnology industries have suffered significant

setbacks in late-stage clinical trials even after achieving promising results in early-stage clinical development.

Our clinical trials,

if allowed to proceed, may produce negative or inconclusive results and we may decide, or regulatory agencies may require us, to conduct

additional clinical trials.

Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies

that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to

obtain the approval for their products by the regulatory agencies.

trials such as our planned clinical trial in LAPC, if allowed to proceed.

The previous Phase 1/2 and Phase 2 clinical trials had a relatively

limited number of patients in each trial.

These trials resulted in outcomes that were not statistically significant and may not be representative

of future results.

In addition, interim results obtained after a clinical trial has commenced do not necessarily predict results in future

clinical trials.

Numerous companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage

clinical trials even after achieving promising results in early-stage clinical development.

Our clinical trials, if allowed to proceed,

may produce negative or inconclusive results and we may decide, or regulatory agencies may require us, to conduct additional clinical

Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their

product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain the approval

for their products by the regulatory agencies.

If we experience any unforeseen events in

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protect the product candidate from competition because different drugs can be approved for the same condition, and the same drug may be

approved for a different condition that may be used offlabel for an orphan indication.

approved for a different condition that may be used off label for an orphan indication.

Even after an Orphan Drug is approved and granted

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and the reasonableness of these assumptions has not been assessed by an independent source.

If any of the assumptions proves to be inaccurate,

If any of the assumptions prove to be inaccurate,

the actual markets for our product candidates could be smaller than our estimates of the potential market opportunities.

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or may be delayed in our efforts to, successfully commercialize our product candidates.

In addition, disruptions in the global economy and supply chains could

adversely affect the financial conditions of the third parties on which we rely, resulting in delays in preclinical studies and clinical

trials that could adversely affect our business, financial condition and results of operations.

For instance, Austrianova from time to

time has experienced significant supply chain delays, some of which may be related to COVID-19, and we believe it may be experiencing

liquidity issues.

In addition, disruptions in the global economy

and supply chains could adversely affect the financial conditions of the third parties on which we rely, resulting in delays in preclinical

studies and clinical trials that could adversely affect our business, financial condition and results of operations.

For instance, Austrianova

from time to time has experienced significant supply chain delays, some of which may be related to COVID-19, and we believe it may be

experiencing liquidity issues.

We rely on numerous consultants for a substantial

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to us through the respective consulting agreements we have entered with the consulting companies through which they provide services.

The consulting agreements may be terminated for any reason at any time upon one party giving the other a written notice prior to the effective

The consulting agreements may be terminated for any reason at any time upon one party giving the other written notice prior to the effective

date of the termination.

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from third parties to commercialize our product candidates, including our Cell-in-a-Box ® Technology for LAPC and diabetes.

and our COVID-19 diagnostic kits.

If we materially breach or fail to perform any provision under these license and collaboration agreements,

including failure to make payments to a licensor or collaborator when due for royalties and failure to use commercially reasonable efforts

to develop and commercialize our product candidates, such licensors and collaborators have the right to terminate our agreements, and

upon the effective date of such termination, our right to practice the licensed intellectual property would end.

Any uncured, material

breach under the agreements could result in our loss of rights to practice the patent rights and other intellectual property licensed

to us under the agreements and could result in the loss of our ability to develop or commercialize our product candidates.

If we materially breach or fail to perform any provision under these license and collaboration agreements, including failure to make payments

to a licensor or collaborator when due for royalties and failure to use commercially reasonable efforts to develop and commercialize our

product candidates, such licensors and collaborators have the right to terminate our agreements, and upon the effective date of such termination,

our right to practice the licensed intellectual property would end.

Any uncured, material breach under the agreements could result in

our loss of rights to practice the patent rights and other intellectual property licensed to us under the agreements and could result

in the loss of our ability to develop or commercialize our product candidates.

We may need to license certain intellectual

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we may not develop additional proprietary technologies that are patentable.

Additional Risks Related to Our Business Model and Operations

Risks Related to Our Business Model and Operations

Development of brand awareness is critical

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information which could have an adverse effect on the trading price of our securities.

The success of our cannabis program may

depend on additional states legalizing medical Cannabis.

Continued development of the medical Cannabis

market is dependent upon continued legislative authorization of Cannabis at the state level for medical purposes.

Any number of

factors could slow or halt the progress.

Further, progress, while encouraging, is not assured and the process normally encounters setbacks

before achieving success.

While there may be ample public support for legislative proposal, key support must be created in the legislative

committee, or a bill may never advance to a vote.

Numerous factors impact the legislative process.

Any one of these factors could slow

or halt the progress and adoption of Cannabis for medical purposes, which would limit the market for our product candidates that

are based on Cannabis constituents and negatively impact our business in this area.

Medicinal Cannabis faces strong opposition.

Certain well-funded and significant businesses

may have a strong economic opposition to the medical Cannabis industry.

Lobbying by groups within the pharmaceutical industry or

changes in the regulation of Cannabis -based therapies could affect our ability to develop and market cannabinoid-based cancer therapies.

Our product candidates involving Cannabis

will be subject to controlled substance laws and regulations.

Failure to receive necessary approvals may delay the launch of our products

and failure to comply with these laws and regulations may adversely affect the results of our business operations.

Our product candidates involving Cannabis

contain controlled substances as defined in the CSA.

Controlled substances that are pharmaceutical products are subject to a high degree

of regulation under the CSA, which establishes, among other things, certain registration, manufacturing quotas, security, recordkeeping,

reporting, import, export and other requirements administered by the DEA.

The DEA classifies controlled substances into five schedules:

Schedule I, II, III, IV or V substances.

Schedule I substances by definition have a high potential for abuse, have not currently “accepted

medical use” in the U.S., lack accepted safety for use under medical supervision, and may not be prescribed, marketed or sold in

Pharmaceutical products approved for use in the U.S.

may be listed as Schedule II, III, IV or V, with Schedule II substances

considered to present the highest potential for abuse or dependence and Schedule V substances the lowest relative risk of abuse among

such substances.

Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing and procurement

quotas, security requirements and criteria for importation.

In addition, dispensing of Schedule II drugs is further restricted.

they may not be refilled without a new prescription.

While Cannabis is a Schedule I controlled

substance, products approved for medical use in the U.S.

that contain Cannabis or Cannabis extracts must be placed in Schedules

II - V, since approval by the FDA satisfies the “accepted medical use” requirement.

If we receive FDA approval for a product

candidate involving Cannabis , the DEA will make a scheduling determination and place it in a schedule other than Schedule I for

it to be prescribed to patients in the U.S.

If approved by the FDA, we expect the product candidates to be listed by the DEA as a Schedule

II or III controlled substance.

Consequently, their manufacture, importation, exportation, domestic distribution, storage, sale and legitimate

use will be subject to a significant degree of regulation by the DEA.

The scheduling process may take one or more years beyond FDA approval,

thereby significantly delaying the launch of our product candidates involving Cannabis .

Furthermore, if the FDA, DEA or any foreign

regulatory authority determines that our product candidates involving Cannabis may have potential for abuse, it may require us

to generate more clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of such

Because one or more of our product candidates

contain active ingredients of Cannabis , which are Schedule I substances, to conduct preclinical studies and clinical trials with

these product candidates in the U.S.

prior to approval, each of our research sites must submit a research protocol to the DEA and obtain

and maintain a DEA researcher registration that will allow those sites to handle and dispense our product candidates and to obtain the

product from our manufacturer.

If the DEA delays or denies the grant of a research registration to one or more research sites, the preclinical

studies or clinical trials could be significantly delayed, and we could lose and be required to replace clinical trial sites, resulting

in additional costs.

Individual states have also established controlled

substance laws and regulations.

Though state-controlled substance laws often mirror federal law because the states are separate jurisdictions,

they may separately schedule our product candidates involving Cannabis as well.

While some states automatically schedule a drug

based on federal action, other states schedule drugs through rulemaking or a legislative action.

State scheduling may delay commercial

sale of any product for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the

commercial attractiveness of such product.

We or our partners must also obtain separate state registrations, permits or licenses to be

able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory

requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal

Because of these risks, no assurance can be given

that our Cannabis therapy under development will be successful.

The insurance coverage and reimbursement

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Any such violations

could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our

brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results

could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation,

our brand, our international expansion efforts, our ability to attract and retain employees and our business, prospects, operating results

and financial condition.

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decreased ability to issue additional shares of our common stock or obtain additional financing in the future.

We cannot assure you that we will be able to continue to comply

with the minimum bid price requirement of Nasdaq .

There can be no assurance that the market price

of our common stock will remain at the level required for continuing compliance with Nasdaq’s minimum bid requirement.

uncommon for the market price of a company’s common stock to decline in the period following a reverse stock split.

If the market

price of our common stock declines following the effectuation of the reverse stock split, the percentage decline may be greater than would

occur in the absence of a reverse stock split.

In any event, other factors unrelated to the number of shares of our common stock outstanding,

such as negative financial or operational results, could adversely affect the market price of our common stock and jeopardize our ability

to maintain compliance with Nasdaq’s minimum bid price requirement.

There can be no assurance that we will be

able to comply with the continued listing standards of Nasdaq, a failure of which could result in a de-listing of our common stock .

Nasdaq requires that the trading price of its

listed stocks remain above one dollar in order for the stock to remain listed.

It is not uncommon for the market price of a company’s

common stock to decline in the period following a reverse stock split.

If the market price of our common stock declines following the

effectuation of the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split.

In any event, other factors unrelated to the number of shares of our common stock outstanding, such as negative financial or operational

results, could adversely affect the market price of our common stock and jeopardize our ability to maintain compliance with Nasdaq’s

minimum bid price requirement.

If a listed stock trades below one dollar for more than 30 consecutive trading days, then it is subject

to delisting from Nasdaq.

In addition, to maintain a listing on Nasdaq, we must satisfy minimum financial and other continued listing

requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’

equity and certain corporate governance requirements.

If we are unable to satisfy these requirements or standards, we could be subject

to delisting.

This would have a negative effect on the price of our common stock and would impair your ability to sell or purchase our

common stock when you wish to do so.

In the event of a delisting, we can provide no assurance that any action we may take to restore our

compliance with the listing requirements would allow our common stock to become listed again, stabilize the market price or improve the

liquidity of our common stock, prevent our common stock from dropping below the minimum bid price requirement, or prevent future non-compliance

with the listing requirements.

Since our common stock is listed on Nasdaq, we will incur materially

increased costs and become subject to additional regulations and requirements.

Since our common stock was recently listed on

Nasdaq, we will incur material legal, accounting and other expenses, including payment of annual exchange fees, to satisfy the continued

listing standards for Nasdaq.

If our common stock is listed on Nasdaq, we must meet certain financial and liquidity criteria to maintain

If we fail to meet any of Nasdaq’s listing standards, our common stock may be delisted.

In addition, our Board may

determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.

of our common stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our common stock and could have

an adverse effect on the market price of, and the efficiency of the trading market for, our common stock.

The delisting of our common

stock could significantly impair our ability to raise capital and the value of your investment.

A large number of shares may be issued and subsequently sold

upon the exercise of existing options and warrants.

upon the exercise of existing options and warrants and upon the conversion of the Series B Preferred Stock.

As of July 25, 2023, there were 281,269 shares

of common stock issuable under outstanding options and 9,890,847 shares issuable upon exercise of outstanding warrants at various exercise

To the extent that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants,

the market price of our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances

of shares of common stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further

decline in the market price.

In addition, we will be issuing Common Warrants to purchase shares of common stock which are immediately

of common stock issuable under outstanding options, 18,570,847 shares of common stock issuable upon exercise of outstanding warrants at

various exercise prices and 68,183,469 shares of common stock reserved for issuance upon conversion of the Series B Preferred Stock.

the extent that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants, the market

price of our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances of shares

of common stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further decline

in the market price.

The requirement

that we redeem the Series B Preferred Stock in cash could adversely affect our business plan, liquidity, financial condition, and results

of operations.

If not converted, we are required to redeem some

or all of the outstanding shares of Series B Preferred Stock for cash under certain circumstances.

These obligations could have important

consequences on our business.

In particular, they could:

· limit our flexibility in planning

for, or reacting to, changes in our businesses and the industries in which we operate;

· increase our vulnerability to

general adverse economic and industry conditions;

· place us at a competitive disadvantage

compared to our competitors.

No assurances can be given that we will be successful

in making the required payments to the holders of the Series B Preferred Stock or that we will be able to comply with the financial or

other covenants contained in the Certificate of Designations.

If we are unable to make the required cash payments or otherwise comply

with the Certificate of Designations:

· dividends will accrue on the

Series B Preferred Stock at 15% per annum;

· the holders of the Series B

Preferred Stock could foreclose against our assets;

· we could be forced into bankruptcy

or liquidation.

The terms of the

Series B Preferred Stock could limit our growth and our ability to finance our operations, fund our capital needs, respond to changing

conditions and engage in other business activities that may be in our best interests.

The Certificate of Designations contains a number

of affirmative and negative covenants regarding matters such as the payment of dividends, maintenance of our properties and assets, transactions

with affiliates, and our ability to issue other indebtedness.

Our ability to comply with these covenants may

be adversely affected by events beyond our control, and we cannot assure you that we can maintain compliance with these covenants.

financial covenants could limit our ability to make needed expenditures or otherwise conduct necessary or desirable business activities.

We may obtain additional

capital through the issuance of preferred stock, which may limit your rights as a holder of our common stock.

Without any stockholder vote or action, our Board

may designate and approve for issuance shares of our preferred stock.

The terms of any preferred stock may include priority claims to

assets and dividends and special voting rights which could limit the rights of the holders of our common stock.

The designation and issuance

of preferred stock favorable to current management or stockholders could make any possible takeover of us or the removal of our management

more difficult.

We may experience volatility in our stock price, which may adversely

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stock and do not anticipate paying such dividends in the foreseeable future.

In addition, the terms of the certificate of designations

governing our Series B convertible preferred stock presently restricts our ability to pay dividends.

We are a “smaller reporting company” under the SEC’s

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the auditor attestation requirements of the Sarbanes-Oxley Act.

We are a non-accelerated filer under the Securities

Exchange Act of 1934, as amended, or the Exchange Act, and we are not required to comply with the auditor attestation requirements of

Section 404(b) of the Sarbanes-Oxley Act of 2002.

Therefore, our internal controls over financial reporting will not receive the level

of review provided by the process relating to the auditor attestation included in annual reports of issuers that are subject to the auditor

attestation requirements.

In addition, we cannot predict if investors will find our common stock less attractive because we are not required

to comply with the auditor attestation requirements.

If some investors find our common stock less attractive as a result, there may be

a less active trading market for our common stock and trading price for our common stock may be negatively affected.

We are a non-accelerated filer under the Exchange

Act, and we are not required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002.

Therefore, our internal controls over financial reporting will not receive the level of review provided by the process relating to the

auditor attestation included in annual reports of issuers that are subject to the auditor attestation requirements.

In addition, we cannot

predict if investors will find our common stock less attractive because we are not required to comply with the auditor attestation requirements.

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and

trading price for our common stock may be negatively affected.

Risks Related to Employee and Tax Matters,

Managing Growth and Macroeconomic Conditions

We have experienced

significant management changes which could increase our control risks and have a material adverse effect on our ability to do business

and our results of operations.

We have recently experienced

a number of changes in our management, including changes in our Chief Executive Officer and Board.

The magnitude of these changes and

the short time interval in which they have occurred add to the risks of control failures, including a failure in the effective operation

of our internal control over financial reporting or our disclosure controls and procedures.

Control failures could result in material

adverse effects on our financial condition and results of operations.

It may take time for the new management team to become sufficiently

familiar with our business and each other to effectively develop and implement our business strategies.

The turnover of key management

positions could further harm our financial performance and results of operations.

Management attention may be diverted from regular business

concerns by reorganizations.

We have a limited number of employees and

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a limited operating history.

As of April 30, 2022, we had 4 full-time employees and 23 consultants.

We are highly dependent on the R&D,

clinical and business development expertise of the principal members of our management, scientific and clinical teams, specifically, on

our Chief Executive Officer and Chief Financial Officer.

Recruiting and retaining qualified scientific, clinical, manufacturing and sales

and marketing personnel will also be critical to our success.

The loss of the services of our Chief Executive Officer and Chief Financial

Officer or other key employees or consultants could severely impede the achievement of our R&D and commercialization of our product

candidates and seriously harm our ability to successfully implement our business strategy.

As of April 30, 2023, we had 2 full-time employees and numerous consultants.

We are highly dependent on the

R&D, clinical and business development expertise of the principal members of our management, scientific and clinical teams, specifically,

on our Interim Chief Executive Officer and Chief Financial Officer.

Recruiting and retaining qualified scientific, clinical, manufacturing

and sales and marketing personnel will also be critical to our success.

The loss of the services of our Interim Chief Executive Officer

and Chief Financial Officer or other key employees or consultants could severely impede the achievement of our R&D and commercialization

of our product candidates and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and

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As of April 30, 2023, we had federal net operating

loss carryforwards of approximately $62 million, which will begin to expire in varying amounts beginning in 2022.

Under Sections 382 and

383 of the United States Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of state law, if a corporation

undergoes an “ownership change,” (generally defined as a greater than 50-percentage-point cumulative change (by value) in

the equity ownership of certain stockholders over a rolling three-year period), the corporation’s ability to use its pre-change

net operating loss carryforwards and other pre-change tax attributes to offset its post-change taxable income or taxes may be limited.

We may have experienced ownership changes in the

past and could experience one or more ownership changes in the future, some of which are outside our control.

loss carryforwards of approximately $56 million, and approximately $47 million for state net operating losses, which will begin to expire

in varying amounts beginning in 2023.

Under Sections 382 and 383 of the United States Internal Revenue Code of 1986, as amended, or the

Code, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” (generally defined as a

greater than 50-percentage-point cumulative change (by value) in the equity ownership of certain stockholders over a rolling three-year

period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to

offset its post-change taxable income or taxes will be limited to approximately $19 million and $6 million for federal and state, respectively.

We experienced ownership changes in the past and

could experience one or more ownership changes in the future, some of which are outside our control.

Our net operating loss carryforwards

may also be subject to limitation under state laws.

Further, our ability to utilize net operating loss carryforwards of companies that

we may acquire in the future may also be subject to limitations.

There is also a risk that due to tax law changes, such as suspensions

on the use of net operating loss carryforwards, or other unforeseen reasons, our ability to use our pre-change net operating loss carryforwards

are subject to limitation under state laws.

Further, our ability to utilize net operating loss carryforwards of companies that we may

acquire in the future may also be subject to limitations.

There is also a risk that due to tax law changes, such as suspensions on the

use of net operating loss carryforwards, or other unforeseen reasons, our ability to use our pre-change net operating loss carryforwards

and other pre-change tax attributes to offset post-change taxable income or taxes may be subject to limitation or expire.

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caused extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn, such as the recent

global financial crisis, could result in a variety of risks to our business, including our ability to raise additional capital when needed

on acceptable terms, if at all.

A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption.

Also, geopolitical tensions and the conflict between Russia

and Ukraine continue to escalate, and numerous jurisdictions have imposed harsh sanctions on certain industry sectors and parties in Russia,

as well as enhanced export controls on certain products and industries.

These and any additional sanctions and export controls, as well

as any counter responses by the governments of Russia or other jurisdictions, could adversely affect, directly or indirectly, the global

supply chain, with negative implications on the availability and prices of raw materials, energy prices, and our customers, as well as

the global financial markets and financial services industry.

A severe or prolonged economic downturn, such

as the recent global financial crisis, could result in a variety of risks to our business, including our ability to raise additional capital

when needed on acceptable terms, if at all.

A weak or declining economy could also strain our suppliers, possibly resulting in supply

Any of the foregoing could adversely impact our business.

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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