What changed in this filing

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Item 1A. Risk Factors

2021-02-04 compared with 2020-11-05 · 542 added, 604 removed, 1366 unchanged (46% of the section changed)

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with all of the other information in this Quarterly Report on Form 10-Q, including our consolidated financial statements and

related notes and “Management’s Discussion and Analysis of Results of Operations and Financial Condition.” If

related notes and “Management’s Discussion and Analysis of Results of Operations and Financial Condition.”

any of the following risks are realized, our business, financial condition, operating results and prospects could be materially

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to us or that we currently believe to be immaterial may also adversely affect our business.

Summary of Risk Factors

Material risks that

may affect our business, operating results and financial condition include, but are not necessarily limited to, those relating

the timing, progress, and results of our preclinical studies and clinical trials for our product

candidates, and the timing, scope or likelihood of regulatory filings and approvals for any of our other product candidates;

our ability to develop and advance any future product candidates based on our Immulytic platform

and successfully complete clinical trials;

our ability to develop our product candidates for use in combination with other checkpoint blockade

therapies, including anti-PD-1;

our ability to successfully commercialize any product candidate for which we receive regulatory

approval and our expectations regarding the size of the patient populations our product candidates if approved for commercial use;

our ability to compete with other biopharmaceutical, biotechnology companies and other third parties

and risks associated with such third parties developing or commercializing products more quickly or marketing them more successfully

negative developments in the field of immono-oncology;

our history of losses, the likelihood that we will continue to incur substantial and increasing

net losses in the future, and the likelihood that we will require additional financing to achieve our goals;

our intellectual property position, including the scope of protection we are able to establish

and maintain for intellectual property rights covering RP1 and our other product candidates, claims others may make regarding rights

in our intellectual property, and any potential infringement, misappropriation or other violation of any third-party intellectual

property rights;

the costs of operating our in-house manufacturing facility and our reliance on third-party collaborators

and clinical trial service providers;

our compliance with domestic and foreign laws, rules and regulations and the consequences

in the event that we fail to comply with such laws, rules and regulations;

our ability to retain the continued service of our key professionals and to identify, hire and

retain additional qualified professionals;

our competitive position, and developments and projections relating to our competitors and our

the impact of the COVID-19 coronavirus, or COVID-19, as a global pandemic and related public health

our ability to remediate the material weaknesses in internal control over financial reporting and

to maintain effective internal control over financial reporting.

Risks Related to Product Development

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approval or be successfully introduced and marketed at prices that would permit us to operate profitably.

We currently have only two product

candidates in clinical development.

A failure of these product candidates in clinical development would adversely affect our business

and may require us to discontinue development of other product candidates based on the same or similar therapeutic approaches.

RP1 and RP2 are our

only clinical development-stage product candidates.

Although we have another product candidate, RP3, in preclinical development

and we may develop additional product candidates in the coming years, it will take additional investment and time for such product

candidates to reach the same stage of development as those that are in clinical development, and there can be no assurance that

they will ever do so.

Since all of the product candidates in our current pipeline are based on our Immulytic platform, if RP1 fails

in development as a result of any underlying problem with our Immulytic platform, then we may be required to discontinue development

of all product candidates that are based on our therapeutic approach.

If we were required to discontinue development of RP1, RP2

or our other product candidates, or if any of them were to fail to receive regulatory approval or achieve sufficient market acceptance,

we could be prevented from or significantly delayed in achieving profitability.

We can provide no assurance that we would be successful

at developing other product candidates based on an alternative therapeutic approach.

An underlying problem with our Immulytic

platform would adversely affect our business and may require us to discontinue development of product candidates based on the same

or similar therapeutic approaches.

Since all of the product

candidates in our current pipeline are based on our Immulytic platform, if any of our product candidates fail in development as

a result of any underlying problem with our Immulytic platform, then we may be required to discontinue development of all product

candidates that are based on our therapeutic approach.

If we were required to discontinue development of our product candidates

that are based on our therapeutics approach, or if any of them were to fail to receive regulatory approval or achieve sufficient

market acceptance, we could be prevented from or significantly delayed in achieving profitability.

We can provide no assurance

that we would be successful at developing other product candidates based on an alternative therapeutic approach.

We will not be able to commercialize

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the safety and efficacy of our product candidates.

Our lead product candidate,

RP1, is in an ongoing Phase 1/2 clinical trial alone and in combination with nivolumab and we have an ongoing randomized Phase 2

clinical trial of RP1 in combination with cemiplimab versus cemiplimab in CSCC.

We have also opened for enrollment a single arm

Phase 1b clinical trial of single agent RP1 in solid organ transplant recipients in approximately 30 patients with CSCC.

Additionally,

RP2, the next product candidate from our Immulytic platform, is in an ongoing Phase 1/2 clinical trial alone and in combination

with nivolumab.

Our third product candidate, RP3, is in preclinical development, and we expect to enter clinical development in

Our product candidates will require preclinical and/or clinical trials before we can submit a marketing application to the

applicable regulatory authorities.

Our product candidates

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approval or commercialize our product candidates, including:

the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than we anticipate, or may elect to participate in alternative clinical trials sponsored by our competitors with product candidates that treat the same indications as our product candidates;

regulators or institutional review boards, or IRBs, may not authorize us or our investigators to commence a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that we modify or amend our clinical trial protocols;

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clinical trials of our product candidates may produce negative or inconclusive results, or our studies may fail to reach the necessary level of statistical significance, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

our third-party contractors may fail to comply with regulatory requirements or the clinical trial protocol, or meet their contractual obligations to us in a timely manner, or at all, or we may be required to engage in additional clinical trial site monitoring;

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there may be regulatory questions or disagreements regarding interpretations of data and results;

the FDA or comparable foreign regulatory authorities may disagree with our study design, including endpoints, or our interpretation of data from preclinical studies and clinical trials or find that a product candidate’s benefits do not outweigh its safety risks;

the FDA or comparable foreign regulatory authorities may not accept data from studies with clinical trial sites in foreign countries;

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may be administered in combination with checkpoint blockade drugs, a class of drugs that are intended to stop tumor cells from

“switching off” an immune system attack against themselves.

“switching off”

an immune system attack against themselves.

We have entered into agreements with BMS for the supply

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Such developments

may include changes to the other product’s safety or efficacy profile, changes to the availability of the approved product,

and changes to the standard of care.

In the event that

BMS, Regeneron or any future collaborator or supplier cannot continue to supply their products on commercially reasonable

terms, we would need to identify alternatives for accessing an anti-PD-1 therapy.

Additionally, should the supply of products

from BMS, Regeneron or any future collaborator or supplier be interrupted, delayed or otherwise be unavailable to us, our

clinical trials may be delayed.

In the event we are unable to source a supply of an alternative anti-PD-1 therapy, or are

unable to do so on commercially reasonable terms, our business, financial condition, results of operations, stock price and

prospects may be materially harmed.

In the event that BMS,

Regeneron or any future collaborator or supplier cannot continue to supply their products on commercially reasonable terms or at

all, we would need to identify alternatives for accessing an anti-PD-1 therapy.

Additionally, should the supply of products from

BMS, Regeneron or any future collaborator or supplier be interrupted, delayed or otherwise be unavailable to us, our clinical trials

may be delayed.

In the event we are unable to source a supply of an alternative anti-PD-1 therapy, or are unable to do so on commercially

reasonable terms, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

If we fail to develop additional

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approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities

for each therapeutic indication to establish the product candidate’s safety and efficacy for that indication.

Securing marketing

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In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during

the course of a product candidate’s clinical development and may vary among jurisdictions and there may be varying interpretations

of data obtained from preclinical studies or clinical trials, any of which may cause delays or limitations in the approval or a

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approval or commercialization.

To date, the most commonly

reported adverse events observed for RP1 are local injection site reactions and systemic constitutional symptoms, such as fatigue,

fevers and chills.

However, there can be no assurance that additional undesirable side effects or serious adverse events will not

be caused by or associated with RP1 or our other product candidates as they continue through or enter clinical development.

adverse events or undesirable side effects caused by our product candidates could cause us, IRBs, and other reviewing entities

or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label or the delay

or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.

For example, if concerns are raised regarding

the safety of a new therapeutic as a result of undesirable side effects identified during clinical or preclinical testing, the

FDA or comparable foreign regulatory authority may order us to cease further development, decline to approve the product candidate

or issue a letter requesting additional data or information prior to making a final decision regarding whether or not to approve

the product candidate.

The FDA or comparable foreign regulatory authorities, or IRBs and other reviewing entities, may also require,

or we may voluntarily develop, strategies for managing adverse events during clinical development, which could include restrictions

on our enrollment criteria, the use of stopping criteria, adjustments to a study’s design, or the monitoring of safety data

by a data monitoring committee, among other strategies.

The FDA or comparable foreign regulatory authority requests for additional

data or information could also result in substantial delays in the approval of our product candidates.

There can be no assurance

that undesirable side effects or serious adverse events will not be caused by or associated with RP1 or our other product candidates

as they continue through or enter clinical development.

Serious adverse events or undesirable side effects caused by our product

candidates could cause us, IRBs, and other reviewing entities or regulatory authorities to interrupt, delay, or halt clinical

trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable foreign

regulatory authorities.

For example, if concerns are raised regarding the safety of a new therapeutic as a result of undesirable

side effects identified during clinical or preclinical testing, the FDA or comparable foreign regulatory authority may order us

to cease further development, decline to approve the product candidate or issue a letter requesting additional data or information

prior to making a final decision regarding whether or not to approve the product candidate.

The FDA or comparable foreign regulatory

authorities, or IRBs and other reviewing entities, may also require, or we may voluntarily develop, strategies for managing adverse

events during clinical development, which could include restrictions on our enrollment criteria, the use of stopping criteria,

adjustments to a study’s design, or the monitoring of safety data by a data monitoring committee, among other strategies.

The FDA or comparable foreign regulatory authority requests for additional data or information could also result in substantial

delays in the approval of our product candidates.

Undesirable side effects

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and we may be subject to substantial fines, criminal penalties, injunctions, or other enforcement actions if we are determined

to be promoting the use of our products for unapproved or “off label” uses, resulting in damage to our reputation and

to be promoting the use of our products for unapproved or “off label”

uses, resulting in damage to our reputation and

We must comply with

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communications with respect to therapeutics are subject to a variety of legal and regulatory restrictions and continuing review

by the FDA, Department of Justice, Department of Health and Human Services’ Office of Inspector General, state attorneys

by the FDA, Department of Justice, Department of Health and Human Services’

Office of Inspector General, state attorneys

general, members of Congress, and the public.

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We also must sufficiently substantiate any claims that we make for our products,

including claims comparing our products to other companies’ products, and must abide by the FDA’s strict requirements

including claims comparing our products to other companies’

products, and must abide by the FDA’s strict requirements

regarding the content of promotion and advertising.

While physicians may

choose to prescribe products for uses that are not described in the product’s labeling and for uses that differ from those

tested in clinical trials and approved by the regulatory authorities, we are prohibited from marketing and promoting the products

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decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

In the United

States, engaging in the impermissible promotion of our products, following approval, for off label uses can also subject us

to false claims and other litigation under federal and state statutes.

These include fraud and abuse and consumer protection

laws, which can lead to civil and criminal penalties and fines and agreements with governmental authorities that materially

restrict the manner in which we promote or distribute therapeutic products and conduct our business.

These restrictions could

include corporate integrity agreements, suspension or exclusion from participation in federal and state healthcare programs,

and suspension and debarment from government contracts and refusal of orders under existing government contracts.

Claims Act lawsuits against manufacturers of drugs and biologics have increased significantly in volume and breadth.

addition, False Claims Act lawsuits may expose manufacturers to follow-on claims by private payers based on fraudulent

marketing practices.

This growth in litigation has increased the risk that a biopharmaceutical company will have to defend a

false claim action, pay settlement fines or restitution, as well as criminal and civil penalties, agree to comply with

burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid, or other federal and state

healthcare programs.

If we do not lawfully promote our approved products, if any, we may become subject to such litigation

and, if we do not successfully defend against such actions, those actions may have a material adverse effect on our business,

financial condition, results of operations, stock price and prospects.

In the United States,

engaging in the impermissible promotion of our products, following approval, for off label uses can also subject us to false claims

and other litigation under federal and state statutes.

These include fraud and abuse and consumer protection laws, which can lead

to civil and criminal penalties and fines and agreements with governmental authorities that materially restrict the manner in which

we promote or distribute therapeutic products and conduct our business.

These restrictions could include corporate integrity agreements,

suspension or exclusion from participation in federal and state healthcare programs, and suspension and debarment from government

contracts and refusal of orders under existing government contracts.

These False Claims Act lawsuits against manufacturers of drugs

and biologics have increased significantly in volume and breadth.

In addition, False Claims Act lawsuits may expose manufacturers

to follow-on claims by private payers based on fraudulent marketing practices.

This growth in litigation has increased the risk

that a biopharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, as well as criminal

and civil penalties, agree to comply with burdensome reporting and compliance obligations, and be excluded from Medicare, Medicaid,

or other federal and state healthcare programs.

If we do not lawfully promote our approved products, if any, we may become subject

to such litigation and, if we do not successfully defend against such actions, those actions may have a material adverse effect

on our business, financial condition, results of operations, stock price and prospects.

In the United States,

the promotion of biopharmaceutical products is subject to additional FDA requirements and restrictions on promotional statements.

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they may withdraw approval, issue public safety alerts, require labeling changes or establishment of a REMS or similar strategy,

impose significant restrictions on a product’s indicated uses or marketing, or impose ongoing requirements for potentially

costly post approval studies or post-market surveillance.

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and business and could adversely impact our business, financial condition, results of operations, stock price and prospects.

The FDA’s policies

or those of comparable foreign regulatory authorities may change and additional government regulations may be enacted that could

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In some cases, the price that we intend to charge for our products is also subject to approval.

Additionally, the outcome of the United Kingdom’s impending withdrawal from the European Union, commonly referred to as Brexit,

remains uncertain.

Since a significant proportion of the regulatory framework in the United Kingdom is derived from European Union

directives and regulations, the withdrawal of the United Kingdom from the European Union could materially impact the regulatory

regime with respect to the approval of our product candidates in the United Kingdom or the European Union.

Additionally, the outcome of the United Kingdom’s withdrawal from the European Union, commonly referred to as Brexit, remains

Since a significant proportion of the regulatory framework in the United Kingdom is derived from European Union directives

and regulations, the withdrawal of the United Kingdom from the European Union could materially impact the regulatory regime with

respect to the approval of our product candidates in the United Kingdom or the European Union.

Regulatory authorities

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when used alone or in combination with other drugs.

Our commercial

opportunities could be reduced or eliminated if our competitors develop and commercialize products that are safer, more

effective, have fewer or less severe side effects, are easier to administer or are less expensive alone or in combination

with other therapies than any products that we may develop alone or in combination with other therapies.

Our competitors also

may obtain FDA or comparable foreign regulatory authority approval for their products more rapidly than we may obtain

approval for ours, which could result in our competitors establishing a strong market position before we are able to enter

In addition, our ability to compete may be affected in many cases by insurers or other third-party payors

coverage decisions.

Many of the companies

Our commercial opportunities

could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer

or less severe side effects, are easier to administer or are less expensive alone or in combination with other therapies than any

products that we may develop alone or in combination with other therapies.

Our competitors also may obtain FDA or comparable foreign

regulatory authority approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors

establishing a strong market position before we are able to enter the market.

In addition, our ability to compete may be affected

in many cases by insurers or other third-party payors coverage decisions.

Certain of the companies

with which we are competing or may compete in the future have significantly greater financial resources and expertise in research

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the clinical indications for which the products are approved and the claims that we may make for the products;

limitations or warnings, including distribution or use restrictions, contained in the products’ approved labeling;

limitations or warnings, including distribution or use restrictions, contained in the products’

approved labeling;

any distribution and use restrictions imposed by the FDA or comparable foreign regulatory authorities or to which we agree as part of a mandatory REMS or voluntary risk management plan;

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the clinical indications for which the products are approved and the approved claims that we may make for the products;

limitations or warnings contained in the product’s FDA-approved labeling or those of comparable foreign regulatory authorities, including potential limitations or warnings for our product candidates that may be more restrictive than other competitive products;

changes in the standard of care for the targeted indications for our product candidates, which could reduce the marketing impact of any claims that we could make following FDA approval or approval by comparable foreign regulatory authorities, if obtained;

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Negative developments in the field

of immuno-oncology could damage public perception of RP1 or any of our other product candidates and negatively affect our business.

of immuno-oncology could damage public perception of our product candidates and negatively affect our business.

The commercial success

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as well as any other negative developments in the field of immuno-oncology that may occur in the future, including in connection

with competitor therapies, could result in a decrease in demand for RP1 or our other product candidates that we may develop.

events could also result in the suspension, discontinuation, or clinical hold of or modification to our clinical trials.

perception is influenced by claims that the use of cancer immunotherapies is unsafe, whether related to our therapies or those

of our competitors, our product candidates may not be accepted by the general public or the medical community and potential clinical

trial subjects may be discouraged from enrolling in our clinical trials.

As a result, we may not be able to continue or may be

delayed in conducting our development programs.

with competitor therapies, could result in a decrease in demand for our product candidates.

These events could also result in the

suspension, discontinuation, or clinical hold of or modification to our clinical trials.

If public perception is influenced by

claims that the use of cancer immunotherapies is unsafe, whether related to our therapies or those of our competitors, our product

candidates may not be accepted by the general public or the medical community and potential clinical trial subjects may be discouraged

from enrolling in our clinical trials.

As a result, we may not be able to continue or may be delayed in conducting our development

As our product candidates

consist of a modified virus, adverse developments in antiviral vaccines or clinical trials of other oncolytic immunotherapy products

based on viruses may result in a disproportionately negative effect for RP1 or our other product candidates as compared to other

products in the field of immuno-oncology that are not based on viruses.

Future negative developments in the field of immuno-oncology

or the biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential

regulatory delays in the testing or approvals of our products.

Any increased scrutiny could delay or increase the costs of obtaining

marketing approval for RP1 or our other product candidates.

based on viruses may result in a disproportionately negative effect for our product candidates as compared to other products in

the field of immuno-oncology that are not based on viruses.

Future negative developments in the field of immuno-oncology or the

biopharmaceutical industry could also result in greater governmental regulation, stricter labeling requirements and potential regulatory

delays in the testing or approvals of our products.

Any increased scrutiny could delay or increase the costs of obtaining marketing

approval for our product candidates.

Risks Related to Our Financial Position

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We have financed our operations to date primarily through the sale of equity securities, including the sale of our common stock

in our public offerings.

Since our inception, most of our resources have been dedicated to the preclinical and clinical development

of our Immulytic platform, RP1 and our other product candidates.

The size of our future net losses will depend, in part, on our

future expenses and our ability to generate revenue, if any.

and pre-funded warrants in our public offerings.

Since our inception, most of our resources have been dedicated to the preclinical

and clinical development of our Immulytic platform RP1 and our other product candidates.

The size of our future net losses will

depend, in part, on our future expenses and our ability to generate revenue, if any.

We are not profitable

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Our prior losses and expected future losses have had and will continue to

have an adverse effect on our stockholders’ equity and working capital.

have an adverse effect on our stockholders’

equity and working capital.

We have never generated any revenue

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revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability.

We will require substantial additional

financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could

force us to delay, limit, reduce or terminate our product development or commercialization efforts.

We will require additional financing

to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us

to delay, limit, reduce or terminate our product development or commercialization efforts.

Our operations have

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and preclinical development of RP1 and our other product candidates.

Accordingly, we will need to obtain substantial additional

funds to achieve our business objectives.

If we are able to gain marketing approval of any product candidate, we will require significant

additional amounts of cash in order to launch and commercialize such product.

Accordingly, we will need to obtain additional funds to achieve

our business objectives.

If we are able to gain marketing approval of any product candidate, we will require significant additional

amounts of cash in order to launch and commercialize such product.

In addition, other unanticipated costs may arise.

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distribution arrangements.

Our ability to obtain debt financing may be limited by covenants we have made under our Loan and Security

Agreement with Hercules Capital, Inc.

(“Hercules”) and our pledge to Hercules of our assets as collateral.

on our research and development plans, we expect that our existing cash and cash equivalents and short-term investments will enable

us to fund our planned operating expenses and capital expenditure requirements to mid-2023.

We have based this estimate on assumptions

that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

In addition, because the

design and outcome of our planned and anticipated clinical trials is highly uncertain, we cannot reasonably estimate the actual

amounts necessary to successfully complete the development and commercialization of RP1 or our other product candidates.

Raising additional capital may cause

dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

To the extent that

we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, our existing

stockholders’ interest will be diluted.

Debt financing, if available, would increase our fixed payment obligations and may

involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional

debt, making capital expenditures or declaring dividends.

If we are unable to

raise additional funds through equity or debt financings when needed, we may be required to grant rights to develop and market

one or more of our product candidates or technologies that we would otherwise prefer to develop and market ourselves.

Based on our research and development plans, we expect that our existing cash and cash equivalents and

short-term investments will enable us to fund our planned operating expenses and capital expenditure requirements into the second

half of 2024.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital

resources sooner than we expect.

In addition, because the design and outcome of our planned and anticipated clinical trials is

highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization

of RP1 or our other product candidates.

Risks Related to Intellectual Property

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all of which offer only limited protection.

The patent positions

of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual questions and have

in recent years been the subject of much litigation.

As a result, the issuance, scope, validity, enforceability and commercial

value of our licensed patents and any patents we own in the future are highly uncertain.

The steps we have taken to protect our

proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual

property rights, both inside and outside of the United States.

positions of biotechnology and pharmaceutical companies generally are highly uncertain, involve complex legal and factual

questions and have in recent years been the subject of much litigation and subject to change with regulatory agencies and

court decisions.

As a result, the issuance, scope, validity, enforceability and commercial value of our licensed patents and

any patents we own in the future are highly uncertain.

The steps we have taken to protect our proprietary rights may not be

adequate to preclude misappropriation of our proprietary information, use by third parties of our products or infringement of

our intellectual property rights, both inside and outside of the United States.

applications cannot be enforced against third parties practicing the inventions claimed in such applications unless and until

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Because the issuance of a patent is not conclusive as to its inventorship, scope,

validity or enforceability, issued patents that we license from third parties or own in the future may be challenged in the

courts or patent offices in the United States and abroad.

Further, the examination process may require us to narrow the

claims for our pending patent applications, which may limit the scope of patent protection that may be obtained if these

applications issue.

The scope of a patent may also be reinterpreted after issuance.

The rights that may be granted under our

future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking.

we enter into nondisclosure and confidentiality agreements with parties who have access to confidential or patentable aspects

of our research and development output, such as our employees, collaborators, and other third parties, any of these parties

may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to

seek patent protection.

In addition, the patent prosecution process is expensive, time consuming and complex, 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.

If we are unable to obtain and maintain patent protection for our technology or for RP1 or our other

product candidates, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and

commercialize products similar or superior to ours, and our ability to successfully commercialize RP1 or our other product

candidates and future technologies may be adversely affected.

Subject to continued review by specialist.

terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and our product candidates

for which we intend to seek approval as biological products may face competition sooner than anticipated.

Given the amount

of time required for the development, testing and regulatory review of new product candidates, such as RP1 and our other product

candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized.

Filing, prosecuting

and defending patents on our technology in all countries throughout the world would be prohibitively expensive, and our intellectual

property rights in some countries outside the United States can be less extensive than those in the United States.

the laws and practices of some foreign countries do not protect intellectual property rights to the same extent as federal and

state laws in the United States.

Changes to the patent law in the United States and other jurisdictions could diminish the value

of patents in general, thereby impairing our ability to protect RP1 and our other product candidates.

Consequently, we may not

be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or

importing products made using our inventions in and into the United States or other jurisdictions.

validity or enforceability, our issued parents and issued patents that we license from third parties or may own in the future

may be challenged in the courts or patent offices in the United States and abroad.

Further, the examination process may

require us to narrow the claims for our pending patent applications, which may limit the scope of patent protection that may

be obtained if these applications issue.

The scope of a patent may also be interpreted or reinterpreted after issuance.

rights that may be granted under our future issued patents may not provide us with the proprietary protection or competitive

advantages we are seeking.

Although we enter into nondisclosure and confidentiality agreements with parties who have access

to confidential or patentable aspects of our research and development output, such as our employees, collaborators, and other

third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed,

thereby jeopardizing our ability to seek patent protection.

In addition, the patent prosecution process is expensive, time

consuming and complex, 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.

If we are unable to obtain and maintain patent protection for

our technology or inventions, or for RP1 or our other product candidates, or if the scope of the patent protection obtained

is not sufficient, our competitors could develop and commercialize products similar or superior to ours, and our ability to

successfully commercialize RP1 or our other product candidates and future technologies or inventions may be adversely

terms may be inadequate to protect our competitive position on our products for an adequate amount of time, and our product

candidates for which we intend to seek approval as biological products may face competition sooner than anticipated.

Given the amount of time required for the development, testing and regulatory review of our product candidates, such as RP1

and our other product candidates, patents protecting such product candidates might expire before or shortly after such

product candidates are commercialized.

prosecuting and defending patents on our technology or inventions in all countries throughout the world would be

prohibitively expensive, and our intellectual property rights in some countries or religions outside the United States can be

less protective of our products than those in the United States.

In addition, the laws and practices of some foreign

countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general,

thereby impairing our ability to protect RP1 and our other product candidates.

Consequently, we may not be able to prevent

third parties from practicing our inventions in all countries outside the United States, or from selling or importing

products made using our inventions in and into the United States or other jurisdictions.

Competitors may use our technologies

in jurisdictions where we have not obtained patent protection to develop and/or manufacture their own products and may export otherwise

infringing products to territories where we have patent protection but where enforcement is not as strong as that in the United

These products may compete with our products and our patent claims or other intellectual property rights may not be effective

or sufficient to prevent them from so competing.

Protecting against

the unauthorized use of our patented inventions, trademarks and other intellectual property rights is expensive, time consuming,

difficult and in some cases may not be possible.

In some cases, it may be difficult or impossible to detect third-party infringement

or misappropriation of our intellectual property rights, even in relation to issued patent claims, and proving any such infringement

may be even more difficult.

If we are unable to obtain, maintain, and protect our intellectual property our competitive advantage

could be harmed, and it could result in a material adverse effect on our business, financial condition, results of operations,

stock price and prospects.

In addition to seeking

patent protection, we also rely on other proprietary rights, including protection of trade secrets, know-how and confidential and

proprietary information.

Although we enter into confidentiality agreements with our employees, consultants, collaborators and other

third parties who have access to our trade secrets, and our agreements with employees also provide that any inventions conceived

by the individual in the course of rendering services to us shall be our exclusive property, we may not obtain these agreements

in all circumstances, and individuals with whom we have these agreements may not comply with their terms.

or inventions in jurisdictions where we have not obtained patent protection to develop and/or manufacture their own products

and may export otherwise infringing products to territories where we have patent protection but where enforcement is not as

strong as that in the United States.

These products may compete with our products and our patent claims or other intellectual

property rights may not be effective or sufficient to prevent them from so competing.

against the unauthorized use of our patented inventions, trademarks and other intellectual property rights is expensive, time

consuming, difficult and in some cases may not be possible.

In some cases, it may be difficult or impossible to detect

third-party infringement or misappropriation of our intellectual property rights, even in relation to issued patent claims,

and proving any such infringement or misappropriation may be even more difficult.

If we are unable to obtain, maintain, and

protect our intellectual property our competitive advantage could be harmed, and it could result in a material adverse effect

on our business, financial condition, results of operations, stock price and prospects.

In addition to

seeking patent protection, we also rely on other proprietary rights, including protection of trade secrets, know-how and

confidential and proprietary information.

Although we enter into confidentiality agreements with our employees, consultants,

collaborators, suppliers, manufacturers and other third parties who have access to our trade secrets, and our agreements with

employees also provide that any inventions conceived by the individual in the course of rendering services to us shall be our

exclusive property, we may not obtain these agreements in all circumstances, and individuals with whom we have these

agreements may not comply with their terms or may have conflicting agreements with third parties.

In addition, in the event

of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not

provide meaningful protection, particularly for our trade secrets or other confidential information.

To the extent that our employees,

consultants or contractors use technology or know-how owned by third parties in their work for us, disputes may arise between us

and those third parties as to the rights in related inventions.

If any of our trade secrets were to be lawfully obtained or independently

developed by a competitor or other third party, we would have no right to prevent them from using that technology or information

to compete with us.

The disclosure of our trade secrets or the independent development of our trade secrets by a competitor or

other third party would impair our competitive position and may materially harm our business, financial condition, results of operations,

stock price and prospects.

of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may

not provide meaningful protection, particularly for our trade secrets or other confidential information.

To the extent that

our employees, consultants or contractors use technology or know-how owned by third parties in their work for us, disputes

may arise between us and those third parties as to the rights in related inventions.

If any of our trade secrets, know-how or

confidential or proprietary information were to be lawfully obtained, patented or independently developed by a competitor or

other third party, we would have no right to prevent them from using that technology or information to compete with us and

may be blocked from using such trade secrets, know-how or confidential or proprietary information ourselves.

The disclosure

of our trade secrets or the independent development of our trade secrets by a competitor or other third party would impair

our competitive position and may materially harm our business, financial condition, results of operations, stock price and

Third parties may in the future initiate

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Third parties may assert infringement or other intellectual property claims against us based on existing patents

or patents that may be granted in the future.

If we are found to infringe a third-party’s intellectual property rights, and

we are unsuccessful in demonstrating that such intellectual property rights are invalid or unenforceable, we could be required

to obtain a license from such third-party to continue developing, manufacturing and commercializing RP1 and our other product candidates.

Even if we were able to obtain a license, it could be nonexclusive, thereby giving our competitors and other third parties access

to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments.

We also could

be forced, including by court order, to cease developing, manufacturing, and commercializing RP1 or our other product candidates

or we could be found liable for significant monetary damages if we are found to have willfully infringed a patent or other intellectual

property right.

or patents that may be filed and\or granted in the future.

If we are found to infringe a third-party’s intellectual property

rights, and we are unsuccessful in demonstrating that such intellectual property rights are invalid or unenforceable, we could

be required to obtain a license from such third-party to continue developing, manufacturing and commercializing RP1 and our other

product candidates.

Such a license may not be available on commercially reasonable terms, or at all.

Even if we were able to obtain

a license, it could be nonexclusive, thereby giving our competitors and other third parties access to the same technologies and

inventions licensed to us, and it could require us to make substantial licensing and royalty payments.

We also could be forced,

including by court order, to cease developing, manufacturing, and commercializing RP1 or our other product candidates or we could

be found liable for significant monetary damages if we are found to have willfully infringed a patent or other intellectual property

Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations,

stock price and prospects.

Any claims by third parties that we have misappropriated their confidential information or trade secrets

could have a similar material adverse effect on our business.

If we or one of our

licensing partners initiate legal proceedings against a third party to enforce a patent covering any of our technology, the defendant

could counterclaim that the patent covering our product candidate is invalid or unenforceable.

If a third party were to prevail

on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection

on RP1 and our other product candidates.

Such a loss of patent protection could have a material adverse impact on our business.

Any claims by third parties that we have misappropriated their know-how, confidential or proprietary

information or trade secrets could have a similar material adverse effect on our business, financial condition, results of operations,

stock price and prospects.

If we or one of

our licensing partners initiate legal proceedings against a third party to enforce a patent covering any of our technology

or inventions, the defendant could counterclaim that the patent covering our product candidate is invalid or unenforceable.

a third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and

perhaps all, of the patent protection on RP1 and our other product candidates.

Such a loss of patent protection could have a

material adverse impact on our business, financial condition, results of operations, stock price and prospects.

Many of our employees,

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Although we take steps to ensure that our employees do not use,

claim as theirs, or misappropriate the intellectual property, proprietary information or know-how of others in their work for us,

we may be subject to claims that we or these employees have used, claimed as theirs, misappropriated or disclosed intellectual

property, including trade secrets or other proprietary information, of any such individual’s current or former employer.

claim as theirs, or misappropriate the intellectual property, confidential or proprietary information, know-how or trade secrets

of others in their work for us, we may be subject to claims that we or these employees have used, claimed as theirs, misappropriated

or disclosed intellectual property, including trade secrets, know-how or other confidential or proprietary information, of any

such individual’s current or former employer.

Litigation may be necessary to defend against such claims.

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

damages, we may lose valuable intellectual property rights or personnel or sustain damages.

Such intellectual property rights could

be awarded to a third party, and we could be required to obtain a license from such third-party to commercialize our technology

Such a license may not be available on commercially reasonable terms, or at all.

If we fail in defending

any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel or sustain

Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from

such third-party to commercialize our technology or products.

Such a license may not be available on commercially reasonable terms,

In addition, we are

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clinical trial.

We also plan to develop our product candidates in combination with products developed by additional companies that

We also may develop our product candidates in combination with products developed by additional companies that

are covered by patents or licenses held by those entities to which we do not have a license.

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In such a case, we could be required to obtain a license from the other company or institution to use the required or desired package

labeling, which may not be available on commercially reasonable terms, or at all.

labeling, which license may not be available on commercially reasonable terms, or at all.

Competitors may infringe

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

with intellectual property litigation in the United States, there is a risk that some of our confidential information could be

compromised by disclosure during this type of litigation.

There could also be public announcements of the results of hearings,

motions or other interim proceedings or developments in any such proceedings.

If securities analysts or investors perceive these

results to be negative, it could have a material adverse effect on the price of shares of our common stock.

Any of the foregoing

may have a material adverse effect on our business, financial condition, results of operations, stock price and prospects.

with intellectual property litigation in the United States, there is a risk that some of our trade secrets, know-how, or proprietary

or confidential information could be compromised by disclosure during this type of litigation.

There could also be public announcements

of the results of hearings, motions or other interim proceedings or developments in any such proceedings.

If securities analysts

or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our common

Any of the foregoing may have a material adverse effect on our business, financial condition, results of operations, stock

price and prospects.

Risks Related to Manufacturing and Our

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other product candidates.

The outcome of these clinical trials is dependent both on the performance of our partners’ products

and product candidates and also on our partners’ ability to deliver sufficient quantities of adequately produced product.

Should any of our partners’ products or product candidates fail to produce the results that we anticipate, we may have to

The outcome of these clinical trials is dependent both on the performance of our partners’

and product candidates and also on our partners’

ability to deliver sufficient quantities of adequately produced product.

Should any of our partners’

products or product candidates fail to produce the results that we anticipate, we may have to

re-run clinical trials for RP1 or our other product candidates or may otherwise be delayed in the commercialization of RP1 or our

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collaborators may not perform their obligations as expected;

collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;

collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

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Our ability to reach a definitive agreement for any collaboration will depend

upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of a number of factors.

upon, among other things, our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed

collaboration and the proposed collaborator’s evaluation of a number of factors.

If we are unable to

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ensuring that each of our trials is conducted in accordance with the general investigational plan and protocols for the trial.

We must also ensure that our preclinical trials are conducted in accordance with the FDA’s Good Laboratory Practice, or GLP,

regulations, as appropriate.

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trials, which would delay the regulatory approval process.

If these third

parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or

clinical trials in accordance with regulatory requirements or our stated protocols, if they need to be replaced or if the

quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory

requirements or for other reasons, our trials may be repeated, extended, delayed, or terminated;

we may not be able to

obtain, or may be delayed in obtaining, marketing approvals for our product candidates;

we may not be able to, or may be

delayed in our efforts to, successfully commercialize our product candidates, or we or they may be subject to regulatory

enforcement actions.

As a result, our results of operations and the commercial prospects for our product candidates would be

harmed, our costs could increase and our ability to generate revenues could be delayed.

To the extent we are unable to

successfully identify and manage the performance of third-party service providers in the future, our business, financial

condition, results of operations, stock price and prospects may be materially harmed.

If these third parties

do not successfully carry out their contractual duties, meet expected deadlines or conduct our preclinical studies or clinical

trials in accordance with regulatory requirements or our stated protocols, if they need to be replaced or if the quality or accuracy

of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory requirements or for other reasons,

our trials may be repeated, extended, delayed, or terminated;

we may not be able to obtain, or may be delayed in obtaining, marketing

approvals for our product candidates;

we may not be able to, or may be delayed in our efforts to, successfully commercialize our

product candidates, or we or they may be subject to regulatory enforcement actions.

As a result, our results of operations and

the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues

could be delayed.

To the extent we are unable to successfully identify and manage the performance of third-party service providers

in the future, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

If any of our relationships

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unable to meet demand for, our product candidates and may lose potential revenues.

Until our manufacturing

facility is fully operational and for a period of time thereafter, we will rely on third-party contract manufacturers to manufacture

our clinical trial product supplies.

As a result, there can be no assurance that our clinical development will not be limited,

interrupted, or of satisfactory quality or continue to be available at acceptable prices.

We continue to rely

on third-party contract manufacturers to manufacture our clinical trial product supplies.

As a result, there can be no assurance

that our clinical development will not be limited, interrupted, or of satisfactory quality or continue to be available at acceptable

We currently have only

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standards may delay our development or commercialization.

Any problems or delays

we experience in preparing for commercial scale manufacturing of a product candidate or component may result in a delay in product

development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability

to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention,

or impairment of clinical development and commercialization of our product candidates and may materially harm our business, financial

condition, results of operations, stock price and prospects.

If our manufacturers

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responsible for the manufacturing of our product candidates and therapeutic substances, other than through our contractual arrangements,

we have little control over our manufacturers’ compliance with these regulations and standards.

we have little control over our manufacturers’

compliance with these regulations and standards.

If the FDA or a comparable

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environmental or safety incidents and other liabilities.

If the safety of any quantities supplied is compromised due to our manufacturers’

failure to adhere to applicable laws or for other reasons, we may not be able to obtain regulatory approval for or successfully

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which may be delayed or which we may never receive.

We will further need to comply with the FDA’s and applicable foreign

regulatory authorities’ cGMP requirements for the production of our product candidates for clinical trials and, if approved,

We will further need to comply with the FDA’s and applicable foreign

regulatory authorities’

cGMP requirements for the production of our product candidates for clinical trials and, if approved,

commercial supply, and will be subject to FDA and comparable foreign regulatory authority inspection.

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manufacturing facility, we may be forced to devote greater resources and management time than anticipated, particularly in areas

relating to operations, quality, regulatory, facilities and information technology.

If we experience unanticipated employee turnover

in any of these areas, we may not be able to effectively manage our ongoing manufacturing operations and we may not achieve the

operating efficiencies that we anticipate from the new facility, which may negatively affect our product development timeline.

Any such problems could

result in the delay, prevention, or impairment of clinical development and commercialization of our product candidates and may

materially harm our business, financial condition, results of operations, stock price and prospects.

relating to operations, quality, raw material supply, regulatory, facilities and information technology.

If we experience unanticipated

employee turnover in any of these areas, we may not be able to effectively manage our ongoing manufacturing operations and we may

not achieve the operating efficiencies that we anticipate from the new facility, which may negatively affect our product development

If we experience any unanticipated shortages of key raw materials, or other difficulties related to our raw material

supply, we may not be able to effectively manage our ongoing manufacturing timelines which may negatively affect our product development

schedule and our ability to provide clinical trial supplies to patients in our clinical trials.

Any problems or delays

we experience in preparing for commercial scale manufacturing of a product candidate or component may result in a delay in product

development timelines and FDA or comparable foreign regulatory authority approval of the product candidate or may impair our ability

to manufacture commercial quantities or such quantities at an acceptable cost and quality, which could result in the delay, prevention,

or impairment of clinical development and commercialization of our product candidates and may materially harm our business, financial

condition, results of operations, stock price and prospects.

Any such problems could result in the delay,

prevention, or impairment of clinical development and commercialization of our product candidates and may materially harm our business,

financial condition, results of operations, stock price and prospects.

Risks Related to Legal and Compliance

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of any approved products and/or our product candidates.

The use of our

product candidates in clinical trials, and the sale of any product for which we obtain regulatory approval, exposes us to the

risk of product liability claims.

We face inherent risk of product liability related to the testing of our product candidates

in human clinical trials, including liability relating to the actions and negligence of our investigators, and will face an

even greater risk if we commercially sell any product candidates that we may develop.

Any such product liability claims may

include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product,

negligence, strict liability or a breach of warranties.

The use of our product

candidates in clinical trials, and the sale of any product for which we obtain regulatory approval, exposes us to the risk of product

liability claims.

We face inherent risk of product liability related to the testing of our product candidates in human clinical

trials, including liability relating to the actions and negligence of our investigators, and will face an even greater risk if

we commercially sell any product candidates that we may develop.

Any such product liability claims may include allegations of defects

in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach

of warranties.

Claims could also be asserted under state consumer protection acts.

Product liability claims might be brought against us by consumers, healthcare providers or others using, administering or

selling our products.

If we cannot successfully defend ourselves against these claims, we will incur substantial liabilities

or be required to limit commercialization of our product candidates.

Even successful defense would require significant

financial and management resources.

Regardless of merit or eventual outcome, liability claims may result in:

Product liability claims might be brought against

us by consumers, healthcare providers or others using, administering or selling our products.

If we cannot successfully defend

ourselves against these claims, we will incur substantial liabilities or be required to limit commercialization of our product

Even successful defense would require significant financial and management resources.

Regardless of merit or eventual

outcome, liability claims may result in:

loss of revenue from decreased demand for our products and/or product candidates;

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of operations, stock price and prospects.

Our operations are subject to

anticorruption laws, including the U.S.

Our operations are

subject to anticorruption laws, including the U.S.

Foreign Corrupt Practices Act, or FCPA, the U.K.

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Act, and other anticorruption laws that apply in countries where we do business.

We also may participate in collaborations

and relationships with third parties whose actions, if noncompliant, could potentially subject us to liability under the

FCPA, Bribery Act or local anticorruption laws.

We are also subject to other laws and regulations governing our international

operations, including regulations administered by the governments of the United States and the United Kingdom and authorities

in the European Union, including applicable import and export control regulations, economic sanctions on countries and

persons, anti-money laundering laws, customs requirements and currency exchange regulations, collectively referred to as the

trade control laws.

We also may participate in collaborations and

relationships with third parties whose actions, if noncompliant, could potentially subject us to liability under the FCPA, Bribery

Act or local anticorruption laws.

We are also subject to other laws and regulations governing our international operations, including

regulations administered by the governments of the United States and the United Kingdom and authorities in the European Union,

including applicable import and export control regulations, economic sanctions on countries and persons, anti-money laundering

laws, customs requirements and currency exchange regulations, collectively referred to as the trade control laws.

We can provide no assurance

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certain federal and state healthcare laws, and regulations pertaining to fraud and abuse, reimbursement programs, government procurement,

and patients’ rights are and will be applicable to our business.

and patients’

rights are and will be applicable to our business.

We would be subject to healthcare fraud and abuse and patient

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Union to the United States to ensure that European Union standards of data privacy will be applied to such data.

If we or our operations are found to be

in violation of any federal or state healthcare law, or any other governmental laws or regulations that apply to us, we may be

subject to penalties, including civil, criminal, and administrative penalties, damages, fines, disgorgement, suspension and debarment

from government contracts, and refusal of orders under existing government contracts, exclusion from participation in U.S.

or state health care programs, corporate integrity agreements, and the curtailment or restructuring of our operations, any of which

could materially adversely affect our ability to operate our business and our financial results.

If any of the physicians or other

healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, it may

be subject to criminal, civil or administrative sanctions, including but not limited to, exclusions from participation in government

healthcare programs, which could also materially affect our business.

Any action against us for violation of these laws, even if

we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s attention

from the operation of our business.

If the government or third- party

payors fail to provide adequate coverage, reimbursement and payment rates for our product candidates, or if health maintenance

organizations or long-term care facilities choose to use therapies that are less expensive or considered a better value, our revenue

and prospects for profitability will be limited.

In both domestic

and foreign markets, sales of our products will depend in part upon the availability of coverage and reimbursement from

third-party payors.

Such third-party payors include government health programs such as Medicare and Medicaid, managed care

providers, private health insurers, and other organizations.

Coverage decisions may depend upon clinical and economic

standards that disfavor new therapeutic products when more established or lower cost therapeutic alternatives are already

available or subsequently become available, even if our products are alone in a class.

If reimbursement is not available, or

is available only to limited levels, our product candidates may be competitively disadvantaged, and we may not be able to

successfully commercialize our product candidates.

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

high enough to allow us to establish or maintain a market share sufficient to realize a sufficient return on our or their

Alternatively, securing favorable reimbursement terms may require us to compromise pricing and prevent us from

realizing an adequate margin over cost.

There is significant

uncertainty related to third-party payor coverage and reimbursement of newly approved therapeutics.

Marketing approvals, pricing,

and reimbursement for new therapeutic products vary widely from country to country.

Current and future legislation may significantly

change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals.

Some countries

require approval of the sale price of a therapeutic before it can be marketed.

In many countries, the pricing review period begins

after marketing or product licensing approval is granted.

In some foreign markets, prescription biopharmaceutical pricing remains

subject to continuing governmental control even after initial approval is granted.

As a result, we might obtain marketing approval

for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly

for lengthy time periods, which may negatively impact the revenues we are able to generate from the sale of the product in that

Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if

our product candidates obtain marketing approval.

Our ability to commercialize our product candidates will depend in part on the

extent to which coverage and reimbursement for these products and related treatments will be available from government health administration

authorities, private health insurers and other organizations.

Third-party payors,

whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare

In addition, in the United States, no uniform policy of coverage and reimbursement for products exists among third-party

Therefore, coverage and reimbursement for products can differ significantly from payor to payor.

Further, we believe that

future coverage and reimbursement will likely be subject to increased restrictions both in the United States and in international

Third-party coverage and reimbursement for our products or product candidates for which we receive regulatory approval

may not be available or adequate in either the United States or international markets, which could have a negative effect on our

business, financial condition, results of operations, stock price and prospects.

Assuming coverage is

approved, the resulting reimbursement payment rates might not be adequate.

If payors subject our product candidates to maximum

payment amounts, or impose limitations that make it difficult to obtain reimbursement, providers may choose to use therapies which

are less expensive when compared to our product candidates.

Additionally, if payors require high copayments, beneficiaries may

seek alternative therapies.

We may need to conduct post-marketing studies in order to demonstrate the cost effectiveness of any

products to the satisfaction of hospitals, other target customers and their third-party payors.

Such studies might require us to

commit a significant amount of management time and financial and other resources.

Our products might not ultimately be considered

cost effective.

Adequate third-party coverage and reimbursement might not be available to enable us to maintain price levels sufficient

to realize an appropriate return on investment in product development.

In addition, federal

programs impose penalties on manufacturers of therapeutics in the form of mandatory additional rebates and/or discounts if commercial

prices increase at a rate greater than the Consumer Price Index Urban, and these rebates and/or discounts, which can be substantial,

may impact our ability to raise commercial prices.

A few states have also passed or are considering legislation intended to prevent

significant price increases.

Regulatory authorities and third-party payors have attempted to control costs by limiting coverage

and the amount of reimbursement for particular medications, which could affect our ability to sell our product candidates profitably.

These payors may not view our products, if any, as cost effective, and coverage and reimbursement may not be available to our customers,

or may not be sufficient to allow our products, if any, to be marketed on a competitive basis.

Cost control initiatives could cause

us to decrease, discount, or rebate a portion of the price we, or they, might establish for products, which could result in lower

than anticipated product revenues.

If the realized prices for our products, if any, decrease or if governmental and other third-party

payors do not provide adequate coverage or reimbursement, our prospects for revenue and profitability will suffer.

There may also be

delays in obtaining coverage and reimbursement for newly approved therapeutics, and coverage may be more limited than the

indications for which the product is approved by the FDA or comparable foreign regulatory authorities.

Such delays have made

it increasingly common for manufacturers to provide newly approved drugs to patients experiencing coverage delays or

disruption at no cost for a limited period in order to ensure that patients are able to access the drug.

eligibility for reimbursement does not imply that any therapeutic will be paid for in all cases or at a rate that covers our

costs, including research, development, manufacture, sale, and distribution.

Interim reimbursement levels for new

therapeutics, if applicable, may also not be sufficient to cover our costs and may only be temporary.

In addition, third-party

payors are increasingly requiring higher levels of evidence of the benefits and clinical outcomes of new technologies, benchmarking

against other therapies, seeking performance-based discounts, and challenging the prices charged.

We cannot be sure that coverage

will be available for any product candidate that we commercialize and, if available, that the reimbursement rates will be adequate.

An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any of our

product candidates for which we obtain marketing approval could have a material adverse effect on our operating results, our ability

to raise capital needed to commercialize products and our overall financial condition.

If we or our operations

are found to be in violation of any federal or state healthcare law, or any other governmental laws or regulations that apply to

us, we may be subject to penalties, including civil, criminal, and administrative penalties, damages, fines, disgorgement, suspension

and debarment from government contracts, and refusal of orders under existing government contracts, exclusion from participation

federal or state health care programs, corporate integrity agreements, and the curtailment or restructuring of our operations,

any of which could materially adversely affect our ability to operate our business and our financial results.

If any of the physicians

or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws,

it may be subject to criminal, civil or administrative sanctions, including but not limited to, exclusions from participation in

government healthcare programs, which could also materially affect our business.

Any action against us for violation of these laws,

even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’s

attention from the operation of our business.

We are subject to new legislation,

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adverse effect on the success of our business.

We are subject to

numerous environmental, health and safety laws and regulations, including those governing laboratory procedures, the

handling, use, storage, treatment and disposal of hazardous materials and wastes and the cleanup of contaminated sites.

operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive

Our operations also produce hazardous waste products.

We would incur substantial costs as a result of violations

of or liabilities under environmental requirements in connection with our operations or property, including fines, penalties

and other sanctions, investigation and cleanup costs and third-party claims.

In the event of contamination or injury

resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could

exceed our resources.

We also could incur significant costs associated with civil or criminal fines and penalties.

We are subject to numerous

environmental, health and safety laws and regulations, including those governing laboratory procedures, the handling, use, storage,

treatment and disposal of hazardous materials and wastes and the cleanup of contaminated sites.

Our operations involve the use

of hazardous and flammable materials, including chemicals and biological and radioactive materials.

Our operations also produce

hazardous waste products.

We would incur substantial costs as a result of violations of or liabilities under environmental requirements

in connection with our operations or property, including fines, penalties and other sanctions, investigation and cleanup costs

and third-party claims.

In the event of contamination or injury resulting from our use of hazardous materials, we could be held

liable for any resulting damages, and any liability could exceed our resources.

We also could incur significant costs associated

with civil or criminal fines and penalties.

Although we maintain

workers’ compensation insurance to cover costs and expenses we may incur due to injuries to our employees resulting from

workers’

compensation insurance to cover costs and expenses we may incur due to injuries to our employees resulting from

the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities.

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Our financial condition and results

of operations could be adversely affected by the recent novel coronavirus disease-2019, or COVID-19, outbreak.

of operations could be adversely affected by the coronavirus disease-2019, or COVID-19, outbreak.

In December 2019,

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trial staff to work remotely and avoid unnecessary travel.

While these restrictions and orders have eased in certain geographies

in which we operate, the effect of these restrictions and orders has impacted the pace of enrollment in our clinical trials, and

if they continue, may affect our results and operations.

pandemic is affecting the United States and global economies and has affected and may continue to affect our operations and

those of third parties on which we rely, including by causing disruptions in our raw material and anti-PD-1 supply, the

manufacturing of our product candidates, the commercialization of our product candidates and the conduct of current and

future clinical trials.

In addition, the COVID-19 pandemic has affected and may continue to affect the operations of the FDA

and comparable foreign regulatory authorities, which could result in delays of reviews and approvals, including with respect

to RP1 and our other product candidates.

The evolving COVID-19 pandemic has also directly or indirectly impacted and is

likely to continue to impact the pace of enrollment in our clinical trials as patients may avoid or may not be able to travel

to healthcare facilities and physicians' offices unless due to a health emergency and clinical trial staff may no longer be

able to get to the clinic.

Such facilities and offices have and may continue to be required to focus limited resources on

non-clinical trial matters, including treatment of COVID-19 patients, and may not be available, in whole or in part, for

clinical trial services.

For example, our clinical trial of RP1 in solid organ transplant patients with CSCC, representing a

highly immunocompromised patient populations, has been slower than expected.

In addition, employee disruptions and remote

working environments related to the COVID-19 pandemic and the federal, state and local responses to such virus, could

materially impact the efficiency and pace with which we work and develop our product candidates.

The effect of these restrictions and orders has impacted the pace of

enrollment in our clinical trials, and if they continue, may affect our results and operations.

The COVID-19 pandemic

and the government and public health response continues to rapidly evolve.

In light of the COVID-19 pandemic, the FDA has issued

a number of new guidance documents.

Specifically, as a result of the potential effect of the COVID-19 pandemic on many clinical

trial programs in the United States and globally, the FDA issued guidance concerning potential impacts on clinical trial programs,

changes that may be necessary to such programs if they proceed, considerations regarding trial suspensions and discontinuations,

the potential need to consult with or make submissions to relevant ethics committees, IRBs, and the FDA, the use of alternative

drug delivery methods, and considerations with respect the outbreak's impacts on endpoints, data collection, study procedures,

and analysis.

Additionally, in March 2020, the U.S.

Congress passed the Coronavirus Aid, Relief, and Economic Security Act,

which includes a number of provisions that are applicable to the pharmaceutical industry, and further acts, laws or regulations

may be enacted or implemented in the future.

is affecting the United States and global economies and has affected and may continue to affect our operations and those of third

parties on which we rely, including by causing disruptions in our raw material and anti-PD-1 supply, the manufacturing of our product

candidates, our commercialization processes and the conduct and the enrollment of current and future clinical trials.

the COVID-19 pandemic has affected and may continue to affect the operations of the FDA and comparable foreign regulatory authorities,

which could result in delays of reviews and approvals, including with respect to RP1 and our other product candidates.

COVID-19 pandemic has also directly or indirectly impacted and is likely to continue to impact the pace of enrollment in our clinical

trials as patients may avoid or may not be able to travel to healthcare facilities and physicians' offices unless due to a health

emergency, and clinical trial staff may no longer be able to get to the clinic.

Such facilities and offices have and may continue

to be required to focus limited resources on non-clinical trial matters, including treatment of COVID-19 patients, and may not

be available, in whole or in part, for clinical trial services.

For example, our clinical trial of RP1 in solid organ transplant

patients with CSCC, representing a highly immunocompromised patient populations, has been and continues to be slower than expected

as a result, in part, of the COVID-19 pandemic.

In addition, employee disruptions and remote working environments related to the

COVID-19 pandemic and the federal, state and local responses to such virus, could materially impact the efficiency and pace with

which we work and develop our product candidates.

The COVID-19 pandemic

and the government and public health response continues to rapidly evolve and fluctuation in infection rates in the regions in

which we operate has resulted in periodic changes in restrictions that vary from region to region and require vigilant attention

and rapid response to new or reinstated orders.

In light of the COVID-19 pandemic, the FDA has issued a number of new guidance

Specifically, as a result of the potential effect of the COVID-19 pandemic on many clinical trial programs in the United

States and globally, the FDA issued guidance concerning potential impacts on clinical trial programs, changes that may be necessary

to such programs if they proceed, considerations regarding trial suspensions and discontinuations, the potential need to consult

with or make submissions to relevant ethics committees, IRBs, and the FDA, the use of alternative drug delivery methods, and

considerations with respect the outbreak's impacts on endpoints, data collection, study procedures, and analysis.

Additionally,

in March 2020, the U.S.

Congress passed the Coronavirus Aid, Relief, and Economic Security Act, which includes a number of

provisions that are applicable to the pharmaceutical industry, and further acts, laws or regulations may be enacted or implemented

in the future.

While the potential

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of actions taken in the United States and other countries to contain and treat the disease.

While vaccines for COVID-19 are being,

and have been developed, there is no guarantee that any such vaccine will be effective, work as expected or be made available or

will be accepted on a significant scale and in a timely manner.

We do not yet know

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retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the highly competitive

biotechnology and pharmaceutical industries depends upon our ability to attract, motivate and retain highly qualified managerial,

scientific and medical personnel.

We are highly dependent on our management and particularly on the services of our founders, as

well as our other scientific, manufacturing, quality and medical personnel, including Philip Astley-Sparke, our Chief Executive

Officer, Robert Coffin, Ph.D., our President and Chief Research & Development Officer, and Colin Love, Ph.D., our Chief

Operating Officer.

The loss of the services of our key personnel and any of our other executive officers, key employees, and scientific

and medical advisors, and our inability to find suitable replacements, could result in delays in product development and harm our

Competition for skilled

personnel is intense and the turnover rate can be high, which may limit our ability to hire and retain highly qualified personnel

on acceptable terms or at all.

Our ability to compete

in the highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract, motivate and retain

highly qualified managerial, scientific and medical personnel.

We are highly dependent on our management and particularly on the

services of our founders, as well as our other scientific, manufacturing, quality and medical personnel, including Philip Astley-Sparke,

our Chief Executive Officer, Robert Coffin, Ph.D., our President and Chief Research & Development Officer, and Colin Love,

Ph.D., our Chief Operating Officer.

The loss of the services of our key personnel and any of our other executive officers, key

employees, and scientific and medical advisors, and our inability to find suitable replacements, could result in delays in product

development and harm our business.

Additionally, competition for skilled personnel is intense and the turnover rate can be

high, which may limit our ability to hire and retain highly qualified personnel on acceptable terms or at all.

To induce valuable

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In connection with

the audits of our consolidated financial statements as of and for the years ended March 31, 2020, 2019 or 2018, we identified

the audits of our consolidated financial statements as of and for the years ended March 31, 2020, 2019, 2018 and 2017 we identified

material weaknesses in our internal control over financial reporting.

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for the years ended March 31, 2020, 2019, 2018 or 2017.

A material weakness is a deficiency, or a combination of deficiencies, in

internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual

A material weakness is a deficiency, or a combination of deficiencies,

in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual

or interim financial statements will not be prevented or detected on a timely basis.

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In December 2019 we hired Jean Franchi, our first Chief Financial Officer, and we continue

to hire additional finance and accounting personnel.

We have also engaged a third-party consulting firm to assist us in the design

and documentation of appropriate controls.

We are continuing these efforts in order to design and implement our financial control

environment, including the establishment of controls to account for and disclose complex transactions.

to hire additional finance, legal and accounting personnel.

We have also engaged a third-party consulting firm to assist us in

the design and documentation of appropriate controls.

We are continuing these efforts in order to design and implement our financial

control environment, including the establishment of controls to account for and disclose complex transactions.

We cannot assure you

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all control issues and instances of fraud will be detected.

These inherent

limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of simple

error or mistake.

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more

people or by an unauthorized override of the controls.

Accordingly, because of the inherent limitations in our control system,

misstatements due to error or fraud may occur and not be detected.

These inherent limitations

include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of simple error or

Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people

or by an unauthorized override of the controls.

Accordingly, because of the inherent limitations in our control system, misstatements

due to error or fraud may occur and not be detected.

Our disclosure controls and procedures

were not effective as of September 30, 2020, and in any event may not prevent or detect all errors or acts of fraud.

were not effective as of December 31, 2020, and in any event may not prevent or detect all errors or acts of fraud.

We must design our

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specified in the rules and forms of the SEC.

Based on the evaluation of our disclosure controls and procedures as of September

30, 2020, we concluded that, as of September 30, 2020, our disclosure controls and procedures were not effective at the

reasonable assurance level as a result of the material weaknesses discussed above.

Notwithstanding these material weaknesses, our

management has concluded that the financial statements included elsewhere in this Quarterly Report present fairly, in all material

respects, our financial position, results of operations and cash flows in conformity with generally accepted accounting principles.

We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated,

can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

Based on the evaluation of our disclosure controls and procedures as of December 31,

2020, we concluded that, as of December 31, 2020, our disclosure controls and procedures were not effective at the reasonable

assurance level as a result of the material weaknesses discussed above.

Notwithstanding these material weaknesses, our management

has concluded that the financial statements included elsewhere in this Quarterly Report present fairly, in all material respects,

our financial position, results of operations and cash flows in conformity with generally accepted accounting principles.

that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can

provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations

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due to error or fraud may occur and not be detected.

If we engage in future acquisitions

or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume

contingent liabilities, and subject us to other risks.

We may evaluate various

acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights,

technologies, or businesses.

Any potential acquisition or strategic partnership may entail numerous risks, including:

increased operating expenses and cash requirements;

the assumption of additional indebtedness or contingent liabilities;

the issuance of our equity securities;

assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;

risks and uncertainties associated with the other party to such a transaction, including the prospects of that party, their regulatory compliance status, and their existing products or product candidates and marketing approvals;

our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance costs.

In addition, if we

undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large onetime expenses and acquire

intangible assets that could result in significant future amortization expense or intangible asset impairment charges.

we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access

to technology or products that may be important to the development of our business.

Any of the foregoing may materially harm our

business, financial condition, results of operations, stock price and prospects.

Unfavorable market and economic conditions

may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.

Our results of operations

could be adversely affected by general conditions in the global economy and in the global financial markets.

The most recent global

financial crisis caused extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn

could result in a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable

terms, if at all.

A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption.

the foregoing could harm our business and we cannot anticipate all of the ways in which the economic climate and financial market

conditions could adversely impact our business.

Global financial markets

have been experiencing extreme disruption in recent months, including, among other things, extreme volatility in securities prices.

We are unable to predict the likely duration and severity of the current disruptions in financial markets and adverse economic

conditions throughout the world.

These economic developments affect businesses such as ours and those of third parties on which

we rely in a number of ways that could result in unfavorable consequences to us.

Current economic conditions or a deepening economic

downturn in the United States and elsewhere may reduce our ability to access capital, which could negatively impact our short-term

and long-term liquidity.

Although we are not

aware of any downgrades, material losses, or other significant deterioration in the fair value of our cash equivalents or short-term

investments, we cannot assure you that deterioration of the global credit and financial markets would not negatively impact our

current portfolio of cash equivalents or short-term investments, or our ability to meet our financing objectives.

our stock price may decline due, in part, to the volatility of the stock market and general economic downturns.

Exchange rate fluctuations may materially

affect our results of operations and financial conditions.

Owing to the international

scope of our operations, fluctuations in exchange rates, particularly between the U.S.

dollar and the British pound and the euro,

may adversely affect us.

Although we are based in the United States, we have significant research and development operations in

the United Kingdom, and source third-party manufacturing, consulting and other services in the United Kingdom and the European

As a result, our business and the price of our common stock may be affected by fluctuations in foreign exchange rates, which

may have a significant impact on our results of operations and cash flows from period to period.

Currently, we do not have any

exchange rate hedging arrangements in place.

Risks Related to Our Common Stock

Risks Related to Our Common Stock and

General Risks

An active trading market for our

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political and economic instability, including the impact of COVID-19, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships and military and political alliances;

the other factors described in this “Risk factors” section.

the other factors described in this “Risk factors”

Our operating results may fluctuate

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compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award

as determined by our board of directors, and recognize the cost as an expense over the employee’s requisite service period.

As the variables that we use as a basis for valuing these awards change over time, including, our underlying stock price and stock

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our ability to enroll patients in clinical trials and the timing of enrollment;

the cost of manufacturing our current and any future product candidates, which may vary depending on the FDA’s and comparable foreign regulatory authorities’ guidelines and requirements, the quantity of production and the terms of any agreements with manufacturers;

the cost of manufacturing our current and any future product candidates, which may vary depending on the FDA’s and comparable foreign regulatory authorities’

guidelines and requirements, the quantity of production and the terms of any agreements with manufacturers;

expenditures that we will or may incur to acquire or develop additional product candidates and technologies;

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potential unforeseen business disruptions that increase our costs or expenses;

political and economic instability, including the impact of the COVID-19 coronavirus, the possibility of an economic recession, international hostilities, acts of terrorism and governmental restrictions, inflation, trade relationships and military and political alliances;

future accounting pronouncements or changes in our accounting policies;

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and other operating expenses.

As a result, investors will be relying upon management’s judgment with only limited information

about our specific intentions for the use of our resources.

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We may sell up to $62.5

million of shares of our common stock in “at-the-market” offerings pursuant to the sales agreement entered into with

million of shares of our common stock in “at-the-market”

offerings pursuant to the sales agreement entered into with

SVB Leerink LLC on August 11, 2020 and as amended on October 21 2020.

The sale of a substantial number of shares of our common

stock pursuant to the sales agreement, or anticipation of such sales, could cause the trading price of our common stock to decline

or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might

otherwise desire.

In addition, issuances of any shares of our common stock sold pursuant to the sales agreement will have a dilutive

effect on our existing stockholders.

The sale of a substantial number of shares of our

common stock pursuant to the sales agreement, or anticipation of such sales, could cause the trading price of our common stock

to decline or make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price

that we might otherwise desire.

In addition, issuances of any shares of our common stock sold pursuant to the sales agreement will

have a dilutive effect on our existing stockholders.

Raising additional capital may cause

dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

To the extent that

we raise additional capital through the sale of common stock or securities convertible, exercisable or exchangeable into common

stock, our existing stockholders’

interest will be diluted.

Debt financing, if available, would increase our fixed payment

obligations and may involve agreements that include covenants limiting or restricting our ability to take specific actions, such

as incurring additional debt, making capital expenditures or declaring dividends.

If we are unable to

raise additional funds through equity or debt financings when needed, we may be required to grant rights to develop and market

one or more of our product candidates or technologies that we would otherwise prefer to develop and market ourselves.

If we engage in future acquisitions

or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume

contingent liabilities, and subject us to other risks.

We may evaluate various

acquisitions and strategic partnerships, including licensing or acquiring complementary products, intellectual property rights,

technologies, or businesses.

Any potential acquisition or strategic partnership may entail numerous risks, including:

increased operating expenses and cash requirements;

the assumption of additional indebtedness or contingent liabilities;

the issuance of our equity securities;

assimilation of operations, intellectual property and products of an acquired company, including difficulties associated with integrating new personnel;

the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;

retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;

In addition, if we

undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large onetime expenses and acquire

intangible assets that could result in significant future amortization expense or intangible asset impairment charges.

we may not be able to locate suitable acquisition opportunities and this inability could impair our ability to grow or obtain access

to technology or products that may be important to the development of our business.

Any of the foregoing may materially harm our

business, financial condition, results of operations, stock price and prospects.

Unfavorable market and economic conditions

may have serious adverse consequences on our business, financial condition, results of operations, stock price and prospects.

Our results of operations

could be adversely affected by general conditions in the global economy and in the global financial markets.

The most recent global

financial crisis caused extreme volatility and disruptions in the capital and credit markets.

A severe or prolonged economic downturn

could result in a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable

terms, if at all.

A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption.

the foregoing could harm our business and we cannot anticipate all of the ways in which the economic climate and financial market

conditions could adversely impact our business.

Global financial markets

have been experiencing extreme disruption in recent months, including, among other things, extreme volatility in securities prices.

We are unable to predict the likely duration and severity of the current disruptions in financial markets and adverse economic

conditions throughout the world.

These economic developments affect businesses such as ours and those of third parties on which

we rely in a number of ways that could result in unfavorable consequences to us.

Current economic conditions or a deepening economic

downturn in the United States and elsewhere may reduce our ability to access capital, which could negatively impact our short-term

and long-term liquidity.

Although we are not

aware of any downgrades, material losses, or other significant deterioration in the fair value of our cash equivalents or short-term

investments, we cannot assure you that deterioration of the global credit and financial markets would not negatively impact our

current portfolio of cash equivalents or short-term investments, or our ability to meet our financing objectives.

our stock price may decline due, in part, to the volatility of the stock market and general economic downturns.

Exchange rate fluctuations may materially

affect our results of operations and financial conditions.

Owing to the international

scope of our operations, fluctuations in exchange rates, particularly between the U.S.

dollar and the British pound and the euro,

may adversely affect us.

Although we are based in the United States, we have significant research and development operations in

the United Kingdom, and source third-party manufacturing, consulting and other services in the United Kingdom and the European

As a result, our business and the price of our common stock may be affected by fluctuations in foreign exchange rates, which

may have a significant impact on our results of operations and cash flows from period to period.

Currently, we do not have any

exchange rate hedging arrangements in place.

Unregistered Sales of Equity Securities and

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

What changed 10-Q

Item 1A. Risk Factors