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Item 1A. Risk Factors

2021-08-06 compared with 2021-02-04 · 643 added, 1709 removed, 199 unchanged (92% of the section changed)

Investing in our

common stock involves a high degree of risk.

You should carefully consider the risks and uncertainties described below, together

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.”

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

and adversely affected.

Investing in our common stock involves a high degree of risk.

You should carefully consider the risks and uncertainties described below, together 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 any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected.

In that event, the price of our common stock could decline, and you could lose part or all of your investment.

The risks and uncertainties described below are not the only ones we face.

Additional risks and uncertainties not presently known

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

Additional risks and uncertainties not presently known 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.

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

• 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 novel 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 or the market acceptance of 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 than us;

• negative developments in the field of immuno-oncology including clinical or commercial developments that may be attributed to our product candidates;

• 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 industry;

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

Risks related to product development

Our product candidates are in the

early stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially

Our product candidates are in the early stages of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.

We have never generated any revenue from product sales and may never be profitable.

All of our product

candidates are in research or early development.

We have not generated any revenues from the sale of products and do not expect

to do so for at least the next several years.

Our lead product candidate, RP1, and any other product candidates will require extensive

preclinical and/or clinical testing and regulatory approval prior to commercial use.

Our research and development efforts may not

be successful.

Even if our clinical development efforts result in positive data, our product candidates may not receive regulatory

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

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

our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate

the safety and efficacy of our product candidates.

Our product candidates

are susceptible to the risks of failure inherent at any stage of product development, including the occurrence of unexpected or

unacceptable adverse events or the failure to demonstrate efficacy in clinical trials.

Clinical development is expensive and can

take many years to complete, and its outcome is inherently uncertain.

The results of preclinical

studies, preliminary study results, and early clinical trials of our product candidates may not be predictive of the results of

later stage clinical trials.

Our product candidates may not perform as we expect, may ultimately have a different or no impact

on tumors, may have a different mechanism of action than we expect in humans, and may not ultimately prove to be safe and effective.

Preliminary and final

results from preclinical studies and early stage trials, and trials in compounds that we believe are similar to ours, may not be

representative of results that are found in larger, controlled, blinded, and longer-term studies.

Product candidates may fail at

any stage of preclinical or clinical development.

Product candidates may fail to show the desired safety and efficacy traits even

if they have progressed through preclinical studies or initial clinical trials.

Preclinical studies and clinical trials may also

reveal unfavorable product candidate characteristics, including safety concerns.

A number of companies in the biopharmaceutical

industry have suffered significant setbacks in clinical trials, notwithstanding promising results in earlier preclinical studies

or clinical trials or promising mechanisms of action.

In some instances, there can be significant variability in safety or efficacy

results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures

set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial

protocols and the rate of dropout among clinical trial participants.

Moreover, should there be an issue with the design of a clinical

trial, our results may be impacted.

All of our product candidates are in research or early development.

We have not generated any revenues from the sale of products and do not expect to do so for at least the next several years.

Our lead product candidate, RP1, and any other product candidates will require extensive preclinical and/or clinical testing and regulatory approval prior to commercial use.

Our research and development efforts may not be successful.

Even if our clinical development efforts result in positive data, our product candidates may not receive regulatory approval or be successfully introduced and marketed at prices that would permit us to operate profitably.

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 our product candidates if our preclinical studies do not produce successful results and/or our clinical trials do not demonstrate the safety and efficacy of our product candidates.

Our product candidates are susceptible to the risks of failure inherent at any stage of product development, including the occurrence of unexpected or unacceptable adverse events or the failure to demonstrate efficacy in clinical trials.

Clinical development is expensive and can take many years to complete, and its outcome is inherently uncertain.

The results of preclinical studies, preliminary study results, and early clinical trials of our product candidates may not be predictive of the results of later stage clinical trials.

Our product candidates may not perform as we expect, may ultimately have a different or no impact on tumors, may have a different mechanism of action than we expect in humans, and may not ultimately prove to be safe and effective.

Preliminary and final results from preclinical studies and early stage trials, and trials in compounds that we believe are similar to ours, may not be representative of results that are found in larger, controlled, blinded, and longer-term studies.

Product candidates may fail at any stage of preclinical or clinical development.

Product candidates may fail to show the desired safety and efficacy traits even if they have progressed through preclinical studies or initial clinical trials.

Preclinical studies and clinical trials may also reveal unfavorable product candidate characteristics, including safety concerns.

A number of companies in the biopharmaceutical industry have suffered significant setbacks in clinical trials, notwithstanding promising results in earlier preclinical studies or clinical trials or promising mechanisms of action.

In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Moreover, should there be an issue with the design of a clinical trial, our results may be impacted.

We may not discover such a flaw until the clinical trial is at an advanced stage.

We may also experience

numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing

approval or commercialize our product candidates, including:

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

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• changes could be adopted in marketing approval policies during the development period, rendering our data insufficient to obtain marketing approval;

statutes or regulations could be amended or new ones could be adopted;

• statutes or regulations could be amended or new ones could be adopted, especially in light of the new Administration in the United States;

• changes could be adopted in the regulatory review process for submitted product applications;

• the cost of clinical trials of our product candidates may be greater than we anticipate or we may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA upon the filing of a Biologics License Application, or BLA, or equivalent authorizations from comparable foreign regulatory authorities;

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate;

• the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate or we may not be able to obtain them on favorable terms due to reasons such as international trade policies;

• we may decide, or regulators may require us, to conduct or gather, as applicable, additional clinical trials, analyses, reports, data, or preclinical trials, or we may abandon product development programs;

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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 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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• the FDA or comparable foreign regulatory authorities may fail to approve or subsequently find fault with the manufacturing processes or our manufacturing facilities for clinical and future commercial supplies;

the data collected from clinical trials of our product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;

• the data collected from clinical trials of our product candidates, including our registration directed or registration intended trials, may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;

• the FDA or comparable foreign regulatory authorities may take longer than we anticipate to make a decision on our product candidates;

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• we, the third parties on which we rely, and the FDA may have delays in the conduct of our respective operations as a result of the effects of the COVID-19 pandemic, which could result in delays or prevent our ability to receive marketing approval or commercialize our product candidates.

Our development costs

will also increase if we experience delays in testing or approvals, and we may not have sufficient funding to complete the testing

and approval process for any of our product candidates.

We may be required to obtain additional funds to complete clinical trials

and prepare for possible commercialization of our product candidates.

We do not know whether any preclinical tests or clinical

trials beyond what we currently have planned will be required, will begin as planned, will need to be restructured, or will be

completed on schedule, or at all.

Significant delays relating to any preclinical or clinical trials also could shorten any periods

during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products

to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and

results of operations.

In addition, many of the factors that cause, or lead to, delays in clinical trials may ultimately lead to

the denial of marketing approval of any of our product candidates.

If any of these occur, our business, financial condition, results

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

We anticipate that our product candidates

will be used in combination with third-party drugs, some of which are still in development, and we have limited or no control over

the supply, regulatory status, or regulatory approval of such drugs.

Our product candidates

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.

We have entered into agreements with BMS for the supply

of nivolumab, its anti-PD-1 therapy, for use in connection with our current Phase 1/2 clinical trials with RP1 and RP2.

also entered into a clinical collaboration agreement with Regeneron, which includes the supply of cemiplimab, its anti-PD-1 therapy,

for clinical trials conducted thereunder.

We are enrolling patients in our first planned clinical trial under the Regeneron agreement,

a randomized, controlled Phase 2 clinical trial of RP1 in combination with cemiplimab, versus cemiplimab alone, in approximately

240 patients with CSCC.

We may enter into additional agreements for the supply of anti-PD-1 products for use in combination with

and for the continued development of one or more of our product candidates.

Our ability to develop and ultimately commercialize

our product candidates used in combination with nivolumab, cemiplimab or any other checkpoint blockade therapy will depend on our

ability to access such drugs on commercially reasonable terms for the clinical trials and their availability for use with the commercialized

product, if approved.

We cannot be certain that current or potential future commercial relationships will provide us with a steady

supply of such drugs on commercially reasonable terms or at all.

Any failure to maintain

or enter into new successful commercial relationships, or the expense of purchasing checkpoint blockade therapies in the market,

may delay our development timelines, increase our costs and jeopardize our ability to develop our product candidates as commercially

viable therapies.

If any of these occur, our business, financial condition, results of operations, stock price and prospects may

be materially harmed.

Moreover, the development

of product candidates for use in combination with another product or product candidate may present challenges that are not faced

for single agent product candidates.

While we have opened a clinical trial for use of RP1 as a monotherapy, we are generally developing

RP1 and our other product candidates for use in combination with anti-PD-1 or potentially anti-PDL1 therapies, and may develop

RP1 or our other product candidates for use with other therapies.

The FDA may require us to use more complex clinical trial designs

in order to evaluate the contribution of each product and product candidate to any observed effects.

It is possible that the results

of these trials could show that any positive previous trial results are attributable to the therapy with which our products were

combined and not our product candidates.

Moreover, following product approval, the FDA may require that products used in conjunction

with each other be cross-labeled for combined use.

To the extent that we do not have rights to the other product, this may require

us to work with a third party to satisfy such a requirement.

Moreover, developments related to the other product may impact our

clinical trials for the combination as well as our commercial prospects should we receive marketing approval.

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 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

product candidates, our commercial opportunity could be limited.

Our lead product candidate

A key part of our strategy is to pursue clinical development of RP1 and additional product candidates, including RP2 and

Developing, obtaining marketing approval for, and commercializing additional product candidates will require substantial additional

funding and will be subject to the risks of failure inherent in medical product development.

We cannot assure our shareholders

that we will be able to successfully advance any of these additional product candidates through the development process.

Even if we obtain approval

from the FDA or comparable foreign regulatory authorities to market additional product candidates for the treatment of solid tumors,

we cannot assure our shareholders that any such product candidates will be successfully commercialized, widely accepted in the

marketplace, or more effective than other commercially available alternatives.

If we are unable to successfully develop and commercialize

additional product candidates, our commercial opportunity may be limited and our business, financial condition, results of operations,

stock price and prospects may be materially harmed.

Our development costs will also increase if we experience delays in testing or approvals, and we may not have sufficient funding to complete the testing and approval process for any of our product candidates.

We may be required to obtain additional funds to complete clinical trials and prepare for possible commercialization of our product candidates.

We do not know whether any preclinical tests or clinical trials beyond what we currently have planned will be required, will begin as planned, will need to be restructured, or will be completed on schedule, or at all.

Significant delays relating to any preclinical or clinical trials also could shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

In addition, many of the factors that cause, or lead to, delays in clinical trials may ultimately lead to the denial of marketing approval of any of our product candidates.

If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

We anticipate that our product candidates will be used in combination with third-party drugs, some of which are still in development, and we have limited or no control over the supply, regulatory status, or regulatory approval of such drugs.

Our product candidates 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.

We have entered into agreements with BMS for the supply of nivolumab, its anti-PD-1 therapy, for use in connection with our ongoing IGNYTE Phase 1/2 trials with RP1 and our clinical trial with RP2.

We have also entered into a clinical collaboration agreement with Regeneron, which includes the supply of cemiplimab, its anti-PD-1 therapy, for clinical trials conducted thereunder.

We are enrolling patients in the CERPASS trial, our first planned clinical trial under the Regeneron agreement.

We may enter into additional agreements for the supply of anti-PD-1 products for use in combination with and for the continued development of one or more of our product candidates.

Our ability to develop and ultimately commercialize our product candidates used in combination with nivolumab, cemiplimab or any other checkpoint blockade therapy will depend on our ability to access such drugs on commercially reasonable terms for the clinical trials and their availability for use with the commercialized product, if approved.

We cannot be certain that current or potential future commercial relationships will provide us with a steady supply of such drugs on commercially reasonable terms or at all.

Any failure to maintain or enter into new successful commercial relationships, or the expense of purchasing checkpoint blockade therapies in the market, may delay our development timelines, increase our costs and jeopardize our ability to develop our product candidates as commercially viable therapies.

If any of these occur, our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Moreover, the development of our product candidates for use in combination with another product or product candidate may present challenges that are not faced for single agent product candidates.

While we have opened a clinical trial for use of RP1 as a monotherapy, we are generally developing RP1 and our other product candidates for use in combination with anti-PD-1 or potentially anti-PDL-1 therapies, and may develop RP1 or our other product candidates for use with other therapies.

Although we intend our IGNYTE anti-PD-1 failed melanoma cohort and our CERPASS trial to be registration directed, the FDA may require us to use more complex clinical trial designs in order to evaluate the contribution of each product and product candidate to any observed effects.

It is possible that the results of these trials could show that any positive previous trial results are attributable to the therapy with which our products were combined and not our product candidates.

Moreover, following product approval, the FDA may require that products used in conjunction with each other be cross-labeled for combined use.

To the extent that we do not have rights to the other product, this may require us to work with a third party to satisfy such a requirement.

Moreover, developments related to the other product may impact our clinical trials for the combination as well as our commercial prospects should we receive marketing approval.

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 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, interrupted or halted.

In the event we are unable to source a supply of an acceptable 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 product candidates, our commercial opportunity could be limited.

Our lead product candidate is RP1.

A key part of our strategy is to pursue clinical development of RP1 and additional product candidates, including RP2 and RP3.

Developing, obtaining marketing approval for, and commercializing additional product candidates will require substantial additional funding and will be subject to the risks of failure inherent in medical product development.

We cannot assure our shareholders that we will be able to successfully advance any of these additional product candidates through the development process.

Even if we obtain approval from the FDA or comparable foreign regulatory authorities to market additional product candidates for the treatment of solid tumors, we cannot assure our shareholders that any such product candidates will be successfully commercialized, widely accepted in the marketplace, or more effective than other commercially available alternatives.

If we are unable to successfully develop and commercialize additional product candidates, our commercial opportunity may be limited and our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Risks related to regulatory approval

Even if our development efforts are

successful, we may not obtain regulatory approval for any of our product candidates in the United States or other jurisdictions,

which would prevent us from commercializing our product candidates.

Even if we obtain regulatory approval for our product candidates,

any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which

could impair our ability to successfully commercialize our product candidates.

We are not permitted

to market or promote or sell any of our product candidates before we receive regulatory approval from the FDA or comparable foreign

regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.

Securing marketing

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

approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing

facilities and clinical trial sites by, the regulatory authorities.

If we do not receive approval from the FDA and comparable foreign

regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in the United

States or in other jurisdictions.

If significant delays in obtaining approval for and commercializing our product candidates occur

in any jurisdictions, our business, financial condition, results of operations, stock price and prospects will be materially harmed.

Even if our development efforts are successful, we may not obtain regulatory approval for any of our product candidates in the United States or other jurisdictions, which would prevent us from commercializing our product candidates.

Even if we obtain regulatory approval for our product candidates, any such approval may be subject to limitations, including with respect to the approved indications or patient populations, which could impair our ability to successfully commercialize our product candidates.

We are not permitted to market or promote or sell any of our product candidates before we receive regulatory approval from the FDA or comparable foreign regulatory authorities, and we may never receive such regulatory approval for any of our product candidates.

Securing marketing 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 approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities and clinical trial sites by, the regulatory authorities.

If we do not receive approval from the FDA and comparable foreign regulatory authorities for any of our product candidates, we will not be able to commercialize such product candidates in the United States or in other jurisdictions.

If significant delays in obtaining approval for and commercializing our product candidates occur in any jurisdictions, our business, financial condition, results of operations, stock price and prospects will be materially harmed.

Even if our product candidates are approved, they may:

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• contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a risk evaluation and mitigation strategy, or REMS, to monitor the safety or efficacy of the products.

We have not previously

submitted a BLA to the FDA, or a similar marketing application to comparable foreign regulatory authorities, for any product candidate,

and we can provide no assurance that we will ultimately be successful in obtaining regulatory approval for claims that are necessary

or desirable for successful marketing, or at all.

The regulatory approval processes

of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.

If we are not

able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our product

candidates as expected, and our ability to generate revenue may be materially impaired.

The time required to

obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following

the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.

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

decision not to approve an application.

These regulatory requirements may require us to amend our clinical trial protocols, conduct

additional preclinical studies or clinical trials that may require regulatory or IRB approval, or otherwise cause delays in the

approval or rejection of an application.

Any delay in obtaining or failure to obtain required approvals could materially adversely

affect our ability to generate revenue from the particular product candidate, which may materially harm our business, financial

condition, results of operations, stock price and prospects.

If we experience delays

in obtaining approval, if we fail to obtain approval of a product candidate or if the label for a product candidate does not include

the labeling claims necessary or desirable for the successful commercialization of that product candidate, the commercial prospects

for such product candidate may be harmed and our ability to generate revenues from that product candidate may be materially impaired.

The FDA or a comparable foreign regulatory

authority may determine that our product candidates have undesirable side effects that could delay or prevent their regulatory

approval or commercialization.

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

caused by any of our product candidates could also result in denial of regulatory approval by the FDA or comparable foreign regulatory

authorities for any or all targeted indications or the inclusion of unfavorable information in our product labeling, such as limitations

on the indicated uses for which the products may be marketed or distributed, a label with significant safety warnings, including

boxed warnings, contraindications, and precautions, a label without statements necessary or desirable for successful commercialization,

or may result in requirements for costly post-marketing testing and surveillance, or other requirements, including REMS, to monitor

the safety or efficacy of the products, and in turn prevent us from commercializing and generating revenues from the sale of our

product candidates.

Undesirable side effects may limit the potential market for any approved products or could result in the discontinuation

of the sales and marketing of the product, or withdrawal of product approvals.

Later discovered undesirable side effects may further

result in the imposition of a REMS, label revisions, post approval study requirements, or other testing and surveillance.

If any of our product

candidates is associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may

need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable

side effects or other characteristics are less prevalent, less severe or more acceptable from a risk/benefit perspective.

The therapeutic-related

side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential

product liability claims.

Any of these occurrences may materially harm our business, financial condition, results of operations,

stock price and prospects.

Changes in product candidate manufacturing

or formulation may result in additional costs or delay.

As product candidates

are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it is common that

various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort

to optimize processes and results.

Any of these changes could cause our product candidates to perform differently and affect the

results of planned clinical trials or other future clinical trials conducted with the altered materials.

Such changes may also

require additional testing, or notification to, or approval by the FDA or a comparable foreign regulatory authority.

delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one

or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability

to commence product sales and generate revenue.

Regulatory approval by the FDA or

comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted,

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

We must comply with

requirements concerning advertising and promotion for any product candidates for which we obtain marketing approval.

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

general, members of Congress, and the public.

When the FDA or comparable foreign regulatory authorities issue regulatory approval

for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved.

If we are not able to obtain FDA approval for desired uses or indications for our product candidates, we may not market or promote

them for those indications and uses, referred to as off label uses, and our business, financial condition, results of operations,

stock price and prospects may be materially harmed.

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

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

for indications and uses that are not specifically approved by the FDA.

These off label uses are common across medical specialties

and may constitute an appropriate treatment for some patients in varied circumstances.

Regulatory authorities in the United States

generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine.

We have not previously submitted a BLA to the FDA, or a similar marketing application to comparable foreign regulatory authorities, for any product candidate, and we can provide no assurance that we will ultimately be successful in obtaining regulatory approval for claims that are necessary or desirable for successful marketing, or at all.

The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.

If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our product candidates as expected, and our ability to generate revenue may be materially impaired.

The time required to obtain approval by the FDA and comparable foreign regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.

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 decision not to approve an application.

These regulatory requirements may require us to amend our clinical trial protocols, conduct additional preclinical studies or clinical trials that may require regulatory or IRB approval, or otherwise cause delays in the approval or rejection of an application.

Any delay in obtaining or failure to obtain required approvals could materially adversely affect our ability to generate revenue from the particular product candidate, which may materially harm our business, financial condition, results of operations, stock price and prospects.

If we experience delays in obtaining approval, if we fail to obtain approval of a product candidate or if the label for a product candidate does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate, the commercial prospects for such product candidate may be harmed and our ability to generate revenues from that product candidate may be materially impaired.

The FDA or a comparable foreign regulatory authority may determine that our product candidates have undesirable side effects that could delay or prevent their regulatory approval or commercialization.

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 caused by any of our product candidates could also result in denial of regulatory approval by the FDA or comparable foreign regulatory authorities for any or all targeted indications or the inclusion of unfavorable information in our product labeling, such as limitations on the indicated uses for which the products may be marketed or distributed, a label with significant safety warnings, including boxed warnings, contraindications, and precautions, a label without statements necessary or desirable for successful commercialization, or may result in requirements for costly post-marketing testing and surveillance, or other requirements, including REMS, to monitor the safety or efficacy of the products, and in turn prevent us from commercializing and generating revenues from the sale of our product candidates.

Undesirable side effects may limit the potential market for any approved products or could result in the discontinuation of the sales and

marketing of the product, or withdrawal of product approvals.

Later discovered undesirable side effects may further result in the imposition of a REMS, label revisions, post approval study requirements, or other testing and surveillance.

If any of our product candidates is associated with serious adverse events or undesirable side effects or have properties that are unexpected, we may need to abandon development or limit development of that product candidate to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk/benefit perspective.

The therapeutic-related side effects could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.

Any of these occurrences may materially harm our business, financial condition, results of operations, stock price and prospects.

Changes in product candidate manufacturing or formulation may result in additional costs or delay.

As product candidates are developed through preclinical studies to later stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results.

Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials.

Such changes may also require additional testing, or notification to, or approval by the FDA or a comparable foreign regulatory authority.

This could delay completion of clinical trials, require the conduct of bridging clinical trials or studies, require the repetition of one or more clinical trials, increase clinical trial costs, delay approval of our product candidates and/or jeopardize our ability to commence product sales and generate revenue.

Regulatory approval by the FDA or comparable foreign regulatory authorities is limited to those specific indications and conditions for which approval has been granted, 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 business.

We must comply with requirements concerning advertising and promotion for any product candidates for which we obtain marketing approval.

Promotional 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 general, members of Congress, and the public.

When the FDA or comparable foreign regulatory authorities issue regulatory approval for a product candidate, the regulatory approval is limited to those specific uses and indications for which a product is approved.

If we are not able to obtain FDA approval for desired uses or indications for our product candidates, we may not market or promote them for those indications and uses, referred to as off label uses, and our business, financial condition, results of operations, stock price and prospects may be materially harmed.

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 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 for indications and uses that are not specifically approved by the FDA.

These off label uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances.

Regulatory authorities in the United States generally do not restrict or regulate the behavior of physicians in their choice of treatment within the practice of medicine.

Regulatory authorities do, however, restrict communications by biopharmaceutical companies concerning off label use.

If we are found to

have impermissibly promoted any of our product candidates, we may become subject to significant liability and government fines.

The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting

the promotion of off label uses, and a company that is found to have improperly promoted a product may be subject to significant

The federal government has levied large civil and criminal fines against companies for alleged improper promotion and

has enjoined several companies from engaging in off label promotion.

The FDA has also requested that companies enter into consent

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.

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.

If after one or more of our product candidates obtains marketing approval the FDA determines that our promotional activities violate

its regulations and policies pertaining to product promotion, it could request that we modify our promotional materials or subject

us to regulatory or other enforcement actions, including issuance of warning letters or untitled letters, suspension or withdrawal

of an approved product from the market, requests for recalls, payment of civil fines, disgorgement of money, imposition of operating

restrictions, injunctions or criminal prosecution, and other enforcement actions.

Similarly, industry codes in foreign jurisdictions

may prohibit companies from engaging in certain promotional activities and regulatory agencies in various countries may enforce

violations of such codes with civil penalties.

If we become subject to regulatory and enforcement actions our business, financial

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

Even if our product candidates receive

regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant

additional expense and limit how we manufacture and market our products.

Any product candidate

for which we obtain marketing approval will be subject to extensive and ongoing requirements of and review by the FDA and comparable

foreign regulatory authorities, including requirements related to the manufacturing processes, post approval clinical data, labeling,

packaging, distribution, adverse event reporting, shortage reporting, risk management plans, supply chain security, storage, recordkeeping,

export, import, advertising, marketing, and promotional activities for such product.

These requirements further include submissions

of safety and other post-marketing information, including manufacturing deviations and reports, registration and listing requirements,

the payment of annual fees, continued compliance with current Good Manufacturing Practice, or cGMP, requirements relating to manufacturing,

quality control, quality assurance, and corresponding maintenance of records and documents, and good clinical practices, or GCPs,

for any clinical trials that we conduct post approval.

The FDA and comparable

foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.

or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates,

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.

If we are found to have impermissibly promoted any of our product candidates, we may become subject to significant liability and government fines.

The FDA and other agencies actively enforce the laws and regulations regarding product promotion, particularly those prohibiting the promotion of off label uses, and a company that is found to have improperly promoted a product may be subject to significant sanctions.

The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off label promotion.

The FDA has also requested that companies enter into consent 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.

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.

If after one or more of our product candidates obtains marketing approval the FDA determines that our promotional activities violate its regulations and policies pertaining to product promotion, it could request that we modify our promotional materials or subject us to regulatory or other enforcement actions, including issuance of warning letters or untitled letters, suspension or withdrawal of an approved product from the market, requests for recalls, payment of civil fines, disgorgement of money, imposition of operating restrictions, injunctions or criminal prosecution, and other enforcement actions.

Similarly, industry codes in foreign jurisdictions may prohibit companies from engaging in certain promotional activities and regulatory agencies in various countries may enforce violations of such codes with civil penalties.

If we become subject to regulatory and enforcement actions our business, financial condition, results of operations, stock price and prospects will be materially harmed.

Even if our product candidates receive regulatory approval, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense and limit how we manufacture and market our products.

Any product candidate for which we obtain marketing approval will be subject to extensive and ongoing requirements of and review by the FDA and comparable foreign regulatory authorities, including requirements related to the manufacturing processes, post approval clinical data, labeling, packaging, distribution, adverse event reporting, shortage reporting, risk management plans, supply chain security, storage, recordkeeping, export, import, advertising, marketing, and promotional activities for such product.

These requirements further include submissions of safety and other post-marketing information, including manufacturing deviations and reports, registration and listing requirements, the payment of annual fees, continued compliance with current Good Manufacturing Practice, or cGMP, requirements relating to manufacturing, quality control, quality assurance, and corresponding maintenance of records and documents, and good clinical practices, or GCPs, for any clinical trials that we conduct post approval.

The FDA and comparable foreign regulatory authorities will continue to closely monitor the safety profile of any product even after approval.

If the FDA or comparable foreign regulatory authorities become aware of new safety information after approval of any of our product candidates, 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.

Any such restrictions could limit sales of the product.

We and any of our suppliers

or collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA to monitor

and ensure compliance with cGMPs and other FDA regulatory requirements.

Application holders must further notify the FDA, and depending

on the nature of the change, obtain FDA preapproval for product and manufacturing changes.

In addition, later

discovery of previously unknown adverse events or that the product is less effective than previously thought or other problems

with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements both before and

after approval, may yield various negative results, including:

We and any of our suppliers or collaborators, including our contract manufacturers, could be subject to periodic unannounced inspections by the FDA to monitor and ensure compliance with cGMPs and other FDA regulatory requirements.

Application holders must further notify the FDA, and depending on the nature of the change, obtain FDA preapproval for product and manufacturing changes.

In addition, later discovery of previously unknown adverse events or that the product is less effective than previously thought or other problems with our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements both before and after approval, may yield various negative results, including:

• restrictions on manufacturing, distribution, or marketing of such products;

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• injunctions or the imposition of civil or criminal penalties, including imprisonment.

Any of these events

could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, or could substantially

increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating significant

revenues from its marketing and sale.

Any of these events could further have other material and adverse effects on our operations

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

prevent, limit or delay regulatory approval of our product candidates, limit the marketability of our product candidates, or impose

additional regulatory obligations on us.

Changes in medical practice and standard of care may also impact the marketability of

our product candidates.

If we are slow or unable

to adapt to changes in existing requirements, standards of care, or the adoption of new requirements or policies, or if we are

not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject to regulatory

enforcement action.

Should any of the above

actions take place, we could be prevented from or significantly delayed in achieving profitability.

Further, the cost of compliance

with post approval regulations may have a negative effect on our operations and business and could adversely impact our business,

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

Obtaining and maintaining marketing

approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining marketing approval

of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.

Obtaining and maintaining

marketing approval of our product candidates in one jurisdiction would not guarantee that we will be able to obtain or maintain

marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may

have a negative effect on the marketing approval process in others.

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

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

product candidate in those countries.

Approval procedures vary among jurisdictions and can involve requirements and administrative

review periods different from and, in some cases, greater than, those in the United States, including additional preclinical studies

or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved

for sale in that jurisdiction.

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, or could substantially increase the costs and expenses of commercializing such product, which in turn could delay or prevent us from generating significant revenues from its marketing and sale.

Any of these events could further have other material and adverse effects on our operations 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 prevent, limit or delay regulatory approval of our product candidates, limit the marketability of our product candidates, or impose additional regulatory obligations on us.

Changes in medical practice and standard of care may also impact the marketability of our product candidates.

If we are slow or unable to adapt to changes in existing requirements, standards of care, or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and be subject to regulatory enforcement action.

Should any of the above actions take place, we could be prevented from or significantly delayed in achieving profitability.

Further, the cost of compliance with post approval regulations may have a negative effect on our operations and business and could adversely impact our business, financial condition, results of operations, stock price and prospects.

Obtaining and maintaining marketing approval for our product candidates in one jurisdiction would not mean that we will be successful in obtaining marketing approval of that product candidate in other jurisdictions, which could prevent us from marketing our products internationally.

Obtaining and maintaining marketing approval of our product candidates in one jurisdiction would not guarantee that we will be able to obtain or maintain marketing approval in any other jurisdiction, while a failure or delay in obtaining marketing approval in one jurisdiction may have a negative effect on the marketing approval process in others.

For example, even if the FDA grants marketing approval of a product candidate, comparable foreign regulatory authorities must also approve the manufacturing, marketing and promotion of the product candidate in those countries.

Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from and, in some cases, greater than, those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction.

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

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

in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior

to marketing in those jurisdictions.

Obtaining foreign marketing approvals and compliance with foreign regulatory requirements

could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in

certain countries.

If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing

approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will

If we obtain approval for any product candidate and ultimately commercialize that product in foreign markets, we would

be subject to additional risks and uncertainties, including the burden of complying with complex and changing foreign regulatory,

tax, accounting and legal requirements and the reduced protection of intellectual property rights in some foreign countries.

Additionally, with the full departure of the United Kingdom from the European Union in January 2021, commonly referred to as Brexit, there is continuing regulatory uncertainty.

Since a significant proportion of the regulatory framework in the United Kingdom is derived from European Union directives and regulations, and the degree to which the United Kingdom and European Union regulatory regimes align or diverge could materially impact the execution of our clinical trials or approval of our product candidates in the United Kingdom or the European Union.

Regulatory authorities in jurisdictions outside of the United States have requirements for approval of product candidates with which we must comply prior to marketing in those jurisdictions.

Obtaining foreign marketing approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries.

If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.

If we obtain approval for any product candidate and ultimately commercialize that product in foreign markets, we would be subject to additional risks and uncertainties, including the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements and the reduced protection of intellectual property rights in some foreign countries.

Risks related to commercialization

If we are unable to successfully

commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our

business will be materially harmed.

If we are successful

in obtaining marketing approval from applicable regulatory authorities for RP1 or any of our other product candidates, our ability

to generate revenues from our product candidates will depend on our success in:

If we are unable to successfully commercialize any product candidate for which we receive regulatory approval, or experience significant delays in doing so, our business will be materially harmed.

If we are successful in obtaining marketing approval from applicable regulatory authorities for RP1 or any of our other product candidates, our ability to generate revenues from our product candidates will depend on our success in:

• launching commercial sales of our product candidates, whether alone or in collaboration with others;

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• maintaining a continued acceptable safety profile of our product candidates following launch.

To the extent we are

not able to do any of the foregoing, our business, financial condition, results of operations, stock price and prospects will be

materially harmed.

We face significant competition from

other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations,

which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully

If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced

or eliminated.

The development and

commercialization of cancer immunotherapy products is characterized by rapidly advancing technologies, intense competition and

a strong emphasis on proprietary rights.

We face competition with respect to our current product candidates, and will face competition

with respect to any product candidates that we may seek to develop or commercialize in the future, from major biopharmaceutical

companies, specialty biopharmaceutical companies, and biotechnology companies worldwide.

There are a number of large biopharmaceutical

and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment

of solid tumors, including oncolytic immunotherapy and cancer vaccine approaches.

Potential competitors also include academic institutions,

government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish

collaborative arrangements for research, development, manufacturing, and commercialization.

While our product candidates

are intended to be used in combination with other drugs with different mechanisms of action, if and when marketed they will still

compete with a number of drugs that are currently marketed or in development that also target cancer.

To compete effectively with

these drugs, our product candidates will need to demonstrate advantages in clinical efficacy and safety compared to these competitors

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 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

and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing

approved products than we do.

Mergers and acquisitions in the biopharmaceutical and biotechnology industries may result in even

more resources being concentrated among a smaller number of our competitors.

Early stage companies may also prove to be significant

competitors, particularly through collaborative arrangements with large and established companies.

These third parties compete

with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient

registration for clinical trials, as well as in developing or acquiring technologies complementary to, or necessary for, our programs.

If we are unable to successfully compete with these companies our business, financial condition, results of operations, stock price

and prospects may be materially harmed.

If we are unable to establish effective

marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our product candidates,

if they are approved, the revenues that we generate may be limited and we may never become profitable.

We currently do not

have a commercial infrastructure for the marketing, sale, and distribution of our product candidates.

If and when our product candidates

receive marketing approval, we intend to commercialize our product candidates on our own in the United States and potentially with

pharmaceutical or biotechnology partners in other geographies.

In order to commercialize our products, we must build our marketing,

sales, and distribution capabilities or make arrangements with third parties to perform these services.

We may not be successful

Should we decide to move forward in developing our own marketing capabilities, we may incur expenses prior to product

launch or even approval in order to recruit a sales force and develop a marketing and sales infrastructure.

If a commercial launch

is delayed as a result of FDA or comparable foreign regulatory authority requirements or other reasons, we would incur these expenses

prior to being able to realize any revenue from sales of our product candidates.

Even if we are able to effectively hire a sales

force and develop a marketing and sales infrastructure, our sales force and marketing teams may not be successful in commercializing

our product candidates.

This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing

We may also or alternatively

decide to collaborate with third-party marketing and sales organizations to commercialize any approved product candidates in the

United States, in which event, our ability to generate product revenues may be limited.

To the extent we rely on third parties

to commercialize any products for which we obtain regulatory approval, we may receive less revenues than if we commercialized these

products ourselves, which could materially harm our prospects.

In addition, we would have less control over the sales efforts of

any other third parties involved in our commercialization efforts, and could be held liable if they failed to comply with applicable

legal or regulatory requirements.

We have no prior experience

in the marketing, sale, and distribution of biopharmaceutical products, and there are significant risks involved in building and

managing a commercial infrastructure.

The establishment and development of commercial capabilities, including compliance plans,

to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be

able to successfully develop this capability.

We will have to compete with other biopharmaceutical and biotechnology companies,

including oncology-focused companies, to recruit, hire, train, manage, and retain marketing and sales personnel, which is expensive

and time consuming and could delay any product launch.

Developing our sales capabilities may also divert resources and management

attention away from product development.

In the event we are

unable to develop a marketing and sales infrastructure, we may not be able to commercialize our product candidates in the United

States or elsewhere, which could limit our ability to generate product revenues and materially harm our business, financial condition,

results of operations, stock price and prospects.

Factors that may inhibit our efforts to commercialize our product candidates

To the extent we are not able to do any of the foregoing, our business, financial condition, results of operations, stock price and prospects will be materially harmed.

We face significant competition from other biopharmaceutical and biotechnology companies, academic institutions, government agencies, and other research organizations, which may result in others discovering, developing or commercializing products more quickly or marketing them more successfully than us.

If their product candidates are shown to be safer or more effective than ours, our commercial opportunity may be reduced or eliminated.

The development and commercialization of cancer immunotherapy products is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary rights.

We face competition with respect to our current product candidates, and will face competition with respect to any product candidates that we may seek to develop or commercialize in the future, from major biopharmaceutical companies, specialty biopharmaceutical companies, and biotechnology companies worldwide.

There are a number of large biopharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of products for the treatment of solid tumors, including oncolytic immunotherapy and cancer vaccine approaches.

Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization.

While our product candidates are intended to be used in combination with other drugs with different mechanisms of action, if and when marketed they will still compete with a number of drugs that are currently marketed or in development that also target cancer.

To compete effectively with these drugs, our product candidates will need to demonstrate advantages in clinical efficacy and safety compared to these competitors 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 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 and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do.

Mergers and acquisitions in the biopharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors.

Early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

These third parties compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in developing or acquiring technologies complementary to, or necessary for, our programs.

If we are unable to successfully compete with these companies our business, financial condition, results of operations, stock price and prospects may be materially harmed.

If we are unable to establish effective marketing, sales and distribution capabilities or enter into agreements with third parties to market and sell our product candidates, if they are approved, the revenues that we generate may be limited and we may never become profitable.

We currently do not have a commercial infrastructure for the marketing, sale, and distribution of our product candidates.

If and when our product candidates receive marketing approval, we intend to commercialize our product candidates on our own in the United States and potentially with pharmaceutical or biotechnology partners in other geographies.

In order to commercialize our products, we must build our marketing, sales, and distribution capabilities or make arrangements with third parties to perform these services.

We may not be successful in doing so.

Should we decide to move forward in developing our own marketing capabilities, we may incur expenses prior to product launch or even approval in order to recruit a sales force and develop a marketing and sales infrastructure.

If a commercial launch is delayed as a result of FDA or comparable foreign regulatory authority requirements or other reasons, we would incur these expenses prior to being able to realize any revenue from sales of our product candidates.

Even if we are able to effectively hire a sales force and develop a marketing and sales infrastructure, our sales force and marketing teams may not be successful in commercializing our product candidates.

This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

We may also or alternatively decide to collaborate with third-party marketing and sales organizations to commercialize any approved product candidates in the United States, in which event, our ability to generate product revenues may be limited.

To the extent we rely on third parties to commercialize any products for which we obtain regulatory approval, we may receive less revenues than if we commercialized these products ourselves, which could materially harm our prospects.

In addition, we would have less control over the sales efforts of any other third parties involved in our commercialization efforts, and could be held liable if they failed to comply with applicable legal or regulatory requirements.

We have no prior experience in the marketing, sale, and distribution of biopharmaceutical products, and there are significant risks involved in building and managing a commercial infrastructure.

The establishment and development of commercial capabilities, including compliance plans, to market any products we may develop will be expensive and time consuming and could delay any product launch, and we may not be able to successfully develop this capability.

We will have to compete with other biopharmaceutical and biotechnology companies, including oncology-focused companies, to recruit, hire, train, manage, and retain marketing and sales personnel, which is expensive and time consuming and could delay any product launch.

Developing our sales capabilities may also divert resources and management attention away from product development.

In the event we are unable to develop a marketing and sales infrastructure, we may not be able to commercialize our product candidates in the United States or elsewhere, which could limit our ability to generate product revenues and materially harm our business, financial condition, results of operations, stock price and prospects.

Factors that may inhibit our efforts to commercialize our product candidates include:

• the inability to recruit, train, manage, and retain adequate numbers of effective sales and marketing personnel;

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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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• unforeseen costs and expenses associated with creating an independent sales and marketing organization or engaging a contract sales organization.

Our product candidates are based

on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.

We have concentrated

all of our research and development efforts on product candidates based on our Immulytic platform, and our future success depends

on the successful development of this therapeutic approach.

There can be no assurance that any development problems we experience

in the future will not cause significant delays or unanticipated costs, or that such development problems can be solved.

we encounter development problems, including unfavorable preclinical or clinical trial results, the FDA and foreign regulatory

authorities may refuse to approve our product candidates, or may require additional information, tests, or trials, which could

significantly delay product development and significantly increase our development costs.

Moreover, even if we are able to provide

the requested information or trials to the FDA, there would be no guarantee that the FDA would accept them or approve our product

We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process, or developing

or qualifying and validating product release assays, other testing and manufacturing methods, and our equipment and facilities

in a timely manner, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely

or profitable basis, if at all.

In addition, the clinical

trial requirements of the FDA and comparable foreign regulatory authorities and the criteria these regulators use to determine

the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and

market of the potential products.

The FDA and comparable foreign regulatory authorities have limited experience with the approval

of oncolytic immunotherapies.

Our product candidates are based on a novel approach to the treatment of cancer, which makes it difficult to predict the time and cost of product candidate development.

We have concentrated all of our research and development efforts on product candidates based on our Immulytic platform, and our future success depends on the successful development of this therapeutic approach.

There can be no assurance that any development problems we experience in the future will not cause significant delays or unanticipated costs, or that such development problems can be solved.

Should we encounter development problems, including unfavorable preclinical or clinical trial results, the FDA and foreign regulatory authorities may refuse to approve our product candidates, or may require additional information, tests, or trials, which could significantly delay product development and significantly increase our development costs.

Moreover, even if we are able to provide the requested information or trials to the FDA, there would be no guarantee that the FDA would accept them or approve our product candidates.

We may also experience delays in developing a sustainable, reproducible and scalable manufacturing process, or developing or qualifying and validating product release assays, other testing and manufacturing methods, and our equipment and facilities in a timely manner, which may prevent us from completing our clinical trials or commercializing our product candidates on a timely or profitable basis, if at all.

In addition, the clinical trial requirements of the FDA and comparable foreign regulatory authorities and the criteria these regulators use to determine the safety and efficacy of a product candidate vary substantially according to the type, complexity, novelty and intended use and market of the potential products.

The FDA and comparable foreign regulatory authorities have limited experience with the approval of oncolytic immunotherapies.

Only one oncolytic immunotherapy, T-Vec, has received FDA approval to date.

Any product candidates

that are approved may be subject to extensive post approval regulatory requirements, including requirements pertaining to manufacturing,

distribution, and promotion.

Any product candidates that are approved may be subject to extensive post approval regulatory requirements, including requirements pertaining to manufacturing, distribution, and promotion.

We may need to devote significant time and resources to compliance with these requirements.

If our product candidates do not

achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we may never become profitable.

We have never commercialized

a product candidate for any indication.

Even if our product candidates are approved by the appropriate regulatory authorities for

marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical community.

If any product candidates for which we obtain regulatory approval do not gain an adequate level of market acceptance, we could

be prevented from or significantly delayed in achieving profitability.

Market acceptance of our product candidates by the medical

community, patients, and third-party payors will depend on a number of factors, some of which are beyond our control.

physicians are often reluctant to switch their patients and patients may be reluctant to switch from existing therapies even when

new and potentially more effective or safer treatments enter the market.

Efforts to educate

the medical community and third-party payors on the benefits of our product candidates may require significant resources and may

not be successful.

If any of our product candidates is approved but does not achieve an adequate level of market acceptance, we

could be prevented from or significantly delayed in achieving profitability.

The degree of market acceptance of any of our product

candidates will depend on a number of factors, including:

If our product candidates do not achieve broad market acceptance, the revenues that we generate from their sales may be limited, and we may never become profitable.

We have never commercialized a product candidate for any indication.

Even if our product candidates are approved by the appropriate regulatory authorities for marketing and sale, they may not gain acceptance among physicians, patients, third-party payors, and others in the medical community.

If any product candidates for which we obtain regulatory approval do not gain an adequate level of market acceptance, we could be prevented from or significantly delayed in achieving profitability.

Market acceptance of our product candidates by the medical community, patients, and third-party payors will depend on a number of factors, some of which are beyond our control.

For example, physicians are often reluctant to switch their patients and patients may be reluctant to switch from existing therapies even when new and potentially more effective or safer treatments enter the market.

Efforts to educate the medical community and third party payors on the benefits of our product candidates may require significant resources and may not be successful.

If any of our product candidates is approved but does not achieve an adequate level of market acceptance, we could be prevented from or significantly delayed in achieving profitability.

The degree of market acceptance of any of our product candidates will depend on a number of factors, including:

• the efficacy of our product candidates in combination with marketed checkpoint blockade drugs;

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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;

• 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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• potential product liability claims.

The size of the potential market

for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product

candidates may be smaller than our estimates.

The potential market

opportunities for our product candidates are difficult to estimate and will depend in large part on the drugs with which our product

candidates are co-administered and the success of competing therapies and therapeutic approaches.

In particular, the market opportunity

for oncolytic immunotherapies is hard to estimate given that it is an emerging field with only one existing FDA-approved oncolytic

immunotherapy, T-Vec, which has yet to enjoy broad market acceptance.

Our estimates of the potential market opportunities are predicated

on many assumptions, which may include industry knowledge and publications, third-party research reports, and other surveys.

we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the

part of our management, are inherently uncertain, and their reasonableness has not been assessed by an independent source.

of the assumptions proves to be inaccurate, the actual markets for our product candidates could be smaller than our estimates of

the potential market opportunities.

Negative developments in the field

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

The commercial success

of our product candidates will depend in part on public acceptance of the use of cancer immunotherapies.

Adverse events in clinical

trials of RP1 or our other product candidates or in clinical trials of others developing similar products and the resulting publicity,

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 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 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

and Need for Additional Capital

We are a clinical stage biopharmaceutical

company with a very limited operating history.

We have incurred net losses since our inception and anticipate that we will continue

to incur substantial and increasing net losses in the foreseeable future.

The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates.

The potential market opportunities for our product candidates are difficult to estimate and will depend in large part on the drugs with which our product candidates are co-administered and the success of competing therapies and therapeutic approaches.

In particular, the market opportunity for oncolytic immunotherapies is hard to estimate given that it is an emerging field with only one existing FDA-approved oncolytic immunotherapy, T-Vec, which has yet to enjoy broad market acceptance.

Our estimates of the potential market opportunities are predicated on many assumptions, which may include industry knowledge and publications, third-party research reports, and other surveys.

Although we believe that our internal assumptions are reasonable, these assumptions involve the exercise of significant judgment on the part of our management, are inherently uncertain, and their reasonableness has not been assessed by an independent source.

If any of the assumptions proves to be inaccurate, the actual markets for our product candidates could be smaller than our estimates of the potential market opportunities.

Negative developments in the field of immuno-oncology could damage public perception of our product candidates and negatively affect our business.

The commercial success of our product candidates will depend in part on public acceptance of the use of cancer immunotherapies.

Adverse events in clinical trials of RP1 or our other product candidates or in clinical trials of others developing similar products and the resulting publicity, 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 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 programs.

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 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 and need for additional capital

We are a clinical stage biopharmaceutical company with a very limited operating history.

We have incurred net losses since our inception and anticipate that we will continue to incur substantial and increasing net losses in the foreseeable future.

We may never achieve or sustain profitability.

We are a clinical stage

biopharmaceutical company with a limited operating history, and we are early in our development efforts.

We have no products approved

for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research

and development and other expenses related to our ongoing operations.

Investment in biopharmaceutical product development is highly

speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate

will fail to demonstrate adequate efficacy or an acceptable safety profile, gain marketing approval and become commercially viable.

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

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

and have incurred losses in each period since our inception.

We expect to continue to incur significant losses for the foreseeable

future, and we expect these losses to increase as we continue our research and development of, and seek marketing approvals for,

RP1, our other product candidates and any additional product candidates we may develop.

Even if we succeed in receiving marketing

approval for and commercialize RP1, we will continue to incur substantial research and development and other expenditures to develop

and market additional potential products.

We may encounter unforeseen expenses, difficulties, complications, delays and other unknown

factors that may adversely affect our business.

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

of our expenses and our ability to generate revenue.

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

have an adverse effect on our stockholders’

equity and working capital.

We have never generated any revenue

from product sales, and our ability to generate revenue from product sales and become profitable will depend significantly on our

success in achieving a number of goals.

We have no products

approved for commercial sale, have not generated any revenue from product sales, and do not anticipate generating any revenue from

product sales until after we have received marketing approval for the commercial sale of a product candidate, if ever.

to generate revenue and achieve profitability depends significantly on our success in achieving a number of goals, including:

We are a clinical stage biopharmaceutical company with a limited operating history, and we are early in our development efforts.

We have no products approved for commercial sale and have not generated any revenue from product sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain marketing approval and become commercially viable.

We have financed our operations to date primarily through the sale of equity securities, including the sale of our common stock 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 and have incurred losses in each period since our inception.

For the three months ended June 30, 2021 and 2020, we reported a net loss of $27.3 million and $17.5 million, respectively.

At June 30, 2021, we had an accumulated deficit of $220.5 million.

We expect to continue to incur significant losses for the foreseeable future, and we expect these losses to increase as we continue our research and development of, and seek marketing approvals for, RP1, our other product candidates and any additional product candidates we may develop.

Even if we succeed in receiving marketing approval for and commercialize RP1 or our other product candidates, we will continue to incur substantial research and development and other expenditures to develop and market additional potential products.

We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue.

Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity and working capital.

We have never generated any revenue from product sales, and our ability to generate revenue from product sales and become profitable will depend significantly on our success in achieving a number of goals.

We have no products approved for commercial sale, have not generated any revenue from product sales, and do not anticipate generating any revenue from product sales until after we have received marketing approval for the commercial sale of a product candidate, if ever.

Our ability to generate revenue and achieve profitability depends significantly on our success in achieving a number of goals, including:

• completing research regarding, and preclinical and clinical development of, RP1 and our other product candidates;

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• attracting, hiring, and retaining qualified personnel.

Even if our product

candidates or any future product candidates that we develop are approved for commercial sale, we anticipate incurring significant

costs associated with commercializing any such product candidate.

Our expenses could increase beyond expectations if we are required

by the FDA or comparable foreign regulatory authorities to change our manufacturing processes or assays, or to perform clinical,

nonclinical, or other types of studies in addition to those that we currently anticipate.

If we are successful

in obtaining regulatory approvals to market RP1 or our other product candidates, our revenue will be dependent, in part, upon the

size of the markets in the territories for which we gain marketing approval, the accepted price for the product, the ability to

get reimbursement at any price, and whether we own the commercial rights for that territory.

If the number of our addressable patients

is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, the labels

for our product candidates contain significant safety warnings, regulatory authorities impose burdensome or restrictive distribution

requirements, or the reasonably accepted patient population for treatment is narrowed by competition, physician choice or treatment

guidelines, we may not generate significant revenue from sales of such products, even if approved.

If we are not able to generate

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

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

consumed substantial amounts of cash since inception.

We expect to continue to spend substantial amounts to continue the clinical

and preclinical development of RP1 and our other product candidates.

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.

Even if our product candidates or any future product candidates that we develop are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any such product candidate.

Our expenses could increase beyond expectations if we are required by the FDA or comparable foreign regulatory authorities to change our manufacturing processes or assays, or to perform clinical, nonclinical, or other types of studies in addition to those that we currently anticipate.

If we are successful in obtaining regulatory approvals to market RP1 or our other product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain marketing approval, the accepted price for the product, the ability to get reimbursement at any price, and whether we own the commercial rights for that territory.

If the number of our addressable patients is not as significant as we estimate, the indication approved by regulatory authorities is narrower than we expect, the labels for our product candidates contain significant safety warnings, regulatory authorities impose burdensome or restrictive distribution requirements, or the reasonably accepted patient population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved.

If we are not able to generate revenue from the sale of any approved products, we could be prevented from or significantly delayed in achieving profitability.

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 consumed substantial amounts of cash since inception.

At June 30, 2021, our cash and cash equivalents and short-term investments were $458.3 million.

We expect to continue to spend substantial amounts to continue the clinical and preclinical development of RP1 and our other product candidates.

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.

Our future capital

requirements depend on many factors, including:

Our future capital requirements depend on many factors, including:

• the scope, progress, results and costs of researching and developing RP1 and our other product candidates, and conducting preclinical studies and clinical trials;

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• the emergence of competing cancer therapies and other adverse market developments.

We do not have any

committed external source of funds or other support for our development efforts.

Until we can generate sufficient product revenue

to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public

or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or

distribution arrangements.

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.

We do not have any committed external source of funds or other support for our development efforts.

Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements.

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, excluding any confirmatory trial required by the FDA or other regulatory body.

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

If we are unable to obtain, maintain

and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights

are inadequate, our competitive position could be harmed.

Our commercial success

will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States

and other countries with respect to our technology, Immulytic platform, RP1 and our other product candidates.

We rely on trade

secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties,

all of which offer only limited protection.

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

a patent issues from such applications.

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

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.

If we are unable to obtain, maintain and protect our intellectual property rights for our technology and product candidates, or if our intellectual property rights are inadequate, our competitive position could be harmed.

Our commercial success will depend in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and other countries with respect to our technology, Immulytic platform, RP1 and our other product candidates.

We rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing and other agreements with employees and third parties, 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 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.

Our pending applications cannot be enforced against third parties practicing the inventions claimed in such applications unless and until a patent issues from such applications.

Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, our issued patents and issued patents that we license from third parties or may own have been and 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

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, 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

legal proceedings alleging that we are infringing their intellectual property rights, and we may become involved in lawsuits to

protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse

effect on the success of our business.

Our commercial success

depends on our ability and the ability of our current or future collaborators to develop, manufacture, market and sell RP1 and

our other product candidates, and to use our related proprietary technologies without infringing, misappropriating or otherwise

violating the intellectual property and proprietary rights of third parties.

The biotechnology and pharmaceutical industries are

characterized by extensive litigation regarding patents and other intellectual property rights.

We may become party to, or threatened

with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and any other future

product candidates.

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

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.

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.

In addition, defending against challenges in respect of the inventorship, scope, validity or enforceability of our patents may be expensive, time consuming, difficult and in some cases may not be possible.

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 affected.

Patent 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.

Filing, 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 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.

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 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, 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 prospects.

Third parties may in the future initiate legal proceedings alleging that we are infringing their intellectual property rights, and we may become involved in lawsuits or other administrative procedures to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business.

Our commercial success depends on our ability and the ability of our current or future collaborators to develop, manufacture, market and sell RP1 and our other product candidates, and to use our related proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties.

The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights.

We may become party to, or threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to our current and any other future product candidates.

Third parties may assert infringement or other intellectual property claims against us based on existing patents or patents that may be filed and/or granted in the future.

At times we may attempt to initiate litigation or other administrative procedures to invalidate or otherwise limit the scope of a third party’s intellectual property and these attempts may not be successful.

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, unenforceable or otherwise not infringed, 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 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,

including our senior management team, were previously employed at, or consulted for, universities or other biotechnology or pharmaceutical

companies, including our competitors or potential competitors.

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

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.

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 right.

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 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.

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

Many of our employees, including our senior management team, were previously employed at, or consulted for, universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.

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

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

developing certain of our product candidates in combination with nivolumab and cemiplimab, which are covered by patents or licenses

held by BMS and Regeneron, respectively, to which we do not have a license other than for use in connection with the applicable

clinical trial.

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.

In the event that a labeling instruction

is required in product packaging recommending that combination, we could be accused of, or held liable for, infringement of the

third-party patents covering the product candidate or product recommended for administration with RP1 or our other product candidates.

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

Competitors may infringe

any future licensed patents or any patent we own in the future or misappropriate or otherwise violate our intellectual property

We may also be required to defend against claims of infringement and our licensed patents and any patents we own in the

future may become involved in priority or other intellectual property related disputes.

To counter infringement or unauthorized

use, litigation may be necessary in the future to enforce or defend our intellectual property rights, to protect our trade secrets

or to determine the validity and scope of our own intellectual property rights or the proprietary rights of others.

These proceedings

can be expensive and time consuming.

Many of our current and potential competitors have the ability to dedicate substantially

greater resources to conduct intellectual property related litigations or proceedings than we can.

We may not have sufficient

financial or other resources to conduct such litigation or proceedings adequately.

Accordingly, despite our efforts, we may not

be able to prevent third parties from infringing upon or misappropriating our intellectual property.

An adverse result in any

litigation or other intellectual property related proceeding could put one or more of our patents at risk of being invalidated,

held unenforceable or interpreted narrowly.

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 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

Reliance on Third Parties

We have agreements with BMS and Regeneron,

and in the future may have agreements with other companies, to obtain the supply of anti-PD-1 therapies for the development of

our product candidates.

If our relationships with BMS, Regeneron, or any future collaborator or supplier are not successful, we

may be delayed in completing the development of our product candidates.

We have entered into

arrangements with BMS and Regeneron as part of our clinical development for RP1 and RP2.

BMS is providing nivolumab, its anti-PD-1

therapy, for use in our ongoing Phase 1/2 clinical trials with RP1 and RP2 and Regeneron is providing cemiplimab, its anti-PD-1

therapy, for use in our Phase 2 clinical trial and may potentially do so for other clinical trials in the future.

enter into agreements with additional companies for the supply of anti-PD-1 therapies for use in the development of RP1 and our

other product candidates.

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

other product candidates.

Similarly, should any partner fail to provide us with a product or product candidate that suits our requirements,

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

of RP1 or our other product candidates.

Our collaboration agreements with

any future partners may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.

We may in the future

seek collaboration arrangements with other parties for the development or commercialization of our product candidates.

of any collaboration arrangements may depend on the efforts and activities of our collaborators.

Collaborators generally have significant

discretion in determining the efforts and resources that they will apply to these arrangements.

Disagreements between parties to

a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development

process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement.

Collaborations with

biopharmaceutical companies and other third parties often are terminated or allowed to expire by the other party.

Any such termination

or expiration could adversely affect us financially and could harm our business reputation.

Any future collaborations

we might enter into may pose a number of risks, including the following:

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 or products.

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

In addition, we are developing certain of our product candidates in combination with nivolumab and cemiplimab, which are covered by patents or licenses held by BMS and Regeneron, respectively, to which we do not have a license other than for use in connection with the applicable clinical trial.

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.

In the event that a labeling instruction is required in product packaging recommending that combination, we could be accused of, or held liable for, infringement of the third-party patents covering the product candidate or product recommended for administration with RP1 or our other product candidates.

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

Competitors may infringe any future licensed patents or any patent we own in the future or misappropriate or otherwise violate our intellectual property rights.

We may also be required to defend against claims of infringement and our licensed patents and any patents we own in the future may become involved in priority or other intellectual property related disputes.

To counter infringement or unauthorized use, litigation may be necessary in the future to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of our own intellectual property rights or the proprietary rights of others.

These proceedings can be expensive and time consuming.

Many of our current and potential competitors have the ability to dedicate substantially greater resources to conduct intellectual property related litigation or proceedings than we can.

We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately.

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property.

An adverse result in any litigation or other intellectual property related proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly.

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 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 stock.

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 reliance on third parties

We have agreements with BMS and Regeneron, and in the future may have agreements with other companies, to obtain the supply of anti-PD-1 therapies for the development of our product candidates.

If our relationships with BMS, Regeneron, or

any future collaborator or supplier are not successful, we may be delayed in completing the development of our product candidates.

We have entered into arrangements with BMS and Regeneron as part of our clinical development for RP1 and RP2.

BMS is providing nivolumab, its anti-PD-1 therapy, for use in our ongoing IGNYTE Phase 1/2 trials with RP1 and our clinical trial with RP2 and Regeneron is providing cemiplimab, its anti-PD-1 therapy, for use in our ongoing CERPASS Phase 2 trial and may potentially do so for other clinical trials in the future.

We may also enter into agreements with additional companies for the supply of anti-PD-1 therapies for use in the development of RP1 and our 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 re-run clinical trials for RP1 or our other product candidates or may otherwise be delayed in the commercialization of RP1 or our other product candidates.

Similarly, should any partner fail to provide us with a product or product candidate that suits our requirements, we may have to re-run clinical trials for RP1 or our other product candidates or may be otherwise delayed in the commercialization of RP1 or our other product candidates.

Our collaboration agreements with any future partners may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.

We may in the future seek collaboration arrangements with other parties for the development or commercialization of our product candidates.

The success of any collaboration arrangements may depend on the efforts and activities of our collaborators.

Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these arrangements.

Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of the collaboration arrangement.

Collaborations with biopharmaceutical companies and other third parties often are terminated or allowed to expire by the other party.

Any such termination or expiration could adversely affect us financially and could harm our business reputation.

Any future collaborations we might enter into may pose a number of risks, including the following:

• 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;

• 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;

• 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;

7 unchanged sentences

• collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability.

If any collaborations

we might enter into in the future do not result in the successful development and commercialization of products or if one of our

collaborators subsequently terminates its agreement with us, we may not receive any future research funding or milestone or royalty

payments under such potential future collaboration.

If we do not receive the funding we expect under the agreements, our development

of our product candidates could be delayed and we may need additional resources to develop our product candidates and our product

Additionally, if any

future collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate development

or commercialization of any product candidate it licenses to us.

If one of our collaborators terminates its agreement with us,

we may find it more difficult to attract new collaborators and our reputation in the business and financial communities could be

adversely affected.

We face significant

competition in seeking appropriate collaborators.

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.

If we are unable to

reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development

of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential

commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development

or commercialization activities at our own expense.

If we elect to fund and undertake development or commercialization activities

on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms,

If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development

and commercialization activities, we may not be able to further develop our product candidates or bring them to market or continue

to develop our product platform and our business may be materially and adversely affected.

We rely, and expect to continue to

rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials.

If those third parties do

not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory

requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we

may develop in the future.

We rely on third-party

CROs, study sites, and others to conduct, supervise, and monitor our preclinical studies and clinical trials for our product candidates

and do not currently plan to independently conduct preclinical studies or clinical trials of any other potential product candidates.

We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions, and

clinical investigators, to conduct our preclinical studies and clinical trials.

Although we have agreements governing their activities,

we have limited influence over their actual performance and control only certain aspects of their activities.

The failure of these

third parties to successfully carry out their contractual duties or meet expected deadlines could substantially harm our business

because we may be delayed in completing or unable to complete the studies required to support future approval of our product candidates,

or we may not obtain marketing approval for or commercialize our product candidates in a timely manner or at all.

Moreover, these

agreements might terminate for a variety of reasons, including a failure to perform by the third parties.

If we need to enter into

alternative arrangements our product development activities would be delayed and our business, financial condition, results of

operations, stock price and prospects may be materially harmed.

Our reliance on these

third parties for development activities will reduce our control over these activities.

Nevertheless, we are responsible for ensuring

that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and

our reliance on third parties does not relieve us of our regulatory responsibilities.

For example, we will remain responsible for

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.

Moreover, the FDA and comparable foreign regulatory authorities require us to comply with standards,

commonly referred to as GCPs for conducting, recording, and reporting the results of clinical trials to assure that data and reported

results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected.

authorities enforce these requirements through periodic inspections of trial sponsors, clinical investigators, and trial sites.

If we or any of our third parties fail to comply with applicable GCPs or other regulatory requirements, we or they may be subject

to enforcement or other legal actions, the data generated in our trials may be deemed unreliable and the FDA or comparable foreign

regulatory authorities may require us to perform additional studies.

In addition, our clinical trials must be conducted with product

candidates that were produced under cGMP regulations.

Failure to comply with these regulations may require us to repeat clinical

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 any of our relationships

with these third parties terminate, we may not be able to enter into arrangements with alternative providers or to do so on commercially

reasonable terms.

Switching or adding additional third parties involves additional cost and may result in delays that could compromise

our ability to meet our desired development timelines.

We also rely on other

third parties to store and distribute our products for the clinical trials that we conduct.

Any performance failure on the part

of our distributors could delay clinical development, marketing approval, or commercialization of our product candidates, which

could result in additional losses and deprive us of potential product revenue.

If the manufacturers upon which we

rely fail to produce our product candidates in the volumes that we require on a timely basis, or fail to comply with stringent

regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be

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

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

one contract manufacturer for our product candidates for use in our clinical trials.

In addition, we do not have any long-term

commitments from our suppliers of clinical trial material or guaranteed prices for our product candidates or their components.

There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing and

filling our viral product for us and willing to do so.

If our existing third-party manufacturers, or the third parties that we

engage in the future, should cease to work with us, we likely would experience delays in obtaining sufficient quantities of our

product candidates for us to meet commercial demand or to advance our clinical trials while we identify and qualify replacement

Any replacement of our contract manufacturer could require significant effort and expertise because there may be a limited

number of qualified replacements.

Any delays in obtaining adequate supplies of our product candidates that meet the necessary quality

standards may delay our development or commercialization.

If our manufacturers

do not perform as agreed or encounter difficulties in production costs and yields, quality control, shortages of qualified personnel

or key raw materials, compliance with strictly enforced federal, state, and foreign regulations, or other difficulties, our ability

to provide product candidates to patients in our clinical trials could be jeopardized.

In addition, if our

contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements

of the FDA or other regulatory authorities, they will not be able to secure or maintain regulatory approval for their manufacturing

Any such deviations may also require remedial measures that may be costly and/or time consuming for us or a third party

to implement and that may include the temporary or permanent suspension of a clinical trial or the temporary or permanent closure

of a facility.

If any collaborations we might enter into in the future do not result in the successful development and commercialization of products or if one of our collaborators subsequently terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under such potential future collaboration.

If we do not receive the funding we expect under the agreements, our development of our product candidates could be delayed and we may need additional resources to develop our product candidates and our product platform.

Additionally, if any future collaborator of ours is involved in a business combination, the collaborator might de-emphasize or terminate development or commercialization of any product candidate it licenses to us.

If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our reputation in the business and financial communities could be adversely affected.

We face significant competition in seeking appropriate collaborators.

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.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.

If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms, or at all.

If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our product candidates or bring them to market or continue to develop our product platform and our business may be materially and adversely affected.

We rely, and expect to continue to rely, on third parties to conduct, supervise, and monitor our preclinical studies and clinical trials.

If those third parties do not perform satisfactorily, including failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements, we may be unable to obtain regulatory approval for our product candidates or any other product candidates that we may develop in the future.

We rely on third-party CROs, study sites, and others to conduct, supervise, and monitor our preclinical studies and clinical trials for our product candidates and do not currently plan to independently conduct preclinical studies or clinical trials of any other potential product candidates.

We expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions, and clinical investigators, to conduct our preclinical studies and clinical trials.

Although we have agreements governing their activities, we have limited influence over their actual performance and control only certain aspects of their activities.

The failure of these third parties to successfully carry out their contractual duties or meet expected deadlines could substantially harm our business because we may be delayed in completing or unable to complete the studies required to support future approval of our product candidates, or we may not obtain marketing approval for or commercialize our product candidates in a timely manner or at all.

Moreover, these agreements might terminate for a variety of reasons, including a failure to perform by the third parties.

If we need to enter into alternative arrangements our product development activities would be delayed and our business, financial condition, results of operations, stock price and prospects may be materially harmed.

Our reliance on these third parties for development activities will reduce our control over these activities.

Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on third parties does not relieve us of our regulatory responsibilities.

For example, we will remain responsible for 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.

Moreover, the FDA and comparable foreign regulatory authorities require us to comply with standards, commonly referred to as GCPs for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected.

Regulatory authorities enforce these requirements through periodic inspections of trial sponsors, clinical investigators, and trial sites.

If we or any of our third parties fail to comply with applicable GCPs or other regulatory requirements, we or they may be subject to enforcement or other legal actions, the data generated in our trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional studies.

In addition, our clinical trials must be conducted with product candidates that were produced under cGMP regulations.

Failure to comply with these regulations may require us to repeat clinical 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 any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative providers or to do so on commercially reasonable terms.

Switching or adding additional third parties involves additional cost and may result in delays that could compromise our ability to meet our desired development timelines.

We also rely on other third parties to store and distribute our products for the clinical trials that we conduct.

Any performance failure on the part of our distributors could delay clinical development, marketing approval, or commercialization of our product candidates, which could result in additional losses and deprive us of potential product revenue.

If the manufacturers upon which we rely fail to produce our product candidates in the volumes that we require on a timely basis, or fail to comply with stringent regulations applicable to biopharmaceutical manufacturers, we may face delays in the development and commercialization of, or be unable to meet demand for, our product candidates and may lose potential revenues.

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 prices.

We currently have only one contract manufacturer for our product candidates for use in our clinical trials.

In addition, we do not have any long-term commitments from our suppliers of clinical trial material or guaranteed prices for our product candidates or their components.

There are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing and filling our viral product for us and willing to do so.

If our existing third-party manufacturers, or the third parties that we engage in the future, should cease to work with us, we likely would experience delays in obtaining sufficient quantities of our product candidates for us to meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers.

Any replacement of our contract manufacturer could require significant effort and expertise because there may be a limited number of qualified replacements.

Any delays in obtaining adequate supplies of our product candidates that meet the necessary quality standards may delay our development or commercialization.

If our manufacturers do not perform as agreed or encounter difficulties in production costs and yields, quality control, shortages of qualified personnel or key raw materials, compliance with strictly enforced federal, state, and foreign regulations, or other difficulties, our ability to provide product candidates to patients in our clinical trials could be jeopardized.

In addition, if our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or other regulatory authorities, they will not be able to secure or maintain regulatory approval for their manufacturing facilities.

Any such deviations may also require remedial measures that may be costly and/or time consuming for us or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or the temporary or permanent closure of a facility.

Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business.

Any delays in obtaining products or product candidates that comply with the applicable regulatory requirements may result in delays

to clinical trials, product approvals, and commercialization.

While we are ultimately

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.

If the FDA or a comparable

foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws

any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our

ability to develop, obtain regulatory approval for or market our product candidates, if approved.

We must also receive FDA approval

for the use of any new manufacturers for commercial supply.

A failure to comply

with the applicable regulatory requirements, including periodic regulatory inspections, may result in regulatory enforcement actions

against our manufacturers or us (including fines and civil and criminal penalties, including imprisonment) suspension or restrictions

of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination

of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues with

the product candidate, refusal to permit the import or export of the products, product seizure, detention, or recall, operating

restrictions, suits under the civil False Claims Act, corporate integrity agreements, consent decrees, withdrawal of product approval,

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

commercialize our product candidates.

The transition of our manufacturing

operations to our new facility may result in further delays or expenses, and we may not experience the anticipated operating efficiencies.

Our approximately 63,000

square foot manufacturing facility in Framingham, Massachusetts is now fully operational.

This facility is intended to give us

control over key aspects of the supply chain for our products and product candidates.

However, we may not experience the anticipated

operating efficiencies as we commence manufacturing operations at the new facility.

Any such delays may disrupt or delay the supply

of our product candidates if we have not maintained a sufficient backup supply of our product candidates through third-party manufacturers.

Moreover, changing manufacturing facilities may also require that we conduct additional studies, make notifications to the regulatory

authorities, make additional filings to the regulatory authorities, and obtain regulatory authority approval for the new facilities,

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,

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

We may not be able to develop

or acquire the internal expertise and resources necessary for compliance with these requirements.

If we fail to achieve the operating

efficiencies that we anticipate, our manufacturing and operating costs may be greater than expected, which could have a material

adverse impact on our operating results.

In operating our own

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

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

We face potential product liability

exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization

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.

Any delays in obtaining products or product candidates that comply with the applicable regulatory requirements may result in delays to clinical trials, product approvals, and commercialization.

While we are ultimately 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.

If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.

We must also receive FDA approval for the use of any new manufacturers for commercial supply.

A failure to comply with the applicable regulatory requirements, including periodic regulatory inspections, may result in regulatory enforcement actions against our manufacturers or us (including fines and civil and criminal penalties, including imprisonment) suspension or restrictions of production, injunctions, delay or denial of product approval or supplements to approved products, clinical holds or termination of clinical trials, warning or untitled letters, regulatory authority communications warning the public about safety issues with the product candidate, refusal to permit the import or export of the products, product seizure, detention, or recall, operating restrictions, suits under the civil False Claims Act, corporate integrity agreements, consent decrees, withdrawal of product approval, 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 commercialize our product candidates.

The transition of our manufacturing operations to our new facility may result in further delays or expenses, and we may not experience the anticipated operating efficiencies.

Our approximately 63,000 square foot manufacturing facility in Framingham, Massachusetts is now fully operational.

This facility is intended to give us control over key aspects of the supply chain for our products and product candidates.

However, we may not experience the direct transfer of manufacturing processes or the anticipated operating efficiencies as we commence manufacturing operations at the new facility.

Any such delays may disrupt or delay the supply of our product candidates if we have not maintained a sufficient backup supply of our product candidates through third-party manufacturers.

Moreover, changing manufacturing facilities may also require that we conduct additional studies, make notifications to the regulatory authorities, make additional filings to the regulatory authorities, and obtain regulatory authority approval for the new facilities, 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, commercial supply, and will be subject to FDA and comparable foreign regulatory authority inspections.

We may not be able to develop or acquire the internal expertise and resources necessary for compliance with these requirements.

If we fail to achieve the operating efficiencies that we anticipate, our manufacturing and operating costs may be greater than expected, which could have a material adverse impact on our operating results.

In operating our own manufacturing facility, we may be forced to devote greater resources and management time than anticipated, particularly in areas 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 timeline.

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 matters

We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and have to limit the commercialization 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.

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

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:

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

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

9 unchanged sentences

• product recalls, withdrawals or labeling, marketing or promotional restrictions, including withdrawal of marketing approval.

We believe we have

sufficient insurance coverage in place for our business operations.

However, our insurance coverage may not reimburse us or may

not be sufficient to reimburse us for any expenses or losses we may suffer.

Moreover, insurance coverage is becoming increasingly

expensive and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to

protect us against losses due to liability.

We intend to expand our insurance coverage to include the sale of commercial products

if we obtain FDA or comparable foreign regulatory approval for our product candidates in development, but we may be unable to obtain

commercially reasonable product liability insurance for any products approved for marketing, or at all.

Failure to obtain and retain

sufficient product liability insurance at an acceptable cost could prevent or inhibit the commercialization of products we develop.

A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments

exceed our insurance coverage, could decrease our cash, and materially harm our business, financial condition, results of operations,

stock price and prospects.

We believe we have sufficient insurance coverage in place for our business operations.

However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer.

Moreover, insurance coverage is becoming increasingly expensive and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability.

We intend to expand our insurance coverage to include the sale of commercial products if we obtain FDA or comparable foreign regulatory approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing, or at all.

Failure to obtain and retain sufficient product liability insurance at an acceptable cost could prevent or inhibit the commercialization of products we develop.

A successful product liability claim or series of claims brought against us could cause our stock price to fall and, if judgments exceed our insurance coverage, could decrease our cash, and materially harm our business, financial condition, results of operations, stock price and prospects.

We are subject to the U.S.

Corrupt Practices Act, the U.K.

Bribery Act and other anticorruption laws, as well as import and export control laws, customs laws,

sanctions laws and other laws governing our operations.

If we fail to comply with these laws, we could be subject to civil or criminal

penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results

of operations, stock price and prospects.

Our operations are

subject to anticorruption laws, including the U.S.

Foreign Corrupt Practices Act, the U.K.

Bribery Act and other anticorruption laws, as well as import and export control laws, customs laws, sanctions laws and other laws governing our operations.

If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, financial condition, results of operations, stock price and prospects.

Our operations are subject to anticorruption laws, including the U.S.

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

Bribery Act 2010, or the Bribery

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 can provide no assurance

that we will be completely effective in ensuring our compliance with all applicable anticorruption laws or other legal requirements,

including trade control laws.

If we are not in compliance with applicable anticorruption laws or trade control laws, we may be

subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could

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

Likewise, any investigation

of any potential violations of these anticorruption laws or trade control laws by U.S., U.K.

or other authorities could also have

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

If we fail to comply with federal

and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face

substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially

We are subject to many

federal and state healthcare laws, such as the federal Anti-Kickback Statute, the federal civil and criminal False Claims Acts,

the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the Veterans Health

Care Act of 1992, or VHCA, the federal Health Insurance Portability and Accountability Act of 1996 (as amended by the Health Information

Technology for Economics and Clinical Health Act, or HITECH), or HIPAA, the FCPA, the ACA, and similar state laws.

we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors,

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.

We would be subject to healthcare fraud and abuse and patient

privacy regulation by both the federal government and the states and foreign jurisdictions in which we conduct our business.

the European Union, the data privacy laws are generally stricter than those that apply in the United States and include specific

requirements for the collection of personal data of European Union persons or the transfer of personal data outside of the European

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

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,

regulatory proposals and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability

to market our products, obtain collaborators, and raise capital.

In the United States

and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the

healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post approval

activities and affect our ability to profitably sell any products for which we obtain marketing approval.

We expect that current

laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria

and in additional downward pressure on the price that we may receive for any approved products, which could have a material adverse

effect on customers for our products, if approved, and, accordingly, on our results of operations.

Any reduction in reimbursement

from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors.

The implementation

of cost containment measures or other healthcare reforms may prevent us from commercializing our products and being able to generate

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

Compliance with the

federal track and trace requirements may increase our operational expenses and impose significant administrative burdens.

result of these and other new proposals, we may determine to change our current manner of operation, provide additional benefits

or change our contract arrangements, any of which could have a material adverse effect on our business, financial condition, results

of operations, stock price and prospects.

Our employees, independent contractors,

consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities,

including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the

risk of employee fraud or other misconduct.

Misconduct by employees, independent contractors, consultants, commercial partners,

principal investigators, CMOs, or CROs could include intentional, reckless, negligent, or unintentional failures to comply with

FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing

information required by federal programs, report financial information or data accurately or disclose unauthorized activities to

This misconduct could also involve the improper use or misrepresentation of information obtained in the course of clinical

trials, which could result in regulatory sanctions and serious harm to our reputation.

Moreover, it is possible for a whistleblower

to pursue a False Claims Act case against us even if the government considers the claim unmeritorious and declines to intervene,

which could require us to incur costs defending against such a claim.

If any such actions are instituted against us, and we are

not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial

condition, results of operations, stock price and prospects, including the imposition of significant fines or other sanctions.

Violations of or liabilities under

environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material

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.

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

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

We do not maintain

insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal

of biological or hazardous materials.

Our internal computer systems, or

those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in

a material disruption of our development programs.

Our internal computer

systems, and those of our CROs, CMOs, information technology suppliers and other contractors and consultants are vulnerable to

damage from computer viruses, cyber-attacks and other unauthorized access, natural disasters, terrorism, war, and telecommunication

and electrical failures.

If such an event were to occur and cause interruptions in our operations, it could result in a material

disruption of our development programs.

For example, the loss of clinical trial data from completed, ongoing or planned clinical

trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the

To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or

inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development

of any of our product candidates could be delayed.

Bribery Act 2010, or the Bribery 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 can provide no assurance that we will be completely effective in ensuring our compliance with all applicable anticorruption laws or other legal requirements, including trade control laws.

If we are not in compliance with applicable anticorruption laws or trade control laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations, stock price and prospects.

Likewise, any investigation of any potential violations of these anticorruption laws or trade control laws by U.S., U.K.

or other authorities could also have an adverse impact on our reputation, our business, financial condition, results of operations, stock price and prospects.

If we fail to comply with federal and state healthcare laws, including fraud and abuse and health and other information privacy and security laws, we could face substantial penalties and our business, financial condition, results of operations, stock price and prospects will be materially harmed.

We are subject to many federal and state healthcare laws, such as the federal Anti-Kickback Statute, the federal civil and criminal False Claims Acts, the civil monetary penalties statute, the Medicaid Drug Rebate statute and other price reporting requirements, the Veterans Health Care Act of 1992, or VHCA, the federal Health Insurance Portability and Accountability Act of 1996 (as amended by the Health Information Technology for Economics and Clinical Health Act, or HITECH), or HIPAA, the FCPA, the ACA, and similar state laws.

Even though we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, 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.

We would be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states and foreign jurisdictions in which we conduct our business.

In the European Union, the data privacy laws are generally stricter than those that apply in the United States and include specific requirements for the collection of personal data of European Union persons or the transfer of personal data outside of the European 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 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.

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, regulatory proposals and healthcare payor initiatives that may increase our costs of compliance, and adversely affect our ability to market our products, obtain collaborators, and raise capital.

In the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post approval activities and affect our ability to profitably sell any products for which we obtain marketing approval.

We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we may receive for any approved products, which could have a material adverse effect on customers for our products, if approved, and, accordingly, on our results of operations.

Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may

prevent us from commercializing our products and being able to generate revenue, and we could be prevented from or significantly delayed in achieving profitability.

Compliance with the federal track and trace requirements may increase our operational expenses and impose significant administrative burdens.

As a result of these and other new proposals, we may determine to change our current manner of operation, provide additional benefits or change our contract arrangements, any of which could have a material adverse effect on our business, financial condition, results of operations, stock price and prospects.

Our employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the risk of employee fraud or other misconduct.

Misconduct by employees, independent contractors, consultants, commercial partners, principal investigators, CMOs, or CROs could include intentional, reckless, negligent, or unintentional failures to comply with FDA regulations, comply with applicable fraud and abuse laws, provide accurate information to the FDA, properly calculate pricing information required by federal programs, report financial information or data accurately or disclose unauthorized activities to us.

This misconduct could also involve the improper use or misrepresentation of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

Moreover, it is possible for a whistleblower to pursue a False Claims Act case against us even if the government considers the claim unmeritorious and declines to intervene, which could require us to incur costs defending against such a claim.

If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, financial condition, results of operations, stock price and prospects, including the imposition of significant fines or other sanctions.

Violations of or liabilities under environmental, health and safety laws and regulations could subject us to fines, penalties or other costs that could have a material 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.

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

We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.

Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our development programs.

Our internal computer systems, and those of our CROs, CMOs, information technology suppliers and other contractors and consultants are vulnerable to damage from computer viruses, cyber-attacks and other unauthorized access, natural disasters, terrorism, war, and telecommunication and electrical failures.

If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs.

For example, the loss of clinical trial data from completed, ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

To the extent that any disruption or security breach were to result in a loss of or damage to our data or applications, or inappropriate disclosure of personal, confidential or proprietary information, we could incur liability and the further development of any of our product candidates could be delayed.

Risks related to our operations

Our financial condition and results

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

In December 2019,

a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China.

The virus continues to spread globally, including

the United States, the United Kingdom and other countries in which we conduct clinical trials, and has been declared a pandemic

by the World Health Organization.

The impact of this pandemic has been and will likely continue to be extensive in many aspects

of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well

as businesses and capital markets around the world.

In an effort to halt the outbreak of COVID-19, many countries, including the

United States, the United Kingdom and certain other countries in which we conduct clinical trials, placed significant restrictions

on travel and business operations or issued shelter-in-place orders.

These restrictions and orders continue to remain in effect

to varying degrees, the effect of which required, and in some instances, continue to require, certain of our employees and clinical

trial staff to work remotely and avoid unnecessary travel.

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

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

economic impact brought by, and the duration and severity of, the COVID-19 pandemic are difficult to assess or predict, the impact

of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact

our short-term and long-term liquidity.

Additionally, the stock market has been unusually volatile during the COVID-19 outbreak

and such volatility may continue.

To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly,

and such fluctuation may continue to occur.

The ultimate impact of the COVID-19 pandemic on our business will largely depend on

future developments, which are highly uncertain, cannot be predicted with confidence, such as the ultimate geographic spread of

the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries,

business closures or business disruptions, the ultimate impact on financial markets and the global economy, and the effectiveness

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

the full extent of the delays or impacts on our business, financing or clinical trial activities, healthcare systems or the global

economy as a whole.

However, these effects could have a material impact on our liquidity, capital resources, operations and business

and those of the third parties on which we rely.

To the extent to COVID-19 pandemic materially impacts our business and financial

results, it may also have the effect of significantly heightening many of the other risk described in this "Risk Factors"

We will need to expand the size of

our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

As our development

and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales, marketing, financial

and other personnel.

Our future financial performance and our ability to commercialize RP1 and our other product candidates will

depend, in part, on our ability to effectively manage any future growth, which would impose significant additional responsibilities

on members of management and may divert their attention away from day-to-day activities.

We currently rely,

and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants

to provide certain services.

The services include substantially all aspects of clinical trial management and manufacturing, as

well as support for our financial reporting and accounting functions.

If the services of independent organizations, advisors and

consultants become unavailable to us or we are unable to effectively manage our outsourced activities, or if the quality or accuracy

of such services is compromised for any reason, our clinical trials may be extended, delayed or terminated, we may not comply with

our financial reporting and accounting obligations on a timely basis and we may not be able to obtain marketing approval of RP1

and our other product candidates or otherwise advance our business.

If we are not able

to effectively expand our organization by hiring qualified new employees and expanding our groups of consultants and contractors,

we may not be able to successfully implement the tasks necessary to further develop and commercialize RP1 and our other product

candidates and, accordingly, may not achieve our research, development and commercialization goals.

We are highly dependent on our key

personnel, including Philip Astley-Sparke, our Chief Executive Officer;

Robert Coffin, Ph.D., our President and Chief Research &

Development Officer;

Our financial condition and results of operations could be adversely affected by the coronavirus disease-2019, or COVID-19, outbreak.

In December 2019, a novel strain of coronavirus, now referred to as COVID-19, surfaced in Wuhan, China.

The virus continues to spread globally, including the United States, the United Kingdom and other countries in which we conduct clinical trials, and has been declared a pandemic by the World Health Organization.

The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

In an effort to halt the outbreak of COVID-19, many countries, including the United States, the United Kingdom and certain other countries in which we conduct clinical trials, placed significant restrictions on travel and business operations or issued shelter-in-place orders.

These restrictions and orders continue to remain in effect to varying degrees, the effect of which required, and in some instances, continue to require, certain of our employees and clinical trial staff to work remotely and avoid unnecessary travel.

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 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 access to laboratory and other supplies necessary for development and packaging of our product candidates, our commercialization processes and the conduct and the enrollment 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 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 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 to 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 economic impact brought by, and the duration and severity of, the COVID-19 pandemic are difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce our ability to access capital, which could negatively impact our short-term and long-term liquidity.

Additionally, the stock market has been unusually volatile during the COVID-19 pandemic and such volatility may continue.

To date, during certain periods of the COVID-19 pandemic, our stock price fluctuated significantly, and such fluctuation may continue to occur.

The ultimate impact of the COVID-19 pandemic on our business will largely depend on future developments, which are highly uncertain, cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions, the ultimate impact on financial markets and the global economy, and the effectiveness of any COVID-19 vaccines and 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, work against evolving COVID-19 strains or be made available or will be accepted on a significant scale and in a timely manner.

We do not yet know the full extent of the delays or impacts on our business, financing or clinical trial activities, healthcare systems or the global economy as a whole.

However, these effects could have a material impact on our liquidity, capital resources, operations and business and those of the third parties on which we rely.

To the extent the COVID-19 pandemic materially impacts our business and financial results, it may also have the effect of significantly heightening many of the other risk described in this "Risk Factors" section.

We will need to expand the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

As our development and commercialization plans and strategies develop, we expect to need additional managerial, operational, sales, marketing, financial and other personnel.

Our future financial performance and our ability to commercialize RP1 and our other product candidates will depend, in part, on our ability to effectively manage any future growth, which would impose significant additional responsibilities on members of management and may divert their attention away from day-to-day activities.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services.

The services include substantially all aspects of clinical trial management and manufacturing, as well as support for our financial reporting and accounting functions.

If the services of independent organizations, advisors and consultants become unavailable to us or we are unable to effectively manage our outsourced activities, or if the quality or accuracy of such services is compromised for any reason, our clinical trials may be extended, delayed or terminated, we may not comply with our financial reporting and accounting obligations on a timely basis and we may not be able to obtain marketing approval of RP1 and our other product candidates or otherwise advance our business.

If we are not able to effectively expand our organization by hiring qualified new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to further develop and commercialize RP1 and our other product candidates and, accordingly, may not achieve our research, development and commercialization goals.

We are highly dependent on our key 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.

If we are not successful in attracting, motivating and

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 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

employees to remain at our company, in addition to salary and cash incentives, we have provided stock option grants that vest over

The value to employees of these equity grants that vest over time may be significantly affected by movements in our stock

price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies.

Although we have employment agreements with our key employees, these employment agreements generally provide for at-will employment,

which means that any of our employees could leave our employment at any time, with or without notice.

We have identified material weaknesses

in our internal control over financial reporting.

If we are unable to remediate these material weaknesses, or if we identify additional

material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to

accurately or timely report our financial condition or results of operations, which may adversely affect our business.

In connection with

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.

However, these material weaknesses did not result in a restatement

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

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

If we are unable to remediate these material

weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of

internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may

adversely affect investor confidence in us and, as a result, our stock price and ability to access the capital markets in the future.

The material weaknesses

we identified were as follows:

We did not design or maintain an effective control environment commensurate with our financial reporting requirements.

We lacked a sufficient number of professionals with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters timely and accurately.

Additionally, the limited personnel resulted in our inability to consistently establish appropriate authorities and responsibilities in pursuit of our financial reporting objectives, as demonstrated by, among other things, our insufficient segregation of duties in our accounting function.

This material weakness further contributed to the material weakness below.

We did not design and maintain formal accounting policies, processes and controls to analyze, account for and disclose complex transactions, including accounting for preferred stock, stock-based compensation, warrant liabilities and leases.

Each of these control

deficiencies could result in a misstatement of our accounts or disclosures that would result in a material misstatement of our

annual or interim consolidated financial statements that would not be prevented or detected, and accordingly, we determined that

these control deficiencies constitute material weaknesses.

These material weaknesses

also resulted in adjustments to preferred stock, stock compensation expense, warrant liability and deferred rent in our consolidated

financial statements as of and for the year ended March 31, 2017, which were recorded prior to their issuance.

Prior to the completion

of our IPO, we were a private company with limited accounting personnel to adequately execute our accounting processes and other

supervisory resources with which to address our internal control over financial reporting.

We have implemented, and continue to

implement, measures designed to improve our internal control over financial reporting and remediate the control deficiencies that

led to these material weaknesses.

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

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

that the measures we have taken to date, and actions we intend to take in the future, will be sufficient to remediate the control

deficiencies that led to these material weaknesses in our internal control over financial reporting or that they will prevent or

avoid potential future material weaknesses.

In addition, our independent registered public accounting firm has not performed an

evaluation of our internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act because

no such evaluation has been required.

Had our independent registered public accounting firm performed an evaluation of our internal

control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act, additional material weaknesses may

have been identified.

If we are unable to successfully remediate our existing or any future material weaknesses in our internal

control over financial reporting, or identify any additional material weaknesses, the accuracy and timing of our financial reporting

may be adversely affected, potentially resulting in restatements of our financial statements, we may be unable to maintain compliance

with securities law requirements regarding timely filing of periodic reports and applicable Nasdaq listing requirements, investors

may lose confidence in our financial reporting, and our share price may decline as a result.

If we fail to establish and maintain

proper and effective internal control over financial reporting our ability to produce accurate and timely financial statements

could be impaired.

We are required to

maintain internal control over financial reporting.

We must perform system and process design evaluation and testing of the effectiveness

of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over

financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.

We continue to be engaged in a process to document

and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we will need

to continue to incur substantial professional fees and internal costs for our accounting and finance functions, expend significant

management efforts, continue to implement plans developed to address areas that we have identified as requiring improvement, validate

through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal

control over financial reporting.

If we are not able

to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain

proper and effective internal controls over financial reporting, we may not be able to produce timely and accurate financial statements.

If that were to happen, our investors could lose confidence in our reported financial information, the market price of our stock

could decline and we could be subject to sanctions or investigations by the SEC, Nasdaq or other regulatory authorities.

We believe that any

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.

We may discover weaknesses in our system of internal financial and accounting

controls and procedures that could result in a material misstatement of our consolidated financial statements.

Our internal control

over financial reporting will not prevent or detect all errors and all fraud.

Because of the inherent limitations in all control

systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that

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

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

We must design our

disclosure controls and procedures to reasonably assure that information we must disclose in reports we file or submit under the

Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods

specified in the rules and forms of the SEC.

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

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.

Risks Related to Our Common Stock and

General Risks

An active trading market for our

common stock may not be sustained.

Our common stock began

trading on the Nasdaq Global Select Market on July 20, 2018.

Given the limited trading history of our common stock, there

is a risk that an active trading market for shares of our common stock may not be sustained.

In the absence of an active trading

market for shares of our common stock, our stockholders may not be able to sell their common stock at or above the price at which

such stockholder acquired our common stock or at the time that they would like to sell.

The price of our common stock may

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

Our stock price has

been and is likely to be volatile.

The stock market in general and the market for biopharmaceutical companies in particular have

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

of this volatility, you may not be able to sell your common stock at or above the price at which it was acquired.

The market price

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

If we are not successful in attracting, motivating and 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 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 employees to remain at our company, in addition to salary and cash incentives, we have provided stock option and restricted stock unit grants that vest over time.

The value to employees of these equity grants that vest over time may be significantly affected by movements in our stock price that are beyond our control, and may at any time be insufficient to counteract more lucrative offers from other companies.

Although we have employment agreements with our key employees, these employment agreements generally provide for at-will employment, which means that any of our employees could leave our employment at any time, with or without notice.

If we fail to establish and maintain proper and effective internal control over financial reporting our ability to produce accurate and timely financial statements could be impaired.

We are required to maintain internal control over financial reporting.

We must perform system and process design evaluation and testing of the effectiveness of our internal controls over financial reporting to allow management to report on the effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.

We continue to be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging.

In this regard, we will need to continue to incur substantial professional fees and internal costs for our accounting and finance functions, expend significant management efforts, continue to implement plans developed to address areas that we have identified as requiring improvement, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

If we are not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act in a timely manner, or if we are unable to maintain proper and effective internal controls over financial reporting, we may not be able to produce timely

and accurate financial statements.

If that were to happen, our investors could lose confidence in our reported financial information, the market price of our stock could decline and we could be subject to sanctions or investigations by the SEC, Nasdaq or other regulatory authorities.

We believe that any 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.

We may discover weaknesses in our system of internal financial and accounting controls and procedures that could result in a material misstatement of our consolidated financial statements.

Our internal control over financial reporting will not prevent or detect all errors and all fraud.

Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that 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.

We previously had identified material weaknesses in our internal control over financial reporting, which have now been remediated.

Any failure to maintain effective internal control over financial reporting could result in material misstatements in our financial statements and cause investors to lose confidence in our reported financial information, which in turn could cause the trading price of our securities to decline.

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting, as such term is defined in Rule 13a-15(f) under the Exchange Act.

As disclosed in our Annual Report on Form 10-K for the year ended March 31, 2020, management identified material weaknesses in our internal control over financial reporting as of the end of that fiscal year.

A material weakness is a deficiency, or 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.

Effective internal controls are necessary for us to provide reliable and accurate financial statements and to effectively prevent fraud.

We devote significant resources and time to comply with the internal control over financial reporting requirements of the Sarbanes Oxley Act of 2002, and we continue to enhance our controls and processes.

In the year ended March 31, 2021, we remediated the previously disclosed material weakness in our internal controls over our ability to maintain an effective control environment commensurate with our financial reporting requirements.

The Company hired additional resources in the finance department with the accounting knowledge and skills necessary to appropriately analyze, record and disclose accounting matters timely and accurately.

The additional resources have allowed for more appropriate structure of responsibilities within the finance department and sufficient segregation of duties.

Furthermore, we remediated the material weakness over the accounting for, and disclosure of, complex transactions, including accounting for preferred stock, stock-based compensation, warrant liabilities and leases.

Although these material weaknesses are remediated as of March 31, 2021, we cannot be certain that we will be able to prevent future significant deficiencies or material weaknesses.

Inadequate internal controls could cause investors to lose confidence in our reported financial information, which could have a negative effect on investor confidence in our financial statements, the trading price of our stock and our access to capital.

Risks related to our common stock and general risks

An active trading market for our common stock may not be sustained.

Our common stock began trading on the Nasdaq Global Select Market on July 20, 2018.

Given the limited trading history of our common stock, there is a risk that an active trading market for shares of our common stock may not be sustained.

In the absence of an active trading market for shares of our common stock, our stockholders may not be able to sell their common stock at or above the price at which such stockholder acquired our common stock or at the time that they would like to sell.

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

Our stock price has been and is likely to be volatile.

The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of

particular companies.

As a result of this volatility, you may not be able to sell your common stock at or above the price at which it was acquired.

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

• the success of competitive products or technologies;

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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”

Our operating results may fluctuate

significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below

expectations or our guidance.

Our quarterly and annual

operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future operating results.

From time to time, we may enter into license or collaboration agreements with other companies that include development funding

and significant upfront and milestone payments and/or royalties, which may become an important source of our revenue.

our revenue may depend on development funding and the achievement of development and clinical milestones under current and any

potential future license and collaboration agreements and sales of our products, if approved.

These upfront and milestone payments

may vary significantly from period to period and any such variance could cause a significant fluctuation in our operating results

from one period to the next.

In addition, we measure

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

price volatility, the magnitude of the expense that we must recognize may vary significantly.

Furthermore, our operating

results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict,

including the following:

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

Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or our guidance.

Our quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for us to predict our future operating results.

From time to time, we may enter into license or collaboration agreements with other companies that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source of our revenue.

Accordingly, our revenue may depend on development funding and the achievement of development and clinical milestones under current and any potential future license and collaboration agreements and sales of our products, if approved.

These upfront and milestone payments may vary significantly from period to period and any such variance could cause a significant fluctuation in our operating results from one period to the next.

In addition, we measure 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 price volatility, the magnitude of the expense that we must recognize may vary significantly.

Furthermore, our operating results may fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict, including the following:

• timing and cost of, and level of investment in, research and development activities relating to our current and any future product candidates, which will change from time to time;

• the total expenses we incur in connection with equipping and operating our manufacturing facility;

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;

• our ability to engage clinical trial sites in the U.S.

and in foreign territories, obtain the approval for conducing our clinical trials in foreign territories from their regulatory authorities, as well as our ability to enroll the number of patients necessary in our 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;

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

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• the changing and volatile global economic environment.

These factors could

result in large fluctuations and unpredictability in our quarterly and annual operating results.

As a result, comparing our operating

results on a period-to-period basis may not be meaningful.

Investors should not rely on our past results as an indication of our

future performance.

This variability and

unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any

If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may

provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price

of our common stock could decline substantially.

Such a stock price decline could occur even when we have met any previously publicly

stated revenue and/or earnings guidance we may provide.

We have broad discretion in how we

use our cash, cash equivalents and investments, and may not use these resources effectively, which could affect our results of

operations and cause our stock price to decline.

Our management has

considerable discretion in the application of our cash, cash equivalents and investments.

We intend to use our resources to fund

our preclinical and clinical development programs as well as for general corporate purposes, including working capital requirements

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.

We may use our resources for purposes that do not yield a significant

return or any return at all for our stockholders.

In addition, pending their use, we may invest our cash, cash equivalents and

investments in a manner that does not produce income or that loses value.

We do not intend to pay dividends

on our common stock so any returns will be limited to the value of our stock.

We currently anticipate

that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring

or paying any cash dividends for the foreseeable future.

Any return to stockholders will therefore be limited to the appreciation

of their stock, which may never occur, as the only way to realize any return on their investment.

Our executive officers, directors,

and stockholders and their affiliates who beneficially own more than 5% of our common stock exercise significant influence over

our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.

Our executive officers,

directors, holders of 5% or more of our capital stock and their respective affiliates beneficially own a significant portion of

our voting stock and, accordingly, these stockholders will continue to have significant influence over matters requiring stockholder

For example, these stockholders will continue to significantly influence elections of directors, amendments of our organizational

documents, or approval of any merger, sale of assets, or other major corporate transaction.

This may prevent or discourage unsolicited

acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Conflicts of interest may arise because

some members of our board of directors are representatives of our principal stockholders.

Certain of our principal

stockholders or their affiliates are venture capital funds or other investment vehicles that could invest in entities that directly

or indirectly compete with us.

As a result of these relationships, when conflicts arise between the interests of the principal

stockholders or their affiliates and the interests of other stockholders, members of our board of directors that are representatives

of the principal stockholders may not be disinterested.

Neither the principal stockholders nor the representatives of the principal

stockholders on our board of directors, by the terms of our amended and restated certificate of incorporation, are required to

offer us any transaction opportunity of which they become aware and could take any such opportunity for themselves or offer it

to their other affiliates, unless such opportunity is expressly offered to them solely in their capacity as members of our board

of directors.

Sales of a substantial number of

shares of our common stock in the public market could cause our stock price to fall.

If our existing stockholders

sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the expiration of contractual

or legal restrictions on resale lapse, the market price of our common stock could decline.

These sales may make it more difficult

for us to sell equity or equity related securities in the future at a time and price that we deem appropriate, or to use equity

as consideration for future acquisition.

In addition, a significant

number of shares of common stock that are either subject to outstanding options, reserved for future issuance under our equity

incentive plans or subject to outstanding warrants are eligible for sale in the public market to the extent permitted by the provisions

of various vesting schedules and Rule 144 and Rule 701 under the Securities Act.

If these additional shares of common

stock are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could

Certain holders of

shares of our common stock, or their permitted transferees, are entitled to rights with respect to the registration under the Securities

Act of shares of our common stock pursuant to the amended and restated investors' rights agreement by and among us and certain

of our stockholders.

Registration of these shares under the Securities Act would result in the shares becoming freely tradable

without restriction under the Securities Act, except for shares purchased by affiliates.

Any sales of securities by these stockholders

could have a material adverse effect on the market price of our common stock.

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

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.

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.

These factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.

As a result, comparing our operating results on a period-to-period basis may not be meaningful.

Investors should not rely on our past results as an indication of our future performance.

This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.

If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially.

Such a stock price decline could occur even when we have met any previously publicly stated revenue and/or earnings guidance we may provide.

We have broad discretion in how we use our cash, cash equivalents and investments, and may not use these resources effectively, which could affect our results of operations and cause our stock price to decline.

Our management has considerable discretion in the application of our cash, cash equivalents and investments.

We intend to use our resources to fund our preclinical and clinical development programs as well as for general corporate purposes, including working capital requirements 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.

We may use our resources for

purposes that do not yield a significant return or any return at all for our stockholders.

In addition, pending their use, we may invest our cash, cash equivalents and investments in a manner that does not produce income or that loses value.

We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future.

Any return to stockholders will therefore be limited to the appreciation of their stock, which may never occur, as the only way to realize any return on their investment.

Our executive officers, directors, and stockholders and their affiliates who beneficially own more than 5% of our common stock exercise significant influence over our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.

Based on the number of shares outstanding as of June 30, 2021, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned a significant portion of our voting stock and, accordingly, these stockholders will continue to have significant influence over matters requiring stockholder approval.

For example, these stockholders will continue to significantly influence elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction.

This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

Conflicts of interest may arise because some members of our board of directors are representatives of our principal stockholders.

Certain of our principal stockholders or their affiliates are venture capital funds or other investment vehicles that could invest in entities that directly or indirectly compete with us.

As a result of these relationships, when conflicts arise between the interests of the principal stockholders or their affiliates and the interests of other stockholders, members of our board of directors that are representatives of the principal stockholders may not be disinterested.

Neither the principal stockholders nor the representatives of the principal stockholders on our board of directors, by the terms of our amended and restated certificate of incorporation, are required to offer us any transaction opportunity of which they become aware and could take any such opportunity for themselves or offer it to their other affiliates, unless such opportunity is expressly offered to them solely in their capacity as members of our board of directors.

Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the expiration of contractual or legal restrictions on resale lapse, the market price of our common stock could decline.

These sales may make it more difficult for us to sell equity or equity related securities in the future at a time and price that we deem appropriate, or to use equity as consideration for future acquisition.

In addition, a significant number of shares of common stock that are either subject to outstanding options and restricted stock units, reserved for future issuance under our equity incentive plans or subject to outstanding warrants are eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules and Rule 144 and Rule 701 under the Securities Act, including our ESPP if activated.

If these additional shares of common stock are sold, or if it is perceived that they will be sold, in the public market, the market price of our common stock could decline.

Certain holders of shares of our common stock, or their permitted transferees, are entitled to rights with respect to the registration under the Securities Act of shares of our common stock pursuant to the amended and restated investors' rights agreement by and among us and certain of our stockholders.

Registration of these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares purchased by affiliates.

Any sales of securities by these stockholders could have a material adverse effect on the market price of our common stock.

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 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.

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:

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• 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;

• 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;

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• 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.

In addition, if we undertake acquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense or intangible asset impairment charges.

Moreover, 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

Use of Proceeds.

Any of 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.

Furthermore, 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 Union.

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 Use of Proceeds.

Defaults Upon Senior Securities.

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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