What changed in this filing

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Item 1A. Risk Factors

2024-03-27 compared with 2023-03-23 · 789 added, 1000 removed, 379 unchanged (83% of the section changed)

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are a clinical-stage biotechnology company that commenced activities in January 2012.

We only have a limited operating history and our

business plan has not been tested.

We have a limited operating history, and our business

plan has not been tested.

Since inception, we have had no revenue and have incurred significant operating losses.

We have financed

our operations primarily through equity and debt offerings.

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).

We have financed our

operations primarily through equity and debt offerings.

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

complete our existing clinical trials, cultivate partnerships with pharmaceutical companies, and develop and commercialize gedatolisib

pursuant to our license agreement with Pfizer.

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/or 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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therapeutic and companion diagnostic strategy and expand our infrastructure, commercial operations and research and development activities.

We may seek to raise additional capital through equity offerings, debt financings, collaborations or licensing arrangements.

If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more research

and development programs or selling and marketing initiatives.

In addition, we may have to work with a partner on one or more of our

products or market development programs, which could lower the economic value of those programs to our company.

financing activities could dilute the percentage ownership of our stockholders and could cause our stock price to fall, or could result

in operating or other restrictions.

may seek to raise additional capital through equity offerings, debt financings, collaborations or licensing arrangements.

funding may not be available to us on acceptable terms, or at all.

If we raise funds by issuing equity securities, dilution to our stockholders

could result.

Any equity securities issued may also provide for rights, preferences or privileges senior to those of holders of our existing

The incurrence of additional indebtedness or the issuance of certain equity securities could result in increased fixed payment

obligations and could also include restrictive covenants, such as limitations on our ability to incur additional debt or issue additional

equity, limitations on our ability to acquire or license intellectual property rights, and other operating restrictions that could adversely

affect our ability to conduct our business.

In the event that we enter into collaborations or licensing arrangements to raise capital,

we may be required to accept unfavorable terms.

If we are not able to secure additional funding when needed, we may have to delay, reduce

the scope of or eliminate one or more research and development programs or selling and marketing initiatives.

In addition, we may have

to work with a partner on one or more of our products or market development programs, which could lower the economic value of those programs

to our company.

If we raise funds by issuing equity securities, it will result in

dilution to current stockholders.

Any equity securities issued may also provide for rights, preferences or privileges senior to those

of holders of our existing securities.

The incurrence of additional indebtedness or the issuance of certain equity securities could result

in increased fixed payment obligations and could also include restrictive covenants, such as limitations on our ability to incur additional

debt or issue additional equity, limitations on our ability to acquire or license intellectual property rights, and other operating restrictions

that could adversely affect our ability to conduct our business.

In the event that we enter into collaborations or licensing arrangements

to raise capital, we may be required to accept unfavorable terms.

will be dependent on our ability to attract and retain key personnel.

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Laing, we may be unable to successfully implement our business plan.

COVID-19 pandemic may materially and adversely impact our business, including ongoing clinical trials.

outbreak of COVID-19 and government measures taken in response have had a significant impact on the global economy, with healthcare systems

particularly affected.

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;

rates of patients withdrawing from clinical trials following enrollment as a result of quarantine or concerns about COVID-19;

of healthcare resources away from the conduct of clinical trials;

in prospective clinical trial collaborations with pharmaceutical companies and sponsors;

or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions;

on employee resources that would otherwise be focused on the conduct of clinical trials and research as a result of focus addressing

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

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

may occur in the future.

Related to Our Drug Product, Gedatolisib

future strategy is dependent on the success of our initial drug product, gedatolisib, as well as other drug products we may develop.

If we are unable to successfully complete clinical development of, obtain regulatory approval for or commercialize our drug products,

or if we experience delays in doing so, our business will be materially harmed.

date, we have not yet completed any registrational clinical trials or the development of any drug products.

Our future success and ability

to generate revenue from our drug products, which we do not expect will occur for several years, if ever, is dependent on our ability

to successfully develop, obtain regulatory approval for and commercialize one or more drug products.

We may not have the financial resources

to continue development of, or to modify existing or enter into new collaborations for, a drug product if we experience any issues that

delay or prevent regulatory approval of, or our ability to commercialize, our drug products, including:

inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our drug products are safe

and effective;

Related to Our Product Strategy

near-term revenue prospects depend on the success of our initial drug product, gedatolisib.

If we are unable to successfully complete

clinical development of, obtain regulatory approval for or commercialize gedatolisib, or if we experience delays in doing so, our business

will be materially harmed.

date, we have not yet completed any registrational clinical trials or the development of our initial drug candidate, gedatolisib.

future success and ability to generate revenue, which we do not expect will occur for several years, if ever, is dependent on our ability

to successfully develop, obtain regulatory approval for and commercialize one or more products, and currently, our primary focus is to

pursue approval and commercialization of gedatolisib for one or more intended uses.

We may not have the financial resources to continue

development of, or to modify existing or enter into new collaborations for, our current or future product candidates if we experience

any issues that delay or prevent regulatory approval of, or our ability to commercialize, gedatolisib, including:

inability to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that gedatolisib is safe and

insufficiency

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product-related

adverse events experienced by subjects in our clinical trials or by individuals using drugs or therapeutic biologics similar to our

drug products;

adverse events experienced by subjects in our clinical trials or by individuals using drugs or therapeutic biologics similar to gedatolisib;

in submitting applications, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial

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imposed by the FDA or comparable foreign regulatory authorities regarding the scope or design of our clinical trials;

effectiveness of our drug products during clinical trials;

effectiveness of gedatolisib or companion therapeutics during clinical trials;

than expected performance of control arms, such as placebo groups, which could lead to negative or inconclusive results from our

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If these activities were not compliant, accurate or correct, the

clinical development, regulatory approval or commercialization of our drug product will be adversely affected.

clinical development, regulatory approval or commercialization of our drug product will be delayed and may be adversely affected.

an organization, we have never successfully completed any registrational clinical trials, and we may be unable to do so for any drug

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drug products.

successful development of our products is highly uncertain.

business depends on the successful development of biopharmaceuticals, which is highly uncertain and is dependent on numerous factors,

many of which are beyond our control.

Product candidates that appear promising in the early phases of development may fail to reach the

market for several reasons including, among other things, that clinical trial results may show the product candidates to be less effective

than expected or to have unacceptable side effects or toxicities;

we may fail to receive the necessary regulatory approvals or there

may be a delay in receiving such approvals;

or the proprietary rights of others and their competing products and technologies that may

prevent our product candidates from being commercialized.

length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory

authority varies significantly from one drug product to the next and from one country to the next and may be difficult to predict.

will incur significant research and development expenses before knowing whether our products are commercially viable, and may abandon

development of a specific trial, or a product candidate, at any time for a variety of reasons.

For example, we terminated the FACT-2

Trial for our CELsignia diagnostic test in the third quarter of 2023 in response to FDA approvals of new therapeutic options for certain

patients that negatively impacted enrollment.

If we expend resources on products that are ultimately not commercially viable, our timing

for becoming profitable and our ability to invest in other products in our pipeline would be adversely affected.

addition, if gedatolisib receives marketing approval for the intended uses that we are pursuing,

we will continue to be subject to significant post-approval regulatory obligations.

In addition, there is always the risk that we, a

regulatory authority or a third party might identify previously unknown problems with a product post-approval, such as adverse events

of unanticipated severity or frequency.

Compliance with these requirements is costly, and any failure to comply or other issues with

our drug products post-approval could adversely affect our business, financial condition and results of operations.

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

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would consider clinically meaningful, and a clinical trial can fail at any stage of testing.

in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier

clinical trials to later clinical trials.

Moreover, clinical data are often susceptible to varying interpretations and analyses, and

many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain

marketing approval of their products.

Additionally, we are conducting and plan to conduct some open-label trials, where both the patient

and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo.

Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose

Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in those

trials are aware when they are receiving treatment.

Open-label clinical trials may be subject to a “patient bias” where patients

perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment.

In addition, open-label

clinical trials may be subject to an “investigator bias” where those assessing and reviewing the outcomes of the clinical

trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given

this knowledge.

Where a randomized, placebo-controlled clinical trial is designed to allow enrolled subjects to cross-over to the treatment

arm, there may be a risk of inadvertent unblinding of subjects prior to cross-over, which may limit the clinical meaningfulness of those

data and may require the conduct of additional clinical trials.

As such, the results from an open-label trial may not be predictive of

future clinical trial results with any of our product candidates for which we include an open-label clinical trial when studied in a

controlled environment with a placebo or active control.

in trial design between early-stage clinical trials and later-stage clinical trials, which involve a greater number of patients and take

years to complete, make it difficult to extrapolate the results of earlier clinical trials to later clinical trials.

Moreover, clinical

data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed

satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their products.

Additionally, we are conducting

and plan to conduct some open-label trials, where both the patient and investigator know whether the patient is receiving the investigational

product candidate or either an existing approved drug or placebo.

Most typically, open-label clinical trials test only the investigational

product candidate and sometimes may do so at different dose levels.

Open-label clinical trials are subject to various limitations that

may exaggerate any therapeutic effect as patients in those trials are aware when they are receiving treatment.

Open-label clinical trials

may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness

of receiving an experimental treatment.

In addition, open-label clinical trials may be subject to an “investigator bias”

where those assessing and reviewing the outcomes of the clinical trials are aware of which patients have received treatment and may interpret

the information of the treated group more favorably given this knowledge.

Where a randomized, placebo-controlled clinical trial is designed

to allow enrolled subjects to cross-over to the treatment arm, there may be a risk of inadvertent unblinding of subjects prior to cross-over,

which may limit the clinical meaningfulness of those data and may require the conduct of additional clinical trials.

As such, the results

from an open-label trial may not be predictive of future clinical trial results with any of our product candidates for which we include

an open-label clinical trial when studied in a controlled environment with a placebo or active control.

completion of clinical trials is a prerequisite to submitting a new drug application, or NDA, to the FDA and similar marketing applications

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of any drug products.

We may experience delays in initiating or completing clinical trials and preparing for regulatory submissions.

We may experience delays in initiating our Phase 3 clinical trial due to requests from the FDA for additional information, including additional nonclinical or clinical data, or for requests to amend the clinical trial protocol.

Additional delays may be incurred once the Phase 3 clinical trial is initiated if it takes longer than expected to activate the targeted number of clinical sites, if the enrollment of patients is negatively affected by staffing shortages at clinical sites, or by other unanticipated factors, or if the FDA and other regulatory authorities require us to pause our Phase 3 clinical trial due to unexpected safety issues.

We also may experience numerous unforeseen events during, or as a result of, any future clinical trials that we could conduct that could

delay or prevent our ability to receive marketing approval or commercialize our current product candidates or any future product candidates.

Our costs will increase if we experience delays in clinical testing or marketing approvals.

We do not know whether any of our clinical

trials will begin as planned, will need to be reassigned or will be completed on schedule, or at all.

costs will increase if we experience delays in clinical testing or marketing approvals.

We do not know whether our clinical trials will

begin or continue as planned, will need to be reassigned or will be completed on schedule, or at all.

Significant clinical trial delays

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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.

face significant competition, and our operating results will suffer if we fail to compete effectively.

industry is characterized by intense competition and rapid innovation.

Our competitors may be able to develop other compounds or drugs

that are able to achieve similar or better results than our lead product candidate, gedatolisib.

Our potential competitors include major

multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and diagnostic companies, and universities

and other research institutions.

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

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

or early-stage companies may also prove to be significant competitors, particularly as they develop novel approaches to treating disease

indications that gedatolisib is also focused on treating.

Established pharmaceutical companies may also invest heavily to accelerate

discovery and development of novel therapeutics or to in-license novel therapeutics that could make the product candidates that we develop

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

in our competitors.

may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for

investment in these industries.

Our competitors, either alone or with collaboration partners, may succeed in developing, acquiring or

licensing on an exclusive basis products that are more effective, safer, more easily commercialized or less costly than our product candidates

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

We believe the key competitive factors that will affect the development and commercial success of our product candidates are efficacy,

safety, tolerability, reliability, convenience of use, price, and reimbursement.

With respect to our CELsignia platform, which is a novel

approach to companion diagnostics, we will need to demonstrate compelling advantages on a cost-competitive basis, educate key opinion

leaders, and successfully collaborate with partners in the discovery, development, and commercialization of our tests.

if we obtain regulatory approval of drug products, the availability and price of our competitors’ products could limit the demand

and the price we are able to charge for our product candidates.

We may not be able to implement our business plan if the acceptance of

our product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment

to our product candidates, or if physicians switch to other new drug or biologic products or choose to reserve our product candidates

for use in limited circumstances.

our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could face clinical

trial delays;

regulatory investigations or actions;

fines and penalties, disruptions of our business operations;

and other adverse consequences.

Cyberattacks,

malicious internet-based activity, online and offline fraud, and other similar activities threaten the confidentiality, integrity, and

availability of our sensitive information and information technology systems, and those of the third parties upon which we rely.

on contract research organizations, contract manufacturing organizations, distributors, supply chain resources, and other third-party

service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including,

without limitation, on-site systems and cloud-based data centers, systems handling human resources, financial reporting and controls,

customer relationship management, regulatory compliance, and other infrastructure operations.

We also communicate sensitive data, including

patient data, electronically, and through relationships with multiple third-party vendors and their subcontractors.

These applications

and data encompass a wide variety of sensitive information, including research and development information, patient data, commercial

information, and business and financial information.

Our ability to monitor these third parties’ security practices is limited,

and these third parties may not have adequate security measures in place.

If we or any of our third-party service providers experience

a security incident or other interruption, we could experience adverse consequences.

We cannot guarantee that third parties and infrastructure

in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable

defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology

systems that support us and our services.

Cybersecurity

threats are becoming increasingly difficult to detect, and come from a variety of sources, including without limitation nation-state

actors and activists that create disruption for geopolitical reasons and in conjunction with military conflicts and defense activities.

This risk is heightened during times of war and other major conflicts, including the war between Russia and Ukraine, the state of war

between Israel and Hamas and the risk of a larger regional conflict.

In addition, we and the third parties upon which we rely face an

evolving cybersecurity threat landscape, which includes social-engineering attacks (including through deep fakes, which may be increasingly

more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result

of advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting, personnel misconduct

or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, attacks enhanced or facilitated by artificial

intelligence (“AI”), software or hardware failures, loss of data or other information technology assets, adware, telecommunications

failures, natural disasters, terrorism, and other similar threats.

Many of our employees and contractors are working remotely at least

part of the time.

Remote work involves risks to our information technology systems and data, as individuals utilize network connections,

computers and devices outside our premises or network, including working at home, while in transit and in public locations.

attacks also continue to increase in prevalence and severity and can lead to significant interruptions in our operations, ability to

provide our services, loss of data and income, reputational harm, and diversion of funds.

Extortion payments may alleviate the negative

impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations

prohibiting such payments.

we take steps designed to identify, prevent, assess and mitigate vulnerabilities in our information systems and to mitigate related third-party

risks, there can be no assurance that we will be able to detect and remediate all such vulnerabilities, including on a timely basis.

The threats and techniques used to exploit the vulnerability change frequently and are often sophisticated in nature.

Therefore, we (or

third parties on whom we rely) may be unable to detect a vulnerability until after a security incident has occurred.

Further, we or third

parties on which we rely may face downtime as a result of adopting new information technology systems that are designed to enhance compliance

or reduce vulnerabilities.

security incident or other interruption could result in unauthorized, unlawful, or accidental acquisition, modification, destruction,

loss, alteration, encryption, disclosure of, or access to our sensitive information or our information technology systems, or those of

the third parties upon whom we rely.

This could disrupt our clinical trials, damage our reputation, and negatively affect our ability

to conduct our business in the ordinary course, including our ability to collect, process, and prepare company financial information,

provide information and educational materials through our website, and manage the administrative aspects of our business.

may expend significant resources or modify our business activities (including our clinical trial activities) to try to protect against

security incidents.

Additionally, certain data privacy and security obligations may require us to implement and maintain certain measures

to protect our information technology systems and sensitive information and to notify relevant stakeholders, including affected individuals,

regulatory authorities and our stockholders, of certain security incidents.

The disclosure decisions are complex, may take time to determine,

and may be subject to change as an investigation progresses.

Providing disclosure may be costly, and the failure to comply with such

requirements could also lead to adverse consequences.

If we (or a third party upon whom we rely) experience a security incident or are

perceived to have experienced a security incident, we may face government enforcement actions (for example, investigations, fines, penalties,

audits, and inspections);

additional reporting requirements and/or oversight;

restrictions on processing sensitive information (including

personal information);

litigation (including class claims) and mass arbitration;

indemnification obligations;

negative publicity;

monetary fund diversions;

interruptions in our operations (including availability of data);

financial loss;

and other similar harms.

Accordingly, security incidents and attendant consequences may damage our financial position and negatively impact our ability to grow

and operate our business.

if the information technology systems of the third parties upon which we rely become subject to security incidents, we may have insufficient

recourse against such third parties, and we may have to expend significant resources to mitigate the impact of such an event, and to

develop and implement protections to prevent future events of this nature from occurring.

There can be no assurance that limitations

of liability in our third-party contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy

and security obligations.

We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate

liabilities arising out of our data privacy and security practices.

Additionally, we cannot be sure that such coverage will continue

to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public

sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine

our competitive advantage or market position.

Additionally, our sensitive information could be leaked, disclosed, or revealed as a result

of or in connection with our employee’s, personnel’s, or vendor’s use of generative AI technologies.

health matters may materially and adversely impact our business, including ongoing clinical trials.

outbreak of COVID-19 and government measures taken in response demonstrated that public health matters have a significant impact on the

global economy, with healthcare systems particularly affected.

As a result of the COVID-19 outbreak and related public health measures,

we experienced delays in the enrollment of patients in certain CELsignia-related clinical trials.

Future outbreaks or variants of the

virus, or the emergence of other pandemics or public health disruptions, 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;

rates of patients withdrawing from clinical trials following enrollment as a result of quarantine or public health concerns;

of healthcare resources away from the conduct of clinical trials;

in prospective clinical trial collaborations with pharmaceutical companies and sponsors;

or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines;

on our ability to recruit and hire key personnel due to our inability to meet with candidates because of travel restrictions;

on employee resources that would otherwise be focused on the conduct of clinical trials and research as a result of focus on health

matters and loss of productivity from remote work.

Related to Product Development and Product Regulation

we are unable to obtain approval from the FDA or comparable foreign regulatory authorities to market our products for their intended

use, we will not be able to generate revenue.

For 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.

marketability of our products, particularly gedatolisib, depends on securing approval from the FDA and equivalent foreign regulatory

This requires rigorous pre-clinical and clinical studies, including Phase 3 clinical trials for each intended use, that the benefits

of the therapy 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.

Satisfaction of the FDA’s regulatory requirements typically takes many years

and requires substantial resources for research, development and testing.

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

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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

We are currently conducting a Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with

fulvestrant with or without palbociclib, in patients with HR+/HER2-

advanced breast cancer after progression on CDK4/6 therapy , and a Phase 1b/2 clinical trial, CELC-G-201,

evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer.

have sought feedback from the FDA and other regulatory authorities on the design of gedatolisib clinical trials, with the goal of addressing

these considerations in the clinical trials’ 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 clinical trial so that sufficient evidence is

generated to support a marketing approval, even if the primary endpoint objective is achieved in the Phase 3 stage of the trial.

FDA 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;

Regulatory approval may

also be delayed by changes in government regulation, future legislation or administrative action or changes in FDA policy that occur

prior to or during our regulatory review.

We cannot predict whether our research and clinical approaches will result in a drug that the

FDA considers safe for humans and effective for indicated uses.

results from clinical trials that we conduct may not support approval of gedatolisib, and the results of clinical trials of other pharmaceutical

collaborators may not support use of our CELsignia platform as a companion diagnostic or standalone testing tool.

In addition, we may

be unable to execute on our intention of using our CELsignia PI3K Activity Test in evaluating tumors in certain of our gedatolisib clinical

regulatory approvals are delayed or not obtained, especially with respect to gedatolisib, it will negatively impact our ability to commercialize

our products and generate revenue and may diminish any

competitive advantages that we may otherwise enjoy .

If we are required to conduct additional clinical

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

trials or other testing of gedatolisib, or if the results of these trials or tests are not positive or are only modestly positive or

if there are safety concerns, we may:

delayed in obtaining marketing approval 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;

subject to changes in the way our products are 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;

of the FDA’s Risk Evaluation and Mitigation Strategies program(“REMS”) or through modification to an existing REMS;

damage to our reputation.

successful development of biopharmaceuticals is highly uncertain.

development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

candidates that appear promising in the early phases of development may fail to reach the market for several reasons including, among

other things, that clinical trial results may show the product candidates to be less effective than expected or to have unacceptable

side effects or toxicities;

we may fail to receive the necessary regulatory approvals or there may be a delay in receiving such approvals;

or the proprietary rights of others and their competing products and technologies that may prevent our product candidates from being

commercialized.

length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory

authority varies significantly from one drug product to the next and from one country to the next and may be difficult to predict.

if we are successful in obtaining marketing approval, commercial success of any approved products will also depend in large part on the

availability of coverage and adequate reimbursement from third-party payors, including government payors such as the Medicare and Medicaid

programs and managed care organizations in the U.S.

or country specific governmental organizations in foreign countries, which may be

affected by existing and future healthcare reform measures designed to reduce the cost of healthcare.

Third-party payors could require

us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify for reimbursement,

which could be costly and divert our resources.

If government and other healthcare payors were not to provide coverage and adequate reimbursement

for our products once approved, market acceptance and commercial success would be reduced.

addition, if any of our drug products receive marketing approval, we will be subject to significant post-approval regulatory obligations.

In addition, there is always the risk that we, a regulatory authority or a third party might identify previously unknown problems with

a product post-approval, such as adverse events of unanticipated severity or frequency.

Compliance with these requirements is costly,

and any failure to comply or other issues with our drug products post-approval could adversely affect our business, financial condition

and results of operations.

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

biopharmaceutical industry is characterized by intense competition and rapid innovation.

Our competitors may be able to develop other

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

Our potential competitors include major multinational pharmaceutical

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

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

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

Smaller or early-stage companies may

also prove to be significant competitors, particularly as they develop novel approaches to treating disease indications that our product

candidates are also focused on treating.

Established pharmaceutical companies may also invest heavily to accelerate discovery and development

of novel therapeutics or to in-license novel therapeutics that could make the product candidates that we develop obsolete.

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

Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of

capital for investment in these industries.

Our competitors, either alone or with collaboration partners, may succeed in developing,

acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or

less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the

development of our technologies and products.

We believe the key competitive factors that will affect the development and commercial

success of our product candidates are efficacy, safety, tolerability, reliability, convenience of use, price and reimbursement.

if we obtain regulatory approval of drug products, the availability and price of our competitors’ products could limit the demand

and the price we are able to charge for our product candidates.

We may not be able to implement our business plan if the acceptance of

our product candidates is inhibited by price competition or the reluctance of physicians to switch from existing methods of treatment

to our product candidates, or if physicians switch to other new drug or biologic products or choose to reserve our product candidates

for use in limited circumstances.

if any drug product we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients,

third-party payors and others in the medical community necessary for commercial success.

any future drug product we develop receives marketing approval, whether as a single agent or in combination with other therapies, it

may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community.

If the product candidates we develop do not achieve an adequate level of acceptance, we may not generate significant product revenues

and we may not become profitable.

The degree of market acceptance of any product candidate, if approved for commercial sale, will depend

on a number of factors, including:

and potential advantages compared to other treatments;

ability to offer our products, if approved, for sale at competitive prices;

and ease of administration compared to other treatments;

willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

strength of marketing and distribution support;

ability to obtain sufficient third-party coverage, market access and adequate reimbursement;

prevalence and severity of any side effects.

Related to Intellectual Property for Gedatolisib

depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidate, and termination of

this license could result in the loss of significant rights, which would harm our business.

are dependent on patents, know-how and proprietary technology, both our own and licensed from others.

All patents covering gedatolisib

and any combination therapies using our product candidates are licensed from third parties.

Any termination of a product license could

result in the loss of significant rights and would cause material adverse harm to our ability to commercialize our product candidates.

may also arise between us and our licensors regarding intellectual property subject to a license agreement, including:

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

and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the

licensing agreement;

right to sublicense patent and other rights to third parties under collaborative development relationships;

diligence obligations with respect to the use of licensed technology in relation to our development and commercialization of our

product candidates and what activities satisfy those diligence obligations;

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

our partners.

disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

are generally also subject to all of the same risks with respect to protection of intellectual property that we own, as we are for intellectual

property that we license.

If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize

products could materially suffer.

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 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.

We may have limited control over the maintenance and prosecution of these in-licensed rights, activities or any

other intellectual property that may be related to our in-licensed intellectual property.

For example, we cannot be certain that such

activities by these licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid

and enforceable patents and other intellectual property rights.

We have limited control over the manner in which our licensors initiate

an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual

property that is licensed to us.

It is possible that the licensors’ infringement proceeding or defense activities may be less vigorous

than had we conducted them ourselves.

may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.

our programs may involve additional product candidates that may require the use of proprietary rights held by third parties, the growth

of our business may depend in part on our ability to acquire, in-license or use these proprietary rights.

We may be unable to acquire

or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that we

identify as necessary or important to our business operations.

We may fail to obtain any of these licenses at a reasonable cost or on

reasonable terms, if at all, which could harm our business.

We may need to cease use of the compositions or methods covered by such third-party

intellectual property rights, and may need to seek to develop alternative approaches that do not infringe on such intellectual property

rights which may entail additional costs and development delays, even if we were able to develop such alternatives, which may not be

Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies

licensed to us.

In that event, we may be required to expend significant time and resources to develop or license replacement technology.

licensing and acquisition of third-party intellectual property rights is a competitive area, and companies, which may be more established,

or have greater resources than we do, may also be pursuing strategies to license or acquire third-party intellectual property rights

that we may consider necessary or attractive in order to commercialize our product candidates.

More established companies may have a

competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

There can be no assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual

property surrounding the additional product candidates that we may seek to acquire.

Related to Government Regulation for Gedatolisib

may not obtain the necessary regulatory approvals to commercialize our product candidate.

will need FDA approval to commercialize our product candidate in the U.S.

In order to obtain FDA approval, we must submit to the FDA

a new drug application, or NDA, demonstrating that the drug product is safe for humans and effective for its intended use.

This demonstration

requires significant research and animal tests, which are referred to as pre-clinical studies, as well as human tests, which are referred

to as clinical trials.

Satisfaction of the FDA’s regulatory requirements typically takes many years, depends upon the type, complexity

and novelty of the drug product and requires substantial resources for research, development and testing.

We cannot predict whether our

research and clinical approaches will result in a drug that the FDA considers safe for humans and effective for indicated uses.

has substantial discretion in the drug approval process and may require us to conduct additional pre-clinical and clinical testing or

to perform post-marketing studies.

The approval process may also be delayed by changes in government regulation, future legislation or

administrative action or changes in FDA policy that occur prior to or during our regulatory review.

Delays in obtaining regulatory approvals

may delay commercialization of, and our ability to derive product revenues from, our drug product;

impose costly procedures on us;

diminish any competitive advantages that we may otherwise enjoy.

Even if we comply with all FDA requests, the FDA may ultimately reject

We cannot be sure that we will ever obtain regulatory clearance for our drug product.

Failure to obtain FDA approval of our

drug product will severely undermine our business by reducing our number of salable products and, therefore, corresponding product revenues.

FDA or comparable foreign regulatory authorities may disagree with our regulatory plan for our product candidates.

general approach for FDA approval of a new drug is dispositive data from one or more well-controlled Phase 3 clinical trials of the product

candidate in the relevant patient population.

Phase 3 clinical trials typically involve a large number of patients, have significant

costs and take years to complete.

clinical trial results may not support approval of our product candidates.

In addition, our product candidates could fail to receive

regulatory approval, or regulatory approval could be delayed, for many reasons, including the following:

FDA or comparable foreign regulatory authorities may disagree with the dosing regimen, design or implementation of our clinical trials;

may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates

are safe and effective for any of their proposed indications;

may encounter safety or efficacy problems caused by the COVID-19 pandemic;

results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory

authorities for approval;

may be unable to demonstrate that our product candidates’ clinical and other benefits outweigh their safety risks;

FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical

data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable

foreign regulatory authorities to support the submission of an NDA or other comparable submission in foreign jurisdictions or to

obtain regulatory approval in the U.S.

or elsewhere;

FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers

with which we contract for clinical and commercial supplies;

approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering

our clinical data insufficient for approval.

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

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for our products is also subject to approval.

may also submit marketing applications in other countries.

Regulatory authorities in jurisdictions outside of the U.S.

have requirements

for approval of product candidates with which we must comply prior to marketing in those jurisdictions.

Obtaining foreign regulatory

approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could

delay or prevent the introduction of our products in certain countries.

If we fail to comply with the regulatory requirements in international

markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential

of our product candidates will be harmed.

if we receive regulatory approval of any product candidates, we will be subject to ongoing regulatory obligations and continued regulatory

review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements

or experience unanticipated problems with our product candidates.

foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and

costs for us and could delay or prevent the introduction of our products in certain countries.

If we fail to comply with the regulatory

requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability

to realize the full market potential of our product candidates will be harmed.

if we receive initial regulatory approvals, we will be subject to ongoing regulatory obligations and continued regulatory review, which

may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or

experience unanticipated problems with our product candidates.

any of our product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging,

29 unchanged sentences

only for the approved indications and in accordance with the provisions of the approved label.

The policies of the FDA and comparable

foreign regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future

legislation or administrative action, either in the U.S.

If we are slow or unable to adapt to changes in existing requirements

or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval

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

success with CELsignia is heavily dependent on the success of our first CELsignia trials.

business strategy is focused on attracting pharmaceutical company partnerships that provide revenue from the sale of CELsignia tests

during clinical trials, from milestone payments during clinical trials, from sales of our CELsignia tests as companion diagnostics or

stand-alone tests thereafter, and, potentially, from royalties on the incremental drug revenues our tests enable.

Our ability to obtain

such partnerships and generate such revenue depends in part on the ability of our first CELsignia tests to demonstrate the potential

incremental opportunity available for pharmaceutical companies.

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

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.

intend to develop strategic partnerships with pharmaceutical companies for developing additional CELsignia tests.

Many of the potential

partners are global, multi-billion-dollar pharmaceutical companies with sophisticated research and development organizations and multiple

We may not be successful in our efforts to establish such a strategic partnership or other alternative arrangements for our

CELsignia tests because, among other things, our research and development pipeline may be insufficient, such tests may be deemed to be

at too early of a stage of development for collaborative effort, or third parties may not view such tests as having the requisite potential

to demonstrate efficacy.

In addition, we may be restricted under collaboration agreements from entering into future agreements with other

Even if we are able to find suitable partners, we may not be successful in negotiating development agreements with such partners

that provide revenue from the sale of our CELsignia tests, from milestone payments, and/or from royalties on the incremental drug revenues

that our tests enable.

If we are unable to reach agreements with suitable strategic partners on a timely basis, on acceptable terms or

at all, we may have to curtail the development of additional CELsignia tests, our expected revenue opportunities may be significantly

smaller than expected and our business may fail.

our CELsignia HER2 Pathway Activity Test and CELsignia Multi-Pathway Activity Test are commercially ready, we have not attempted to market

these to physicians or their patients as stand-alone tests and have no ability to determine if these tests or any of our other tests

will be commercially viable.

our CELsignia HER2 Pathway Activity Test and CELsignia Multi-Pathway Activity Test are analytically validated, conducted in our CLIA

certified and CAP accredited laboratory, and currently ready for commercial use as an LDT, we have not attempted to market them to physicians

or their patients.

Furthermore, we have commenced only limited communications with KOLs to build awareness and credibility of our CELsignia

diagnostic platform and CELsignia tests.

Accordingly, we have no ability to determine whether our CELsignia HER2 Pathway Activity Test,

CELsignia Multi-Pathway Activity Test or any other future CELsignia tests, will be commercially viable as stand-alone tests.

be successful in generating revenue from our CELsignia tests as stand-alone tests, and if we are unable to build pharmaceutical partnerships

that enable us to market the CELsignia HER2 Pathway Activity Test, the CELsignia Multi-Pathway Activity Test, and other tests as companion

diagnostic tests, we may never generate any revenue and our business may fail.

our CELsignia tests involves a lengthy and complex process that may not be successful.

CELsignia tests may take several years to develop from the time they are discovered to the time they are available for patient use, if

In order to develop additional CELsignia tests into commercially ready products, we need to successfully complete a variety of

activities, including, among others, conducting substantial research and development, conducting extensive analytical testing, and maintaining

our CLIA certified and CAP accredited laboratory.

In addition, our business strategy is focused on our CELsignia tests being sold as

companion diagnostics.

This will require obtaining and maintaining partnerships with pharmaceutical companies and successfully completing

clinical studies that demonstrate the suitability of the applicable CELsignia test as a companion diagnostic for their targeted therapies.

activities will require us to expend significant resources.

Based on comparable companies in this industry, few research and development

projects result in commercially viable products, and success in early clinical studies often is not replicated in later studies.

point, we may abandon development of a product candidate for several reasons, such as a clinical validation study failing to demonstrate

the prospectively defined endpoints of the study.

We may also be required to expend considerable resources repeating clinical studies,

which would adversely affect the timing for generating potential revenue from a new product and our ability to invest in other products

in our pipeline.

trials are expensive and complex with uncertain outcomes, which may prevent or delay commercialization of our CELsignia tests.

our CELsignia tests to become a companion diagnostic for a matching targeted therapy, we must conduct clinical trials to demonstrate

that patients who have an abnormal signaling pathway, as identified by our CELsignia tests, respond to treatment with a matching targeted

Clinical testing is expensive, is difficult to design and implement, and can take many years to complete, and its outcome is

inherently uncertain.

As a company, we have limited experience in conducting or participating in clinical trials.

We cannot be certain

that any future clinical trials will conclusively demonstrate that any CELsignia test is effective as a companion diagnostic.

trials do not yield positive results, we may be unable to maintain the pharmaceutical company partnerships we build or find additional

partners, we may not be able to successfully commercialize our CELsignia tests or generate any revenue, our business may fail, and you

may lose part or all of your investment.

cannot be certain that our existing clinical trial or future clinical trials, if any, will begin or be completed on time, if at all.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to commercialize

our CELsignia tests, such as:

or failure in reaching agreement on acceptable clinical trial contracts or clinical trial protocols with planned trial sites and/or

strategic partners;

or failure in reaching agreement with the FDA or a comparable foreign regulatory authority on a trial design, in obtaining authorization

from such authorities to commence the trial, and/or in complying with conditions or other requirements imposed by such regulatory

authorities with respect to the trial;

or failure in recruiting and enrolling suitable subjects to participate in one or more clinical trials, or in such participants completing

a trial or returning for follow-up during or after the trial;

sites, investigators or other third-parties deviating from the trial protocol, failing to conduct the trial in accordance with regulatory

and contractual requirements, and/or dropping out of a trial;

imposition of a clinical hold for any of our clinical trials, where a clinical hold in a trial in one indication would result in

a clinical hold for clinical trials in other indications;

in governmental regulations or administrative actions.

nonclinical or clinical trial delays could prevent us from maintaining and/or developing new pharmaceutical company partnerships.

could also shorten any periods during which we may have the exclusive right to commercialize our CELsignia tests or allow our competitors

to bring products to market before we do.

As such, any delays could impair our ability to successfully commercialize our CELsignia tests

and may materially and adversely affect our business, financial condition, results of operations and prospects.

if our CELsignia tests achieve positive clinical trial results, they may fail to achieve the degree of market acceptance by physicians,

patients, third-party payors and others in the medical community necessary for commercial success.

any of our potential CELsignia tests, including our first CELsignia HER2 Pathway Activity Test and CELsignia Multi-Pathway Activity Test,

achieve positive clinical trial results, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party

payors and others in the medical community necessary for commercial success.

For example, conventional genomic- or proteomic-based analyses

are commonly used today to diagnose cancer and prescribe cancer medications, and physicians may continue to rely on these diagnostic

tests instead of adopting the use of a CELsignia test.

The degree of market acceptance of our CELsignia tests will depend on a number

of factors, including:

efficacy and other potential advantages compared to alternative diagnostic tests;

ability to offer them for sale at competitive prices;

convenience and ease of obtaining patient specimens compared to alternative diagnostics;

willingness of the target patient population to try new diagnostics and of physicians to initiate such diagnostics;

strength of marketing and distribution support;

availability of third-party coverage and adequate reimbursement for our diagnostic tests;

ability to partner with pharmaceutical companies to develop companion diagnostic programs for the new cancer sub-types we discover.

our CELsignia tests do not achieve an adequate level of acceptance, we may never generate significant product revenues and we may not

become profitable.

CELsignia related business, operational and financial goals may not be attainable if the market opportunities for our CELsignia tests

or our pharmaceutical company partners are smaller than we expect.

Our internal research and estimates on market opportunities have not

been verified by independent sources, and we have not independently verified market and industry data from third-parties that we have

total market opportunities that we believe exist are based on a variety of assumptions and estimates, including the number of potential

companion diagnostic programs we will be able to successfully pursue, the amount of potential milestone payments that we could receive

in companion diagnostic programs, the number of patients we will test in clinical trials, the price we will be able to charge for our

tests and the total annual number of cancer patients with undiagnosed abnormal cell signaling.

In addition, we have relied on third-party

publications, research, surveys and studies for information related to determining market opportunities, including without limitation,

information on the number of cancer patients and those receiving various forms of treatment, the cost of drug therapy, the amount of

revenue generated from various types of drug therapy, the objective response rates of drug therapies, the number of deaths caused by

cancer and the expected growth in cancer drug therapy and diagnostic markets.

Our internal research and estimates on market opportunities

have not been verified by independent sources, and we have not independently verified market and industry data from third-parties that

we have relied on.

Any or all of our assumptions and/or estimates may prove to be incorrect for several reasons, such as inaccurate reports

or information that we have relied on, potential patients or providers not being amenable to using our CELsignia platform for diagnostic

testing or such patients becoming difficult to identify and access, limited reimbursement for companion diagnostics, pricing pressure

due to availability of alternative diagnostic tests, or an inability of the CELsignia tests’ companion drugs to obtain the necessary

regulatory approvals for new indications.

If any or all of our assumptions and estimates prove inaccurate, we and our companion diagnostic

pharmaceutical partners may not attain our business, operational and financial goals.

expected selling price range of our CELsignia tests is an estimate.

We have not yet sold any such tests and the actual price we are able

to charge may be substantially lower than our expected price range.

have estimated the selling price range of our CELsignia tests based on the pricing of other diagnostic tests currently available and

assumptions regarding the efficacy and market acceptance of our tests.

We have not yet sold our CELsignia tests and cannot be certain

of the actual price we may be able to charge.

The availability and price of our competitors’ products could limit the demand and

the price we are able to charge.

We may not achieve our business plan if acceptance is inhibited by price competition, if pharmaceutical

companies refuse to pay our expected prices for CELsignia tests in clinical trials, if physicians are reluctant to switch from other

diagnostic tests to our CELsignia tests or if physicians switch to other new products or choose to reserve our CELsignia tests for use

in limited circumstances.

Furthermore, reductions in the reimbursement rate of third-party payors have occurred and may occur in the

Each of these factors could cause our selling price to be substantially lower than expected, and we may fail to generate revenue

or become profitable.

insurance coverage and reimbursement status of new diagnostic products is uncertain.

Failure to obtain or maintain adequate coverage

and reimbursement for CELsignia tests could limit our ability to market those CELsignia tests and decrease our ability to generate revenue.

availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford expensive

diagnostic tests and treatments.

Sales of any of our potential CELsignia tests will depend substantially, both in the United States and

internationally, on the extent to which the costs of our CELsignia tests will be paid by health maintenance, managed care, and similar

healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers

and other third-party payors.

Reimbursement by a payor may depend on a number of factors, including a payor’s determination that

the CELsignia tests are neither experimental nor investigational, appropriate for the specific patient, cost-effective, supported by

peer-reviewed publications, and included in clinical practice guidelines.

reimbursement is not available, or is available only to a limited amount, we may not be able to successfully commercialize our CELsignia

tests at expected levels, or potentially at all.

Even if coverage is provided, the approved reimbursement amount may not be high enough

to allow us to establish or maintain pricing sufficient to realize a sufficient return on our research and development investment.

is significant uncertainty related to the insurance coverage and reimbursement of newly approved diagnostic products.

In the United States,

the principal decisions about reimbursement for new diagnostic products and services are typically made by CMS.

CMS decides whether and

to what extent a new product or service will be covered and reimbursed under Medicare.

Private payors tend to follow CMS to a substantial

As such, a significant portion of our potential revenue depends on CMS approving coverage and reimbursement of our CELsignia

the United States, international operations are generally subject to extensive governmental price controls and other market regulations,

and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to

put pressure on the pricing and usage of diagnostic tests such as our potential CELsignia tests.

In many countries, particularly the

countries of the European Union, the prices of medical products are subject to varying price control mechanisms as part of national health

In these countries, pricing negotiations with governmental authorities can take considerable time.

To obtain reimbursement or

pricing approval in some countries, we may be required to demonstrate the cost-effectiveness of our CELsignia tests relative to other

available diagnostic tests.

The prices of products under such systems may be substantially lower than in the United States.

Other countries

allow companies to fix their own prices for products but monitor and control company profits.

Additional foreign price controls or other

changes in pricing regulation could restrict the amount that we are able to charge for our CELsignia tests.

Accordingly, in markets outside

the United States, the reimbursement for our potential CELsignia tests may be reduced compared with the United States and may be insufficient

to generate commercially reasonable revenue and profit.

increasing efforts by governmental and third-party payors, in the United States and internationally, to cap or reduce healthcare costs

may cause such organizations to limit both coverage and level of reimbursement for new products approved and, as a result, they may not

cover or provide adequate payment for our potential CELsignia tests.

The downward pressure on healthcare costs in general, particularly

prescription drugs and surgical procedures and other treatments, has become very intense.

We expect to experience pricing pressures in

connection with the sale of any CELsignia tests due to the trend toward managed healthcare, the increasing influence of health maintenance

organizations and additional legislative changes.

may encounter difficulties in commercializing and marketing our CELsignia products, including in hiring and retaining a qualified sales

order to commercialize any CELsignia test, we must build marketing, sales, managerial and other non-technical capabilities or make arrangements

with third parties to perform these services, and we may not be successful in doing so.

For each CELsignia test we develop, we intend

to pursue development agreements with the pharmaceutical companies that provide matching targeted therapies.

Once we have completed the

analytical validation of a CELsignia test, we plan to target KOLs to build product awareness.

Once we have clinical validation data available,

we expect to expand our sales and marketing efforts to target the broader market and coordinate our go-to-market activities with those

of our partner pharmaceutical companies.

These activities will be expensive and time consuming and will require significant attention

of our executive officers to manage.

In particular, there is intense competition for qualified sales personnel and our inability to hire

or retain an adequate number of sales representatives could limit our ability to maintain or expand our business and increase sales.

Furthermore, there is no guarantee that any new drug indications will require our CELsignia tests as a companion diagnostic or that any

pharmaceutical company will effectively coordinate sales and marketing activities with us.

Any failure or delay in these activities,

including if we are unable to develop our marketing and sales networks or if our sales personnel do not perform as expected, would adversely

impact the commercialization our CELsignia platform, and our business, financial condition, results of operations and prospects may be

materially and adversely affected.

face significant competition from other diagnostic companies and our operating results will suffer if we fail to compete effectively.

diagnostic testing industry is intensely competitive.

We have competitors both in the United States and abroad, including universities

and other research institutions and providers of diagnostics that focus on developing genomic or proteomic analyses of a patient’s

diseased cells or theranostic tests to predict specific patient responses to a drug therapy.

Many of our competitors have substantially

greater financial, technical and other resources, such as larger research and development staff and well-established marketing and sales

Our competitors may succeed in developing, acquiring or licensing, on an exclusive basis, products or services that are more

effective or less costly than the CELsignia tests that we are currently developing or that we may develop.

In addition, established medical

technology, biotechnology and/or pharmaceutical companies may invest heavily to accelerate discovery and development of diagnostic tests

that could make our CELsignia tests less competitive.

ability to compete successfully will depend largely on our ability to:

and develop CELsignia tests for cancer sub-types that are superior to other products in the market;

compelling advantages in the efficacy and convenience of our CELsignia tests on a cost competitive basis;

qualified scientific, product development and commercial personnel;

and maintain patent and other proprietary protection as necessary for our CELsignia platform;

required U.S.

and international regulatory approvals;

collaborate with research institutions and pharmaceutical companies in the discovery, development and commercialization of our current

and future CELsignia tests;

expand our operations and build a sales force to support commercialization.

our sole laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed.

do not have redundant laboratory facilities.

We perform all of our diagnostic services in our laboratory located in Minneapolis, Minnesota.

Our facility and the equipment we use to perform our tests would be costly to replace and could require substantial lead time to repair

The facility may be harmed or rendered inoperable by physical damage from fire, floods, tornadoes, power loss, telecommunications

failures, break-ins and similar events, which may render it difficult or impossible for us to perform our tests for some period of time.

The inability to perform our tests may result in the loss of customers or harm our reputation, and we may be unable to regain those customers

in the future.

Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be

sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

order to rely on a third party to perform our tests, we could only use another facility with established state licensure and CLIA accreditation

under the scope of which our potential CELsignia tests could be performed following validation and other required procedures.

assure you that we would be able to find another CLIA-certified facility willing to adopt CELsignia tests and comply with the required

procedures, or that this laboratory would be willing to perform the tests for us on commercially reasonable terms.

instrument or reagent suppliers may fail to meet our quality requirements for the items we purchase or fail to provide a continuous supply

of the items we utilize to perform our CELsignia tests.

utilize highly specialized reagents and instruments to perform our CELsignia tests.

We may be unable to find suitable replacement reagents

and instruments on a timely basis, if at all.

Interruption in the supply of these items or degradation in their quality could delay analytical

and clinical studies, and/or render us unable to deliver CELsignia tests.

This would interrupt sales and adversely affect our business,

results of operations and financial condition.

issues or price increases by our shipping carriers could adversely affect our business, results of operations and financial condition,

and harm our reputation and ability to provide our CELsignia tests on a timely basis.

reliable shipping is essential to our operations.

Should our shipping carrier encounter delivery performance issues such as loss, damage

or destruction of a sample, such occurrences may damage our reputation and lead to decreased demand for our services and increased cost

and expense to our business.

In addition, any significant increase in shipping rates could adversely affect our operating margins and

results of operations.

Similarly, strikes, severe weather, natural disasters or other service interruptions by delivery services we use

would adversely affect our ability to receive and process patient samples on a timely basis.

There are only a few providers of overnight

nationwide transport services, and there can be no assurance that we will be able to maintain arrangements with providers on acceptable

terms, if at all.

CELsignia tests represent a novel approach to companion diagnostics, which could result in heightened regulatory scrutiny, delays in

clinical development, or delays in our ability to commercialize any products.

unique and proprietary CELsignia technology is the first cancer diagnostic platform we are aware of that can detect the underlying signaling

dysfunction driving a patient’s cancer.

Because this is a novel approach to companion diagnostics, there can be no assurance as

to the length of a clinical trial period, the number of patients the FDA or another applicable regulatory authority will require to be

enrolled in the trials in order to establish the safety and efficacy of our CELsignia tests and the companion drugs, or that the data

generated in these trials will be acceptable to the FDA or another applicable regulatory authority to support marketing approval of new

indications for the companion drugs.

This could delay or prohibit our clinical trials and/or commercialization of our CELsignia tests.

If we are slow or unable to adapt to changes

in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we

may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

success with CELsignia is heavily dependent on the success of our first CELsignia trials and on finding appropriate pharmaceutical company

success of our CELsignia tests depends on our ability to attract pharmaceutical company partnerships that provide revenue from the sale

of CELsignia tests during clinical trials, from milestone payments during clinical trials, from sales of our CELsignia tests as companion

diagnostics or stand-alone tests thereafter, and, potentially, from royalties on the incremental drug revenues our tests enable.

ability to obtain such partnerships and generate such revenue depends in part on the ability of our first CELsignia tests to demonstrate

the potential incremental opportunity available for pharmaceutical companies, as well as our ability to establish strategic partnerships

or other arrangements with suitable pharmaceutical companies.

2 trials are underway to evaluate the efficacy and safety of these therapies in CELsignia selected patients.

We do not expect to receive

final results from our FACT-1 trial until the first half of 2025.

The FACT-2 trial, which was evaluating patients with early-stage triple

negative breast cancer, was terminated in the third quarter of 2023.

This decision was made in response to recent FDA approvals of new

therapeutic options for patients with early-stage triple negative breast cancer.

The availability of these new therapeutic options negatively

impacted enrollment, which led us to conclude that the study was no longer feasible.

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, 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.

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.

the FDA were to begin regulating our tests, we could incur substantial costs and delays associated with trying to obtain premarket clearance

LDTs are not currently subject to FDA regulation, although reagents, instruments, software or components provided by third parties and

used to perform LDTs may be subject to regulation.

We believe that the CELsignia tests are LDTs, which is a term that describes tests

that are designed and performed within a single laboratory.

As a result, we believe the CELsignia tests are not currently subject to

regulation by the FDA in accordance with the FDA’s current policy of exercising enforcement discretion regarding LDTs.

Historically,

the FDA has not required laboratories that furnish only LDTs to comply with the agency’s requirements for medical devices (e.g.,

establishment registration, device listing, quality systems regulations, premarket clearance or premarket approval, and post-market controls).

In mid-2014, the FDA published a draft Guidance Document describing a proposed approach for a regulatory framework for LDTs, but in late

2016, the FDA indicated it did not intend to finalize the LDT Guidance Document at that time.

It is not clear when or if the FDA will

seek to alter the current LDT regulatory framework in the future.

We cannot provide any assurance that FDA regulation, including premarket

review, will not be required in the future for our tests, whether through additional guidance issued by the FDA, new enforcement policies

adopted by the FDA or new legislation enacted by Congress.

We cannot predict with certainty the timing or content of future legislation

enacted or guidance issued regarding LDTs, or how it will affect our business.

laboratory developed tests (“LDTs”) are not currently subject to FDA regulation, although reagents, instruments, software

or components provided by third parties and used to perform LDTs may be subject to regulation.

We believe that the CELsignia tests are

LDTs, which is a term that describes tests that are designed and performed within a single laboratory.

As a result, we believe the CELsignia

tests are not currently subject to regulation by the FDA in accordance with the FDA’s current policy of exercising enforcement

discretion regarding LDTs.

is not clear when or if the FDA will seek to alter the current LDT regulatory framework in the future.

We cannot provide any assurance

that FDA regulation, including premarket review, will not be required in the future for our tests, whether through additional guidance

issued by the FDA, new enforcement policies adopted by the FDA or new legislation enacted by Congress.

We cannot predict with certainty

the timing or content of future legislation enacted or guidance issued regarding LDTs, or how it will affect our business.

premarket review is required by the FDA at a future date or if we decide to voluntarily pursue FDA premarket review of our CELsignia

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to support continued adoption of and reimbursement for our CELsignia tests.

If our CELsignia tests are allowed to remain on the market

but there is uncertainty in the marketplace about our tests, if they are labeled investigational by the FDA, or if labeling claims the

FDA allows us to make are more limited than we expect, reimbursement may be adversely affected and we may not be able to sell our CELsignia

Compliance with FDA regulations would increase the cost of conducting our business and subject us to heightened regulation and

scrutiny by the FDA and penalties for failure to comply with these requirements.

Compliance with FDA regulations would increase the cost of

conducting our business and subject us to heightened regulation and scrutiny by the FDA and penalties for failure to comply with these

requirements.

we fail to obtain required federal and state laboratory licenses, we could lose the ability to perform our tests.

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our CELsignia tests.

Risks Related to Intellectual Property

we are unable to obtain and maintain intellectual property protection for our CELsignia technology, or if the scope of the intellectual

property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and diagnostic tests

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 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.

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;

scope of any existing or future patent protection may not exclude competitors or provide competitive advantages to us;

patents may not be held valid if subsequently challenged;

parties may claim that our products and designs infringe the proprietary rights of others, and even if we are successful in defending

our patents and proprietary rights, such litigation may be costly;

parties may develop similar products, duplicate our products, or design around our patents.

patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, maintain, enforce or license all

necessary or desirable patent applications at a reasonable cost or in a timely manner, or in all jurisdictions.

We may choose not to

seek patent protection for certain innovations and may choose not to pursue patent protection in certain jurisdictions, and under the

laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope.

It is also possible

that we will fail to identify patentable aspects of our discovery and nonclinical development output before it is too late to obtain

patent protection.

patent position of companies like ours is highly uncertain, involves complex legal and factual questions and has in recent years been

the subject of much litigation.

Patent and Trademark Office, or U.S.

PTO, has not established a consistent policy regarding

the breadth of claims that it will allow in medical technology patents.

In addition, the laws of foreign jurisdictions may not protect

our rights to the same extent as the laws of the United States.

For example, India and China do not allow patents for methods of treating

the human body.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications

in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all.

we cannot know with certainty whether we were the first to make the inventions claimed in our owned or licensed patents or pending patent

applications, or that we were the first to file for patent protection of such inventions.

As a result, the issuance, scope, validity,

enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent applications may not result

in patents being issued that protect our technology or CELsignia tests, in whole or in part, or which effectively prevent others from

commercializing competitive technologies and diagnostic tests.

Changes in either the patent laws or interpretation of the patent laws

in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

we may be subject to a third-party pre-issuance submission of prior art to the U.S.

PTO or patent offices in foreign jurisdictions, or

become involved in opposition, derivation, reexamination, inter parties review, post-grant review or interference proceedings challenging

our patent rights or the patent rights of others.

An adverse determination in any such submission, proceeding or litigation could reduce

the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology and compete directly with us, without

payment to us, or result in our inability to commercialize CELsignia platform without infringing third-party patent rights.

if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from

collaborating with us to develop or commercialize current or future CELsignia tests.

if our owned patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection,

prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be able to circumvent

our owned patents by developing similar or alternative technologies or products in a non-infringing manner.

issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned patents may be challenged

in the courts or patent offices in the United States and abroad.

Such challenges may result in loss of exclusivity or freedom to operate

or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others

from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection

of our technology and potential diagnostic tests.

Given the amount of time required for the development, testing and regulatory review

of new diagnostic tests, patents protecting such tests might expire before or shortly after such candidates are commercialized.

result, our owned patent portfolio may not provide us with sufficient rights to exclude others from commercializing diagnostic tests

similar or identical to ours.

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

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

commercial success of CELsignia tests depends upon our ability, and the ability of our collaborators, to develop, manufacture, market

and sell our CELsignia tests and use our proprietary technologies without infringing the proprietary rights of third parties.

considerable intellectual property litigation in the medical technology, biotechnology and pharmaceutical industries.

We may become party

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

platform, including interference or derivation proceedings before the U.S.

PTO and similar bodies in other jurisdictions.

Third parties

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

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 and marketing our CELsignia platform and CELsignia tests.

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 commercializing

the infringing technology or product.

In addition, we could be found liable for monetary damages, including treble damages and attorneys’

fees if we are found to have willfully infringed a patent.

A finding of infringement could prevent us from commercializing our CELsignia

platform or force us to cease some of our business operations, which could materially harm our business.

Claims that we have misappropriated

the confidential information or trade secrets of third parties could have a similar negative impact on our business.

we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our CELsignia platform could

be significantly diminished.

Related to Intellectual Property

depend on intellectual property licensed from third parties, including from Pfizer for our lead product candidate, and termination of

this license could result in the loss of significant rights, which would harm our business.

are dependent on patents, know-how and proprietary technology, both our own and licensed from others.

All patents covering gedatolisib

and any combination therapies using our product candidates are licensed from third parties.

Any termination of a product license could

result in the loss of significant rights and would cause material adverse harm to our ability to commercialize our product candidates.

may also arise between us and our licensors regarding intellectual property subject to a license agreement, including:

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

and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the

licensing agreement;

right to sublicense patent and other rights to third parties under collaborative development relationships;

diligence obligations with respect to the use of licensed technology in relation to our development and commercialization of our

product candidates and what activities satisfy those diligence obligations;

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

our partners.

disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements

on acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates.

are generally also subject to all of the same risks with respect to protection of intellectual property that we own, as we are for intellectual

property that we license.

If we or our licensors fail to adequately protect this intellectual property, our ability to commercialize

products could materially suffer.

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 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.

We may have limited control over the maintenance and prosecution of these in-licensed rights, activities or any

other intellectual property that may be related to our in-licensed intellectual property.

For example, we cannot be certain that such

activities by these licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid

and enforceable patents and other intellectual property rights.

We have limited control over the manner in which our licensors initiate

an infringement proceeding against a third-party infringer of the intellectual property rights, or defend certain of the intellectual

property that is licensed to us.

It is possible that the licensors’ infringement proceeding or defense activities may be less vigorous

than had we conducted them ourselves.

may not be successful in obtaining or maintaining necessary rights to develop any future product candidates on acceptable terms.

clinical trials and other programs currently, and may in the future, involve additional product candidates that require the use of, or

reliance on, proprietary rights held by third parties.

Accordingly, the growth of our business depends in part on our ability to acquire,

in-license or use these proprietary rights.

We may be unable to acquire or in-license any compositions, methods of use, processes or

other third-party intellectual property rights from third parties that we identify as necessary or important to our business operations.

We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all, which could harm our business.

may need to cease use of the compositions or methods covered by such third-party intellectual property rights, and may need to seek to

develop alternative approaches that do not infringe on such intellectual property rights which may entail additional costs and development

delays, even if we were able to develop such alternatives, which may not be feasible.

Even if we are able to obtain a license, it may

be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.

In that event, we may be required to

expend significant time and resources to develop or license replacement technology.

licensing and acquisition of third-party intellectual property rights is a competitive area, and companies that may be more established

or have greater resources than we do may also be pursuing strategies to license or acquire third-party intellectual property rights that

we may consider necessary or attractive in order to commercialize our product candidates.

More established companies may have a competitive

advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

no assurance that we will be able to successfully complete such negotiations and ultimately acquire the rights to the intellectual property

surrounding the additional product candidates that we may seek to acquire.

we are not able to prevent disclosure of our trade secrets and other proprietary information, the value of our products could be significantly

rely on trade secret protection to protect our interests in proprietary know-how and in processes for which patents are difficult to

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could harm our competitive position.

may be subject to claims by employees claiming ownership of what we regard as our own intellectual property.

it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute

agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact

develops intellectual property that we regard as our own.

Our and their assignment agreements may not be self-executing or may be breached,

and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of

what we regard as our intellectual property.

If we fail in prosecuting or defending any such claims, in addition to paying monetary damages,

we may lose valuable intellectual property rights or personnel.

Even if we are successful in prosecuting or defending against such claims,

litigation could result in substantial costs and be a distraction to management.

we are unable to obtain and maintain intellectual property protection for our CELsignia technology, or if the scope of the intellectual

property protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and diagnostic tests

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

have applied for patents that protect our CELsignia technology and our patent portfolio currently includes seven issued U.S.

and more than 30 issued international patents.

We cannot ensure that our intellectual property position will not be challenged or

that all patents for which we have applied will be granted.

We cannot know with certainty whether we were the first to make the

inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent

protection of such inventions.

patent prosecution process is expensive and time-consuming, and we may not be able to file, prosecute, maintain, enforce or license all

necessary or desirable patent applications at a reasonable cost or in a timely manner, or in all jurisdictions.

We may choose not to

seek patent protection for certain innovations and may choose not to pursue patent protection in certain jurisdictions, and under the

laws of certain jurisdictions, patents or other intellectual property rights may be unavailable or limited in scope.

Additionally, the

laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce

our existing patents and patents that we might obtain in the future.

There also may be patent reforms in foreign jurisdictions that could

increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued

patents in those jurisdictions.

It is also possible that we will fail to identify patentable aspects of our discovery and nonclinical

development output before it is too late to obtain patent protection.

a result of these factors, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain.

Our pending and future patent applications may not result in patents being issued that protect our technology or CELsignia tests, in

whole or in part, or which effectively prevent others from commercializing competitive technologies and diagnostic tests.

Moreover, given

the amount of time required for the development, testing and regulatory review of new diagnostic tests, patents protecting such tests

might expire before or shortly after such candidates are commercialized.

As a result, our owned patent portfolio may not provide us with

sufficient rights to exclude others from commercializing diagnostic tests similar or identical to ours.

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

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

commercial success of our products depends upon our ability to use proprietary technologies without infringing the proprietary rights

of third parties.

There is considerable intellectual property litigation in the medical technology, biotechnology and pharmaceutical

We may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property

rights with respect to our products.

Additionally, because current and future employees may have been previously employed at universities

or other biotechnology, diagnostic technology or pharmaceutical companies, including our competitors or potential competitors and strategic

partners, third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future,

or they may allege that our employees or we have used or disclosed intellectual property, including trade secrets or other proprietary

information, of any such employee’s former employer.

Litigation may be necessary to defend against these claims.

litigation could result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable,

in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical technology and product

candidates, or limit the duration of the patent protection of our technology and potential diagnostic tests.

If we are found to infringe

a third party’s intellectual property rights, we could be required to obtain additional licenses from such third party to continue

developing and marketing our applicable products.

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 commercializing the infringing technology or product.

addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully

infringed a patent.

A finding of infringement could prevent us from commercializing our products or force us to cease some of our business

operations, which could materially harm our business.

Claims that we have misappropriated the confidential information or trade secrets

of third parties could have a similar negative impact on our business.

lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly

and time consuming and could be unsuccessful.

competition in our industry is intense, competitors may infringe or otherwise violate our issued patents, patents of our licensors or

other intellectual property.

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be

expensive and time consuming, and could distract our technical and management personnel from their normal responsibilities.

we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their

In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole

or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds

that our patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of our

patents at risk of being invalidated or interpreted narrowly.

We may also elect to enter into license agreements in order to settle patent

infringement claims or to resolve disputes prior to litigation, and any such license agreements may require us to pay royalties and other

fees that could be significant.

Furthermore, because of the substantial amount of discovery required in connection with intellectual

property litigation, there is a risk that some of our confidential information could be compromised by disclosure.

Related to Our Reliance on Third Parties

rely on third parties to conduct certain aspects of our preclinical studies and clinical trials.

If these third parties do not successfully

carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory

approval for, or commercialize, any potential product candidates.

depend upon third parties to execute our operational plans and to conduct certain aspects of our preclinical studies.

Additionally, we

depend on third parties, including independent investigators, to conduct our clinical trials, under agreements with universities, medical

institutions, contract research organizations, or CROs, strategic partners and others.

Our reliance on third parties may affect our development

timelines and increase our costs.

have limited control over third-party clinical investigators and limited visibility into their day-to-day activities, including with

respect to their compliance with the approved clinical protocol.

Nevertheless, we are responsible for ensuring that each of our clinical

trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards.

third parties are required to comply with GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign

regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these GCP requirements through

periodic inspections of clinical trial sponsors, clinical investigators and clinical trial sites.

If we or any of these third parties

fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the

FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials or perform additional preclinical

studies or clinical trials before approving our marketing applications.

Moreover, our business may be adversely affected 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 aspects of our preclinical studies or our clinical trials will not be our employees and, except for remedies

that may be available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time

and resources to our preclinical studies and clinical programs.

These third parties may also have relationships with other commercial

entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which

could affect their performance on our behalf.

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

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

is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our development timelines,

including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, obtain

regulatory approval of or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects

for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed or precluded

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

approval and commercialization of our drug product or result in higher product costs.

have no direct experience in drug formulation or manufacturing and do not intend to establish our own manufacturing facilities.

the resources and expertise to formulate or manufacture our own product candidates.

Instead, we will contract with one or more manufacturers

to manufacture, supply, store and distribute drug supplies for our clinical trials.

If our drug product receives FDA approval, we will

rely on one or more third-party contractors to manufacture our drugs.

Similarly, we rely on instrument and reagent suppliers in connection

with our CELsignia tests.

anticipated future reliance on a limited number of third-party manufacturers exposes us to risks that, among other things, we may be

unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA must

approve any replacement contractor;

our third-party manufacturers might be unable to formulate and manufacture our drugs in the volume

and of the quality required to meet our clinical and/or commercial needs, if any;

our future contract manufacturers may not perform as

agreed or may not remain in the contract manufacturing business for the time required to supply our clinical trials or to successfully

produce, store and distribute our products;

and our contract manufacturers may fail to comply with good manufacturing practice and other

government regulations and corresponding foreign standards.

Each of these risks could delay our clinical trials, the approval, if any,

of our product candidates by the FDA, or the commercialization of our product candidates or result in higher costs or deprive us of potential

product revenues.

pharmaceutical companies that we partner with for our CELsignia tests may not be successful in receiving regulatory approval for drug

indications or may not commercialize their companion therapies for our expected companion diagnostic programs.

can be no assurances that our pharmaceutical partners for our CELsignia tests will be able to obtain regulatory approval for new indications

to treat applicable patient populations or otherwise be successful in commercializing their therapies.

Among other risks, our pharmaceutical

companies we partner with may not meet clinical trial endpoint targets, may encounter regulatory or production delays, may not pursue

commercialization of companion therapeutics, or may terminate their relationship with us.

factors could adversely affect our commercialization strategy for our CELsignia platform, as well as our business, results of operations

and financial condition.

may not be successful in finding pharmaceutical company partners or negotiating favorable terms for continuing development of additional

CELsignia tests.

of the potential partners for CELsignia are global, multi-billion-dollar pharmaceutical companies with sophisticated research and development

organizations and multiple priorities.

We may not be successful in our efforts to establish such a strategic partnership or other alternative

arrangements for our CELsignia tests because, among other things, our research and development pipeline may be insufficient, such tests

may be deemed to be at too early of a stage of development for collaborative effort, or third parties may not view such tests as having

the requisite potential to demonstrate efficacy.

In addition, we may be restricted under collaboration agreements from entering into

future agreements with other partners.

Even if we are able to find suitable partners, we may not be successful in negotiating development

agreements with such partners that provide revenue from the sale of our CELsignia tests, from milestone payments, and/or from royalties

on the incremental drug revenues that our tests enable.

If we are unable to reach agreements with suitable strategic partners on a timely

basis, on acceptable terms or at all, we may have to curtail the development of additional CELsignia tests, our expected revenue opportunities

may be significantly smaller than expected and our business opportunities may be negatively impacted.

issues or price increases by our shipping carriers could adversely affect our business, results of operations and financial condition,

and harm our reputation and ability to provide our products on a timely basis.

reliable shipping is essential to our operations.

Should our shipping carriers encounter delivery performance issues such as loss, damage

or destruction of a sample, such occurrences may damage our reputation and lead to decreased demand for our services and increased cost

and expense to our business.

In addition, any significant increase in shipping rates could adversely affect our operating margins and

results of operations.

Similarly, strikes, severe weather, natural disasters or other service interruptions by delivery services we use

would adversely affect our ability to receive and process patient samples on a timely basis.

There are only a few providers of overnight

nationwide transport services, and there can be no assurance that we will be able to maintain arrangements with providers on acceptable

terms, if at all.

Related to Commercializing Our Products

if our products achieve positive clinical trial results and requisite approvals, they may fail to achieve the degree of market acceptance

by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

any product we develop achieves positive clinical trial results and receives marketing approval, whether on a standalone basis or in

combination with other therapies, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors

and others in the medical community.

For example, existing drug therapies may be viewed as more reliable than gedatolisib, or physicians

may continue to rely on conventional genomic- or proteomic-based analyses to diagnose cancer and prescribe cancer medications, versus

adopting the use of a CELsignia test.

If the product candidates we develop do not achieve an adequate level of acceptance, we may not

generate significant product revenues and we may not become profitable.

The degree of market acceptance of any product candidate, if

approved for commercial sale, will depend on a number of factors, including:

and potential advantages compared to alternatives;

ability to offer our products, if approved, for sale at competitive prices;

and ease of administration compared to other treatments;

willingness of the target patient population to try new therapies or diagnostics and of physicians to prescribe or initiate these

therapies or diagnostics;

strength of marketing and distribution support;

ability to obtain sufficient third-party coverage, market access and adequate reimbursement;

prevalence and severity of any side effects;

CELsignia, our ability to partner with pharmaceutical companies to develop companion diagnostic programs for the new cancer sub-types

our products do not achieve an adequate level of acceptance, we may never generate significant product revenues and we may not become

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.

if we or our partners are successful in obtaining marketing approval, commercial success of any approved products will also depend in

large part on the availability of insurance coverage and adequate reimbursement from third-party payors, including government payors

such as the Medicare and Medicaid programs and managed care organizations in the U.S.

or country specific governmental organizations

in foreign countries.

Government and private payors routinely seek to manage utilization and control costs, and there is considerable

public and government scrutiny of pharmaceutical and diagnostic pricing.

Efforts by states and the federal governments 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.

of reimbursement may be affected by existing and future healthcare reform measures designed to reduce the cost of healthcare, including

the Inflation Reduction Act, which 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.

payors also could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product

and appropriateness for specific patient populations, to qualify for reimbursement, which could be costly and divert our resources.

government and other healthcare payors do not provide coverage and adequate reimbursement for our products once approved, market acceptance

and commercial success would be reduced.

Even if coverage is provided, the approved reimbursement amount may not be high enough to support

pricing that results in a sufficient return on our research and development investment.

expect pricing pressures will continue globally.

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.

may encounter difficulties in scaling production, commercializing, marketing and distributing our products, including in hiring and retaining

a qualified sales force.

order to commercialize any of our products, we must build production, marketing, sales, managerial and other non-technical capabilities

or make arrangements with third parties to perform these services, and we may not be successful in doing so.

Our beliefs that our products

will be commercially viable have not been tested.

These activities will be expensive and time consuming and will require significant

attention of our executive officers to manage.

There are risks involved in establishing our own sales and marketing capabilities, as

well as with entering into arrangements with third parties to perform these services.

particular, there is intense competition for qualified sales personnel and our inability to hire or retain an adequate number of sales

representatives could limit our ability to maintain or expand our business and increase sales.

Furthermore, there is no guarantee that

the market opportunity for gedatolisib will be as significant as we expect or exist at all, or that any new drug indications will require

our CELsignia tests as a companion diagnostic, or that any pharmaceutical company will effectively coordinate sales and marketing activities

with us for our CELsignia tests.

If we are unable to successfully commercialize our products, or if we are delayed in doing so, including

if we are unable to develop our marketing and sales networks or if our sales personnel do not perform as expected, we may never generate

any revenue and our business may fail.

business, operational and financial goals may not be attainable if the market opportunities for our products are smaller than we expect.

Our internal research and estimates on market opportunities have not been verified by independent sources, and we have not independently

verified market and industry data from third parties that we have relied on.

total market opportunities that we believe exist are based on a variety of assumptions and estimates, including the size of the addressable

patient population in applicable jurisdictions, the penetration of other drugs in these markets, the number of potential companion diagnostic

programs we will be able to successfully pursue, the amount of potential milestone payments that we could receive in companion diagnostic

programs, the number of patients we will test in clinical trials, the price we will be able to charge for our products and the total

annual number of cancer patients with undiagnosed abnormal cell signaling.

In addition, we have relied on third-party publications, research,

surveys and studies for information related to determining market opportunities, including without limitation, information on the number

of cancer patients and those receiving various forms of treatment, the cost of drug therapy, the amount of revenue generated from various

types of drug therapy, the objective response rates of drug therapies, the number of deaths caused by cancer and the expected growth

in cancer drug therapy and diagnostic markets.

Our internal research and estimates on market opportunities have not been verified by

independent sources, and we have not independently verified market and industry data from third parties that we have relied on.

all of our assumptions and/or estimates may prove to be incorrect for several reasons, such as inaccurate reports or information that

we have relied on, potential patients or providers not being amenable to using our products or such patients becoming difficult to identify

and access, limited reimbursement for our products, pricing pressure due to availability of alternative drugs or diagnostic tests, or

an inability of the CELsignia tests’ companion drugs to obtain the necessary regulatory approvals for new indications.

all of our assumptions and estimates prove inaccurate, we may not attain our business, operational and financial goals.

our sole laboratory facility becomes inoperable, we will be unable to perform our CELsignia tests and our business will be harmed.

do not have redundant laboratory facilities.

We perform all of our diagnostic services in our laboratory located in Minneapolis, Minnesota.

Our facility and the equipment we use to perform our tests would be costly to replace and could require substantial lead time to repair

The facility may be harmed or rendered inoperable by physical damage from fire, floods, tornadoes, power loss, telecommunications

failures, break-ins and similar events, which may render it difficult or impossible for us to perform our tests for some period of time.

The inability to perform our tests may result in the loss of customers or harm our reputation, and we may be unable to regain those customers

in the future.

Although we possess insurance for damage to our property and the disruption of our business, this insurance may not be

sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

order to rely on a third party to perform our tests, we could only use another facility with established state licensure and CLIA accreditation

under the scope of which our potential CELsignia tests could be performed following validation and other required procedures.

assure you that we would be able to find another CLIA-certified facility willing to adopt CELsignia tests and comply with the required

procedures, or that this laboratory would be willing to perform the tests for us on commercially reasonable terms.

Risks Related to Government Regulation for Our Business

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portion of the data that we obtain and handle for or on behalf of our clients is considered protected health information, or PHI, subject

Under HIPAA and our contractual agreements with our HIPAA-covered entity health plan customers, we are considered a “business

Under HIPAA and our contractual agreements with our HIPAA-covered entity health plan customers, we may be considered a “business

associate” to those customers and are required to maintain the privacy and security of PHI in accordance with HIPAA and the terms

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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

addition to PHI, we collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of,

transmit and share (collectively, process) personal data and other sensitive information.

Accordingly, we are, or may become, subject

to numerous federal, state, local and foreign privacy and security laws regulating the collection, use, safeguarding, transfer and other

processing of information.

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 Economic

Area (the “EEA”), including personal health data, is subject to the EU General Data Protection Regulation (the “GDPR”),

which 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.

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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

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.

actions are either in place or underway in the United States.

For example, the California Consumer Privacy Act of 2018 (the

“CCPA”) applies to personal information of consumers, business representatives, and employees, and requires covered

businesses to provide specific disclosures related to a business’s processing of personal data, new operational practices, and

requirements to respond to certain requests from California residents related to their personal data.

There is uncertainty about how

the CCPA and other similar laws may be implemented and applied, and inconsistencies across jurisdictions complicate our compliance

Accordingly, the CCPA and other similar laws may impact our business activities and increase our compliance costs, as well

as our legal risks.

The 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.

data privacy regulations 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.

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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be disqualified from providing services to healthcare providers doing business with government programs.

Related to Our Reliance on Third Parties

will rely on third parties to conduct certain aspects of our preclinical studies and clinical trials.

If these third parties do not successfully

carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory

approval for, or commercialize, any potential product candidates.

will depend upon third parties to conduct certain aspects of our preclinical studies and depend on third parties, including independent

investigators, to conduct our clinical trials, under agreements with universities, medical institutions, contract research organizations,

or CROs, strategic partners and others.

We expect to negotiate budgets and contracts with such third parties, which may result in delays

to our development timelines and increased costs.

continue to build our infrastructure and hire personnel necessary to execute our operational plans.

We will rely especially heavily on

third parties over the course of our clinical trials, and, as a result, may have limited control over the clinical investigators and

limited visibility into their day-to-day activities, including with respect to their compliance with the approved clinical protocol.

Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol,

legal and regulatory requirements 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 GCP requirements, which are regulations and guidelines enforced by the FDA and

comparable foreign regulatory authorities for product candidates in clinical development.

Regulatory authorities enforce these GCP requirements

through periodic inspections of clinical trial sponsors, clinical investigators and clinical trial sites.

If we or any of these third

parties fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable

and the FDA or comparable foreign regulatory authorities may require us to suspend or terminate these trials or perform additional preclinical

studies or clinical trials before approving our marketing applications.

We cannot be certain that, upon inspection, such regulatory authorities

will determine that any of our clinical trials comply with GCP requirements.

In addition, our clinical trials must be conducted with

product produced under cGMP requirements and may require a large number of patients.

failure or any failure by these third parties to comply with these regulations may require us to repeat clinical trials, which would

delay the regulatory approval process.

Moreover, our business may be adversely affected 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 aspects of our preclinical studies or our clinical trials will not be our employees and, except for remedies

that may be available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time

and resources to our preclinical studies and clinical programs.

These third parties may also have relationships with other commercial

entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which

could affect their performance on our behalf.

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

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

is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our development timelines,

including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, obtain

regulatory approval of or successfully commercialize our product candidates.

As a result, our financial results and the commercial prospects

for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed or precluded

pharmaceutical companies that we partner with may not be successful in receiving regulatory approval for drug indications or may not

commercialize their companion therapies for our expected companion diagnostic programs.

we intend to provide our pharmaceutical company partners with new patient populations for such partners’ existing or investigational

targeted therapies, there can be no assurances that such partners will be able to obtain regulatory approval for new indications to treat

these patient populations or otherwise be successful in commercializing these new therapies.

The pharmaceutical companies we partner

not meet clinical trial endpoint targets in evaluating efficacy of a targeted therapy in the patient population;

encounter regulatory or production difficulties that could constrain the supply of the companion therapies;

have difficulties gaining acceptance of the use of the companion therapies in the clinical community;

not pursue commercialization of any companion therapies;

elect not to continue or renew commercialization programs based on changes in their strategic focus or available funding, or external

factors, such as an acquisition, that divert resources or create competing priorities;

not commit sufficient resources to the marketing and distribution of such companion therapies;

terminate their relationship with us.

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,

regulatory approval and commercialization of our drug product or result in higher product costs.

have no direct experience in drug formulation or manufacturing and do not intend to establish our own manufacturing facilities.

the resources and expertise to formulate or manufacture our own product candidates.

Instead, we will contract with one or more manufacturers

to manufacture, supply, store and distribute drug supplies for our clinical trials.

If our drug product receives FDA approval, we will

rely on one or more third-party contractors to manufacture our drugs.

Our anticipated future reliance on a limited number of third-party

manufacturers exposes us to risks that, among other things, we may be unable to identify manufacturers on acceptable terms or at all

because the number of potential manufacturers is limited and the FDA must approve any replacement contractor;

our third-party manufacturers

might be unable to formulate and manufacture our drugs in the volume and of the quality required to meet our clinical and/or commercial

needs, if any;

our future contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for

the time required to supply our clinical trials or to successfully produce, store and distribute our products;

and our contract manufacturers

may fail to comply with good manufacturing practice and other government regulations and corresponding foreign standards.

Each of these

risks could delay our clinical trials, the approval, if any, of our product candidates by the FDA, or the commercialization of our product

candidates or result in higher costs or deprive us of potential product revenues.

reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement

or defense of our issued patents.

September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law.

The Leahy-Smith Act includes a

number of significant changes to U.S.

These include provisions that affect the way patent applications are prosecuted and

may also affect patent litigation.

PTO recently developed new regulations and procedures to govern administration of the Leahy-Smith

Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions,

only became effective on March 16, 2013.

Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation

of our business.

However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution

of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on

our business and financial condition.

Depending on future actions by the U.S.

Congress, the federal courts, and the U.S.

PTO, the laws

and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce

our existing patents and patents that we might obtain in the future.

In addition, there may be patent law reforms in foreign jurisdictions

that could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense

of our issued patents in those foreign jurisdictions.

may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming

ownership of what we regard as our own intellectual property.

current and future employees may have been previously employed at universities or other biotechnology, diagnostic technology or pharmaceutical

companies, including our competitors or potential competitors and strategic partners.

Although we try to ensure that our employees do

not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these employees or we

have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s

former employer.

Litigation may be necessary to defend against these claims.

addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property

to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party

who in fact develops intellectual property that we regard as our own.

Our and their assignment agreements may not be self-executing or

may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine

the ownership of what we regard as our intellectual property.

we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property

rights or personnel.

Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial

costs and be a distraction to management.

lawsuits relating to infringement of intellectual property rights necessary to defend ourselves or enforce our rights will be costly

and time consuming and could be unsuccessful.

competition in our industry is intense, competitors may infringe or otherwise violate our issued patents, patents of our licensors or

other intellectual property.

To counter infringement or unauthorized use, we may be required to file infringement claims, which can be

expensive and time consuming, and could distract our technical and management personnel from their normal responsibilities.

we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their

In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole

or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds

that our patents do not cover the technology in question.

An adverse result in any litigation proceeding could put one or more of our

patents at risk of being invalidated or interpreted narrowly.

We may also elect to enter into license agreements in order to settle patent

infringement claims or to resolve disputes prior to litigation, and any such license agreements may require us to pay royalties and other

fees that could be significant.

Furthermore, because of the substantial amount of discovery required in connection with intellectual

property litigation, there is a risk that some of our confidential information could be compromised by disclosure.

Relating to Our Common Stock

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success of competitive products or technologies;

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;

of existing or future clinical trials;

or legal developments in the United States and other countries;

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recruitment or departure of key personnel;

level of expenses related to any of our CELsignia tests or clinical development programs;

level of expenses related to any of our products or clinical development programs;

or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;

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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.

Since December 2022, we have issued

1,034,500 shares of common stock pursuant to equity financing arrangements, including pursuant to our 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.

At December 31, 2023, $29.8 million of common stock remains available

for sale under the Jefferies agreement.

We may enter into additional equity financing arrangements in the future.

The shares of common

stock that we have issued pursuant to equity financings, or may issue in the future, may be resold at any time in the discretion of the

addition, an aggregate of 21,552,860 shares of common stock are issuable upon conversion or exercise of currently outstanding preferred

stock and financing warrants, subject to certain beneficial ownership limitations, which the investors may subsequently resell into the

market, and 2,815,392 shares of common stock are issuable upon exercise of awards granted under our 2017 Stock Incentive Plan and 2012

Equity Incentive Plan.

Under our Innovatus Loan Agreement, Innovatus also has the right, at its election, to convert up to $6.6 million

of outstanding principal of our Innovatus loans into common stock at a price of $10.00 per share.

Based on our outstanding principal

as of March 27, 2024, Innovatus has the right to acquire 300,000 shares of common stock pursuant to this provision.

of substantial amounts of shares of our common stock or other securities by these investors or our other stockholders or by us under

the Open Market Sale Agreement SM , 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, 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.

issued 1,120,873 shares of Series A Preferred Stock in a financing transaction in December 2022, and 854,134 shares of Series A Preferred

Stock were outstanding as of December 31, 2023.

The 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.

The 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,

8 unchanged sentences

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

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, 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.

incur increased costs as a result of operating as a public company, and our management devotes substantial time to new compliance initiatives

and corporate governance practices.

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

company competitors do not incur.

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 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 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

7 unchanged sentences

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