What changed in this filing

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Item 1A. Risk Factors

2023-01-04 compared with 2022-01-04 · 138 added, 180 removed, 783 unchanged (29% of the section changed)

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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.

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.

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.

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

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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

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

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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.

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

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ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control).

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.

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

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

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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.

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

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

● successfully

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

● successfully

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

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;

● successfully

meet the primary endpoints in our clinical trials;

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

or execute our current business plan;

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

enter into or maintain contracts with potential commercial partners such as licensors of

technology and suppliers or licensees of our technologies.

our management team;

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.

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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, 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 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.

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

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diversion of management’s time and our resources;

● substantial

monetary awards to clinical trial participants or patients;

recalls, withdrawals or labeling, marketing or promotional restrictions;

of potential revenue;

of any available insurance and our capital resources;

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never be profitable.

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

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

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:

● progressing

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.

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 discovery stage programs into pre-clinical testing;

● progressing

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;

● identifying

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;

● establishing

and maintaining supply and manufacturing relationships with third parties;

● maintaining,

protecting, expanding and enforcing our intellectual property;

● attracting,

hiring and retaining qualified personnel.

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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 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;

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

and personalized therapy.

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

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 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

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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.

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for COVID-19, there is no guarantee that our treatment will be successful against competitors.

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

have not initiated clinical trials for any of our product candidates other than our breast cancer vaccine, for which we do not yet have

any human clinical data, 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.

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 and clinical data are often susceptible to varying interpretations

and analyses, and many companies that have believed their product candidates performed satisfactorily in pre-clinical 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

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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.

are dependent on third parties to conduct our pre-clinical studies 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 MolGenie, as

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

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.

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.

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,

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

clinical and nonclinical programs.

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ability to obtain and maintain patient consents;

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

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

clinical trials and approved therapies available for patients;

impact of the ongoing COVID-19 pandemic.

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

particular, our 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 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 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

clinical trials will compete with other companies’ clinical trials for product candidates that are in the same therapeutic areas

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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

therapies that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our clinical

Patients may also be unwilling to participate in our clinical trials because of negative publicity from adverse events in the

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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.

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

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Gene-modified

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

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

and experience to support a commercial product.

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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

ill-equipped to support our needs, especially in non-routine circumstances like FDA inspections or medical crises, such as widespread

contamination.

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FDA, or similar approval filings to other foreign authorities.

A BLA or NDA must include extensive preclinical and clinical data and

A BLA or NDA must include extensive pre-clinical and clinical data and

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

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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

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;

trial sites deviating from clinical trial protocol, failing to follow cGCPs, 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 trials.

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

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

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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;

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;

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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;

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

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;

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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 authorities;

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

competitive therapies;

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

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.

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If we are not able to obtain and maintain patent

protection our competitive position may be harmed.

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

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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

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;

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.

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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.

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 property.

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

systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade

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

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our COVID-19 therapeutic and for acquisitions of companies.

We have and in the future may issue securities convertible into our common

Any of these events may dilute stockholders’ ownership interests in our company and have an adverse impact on the price

of our common stock.

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.

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

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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, our ovarian

cancer vaccine or our COVID-19 therapeutic;

related to acquisitions, alliances and licenses.

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

● developments

in relationships with third party vendors and laboratories;

● developments

or disputes concerning our patents and other intellectual property;

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announcements

by us or our competitors of significant contracts, acquisitions, strategic partnerships,

joint ventures, capital commitments, new technologies, or patents;

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.

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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.

do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

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related to the COVID-19 pandemic

business activities are expected to be adversely affected by the ongoing COVID-19 pandemic.

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.

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

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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.

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.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors