What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2024-01-16 compared with 2023-01-04 · 165 added, 206 removed, 715 unchanged (34% of the section changed)

17 unchanged sentences

on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents and short-term investments

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 and short-term investments 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, including

through our current “at the market offering” program, or through bank credit facilities or public or private debt from various

will be sufficient to fund our activities for at least 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 and short-term investments 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,

including through our current at-the-market offering program, or through bank credit facilities or public or private debt from various

financial institutions where possible.

18 unchanged sentences

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.

We do not expect to generate significant

revenues for the foreseeable 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

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 therapeutics and vaccine businesses which would have a material adverse effect

on the Company.

ovarian cancer therapeutic and our breast and ovarian cancer vaccines.

We do not expect to generate significant revenues for the foreseeable

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.

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

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

and vaccine 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

39 unchanged sentences

Therefore, 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, as well as whether our current business plan is sound.

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.

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

cancer vaccines, as well as whether our current business plan is sound.

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

cancer vaccines 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

1 unchanged sentence

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;

the risks and uncertainties that a business with limited operating history will face.

In particular, shareholders should consider that

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

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

11 unchanged sentences

Over the next several quarters, we will

need to broaden our focus from a research and development company to a company capable of supporting clinical trials and commercial activities,

or enter into collaborations with partners that may provide those capabilities.

We may not be able to reach such achievements, which

would have a material adverse effect on our Company.

need to continue broadening our focus from a research and development company to a company capable of supporting clinical trials and

commercial activities, or enter into collaborations with partners that may provide those capabilities.

We may not be able to reach such

achievements, which would have a material adverse effect on our Company.

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

57 unchanged sentences

never be profitable.

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

our CAR-T therapeutic technology and 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.

are in the pre-clinical stage of developing our ovarian cancer vaccine technology and in the clinical stage with our CAR-T therapeutic

technology and 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

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

ability to generate future revenues from product sales of our technologies depends heavily on our success in:

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;

60 unchanged sentences

guarantee that there is no FSH-Receptor on any other healthy tissue in the human body.

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

April 2020, we entered into a collaboration agreement with OntoChem, such agreement subsequently assigned to MolGenie, 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 have performed in vitro and in vivo analyses of such compounds, 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.

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.

Many 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 our treatment will be successful against competitors.

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

have not initiated clinical trials for our product candidates other than our breast cancer vaccine and our CAR-T ovarian cancer therapeutic,

for which we have limited human clinical data, and we may not be able to commence clinical trials on the time frames we expect.

discovery stage product candidates have only been tested in animals and our clinical stage candidates currently have limited human data,

we face significant uncertainty regarding how effective and safe they will be in human patients and the results from pre-clinical studies

may not be indicative of the results of clinical trials.

pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable

results once we collect statistically significant data from human clinical trials.

have limited human clinical data from our breast cancer vaccine and our CAR-T ovarian cancer therapeutic, and we have not initiated clinical

trials for our ovarian cancer vaccine and we may not be able to commence clinical trials on the time frames we expect.

As our discovery

stage product candidate has only been tested in animals and our clinical stage candidates currently have limited human data, we face

significant uncertainty regarding how effective and safe they will be in human patients and the results from pre-clinical studies may

not be indicative of the results of clinical trials.

Pre-clinical and clinical data are often susceptible to varying interpretations

9 unchanged sentences

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 MolGenie, as

well as other European partners, for our COVID-19 therapy to conduct our pre-clinical studies and clinical trials under agreements with

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

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.

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

pre-clinical studies 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.

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

28 unchanged sentences

clinical trials and approved therapies available for patients.

impact of the ongoing COVID-19 pandemic.

particular, our CAR-T ovarian cancer clinical trial is enrolling patients with late stage ovarian cancer who have failed conventional

particular, our Phase 1 CAR-T ovarian cancer clinical trial is enrolling 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 is enrolling patients who

have undergone standard of care treatment for TNBC.

Our second breast cancer vaccine clinical trial is enrolling 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 must be willing and able to undergo treatment at the Cleveland

Our Phase 1a breast cancer vaccine clinical trial is enrolling patients

who have undergone standard of care treatment for TNBC.

Our Phase 1b breast cancer vaccine clinical trial is enrolling healthy women

who, as a result of, among other things, testing positive for the BRCA1, BRCA2 or PALB2 gene mutations which are leading predictors of

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

Our Phase 1c breast cancer vaccine clinical trial

is enrolling post-operative TNBC patients who have residual disease following neoadjuvant chemo-immunotherapy and are being treated with

pembrolizumab (Keytruda®).

These potential trial participants must 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

8 unchanged sentences

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

2 unchanged sentences

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.

clinical trials under independent IND applications 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

48 unchanged sentences

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

one of our 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.

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

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.

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

125 unchanged sentences

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, including our ability to license any product if we choose to have other

parties commercialize them.

our breast cancer vaccine technologies, our ovarian cancer vaccine technologies and other proprietary discoveries and technologies.

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, including our ability to license any product if we choose to have other parties commercialize them.

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

1 unchanged sentence

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

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.

our ovarian 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 CAR-T therapeutics, our breast cancer vaccine, our ovarian 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 CAR-T therapeutics, our breast cancer vaccine,

our ovarian 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

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.

rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and

3 unchanged sentences

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,

Our license agreements impose, and we expect that future license agreements if necessary will impose, various development, diligence,

commercialization and other obligations on us.

168 unchanged sentences

companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions.

systems of certain countries, particularly China and certain 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.

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

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

systems of certain countries, particularly China and certain 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.

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

2 unchanged sentences

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 4,

2022 we may issue up to approximately $100 million of common stock, which is currently effective and under which we have not yet sold

any shares, and which may remain available to us in the future.

We also 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.

the development of our breast cancer vaccine, to pay for the development of our ovarian cancer vaccine and for acquisitions of companies.

We have an at-the-market equity offering under which, as of January 16, 2024 we may issue up to approximately $98 million of common stock,

which is currently effective, and which may remain available to us in the future.

We also 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.

addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur, could

8 unchanged sentences

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 or expenses could rise above 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

in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our breast and ovarian cancer

It is possible that in future periods, we will have no revenue or, in any event, revenues could fall below or expenses could

rise above the expectations of securities analysts or investors, which could cause the market price of our common stock to decline.

following are among the factors that could cause our operating results to fluctuate significantly from period to period:

enrollment rates for our clinical trials;

3 unchanged sentences

of pre-clinical studies relating to our ovarian cancer vaccine;

of pre-clinical studies relating to our COVID-19 therapeutic;

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;

with regulatory authorities towards the certification/approval of our CAR-T cancer therapeutics, our breast cancer vaccine or our

ovarian cancer vaccine;

related to acquisitions, alliances and licenses.

5 unchanged sentences

announcements

of developments in the fields of CAR-T therapeutics, cancer vaccines or COVID-19 treatments;

of developments in the fields of CAR-T therapeutics or cancer vaccines;

in relationships with third party vendors and laboratories;

32 unchanged sentences

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.

if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’

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 12,735,000 shares of our common stock with a weighted

average exercise price of $3.68.

Further, as of the date of this Report, our Board of Directors and Compensation Committee have the

authority to issue awards totaling an additional 875,000 shares of our common stock which is replenished on a yearly basis in accordance

with the provisions of our plan.

Additionally, we have registered for resale all of the shares of common stock issuable under our incentive

Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority

to issue awards totaling an additional 665,000 shares of our common stock which is replenished on a yearly basis in accordance with the

provisions of our plan.

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

22 unchanged sentences

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 may be adversely affected by the ongoing COVID-19 pandemic.

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;

the effect the pandemic may have on the ability to recruit patients to participate in our clinical trials;

and any closures of our and

our business partners’ offices and facilities.

the Company and its partners are not currently experiencing significant negative impact of COVID-19, there can be no assurance that the

current situation will continue.

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 any 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.

Cybersecurity.

will provide the disclosure required under this Item 1C in our annual report for the year ended October 31, 2024 which is the first annual

report for a fiscal year ending on or after December 15, 2023, the date on which disclosure under Item 106 of Regulation S-K is required.

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