What changed in this filing

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Item 1A. Risk Factors

2021-03-25 compared with 2020-03-26 · 318 added, 220 removed, 495 unchanged (52% of the section changed)

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Our business and operations may be

materially and adversely affected by the recent coronavirus outbreak.

materially and adversely affected by the coronavirus pandemic.

In December 2019, a novel strain of coronavirus

was reported to have surfaced in Wuhan, China and has since spread to other parts of the world, including the United States and

that causes COVID-19 was reported to have surfaced in Wuhan, China and has since spread to other parts of the world, including

the United States.

In March 2020, the World Health Organization declared the outbreak a pandemic.

The coronavirus pandemic is affecting the

United States and global economies.

If the outbreak continues to spread, it may affect the Company’s operations and those

of third parties on which the Company relies, including causing disruptions in the supply of the Company’s product candidates

and the conduct of current and planned preclinical and clinical studies.

We may need to limit operations or implement limitations,

and may experience limitations in employee resources.

There are risks that it may be more difficult to contain if the outbreak

reaches a larger population or broader geography, in which case the risks described herein could be elevated significantly.

extent to which the coronavirus impacts our results will depend on future developments, which are highly uncertain and cannot be

predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the

coronavirus or treat its impact, among others.

The coronavirus pandemic is affecting

the United States and global economies and as a result, government authorities have implemented restrictions and limited certain

operations, such as limits on the number of people at a gathering, travel restrictions and stay-at-home orders, to try to slow

the spread of coronavirus.

The Company’s facilities remain operational and are operating in accordance with federal and state

governmental authority guidelines and with the implementation of safety measures such as social distancing protocols, suspending

travel, the wearing of masks and frequently disinfecting our workspaces.

Employee personnel who do not need to be physically present

on our premises are continuing to work remotely, but have the ability to be on site as required.

While the majority of these mandates

have specific end dates, they may be modified or extended and as a result there is uncertainty regarding the length of time that

such measures will be place.

We believe the impact to our internal operations has not been material thus far, however, current

and future restrictions may further impact our operations and may slow or diminish our research and development activities.

a result of the coronavirus pandemic, certain of our third-party suppliers and service providers on which we rely have seen impacts

to their operations.

If the impact to their operations continue or extend, it may in turn affect our operations.

Company does not expect a material impact to its program’s anticipated timelines as a result of potential delays from our

third-party service providers and believes that we have a sufficient supply of our INTASYL compounds to conduct our ongoing preclinical

studies and initial clinical activities.

However, the ultimate impact to the third parties on which we rely is highly uncertain

and subject to change.

If the measures to contain the outbreak are extended or further expanded, it could reduce or delay the availability

of supplies and services that we purchase and outsource, which may in turn slow or delay our preclinical and clinical activities,

and/or result in higher costs.

The extent to which the coronavirus pandemic impacts our results will depend on future developments,

which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus

and the actions to contain the coronavirus or treat its impact, among others.

Additionally, while the potential economic

impact brought by, and the duration of, the coronavirus pandemic is difficult to assess or predict, the impact of the coronavirus

on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s

short-term and long-term liquidity and the Company’s ability to complete its preclinical studies on a timely basis, or at

For instance, our preclinical and clinical may be temporarily delayed or paused, and the operations of our contracted third

parties may be significantly delayed as well.

The ultimate impact of coronavirus is highly uncertain and subject to change.

Company does not yet know the full extent of potential delays or impacts on its business, financing or preclinical and clinical

trial activities or the global economy as a whole.

However, these effects could have a material impact on the Company’s liquidity,

capital resources, operations and business and those of the third parties on which we rely.

pandemic on the global financial markets may reduce the Company’s ability to access capital and negatively affect our future

The coronavirus pandemic continues to evolve

and change rapidly.

The ultimate impact of the coronavirus pandemic, or a similar public health emergency, is highly uncertain

and subject to change.

The Company does not yet know the full extent of potential delays or impacts on its business, financing

activities, preclinical studies, clinical trial activities or the global economy as a whole.

However, these effects could have

a material impact on the Company’s liquidity, results of operations and financial condition.

candidates are in an early stage of development and may fail or experience significant delays or may never advance to the clinic,

which may materially and adversely impact our business.

All of our pipeline programs are in preclinical

development and our future success heavily depends on the successful development of our INTASYL™

product candidates, which

may never occur.

These product candidates could be delayed, not advance into the clinic or unexpectedly fail at any stage of development.

Before we can commence clinical trials for a product candidate, we must conduct extensive preclinical and other non-clinical tests

in order to support an IND application, including IND-enabling good laboratory practice (“

GLP ”) toxicology studies,

in the United States or their equivalents with regulatory authorities in other jurisdictions.

Preclinical studies and clinical

trials are expensive, difficult to design and can take many years.

There is no assurance that we will be able to successfully develop

our product candidates, and we may focus our efforts and resources on product candidates that may prove to be unsuccessful.

We cannot be certain of the outcome of

preclinical testing and clinical studies and results from these studies may not predict the results that will be obtained in later

phase trials of our product candidates.

Even if we are able to complete our preclinical studies and planned clinical trials in

line with our projected timelines, results from such studies and trials may be not replicated in subsequent preclinical studies

or clinical trial results.

Additionally, such studies may be delayed due to events beyond our control including as a result of

natural disasters, epidemics or pandemic outbreaks such as the novel coronavirus.

Further, the FDA, or equivalent regulatory authority,

may not accept the results of our preclinical studies or proposed clinical study designs and may require the Company to complete

additional preclinical studies or impose stricter approval conditions than we expect.

As a result, we cannot guarantee that we

will be able to submit INDs, or similar applications, within our projected timelines, if at all, or that the FDA, or similar regulatory

authorities, will allow us to commence clinical trials.

All of our pipeline programs are currently

in the preclinical development stage and our future success heavily depends on the successful development of our INTASYL product

candidates, which may never occur.

These product candidates could be delayed, not advance into the clinic or unexpectedly fail

at any stage of development.

Before we can commence clinical trials for a product candidate, we must conduct extensive preclinical

and other non-clinical tests in order to support an IND application, including IND-enabling good laboratory practice toxicology

studies, in the United States or their equivalents with regulatory authorities in other jurisdictions.

Preclinical studies and

clinical trials are expensive, difficult to design and can take many years.

There is no assurance that we will be able to successfully

develop our product candidates, and we may focus our efforts and resources on product candidates that may prove to be unsuccessful.

We cannot be certain of the outcome of preclinical

testing and clinical studies and results from these studies may not predict the results that will be obtained in later phase trials

of our product candidates.

Even if we are able to complete our preclinical studies and planned clinical trials in line with our

projected timelines, results from such studies and trials may be not replicated in subsequent preclinical studies or clinical trial

Additionally, such studies may be delayed due to events beyond our control including as a result of natural disasters,

epidemics or pandemic outbreaks such as the novel coronavirus pandemic.

While the steps for us to initiate our clinical trials

with PH-762 in the second half of 2021 are continuing and ongoing, the FDA, or equivalent regulatory authority, may not accept

the results of our preclinical studies or proposed clinical study designs and may require the Company to complete additional preclinical

studies or impose stricter approval conditions than we expect.

As a result, we cannot guarantee that we will be able to submit

INDs, or similar applications, within our projected timelines, if at all, or that the FDA, or similar regulatory authorities, will

allow us to commence clinical trials.

We are dependent on collaboration

partners for the successful development of our adoptive cell therapy product candidates.

We are not a cell company and expect to

depend on third-party collaborators to support the clinical development of our ACT product candidates.

We have entered into research

agreements with our academic and industry collaborators, each of which is terminable by the relevant party at any time, subject

to applicable notice periods.

We may not be successful in negotiating agreements with these collaborators to continue the development

and commercialization of our ACT product candidates through collaborations such as joint development or licensing agreements.

ability to successfully negotiate such agreements will depend on, among other things, potential partners’

evaluation of the

superiority of our technology over competing technologies, the quality of preclinical data that we have generated, the perceived

risks specific to developing our product candidates and our partners’

We are not a cell therapy company and expect

to depend on third-party collaborators to support the clinical development of our ACT product candidates.

We have entered into

a clinical collaboration development agreement with AgonOx, Inc.

for the clinical development of our PH-762 product candidate in

ACT and have entered into research agreements with our academic and industry collaborators, each of which is terminable by the

relevant party at any time, subject to applicable notice periods.

The success of our collaborations depends upon the efforts of

our collaboration partners, and their performance in achieving the development activities to the extent they are responsible under

our collaboration agreements.

Each of our partners may not be successful in performing these activities, including completing the

required preclinical studies and other information to be included in an IND application (or foreign equivalent), obtaining approval

to initiate clinical trials, conducting the necessary clinical trials and arranging for the manufacturing or contract research

organization (“

CRO ”) relationships and obtaining marketing authorization.

Our partners work with other companies,

potentially including some of our competitors, and their corporate objectives may not align with ours, they may change their strategic

focus or pursue alternative technologies.

If our collaborations are not successful or a partner terminates our collaboration agreement,

our business, financial condition, results of operations could be materially and adversely affected.

Further, we may not be successful in negotiating

agreements with these collaborators or with future collaborators for the development and commercialization of our ACT product candidates

through collaborations such as joint development or licensing agreements.

Our ability to successfully negotiate such agreements

will depend on, among other things, potential partners’

evaluation of the superiority of our technology over competing technologies,

the quality of preclinical data that we have generated, the perceived risks specific to developing our product candidates and our

partners’

own strategic and corporate objectives.

to negotiate these agreements, we may not be able commence clinical trials with our ACT product candidates or we may be required

to obtain licenses from third-party cell companies and our business, financial condition, results of operations and prospects could

be materially and adversely affected.

If we fail to negotiate these agreements, we may not be able commence clinical

trials with our ACT product candidates or we may be required to obtain licenses from cell therapy companies and our business, financial

condition, results of operations and prospects could be materially and adversely affected.

We rely upon third-party relationships

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maintain the third-party relationships that are necessary to support their development.

We depend upon third-party contract research

organizations (“

CROs ”), medical institutions, clinical investigators, consultants and other third parties to

support our preclinical research efforts such as through managing and conducting research studies, formulating our product candidates

and manufacturing our product candidates and expect to rely on the same for our future clinical trials.

Because we rely on these

third parties, we cannot necessarily control the timing, quality of work or amount of resources that our contract partners will

devote to these activities and we cannot guarantee that these parties will fulfill their obligations to us under these arrangements.

Furthermore, we compete with many other companies for the resources of these third parties, some of which may be our competitors,

and may detract from our programs.

Additionally, our contracted CROs and other third parties we rely upon may be impacted by the

coronavirus outbreak, resulting in delays or interruptions, If these third parties do not successfully carry out their responsibilities,

as well as within a timely fashion, our preclinical and clinical development may be delayed, unsuccessful or otherwise adversely

We depend upon third-party CROs, medical

institutions, clinical investigators, consultants and other third parties to support our preclinical research efforts such as

through managing and conducting research studies, formulating our product candidates and manufacturing our product candidates

and expect to rely on the same for our future clinical trials.

Because we rely on these third parties, we cannot necessarily control

the timing, quality of work or amount of resources that our contract partners will devote to these activities and we cannot guarantee

that these parties will fulfill their obligations to us under these arrangements.

Furthermore, we compete with many other companies

for the resources of these third parties, some of which may be our competitors, and may detract from our programs.

Additionally,

as a result of the coronavirus pandemic, certain of our contracted CROs and other third parties are now facing impacts to their

operations, resulting in delays or interruptions.

We previously had been able to engage

with third-party service providers in areas with limited or no impact (e.g.

countries with limited or no restrictions), but

with the global spread of the virus and associated restrictions, this has been no longer possible.

The Company has also undertaken

efforts to mitigate potential future impact by identifying and engaging alternative third-party service providers and suppliers.

However, the ultimate impact to the third parties on which we rely is highly uncertain and subject to change.

If the measures

to contain the coronavirus outbreak are extended or further expanded, it could reduce or delay the availability of supplies and

services that we purchase and outsource, which may in turn slow or delay our preclinical and clinical activities, and/or result

in higher costs.

If these third parties do not successfully carry out their responsibilities, as well as within a timely

fashion, our preclinical and clinical development may be delayed, unsuccessful or otherwise adversely affected.

We cannot guarantee that we will be able

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We rely on third party suppliers and manufacturers

to provide us with the materials and services to manufacture our INTASYL™

compounds and product candidates for certain of

our preclinical research and expect that we will rely on them for our future clinical trials.

While we do have in-house expertise

and capacity to manufacture our INTASYL™

compounds, we do not own or lease manufacturing facilities or have our own supply

source for the required materials.

Accordingly, we will be dependent upon third party suppliers and our contract manufacturers

to obtain supplies, and we will need to either develop, contract for, or otherwise arrange for the necessary manufacturers for

these supplies.

If for any reason we are unable to obtain the supplies for our INTASYL™

compounds from our current manufacturer,

we would have to seek to obtain it from another major manufacturer.

There is no assurance that we will be able to timely secure

needed supply arrangements on satisfactory terms, or at all.

Although we have used multiple contract

manufacturers, we currently contract with only one manufacturer for the supply of our clinical product candidates.

assurance that our supply of our clinical drug product will not be limited, interrupted, of satisfactory quality or be available

to provide us with the materials and services to manufacture our INTASYL compounds and product candidates for certain of our preclinical

research activities and expect that we will rely on them for the supply of our product candidates for our future clinical trials.

While we do have in-house expertise and capacity to manufacture our INTASYL compounds, we do not own or lease manufacturing facilities

or have our own supply source for the required materials.

Accordingly, we will be dependent upon third party suppliers and our

contract manufacturers to obtain supplies, and we will need to either develop, contract for, or otherwise arrange for the necessary

manufacturers for these supplies.

If for any reason we are unable to obtain the supplies for our INTASYL compounds from our current

manufacturer, we would have to seek to obtain it from another major manufacturer.

There is no assurance that we will be able to

timely secure needed supply arrangements on satisfactory terms, or at all.

We currently contract with multiple manufacturers

for the supply of our clinical product candidates to reduce the risk of supply interruption or availability.

However, there is

no assurance that our supply of our clinical drug product will not be limited, interrupted, of satisfactory quality or be available

at acceptable prices.

If for any reason we are unable to obtain the clinical supply of our product candidates from our current

manufacturer, we would have to seek to contract with another major manufacturer.

manufacturers, we would have to seek to contract with another major manufacturer.

While we believe that we currently have sufficient

supply of our PH-762 product candidate for our planned preclinical and clinical studies, some of our other product candidates

or the materials contained therein, may come from facilities in areas impacted by the coronavirus, which may result in delays

or shortages due to ongoing efforts to address the outbreak.

Our failure to secure these arrangements as needed could have a material

adverse effect on our ability to complete the development of our clinical product candidates or, if we obtain regulatory approval,

to commercialize them.

supply of our INTASYL compounds to conduct our ongoing preclinical studies and initial clinical activities, we have begun to see

some of our third-party supplies on which we rely becoming impacted from the coronavirus pandemic, which may result in delays or

shortages due to ongoing efforts to address the pandemic.

The Company has also undertaken

efforts to mitigate potential future impact by identifying and engaging alternative third-party suppliers and manufacturers.

the ultimate impact to these third parties on which we rely is highly uncertain and subject to change.

If the measures to

contain the outbreak are extended or further expanded, it could reduce or delay the availability

of supplies and services that we purchase and outsource, which may in turn slow or delay our preclinical and clinical activities,

and/or result in higher costs.

Our failure to secure these arrangements as needed could have a material adverse effect on

our ability to complete the development of our clinical product candidates or, if we obtain regulatory approval, to commercialize

The FDA, or equivalent regulatory authority,

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A wide variety of events beyond our control,

including natural disasters, epidemic or pandemic disease outbreaks (such as the recent novel coronavirus outbreak), trade wars,

political unrest or other events could disrupt our business or operations or those of our manufacturers, regulatory authorities,

or other third parties with whom we conduct business.

These events may cause businesses and government agencies to be shut down,

supply chains to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable

to work and/or travel due to health reasons or governmental restrictions.

For example, Massachusetts recently ordered most businesses

closed, mandating work-from-home arrangements, where feasible, in response to the coronavirus pandemic.

These limitations could

negatively affect our business operations and continuity, and could negatively impact our development timelines and ability to

timely perform basic business functions, including making SEC filings and preparing financial reports.

If our operations or those

of third parties with whom we have business are impaired or curtailed as a result of these events, the development and commercialization

of our products and product candidates could be impaired or halted, which could have a material adverse impact on our business.

including natural disasters, epidemic or pandemic disease outbreaks (such as the coronavirus pandemic), trade wars, political unrest

or other events could disrupt our business or operations or those of our manufacturers, regulatory authorities, or other third

parties with whom we conduct business.

These events may cause businesses and government agencies to be shut down, supply chains

to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable to work and/or

travel due to health reasons or governmental restrictions.

These limitations could negatively affect our business operations and

continuity, and could negatively impact our development timelines and ability to timely perform basic business functions, including

making SEC filings and preparing financial reports.

If our operations or those of third parties with whom we have business are

impaired or curtailed as a result of these events, the development and commercialization of our products and product candidates

could be impaired or halted, which could have a material adverse impact on our business.

The approach we are taking to discover

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Our research and development efforts and

our future success is based on our INTASYL™

technology platform.

We plan to develop our INTASYL™

products for the treatment

of cancer to be delivered via direct injection for use intratumorally and with ACT by isolating immune cells from patients, treating

the cells ex vivo and then returning them to the patient for treatment.

We believe that our INTASYL™

compounds may

offer a new treatment option to current standards of care, such as antibodies, and potentially with a more cost-effective approach.

Successful development of our INTASYL™

compounds by us, or by our collaborative partners, is highly uncertain and depends

on a number of factors, many of which are beyond our control.

The scientific research used to support our efforts and approach

to developing RNAi therapeutics is limited.

Decisions made by the Company to advance the development of our pipeline, including

those related to our technology or manufacturing processes, may show to be incorrect based on further work by us or our collaborators.

our future success is based on our INTASYL technology platform.

We plan to develop our INTASYL products for the treatment of cancer

to be delivered via direct injection for use intratumorally and with ACT by isolating immune cells from patients, treating the

cells ex vivo and then returning them to the patient for treatment.

We believe that our INTASYL compounds may offer a new

treatment option to current standards of care, such as antibodies, and potentially with a more cost-effective approach.

development of our INTASYL compounds by us, or by our collaborative partners, is highly uncertain and depends on a number of factors,

many of which are beyond our control.

The scientific research used to support our efforts and approach to developing RNAi therapeutics

Decisions made by the Company to advance the development of our pipeline, including those related to our technology

or manufacturing processes, may show to be incorrect based on further work by us or our collaborators.

The use of RNAi

is a relatively new scientific discovery and the scientific evidence to support the feasibility of developing drugs based on these

discoveries, or INTASYL™, is limited.

Therefore, it is difficult to accurately predict challenges we may face with our product

candidates as they move through the discovery, preclinical and clinical development stages.

We may spend large amounts of money

trying to develop our INTASYL™

technology and may never succeed in doing so.

In addition, our research methodology by be

unsuccessful in identifying product candidates and results from preclinical and clinical studies may not predict the results that

will be obtained in later phase trials of our product candidates or our product candidates may interact with patients in unforeseen

or harmful ways that may make it impractical to manufacture, market or receive regulatory approval.

If we are not successful in

bringing an INTASYL™

product candidate to market, it could negatively impact our business and financial condition and we

may not be able to identify and successfully implement an alternative product development strategy.

discoveries, or INTASYL, is limited.

Therefore, it is difficult to accurately predict challenges we may face with our product candidates

as they move through the discovery, preclinical and clinical development stages.

We may spend large amounts of money trying to

develop our INTASYL technology and may never succeed in doing so.

In addition, our research methodology may be unsuccessful in

identifying product candidates and results from preclinical and clinical studies may not predict the results that will be obtained

in later phase trials of our product candidates or our product candidates may interact with patients in unforeseen or harmful ways

that may make it impractical to manufacture, market or receive regulatory approval.

If we are not successful in bringing an INTASYL

product candidate to market, it could negatively impact our business and financial condition and we may not be able to identify

and successfully implement an alternative product development strategy.

A number of different factors could

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Also, animal models may not exist for some of

the disease areas we choose to develop our INTASYL™

product candidates for.

As a result, our clinical trials may be delayed

or we may be required to incur more expense than we anticipated.

the disease areas we choose to develop our INTASYL product candidates for.

As a result, our clinical trials may be delayed or we

may be required to incur more expense than we anticipated.

Clinical trials require the review and oversight

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and delays in subject enrollment can result in increased costs and longer development times.

Clinical testing is lengthy and expensive,

and its outcome is highly uncertain.

Historical failure rates are high due to number of factors, such as safety and efficacy of

drug candidates.

We, our collaborators, the FDA, or an IRB may suspend clinical trials of a drug candidate at any time for various

reasons, including if we or they believe the subjects participating in such trials are being exposed to unacceptable health risks.

Among other reasons, adverse side effects of a drug candidate on subjects in a clinical trial could result in the FDA or other

regulatory authorities suspending or terminating the trial and refusing to approve a particular drug candidate for any or all indications

the global spread of the coronavirus and the associated safety measures to contain the spread by governmental authorities, a delay

in the commencement of new clinical trials and in the enrollment and participation of patients in clinical trials may occur.

steps required for us to initiate our clinical trials with PH-762 in the second half of 2021 are continuing and ongoing, however,

the Company does not yet know the full extent of potential delays or impacts related to its planned clinical activities from the

coronavirus pandemic.

Preclinical studies and clinical trials

are lengthy and expensive, and their outcome is highly uncertain.

Historical failure rates are high due to number of factors, such

as safety and efficacy of drug candidates.

We, our collaborators, the FDA, or an IRB may suspend clinical trials of a drug candidate

at any time for various reasons, including if we or they believe the subjects participating in such trials are being exposed to

unacceptable health risks.

Among other reasons, adverse side effects of a drug candidate on subjects in a clinical trial could

result in the FDA or other regulatory authorities suspending or terminating the trial and refusing to approve a particular drug

candidate for any or all indications of use.

An additional number of factors could affect

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The need to suspend or terminate clinical trials if the participants are being exposed to unacceptable health risks;

Insufficient or inadequate supply or quality of our drug candidates or other necessary materials necessary to conduct our clinical trials;

Effects of our drug candidates not having the desired effects or including undesirable side effects or the drug candidates having other unexpected characteristics;

Insufficient or inadequate supply or quality of our product candidates or other necessary materials necessary to conduct our clinical trials;

Effects of our product candidates not having the desired effects or including undesirable side effects or the product candidates having other unexpected characteristics;

The cost of our clinical trials being greater than we anticipate;

Negative or inconclusive results from our clinical trials or the clinical trials of others for similar drug candidates or inability to generate statistically significant data confirming the efficacy of the product being tested;

Negative or inconclusive results from our clinical trials or the clinical trials of others for similar product candidates or inability to generate statistically significant data confirming the efficacy of the product being tested;

Changes in the FDA’s requirements for testing during the course of that testing;

The impact from the recent coronavirus outbreak;

The impact from the recent coronavirus pandemic;

Reallocation of our limited financial and other resources to other clinical programs;

Adverse results obtained by other companies developing similar drugs.

A failure of any preclinical study or clinical

trial can occur at any stage of testing.

The results of preclinical and initial clinical testing of these products may not necessarily

indicate the results that will be obtained from later or more extensive testing.

Preliminary observations made in early stages

of clinical trials with small numbers of subjects are inherently uncertain and initial clinical trial results are not necessarily

indicative of results that will be obtained when full data sets are analyzed or in subsequent clinical trials.

Because of these

factors, it is difficult to predict the time and cost of the development of our product candidates.

Any delay or failure in obtaining

required approvals may prevent us from completing our preclinical or clinical studies and could have a material adverse effect

on our ability to initiate or commercialize any drug candidate on a timely basis, or at all.

A failure of any preclinical study

or clinical trial can occur at any stage of testing.

The results of preclinical and initial clinical testing of these products

may not necessarily indicate the results that will be obtained from later or more extensive testing.

Preliminary observations

made in early stages of clinical trials with small numbers of subjects are inherently uncertain and initial clinical trial results

are not necessarily indicative of results that will be obtained when full data sets are analyzed or in subsequent clinical trials.

Because of these factors, it is difficult to predict the time and cost of the development of our product candidates.

or failure in obtaining required approvals may prevent us from completing our preclinical or clinical studies and could have a

material adverse effect on our ability to initiate or commercialize any drug candidate on a timely basis, or at all.

Additionally,

preclinical studies and clinical trials are lengthy and expensive and if our cash resources become limited we may not be able

to commence, continue or complete our clinical trials.

We also are subject to numerous foreign

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We have no experience in filing the applications

necessary to obtain marketing approval and expect that we and need to rely on CROs and regulatory consultants to assist us with

necessary to obtain marketing approval and expect that we will need to rely on CROs and regulatory consultants to assist us with

this process.

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Our competitors also compete with us in

acquiring technologies complementary to our INTASYL™

We may face competition with respect to product efficacy

and safety, ease of use and adaptability to modes of administration, acceptance by physicians, timing and scope of regulatory approvals,

reimbursement coverage, price and patent position, including dominant patent positions of others.

If we are not able to successfully

obtain regulatory approval or commercialize our product candidates, we may not be able to establish market share and generate revenues

from our technology.

acquiring technologies complementary to our INTASYL technology.

We may face competition with respect to product efficacy and safety,

ease of use and adaptability to modes of administration, acceptance by physicians, timing and scope of regulatory approvals, reimbursement

coverage, price and patent position, including dominant patent positions of others.

If we are not able to successfully obtain regulatory

approval or commercialize our product candidates, we may not be able to establish market share and generate revenues from our technology.

We are subject to potential liabilities

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Risks Relating to Our Financial Condition

We may not be able to obtain sufficient

financing and may not be able to develop our product candidates.

believe that our existing cash at December 31, 2019, and the proceeds received from our capital raises completed in February 2020,

will be sufficient to fund our currently planned operations for at least the next 12 months from the date this Annual Report on

Form 10-K is filed.

However, w e have generated significant losses to date, have not generated any product revenue and may

not generate product revenue in the foreseeable future, or ever.

We expect to incur significant operating losses as we advance

our product candidates through drug development and the regulatory process.

In the future, we may need to issue equity or incur

debt in order to fund our planned expenditures, as well as to make acquisitions and other investments.

We cannot assure you that

equity or debt financing will be available to us on acceptable terms, or at all.

If we cannot, or are limited in the ability to,

issue equity, incur debt or enter into strategic collaborations, we may be unable to fund the discovery and development of our

product candidates, address gaps in our product offerings or improve our technology.

We anticipate that we will need to raise

substantial amounts of money to fund a variety of future activities integral to the development of our business, which may include

but is not limited to the following:

history of net losses, and we expect to continue to incur net losses for the foreseeable future and may not achieve or maintain

profitability.

We have generated

significant losses to date, have not generated any product revenue and may not generate product revenue in the foreseeable future,

We expect to incur significant operating losses as we advance our product candidates through drug development and the

regulatory process.

Our ability to achieve profitability, if ever, will depend on, among

other things, us or our collaborators, obtaining regulatory approvals and successfully commercializing our drug candidates.

if we are able to successfully commercialize our drug candidates, we may not be able to achieve or sustain profitability, which

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

will require substantial additional funds to complete our research and development activities.

have used substantial funds to develop our product candidates and will need to raise additional substantial funds to continue

our drug development efforts and support our operations.

Based on our current operating plans and liquidity, we believe that

our existing cash at December 31, 2020 and the proceeds received from our capital raise activities subsequent to the balance

sheet date, will be sufficient to fund our currently planned operations for at least the next 12 months from the date of

release of the associated financial statements.

However, our future capital requirements and the period for which our

existing resources are able to support our operations may vary significantly from what we expect.

We anticipate

that we will need to raise substantial amounts of money to fund a variety of future activities integral to the development of

our business, which may include but is not limited to the following:

To conduct research and development to successfully develop our technologies;

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To acquire new technologies, licenses or products.

Moreover, the global coronavirus pandemic

has led to significant uncertainty and increased volatility in the capital markets.

If these conditions in the capital markets

continue for an extended period of time it may impact our ability to raise capital.

we fail to obtain additional funding when needed, we may ultimately be unable to continue to develop and potentially commercialize

our product candidates, and we may be forced to scale back or terminate our operations or seek to merge with or be acquired by

another company.

In the future, we will need to obtain funding

from third parties, such as proceeds from the issuance of debt, sale of equity or strategic opportunities in order to fund our

planned expenditures, as well as to make acquisitions and other investments.

Historically, the Company’s primary source of

funding has been through the sale of its securities.

We cannot assure you that equity or debt financing will be available to us

on acceptable terms, or at all.

If we cannot, or are limited in the ability to, issue equity, incur debt or enter into strategic

collaborations, we may be unable to fund the discovery and development of our product candidates, address gaps in our product offerings

or improve our technology.

Moreover, the global coronavirus pandemic has led to significant uncertainty and increased volatility

in the capital markets.

If these conditions in the capital markets continue for an extended period of time it may impact our ability

to raise capital.

If we fail to obtain additional funding when needed, we may ultimately be unable to continue to develop

and potentially commercialize our product candidates, and we may be forced to scale back or terminate our operations or seek to

merge with or be acquired by another company.

Future financing may be obtained through,

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events will all affect our ability to continue as a going concern.

to utilize net operating loss carryforwards and other tax benefits may be limited.

We have historically

incurred net losses.

Under the Internal Revenue Code of 1986, as amended (the “

Code ”), a corporation is generally

allowed a deduction for net operating losses carried forward from a prior taxable year.

Under that provision, we can carryforward

our net operating losses to offset our future taxable income, if any, until such net operating losses are used or expire.

net operating loss carryforwards could expire unused before offsetting potential future income tax liabilities.

Additionally, an

ownership change, as defined by Section 382 of the Code, results from transactions increasing the ownership of certain stockholders

or public groups in the stock of a corporation by more than 50% over a three-year period.

If the Company has experienced a change

of control, as defined by Section 382 of the Code, at any time since inception, utilization of the Company’s net operating

loss carryforwards would be subject to an annual limitation.

Any limitation may result in expiration of a portion of the net operating

loss carryforwards before utilization.

The Company has not conducted a study to assess whether a change of control, as defined

by Section 382 of the Code, has occurred and it is possible that we have experienced an ownership change limitation.

We may experience

ownership changes in the future as a result of subsequent shifts in our stock ownership, some of which may be outside of our control.

If an ownership change occurs and our ability to use our net operating loss carryforwards is materially limited, it would harm

our future operating results by effectively increasing our future tax obligations.

Risks Relating to Our Securities

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been and may continue to be volatile.

The stock markets, in general, and

the markets for drug delivery and pharmaceutical company stocks, in particular, have experienced extreme volatility, particularly

in response to the coronavirus outbreak, that has often been unrelated to the operating performance of particular companies.

broad market fluctuations may adversely affect the trading price of our common stock.

In addition, the limited trading volume

of our stock may contribute to its volatility.

In the past, following periods of volatility

in the market price of a particular company’s securities, litigation has often been brought against that company.

If litigation

of this type is brought against us, it could be extremely expensive and divert management’s attention and the Company’s

We have issued preferred stock in

the past and possibly may issue more preferred stock in the future, and the terms of the preferred stock may reduce the value of

Our stock price has historically fluctuated

widely and is likely to continue to be volatile.

Because we are at an early stage of development and in the absence of product

revenue as a measure of operating performance, we anticipate that the market price for our common stock may be influenced by, but

not limited to, such factors as:

Announcements regarding the initiation or completion, and the results of preclinical studies and clinical trials of our product candidates;

Announcements regarding clinical trial results or development announcements concerning our competitors product candidates;

Regulatory or legal developments in the United States and other countries;

The recruitment or departure of key personnel;

The issuance of competitive patents or disallowance or loss of our patent rights;

Our ability to raise additional capital and the terms on which additional capital is raised;

To acquire new technologies, licenses or products;

Natural disasters and calamities, including the coronavirus pandemic;

General economic, industry and market conditions.

The stock markets, in general, and the markets

for drug delivery and pharmaceutical company stocks, in particular, have experienced extreme volatility, that has often been unrelated

to the operating performance of particular companies.

These broad market fluctuations may adversely affect the trading price of

our common stock.

In addition, the limited trading volume of our stock may contribute to its volatility.

may incur significant costs from class action litigation due to our historical or expected stock volatility.

Our stock price has historically fluctuated

significantly and may continue to do so in the future.

This risk is relevant to us as in the past, following periods of volatility

in the market price of a particular company’s securities, litigation has often been brought against that company that issued

If litigation of this type is brought against us by any of our stockholders, even if the lawsuit is without merit, it

could be extremely expensive and divert management’s attention and the Company’s resources.

Our Board of Directors has the authority

to issue shares of “blank check”

preferred stock and the terms of the preferred stock may reduce the value of our common

We are authorized to issue up to 10,000,000

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What changed 10-K

Item 1A. Risk Factors