What changed in this filing

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Item 1A. Risk Factors

2023-03-23 compared with 2022-03-23 · 259 added, 146 removed, 1120 unchanged (27% of the section changed)

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our operations primarily through equity and debt offerings.

To generate revenue and become and remain profitable, we must continue to

pursue our integrated companion diagnostic (CDx) and therapeutic (Rx) strategy that leverages our CELsignia CDx platform.

need to successfully complete our five existing clinical trial collaborations, continue to develop other CELsignia tests for other cancer

sub-types, cultivate partnerships with pharmaceutical companies, and develop and commercialize gedatolisib pursuant to our license agreement

We must also build operational and financial infrastructure to support commercial operations, train and manage employees,

and market and sell our CELsignia tests (as a companion diagnostic and/or as a stand-alone test) and, once fully developed and commercialized,

our anticipated drug products.

To generate revenue and become and remain profitable, we need to develop

and commercialize gedatolisib pursuant to our license agreement with Pfizer and successfully complete our existing clinical trial collaborations

and cultivate partnerships with pharmaceutical companies.

We must also build operational and financial infrastructure to support commercial

operations, train and manage employees, and market and sell our anticipated drug products and our CELsignia tests (as a companion diagnostic

and/or as a stand-alone test).

may never succeed in any of these activities and, even if we do, we may never generate revenue that is sufficient to achieve profitability.

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particularly affected.

In response to the COVID-19 outbreak, public health measures have been implemented across much of the United States,

Europe and Asia, including in the locations of our offices, clinical trial sites, and partners.

Due to these public health measures,

we are allowing employees who do not need to be physically present in the lab to perform their work at home.

Our increased reliance on

employees working from home may negatively impact productivity, or disrupt, delay or otherwise adversely impact our business.

a result of the COVID-19 outbreak and related public health measures, we have and may in the future experience disruptions that could

materially and adversely impact our clinical trials, business, financial condition and results of operations.

Potential disruptions include

but are not limited to:

As a result of the COVID-19 outbreak and related public health measures, we have and may in the future experience

disruptions that could materially and adversely impact our clinical trials, business, financial condition and results of operations.

Potential disruptions include but are not limited to:

or difficulties in enrolling patients in clinical trials and obtaining the results of completed clinical trials;

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COVID-19 mitigation and loss of productivity from remote work.

COVID-19 pandemic continues to rapidly evolve.

The extent to which the outbreak impacts our business will depend on future developments,

which are highly uncertain and cannot be predicted with confidence, such as the magnitude of the pandemic, the duration of social distancing

in the United States and other countries, business closures or business disruptions, and the effectiveness of actions taken in the United

States and other countries to contain and treat the disease.

the direct effect of the pandemic, mitigation efforts have had broad economic effects.

The extent of the scope and duration of these

economic effects cannot currently be predicted, although they are likely to be significant for the near future.

The economic impact of

COVID-19 will affect us in a variety of ways, including without limitation making our stock price more volatile, making it more difficult

to raise additional capital through offerings of equity or debt securities, and reducing the availability of bank loans.

we may face difficulties raising capital and capital raising efforts may be on terms than are less favorable than would have been previously

of the effects of COVID-19 described herein are expected to apply to any future recurrences of COVID-19 and any other pandemics that

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interpretations of data by the FDA and comparable foreign regulatory authorities.

preliminary efficacy and safety data reported for the B2151009 Phase 1b clinical trial was provided to us by Pfizer and is subject to

change once data cleansing and data verification activities are completed.

preliminary efficacy and safety data reported for the B2151009 Phase 1b clinical trial was provided to us by Pfizer.

Pfizer provided

this data as of a data cutoff date of January 11, 2021, before Pfizer had cleaned the data, locked the clinical database, and completed

preparation of a final Clinical Study Report.

We have not independently reviewed or verified the data, which includes case report forms

(CRF) for each patient and reconciliation with the data endpoints reported.

We may discover, upon performing the study close out activities

for B2151009, which includes reconciliation and adjudication of the endpoint reported data with the CRF, inconsistencies with the data

as originally provided by Pfizer to us.

As a result, the data presented as of the date hereof is subject to change once data cleaning

and verification activities have been completed and other study close-out procedures are completed.

were not involved in the early development of gedatolisib;

therefore, we are dependent on third parties having accurately generated,

collected, interpreted and reported data from certain preclinical and clinical trials gedatolisib.

collected, interpreted and reported data from certain preclinical and clinical trials of gedatolisib.

had no involvement with or control over the initial preclinical and clinical development of gedatolisib.

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condition and results of operations significantly.

a new drug to be approved for marketing, the FDA and other regulatory authorities must determine that the drug is safe and effective.

Because all drugs can have adverse effects, the data from our Phase 3 clinical study must demonstrate to the satisfaction of the FDA

and other health authorities that the benefits of gedatolisib in combination with palbociclib and fulvestrant, or gedatolisib in combination

with fulvestrant, outweigh its risks.

Failure to demonstrate sufficient magnitude of benefit, even if the benefit is found to be statistically

significant, may not support regulatory approval.

a drug meets its primary efficacy endpoint objective in a Phase 3 clinical trial, and the drug sponsor has additional nonclinical and

clinical data required by the FDA or other regulatory authorities, the drug sponsor may submit an NDA seeking marketing approval.

submission of an NDA, these health authorities perform a benefit-risk assessment that considers the strength and quality of evidence

available and takes remaining uncertainties into account.

These considerations include an assessment of the strengths and limitations

of clinical trials, including design, and potential implications for assessing drug efficacy, the magnitude of benefit and interpretation

of clinical importance, the benefit attributed to the drug when studied in combination with other therapies, and the clinical relevance

of the study endpoints.

We have sought feedback from the FDA and other regulatory authorities on the design of our Phase 3 clinical trial

with the goal of addressing these considerations in the clinical trial’s design.

However, due to the complexity of clinical trials,

the uncertainty of outcomes, and the uncertainty of how the FDA and other regulatory authorities may balance benefits and risks in their

review of an NDA, it may not be practical or possible to address all benefit-risk assessment considerations in a Phase 3 clinical trial

so that sufficient evidence is generated to support a marketing approval, even if the primary endpoint objective is achieved.

or other regulatory authorities may require us to redesign or conduct additional unplanned clinical trials before granting any approval

and we may not get approval at all.

If we are required to conduct additional clinical trials or other testing of our drug candidates

beyond those that we currently contemplate, if we are unable to successfully complete clinical trials or other testing of our product

candidates, or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns,

delayed in obtaining marketing approval for our product candidates or not obtain marketing approval at all;

approval for indications or patient populations that are not as broad as intended or desired;

approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

subject to changes in the way the product is administered;

required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions on its distribution in the form

of a REMS or through modification to an existing REMS;

damage to our reputation.

successful development of biopharmaceuticals is highly uncertain.

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we fail to comply with our obligations under our patent license with Pfizer, we could lose license rights that are important to our business.

are a party to a license agreement with Pfizer pursuant to which we in-license key patents for our gedatolisib.

This license imposes

various diligence, milestone payment, royalty, insurance and other obligations on us.

If we fail to comply with these obligations, Pfizer

may have the right to terminate the license, in which event we would not be able to develop or market the products covered by such licensed

are a party to a license agreement with Pfizer pursuant to which we in-license key patents for gedatolisib.

This license imposes various

diligence, milestone payment, royalty, insurance and other obligations on us.

If we fail to comply with these obligations, Pfizer may

have the right to terminate the license, in which event we would not be able to develop or market the products covered by such licensed

intellectual property.

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Therapy Designation or Fast Track Designation from the FDA may not actually lead to a faster development or regulatory review or approval

have received Fast Track Designation and may seek Breakthrough Therapy Designation for our product candidates.

If a product is intended

for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs

for this condition, the product sponsor may apply for Fast Track Designation.

The FDA has broad discretion whether or not to grant this

designation, so even if we believe one of our product candidates is eligible for this designation, we cannot assure you that the FDA

would decide to grant it.

Even if we do receive Fast Track Designation, we may not experience a faster development process, review or

approval compared to conventional FDA procedures.

The FDA may withdraw Fast Track Designation if it believes that the designation is

no longer supported by data from our clinical development program.

breakthrough therapy is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious

or life-threatening disease or condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement

over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical

For products that have been designated as breakthrough therapies, interaction and communication between the FDA and the

sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed

in ineffective control regimens.

as a breakthrough therapy is within the discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets the

criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event,

the receipt of a Breakthrough Therapy Designation may not result in a faster development process, review or approval compared to products

considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

In addition, even if a product

candidate qualifies as a breakthrough therapy, the FDA may later decide that the product no longer meets the conditions for qualification

and rescind the Breakthrough Therapy Designation.

a drug is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address

unmet medical needs for this condition, the product sponsor may apply for Fast Track Designation.

The designation offers the opportunity

for frequent interactions with the FDA to discuss the drug’s development plan and to ensure collection of appropriate data needed

to support drug approval, as well as eligibility for submission of a New Drug Application.

addition, a drug may receive Breakthrough Therapy Designation if it is intended, alone or in combination with one or more other products,

to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the product may demonstrate

substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects

observed early in clinical development.

The benefits of Breakthrough Therapy Designation include more intensive guidance from the FDA

on an efficient development program, access to a scientific liaison to help accelerate review time, and potential eligibility for priority

review if relevant criteria are met.

This designation can expedite the development and regulatory review of an investigational medicine

that is intended to treat a serious or life-threatening condition.

Fast Track and Breakthrough Therapy Designations are within the discretion of the FDA.

While the FDA has granted both designations to

our lead drug candidate, gedatolisib, such designations may not result in a faster development process, review or approval compared to

products considered for approval under conventional FDA procedures, and neither designation assures ultimate approval by the FDA.

addition, the FDA may later decide that the product no longer meets the qualification conditions and may rescind either or both such

designations.

and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining

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that we may have obtained and we may not achieve or sustain profitability.

we commercialize any product candidates, we will be subject to U.S.

and foreign governmental regulations as well as private payor policies

that mandate price controls or limitations on patient access to our products or establish prices paid by government entities or programs

for our products.

Our business, and our future results could be adversely affected by changes in such regulations.

and private payors routinely seek to manage utilization and control the costs of our products, and there is considerable public and government

scrutiny of pharmaceutical pricing.

Efforts by states and the federal government to regulate prices or payment for pharmaceutical products,

including proposed actions to facilitate drug importation, limit reimbursement to lower international reference prices, require deep

discounts, and require manufacturers to report and make public price increases and sometimes provide a written justification for such

price increases, could adversely affect our business if implemented.

and foreign governmental regulations that mandate price controls or limitations on patient access to our products or establish prices

paid by government entities or programs for our products could impact our business, and our future results could be adversely affected

by changes in such regulations or policies.

The adoption of restrictive price controls in new jurisdictions, more restrictive controls

in existing jurisdictions or the failure to obtain or maintain timely or adequate pricing could also adversely impact revenue.

pricing pressures will continue globally.

In the U.S., pharmaceutical product pricing is subject to government and public scrutiny and

calls for reform, and many of our products are subject to increasing pricing pressures as a result.

We expect to see continued focus

by the federal government on regulating pricing which could result in legislative and regulatory changes designed to control costs.

example, in August 2022, the IRA was signed into law, which, among other things, requires manufacturers of certain drugs to engage in

price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace

inflation, and replaces the Part D coverage gap discount program with a new discounting program.

Some states have implemented, and others

are considering implementing, patient access constraints or cost cutting under the Medicaid program, and some are considering measures

that would apply to broader segments of their populations that are not Medicaid-eligible.

State legislatures also have continued to focus

on addressing drug costs, generally by increasing price transparency or limiting drug price increases.

Measures to regulate prices or

payment for pharmaceutical products, including legislation on drug importation, could adversely affect our business.

Related to Our CELsignia Tests

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We do not expect to receive the first interim results for our prospective

clinical trials for the CELsignia HER2 Pathway Activity Test until the first half of 2023 and with final results expected approximately

nine months later.

Success of the clinical trials using the CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway Activity

Test will depend on many factors, such as successfully enrolling patients, meeting trial endpoint goals, and completing the trial in

a timely manner.

Our ability to complete the trial could be delayed or prevented for several reasons that are out of our control, such

as the FDA withdrawing its authorization and approval to perform the study, NSABP, West Cancer Center, Massachusetts General Hospital,

MD Anderson Cancer Center, or University of Rochester determining that the human and/or toxicology test results do not support continuing

the trial, or participants having adverse reactions or side-effects to the drugs administered in the study.

If we are unable to demonstrate

that the CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway Activity Test is suitable as a companion diagnostic for the

targeted therapy, we will likely not be able to generate future revenue from our CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway

Activity test and may not be able to attract other pharmaceutical companies to partner with us for the development and commercialization

of other CELsignia tests.

Further, potential pharmaceutical company partners may delay negotiating development agreements until results

of the first clinical trial using our CELsignia HER2 Pathway Activity Test trial are available.

Even if the ultimate outcome of the first

clinical trial using a CELsignia HER2 Pathway Activity Test trial is positive, any delays could materially and adversely affect our business.

clinical trials for the CELsignia HER2 Pathway Activity Test until the second half of 2023.

Success of the clinical trials using the

CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway Activity Test will depend on many factors, such as successfully enrolling

patients, meeting trial endpoint goals, and completing the trial in a timely manner.

Our ability to complete the trial could be delayed

or prevented for several reasons that are out of our control, such as the FDA withdrawing its authorization and approval to perform the

study, NSABP, West Cancer Center, MD Anderson Cancer Center, or University of Rochester determining that

the human and/or toxicology test results do not support continuing the trial, or participants having adverse reactions or side-effects

to the drugs administered in the study.

If we are unable to demonstrate that the CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway

Activity Test is suitable as a companion diagnostic for the targeted therapy, we will likely not be able to generate future revenue from

our CELsignia HER2 Pathway Activity Test or CELsignia Multi-Pathway Activity test and may not be able to attract other pharmaceutical

companies to partner with us for the development and commercialization of other CELsignia tests.

Further, potential pharmaceutical company

partners may delay negotiating development agreements until results of the first clinical trial using our CELsignia HER2 Pathway Activity

Test trial are available.

Even if the ultimate outcome of the first clinical trial using a CELsignia HER2 Pathway Activity Test trial

is positive, any delays could materially and adversely affect our business.

may not be successful in finding pharmaceutical company partners for continuing development of additional CELsignia tests.

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similar or identical to ours, and our ability to successfully commercialize our technology and diagnostic tests may be impaired.

ability to compete successfully will depend in part on our ability to obtain and enforce patent protection for our products, preserve

our trade secrets and operate without infringing the proprietary rights of third parties.

We have applied for patents that protect our

Our patent portfolio includes three issued U.S.

patents, five issued international patents, five pending U.S.

patent applications,

23 pending non-U.S.

patent applications, one pending international PCT patent application, and numerous corresponding non-U.S.

applications.

ability to compete successfully will depend in part on our ability to obtain and enforce patent protection for our products,

preserve our trade secrets and operate without infringing the proprietary rights of third parties.

We have applied for patents that

protect our technology.

Our patent portfolio includes six issued U.S.

patents and 30 issued international patents.

Each patent and patent application covers methods of use.

However, we cannot assure you that our intellectual property

position will not be challenged or that all patents for which we have applied will be granted.

The validity and breadth of claims in

patents involve complex legal and factual questions and, therefore, may be highly uncertain.

Uncertainties and risks that we face include

the following:

However, we cannot assure you

that our intellectual property position will not be challenged or that all patents for which we have applied will be granted.

validity and breadth of claims in patents involve complex legal and factual questions and, therefore, may be highly uncertain.

Uncertainties and risks that we face include the following:

pending or future patent applications may not result in the issuance of patents;

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compromised, we could be subject to significant liabilities and consequences.

with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect

and process data globally, and the failure to comply with such requirements could subject us to significant fines and penalties, which

may have a material adverse effect on our business, financial condition or results of operations.

regulatory framework for the collection, use, safeguarding, transfer and other processing of information is rapidly evolving and is likely

to remain uncertain for the foreseeable future.

Globally, virtually every jurisdiction in which we operate has established its own data

security and privacy frameworks with which we must comply.

For example, the collection, use, disclosure, transfer, or other processing

of personal data regarding individuals in the European Union, including personal health data, is subject to the EU General Data Protection

Regulation (the “GDPR”), which took effect across all member states of the European Economic Area (the “EEA”)

The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements

relating to the processing of health and other sensitive data, obtaining consent of the individuals to whom the personal data relates,

providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality

of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.

the GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the United States,

and, as a result, increases the scrutiny that clinical trial sites located in the EEA should apply to transfers of personal data from

such sites to countries that are considered to lack an adequate level of data protection, such as the United States.

The GDPR also permits

data protection authorities to require destruction of improperly gathered or used personal information and/or impose substantial fines

for violations of the GDPR, which can be up to 4% of global revenue or €20 million, whichever is greater, and it also confers a

private right of action on data subjects and consumer associates to lodge complaints with supervisory authorities, seek judicial remedies,

and obtain compensation for damages resulting from violations of the GDPR.

In addition, the GDPR provides that EU member states may make

their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data.

actions are either in place or under way in the United States.

There are a broad variety of data protection laws that are applicable

to our activities, and a wide range of enforcement agencies at both the state and federal levels that can review companies for privacy

and data security concerns based on general consumer protection laws.

The Federal Trade Commission and state Attorneys General all are

aggressive in reviewing privacy and data security protections for consumers.

New laws are also being considered at both the state and

federal levels.

For example, the California Consumer Privacy Act (the “CCPA”), which went into effect on January 1, 2020,

and was amended by the California Privacy Rights Act (the “CPRA”), effective January 1, 2023, secure new privacy rights for

consumers and impose new obligations on us.

Many other states have implemented or are considering similar legislation which will change

the privacy law landscape in the United States.

For example, Virginia, Colorado, Utah and Connecticut have all adopted privacy laws,

which take effect in 2023.

A broad range of legislative measures also have been introduced at the federal level.

Accordingly, failure

to comply with federal and state laws (both those currently in effect and future legislation) regarding privacy and security of personal

information could expose us to fines and penalties under such laws.

There also is the threat of consumer class actions related to these

laws and the overall protection of personal data.

the breadth and depth of changes in data protection obligations, preparing for and complying with these requirements is rigorous and

time intensive and requires significant resources and a review of our technologies, systems and practices, as well as those of any third-party

collaborators, service providers, contractors or consultants that process or transfer personal data collected in the European Union.

The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as

healthcare data or other personal information from our clinical trials, could require us to change our business practices and put in

place additional compliance mechanisms, may interrupt or delay our development, regulatory and commercialization activities and increase

our cost of doing business, and could lead to government enforcement actions, private litigation and significant fines and penalties

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

Similarly, failure

to comply with federal and state laws regarding privacy and security of personal information could expose us to fines and penalties under

Even if we are not determined to have violated these laws, government investigations into these issues typically require the

expenditure of significant resources and generate negative publicity, which could harm our reputation and our business.

will also need to expend a considerable amount of resources complying with other federal, state and foreign laws and regulations.

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terminate their relationship with us.

of these factors could adversely affect our commercialization strategy, business, results of operations and financial condition.

of these factors could adversely affect our commercialization strategy, business, results of operations and financial

reliance on third parties to formulate and manufacture our drug product will expose us to a number of risks that may delay the development,

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success of competitive products or technologies;

of planned clinical trials of our CELsignia HER2 Pathway Activity Test, CELsignia Multi-Pathway Activity Test or other CELsignia

tests may develop in the future;

of planned clinical trials of our Phase 3 (VIKTORIA-1), CELsignia HER2 Pathway Activity Test, CELsignia Multi-Pathway Activity Test or

other CELsignia tests may develop in the future;

or legal developments in the United States and other countries;

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in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.

sales of shares of our common stock, including by us and significant stockholders, could negatively affect our stock price.

of a substantial number of shares of our common stock in the public market could occur at any time.

Such sales, or the perception in

the market that the holders of a large number of shares of our common stock intend to sell their shares, could reduce the trading price

of our common stock.

December 9, 2022, we issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants exercisable for

6,956,450 shares of common stock to certain institutional and other accredited investors in a private placement pursuant to a securities

purchase agreement entered into on May 15, 2022.

Each share of Series A Preferred Stock is convertible at the option of the holder, subject

to the Beneficial Ownership Limitation described below, into 10 shares of common stock.

Under the terms of the Series A Preferred Stock

and the warrants, we will not effect the conversion of any Series A Preferred Stock or the exercise of any such warrant, and the investor

will not have the right to convert any portion of the Series A Preferred Stock or to exercise any portion of any warrant, to the extent

that, after giving effect to an attempted conversion or exercise, the aggregate number of shares of common stock beneficially owned by

the investor, together with its affiliates, would exceed 9.99% of the number of shares of common stock outstanding immediately after

giving effect to the conversion or exercise, which percentage may be reset at the investor’s election to a higher percentage, not

to exceed 19.9%, upon 61 days’ notice to us, or to a lower percentage, effective immediately after notice to us.

We refer to such

percentage limitation as the Beneficial Ownership Limitation.

We filed a registration statement on Form S-3 covering the resale of up

to 24,347,754 shares of common stock, consisting of (i) 6,182,574 shares of common stock purchased by the investors under the securities

purchase agreement, (ii) 11,208,730 shares of common stock issuable upon conversion of the Series A Preferred Stock and (iii) 6,956,450

shares of common stock issuable upon exercise of the warrants, which was declared effective in January 2023.

The Form S-3 covers the

resale of the number of shares of common stock issued or issuable to the investors without giving effect to the Beneficial Ownership

Limitation, but the investors may not convert or exercise, and subsequently resell the underlying shares of common stock of, any portion

of the Series A Preferred Stock or the warrants to the extent such conversion or exercise would result in the investor exceeding the

applicable Beneficial Ownership Limitation.

The investors may resell all, some or none of the shares of common stock registered pursuant

to the Form S-3 at any time or in their discretion, subject to the Beneficial Ownership Limitation.

February 4, 2022, we entered into an Open Market Sale Agreement SM with Jefferies LLC, as agent, pursuant to which we may offer

and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of up to $50,000,000.

October 12, 2022, pursuant to this agreement, we sold 500,000 shares of common stock in a single transaction at a price of $10.35 per

share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses).

At December 31, 2022, $44.8

million of common stock remains available for sale under the Jefferies agreement.

The extent to which we utilize the Open Market Sale

Agreement SM as a source of funding will depend on a number of factors, including the prevailing market price of our common

stock, general market conditions and the extent to which we are able to secure funds from other sources.

of substantial amounts of shares of our common stock or other securities by our stockholders, by us under the Open Market Sale Agreement SM ,

by the private placement investors pursuant to the Form S-3 or through any other means could also lower the market price of our common

stock, make it more difficult for you to sell your shares at a price that you desire and impair our ability to raise capital through

the sale of equity or equity-related securities.

Series A Preferred Stock has rights, preferences, and privileges that are not held by, and are preferential to, the rights of holders

of our common stock.

Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock provides that, in the event

of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or in the event of a Deemed Liquidation Event

(as defined in the Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock), the holders

of Series A Preferred Stock are entitled to be paid from assets of the Company available for distribution to its stockholders, before

any payment is made to the holders of common stock by reason of their ownership thereof, an amount per share equal to the greater of

(i) the original issue price ($5.75 on an as-converted-to-common stock basis), plus all accrued and unpaid dividends and (ii) the amount

that the holder would have been entitled to receive at such time if the Series A Preferred Stock were converted into common stock.

Company may not, without the consent of holders of a majority of the outstanding shares of Series A Preferred Stock, amend its charter

in a manner that adversely affects the powers, preferences or rights of the Series A Preferred Stock or issue or obligate itself to issue

shares of any additional class or series of capital stock unless the same ranks junior to the Series A Preferred Stock with respect to

the distribution of assets on the liquidation, dissolution or winding up of the Company and the payment of dividends.

securities or industry analysts do not publish research or reports about our business, or publish negative reports about our business,

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visibility in the financial markets, which could cause our stock price or trading volume to decline.

are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make

our common stock less attractive to investors.

are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company for up to five years.

For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements

that are applicable to other public companies that are not emerging growth companies.

These exemptions include:

permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements,

with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting

of Section 404(b) of the Sarbanes-Oxley Act;

being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory

audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial

disclosure obligations regarding executive compensation;

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved.

have taken advantage of reduced reporting burdens in this report.

We cannot predict whether investors will find our common stock less

attractive if we rely on 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.

incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to

new compliance initiatives and corporate governance practices.

a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting and

other expenses that we did not incur as a private company.

The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection

Act, the continued listing requirements of The Nasdaq Stock Market and other applicable securities rules and regulations impose various

requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate

governance practices.

Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations have increased our ongoing legal and financial compliance costs and will make some activities more

time-consuming and costly.

a public company, we will incur significant legal, accounting and other expenses that we did not incur as a private company.

The Sarbanes-Oxley

Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the continued listing requirements of The Nasdaq Stock Market and

other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance

of effective disclosure and financial controls and corporate governance practices.

Our management and other personnel will need to devote

a substantial amount of time to these compliance initiatives.

Moreover, these rules and regulations have increased our ongoing legal

and financial compliance costs and will make some activities more time-consuming and costly.

to Section 404 of the Sarbanes-Oxley Act, or Section 404, we are required to furnish a report by our management on our internal control

over financial reporting.

Depending upon our filer status, if we cease to be an emerging growth company, we could also be required to

include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm

as required by Section 404(b).

While we, as of December 31, 2021, concluded that our internal control over financial reporting was effective,

we may need to dedicate additional internal resources and engage outside consultants to maintain compliance with Section 404 in the future.

Any material weaknesses that we may identify in the future could result in an adverse reaction in the financial markets due to a loss

of confidence in the reliability of our financial statements.

Depending upon our filer status, we could also be required to include an attestation report on internal control

over financial reporting issued by our independent registered public accounting firm as required by Section 404(b).

While we, as of December

31, 2022, concluded that our internal control over financial reporting was effective, we may need to dedicate additional internal resources

and engage outside consultants to maintain compliance with Section 404 in the future.

Any material weaknesses that we may identify in

the future could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial

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