What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2021-01-07 compared with 2020-01-09 · 960 added, 594 removed, 34 unchanged (98% of the section changed)

Risk Factors.

Our business involves a high degree of risk and uncertainty, including the following risks and uncertainties:

Risks Related to Our Financial Condition and Operations

We have a history of losses and may incur additional losses in the future .

On a cumulative basis we have sustained substantial losses and negative cash flows from operations since our inception.

As of October 31, 2019, our accumulated deficit was approximately $181,817,000.

As of October 31, 2019, we had approximately $5,842,000 in cash, cash equivalents and short-term investments, and working capital of approximately $4,612,000.

In fiscal year 2019, we incurred losses of approximately $11,819,000 and we experienced negative cash flows from operations of approximately $4,773,000.

We expect to continue incurring material research and development and general and administrative expenses in connection with our operations.

business involves a high degree of risk and uncertainty, including the following risks and uncertainties:

Related to Our Financial Condition and Operations

have a history of losses and may incur additional losses in the future .

a cumulative basis we have sustained substantial losses and negative cash flows from operations since our inception.

As of October

31, 2020, our accumulated deficit was approximately $191,836,000.

As of October 31, 2020, we had approximately $9,057,000 in cash,

cash equivalents and short-term investments, and working capital of approximately $8,180,000.

In fiscal year 2020, we incurred

losses of approximately $10,092,000 and we experienced negative cash flows from operations of approximately $6,176,000.

to continue incurring material research and development and general and administrative expenses in connection with our operations.

As a result, we anticipate that we will incur losses in the future.

We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders .

Based on currently available information as of January 9, 2020, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for the next 12 months.

However, our projections of future cash needs and cash flows may differ from actual results.

If current cash on hand, cash equivalents, short term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies that are synergistic with or complimentary to our technologies, we may be required to obtain more working capital.

We may seek to obtain working capital through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible.

We cannot be certain that additional funding will be available on acceptable terms, or at all.

If we do identify sources for additional funding, the sale of additional equity securities or convertible debt could result in dilution to our stockholders.

Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.

We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all.

If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.

Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and development of operations.

Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results .

Our business strategy and potential growth may place a strain on managerial, operational and financial resources and systems.

Although we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial resources and systems, our business and financial results will be materially harmed.

We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

Because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

Our spending on current and future research and development programs for product candidates may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate which it would have been more advantageous to enter into a partnering arrangement.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We have incurred net losses since our inception and we may never achieve or sustain profitability.

Generally, losses incurred will carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any.

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the Internal Revenue Code), if a corporation undergoes an ownership change, generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, the corporations ability to use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited.

We have not completed a study to assess whether an ownership change for purposes of Section 382 or 383 has occurred, or whether there have been multiple ownership changes since our inception.

We may have experienced ownership changes in the past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control).

As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset such taxable income will be subject to limitations.

Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes.

As a result, even if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows.

Our employees, scientific advisors, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, scientific advisors, principal investigators, consultants and commercial partners.

Misconduct by these parties could include intentional failures to comply with the regulations of the FDA or other regulatory bodies, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us.

In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.

These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation.

We currently have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, individual imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, which could have a significant impact on our business.

Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees and divert the attention of management in defending ourselves against any of these claims or investigations.

Risks Related to our Biotechnology Research & Development and Commercialization Activities

Our cancer diagnostic and cancer therapeutics businesses are pre-revenue, and subject to the risks of an early stage biotechnology company.

Since the Companys primary focus for the foreseeable future will likely be our cancer diagnostics and therapeutics businesses, shareholders should understand that we are primarily an early stage biotechnology company with no history of revenue-generating operations, and our only assets consist of our proprietary and licensed technologies and the know-how of our officers.

Therefore we are subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in the early detection of certain cancers, CAR-T cancer therapeutics and cancer vaccines.

Cchek Ô, our CAR-T ovarian cancer therapeutic and our breast cancer vaccine are in their early stages of development, and we still must establish and implement many important functions necessary to commercialize the technologies.

Accordingly, you should consider the Companys prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue generating stages, particularly those in the biotechnology field.

Shareholders should carefully consider the risks and uncertainties that a business with no operating history will face.

In particular, shareholders should consider that there is a significant risk that we will not be able to:

· demonstrate the effectiveness and clinical utility of the Cchek platform;

· develop a reimbursement pathway for our Cchek PCC test;

· recruit key opinion leaders in urology to order Cchek PCC for their patients;

· successfully complete studies necessary to submit IND applications to the FDA for our CAR-T ovarian cancer therapeutic or breast cancer vaccine;

· obtain FDA approvals to commence human clinical trials of our CAR-T ovarian cancer therapeutic or breast cancer vaccine;

· successfully enroll sufficient numbers of qualified patients to participate in our clinical trials;

· obtain sufficient quantity and quality of materials manufactured for use in our clinical trials;

· successfully meet the primary endpoints in our clinical trials;

· implement or execute our current business plan, or that our current business plan is sound;

· raise sufficient funds in the capital markets or otherwise to fully effectuate our business plan;

· maintain our management team, including the members of our scientific advisory board;

· determine that the processes and technologies that we have developed or will develop are commercially viable;

· attract, enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers or licensees of our technologies.

Any of the foregoing risks may adversely affect the Company and result in the failure of our business.

In addition, we expect to encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.

Over the next several quarters, we will need to transition from a company with a research and development focus to a company capable of supporting clinical trials and commercial activities.

will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result

in dilution to our stockholders.

on currently available information as of January 7, 2021, we believe that our existing cash, cash equivalents, short-term

investments and expected cash flows will be sufficient to fund our activities for the next 12 months.

However, our projections

of future cash needs and cash flows may differ from actual results.

If current cash on hand, cash equivalents, short term investments

and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect

to invest in or acquire a company or companies that are synergistic with or complementary to our technologies, we may be required

to obtain more working capital.

We may seek to obtain working capital through sales of our equity securities or through bank credit

facilities or public or private debt from various financial institutions where possible.

We cannot be certain that additional

funding will be available on acceptable terms, or at all.

If we do identify sources for additional funding, the sale of additional

equity securities or convertible debt could result in dilution to our stockholders.

Additionally, the sale of equity securities

or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of

the exercise or conversion price of our outstanding securities.

We can give no assurance that we will generate sufficient cash

flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such

as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or

If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact

on our business, results of operations and financial condition.

Furthermore, such lack of funds may inhibit our ability to respond

to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly

harm the business and development of operations.

may have difficulty in raising capital and may consume resources faster than expected.

currently do not generate any revenue from our therapeutics or vaccines nor do we generate any other recurring revenues and as

of October 31, 2020, the Company only had approximately $9,057,000 in cash, cash equivalents and short-term investments.

we have a limited source of cash to meet our future capital requirements, which may include the expensive process of obtaining

FDA approvals for our CAR-T ovarian cancer therapeutic, our breast and ovarian cancer vaccines and our COVID-19 therapy.

not expect to generate significant revenues for the foreseeable future, and we may not be able to raise funds in the future, which

would leave us without resources to continue our operations and force us to resort to raising additional capital in the form of

equity or debt financings, which may not be available to us.

We may have difficulty raising needed capital in the near or longer

term as a result of, among other factors, the very early stage of our therapeutics and vaccine businesses and our lack of revenues

as well as the inherent business risks associated with an early stage, biotechnology company and present and future market conditions.

Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding

sooner than anticipated.

Our inability to raise funds could lead to decreases in the price of our common stock and the failure

of our cancer diagnostic and therapeutics businesses which would have a material adverse effect on the Company.

to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could

adversely affect our business and operating results .

business strategy and potential growth may place a strain on managerial, operational and financial resources and systems.

we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational

and financial resources and systems, our business and financial results will be materially harmed.

may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize

on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for

indications that later prove to have greater commercial potential.

Our resource allocation decisions may cause us to fail to capitalize

on viable commercial products or profitable market opportunities.

Our spending on current and future research and development

programs for product candidates may not yield any commercially viable products.

If we do not accurately evaluate the commercial

potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through

strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us

to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a

product candidate which it would have been more advantageous to enter into a partnering arrangement.

ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

have incurred net losses since our inception and we may never achieve or sustain profitability.

Generally, losses incurred will

carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income,

Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”),

if a corporation undergoes an “ownership change,”

generally defined as a greater than 50 percentage point change (by

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

net operating loss, or NOL, carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change

income or taxes may be limited.

We have not completed a study to assess whether an ownership change for purposes of Section 382

or 383 has occurred, or whether there have been multiple ownership changes since our inception.

We may have experienced ownership

changes in the past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which

shifts are outside our control).

As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards

to offset such taxable income will be subject to limitations.

Similar provisions of state tax law may also apply to limit our

use of accumulated state tax attributes.

As a result, even if we attain profitability, we may be unable to use a material portion

of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows.

Related to our Research & Development, Clinical and Commercialization Activities

therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early stage biotechnology company.

the Company’s primary focus for the foreseeable future will likely be our therapeutics and vaccine businesses, shareholders

should understand that we are primarily an early stage biotechnology company with no history of revenue-generating operations,

and our only assets consist of our proprietary and licensed technologies and the know-how of our officers and employees.

we are subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in CAR-T cancer

therapeutics, cancer vaccines and anti-viral therapeutics.

Our CAR-T ovarian cancer therapeutic, our breast and ovarian cancer

vaccines and our COVID-19 treatment are in their early stages of development, and we still must establish and implement many important

functions necessary to commercialize the technologies.

you should consider the Company’s prospects in light of the costs, uncertainties, delays and difficulties frequently encountered

by companies in their pre-revenue generating stages, particularly those in the biotechnology field.

Shareholders should carefully

consider the risks and uncertainties that a business with no operating history will face.

In particular, shareholders should consider

that there is a significant risk that we will not be able to:

studies that successfully identify one or more clinical candidates to treat COVID-19;

complete animal studies necessary to submit an IND application to the FDA for our COVID-19 treatment;

complete testing of clinical materials necessary to submit an IND application to the FDA for our CAR-T ovarian cancer therapeutic;

FDA approval to commence human clinical trials of our CAR-T ovarian cancer therapeutic;

enroll sufficient numbers of qualified patients to participate in our clinical trials;

sufficient quantity and quality of materials manufactured for use in our clinical trials;

meet the primary endpoints in our clinical trials;

or execute our current business plan, or that our current business plan is sound;

sufficient funds in the capital markets or otherwise to fully effectuate our business plan;

our management team, including the members of our scientific advisory board;

that the processes and technologies that we have developed or will develop are commercially viable;

enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers or licensees

of our technologies.

of the foregoing risks may adversely affect the Company and result in the failure of our business.

In addition, we expect to encounter

unforeseen expenses, difficulties, complications, delays and other known and unknown factors.

Over the next several quarters,

we will need to transition from a company with a research and development focus to a company capable of supporting clinical trials

and commercial activities.

We may not be able to reach such achievements, which would have a material adverse effect on our Company.

Our current business model, as it relates to both our diagnostic and therapeutics businesses, relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.

We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

We do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies.

While our technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships.

Further, even if we elect to engage with a potential strategic partner, development of these partnerships can take an extended period of time in which significant analysis is performed by the potential strategic partner on our technologies and our intellectual property, as well as on the market opportunities and how well our technologies may fit strategically with the partners existing business.

Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company.

We may have difficulty in raising capital for our cancer diagnostics and therapeutics businesses and may consume resources faster than expected.

We currently do not generate any revenue from Cchek Ô, our CAR-T therapeutic or our breast cancer vaccine nor do we generate any other recurring revenues and as of October 31, 2019, the Company only had approximately $5,842,000 in cash, cash equivalents and short-term investments.

Therefore, we have a limited source of cash to meet our future capital requirements, which may include the expensive process of obtaining FDA approvals for our CAR-T ovarian cancer therapeutic, our breast cancer vaccine and for Cchek for each type of cancer for which we desire to launch a diagnostic test.

We do not expect to generate significant revenues for the foreseeable future, and we may not be able to raise funds in the future, which would leave us without resources to continue our operations and force us to resort to raising additional capital in the form of equity or debt financings, which may not be available to us.

We may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the very early stage of our diagnostic and therapeutics businesses and our lack of revenues as well as the inherent business risks associated with an early stage, biotechnology company and present and future market conditions.

Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated.

Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our cancer diagnostic and therapeutics businesses which would have a material adverse effect on the Company.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We will face an inherent risk of product liability as a result of the upcoming human clinical testing and commercialization of our product candidates.

For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.

current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure

to manufacture and ultimately market and/or sell our technologies.

We may have difficulty in timing the establishment of these

partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies.

technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our

technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships.

Further, even

if we elect to engage with a potential strategic partner, development of these partnerships can take an extended period of time

in which significant analysis is performed by the potential strategic partner on our technologies and our intellectual property,

as well as on the market opportunities and how well our technologies may fit strategically with the partner’s existing business.

Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic

benefit for the Company.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our product candidates.

will face an inherent risk of product liability as a result of the upcoming human clinical testing and commercialization of our

product candidates.

For example, we may be sued if our product candidates cause or are perceived to cause injury or are found

to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.

Any such product liability claims may include

allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence,

strict liability or a breach of warranties.

Claims could also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease commercialization of our product candidates.

If we cannot successfully

defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease commercialization

of our product candidates.

Even successful defense would require significant financial and management resources.

Regardless of the merits or eventual outcome, liability claims may result in:

· decreased demand for our product candidates;

· injury to our reputation;

· withdrawal of clinical trial participants;

· initiation of investigations by regulators;

· costs to defend the related litigation;

· a diversion of managements time and our resources;

· substantial monetary awards to clinical trial participants or patients;

· product recalls, withdrawals or labeling, marketing or promotional restrictions;

· loss of revenue;

· exhaustion of any available insurance and our capital resources;

· the inability to commercialize any product candidate;

· a decline in our share price.

We do not currently carry product liability insurance, but intend to obtain such coverage prior to commencement of our therapeutic clinical trials and broad commercialization of our diagnostic tests.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of any products we develop, alone or with corporate collaborators.

If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.

In the future, we may identify third-party technology we need, including to develop or commercialize new products or services.

In return for the use of a third partys technology, we may agree to pay the licensor royalties based on sales of our products or services.

Regardless of

the merits or eventual outcome, liability claims may result in:

demand for our product candidates;

to our reputation;

of clinical trial participants;

of investigations by regulators;

to defend the related litigation;

diversion of management’s time and our resources;

monetary awards to clinical trial participants or patients;

recalls, withdrawals or labeling, marketing or promotional restrictions;

of any available insurance and our capital resources;

inability to commercialize any product candidate;

decline in our share price.

do not currently carry product liability insurance, but intend to obtain such coverage prior to commencement of our clinical trials.

Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability

claims could prevent or inhibit the commercialization of any products we develop, alone or with corporate collaborators.

we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.

the future, we may identify third-party technology we need, including to develop or commercialize new products or services.

return for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our products

Royalties are a component of cost of products or services and affect the margins on our products or services.

We may also need to negotiate licenses to patents or patent applications before or after introducing a commercial product.

We may not be able to obtain necessary licenses to patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.

Risks Related to Cchek

While our Cchek Ô diagnostic technology has shown favorable results from initial testing, we cannot guarantee that these results will be replicated in future testing nor can we guarantee the success of the technology at all.

We have initially used Cchek to test the blood of small groups of individuals consisting of cancer patients, patients with benign conditions and healthy patients and have in some studies reported sensitivity and specificity of over 90%.

While these preliminary results far exceed existing diagnostic testing, and we have launched Cchek PCC based on these results, there is no guarantee that these results will be replicable when we test a larger group of patients, as we seek to commercialize Cchek Ô PCC, or at all.

If we are unable to consistently attain results that are necessary to realize economic benefit for Cchek Ô PCC or for commercialization of additional Cchek tests, our diagnostic technology will not have any monetary value and we will be unable to generate any revenue from this technology.

Even if we are able to attain results necessary for the commercialization of any test based on the Cchek Ô technology , our ability to commercialize the technology in the future will depend on our ability to provide evidence of clinical utility.

Our ability to successfully commercialize Cchek will depend on numerous factors, including whether health care providers believe that Cchek provides sufficient incremental clinical utility;

whether the medical community accepts that Cchek has sufficient sensitivity (there are no or very few false positives), specificity (detects the cancer the test is supposed to detect) and predictive value to be meaningful in patient care and treatment decisions;

whether the cost of the test is reasonably priced and commercially viable;

and whether health insurers, government health programs and other third-party payers will cover and pay for Cchek and the amount that they will reimburse for such tests.

These factors may present obstacles to commercial acceptance of Cchek.

To the extent these obstacles arise, we will need to devote substantial time and resources to overcome these obstacles, and we might not be successful.

Failure to achieve market acceptance of Cchek would materially harm our business, financial condition and results of operations.

We are unable to give any assurance that we will be successful in providing sufficient evidence of clinical utility or any assurance that we will have adequate managerial, technical or financial resources to support the studies necessary to provide sufficient evidence of clinical utility of Cchek or to adequately differentiate our test from other diagnostic products in the manner, timeframe or cost parameters we anticipate, if at all.

If we are unable to provide evidence of clinical utility and differentiate Cchek, we will not be able to generate the revenues and market growth that we seek.

Our failure to generate revenue from the sale of our products would materially adversely impact our business, financial condition, results of operations and prospects.

To run diagnostic tests on blood samples on our Cchek Ô platform, we rely on certain over the counter reagents and other specialty raw materials which may not be available to us in a timely manner or at all.

When performing diagnostic tests on blood samples on our Cchek platform, we use certain over the counter reagents and other supplies.

Generally, all of the reagents and other supplies that we use for our diagnostic tests are off the shelf, are available from multiple suppliers and are able to be obtained without significant lead time.

However, there is no assurance that this will be true in the future.

For example, if a supplier has quality control issues, the delivery of these materials may be slower than expected.

Further, if we need to find a new supplier for any of these materials, there is a risk that the new materials will not perform precisely as the old materials performed.

While we seek to mitigate these risks by keeping extra supplies of the necessary materials on hand, if we are unable to obtain the necessary materials to run our diagnostic tests, if the materials we are able to obtain do not perform precisely as expected, or if the materials are only available on terms that are unacceptable to us, it would have a material impact on our Cchek platform and operations.

Even though Cchek Ô PCC has been commercially launched, we may not realize any revenues or any other economic benefit from the test.

While we have commercially launched Cchek Ô PCC, the first test based on the Cchek Ô technology platform, there can be no assurance that the test will find any commercial success.

There are a number of factors that may limit our ability to generate an economic benefit from the Cchek Ô PCC test, including the inability to:

· develop a reimbursement pathway for the test;

· maintain third party relationships with one or more CLIA certified labs to perform the test;

· negotiate and maintain a beneficial cost structure with third parties for performing the test;

· recruit key opinion leaders in urology to order the test for their patients;

· develop a strategic relationship with one or more national or regional CLIA certified laboratories to broadly market, sell and perform the test;

· obtain patient test results consistent with results found during product development.

Any of the foregoing factors, or others, could significantly limit our ability to achieve economic success with our Cchek Ô PCC test, and could result in the failure of the Cchek Ô PCC test as well as the Cchek Ô technology platform as a whole.

Diagnostic test development involves a lengthy and complex process, and we may be unable to commercialize additional tests based on the Cchek Ô technology on a timely basis, or at all.

We have devoted considerable resources to research and development for Cchek, however there can be no assurance that Cchek will be capable of reliably predicting the occurrence or recurrence of any cancers with the sensitivity and specificity necessary to be clinically and commercially useful, or, even if such technology is clinically and commercially useful, that it will result in commercially successful products.

In addition, before we can fully develop Cchek and commercialize any additional products, we will need to:

· conduct substantial research and development;

· conduct validation studies;

· expend significant funds;

· enter into agreements and maintain relationships with third party vendors to provide third party blood samples;

· obtain regulatory approval (either CLIA, FDA or both);

· depending on which regulatory pathway we select, establish or contract with the owner of a CLIA certified laboratory to process test samples.

Accordingly, our product development process involves a high degree of risk and may take several years, especially if we seek FDA approval for any of our diagnostic tests.

If additional Cchek tests should fail at the research or development stage, not produce sufficient clinical validation data to support the effectiveness of the product or not gain regulatory approval or if we should run out of cash to devote towards the commercialization of the technology or fail to establish agreements with necessary third party vendors, we will not be able to commercialize any additional Cchek tests and we will not generate any revenue from the technology.

If we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to further commercialize our Cchek Ô technology beyond Cchek Ô PCC, and our ability to generate revenue and the viability of our Company will be materially impaired.

Commercialization of additional Cchek tests will require that we obtain either CLIA certification, FDA approval or both.

If we are unable to timely obtain regulatory approval for additional Cchek tests, we will be unable to commercialize and generate revenue from the technology which would have a material adverse effect on our business, financial condition and results of operations.

Unless we obtain FDA approval for Cchek Ô PCC or any other Cchek Ô tests or we establish a CLIA certified laboratory, we will be dependent on laboratory contractors for performing the Cchek Ô PCC test and any other Cchek Ô tests we may develop in the future for commercial purposes.

To fulfill physician orders and perform the Cchek PCC test or any other Cchek tests we may develop in the future, we will require a CLIA certified laboratory to perform the test.

We have currently contracted with ResearchDx to provide these services with respect to the Cchek PCC test.

Unless and until Cchek PCC (or any other Cchek tests we may develop in the future) receives FDA approval, or we establish our own CLIA certified laboratory, we will continue to be dependent on contractors or collaborators such as ResearchDx for testing of patient blood samples.

We will be dependent on third parties for the patient samples that are essential to the development and validation of additional Cchek Ô tests.

To pursue our development and validation of Cchek tests beyond Cchek PCC, we will need access, over time, to patient blood samples and such patients will need to consent to the use of their blood.

As a result, we have made arrangements with hospitals and medical practices to give us access to patient samples for the development and validation of Cchek.

In the event that we are unable to obtain patient samples, or access to patient samples becomes more limited due to changes in privacy laws governing the use and disclosure of medical information or due to changes in the laws restricting our ability to obtain patient samples and associated information, our ability to pursue the development of Cchek may be slowed or halted, which could have a material adverse effect on our business, financial condition and results of operations.

Our business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or changing interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, the Clinical Laboratory Improvement Amendments of 1988, or the FDA or other federal, state or local agencies.

We will need to seek regulatory approval in order to market Cchek.

The clinical laboratory testing industry is subject to extensive federal and state regulation, and many of these statutes and regulations have not been interpreted by the courts.

The Clinical Laboratory Improvement Act of 1967 and the Clinical Laboratory Improvement Amendments of 1988 are federal regulatory standards that apply to virtually all clinical laboratories (regardless of the location, size or type of laboratory), including those operated by physicians in their offices, by requiring that they be certified under federal law.

CLIA does not pre-empt state law, which in some cases may be more stringent than federal law and require additional personnel qualifications, quality control, record maintenance and proficiency testing.

The sanction for failure to comply with CLIA and state requirements may be suspension, revocation or limitation of a laboratorys CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties.

Several states have similar laws and we may be subject to similar penalties.

The FDA regulates diagnostic products and periodically inspects and reviews their manufacturing processes and product performance.

We may choose to seek FDA approval for one or more Cchek tests, as opposed to seeking CLIA certification.

We cannot assure that applicable statutes and regulations will not be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect our business.

Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorizations, which could have a material adverse effect on our business.

In addition, compliance with future legislation could impose additional requirements on us, which may be costly, including FDA regulation of laboratory developed tests.

Health insurers and other third-party payers may decide not to reimburse our Cchek diagnostic testing or may provide inadequate reimbursement, which could jeopardize our commercial prospects and require customers to pay for the tests out of pocket.

In the United States, the regulatory process that allows diagnostic tests to be marketed is independent of any coverage determinations made by third-party payers.

For new diagnostic tests, private and government payers decide whether to cover the test, the reimbursement amount for a covered test and the specific conditions for reimbursement.

Physicians may order diagnostic tests that are not reimbursed by third-party payers, but coverage determinations and reimbursement levels and conditions are critical to the commercial success of a diagnostic product.

Each third-party payer makes its own decision about which tests it will cover and how much it will pay, although many payers will follow the lead of Medicare.

As a result, the coverage determination process will be a time-consuming and costly process that requires us to provide scientific, clinical and economic support for the use of Cchek diagnostic testing to each payer separately, with no assurance that approval will be obtained.

If third-party payers decide not to cover Cchek or if they offer inadequate payment amounts, our ability to generate revenue from Cchek could be limited since patients who want to take the diagnostic tests would have to pay for it out of pocket.

Even if one or more third-party payers decide to reimburse for Cchek diagnostic testing, a third-party payer may stop or lower payment at any time, which could reduce revenue.

We cannot predict whether third-party payers will cover Cchek diagnostic testing or offer adequate reimbursement.

We also cannot predict the timing of such decisions.

In addition, physicians or patients may decide not to order Cchek tests if third-party payments are inadequate, especially if ordering the test could result in financial liability for the patient.

Whether or not health insurers and other third-party payers decide to reimburse Cchek , the technology may cost patients more than we anticipate.

We believe that our Cchek diagnostic testing will significantly reduce the cost to patients of screening and confirmatory testing for certain types of cancer.

If, however, the cost to utilize Cchek is more expensive than we anticipate, many patients and third-party payers may elect not to utilize the technology which would significantly impact our ability to generate revenue on the technology.

We operate in a competitive market and expect to face intense competition, often from companies with greater resources and experience than us.

The clinical diagnostics industry is highly competitive and subject to rapid change.

We are aware of many different types of diagnostic tests available to detect cancer that are currently in use or being developed and many more types of diagnostic tests may be developed in the future.

If we are able to successfully commercialize Cchek, all of these tests will compete with our products.

If Cchek is more expensive than and/or does not have sufficient specificity, sensitivity or predictive value to compete with tests that are currently on the market, or if any other diagnostic tests that are under development, once successfully developed and commercialized, have greater specificity, sensitivity or predictive value and/or are cheaper than our technology, we may be unable to compete successfully with such products which would have a material adverse effect on our business, financial condition and results of operations.

Furthermore, as the industry continues to expand and evolve, an increasing number of competitors and potential competitors may enter the market.

Many of these competitors and potential competitors have substantially greater financial, technological, managerial and research and development resources and experience than we do.

Some of these competitors and potential competitors have more experience than we do in the development of diagnostic products, including validation procedures and regulatory matters.

In addition, Cchek will compete with product offerings from large and well established companies that have greater marketing and sales experience and capabilities than we do.

If we are unable to compete successfully, we may be unable to sustain and grow our revenue.

We are dependent upon a few key personnel and the loss of their services could adversely affect us.

Our future success of developing Cchek will depend on the efforts of the inventor of the technology, our President and Chief Executive Officer Dr.

We do not have an employment agreement with Dr.

Kumar which means that Dr.

Kumar does not have a set term of employment and may renegotiate his employment arrangement with the Company at any time.

Further, we do not maintain key person life insurance on Dr.

The loss of the services of Dr.

Kumar could have a material adverse effect on our business and operating results.

Risks Related to our Therapeutics Business

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.

We have never generated any revenue from biopharmaceutical product sales and our biopharmaceutical products may never be profitable.

We are in the pre-clinical stage of developing our CAR-T therapeutic and breast cancer vaccine technologies.

Our ability to generate revenue depends in large part on our ability, alone or with partners, to successfully complete the development of, obtain the necessary regulatory approvals for, and commercialize, product candidates.

We do not anticipate generating revenues from sales of such products for the foreseeable future.

Our ability to generate future revenues from product sales of our CAR-T therapeutic and breast cancer vaccine technologies depends heavily on our success in:

· progressing our pre-clinical programs into human clinical trials;

· completing requisite clinical trials through all phases of clinical development of our ovarian cancer therapy and other potential CAR-T product candidates and our breast cancer vaccine;

· seeking and obtaining marketing approvals for our ovarian cancer therapy and other potential CAR-T product candidates and out breast cancer vaccine that successfully complete clinical trials, if any;

· launching and commercializing our ovarian cancer therapy and other potential CAR-T product candidates and our breast cancer vaccine for which we obtain marketing approval, if any, with a partner or, if launched independently, successfully establishing a manufacturing, sales force, marketing and distribution infrastructure;

· identifying and developing new CAR-T product candidates;

· establishing and maintaining supply and manufacturing relationships with third parties;

· maintaining, protecting, expanding and enforcing our intellectual property;

· attracting, hiring and retaining qualified personnel.

Because of the numerous risks and uncertainties associated with biologic product development, we are unable to predict the likelihood or timing for when we may receive regulatory approval of our ovarian cancer therapy and any other potential CAR-T product candidates and our breast cancer vaccine or when we will be able to achieve or maintain profitability, if ever.

If we are unable to establish a development and or commercialization partnership, or do not receive regulatory approvals, our business, prospects, financial condition and results of operations will be adversely affected.

Even if we or a partner obtain the regulatory approvals to market and sell one or more of our product candidates, we may never generate significant revenues from any commercial sales for several reasons, including because the market for our products may be smaller than we anticipate, or products may not be adopted by physicians and payors or because our products may not be as efficacious or safe as other treatment options.

If we fail to successfully commercialize one or more products, by ourselves or through a partner, we may be unable to generate sufficient revenues to sustain and grow our business and our business, prospects, financial condition and results of operations will be adversely affected.

Cancer vaccines are novel and present significant challenges.

The development of preventive and therapeutic cancer vaccines is difficult, with very few cancer vaccines successfully reaching the market.

The only vaccines shown to be effective in preventing cancer have been vaccines against cancer causing agents, not the cancer itself.

Vaccines work by exposing a benign form of a disease agent to an individuals immune system.

The immune system identifies the agent and learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed to the disease agent months or years later.

Most vaccines attack pathogens, such as viruses and bacteria.

may also need to negotiate licenses to patents or patent applications before or after introducing a commercial product.

not be able to obtain necessary licenses to patents or patent applications, and our business may suffer if we are unable to enter

into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors

fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the licensed patents or other

rights are found to be invalid or unenforceable.

Biotechnology

and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.

have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical

products may never be profitable.

are in the discovery stage of developing our COVID-19 treatment and our ovarian cancer vaccine technology, in the pre-clinical

stage of developing our CAR-T therapeutic technology and about to enter the clinical stage with our breast cancer vaccine technology.

Our ability to generate revenue depends in large part on our ability, alone or with partners, to successfully complete the development

of, obtain the necessary regulatory approvals for, and commercialize, product candidates.

We do not anticipate generating revenues

from sales of such products for the foreseeable future.

Our ability to generate future revenues from product sales of our technologies

depends heavily on our success in:

our discovery stage programs into pre-clinical testing;

our pre-clinical programs into human clinical trials;

requisite clinical trials through all phases of clinical development of our product candidates;

and obtaining marketing approvals for our product candidates that successfully complete clinical trials, if any;

and commercializing our product candidates for which we obtain marketing approval, if any, with a partner or, if launched

independently, successfully establishing a manufacturing, sales force, marketing and distribution infrastructure;

and developing new product candidates;

and maintaining supply and manufacturing relationships with third parties;

protecting, expanding and enforcing our intellectual property;

hiring and retaining qualified personnel.

of the numerous risks and uncertainties associated with biologic and pharmaceutical product development, we are unable to predict

the likelihood or timing for when we may receive regulatory approval of our product candidates or when we will be able to achieve

or maintain profitability, if ever.

If we are unable to establish a development and or commercialization partnership, or do not

receive regulatory approvals, our business, prospects, financial condition and results of operations will be adversely affected.

Even if we or a partner obtain the regulatory approvals to market and sell one or more of our product candidates, we may never

generate significant revenues from any commercial sales for several reasons, including because the market for our products may

be smaller than we anticipate, or products may not be adopted by physicians and payors or because our products may not be as efficacious

or safe as other treatment options.

If we fail to successfully commercialize one or more products, by ourselves or through a partner,

we may be unable to generate sufficient revenues to sustain and grow our business and our business, prospects, financial condition

and results of operations will be adversely affected.

vaccines are novel and present significant challenges.

development of preventive and therapeutic cancer vaccines is difficult, with very few cancer vaccines successfully reaching the

The only vaccines shown to be effective in preventing cancer have been vaccines against cancer causing agents, not the

cancer itself.

Vaccines work by exposing a benign form of a disease agent to an individual’s immune system.

The immune system

identifies the agent and learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react

quickly if an individual is exposed to the disease agent months or years later.

Most vaccines attack pathogens, such as viruses

and bacteria.

The immune system is better able to assail these agents because they come from outside the body.

Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical mass, they become cancer.

CAR-T cell therapies are novel and present significant challenges.

CAR-T product candidates represent a relatively new field of cellular immunotherapy.

Advancing this novel and personalized therapy creates significant challenges for us, or a partner, including:

· obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T-cell therapies for cancer;

· sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

· developing a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and infusing the engineered T cells into the patient;

· educating medical personnel regarding the potential safety benefits, as well as the challenges, of incorporating our product candidates into their treatment regimens;

· establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy;

· the availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy.

Our inability to successfully develop CAR-T cell therapies or develop processes related to the manufacture, sales and marketing of these therapies would adversely affect our business, results of operations and prospects.

While CAR-T technology has shown positive results in B-cell cancers by others, its safety and efficacy has not been seen in solid tumors and we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers.

CAR-T therapies function through the binding of a genetically engineered killer T-cell to a cancer cell.

However, these engineered T-cells destroy the cell they are bound to whether it is a cancer cell or a healthy cell.

Therefore, the engineered T-cells must be designed to only bind to either cancer cells or other target cells to minimize toxicity.

Our CAR-T technology relies on the natural affinity of FSH to FSH-Receptor.

Research by others has shown that in women the FSH-Receptor protein is found on ovary cells and generally in no other healthy tissue, and therefore, we engineer our T-cells with FSH.

However, as the research in this field is still new, we cannot guarantee that there is no FSH-Receptor on any other healthy tissue in the human body.

While both our CAR-T technology and our breast cancer vaccine have shown favorable results from in-vitro and in-vivo testing, including in large numbers of animals under the Good Laboratory Practice (GLP) conditions necessary for inclusion in an IND application, we cannot guarantee that these results will be sufficient for the FDA to allow us to commence human clinical trials.

While studies on each of our CAR-T ovarian cancer therapeutic and breast cancer vaccine have generated promising results in large numbers of mice under GLP conditions, and toxicity studies have been performed and have had favorable results, there can be no assurance that the FDA will find these results sufficient to allow us to commence testing of either of our ovarian cancer therapy or breast cancer vaccine in human patients.

If we are unable to commence human clinical trials for either or both of our product candidates, or if commencement of such trials is significantly delayed, we may be required to expend significant additional resources, which may not be available to us, and our business, prospects, financial condition and results of operations may be adversely affected.

While pre-clinical testing of our product candidates have been positive, we may experience unfavorable results once we commence human clinical trials.

We have not initiated clinical trials for our ovarian cancer therapy or our breast cancer vaccine and we may not be able to commence clinical trials on the time frames we expect.

As these product candidates have only been tested in animals, we face significant uncertainty regarding how effective and safe they will be in human patients and the results from preclinical studies may not be indicative of the results of clinical trials.

Preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products.

Even if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do, and more clinical trials could be required before we submit our product candidates for approval.

To the extent that the results of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our product candidates.

We are dependent on third parties to conduct our pre-clinical and clinical trials.

We depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, and strategic partners such as Moffitt for our CAR-T therapy and Cleveland Clinic for our breast cancer vaccine to conduct our preclinical and clinical trials under agreements with us.

Negotiations of budgets and contracts with study sites may result in delays to our development timelines and increased costs.

We will rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities.

Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.

We and these third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal investigators and clinical trial sites.

If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require us to perform additional clinical trials before approving our marketing applications.

It is possible that, upon inspection, such regulatory authorities could determine that any of our clinical trials fail to comply with the cGCP regulations.

In addition, our clinical trials must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and will require a large number of test patients.

Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process.

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

Any third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical, clinical and nonclinical programs.

These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf.

If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus.

Cancer, however,

is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the

diseased cells, especially as advancing age weakens our immune system.

Once these aberrant cells gain critical mass, they become

cell therapies are novel and present significant challenges.

product candidates represent a relatively new field of cellular immunotherapy.

Advancing this novel and personalized therapy creates

significant challenges for us, or a partner, including:

regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T-cell

therapies for cancer;

clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and

infusing the engineered T cells into the patient;

medical personnel regarding the potential safety benefits, as well as the challenges, of incorporating our product candidates

into their treatment regimens;

sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy;

availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy.

inability to successfully develop CAR-T cell therapies or develop processes related to the manufacture, sales and marketing of

these therapies would adversely affect our business, results of operations and prospects.

CAR-T technology has shown positive results in B-cell cancers by others, its safety and efficacy has not been seen in solid tumors

and we cannot guarantee our CAR-T technology will be safe or effective in ovarian or other cancers.

therapies function through the binding of a genetically engineered killer T-cell to a cancer cell.

However, these engineered T-cells

destroy the cell they are bound to whether it is a cancer cell or a healthy cell.

Therefore, the engineered T-cells must be designed

to only bind to either cancer cells or other target cells to minimize toxicity.

Our CAR-T technology relies on the natural affinity

of FSH to FSH-Receptor.

Research by others has shown that in women the FSH-Receptor protein is found on ovary cells and generally

in no other healthy tissue, and therefore, we engineer our T-cells with FSH.

However, as the research in this field is still new,

we cannot guarantee that there is no FSH-Receptor on any other healthy tissue in the human body.

our CAR-T technology has shown favorable results from in-vitro and in-vivo testing, including in large numbers of animals under

the Good Laboratory Practice (“GLP”) conditions necessary for inclusion in an IND application, we cannot guarantee

that these results will be sufficient for the FDA to allow us to commence human clinical trials.

studies on our CAR-T ovarian cancer therapeutic have generated promising results in large numbers of mice under GLP conditions,

and toxicity studies have been performed and have had favorable results, there can be no assurance that the FDA will find these

results sufficient to allow us to commence testing of our ovarian cancer therapy in human patients.

If we are unable to commence

human clinical trials for our product candidate, or if commencement of such trial is significantly delayed, we may be required

to expend significant additional resources, which may not be available to us, and our business, prospects, financial condition

and results of operations may be adversely affected.

is no guarantee that our collaboration with OntoChem will produce a successful anti-viral drug for COVID-19.

April 14, 2020, we entered into a collaboration agreement with OntoChem for the purpose of discovering and ultimately developing

anti-viral drug candidates for COVID-19.

Through this collaboration, we utilized advanced computational methods, machine learning

and molecular modeling techniques to perform in silico screening of over 1.2 billion compounds in OntoChem’s chemistry

and gene ontology database (including publicly available compounds and OntoChem’s proprietary libraries) to evaluate if

any of these compounds could disrupt one of two key enzymes of COVID-19.

While, to date, we have synthesized several potential

COVID-19 compounds and are in the process of performing biological assays, there is no guarantee that any of these compounds (or

any other future compounds that we may identify) will demonstrate sufficient potency as predicted by the molecular modeling algorithms.

Further, even if these compounds do demonstrate sufficient potency, there is no guarantee that the compounds will be effective

in animal or human testing and that they will ultimately be effective anti-viral drugs for COVID-19.

In addition, based on the

current stage of development, while considering the streamlined regulatory processes for COVID-19 therapies, it may take up to

two or more years before we could obtain Emergency Use Authorization from the FDA.

is significant competition in the search for a treatment for COVID-19.

is significant competition, including from other companies and governmental organizations, to find treatments for COVID-19.

of these entities have substantially greater resources (including capital and personnel) than we do and many of these entities

are much further ahead in pursuit of a treatment than we are.

Even if we are successful in identifying a compound that may act

as an effective treatment for COVID-19, there is no guarantee that we will have the only effective treatment for COVID-19 or that

we will be able to get our treatment to market prior to our competitors.

successful preventative vaccine will likely limit the market for a COVID-19 treatment.

number of preventative vaccines have recently been approved for use in human populations by regulatory agencies in the U.S.

The anticipated effectiveness of these vaccines will likely limit the spread of COVID-19 and potentially reduce the market

size for a COVID-19 treatment.

pre-clinical testing of our product candidates have been positive, we may experience unfavorable results once we commence human

clinical trials.

have not initiated clinical trials for any of our product candidates and we may not be able to commence clinical trials on the

time frames we expect.

As these product candidates have only been tested in animals, we face significant uncertainty regarding

how effective and safe they will be in human patients and the results from preclinical studies may not be indicative of the results

of clinical trials.

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

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

failed to obtain marketing approval for their products.

if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do,

and more clinical trials could be required before we submit our product candidates for approval.

To the extent that the results

of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application,

approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources,

which may not be available to us, to conduct additional clinical trials in support of potential approval of our product candidates.

are dependent on third parties to conduct our pre-clinical and clinical trials.

depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions,

and strategic partners such as Moffitt for our CAR-T therapy, Cleveland Clinic for our breast and ovarian cancer vaccines and

OntoChem, as well as other European partners, for our COVID-19 therapy to conduct our preclinical and clinical trials under agreements

Negotiations of budgets and contracts with study sites may result in delays to our development timelines and increased

We will rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects

of their activities.

Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable

protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory

responsibilities.

We and these third parties are required to comply with current good clinical practices, or cGCPs, which are

regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical

Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal investigators

and clinical trial sites.

If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data

generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require

us to perform additional clinical trials before approving our marketing applications.

It is possible that, upon inspection, such

regulatory authorities could determine that any of our clinical trials fail to comply with the cGCP regulations.

our clinical trials must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and

will require a large number of test patients.

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

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

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

claims laws and regulations or healthcare privacy and security laws.

third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under

our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical,

clinical and nonclinical programs.

These third parties may also have relationships with other commercial entities, including our

competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their

performance on our behalf.

If these third parties do not successfully carry out their contractual duties or obligations or meet

expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised

due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may

be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfully

commercialize our product candidates.

As a result, our financial results and the commercial prospects for our product candidates

would be harmed, our costs could increase and our ability to generate revenue could be delayed.

or adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus.

In addition, there is a natural transition period when a new third party commences work.

As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

Even if we are permitted to conduct clinical trials for our product candidates, we may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.

The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.

The enrollment of patients depends on many factors, including:

· the patient eligibility criteria defined in the clinical trial protocol;

· the size of the patient population required for analysis of the trials primary endpoints;

· the proximity of patients to the study site;

· the design of the clinical trial;

· our ability to retain clinical trial investigators with the appropriate competencies and experience;

· our ability to obtain and maintain patient consents;

· the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion;

· competing clinical trials and approved therapies available for patients.

In particular, our CAR-T ovarian cancer clinical trial will look to enroll patients with late stage ovarian cancer who have failed conventional treatment, and are willing and able to be treated at Moffitt.

Our first breast cancer vaccine clinical trial will look to enroll patients who have undergone standard of care treatment for TNBC.

Our second breast cancer vaccine clinical trial will look to enroll healthy women who, as a result of testing positive for the BRCA1 gene mutation which is a leading predictor of future incidence of breast cancer, have elected to have prophylactic mastectomies.

These potential trial participants have to be willing and able to undergo treatment at the Cleveland Clinic.

Our clinical trials will compete with other companies' clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our clinical trials may instead opt to enroll in a trial being conducted by one of our competitors.

We expect to conduct our clinical trials at the same clinical trial sites that some of our competitors may use, which will reduce the number of patients who are available for our clinical trial in these clinical trial sites.

Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use experimental therapies that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our future clinical trials.

Patients may also be unwilling to participate in our clinical trials because of negative publicity from adverse events in the biotechnology or gene therapy industries.

Additionally, due to the design of our breast cancer vaccine trials it is unlikely that any of the trial participants will experience a positive therapeutic effect which may further reduce the number of patients who may enroll in our trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could prevent completion of the clinical trials and adversely affect our ability to advance the development of our ovarian cancer CAR-T therapy and our breast cancer vaccine.

Any adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting clinical trials under independent INDs may negatively affect the conduct of our clinical trials or our ability to obtain regulatory approvals or commercialize our product candidates.

CAR-T, vaccines and other immuno-therapy technologies are being used by third parties in clinical trials for which we are collaborating or in clinical trials which are completely independent of our development programs.

We have little to no control over the conduct of those clinical trials.

If serious adverse events occur during these or any other clinical trials using technologies similar to ours, the FDA and other regulatory authorities may delay our clinical trial, or could delay, limit or deny approval of our product candidates or require us to conduct additional clinical trials as a condition to marketing approval, which would increase our costs.

If we receive regulatory approval for any product candidate and a new and serious safety issue is identified in connection with clinical trials conducted by third parties, the applicable regulatory authorities may withdraw their approval of our products or otherwise restrict our ability to market and sell our products.

In addition, treating physicians may be less willing to administer our products due to concerns over such adverse events, which would limit our ability to commercialize our products.

Adverse side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials or delay or preclude approval.

In third party clinical trials involving CAR-T cell therapies, the most prominent acute toxicities included symptoms thought to be associated with the release of cytokines, such as fever, low blood pressure and kidney dysfunction.

Some patients also experienced toxicity of the central nervous system, such as confusion, cranial nerve dysfunction and speech impairment.

Adverse side effects attributed to CAR-T therapies were severe and life-threatening in some patients.

The life-threatening events were related to kidney dysfunction and toxicities of the central nervous system or other organ failure.

Severe and life-threatening toxicities occurred primarily in the first two weeks after cell infusion and generally resolved within three weeks.

In the past, several patients have also died in clinical trials by others involving CAR-T cells.

Side effects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects such as fever, inflammation, organ failure or other adverse effects.

Undesirable side effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay, suspension or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons.

In addition, because the patients who will be enrolled in our clinical trials may be suffering from a life-threatening disease and may often be suffering from multiple complicating conditions it may be difficult to accurately assess the relationship between our product candidate and adverse events experienced by very ill patients.

If we elect or are required to delay, suspend or terminate any of our clinical trials, the commercial prospects of such therapy will be harmed and our ability to generate product revenues from such therapy will be delayed or eliminated.

In addition, serious adverse events observed in clinical trials could hinder or prevent market acceptance of the product candidate at issue.

Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.

Clinical trials are expensive, time-consuming and difficult to design and implement.

Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

Because our CAR-T ovarian cancer therapy is based on relatively new technology and engineered on a patient-by-patient basis, we expect that it will require extensive research and development and have substantial manufacturing and processing costs.

In addition, costs to treat patients with relapsed/refractory cancer and to treat potential side effects that may result from therapies such as our current and future product candidates can be significant.

Accordingly, our clinical trial costs are likely to be significantly higher than for more conventional therapeutic technologies or drug products.

In addition, our proposed personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us.

In one of our planned breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for the BRCA1 gene mutation, have elected to have prophylactic mastectomies.

Delivering an experimental treatment to a healthy individual is more complex and subject to more rigorous regulatory requirements and is more difficult to design and implement.

In addition, in future clinical trials we will need to determine efficacy of the breast cancer vaccine as a cancer prevention which will be a considerably more complex clinical trial and will have significantly greater costs.

The costs of our clinical trials may increase if the FDA does not agree with our clinical development plans or requires us to conduct additional clinical trials to demonstrate the safety and efficacy of our product candidates.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

The biopharmaceutical industry is characterized by intense competition and rapid innovation.

Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results.

Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.

Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces.

Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors.

Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.

Our competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.

Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

Gene-modified cell therapy manufacture requires many specialty raw materials, some of which are manufactured by small companies with limited resources and experience to support a commercial product.

Some suppliers typically support biomedical researchers or blood-based hospital businesses and may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms.

The suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like a FDA inspection or medical crisis, such as widespread contamination.

We also do not have commercial supply arrangements with many of these suppliers, and may not be able to contract with them on acceptable terms or at all.

Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.

In addition, some raw materials are currently available from a single supplier, or a small number of suppliers.

We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose.

We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

We may form or seek strategic alliances, create joint ventures or collaborations and enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop.

Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.

In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.

Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.

If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture.

It is possible that, following a strategic transaction or license, we may not achieve the revenue or specific net income that justifies such transaction.

Any delays in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.

We have not previously submitted a Biologics License Application (BLA) to the FDA, or similar approval filings to other foreign authorities.

A BLA must include extensive preclinical and clinical data and supporting information to establish the product candidates safety, purity and potency for each desired indication.

As a result, delays occur, which can

materially impact our ability to meet our desired clinical development timelines.

we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise

adversely affected.

if we are permitted to conduct clinical trials for our product candidates, we may experience difficulties in patient enrollment

in our clinical trials for a variety of reasons.

The timely completion of clinical trials in accordance with their protocols depends,

among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.

enrollment of patients depends on many factors, including:

patient eligibility criteria defined in the clinical trial protocol;

size of the patient population required for analysis of the trial’s primary endpoints;

proximity of patients to the study site;

design of the clinical trial;

ability to retain clinical trial investigators with the appropriate competencies and experience;

ability to obtain and maintain patient consents;

risk that patients enrolled in clinical trials will drop out of the clinical trials before completion;

clinical trials and approved therapies available for patients.

particular, our CAR-T ovarian cancer clinical trial will look to enroll patients with late stage ovarian cancer who have failed

conventional treatment, and are willing and able to be treated at Moffitt.

Our first breast cancer vaccine clinical trial will

look to enroll patients who have undergone standard of care treatment for TNBC.

Our second breast cancer vaccine clinical trial

will look to enroll healthy women who, as a result of testing positive for the BRCA1 gene mutation which is a leading predictor

of future incidence of breast cancer, have elected to have prophylactic mastectomies.

These potential trial participants have

to be willing and able to undergo treatment at the Cleveland Clinic.

clinical trials will compete with other companies’

clinical trials for product candidates that are in the same therapeutic

areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some

patients who might have opted to enroll in our clinical trials may instead opt to enroll in a trial being conducted by one of

our competitors.

We expect to conduct our clinical trials at the same clinical trial sites that some of our competitors may use,

which will reduce the number of patients who are available for our clinical trial in these clinical trial sites.

Moreover, because

our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their

doctors may be inclined to use experimental therapies that use conventional technologies, such as chemotherapy and antibody therapy,

rather than enroll patients in our future clinical trials.

Patients may also be unwilling to participate in our clinical trials

because of negative publicity from adverse events in the biotechnology or gene therapy industries.

Additionally,

due to the design of our breast cancer vaccine trials it is unlikely that any of the trial participants will experience a positive

therapeutic effect which may further reduce the number of patients who may enroll in our trials.

in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which

could prevent completion of the clinical trials and adversely affect our ability to advance the development of our ovarian cancer

CAR-T therapy and our breast cancer vaccine.

adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities

conducting clinical trials under independent INDs may negatively affect the conduct of our clinical trials or our ability to obtain

regulatory approvals or commercialize our product candidates.

vaccines and other immuno-therapy technologies are being used by third parties in clinical trials for which we are collaborating

or in clinical trials which are completely independent of our development programs.

We have little to no control over the conduct

of those clinical trials.

If serious adverse events occur during these or any other clinical trials using technologies similar

to ours, the FDA and other regulatory authorities may delay our clinical trial, or could delay, limit or deny approval of our

product candidates or require us to conduct additional clinical trials as a condition to marketing approval, which would increase

If we receive regulatory approval for any product candidate and a new and serious safety issue is identified in connection

with clinical trials conducted by third parties, the applicable regulatory authorities may withdraw their approval of our products

or otherwise restrict our ability to market and sell our products.

In addition, treating physicians may be less willing to administer

our products due to concerns over such adverse events, which would limit our ability to commercialize our products.

side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials

or delay or preclude approval.

third party clinical trials involving CAR-T cell therapies, the most prominent acute toxicities included symptoms thought to be

associated with the release of cytokines, such as fever, low blood pressure and kidney dysfunction.

Some patients also experienced

toxicity of the central nervous system, such as confusion, cranial nerve dysfunction and speech impairment.

Adverse side effects

attributed to CAR-T therapies were severe and life-threatening in some patients.

The life-threatening events were related to kidney

dysfunction and toxicities of the central nervous system or other organ failure.

Severe and life-threatening toxicities occurred

primarily in the first two weeks after cell infusion and generally resolved within three weeks.

In the past, several patients

have also died in clinical trials by others involving CAR-T cells.

effects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects

such as fever, inflammation, organ failure or other adverse effects.

side effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay,

suspension or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons.

because the patients who will be enrolled in our clinical trials may be suffering from a life-threatening disease and may often

be suffering from multiple complicating conditions it may be difficult to accurately assess the relationship between our product

candidate and adverse events experienced by very ill patients.

If we elect or are required to delay, suspend or terminate any

of our clinical trials, the commercial prospects of such therapy will be harmed and our ability to generate product revenues from

such therapy will be delayed or eliminated.

In addition, serious adverse events observed in clinical trials could hinder or prevent

market acceptance of the product candidate at issue.

Any of these occurrences may harm our business, prospects, financial condition

and results of operations significantly.

trials are expensive, time-consuming and difficult to design and implement.

clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.

Because our CAR-T ovarian cancer therapy is based on relatively new technology and engineered on a patient-by-patient basis, we

expect that it will require extensive research and development and have substantial manufacturing and processing costs.

costs to treat patients with relapsed/refractory cancer and to treat potential side effects that may result from therapies such

as our current and future product candidates can be significant.

Accordingly, our clinical trial costs are likely to be significantly

higher than for more conventional therapeutic technologies or drug products.

In addition, our proposed personalized product candidates

involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us.

one of our planned breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for

the BRCA1 gene mutation, have elected to have prophylactic mastectomies.

Delivering an experimental treatment to a healthy individual

is more complex and subject to more rigorous regulatory requirements and is more difficult to design and implement.

in future clinical trials we will need to determine efficacy of the breast cancer vaccine as a cancer prevention which will be

a considerably more complex clinical trial and will have significantly greater costs.

costs of our clinical trials may increase if the FDA does not agree with our clinical development plans or requires us to conduct

additional clinical trials to demonstrate the safety and efficacy of our product candidates.

face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we

fail to compete effectively.

biopharmaceutical industry is characterized by intense competition and rapid innovation.

Our competitors may be able to develop

other compounds or drugs that are able to achieve similar or better results.

Our potential competitors include major multinational

pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research

institutions.

Many of our competitors have substantially greater financial, technical and other resources, such as larger research

and development staff and experienced marketing and manufacturing organizations and well-established sales forces.

early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large,

established companies.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources

being concentrated in our competitors.

Competition may increase further as a result of advances in the commercial applicability

of technologies and greater availability of capital for investment in these industries.

Our competitors, either alone or with

collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that

are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies

or secure patent protection that we may need for the development of our technologies and products.

therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

Gene-modified

cell therapy manufacture requires many specialty raw materials, some of which are manufactured by small companies with limited

resources and experience to support a commercial product.

Some suppliers typically support biomedical researchers or blood-based

hospital businesses and may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical

The suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like a FDA inspection or

medical crisis, such as widespread contamination.

We also do not have commercial supply arrangements with many of these suppliers,

and may not be able to contract with them on acceptable terms or at all.

Accordingly, we may experience delays in receiving key

raw materials to support clinical or commercial manufacturing.

addition, some raw materials are currently available from a single supplier, or a small number of suppliers.

We cannot be sure

that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company

that is not interested in continuing to produce these materials for our intended purpose.

may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the

benefits of such alliances or licensing arrangements.

may form or seek strategic alliances, create joint ventures or collaborations and enter into additional licensing arrangements

with third parties that we believe will complement or augment our development and commercialization efforts with respect to our

product candidates and any future product candidates that we may develop.

Any of these relationships may require us to incur non-recurring

and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt

our management and business.

In addition, we face significant competition in seeking appropriate strategic partners and the negotiation

process is time-consuming and complex.

Moreover, we may not be successful in our efforts to establish a strategic partnership

or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development

for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate

safety and efficacy.

If we license products or businesses, we may not be able to realize the benefit of such transactions if we

are unable to successfully integrate them with our existing operations and company culture.

It is possible that, following a strategic

transaction or license, we may not achieve the revenue or specific net income that justifies such transaction.

Any delays in entering

into new strategic partnership agreements related to our product candidates could delay the development and commercialization

of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition

and results of operations.

FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development

and regulatory approval of our product candidates.

have not previously submitted a Biologics License Application (“BLA”) or a New Drug Application (“NDA”)

to the FDA, or similar approval filings to other foreign authorities.

A BLA or NDA must include extensive preclinical and clinical

data and supporting information to establish the product candidate’s safety, purity and potency for each desired indication.

It must also include significant information regarding the chemistry, manufacturing and controls for the product.

We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval.

For example, the FDA has limited experience with commercial development of T-cell therapies and vaccines for cancer.

The regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:

· the availability of financial resources to commence and complete our planned clinical trials;

· reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

· recruiting suitable patients to participate in a clinical trial;

· having patients complete a clinical trial or return for post-treatment follow-up;

· clinical trial sites deviating from clinical trial protocol, failing to follow GCPs, or dropping out of a clinical trial;

· adding new clinical trial sites;

· manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject by subject basis for use in clinical trials.

Also, before a clinical trial can begin at an NIH-funded institution, that institutions independent institutional review board, or IRB, and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.

In addition, adverse developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any of our product candidates.

We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.

Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such clinical trials are being conducted, the Data Monitoring Committee for such clinical trial, or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed.

In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.

Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates.

Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.

The use of engineered T-cells as a potential cancer treatment and the use of therapeutic and prophylactic cancer vaccines are recently developed technologies and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.

Many factors will influence whether our product candidates are accepted in the market, including:

· the clinical indications for which our product candidates are approved;

· physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment;

· the potential and perceived advantages of our product candidates over alternative treatments;

· the prevalence and severity of any side effects;

· product labeling or product insert requirements of the FDA or other regulatory authorities;

· limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities;

· the extent and quality of the clinical evidence supporting the efficacy and safety of our product candidates;

· the timing of market introduction of our product candidates as well as competitive products;

· the cost of treatment in relation to alternative treatments;

· the availability of adequate reimbursement and pricing by third-party payors and government authorities;

· the willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government authorities;

· relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies;

· the effectiveness of our or any of our strategic partners sales and marketing efforts.

If our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue.

Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.

Our ability to compete and to achieve sustained profitability will be impacted by our ability to protect our Cchek cancer diagnostic technologies, our CAR-T cancer therapeutics technologies, our breast cancer vaccine technologies and other proprietary discoveries and technologies.

We expect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protect our technologies.

Our intellectual property strategy is intended to help develop and maintain our competitive position.

While we have been granted multiple patents related to our technologies, there is no assurance that we will be able to obtain further patent protection for our technologies or any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriation and unauthorized use of our technologies.

We expect the

novel nature of our product candidates to create further challenges in obtaining regulatory approval.

For example, the FDA has

limited experience with commercial development of T-cell therapies and vaccines for cancer.

The regulatory approval pathway for

our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:

availability of financial resources to commence and complete our planned clinical trials;

agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation

and may vary significantly among different clinical trial sites;

suitable patients to participate in a clinical trial;

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

trial sites deviating from clinical trial protocol, failing to follow GCPs, or dropping out of a clinical trial;

new clinical trial sites;

manufacturing

sufficient quantities of qualified materials under cGMPs and applying them on a subject by subject basis for use in clinical

before a clinical trial can begin at an NIH-funded institution, that institution’s independent institutional review board,

or IRB, and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.

addition, adverse developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory

bodies to change the requirements for approval of any of our product candidates.

could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials

of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.

a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such clinical trials are being conducted,

the Data Monitoring Committee for such clinical trial, or by the FDA or other regulatory authorities due to a number of factors,

including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection

of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition

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

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

experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects

for our product candidates will be harmed, and our ability to generate product revenue will be delayed.

In addition, any delays

in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize

our ability to commence product sales and generate revenue.

of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the

denial of regulatory approval of our product candidates.

if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients,

hospitals, cancer treatment centers, third-party payors and others in the medical community.

use of engineered T-cells as a potential cancer treatment and the use of therapeutic and prophylactic cancer vaccines are recently

developed technologies and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, third-party

payors and others in the medical community.

Many factors will influence whether our product candidates are accepted in the market,

clinical indications for which our product candidates are approved;

hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment;

potential and perceived advantages of our product candidates over alternative treatments;

prevalence and severity of any side effects;

labeling or product insert requirements of the FDA or other regulatory authorities;

or warnings contained in the labeling approved by the FDA or other regulatory authorities;

extent and quality of the clinical evidence supporting the efficacy and safety of our product candidates;

timing of market introduction of our product candidates as well as competitive products;

cost of treatment in relation to alternative treatments;

availability of adequate reimbursement and pricing by third-party payors and government authorities;

willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government

convenience and ease of administration, including as compared to alternative treatments and competitive therapies;

effectiveness of our or any of our strategic partners’

sales and marketing efforts.

our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment

centers or others in the medical community, we will not be able to generate significant revenue.

Even if our products achieve

market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced

that are more favorably received than our products, are more cost effective or render our products obsolete.

Related to Our Intellectual Property

we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.

ability to compete and to achieve sustained profitability will be impacted by our ability to protect our CAR-T cancer therapeutics

technologies, our breast cancer vaccine technologies, our ovarian cancer vaccine technologies, our COVID-19 therapeutic technologies

and other proprietary discoveries and technologies.

We expect to rely on a combination of patent protection, copyrights, trademarks,

trade secrets, know-how, and regulatory approvals to protect our technologies.

Our intellectual property strategy is intended

to help develop and maintain our competitive position.

While we have been granted multiple patents related to our technologies,

there is no assurance that we will be able to obtain further patent protection for our technologies or any other technologies,

nor can we be certain that the steps we will have taken will prevent the misappropriation and unauthorized use of our technologies.

If we are not able to obtain and maintain patent protection our competitive position may be harmed.

Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our Cchek cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies without infringing, misappropriating or otherwise violating the proprietary rights or intellectual property of third parties.

We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our Cchek cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.

If we are found to infringe a third-party's intellectual property rights, we could be required to obtain a license from such third-party to continue developing our Cchek cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies.

However, we may not be able to obtain any required license on commercially reasonable terms or at all.

Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

We could be forced, including by court order, to cease developing the infringing technology or product.

parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which

would be uncertain and could have a material adverse effect on the success of our business.

commercial success depends upon our ability to develop, manufacture, market and sell our CAR-T therapeutics, our breast cancer

vaccine, our ovarian cancer vaccine, our COVID-19 treatment and other proprietary discoveries and technologies without infringing,

misappropriating or otherwise violating the proprietary rights or intellectual property of third parties.

We may become party

to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to

our CAR-T therapeutics, our breast cancer vaccine, our ovarian cancer vaccine, our COVID-19 treatment and other proprietary discoveries

and technologies.

Third parties may assert infringement claims against us based on existing patents or patents that may be granted

in the future.

If we are found to infringe a third-party’s intellectual property rights, we could be required to obtain

a license from such third-party to continue developing our CAR-T therapeutics, our breast cancer vaccine, our ovarian cancer vaccine,

our COVID-19 treatment and other proprietary discoveries and technologies.

However, we may not be able to obtain any required

license on commercially reasonable terms or at all.

Even if we were able to obtain a license, it could be non-exclusive, thereby

giving our competitors access to the same technologies licensed to us.

We could be forced, including by court order, to cease

developing the infringing technology or product.

In addition, we could be found liable for monetary damages.

Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.

We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast cancer vaccine technology, and if we lose either of these licenses we may be subjected to future litigation.

We are party to royalty-bearing license agreements that grant us rights to use certain intellectual property, including patents and patent applications.

We may need to obtain additional licenses from others to advance our research, development and commercialization activities.

Our license agreement imposes, and we expect that future license agreements if necessary will impose, various development, diligence, commercialization and other obligations on us.

In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.

If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commercialization activities.

Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

Moreover, disputes may arise with respect to any one of our licensing agreements, including:

· the scope of rights granted under the license agreement and other interpretation-related issues;

· the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

· the sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships;

· our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

· the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners;

· the priority of invention of patented technology.

If we do not prevail in such disputes, we may lose any of such license agreements.

In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects.

Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations and prospects.

Our failure to maintain such licenses could have a material adverse effect on our business, financial condition and results of operations.

Any of these licenses could be terminated, such as if either party fails to abide by the terms of the license, or if the licensor fails to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable.

Absent the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may be subject to litigation by the licensor.

Claims that we have

misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.

rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies,

and if we lose any of these licenses we may be subjected to future litigation.

are party to royalty-bearing license agreements that grant us rights to use certain intellectual property, including patents and

patent applications.

We may need to obtain additional licenses from others to advance our research, development and commercialization

Our license agreement imposes, and we expect that future license agreements if necessary will impose, various development,

diligence, commercialization and other obligations on us.

spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements

and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products

and technology covered by these license agreements.

If these in-licenses are terminated, or if the underlying patents fail to

provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and

to market, products identical to ours and we may be required to cease our development and commercialization activities.

the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations

and prospects.

disputes may arise with respect to any one of our licensing agreements, including:

scope of rights granted under the license agreement and other interpretation-related issues;

extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is

not subject to the licensing agreement;

sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships;

diligence obligations under the license agreement and what activities satisfy those diligence obligations;

inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by

our licensors and us and our partners;

priority of invention of patented technology.

we do not prevail in such disputes, we may lose any of such license agreements.

addition, the agreements under which we currently license intellectual property or technology from third parties are complex,

and certain provisions in such agreements may be susceptible to multiple interpretations.

The resolution of any contract interpretation

disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or

technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which

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

Moreover, if disputes

over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates,

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

failure to maintain such licenses could have a material adverse effect on our business, financial condition and results of operations.

Any of these licenses could be terminated, such as if either party fails to abide by the terms of the license, or if the licensor

fails to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable.

Absent the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated,

we may be subject to litigation by the licensor.

Litigation could result in substantial costs and be a distraction to management.

If we do not prevail, we may be required to pay damages, including treble damages, attorneys fees, costs and expenses, royalties or, be enjoined from selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financial condition.

If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market.

Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets.

Certain intellectual property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such intellectual property.

There are several pending U.S.

and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filed both in the U.S.

If we do not prevail, we may be required to pay damages, including treble damages, attorneys’

fees, costs and expenses,

royalties or, be enjoined from selling our products, which could adversely affect our ability to offer products, our ability to

continue operations and our financial condition.

our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively

in our market.

disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly

duplicate or surpass our technological achievements, thus eroding our competitive position in our markets.

Certain intellectual

property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial

rights to such intellectual property.

are several pending U.S.

and foreign patent applications in our portfolio, and we anticipate additional patent applications will

be filed both in the U.S.

and in other countries, as appropriate.

However, we cannot predict:

· if and when patents will issue;

· the degree and range of protection any issued patents will afford us against competitors including whether third parties will find ways to invalidate or otherwise circumvent our patents;

· whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications;

· whether we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose.

Composition of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property.

We cannot be certain that the claims in our pending patent applications directed to compositions of matter for our product candidates will be considered patentable by the U.S.

Patent and Trademark Office (the USPTO) or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid by courts in the U.S.

or foreign countries.

and when patents will issue;

degree and range of protection any issued patents will afford us against competitors including whether third parties will

find ways to invalidate or otherwise circumvent our patents;

or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications;

we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose.

of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual

We cannot be certain that the claims in our pending patent applications directed to compositions of matter for our product

candidates will be considered patentable by the U.S.

Patent and Trademark Office (the “USPTO”) or by patent offices

in foreign countries, or that the claims in any of our issued patents will be considered valid by courts in the U.S.

Method of use patents have claims directed to the use of a product for the specified method.

This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method.

Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products off-label. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.

The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or uses thereof in the U.S.

This type of patent does

not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside

the scope of the patented method.

Moreover, even if competitors do not actively promote their product for our targeted indications,

physicians may prescribe these products “off-label.”

Although off-label prescriptions may infringe or contribute to

the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.

The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates

or uses thereof in the U.S.

or in other foreign countries.

Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable.

Furthermore, even if they are unchallenged, patents in our portfolio may not adequately exclude third parties from practicing relevant technology or prevent others from designing around our claims.

If the breadth or strength of our intellectual property position with respect to our product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, our product candidates.

Further, if we encounter delays in our clinical trials, the period of time during which we could market our product candidates under patent protection would be reduced.

Since patent applications in the U.S.

and most other countries are confidential for a period of time after filing, it is possible that patent applications in our portfolio may not be the first filed patent applications related to our product candidates.

Even if the patents do successfully issue, third parties may challenge

the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable.

Furthermore, even if they are unchallenged, patents in our portfolio may not adequately exclude third parties from practicing

relevant technology or prevent others from designing around our claims.

If the breadth or strength of our intellectual property

position with respect to our product candidates is threatened, it could dissuade companies from collaborating with us to develop,

and threaten our ability to commercialize, our product candidates.

Further, if we encounter delays in our clinical trials, the

period of time during which we could market our product candidates under patent protection would be reduced.

Since patent applications

and most other countries are confidential for a period of time after filing, it is possible that patent applications

in our portfolio may not be the first filed patent applications related to our product candidates.

Furthermore, for U.S.

applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third-party or instituted by the USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of our applications.

applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law with the passage of the America Invents Act (2012) which brings into effect significant changes to the U.S.

patent laws that are yet untried and untested, and which introduces new procedures for challenging pending patent applications and issued patents.

A primary change under this reform is the creation of a first to file system in the U.S.

in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third-party

or instituted by the USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of

our applications.

applications containing a claim not entitled to priority before March 16, 2013, there is a greater

level of uncertainty in the patent law with the passage of the America Invents Act (2012) which brings into effect significant

changes to the U.S.

patent laws that are yet untried and untested, and which introduces new procedures for challenging pending

patent applications and issued patents.

A primary change under this reform is the creation of a “first to file”

This will require us to be cognizant going forward of the time from invention to filing of a patent application.

Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.

Such noncompliance events are outside of our direct control for (1) non-U.S.

and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements

imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these

requirements.

maintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime

of the patent.

The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary,

fee payment and other similar provisions during the patent application process.

While an inadvertent lapse can in many cases be

cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance

can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights

in the relevant jurisdiction.

Noncompliance events that could result in abandonment or lapse of a patent or patent application

include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and

failure to properly legalize and submit formal documents.

Such noncompliance events are outside of our direct control for (1)

patents and patent applications owned by us, and (2) patents and patent applications licensed to us by another entity.

In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable.

In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may also raise similar claims before administrative bodies in the U.S.

patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product

candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or

unenforceable.

In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace,

and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

Third parties may

also raise similar claims before administrative bodies in the U.S.

or abroad, even outside the context of litigation.

Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions, for example, opposition proceedings.

Any such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates.

Such mechanisms

include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions, for example, opposition proceedings.

Any such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited.

If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patents directed to our product candidates.

A loss of patent rights could have a material adverse impact on our business.

Changes in U.S.

With respect to the validity

question, for example, we cannot be certain that there is no invalidating prior art and that prior art that was cited during prosecution,

but not relied on by the patent examiner, will not be revisited.

If a defendant were to prevail on a legal assertion of invalidity

and/or unenforceability, we would lose at least part, and perhaps all, of the patents directed to our product candidates.

of patent rights could have a material adverse impact on our business.

patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.

is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore

costly, time-consuming and inherently uncertain.

In addition, the U.S.

has recently enacted and is currently implementing wide-ranging patent reform legislation.

Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.

has recently enacted and is currently implementing wide-ranging

patent reform legislation.

Supreme Court rulings have narrowed the scope of patent protection available in certain

circumstances and weakened the rights of patent owners in certain situations.

In addition to increasing uncertainty with regard

to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of

patents, once obtained.

Depending on decisions by the U.S.

Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

For example, in the recent case, Assoc.

Congress, the federal courts, and the USPTO, the laws and regulations

governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing

patents and patents that we might obtain in the future.

For example, in the case, Assoc.

for Molecular Pathology v.

Myriad Genetics, Inc., the U.S.

Myriad Genetics,

Inc., the U.S.

Supreme Court held that certain claims to DNA molecules are not patentable.

While we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, the U.S.

While we do not believe that any of

the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the

courts, the U.S.

Congress or the USPTO may impact the value of our patents.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the U.S.

Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S.

have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the

have limited intellectual property rights outside the U.S.

Filing, prosecuting and defending patents on product candidates in

all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside

can be less extensive than those in the U.S.

In addition, the laws of some foreign countries do not protect intellectual property to the same extent as federal and state laws in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S.

In addition, the laws of some foreign countries do not protect intellectual

property to the same extent as federal and state laws in the U.S.

Consequently, we may not be able to prevent third parties from

practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in

and into the U.S.

or other jurisdictions.

Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may export otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the U.S.

These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions.

The legal systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.

Competitors may use our technologies in jurisdictions where we have not obtained patents

to develop their own products and further, may export otherwise infringing products to territories where we have patents, but

enforcement is not as strong as that in the U.S.

These products may compete with our products and our patents or other intellectual

property rights may not be effective or sufficient to prevent them from competing.

companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions.

legal systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of

patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could

make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary

rights generally.

To date, we have not sought to enforce any issued patents in these foreign jurisdictions.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not be commercially meaningful.

The requirements for patentability may differ in certain countries, particularly developing countries.

Furthermore, generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of our or our licensors patents, requiring us or our licensors to engage in complex, lengthy and costly litigation or other proceedings.

Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents.

This could limit our potential revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties.

In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies.

We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees former employers.

Litigation may be necessary to defend against these claims.

Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

Risks Related to Our Common Stock

The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.

In the future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for the acquisition of assets, as consideration for receipt of goods or services, to pay for the development of our Cchek platform, to pay for the development of our CAR-T cancer therapeutics, to pay for the development of our breast cancer vaccine and for acquisitions of companies.

We have an at-the-market equity offering under which we may issue up to $50 million of common stock, which is currently effective and under which we commenced selling shares in November 2019, and which may remain available to us in the future.

We have and in the future may issue securities convertible into our common stock.

Any of these events may dilute stockholders' ownership interests in our company and have an adverse impact on the price of our common stock.

In addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur, could reduce the market price of our common stock.

This could also impair our ability to raise additional capital through the sale of our securities.

Any actual or anticipated sales of shares by our stockholders may cause the trading price of our common stock to decline.

The sale of a substantial number of shares of our common stock by our stockholders, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

Delaware law and our charter documents contain provisions that could discourage or prevent a potential takeover of our company that might otherwise result in our stockholders receiving a premium over the market price of their shares.

Provisions of Delaware General Corporation Law (DGCL) and our certificate of incorporation, as amended (the Certificate of Incorporation), and By-Laws could make the acquisition of our company by means of a tender offer, proxy contest or otherwise, and the removal of incumbent officers and directors, more difficult.

These provisions include:

· Section 203 of the DGCL, which prohibits a merger with a 15%-or-greater stockholder, such as a party that has completed a successful tender offer, until three years after that party became a 15%-or-greater stockholder;

· the authorization in our Certificate of Incorporation of undesignated preferred stock, which could be issued without stockholder approval in a manner designed to prevent or discourage a takeover;

· provisions in our By-Laws establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings;

· provisions in our By-Laws regarding stockholders' rights to call a special meeting of stockholders limit such rights to stockholders of record holding together at least 66 2/3% of shares of the Company entitled to vote at the meeting, which could make it more difficult for stockholders to wage a proxy contest for control of our Board of Directors or to vote to repeal any of the anti-takeover provisions contained in our Certificate of Incorporation and By-Laws.

Together, these provisions may make the removal of management more difficult and may discourage transactions that could otherwise involve payment of a premium over prevailing market prices for our common stock.

We may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our common stock to decline.

Our reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter in the future, specifically as we continue to devote our resources towards our Cchek diagnostic technology, our CAR-T cancer therapeutics and our breast cancer vaccine.

It is possible that in future periods, we will have no revenue or, in any event, revenues could fall below the expectations of securities analysts or investors, which could cause the market price of our common stock to decline.

The following are among the factors that could cause our operating results to fluctuate significantly from period to period:

· clinical trial results relating to our diagnostic technology;

· adoption and reimbursement rates of our Cchek PCC test;

· patient enrollment rates for our clinical trials;

· delays with respect to our clinical trials;

· clinical trial results relating to our CAR-T cancer therapeutics;

· clinical trial results relating to our breast cancer vaccine;

· progress with regulatory authorities towards the certification/approval of our diagnostic technology, our CAR-T cancer therapeutics or our breast cancer vaccine;

· costs related to acquisitions, alliances and licenses.

Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock.

The stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have been highly volatile.

We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially, including, among others, the following:

· announcements of developments in the cancer diagnostic testing industry or in the fields of CAR-T therapeutics or cancer vaccines;

· developments in relationships with third party vendors and laboratories;

· developments or disputes concerning our patents and other intellectual property;

· our or our competitors' technological innovations;

· variations in our quarterly operating results;

· our failure to meet or exceed securities analysts' expectations of our financial results;

· a change in financial estimates or securities analysts' recommendations;

· changes in management's or securities analysts' estimates of our financial performance;

· announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or patents;

· the timing of or our failure to complete significant transactions.

In addition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental regulations in the diagnostic testing and drug development industries and/or court rulings and/or other developments in our remaining patent licensing and enforcement actions.

For example, if government regulators no longer allow for the use of diagnostic technology that has not been granted FDA approval (e.g.

denying products that have only received CLIA certification), the time and cost to bring our technology to market will increase which will likely have an adverse impact on our stock price.

In the past, companies that have experienced volatility in the market price of their stock have been the objects of securities class action litigation.

If our common stock was the object of securities class action litigation due to volatility in the market price of our stock, it could result in substantial costs and a diversion of management's attention and resources, which could materially harm our business and financial results.

Our common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject to the SECs penny stock rules which may make our shares more difficult to sell.

If our common stock is delisted from NASDAQ Capital Market, our common stock will then fit the definition of a penny stock and therefore would be subject to the rules adopted by the SEC regulating broker-dealer practices in connection with transactions in penny stocks.

The SEC rules may have the effect of reducing trading activity in our common stock making it more difficult for investors to sell their shares.

The SECs rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the customer a risk disclosure document that provides certain information prescribed by the SEC, including, but not limited to, the nature and level of risks in the penny stock market.

The broker or dealer must also disclose the aggregate amount of any compensation received or receivable by him in connection with such transaction prior to consummating the transaction.

In addition, the SECs rules also require a broker or dealer to make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchasers written agreement to the transaction before completion of the transaction.

The existence of the SECs rules may result in a lower trading volume of our common stock and lower trading prices.

We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.

The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock.

As of the date of this report, we have issued and outstanding options to purchase 8,431,668 shares of our common stock with a weighted average exercise price of $3.30 and 1,500,000 restricted stock awards (including options to purchase 1,500,000 shares of our common stock and a restricted stock award of 1,500,000 shares of our common stock that vest based upon achievement of certain stock price based milestones issued to Dr.

Proceedings to enforce

our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects

of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk

of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate,

and the damages or other remedies awarded, if any, may not be commercially meaningful.

The requirements for patentability may

differ in certain countries, particularly developing countries.

Furthermore, generic drug manufacturers or other competitors may

challenge the scope, validity or enforceability of our or our licensors’

patents, requiring us or our licensors to engage

in complex, lengthy and costly litigation or other proceedings.

Certain countries in Europe and developing countries, including

China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.

In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled

to grant a license to a third party, which could materially diminish the value of those patents.

This could limit our potential

revenue opportunities.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate

to obtain a significant commercial advantage from the intellectual property that we develop or license.

Related to Our Common Stock

issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common

the future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for

the acquisition of assets, as consideration for receipt of goods or services, to pay for the development of our CAR-T cancer therapeutics,

to pay for the development of our breast cancer vaccine, to pay for the development of our ovarian cancer vaccine, to pay for

the development of our COVID-19 therapeutic and for acquisitions of companies.

We have an at-the-market equity offering under

which, as of January 7, 2021 we may issue up to approximately $35 million of common stock, which is currently effective

and under which we commenced selling shares in November 2019, and which may remain available to us in the future.

in the future may issue securities convertible into our common stock.

Any of these events may dilute stockholders’

interests in our company and have an adverse impact on the price of our common stock.

addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur,

could reduce the market price of our common stock.

This could also impair our ability to raise additional capital through the

sale of our securities.

actual or anticipated sales of shares by our stockholders may cause the trading price of our common stock to decline.

of a substantial number of shares of our common stock by our stockholders, or anticipation of such sales, could make it more difficult

for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect

may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our

common stock to decline.

reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to

quarter in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics, our breast and

ovarian cancer vaccines and our COVID-19 therapeutic.

It is possible that in future periods, we will have no revenue or, in any

event, revenues could fall below the expectations of securities analysts or investors, which could cause the market price of our

common stock to decline.

The following are among the factors that could cause our operating results to fluctuate significantly

from period to period:

enrollment rates for our clinical trials;

with respect to our clinical trials;

trial results relating to our CAR-T cancer therapeutics;

trial results relating to our breast cancer vaccine;

with regulatory authorities towards the certification/approval of our CAR-T cancer therapeutics, our breast cancer vaccine,

our ovarian cancer vaccine or our COVID-19 therapeutic;

related to acquisitions, alliances and licenses.

Biotechnology

company stock prices are especially volatile, and this volatility may depress the price of our common stock.

stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have

been highly volatile.

We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially,

including, among others, the following:

announcements

of developments in the fields of CAR-T therapeutics, cancer vaccines or COVID-19 treatments;

in relationships with third party vendors and laboratories;

or disputes concerning our patents and other intellectual property;

or our competitors’

technological innovations;

in our quarterly operating results;

failure to meet or exceed securities analysts’

expectations of our financial results;

change in financial estimates or securities analysts’

recommendations;

in management’s or securities analysts’

estimates of our financial performance;

announcements

by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments,

new technologies, or patents;

timing of or our failure to complete significant transactions.

addition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental

regulations in the drug development industry and/or court rulings and/or other developments in our remaining patent licensing

and enforcement actions.

the past, companies that have experienced volatility in the market price of their stock have been the objects of securities class

action litigation.

If our common stock was the object of securities class action litigation due to volatility in the market price

of our stock, it could result in substantial costs and a diversion of management’s attention and resources, which could

materially harm our business and financial results.

common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become

subject to the SEC’s penny stock rules which may make our shares more difficult to sell.

our common stock is delisted from NASDAQ Capital Market, our common stock will then fit the definition of a penny stock and therefore

would be subject to the rules adopted by the SEC regulating broker-dealer practices in connection with transactions in penny stocks.

The SEC rules may have the effect of reducing trading activity in our common stock making it more difficult for investors to sell

their shares.

The SEC’s rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the

customer a risk disclosure document that provides certain information prescribed by the SEC, including, but not limited to, the

nature and level of risks in the penny stock market.

The broker or dealer must also disclose the aggregate amount of any compensation

received or receivable by him in connection with such transaction prior to consummating the transaction.

In addition, the SEC’s

rules also require a broker or dealer to make a special written determination that the penny stock is a suitable investment for

the purchaser and receive the purchaser’s written agreement to the transaction before completion of the transaction.

existence of the SEC’s rules may result in a lower trading volume of our common stock and lower trading prices.

have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.

and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your

percentage ownership interest and may also result in downward pressure on the price of our common stock.

of the date of this Report, we have issued and outstanding options to purchase 8,641,254 shares of our common stock with a weighted

average exercise price of $3.16 and 1,500,000 restricted stock awards (including options to purchase 1,500,000 shares of our common

stock and a restricted stock award of 1,500,000 shares of our common stock that vest based upon achievement of certain stock price

based milestones issued to Dr.

Kumar in May 2018).

Further, as of the date of this report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 2,800,000 shares of our common stock.

Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans.

Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely affect the market price of our common stock.

Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.

federal income tax reform could adversely affect us and holders of our common stock.

On December 22, 2017, President Trump signed into law H.R.

1, originally known as the Tax Cuts and Jobs Act, which significantly reformed the Internal Revenue Code.

The new legislation, among other things, changes the U.S.

federal tax rates, imposes significant additional limitations on the deductibility of interest, allows the expensing of capital expenditures, and puts into effect the migration from a worldwide system of taxation to a territorial system.

Additionally, the legislation imposes a reduction to the maximum deduction allowed for NOLs generated in tax years beginning after December 31, 2017, but allows such NOLs to be carried forward indefinitely.

We continue to examine the impact this tax reform legislation may have on us.

The impact of this tax reform, or of any future administrative guidance interpreting provisions thereof, on holders of our shares is uncertain and could be adverse.

This annual report does not discuss any such tax legislation or the manner in which it might affect holders of our shares.

We urge holders of our shares to consult with their legal and tax advisors with respect to any such legislation and the potential tax consequences of their ownership of our shares.

We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a smaller reporting company (SRC) and a non-accelerated filer, which allows us to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not SRCs or non-accelerated filers, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, reduced disclosure obligations regarding executive compensation in our Annual Report and our periodic reports and proxy statements and providing only two years of audited financial statements in our Annual Report and our periodic reports.

We will remain an SRC until (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter exceeds $250 million or (b) (1) we have over $100 million in annual revenues and (2) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter exceeds $700 million.

We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions.

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 our stock price may be more volatile and may decline.

Changes in accounting rules, assumptions and/or judgments could materially and adversely affect us.

Accounting rules and interpretations for certain aspects of our operations are highly complex and involve significant assumptions and judgment.

Further, as of the date of this Report, our Board of Directors and Compensation

Committee have the authority to issue awards totaling an additional 2,000,000 shares of our common stock.

Additionally,

we have registered for resale all of the shares of common stock issuable under our incentive plans.

Because the market for our

common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely affect the market price

of our common stock.

Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and,

if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could

lead to a decrease in the price of our common stock.

are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our

common stock less attractive to investors.

are a smaller reporting company (“SRC”) and a non-accelerated filer, which allows us to take advantage of exemptions

from various reporting requirements that are applicable to other public companies that are not SRCs or non-accelerated filers,

including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002,

as amended, reduced disclosure obligations regarding executive compensation in our Annual Report and our periodic reports and

proxy statements and providing only two years of audited financial statements in our Annual Report and our periodic reports.

will remain an SRC until (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last

business day our most recently completed second fiscal quarter exceeds $250 million or (b) (1) we have over $100 million in annual

revenues and (2) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day

our most recently completed second fiscal quarter exceeds $700 million.

We cannot predict whether investors will find our common

stock less attractive if we rely on certain or all of these exemptions.

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 our stock price may be more volatile and may decline.

in accounting rules, assumptions and/or judgments could materially and adversely affect us.

rules and interpretations for certain aspects of our operations are highly complex and involve significant assumptions and judgment.

These complexities could lead to a delay in the preparation and dissemination of our financial statements.

Furthermore, changes in accounting rules and interpretations or in our accounting assumptions and/or judgments, such as asset impairments, could significantly impact our financial statements.

In some cases, we could be required to apply a new or revised standard retroactively, resulting in restating prior period financial statements.

Any of these circumstances could have a material adverse effect on our business, prospects, liquidity, financial condition and results of operations.

We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

We have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future.

Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business.

If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business.

In the event securities or industry analysts that cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price may decline.

If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

Furthermore, changes

in accounting rules and interpretations or in our accounting assumptions and/or judgments, such as asset impairments, could significantly

impact our financial statements.

In some cases, we could be required to apply a new or revised standard retroactively, resulting

in restating prior period financial statements.

Any of these circumstances could have a material adverse effect on our business,

prospects, liquidity, financial condition and results of operations.

do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future.

current policy is to retain all funds and any earnings for use in the operation and expansion of our business.

If we do not pay

dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.

related to the COVID-19 pandemic

business activities are expected to be adversely affected by the global COVID-19 pandemic.

has spread globally and the World Health Organization (WHO) has declared it a pandemic.

While still evolving, the COVID-19 pandemic

has caused significant worldwide economic and financial turmoil, and has fueled concerns that it will lead to a global recession.

On March 13, 2020, the United States declared a national emergency with respect to COVID-19 and the majority of states and U.S.

territories, including the State of California, have since issued orders requiring the closure of non-essential businesses and/or

requiring residents to stay at home.

As the pandemic has evolved since March 2020, some restriction have eased, however, with

the recent surge of infection and hospitalization rates, more severe restrictions are being implemented by local government agencies.

The Company is following the recommendations of local health authorities to minimize exposure risk for its team members and visitors,

including requiring its employees to work from home.

The continued and prolonged implementation of restrictions by federal, state

and local authorities to slow the spread of COVID-19 have disrupted and, we expect, will continue to disrupt, our business and

Specifically,

the pandemic has caused periodic shutdowns of the laboratories and other service providers that we rely on to develop our programs,

and those laboratories and service providers that have been operating or that have begun operating recently have been doing so

with limited capacity due to social distancing requirements.

As a result, our progress has been slowed and there is no assurance

that we will be able to meet our previously announced timelines regarding the development of our programs.

extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on numerous evolving

factors that we may not be able to accurately predict, including:

the duration and scope of the pandemic;

governmental, business

and individuals’

actions that have been and continue to be taken in response to the pandemic;

the impact of the pandemic

on economic activity and actions taken in response;

our ability to continue daily operations, including as a result of travel

restrictions and people working from home;

and any closures of our and our business partners’

offices and facilities.

the Company is currently implementing solutions designed to reduce the potential impact of COVID-19, there can be no assurance

that our efforts will adequately mitigate the risks of business disruptions and interruptions.

Further, events such as natural

disasters and public health emergencies divert our attention away from normal operations and limited resources.

Our inability

to timely resume normal operations following the pandemic disruption could adversely affect our business, financial condition

or results of operations in a material manner.

of these events could materially adversely affect our business, financial condition, results of operations and/or stock price.

Unresolved Staff Comments.

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