What changed in this filing

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Item 1A. Risk Factors

2023-05-15 compared with 2022-11-10 · 9 added, 1390 removed, 4 unchanged (100% of the section changed)

factors that could cause actual results to differ from our expectations and that could negatively impact our financial condition and

results of operations are summarized and discussed in more detail below, in each case including certain updates from those set forth

in our Quarterly Report for the period ended March 31, 2022.

Additional risks and uncertainties not presently known to us or that are

currently not believed to be significant to our business may also affect our actual results and could harm our actual business, financial

condition and/or operating results.

of Risk Factors

have a limited operating history and we may never generate revenue or profit;

inability to raise additional capital on acceptable terms in the future may limit our ability

to develop and commercialize our integrated therapeutic (Rx) and companion diagnostic (CDx)

are currently conducting and will continue to conduct clinical trials.

Clinical trials are

expensive and complex with uncertain outcomes, which may prevent or delay commercialization

of any drug product candidates or CELsignia tests;

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

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 and adversely impacted;

successful development of biopharmaceuticals such as gedatolisib is highly uncertain;

were not involved in the early development of gedatolisib;

therefore, we are dependent on

third parties having accurately generated, collected, interpreted and reported data from

certain preclinical and clinical trials;

an organization, we have never successfully completed any registrational clinical trials,

and we may be unable to do so for any drug candidates we may develop;

a new drug to be approved for marketing, the FDA in the United States and health authorities

in other countries, 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;

we encounter difficulties enrolling patients in any of our clinical trials, our clinical

development activities could be delayed or otherwise adversely affected;

we are unable to obtain and maintain intellectual property protection for our products and

technology, or if the scope of the intellectual property protection obtained is not sufficiently

broad, our competitors could develop and commercialize products or technology similar or

identical to ours, and our ability to successfully commercialize our technology and diagnostic

tests may be impaired;

depend on intellectual property licensed from third parties, including from Pfizer for our

lead product candidate, gedatolisib, and termination of this license could result in the

loss of significant rights, which would materially and adversely impact our business;

we fail to comply with our obligations under our patent license with Pfizer, we could lose

certain license rights that are important to our business;

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

and we cannot be certain of the outcomes of such trials;

may not be successful in finding pharmaceutical company partners for continuing development

of additional CELsignia tests;

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

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

face significant competition from other pharmaceutical and diagnostic companies.

Relating to Our Business

have a limited operating history and we may never generate revenue or profit.

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.

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 must continue to

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

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

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

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

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

our anticipated drug products.

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

We expect to continue to incur significant expenses and operating losses for the foreseeable future, and the net losses we incur may

fluctuate significantly from quarter to quarter.

Our failure to become and remain profitable would decrease our value and could impair

our ability to raise capital, maintain or expand our research and development efforts, expand our business, or continue our operations.

inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize our integrated

therapeutic (Rx) and companion diagnostic (CDx) strategy.

may require additional capital to finance capital expenditures and operating expenses over the next several years as we launch our integrated

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.

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 the first dosing of the first patient enrolled in our Phase 3 clinical study (VIKTORIA-1)

does not occur on or before December 31,2022, each investor under the securities purchase agreement we entered into on May 15, 2022,

will have the right to terminate its obligation to purchase our securities under the securities purchase agreement.

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.

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

operations will be materially dependent upon the services of our officers and key employees, including Brian F.

Sullivan, our Chief Executive

Officer, and Dr.

Laing, our Chief Science Officer.

Successful implementation of our business plan will also require the services

of other consultants and additional personnel.

We cannot assure you that we will be able to attract and retain such persons as employees,

independent contractors, consultants or otherwise.

If we are not able to attract individuals with the skills required for our business,

or if we lose the services of either Mr.

Sullivan or Dr.

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.

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

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

a result of the COVID-19 pandemic, 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;

● interruption

or delays in the operations of the FDA or other regulatory authorities, which may impact

review and approval timelines;

● limitations

on our ability to recruit and hire key personnel due to our inability to meet with candidates

because of travel restrictions;

● limitations

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

the direct effect of the pandemic, COVID-19 has had broad economic effects.

The economic impact of COVID-19 may adversely affect us in

a variety of ways, including without limitation making our stock price more volatile, making it more difficult to raise additional capital

through offerings of equity or debt securities, and reducing the availability of bank loans.

As a result, we may face difficulties raising

capital and capital raising efforts may be on terms than are less favorable than would have been previously available.

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;

● insufficiency

of our financial and other resources to complete the necessary preclinical studies and clinical

or inconclusive results from our preclinical studies, clinical trials or the clinical trials

of others for drug products similar to ours, leading to a decision or requirement to conduct

additional preclinical studies or clinical trials or abandon a program;

● product-related

adverse events experienced by subjects in our clinical trials or by individuals using drugs

or therapeutic biologics similar to our drug products;

in submitting applications, or delays or failure in obtaining the necessary approvals from

regulators to commence a clinical trial or a suspension or termination of a clinical trial

once commenced;

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;

than expected performance of control arms, such as placebo groups, which could lead to negative

or inconclusive results from our clinical trials;

in enrolling subjects in clinical trials;

drop-out rates of subjects from clinical trials;

supply or quality of drug products or other materials necessary for the conduct of our clinical

than anticipated clinical trial or manufacturing costs;

● unfavorable

FDA or comparable regulatory authority inspection and review of a clinical trial site;

of our third-party contractors or investigators to comply with regulatory requirements or

otherwise meet their contractual obligations in a timely manner, or at all;

and changes in regulatory requirements, policy and guidelines, including the imposition of

additional regulatory oversight around clinical testing generally or with respect to our

therapies in particular;

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

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

change once data cleansing and data verification activities are completed.

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

Pfizer provided

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

preparation of a final Clinical Study Report.

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

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

We may discover, upon performing the study close out activities

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

as originally provided by Pfizer to us.

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

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

were not involved in the early development of gedatolisib;

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

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

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

We are dependent on third parties

having conducted their research and development in accordance with the applicable protocols and legal, regulatory and scientific standards;

having accurately reported the results of all preclinical studies and clinical trials conducted with respect to such drug product;

having correctly collected and interpreted the data from these trials.

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

clinical development, regulatory approval or commercialization of our drug product will 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

candidates we may develop.

will need to successfully complete registrational clinical trials in order to obtain the approval of the FDA or comparable foreign regulatory

authorities to market our drug products.

Carrying out clinical trials, including later-stage registrational clinical trials, is a complicated

As an organization, we have not previously completed any registrational clinical trials.

In order to do so, we will need to

build and expand our clinical development and regulatory capabilities, and we may be unable to recruit and train qualified personnel.

We also expect to continue to rely on third parties to conduct our 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 of or commercialize any potential product candidates.

Consequently, we may be unable to successfully and efficiently execute

and complete necessary clinical trials in a way that leads to submission and approval of our drug products.

We may require more time

and incur greater costs than our competitors and may not succeed in obtaining regulatory approval of any drug products that we develop.

Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in commercializing our

drug products.

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

adversely affected.

timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient

number of patients who remain in the trial until its conclusion.

We may experience difficulties in patient enrollment in our clinical

trials for a variety of reasons, including:

patient eligibility and exclusion criteria defined in the protocol;

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

proximity of patients to clinical trial sites;

design of the clinical trial;

ability to recruit clinical trial investigators with the appropriate competencies and experience,

and the ability of these investigators to identify and enroll suitable patients;

of the safety profile of our drug products;

ability to obtain and maintain patient consents;

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

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

of these trials and adversely affect our ability to advance the development of our product candidates.

development involves a lengthy and expensive process, with an uncertain outcome.

We may incur additional costs or experience delays in

completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

obtain the requisite regulatory approvals to commercialize any drug products, we must demonstrate through extensive preclinical studies

and clinical trials that such drug product is safe and effective in humans.

Clinical testing is expensive and can take many years to

complete, and its outcome is inherently uncertain.

We may be unable to establish clinical endpoints that applicable regulatory authorities

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.

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

to comparable foreign regulatory authorities for each drug product and, consequently, the ultimate approval and commercial marketing

of any drug products.

We may experience delays in activating 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 COVID-19, 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.

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.

Significant clinical trial delays

also could shorten any periods during which we may have the exclusive right to commercialize our product candidates and may allow our

competitors to bring products to market before we do, potentially impairing our ability to successfully commercialize our product candidates

and harming our business and results of operations.

Any delays in our clinical development programs may harm our business, financial

condition and results of operations significantly.

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

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

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

with fulvestrant, outweigh its risks.

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

significant, may not support regulatory approval.

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

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

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

available and takes remaining uncertainties into account.

These considerations include an assessment of the strengths and limitations

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

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

of the study endpoints.

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

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

However, due to the complexity of clinical trials,

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

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

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

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

and we may not get approval at all.

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

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

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

delayed in obtaining marketing approval for our such product candidates or not obtain marketing

approval at all;

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

approval with labeling that includes significant use or distribution restrictions or safety

warnings, including boxed warnings;

subject to changes in the way the product is administered;

required to perform additional clinical trials to support approval or be subject to additional

post-marketing testing requirements;

regulatory authorities withdraw, or suspend, their approval of the product or impose restrictions

on its distribution in the form of a REMS or through modification to an existing REMS;

damage to our reputation.

successful development of biopharmaceuticals is highly uncertain.

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;

● convenience

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

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 our gedatolisib.

This license imposes

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

If we fail to comply with these obligations, Pfizer

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

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

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 trials;

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

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

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

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

The designation offers the

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

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

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

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

may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial

treatment effects observed early in clinical development.

The benefits of Breakthrough Therapy Designation include more intensive

guidance from the FDA on an efficient development program, access to a scientific liaison to help accelerate review time, and

potential eligibility for priority review if relevant criteria are met.

This designation can expedite the development and regulatory

review of an investigational medicine that is intended to treat a serious or life-threatening condition.

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

While the FDA has granted both designations

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

compared to products considered for approval under conventional FDA procedures, and neither designation assures ultimate approval by

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

or both such designations.

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

regulatory approval of our product candidates in other jurisdictions.

and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or

maintain regulatory approval in any other jurisdiction, while a failure or delay in obtaining regulatory approval in one jurisdiction

may have a negative effect on the regulatory approval process in others.

For example, even if the FDA grants marketing approval of a

product candidate, a comparable foreign regulatory authority must also approve the manufacturing, marketing and promotion of the product

candidate in those countries.

procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than,

those in the U.S., including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may

not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the U.S., a product candidate must be

approved for reimbursement before it can be approved for sale in that jurisdiction.

In some cases, the price that we intend to charge

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.

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

storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other

post-marketing information, including both federal and state requirements in the U.S.

and requirements of comparable foreign regulatory

In addition, we will be subject to continued compliance with requirements for any clinical trials that we conduct post-approval.

Manufacturers

and manufacturers’ facilities are required to comply with extensive FDA and comparable foreign regulatory authority requirements.

Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including

manufacturing, production and quality control.

regulatory approvals that we receive for our product candidates may be subject to limitations on the approved indicated uses for which

the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing,

including Phase 4 clinical trials and surveillance to monitor the safety and efficacy of the product candidate.

Certain endpoint data

we hope to include in any approved product labeling also may not make it into such labeling, including exploratory or secondary endpoint

data such as patient-reported outcome measures.

The FDA may impose consent decrees or withdraw approval if compliance with regulatory

requirements and standards is not maintained or if problems occur after the product reaches the market.

Later discovery of previously

unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, or with our third-party

manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved

labeling to add new safety information, imposition of post-marketing studies or clinical trials to assess new safety risks or imposition

of distribution restrictions or other restrictions under a REMS program.

Other potential consequences include, among other things:

● restrictions

on the marketing or manufacturing of our products, withdrawal of the product from the market

or voluntary or mandatory product recalls;

warning letters or holds on clinical trials;

by the FDA to approve pending applications or supplements to approved applications filed

by us or suspension or revocation of license approvals;

seizure or detention or refusal to permit the import or export of our product candidates;

● injunctions

or the imposition of civil or criminal penalties.

FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market.

Products may be promoted

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.

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 mid 2023 and with final results expected approximately

nine months later.

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

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

a timely manner.

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

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

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

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

If we are unable to demonstrate

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

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

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

of other CELsignia tests.

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

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

Even if the ultimate outcome of the first

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

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

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

● demonstrate

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

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;

● successfully

collaborate with research institutions and pharmaceutical companies in the discovery, development

and commercialization of our current and future CELsignia tests;

● successfully

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.

Our 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.

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.

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

tests, there can be no assurance that our CELsignia tests or any tests we may develop in the future will be cleared or approved by the

FDA on a timely basis, if at all, nor can there be assurance that labeling claims will be consistent with our current claims or adequate

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.

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

laboratory tests, including our CELsignia tests, are regulated under CLIA.

CLIA is a federal law that regulates clinical laboratories

that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment

CLIA regulations mandate specific standards for laboratories in the areas of personnel qualifications, administration, and

participation in proficiency testing, patient test management and quality assurance.

CLIA certification is also required in order for

us to be eligible to bill state and federal healthcare programs, as well as many private third-party payers, for any tests we launch.

We will also be required to maintain state licenses in certain states to conduct testing in our laboratories.

While we currently have

CLIA certification for our Minnesota laboratory, failure to maintain this certification would adversely affect our ability to launch

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

Our patent portfolio includes three issued U.S.

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

patent applications,

23 pending non-U.S.

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

applications.

Each patent and patent application covers methods of use.

However, we cannot assure you that our intellectual property

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

The validity and breadth of claims in

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

Uncertainties and risks that we face include

the following:

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.

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

obtain or enforce.

We may not be able to protect our trade secrets adequately.

We have a policy of requiring our consultants, advisors

and strategic partners to enter into confidentiality agreements and our employees to enter into invention, non-disclosure and non-compete

However, no assurance can be given that we have entered into appropriate agreements with all parties that have had access

to our trade secrets, know-how or other proprietary information.

There is also no assurance that such agreements will provide meaningful

protection of our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure of information.

Furthermore, we cannot provide assurance that any of our employees, consultants, contract personnel, or strategic partners, either accidentally

or through willful misconduct, will not cause serious damage to our programs and/or our strategy, for example by disclosing important

trade secrets, know-how or proprietary information to our competitors.

It is also possible that our trade secrets, know-how or other

proprietary information could be obtained by third parties as a result of breaches of our physical or electronic security systems.

disclosure of confidential data into the public domain or to third parties could allow our competitors to learn our trade secrets and

use the information in competition against us.

In addition, others may independently discover our trade secrets and proprietary information.

Any action to enforce our rights is likely to be time consuming and expensive, and may ultimately be unsuccessful, or may result in a

remedy that is not commercially valuable.

These risks are accentuated in foreign countries where laws or law enforcement practices may

not protect proprietary rights as fully as in the United States.

Any unauthorized disclosure of our trade secrets or proprietary information

could harm our competitive position.

Risks Related to Government Regulation for Our Business

to comply with the HIPAA security and privacy regulations may increase our operational costs.

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

associate” to those customers, and are required to maintain the privacy and security of PHI in accordance with HIPAA and the terms

of our business associate agreements with our clients, including by implementing HIPAA-required administrative, technical and physical

We are also required to maintain similar business associate agreements with our subcontractors that have access to PHI of

our customers in rendering services to us or on our behalf.

We will incur significant costs to establish and maintain these safeguards

and, if additional safeguards are required to comply with HIPAA regulations or our clients’ requirements, our costs could increase

further, which would negatively affect our operating results.

Furthermore, we cannot guarantee that such safeguards have been and will

continue to be adequate under applicable laws.

If we have failed, or fail in the future, to maintain adequate safeguards, or we or our

agents or subcontractors use or disclose PHI in a manner prohibited or not permitted by HIPAA, our subcontractor business associate agreements,

or our business associate agreements with our customers, or if the privacy or security of PHI that we obtain and handle is otherwise

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

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

we are unable to comply or have not complied with such laws, we could face substantial penalties or other adverse actions.

operations are subject, directly or indirectly, to other federal, state and foreign laws and regulations that are complex and their application

to our specific products, services and relationships may not be clear and may be applied to our business in ways that we do not anticipate.

Compliance with laws and regulations will require us to expend considerable resources implementing internal policies and procedures for

compliance and ongoing monitoring and will require significant attention of our management team.

This will be challenging as an early-stage

company with limited financial resources and human capital.

These laws include, for example:

XI of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute,

which prohibits the knowing and willful offer, payment, solicitation or receipt of remuneration,

directly or indirectly, in cash or in kind, in return for or to reward the referral of patients

or arranging for the referral of patients, or in return for the recommendation, arrangement,

purchase, lease or order of items or services that are covered, in whole or in part, by a

federal healthcare program such as Medicare or Medicaid;

civil False Claims Act, that forbids the knowing submission or “causing the submission”

of false or fraudulent information or the failure to disclose information in connection with

the submission and payment of claims for reimbursement to Medicare, Medicaid, federal healthcare

programs or private health plans;

federal Physician Self-referral Law, commonly known as the Stark Law, which prohibits physicians

from referring Medicare or Medicaid patients to providers of “designated health services”

with whom the physician or a member of the physician’s immediate family has an ownership

interest or compensation arrangement, unless a statutory or regulatory exception applies,

and similar state equivalents that may apply regardless of payor;

Foreign Corrupt Practices Act of 1977, as amended, or FCPA, the U.S.

domestic bribery

statute contained in 18 U.S.C.

§ 201, the U.S.

Travel Act, and the USA PATRIOT Act,

which among other things, prohibit companies and their employees, agents, third-party intermediaries,

joint venture partners and collaborators from authorizing, promising, offering, or providing,

directly or indirectly, improper payments or benefits to recipients in the public or private

states and foreign governments have adopted similar laws and regulations.

Violations of law could subject us to civil or criminal penalties,

monetary fines, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and future earnings

and curtailment of our operations.

We could also be required to change or terminate some portions of operations or business or could

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

have difficulties gaining acceptance of the use of the companion therapies in the clinical

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 condition.

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

in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders,

more difficult and may prevent attempts by our stockholders to replace or remove our current management.

in our certificate of incorporation and our bylaws may discourage, delay or prevent a merger, acquisition or other change in control

of our company that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your

These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock,

thereby depressing the market price of our common stock.

In addition, because our board of directors will be responsible for appointing

the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our

current management by making it more difficult for stockholders to replace members of our board of directors.

Among other things, these

the authorized number of our directors to be changed only by resolution of our board of directors;

the manner in which stockholders can remove directors from our board of directors;

advance notice requirements for stockholder proposals that can be acted on at stockholder

meetings and nominations to our board of directors;

that stockholder actions must be effected at a duly called stockholder meeting and prohibit

actions by our stockholders by written consent;

who may call stockholder meetings;

our board of directors to issue preferred stock without stockholder approval, which could

be used to institute a “poison pill” that would work to dilute the stock ownership

of a potential hostile acquirer, effectively preventing acquisitions that have not been approved

by our board of directors;

the approval of the holders of at least two-thirds of the votes that all our stockholders

would be entitled to cast to amend or repeal specified provisions of our certificate of incorporation

we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess

of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction

in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed

of these provisions of our charter documents or Delaware law could, under certain circumstances, depress the market price of our common

price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our

common stock or could subject us to securities litigation.

stock price may be extremely volatile.

The stock market in general and the market for smaller medical technology companies in particular

have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.

As a result of

this volatility, investors may not be able to sell our common stock at or above the price they paid for such stock.

The market price

for our common stock may be influenced by many factors, including:

success of competitive products or technologies;

of planned clinical trials for gedatolisib, as well as our CELsignia HER2 Pathway Activity Test, CELsignia Multi-Pathway

Activity Test or other CELsignia tests may develop in the future;

or legal developments in the United States and other countries;

● developments

or disputes concerning patent applications, issued patents or other proprietary rights;

recruitment or departure of key personnel;

level of expenses related to any of our CELsignia tests or clinical development programs;

or anticipated changes in estimates as to financial results, development timelines or recommendations

by securities analysts;

results that fail to meet expectations of securities analysts that cover our company;

in our financial results or those of companies that are perceived to be similar to us;

in the structure of healthcare payment systems;

conditions in the pharmaceutical, biotechnology and medical technology sectors;

of our stock by us, our insiders and our other stockholders;

economic and market conditions;

other factors described in this “Risk Factors” section.

Additionally,

companies that have experienced volatility in the market price of their stock have been subject to an increased incidence of securities

class action litigation.

We may be the target of this type of litigation in the future.

Securities litigation against us could result

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

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

our stock price and trading volume could decline.

trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us

or our business.

We do not have any control over these analysts.

There can be no assurance that analysts will cover us or provide favorable

If one or more of the analysts who cover us downgrade our stock or change their opinion of our stock, our stock price would

likely decline.

If one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose

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

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

our common stock less attractive to investors.

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

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

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

These exemptions include:

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

unaudited interim financial statements, with correspondingly reduced “Management’s

Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

being required to comply with the auditor attestation requirements in the assessment of our

internal control over financial reporting of Section 404(b) of the Sarbanes-Oxley Act;

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

Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s

report providing additional information about the audit and the financial statements;

disclosure obligations regarding executive compensation;

from the requirements of holding a nonbinding advisory vote on executive compensation and

stockholder approval of any golden parachute payments not previously approved.

have taken advantage of reduced reporting burdens in this report.

We cannot predict whether investors will find our common stock less

attractive if we rely on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active

trading market for our common stock and our stock price may be more volatile.

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

new compliance initiatives and corporate governance practices.

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

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

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

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

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

governance practices.

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

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

time-consuming and costly.

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

over financial reporting.

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

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

as required by Section 404(b).

While we, as of September 30, 2022, concluded that our internal control over financial reporting was effective,

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

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

of confidence in the reliability of our financial statements.

a smaller reporting company, we are not required to provide disclosure pursuant to this item.

However, in addition to other information

set forth in this Quarterly Report, including the important information in the section entitled “Private Securities Litigation

Reform Act,” you should carefully consider the “Risk Factors” discussed in our Annual Report on Form 10-K for the year

ended December 31, 2022, for a discussion of important factors that could cause actual results to differ materially from the results

described in or implied by the forward-looking statements contained in this Quarterly Report.

Additional risks and uncertainties not

currently known to us or that we currently deem to be immaterial might materially adversely affect our actual business, financial condition

and/or operating results.

Unregistered Sales of Equity Securities and Use of Proceeds

3 unchanged sentences

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-Q

Item 1A. Risk Factors