What changed in this filing

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Item 1A. Risk Factors

2022-03-09 compared with 2021-03-17 · 895 added, 1595 removed, 346 unchanged (88% of the section changed)

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Investing in our securities involves a high degree of risk.

The following information about these risks, together with the other information appearing

elsewhere in this Annual Report on form 10-K, including our consolidated financial statements and related notes thereto and managements discussion and analysis of financial condition and results of operation, should be carefully considered

before a decision to invest in our securities.

differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time.

Additional risks that are currently unknown to us or that we currently believe to be immaterial may also impair

our business.

The following information about these risks, together with the other information appearing elsewhere in this Annual Report on form 10-K, including our consolidated financial statements and related notes thereto and management’s discussion and analysis of financial condition and results of operation, should be carefully considered before a decision to invest in our securities.

The occurrence of any of the following risks could have a material adverse effect on our business, financial condition, results of operations and future growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time.

Additional risks that are currently unknown to us or that we currently believe to be immaterial may also impair our business.

In these circumstances, the market price of our securities could decline, and holders of our securities may lose all or part of their investment.

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We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future.

These factors raise substantial doubt regarding our ability to continue as a going concern.

We are a clinical-stage biopharmaceutical company, and we have not yet generated significant income from operating activities.

We have incurred

net losses in each year since our inception in 2002, including net losses of $172.0 million and $159.6 million for the years ended December 31, 2019 and 2020 respectively.

As of December 31, 2020, we had an accumulated deficit of

$958.5 million.

We have incurred net losses in each year since our inception in 2002, including net losses of

$97.8 million and $159.6 million for the years ended December 31, 2021 and 2020 respectively.

As of December 31, 2021, we had an accumulated deficit of $258.5 million.

We have devoted most of our financial resources to research and development, including our clinical and pre-clinical development activities.

To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, such as conditional advances from

OSEO Innovation, or OSEO, reimbursements of research tax credit claims and strategic collaborations.

The amount of our future net losses will depend, in part, on the pace and amount of our future expenditures and our ability to obtain funding

through equity or debt financings, strategic collaborations, or additional grants or tax credits.

To date, we have not generated any product revenue and we continue to advance the clinical and regulatory development of Viaskin Peanut in the United

States and European Union.

ability to achieve sufficient market acceptance, reimbursement from third-party payors and adequate market share for any approved products in those markets.

Our near-term prospects, including our ability to finance our company and generate revenue, will depend heavily on the successful development, regulatory

approval and commercialization of Viaskin Peanut.

To date, we have financed our operations primarily through the sale of equity securities, obtaining public assistance in support of innovation, such as conditional advances from OSEO Innovation, or OSEO, reimbursements of research tax credit claims and strategic collaborations.

The amount of our future net losses will depend, in part, on the pace and amount of our future expenditures and our ability to obtain funding through equity or debt financings, strategic collaborations, or additional grants or tax credits.

To date, we have not generated any product revenue and we continue to advance the clinical and regulatory development of Viaskin Peanut in the

United States and European Union.

Even if we obtain regulatory approval to market Viaskin Peanut or any other product candidate, our future revenues will depend upon the size of any markets in which our product candidates have received approval, and our ability to achieve sufficient market acceptance, reimbursement from third-party payors and adequate market share for any approved products in those markets.

Our near-term prospects, including our ability to finance our company and generate revenue, will depend heavily on the successful development, regulatory approval and commercialization of Viaskin Peanut.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

We anticipate that our expenses will increase substantially if and as we:

seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, for which our

Marketing Authorization Application, or MAA, is currently under review by the European Medical Agency, or EMA;

and for which we continue to seek regulatory and marketing approvals in the United States;

continue our research, pre-clinical and clinical development of our

product candidates, including additional trials related to our pursuit of regulatory approval of Viaskin Peanut in the United States;

seek regulatory and marketing approvals for our other product candidates that successfully complete clinical

establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and

any other products for which we may obtain marketing approval, especially in North America;

further develop the manufacturing process for our product candidates, including any modifications to our patch

seek regulatory and marketing approvals and pursue commercial activities for Viaskin Peanut, and for which we continue to seek regulatory and marketing approvals in the United States;

continue our research, pre-clinical and clinical development of our product candidates, including additional trials related to our pursuit of regulatory approval of Viaskin Peanut in the United States;

seek regulatory and marketing approvals for our other product candidates that successfully complete clinical trials;

establish a sales, marketing and distribution infrastructure to commercialize Viaskin Peanut, if approved, and any other products for which we may obtain marketing approval, especially in North America;

further develop the manufacturing process for our product candidates, including any modifications to our patch technology;

change or add additional manufacturers or suppliers;

expand the scope of our current clinical trials for our product candidates;

initiate and conduct any post-approval clinical trials, if required by the FDA, for our approved products, if

initiate additional pre-clinical, clinical or other studies for our other

product candidates;

initiate and conduct any post-approval clinical trials, if required by the FDA, for our approved products, if any;

initiate additional pre-clinical, clinical or other studies for our other product candidates;

seek to identify and validate additional product candidates;

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attract and retain new and existing skilled personnel;

add operational, financial and management information systems and personnel, including personnel to support our

product development and commercialization efforts, as well as a company listed on both the U.S.

add operational, financial and management information systems and personnel, including personnel to support our product development and commercialization efforts, as well as a company listed on both the U.S.

and French stock markets;

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The net losses we incur may fluctuate significantly from year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

In any particular period or periods, our operating results

could be below the expectations of securities analysts or investors, which could cause the price of our ADSs or ordinary shares to decline.

require substantial additional funding, which may not be available on acceptable terms, or at all.

In any particular period or periods, our operating results could be below the expectations of securities analysts or investors, which could cause the price of our ADSs or ordinary shares to decline.

Based on our current operations, as well as our plans and assumptions as revised pursuant to our change of strategy announced in December 2021, we expect that our balance of cash and cash equivalents of $77.3 million as of December 31, 2021 will be sufficient to fund our operations into the first quarter of 2023.

As of the date of the filing, our available cash is not projected to be sufficient to support our operating plan for at least the next 12 months.

As such, there is substantial doubt regarding our ability to continue as a going concern.

We intend to seek additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

We cannot guarantee that we will be able to obtain the necessary financing to meet our needs or to obtain funds at attractive terms and conditions, including as a result of disruptions to the global financial markets due to the ongoing COVID-19 pandemic.

The ongoing COVID-19 pandemic has already 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 us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If we are not successful in our financing objectives, we could have to scale back our operations, notably by delaying or reducing the scope of our research and development efforts or obtain financing through arrangements with collaborators or others that may require us to relinquish rights to our product candidates that we might otherwise seek to develop or commercialize independently.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that investors will lose all or a part of their investment.

Further, the perception that we may be unable to continue as a going concern may impede our ability to pursue strategic opportunities or operate our business due to concerns regarding our ability to discharge our contractual obligations.

We will require substantial additional funding, which may not be available on acceptable terms, or at all.

Failure to obtain this necessary capital when needed may force us to delay, limit, or terminate our product development efforts or other operations.

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Developing product candidates is expensive, lengthy and risky, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we seek regulatory approval for Viaskin Peanut.

Furthermore, if we obtain marketing approval for Viaskin Peanut or any other product candidate that we may develop, we expect our commercialization expenses related to product sales, marketing, distribution and manufacturing to increase

significantly as we develop the appropriate infrastructure to commercialize.

In addition, our expenses could increase beyond expectations if the FDA requires us to perform nonclinical studies, clinical trials or post-approval clinical trials for our

approved products, if any, in addition to those that we currently anticipate.

As of December 31, 2020, our cash and cash equivalents were

$196.4 million.

We have primarily funded our operations through equity financings, and by obtaining public assistance in support of innovation and reimbursements of research tax credits.

To date, we have not generated any product revenue, and

we continue to advance the clinical and regulatory development of Viaskin Peanut in the United States and European Union.

In October 2019, we announced

the FDAs acceptance for review of our Biologics License Application for Viaskin Peanut, with a target action date, provided by the FDA, of August 5, 2020.

On March 16, 2020, we announced that the FDA has informed us that during its

ongoing review of the BLA, it had identified questions regarding efficacy, including the impact of patch-site adhesion.

On August 3, 2020, we received a Complete Response Letter, or CRL, from the FDA in which the FDA indicated it could not

approve the Viaskin Peanut BLA in its current form.

The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.

The FDA also indicated

that supplementary clinical data would need to be generated to support the modified patch.

In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data.

The FDA did not raise any safety concerns related to Viaskin

On January 13, 2021, we received written responses from the FDA to questions provided in the Type A meeting request we submitted in October

2020 following the CRL.

We believe the FDA feedback provides a well-defined regulatory path forward.

In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA in the CRL:

the impact of patch adhesion and

the need for patch modifications.

The FDA agreed with our position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch, including the peanut protein

dose of 250 µg, remains unchanged and performs in the same way it has performed previously.

In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA has requested an assessment comparing the uptake of

allergen (peanut protein) between the patches in peanut allergic children ages 4-11.

The FDA also recommended conducting a 6-month, well-controlled safety and adhesion

trial to assess a modified Viaskin Peanut patch in the intended patient population.

We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments in the second quarter of 2021

before initiating the trials.

We will address details about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA.

On November 2, 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines

Agency, or EMA.

The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in

children ages 4 to 11 years.

Following the MAA validation, the EMAs Committee for Medicinal Products for Human Use, or CHMP, will review the application and provide a recommendation to the

European Commission, or EC, on whether to grant a marketing authorization.

In addition, our expenses could increase beyond expectations if the FDA requires us to perform nonclinical studies, clinical trials or post-approval clinical trials for our approved products, if any, in addition to those that we currently anticipate.

As of December 31, 2021, our cash and cash equivalents were $77.3 million.

Since our inception, we have primarily funded our operations with equity financings, and, to a lesser extent, public assistance aimed at supporting innovation and payments associated with research tax credits (Crédit d’Impôt Recherche).

We do not generate product revenue and continues to prepare for the potential launch of our first product in the United States and in the European Union, if approved.

We expect our operating losses to continue for the foreseeable future.

on our current operations, plans and assumptions, we expect our current cash-on-hand and cash equivalents, to be sufficient to fund our operating plans to the second

half of 2022.

We expect that we will need to raise substantial additional capital in the future as we commercialize Viaskin Peanut, if approved, and

continue to discover and develop other product candidates using our Viaskin Platform.

We may seek to finance our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development

agreements and other forms of non-dilutive financings.

However, no assurance can be given at this time as to whether we will be able to achieve these financing objectives.

COVID-19 pandemic has already resulted in a significant disruption of global financial markets.

If the disruption persists and deepens, whether as a result of the ongoing

COVID-19 pandemic or otherwise, we could experience an inability to access additional capital.

conduct necessary operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

Additional fundraising efforts may divert our management from their day-to-day

activities, which may adversely affect our ability to develop and commercialize our product candidates.

Moreover, the terms of any financing may adversely affect the holdings or the rights of our shareholders and the issuance of additional

securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our ADSs or ordinary shares to decline.

Based on our current operations, as well as our plans and assumptions as revised pursuant to our change of strategy announced in December 2021, we expect that our current cash and cash equivalents will be sufficient to fund our operations into the first quarter of 2023.

We expect that we will need to raise substantial additional capital as we prepare for the launch of Viaskin Peanut, if approved, and continue other research and development efforts.

The ongoing COVID-19 pandemic has already 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 us, including reduced ability to raise additional capital when needed or on acceptable terms, if at all.

If we cannot conduct necessary operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

Additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates.

Moreover, the terms of any financing may adversely affect the holdings or the rights of our shareholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our ADSs or ordinary shares to decline.

The sale of additional equity or convertible securities would dilute all of our shareholders.

incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell

or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

We could also be required to seek funds through arrangements with collaborative partners or otherwise at an

earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidate or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our

business, operating results and prospects.

If we are unable to obtain sufficient funding on a timely basis, we may be required to scale back our

operating plan, significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidate, or be unable to expand our operations or otherwise capitalize on our business

opportunities, as desired, which could materially affect our business, financial condition and results of operations.

We are limited in our ability

to raise additional share capital, which may make it difficult for us to raise capital to fund our operations.

Under French law,

our share capital may be increased only with shareholders approval at an extraordinary general shareholders meeting following the recommendation of our board of directors.

The shareholders may delegate to our board of directors either

the authority ( délégation de compétence ) or the power ( délégation de pouvoir ) to carry out any increase in share capital.

In addition, the French Commercial Code imposes certain limitations on our ability to price any offering of our share capital without

preferential subscription right ( sans droit préférentiel de souscription ), which limitation may prevent us from successfully completing any such offering.

Specifically, under the French Commercial

Code, unless the offering is less than 10% of issued share capital, securities cannot be sold in an offering at a price that is more than a 5% discount to the volume weighted average trading

price on Euronext Paris over the last three trading days preceding the commencement of the marketing of the transaction.

In addition, the combined shareholders meeting dated April 20, 2020 granted authority to our board of directors to

increase our share capital up to 30% of issued share capital, if the investors in such offering fit within a category of persons meeting certain characteristics.

In this case securities cannot be sold in such an offering at a price that is more than

a 15% discount to (i) the average trading price on Euronext Paris over five consecutive trading days chosen among the last thirty trading sessions preceding the commencement of the marketing of the transaction or (ii) the weighted average trading

price the day preceding the commencement of the marketing of the transaction.

COVID-19 may materially and

adversely affect our business and our financial results

Our business could be materially and adversely affected by the effects of

the ongoing COVID-19 pandemic in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.

The COVID-19 pandemic could materially affect our operations as well as causing significant disruption in the operations and business of third-party manufacturers, CROs, other services providers, and collaborators with

whom we conduct business.

In response to the COVID-19 pandemic, many state, local and foreign

governments, including the French and U.S.

The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidate or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain sufficient funding on a timely basis, we may be required to scale back our operating plan, significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidate, or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

We are limited in our ability to raise additional share capital, which may make it difficult for us to raise capital to fund our operations.

Under French law, our share capital may be increased only with shareholders’ approval at an extraordinary general shareholders’ meeting following the recommendation of our board of directors.

The shareholders may delegate to our board of directors either the authority ( de´le´gation de compe´tence

) or the power ( de´le´gation de pouvoir

) to carry out any increase in share capital.

In addition, the French Commercial Code imposes certain limitations on our ability to price any offering of our share capital without preferential subscription right ( sans droit pre´fe´rentiel de souscription

), which limitation may prevent us from successfully completing any such offering.

Specifically, under the French Commercial Code, unless the offering is less than 10% of issued share capital, securities cannot be sold in an offering at a price that is more than a 5% discount to the volume weighted average trading price on Euronext Paris over the last three trading days preceding the commencement of the marketing of the transaction.

In addition, the combined shareholders’ meeting dated May 19, 2021 granted authority to our board of directors to increase our share capital up to 30% of issued share capital, if the investors in such offering fit within a category of persons meeting certain characteristics.

In this case securities cannot be sold in such an offering at a price that is more than a 15% discount to (i) the average trading price on Euronext Paris over five consecutive trading days chosen among the last thirty trading sessions preceding the commencement of the marketing of the transaction or (ii) the weighted average trading price the day preceding the commencement of the marketing of the transaction.

COVID-19 may materially and adversely affect our business and our financial results

Our business could be materially and adversely affected by the effects of the ongoing COVID-19 pandemic in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of

clinical trial sites or other business operations.

In response to the COVID-19 pandemic, many state, local and foreign governments, including the French and U.S.

governments, put in place quarantines, executive orders, shelter-in-place or stay-at-home orders and similar government orders and restrictions in order to control the spread of the disease.

While some restrictions have recently been relaxed, others have

re-imposed following prior relaxation as a result of continually evolving incidence and rates of infection.

Such orders or restrictions, or the perception that such orders or restrictions could occur or

continue for a protracted period of time, have resulted in business closures, work stoppages, slowdowns and delays, work- from-home policies, travel restrictions and cancellation of events, among other effects that could negatively impact

productivity and disrupt our business and those of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business.

While the rollout of vaccines has begun, the timing of vaccinations, lifting of movement

restrictions, and reinstitution of in-person events is unknown.

As a result of the COVID-19 pandemic, certain of our employees continue to work remotely.

We have prepared plans to reopen our offices to allow employees to return to the office, which will be based on a phased approach.

light of continually changing circumstances regarding infection rates and local government recommendations, we may be required to suspend or reverse any planned return to the office in the future.

Additionally, we may experience disruptions if our

employees become ill, despite the availability of vaccines, and are unable to perform their duties.

The effects of any of our work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and

timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.

In addition, our ability to conduct clinical trials has been and may continue to be affected by the

COVID-19 pandemic.

For example, we have experienced slower than anticipated clinical site activation and patient enrollment in our MAG1C trial conducted as part of our collaboration with Nestlé.

COVID-19 pandemic, including vaccination efforts, or new or renewed shelter-in-place or stay-at-home orders.

While some restrictions have recently been relaxed, others have re-imposed following prior relaxation as a result of continually evolving incidence and rates of infection.

Such orders or restrictions, or the perception that such orders or restrictions could occur or continue for a protracted period of time, have resulted in business closures, work stoppages, slowdowns and delays, work- from-home policies, travel restrictions and cancellation of events, among other effects that could negatively impact productivity and disrupt our business and those of third-party manufacturers, CROs, other services providers, and collaborators with whom we conduct business.

While the rollout of vaccines has begun, the timing of vaccinations, lifting of movement restrictions, and reinstitution of in-person events is unknown.

As a result of the COVID-19 pandemic, our ability to conduct clinical trials has been and may continue to be affected by the COVID-19 pandemic.

For example, we have experienced slower than anticipated clinical site activation and patient enrollment in our MAG1C trial conducted as part of our collaboration with Nestlé.

Clinical site initiation, patient enrollment and patient visits (including food challenges) in any of our clinical trials may be suspended or delayed due to prioritization of hospital resources toward the COVID-19 pandemic, including vaccination efforts, or new or renewed shelter-in-place or stay-at-home orders.

Some patients may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services.

Similarly, our ability to recruit and retain

patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact our future clinical trial operations.

The pandemic and related government and private sector responsive actions have affected the broader economies and financial markets,

triggering an economic downturn, which has at points adversely affected, and could

again adversely affect, our ability to access capital, which could negatively affect our business.

In addition, a recession or resulting adverse impacts on the capital markets resulting from the

ongoing spread of COVID-19 could materially affect our business.

It is impossible to predict all

effects and the ultimate impact of the COVID-19 pandemic, as the situation continues to evolve.

The full extent of COVID-19s impact on our clinical development and

other operations and financial performance depends on future developments that are uncertain and unpredictable, including the timing of vaccine rollouts and herd immunity, virus mutations and variants, and any new information that may emerge

concerning the virus, vaccines, and containment, all of which may vary across regions.

Any of these factors could have a material adverse impact on our business, financial condition, operating results, and ability to execute and capitalize on our

Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may adversely impact our future clinical trial operations.

The pandemic and related government and private sector responsive actions have affected the broader economies and financial markets, triggering an economic downturn, which has at points adversely affected, and could again adversely affect, our ability to access capital, which could negatively affect our business.

In addition, a recession or resulting adverse impacts on the capital markets resulting from the ongoing spread of COVID-19 could materially affect our business.

It is impossible to predict all effects and the ultimate impact of the COVID-19 pandemic, as the situation continues to evolve.

The full extent of COVID-19’s impact on our clinical development and other operations and financial performance depends on future developments that are uncertain and unpredictable, including the timing of vaccine rollouts and herd immunity, virus mutations and variants, and any new information that may emerge concerning the virus, vaccines, and containment, all of which may vary across regions.

Any of these factors could have a material adverse impact on our business, financial condition, operating results, and ability to execute and capitalize on our strategies.

We are obligated to develop and maintain a system of effective internal controls over financial reporting.

These internal controls may

be determined to be not effective, which may adversely affect investor confidence in our company and, as a result, the value of our ordinary shares and ADSs.

We have been and are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the

effectiveness of our internal control over financial reporting on an annual basis.

These internal controls may be determined to be not effective, which may adversely affect investor confidence in our company and, as a result, the value of our ordinary shares and ADSs.

We have been and are required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting on an annual basis.

This assessment includes disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

During the evaluation

and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective and would be required to disclose any material weaknesses

identified in Managements Report on Internal Control over Financial Reporting.

While we have established certain procedures and control over our financial reporting processes, we cannot assure you that these efforts will prevent restatements

of our financial statements in the future.

Depending on our future filer status with the SEC, our independent registered public accounting firm may also

require, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.

This assessment will include disclosure of any material weaknesses identified by our management in our

internal control over financial reporting.

For future reporting periods, our independent registered public accounting firm may issue a report that is adverse in the event it is not satisfied with the level at which our controls are documented,

designed or operating.

During the evaluation and testing process, if we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal controls are effective and would be required to disclose any material weaknesses identified in Management’s Report on Internal Control over Financial Reporting.

While we have established certain procedures and control over our financial reporting processes, we cannot assure you that these efforts will prevent restatements of our financial statements in the future.

Depending on our future filer status with the SEC, our independent registered public accounting firm may also require, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.

This assessment will include disclosure of any material weaknesses identified by our management in our internal control over financial reporting.

We may not be able to remediate any future material weaknesses, or to complete our evaluation, testing and any required remediation in a timely fashion.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm is

unable to express an opinion that our internal controls over financial reporting are effective if and when a report from such accounting firm is required, investors could lose confidence in the accuracy and completeness of our financial reports,

which could cause the price of our ordinary shares and ADSs to decline, and we could be subject to sanctions or investigations by regulatory authorities, including the SEC and Nasdaq.

Failure to remediate any material weakness in our internal

control over financial reporting, or to maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

If we do not obtain the capital necessary to fund our operations, we will be unable to successfully commercialize, develop or pursue regulatory approval

for our biopharmaceutical products.

If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm is unable to express an opinion that our internal controls over financial reporting are effective if and when a report from such accounting firm is required, investors could lose confidence in the accuracy and completeness of our financial reports, which could cause the price of our ordinary shares and ADSs to decline, and we could be subject to sanctions or investigations by regulatory authorities, including the SEC and Nasdaq.

Failure to remediate any material weakness in our internal control over financial reporting, or to maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.

If we do not obtain the capital necessary to fund our operations, we will be unable to successfully commercialize, develop or pursue regulatory approval for our biopharmaceutical products.

The development of biopharmaceutical products is capital-intensive.

We anticipate that we may require

additional financing to continue to fund our operations.

We anticipate that we will require additional financing to continue to fund our operations.

Our future capital requirements will depend on, and could increase significantly as a result of, many factors including:

the scope, progress in, results and the costs of, our pre-clinical

studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials;

the scope, progress in, results and the costs of, our pre-clinical studies and clinical trials and other research and development programs, particularly as we seek regulatory and marketing approvals for our product candidates that successfully complete clinical trials;

the approval of Viaskin Peanut by the EMA, FDA or other regulatory agencies;

the costs of commercialization activities, including product sales, marketing, manufacturing and distribution,

for any of our product candidates for which we receive marketing approval, especially in North America;

the costs of commercialization activities, including product sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, especially in North America;

the costs of securing manufacturing arrangements for commercial production;

revenue, if any, received from commercial sales of our product candidates, should any of our product candidates

receive marketing approval;

revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;

the scope, prioritization and number of our research and development programs;

the costs, timing and outcome of regulatory review of our product candidates;

the achievement of milestones or occurrence of other developments that trigger payments under our existing

collaboration agreements, and any additional collaboration agreements we may enter into;

the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under

our existing collaboration agreements and future collaboration agreements, if any;

the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property

Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through a combination of

public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

Uncertainty and dislocations in the financial markets have generally

made equity and debt financing more difficult to obtain, and may have a material adverse effect on our ability to meet our future fundraising needs.

We cannot be certain that additional funding will be available to us on acceptable terms, if at all.

the achievement of milestones or occurrence of other developments that trigger payments under our existing collaboration agreements, and any additional collaboration agreements we may enter into;

the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under our existing collaboration agreements and future collaboration agreements, if any;

the costs involved in filing, prosecuting, enforcing and defending patent claims and other intellectual property rights.

Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through a combination of public or private equity or debt financings, collaborations, license and development agreements and other forms of non-dilutive financings.

Uncertainty and dislocations in the financial markets have generally made equity and debt financing more difficult to obtain, and may have a material adverse effect on our ability to meet our future fundraising needs.

We cannot be certain that additional funding will be available to us on

acceptable terms, if at all.

If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or development programs or our commercialization efforts.

Additional funding, if obtained, may significantly dilute existing

shareholders if that financing is obtained through issuing equity or instruments convertible into equity.

We could also be required to seek funds through collaborations or licensing arrangements with third parties, and we could be required to do so

at an earlier stage than otherwise would be desirable.

In connection with any such collaborations or licensing arrangements, we may be required to relinquish valuable rights to our intellectual property, future revenue streams, research programs or

product candidates, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business,

operating results and prospects.

Our product development programs for candidates may require substantial financial resources and may ultimately be

unsuccessful.

In addition to the development of our lead product candidates, we have completed and commenced a number of proof-of-concept trials in the field of inflammatory and autoimmune diseases.

In November 2015, Dr.

Jonathan Spergel from the Childrens Hospital of Philadelphia, or

CHOP, initiated the S tudy of Viaskin Milk in MILk -Induced E osinophilic E sophagitis, or SMILEE, a Phase IIa clinical trial assessing the safety and efficacy of Viaskin Milk for the treatment of milk-induced eosinophilic

esophagitis, with findings presented in December 2018 and February 2019.

We also investigated the use of Viaskin rPT for the reactivation of immunity against Bordetella pertussis (whooping cough) in healthy adults.

Following the announcement of

additional Phase I clinical trial results in September 2018, we evaluated further development pathways, including the optimization of Viaskin rPT.

Our current early-stage development programs also include potential treatments for Crohns

disease and respiratory syncytial virus.

These development programs are still in the pre-clinical or proof-of-concept phase, have

been scaled down in 2020, and may not result in product candidates that we can advance to the clinical development phase.

None of our other potential product candidates have commenced

clinical trials, and there are a number of U.S.

Food and Drug Administration, or FDA, and European Medicines Agency, or EMA, regulatory requirements that we must satisfy before we can commence

these clinical trials, if at all.

Satisfaction of these requirements will entail substantial time, effort and financial resources.

We may never satisfy these requirements.

Any time, effort and financial resources we expend on our other early-stage

development programs may adversely affect our ability to continue development and commercialization of

product candidates based on our Viaskin technology

platform, and we may never commence clinical trials of such development programs despite expending significant resources in pursuit of their development.

Even if we do commence clinical trials of our other potential product candidates, such product

candidates may never be approved by the FDA or the EMA.

Additional funding, if obtained, may significantly dilute existing shareholders if that financing is obtained through issuing equity or instruments convertible into equity.

We could also be required to seek funds through collaborations or licensing arrangements with third parties, and we could be required to do so at an earlier stage than otherwise would be desirable.

In connection with any such collaborations or licensing arrangements, we may be required to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

The requirements of being a U.S.

public company may strain our resources, divert

managements attention and affect our ability to attract and retain executive management and qualified board members.

company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not previously incur.

We are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the

Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.

Compliance with these rules and regulations will continue to increase our legal

and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources, particularly as we now qualify as a domestic filer.

The Exchange Act requires that, as a public company

that no longer qualifies as a foreign private issuer, we file annual, quarterly and current reports with respect to our business, financial condition and result of operations.

Because we are no longer a foreign private issuer, we will also be

required to file proxy statements in connection with any meetings of our shareholders.

public company may strain our resources, divert management’s attention and affect our ability to attract and retain executive management and qualified board members.

public company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not previously incur.

We are subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the Nasdaq listing requirements and other applicable securities rules and regulations.

Compliance with these rules and regulations will continue to increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources, particularly as we now qualify as a domestic filer.

The Exchange Act requires that, as a public company that no longer qualifies as a foreign private issuer, we file annual, quarterly and current reports with respect to our business, financial condition and result of operations.

Because we are no longer a foreign private issuer, we will also be required to file proxy statements in connection with any meetings of our shareholders.

As a result of being a U.S.

public company, and particularly during 2021, our first year filing reports with the SEC on U.S.

domestic issuer forms,

managements attention may be diverted from other business concerns, which could adversely affect our business and results of operations.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for

financial reporting and disclosure controls and procedures.

In particular, we must perform system and process evaluations and testing 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 have limited experience complying with Section 404, and such compliance may require that we incur substantial accounting expenses and

expend significant management efforts.

domestic issuer forms, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures.

In particular, we must perform system and process evaluations and testing 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 have limited experience complying with Section 404, and such compliance may require that we incur substantial accounting expenses and expend significant management efforts.

Our independent registered public accounting firm may also be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to report on the effectiveness of our internal control over financial reporting.

Our testing may reveal deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses.

In the event we identify

significant deficiencies or material weaknesses in our internal controls that we cannot remediate in a timely manner, or if our independent registered public accounting firm is unable to express an opinion that our internal controls over financial

reporting are effective, the market price of our ordinary shares and ADSs could decline if investors and others lose confidence in the reliability of our financial statements, we could be subject to sanctions or investigations by the SEC or other

applicable regulatory authorities and our business could be harmed.

public company that is subject to these rules and regulations, we may find

it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These factors could also make it more difficult for us to

attract and retain qualified members of our board of directors, particularly to serve on our audit committee and compensation committee, and qualified executive officers.

In the event we identify significant deficiencies or material weaknesses in our internal controls that we cannot remediate in a timely manner, or if our independent registered public accounting firm is unable to express an opinion that our internal controls over financial reporting are effective, the market price of our ordinary shares and ADSs could decline if investors and others lose confidence in the reliability of our financial statements, we could be subject to sanctions or investigations by the SEC or other applicable regulatory authorities and our business could be harmed.

public company that is subject to these rules and regulations, we may find it is more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These factors could also make it more difficult for us to attract and retain qualified members of our board of directors, particularly to serve on our audit committee and

compensation committee, and qualified executive officers.

As a result of disclosure of information in filings required of a U.S.

public company, particularly as we are no longer a foreign private issuer, our business

and financial condition will become more visible than they would be if we were a privately-owned company or if our securities were listed only on Euronext Paris, which we believe

may result in threatened or actual litigation, including by competitors and other third parties.

If such claims are successful, our business and results of operations could be adversely affected,

and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and adversely affect our business and results of

public company, particularly as we are no longer a foreign private issuer, our business and financial condition will become more visible than they would be

if we were a privately-owned company or if our securities were listed only on Euronext Paris, which we believe may result in threatened or actual litigation, including by competitors and other third parties.

If such claims are successful, our business and results of operations could be adversely affected, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them,

could divert the resources of our management and adversely affect our business and results of operations.

Further, being a U.S.

public company and a French public company has an impact on disclosure of information and compliance with two sets of

applicable rules.

public company and a French public company has an impact on disclosure of information and compliance with two sets of applicable rules.

This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

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We depend almost entirely on the successful development of our novel Viaskin technology.

We cannot be certain that we will be able to obtain regulatory

approval for, or successfully commercialize, Viaskin products.

We currently have no drug or biological product approved for sale and may never be

able to develop a marketable drug or biological product.

In October 2019, we announced the FDAs acceptance for review of our Biologics License

Application for Viaskin Peanut, with a target action date, provided by the FDA, of August 5, 2020.

On March 16, 2020, we announced that the FDA has informed us that during its ongoing review of the BLA, it had identified questions

regarding efficacy, including the impact of patch-site adhesion.

On August 3, 2020, we received a Complete Response Letter, or CRL, from the FDA in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form.

identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.

The FDA also indicated that supplementary clinical data would need to be generated

to support the modified patch.

In addition, the FDA requested additional Chemistry, Manufacturing and Controls, or CMC, data.

The FDA did not raise any safety concerns related to Viaskin Peanut.

On January 13, 2021, we received written responses from the FDA to questions provided in the Type A meeting request we submitted in October 2020

following the CRL.

We believe the FDA feedback provides a well-defined regulatory path forward.

In exchanges with the FDA, we proposed potential resolutions to two main concerns identified by the FDA in the CRL:

the impact of patch adhesion and the

need for patch modifications.

dose of 250 µg, remains unchanged and performs in the same way it has performed previously.

In order to confirm the consistency of efficacy data between the existing and a modified patch, FDA has requested an assessment comparing the uptake of

allergen (peanut protein) between the patches in peanut allergic children ages 4-11.

The FDA also recommended conducting a 6-month, well-controlled safety and adhesion

trial to assess a modified Viaskin Peanut patch in the intended patient population.

We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments in the second quarter of 2021

before initiating the trials.

We will address details about a new human factor, or HF, validation study and additional CMC data in subsequent interactions with the FDA.

On November 2, 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines

Agency, or EMA.

The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years.

Following the MAA validation, the

EMAs Committee for Medicinal Products for Human Use, or CHMP, will review the application and provide a recommendation to the European Commission, or EC, on whether to grant a marketing authorization.

Even if we successfully commercialize Viaskin Peanut, we may not be successful in developing and commercializing our other product candidates, including

Viaskin Milk, and our commercial opportunities may be

We have currently scaled down our research and clinical development efforts related to our product candidates other than Viaskin Peanut.

Viaskin Milk will require substantial additional clinical development, testing, and regulatory approval before we are permitted to commence its

commercialization.

Our other product candidates, such as Viaskin Egg or Viaskin rPT, are still in pre-clinical or early

proof-of-concept phase development.

The clinical trials of our product candidates are, and the manufacturing and marketing of our product candidates will be, subject to

extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and, if approved, market any product candidate.

Before obtaining regulatory approvals for the

commercial sale of any product candidate, we must demonstrate through preclinical testing and clinical trials that, among other things, the product candidate is safe and effective for use in each target indication.

This process can take many years

and may include post-marketing requirements and surveillance, including the completion of pediatric studies to satisfy both U.S.

We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, Viaskin products.

We currently have no drug or biological product approved for sale and may never be able to develop a marketable drug or biological product.

We may not be successful in developing and commercializing Viaskin Peanut and our other product candidates, including Viaskin Milk, and our commercial opportunities may be limited.

We are currently engaged in discussions with the FDA in preparation for protocol submission and review for our Phase III pivotal study of the modified Viaskin Peanut, or mVP, patch, which will require additional clinical development and regulatory approval before we are permitted to commence its commercialization, if ever.

Viaskin Milk will also require substantial additional clinical development, testing, and regulatory approval before we are permitted to commence its commercialization, if ever.

Our other product candidates, such as Viaskin Egg or Viaskin rPT, are still in pre-clinical or early proof-of-concept phase development.

The clinical trials of our product candidates are, and the manufacturing and marketing of our product candidates will be, subject to extensive and rigorous review and regulation by numerous government authorities in the United States and in other countries where we intend to test and, if approved, market any product candidate.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate through preclinical testing and clinical trials that, among other things, the product candidate is safe and effective for use in each target indication.

This process can take many years and may include post-marketing requirements and surveillance, including the completion of pediatric clinical trials to satisfy both U.S.

and EMA requirements, which will require the expenditure of substantial resources.

Of the large number of drugs in

development in the United States, only a small percentage successfully completes the FDA regulatory approval process and is commercialized.

Accordingly, even if we are able to obtain the requisite financing to continue to fund our development and

clinical programs, we cannot assure you that any of our product candidates will be successfully developed or commercialized.

We are not permitted to

market any Viaskin product in the United States until we receive approval of a BLA from the FDA, or in any other countries until we receive the requisite approval from such countries regulatory bodies.

Obtaining requisite marketing approval in

any country, is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory agency may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others:

we may not be able to demonstrate that a Viaskin product is a safe and effective treatment, to the satisfaction

of the FDA or the applicable foreign regulatory agency;

the results of our clinical trials or the clinical trials conducted by third party academic institutions and

included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory agency for marketing approval;

the FDA or the applicable foreign regulatory agency may disagree with the number, design, size, conduct or

implementation of our clinical trials;

Of the large number of drugs in development in the United States, only a small percentage successfully completes the FDA regulatory approval process and is commercialized.

Accordingly, even if we are able to obtain the requisite financing to continue to fund our development and clinical programs, we cannot assure you that any of our product candidates will be successfully developed or commercialized.

We are not permitted to market any of our product candidates in the United States or in any other country until we receive the requisite approval from the applicable regulators.

Obtaining requisite marketing approval in any country is a complex, lengthy, expensive and uncertain process, and the FDA or the applicable foreign regulatory agency may delay, limit or deny approval of a Viaskin product, for many reasons, including, among others:

we may not be able to demonstrate that a product candidate is a safe and effective treatment, to the satisfaction of the FDA or the applicable foreign regulatory agency;

the results of our clinical trials or the clinical trials conducted by third party academic institutions and included in our application package may not meet the level of statistical or clinical significance required by the FDA or the applicable foreign regulatory agency for marketing approval;

the FDA or the applicable foreign regulatory agency may disagree with the number, design, size, conduct or implementation of our clinical trials;

the FDA or the applicable foreign regulatory agency may require that we conduct additional clinical trials;

the FDA or the applicable foreign regulatory agency may not approve the formulation, labeling or specifications

of a Viaskin product;

the clinical research organizations, or CROs, that we retain to conduct our clinical trials may take actions

outside of our control that materially adversely impact our clinical trials;

the FDA or the applicable foreign regulatory agency may find the data from

pre-clinical studies and clinical trials from a Viaskin product insufficient to demonstrate that the clinical or other benefits of either product candidate outweighs its respective safety risks;

the FDA or the applicable foreign regulatory agency may disagree with our analysis or interpretation of data from

our pre-clinical studies and clinical trials;

the FDA or the applicable foreign regulatory agency may not approve the formulation, labeling or specifications of a product candidate;

the clinical research organizations, or CROs, that we retain to conduct our clinical trials may take actions outside of our control that materially adversely impact our clinical trials;

the FDA or the applicable foreign regulatory agency may find the data from pre-clinical studies and clinical trials from a product candidate insufficient to demonstrate that the clinical or other benefits of either product candidate outweighs its respective safety risks;

the FDA or the applicable foreign regulatory agency may disagree with our analysis or interpretation of data from our pre-clinical studies and clinical trials;

the FDA or the applicable foreign regulatory agency may not accept data generated at our clinical trial sites;

an advisory committee, or similar body, may recommend against approval of our application or may recommend that

the FDA or the applicable foreign regulatory agency require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use

restrictions;

the FDA or the applicable foreign regulatory agency may require development of a Risk Evaluation and Mitigation

Strategy, or REMS, as a condition of approval or post-approval;

an advisory committee, or similar body, may recommend against approval of our application or may recommend that the FDA or the applicable foreign regulatory agency require, as a condition of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

the FDA or the applicable foreign regulatory agency may require development of a Risk Evaluation and Mitigation Strategy, or REMS, as a condition of approval or post-approval;

the FDA or the applicable foreign regulatory agency may restrict the use of our products to a narrow population;

the FDA or the applicable foreign regulatory agency may not approve the manufacturing processes or facilities of

our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address;

the FDA or the applicable foreign regulatory agency may not approve the manufacturing processes or facilities of our own or of third-party manufacturers with which we contract, or may issue inspectional findings that require significant expense and time to address;

the FDA or the applicable foreign regulatory agency may change its approval policies or adopt new regulations.

Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market any of our product candidates based on our Viaskin technology platform.

Moreover, because our business

is almost entirely dependent upon Viaskin technology, any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects.

Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which

are unpredictable, and for which there is a high risk of failure.

If clinical trials of our product candidates fail to satisfactorily demonstrate safety and efficacy to the FDA and other regulators, we, or our collaborators, may incur additional

costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates.

Pre-clinical testing and clinical trials are long, expensive and unpredictable processes that can be subject to

extensive delays.

Moreover, because our business is almost entirely dependent upon Viaskin technology, any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects.

Our product candidates have undergone and/or will be required to undergo clinical trials that are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure.

If clinical trials of our product candidates fail to satisfactorily demonstrate safety and efficacy to the FDA and other regulators, we, or our collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates.

Pre-clinical testing and clinical trials are long, expensive and unpredictable processes that can be subject to extensive delays.

We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all.

It may take several years to complete the pre-clinical testing and clinical

development necessary to commercialize a drug or biologic, and delays or failure can occur at any stage.

Interim results of clinical trials do not necessarily predict final results, and success in pre-clinical

testing and early clinical trials does not ensure that later clinical trials will be successful.

A number of companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical

trials even after promising results in earlier trials, and we cannot be certain that we will not face similar setbacks.

The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a

clinical trial may not become apparent until the clinical trial is well advanced.

It may take several years to complete the pre-clinical testing and clinical development necessary to commercialize a drug or biologic, and delays or failure can occur at any stage.

Interim results of clinical trials do not necessarily predict final results, and success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be successful.

A number of companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials even after promising results in earlier trials, and we cannot be certain that we will not face similar setbacks.

The design of a clinical trial can determine whether its results will support approval of a product, and flaws in the

design of a clinical trial may not become apparent until the clinical trial is well advanced.

An unfavorable outcome in one or more trials would be a major setback for our product candidates and for us.

Due to our limited financial resources, an unfavorable

outcome in one or more trials may require us to delay, reduce the scope of, or eliminate one or more product development programs, which could have a material adverse effect on our business and financial condition and on the value of our ADSs and

ordinary shares.

Due to our limited financial resources, an unfavorable outcome in one or more trials may require us to delay, reduce the scope of, or eliminate one or more product development programs, which could have a material adverse effect on our business and financial condition and on the value of our ADSs and ordinary shares.

In connection with clinical testing and trials, we face a number of risks, including:

a product candidate is ineffective, inferior to existing approved medicines, unacceptably toxic, or has

unacceptable side effects;

patients may die or suffer other adverse effects for reasons that may or may not be related to the product

candidate being tested, especially during the double-blind, placebo-controlled food challenges;

extension studies on long-term tolerance could invalidate the use of our product, showing Viaskin does not

generate a sustained protective effect;

a product candidate is ineffective, inferior to existing approved medicines, unacceptably toxic, or has unacceptable side effects;

patients may die or suffer other adverse effects for reasons that may or may not be related to the product candidate being tested, especially during the double-blind, placebo-controlled food challenges;

extension studies on long-term tolerance could invalidate the use of our product, showing Viaskin does not generate a sustained protective effect;

the results may not confirm the positive results of earlier testing or trials;

the results may not meet the level of statistical significance required by the FDA or other regulatory agencies

to establish the safety and efficacy of our product candidates.

The results of pre-clinical studies do not necessarily predict

clinical success, and larger and later-stage clinical trials may not produce the same results as earlier-stage clinical trials.

The prior clinical trials of our product candidates based on our Viaskin technology platform showed favorable safety and

efficacy data;

however, we may have different enrollment criteria in our future clinical trials.

the results may not meet the level of statistical significance required by the FDA or other regulatory agencies to establish the safety and efficacy of our product candidates.

The results of pre-clinical studies do not necessarily predict clinical success, and larger and later-stage clinical trials may not produce the same results as earlier-stage clinical trials.

As a result, we may not observe a similarly favorable safety and efficacy profile as our prior clinical trials.

In addition, we cannot assure you that

in the course of potential widespread use in future, some drawbacks would not appear in maintaining production quality, protein stability or allergenic strength.

Frequently, product candidates developed by pharmaceutical, biopharmaceutical and

biotechnology companies have shown promising results in early pre-clinical studies or clinical trials, but have subsequently suffered significant setbacks or failed in later clinical trials.

clinical trials of potential products often reveal that it is not possible or practical to continue development efforts for these product candidates.

we do not successfully complete pre-clinical and clinical development, we will be unable to market and sell our product candidates and generate revenues.

Even if we do successfully complete clinical trials,

those results are not necessarily predictive of results of additional trials that may be needed before a marketing application may be submitted to the FDA or an applicable foreign regulatory agency.

For example, the FDA has advised us that

additional clinical testing of Viaskin Peanut will be required for evaluation of our BLA of Viaskin Peanut.

Although there are a large number of drugs and biologics in development in the United States and other countries, only a small percentage

result in the submission of a marketing application to a regulatory agency, such as a NDA or a BLA to the FDA, even fewer are approved for commercialization, and only a small number achieve widespread physician and consumer acceptance following

regulatory approval.

If our clinical trials are substantially delayed or fail to prove the safety and effectiveness of our product candidates in development, we may not receive regulatory approval of any of these product candidates and our business

and financial condition will be materially harmed.

In our clinical trials, we utilize an oral food challenge procedure intentionally designed to

trigger an allergic reaction, which could be severe or life-threatening.

In accordance with our food allergy clinical trial protocols, we utilize

a double-blind, placebo-controlled food challenge procedure.

This consists of giving the offending food protein to patients in order to assess the sensitivity of their food allergy, and thus the safety and efficacy of our product candidates versus

For example, in August 2020, we received a Complete Response Letter, or CRL, in which the FDA indicated it could not approve the Viaskin Peanut BLA in its current form.

The FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.

The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch, and requested additional Chemistry, Manufacturing and Controls, or CMC, data.

We are currently engaged in discussions with the FDA in preparation for protocol submission and review for our Phase III pivotal study of the mVP patch.

In addition, we cannot assure you that in the course of potential widespread use in future, some drawbacks would not appear in maintaining production quality, protein stability or allergenic strength.

Frequently, product candidates developed by pharmaceutical, biopharmaceutical and biotechnology companies have shown promising results in early pre-clinical studies or clinical trials,but have subsequently suffered significant setbacks or failed in later clinical trials.

In addition, clinical trials of potential products often reveal that it is not possible or practical to continue development efforts for these product candidates.

If we do not successfully complete pre-clinical and clinical development, we will be unable to market and sell our product candidates and generate revenues.

Even if we do successfully complete clinical trials, those results are not necessarily predictive of results of additional trials that may be needed before a marketing application may be submitted to the FDA or an applicable foreign regulatory agency.

Although there are a large number of drugs and biologics in development in the United States and other countries, only a small percentage result in the submission of a marketing application to a regulatory agency, such as an NDA or a BLA to the FDA, even fewer are approved for commercialization, and only a small number achieve widespread physician and consumer acceptance following regulatory approval.

In our clinical trials, we utilize an oral food challenge procedure intentionally designed to trigger an allergic reaction, which could be severe or life-threatening.

In accordance with our food allergy clinical trial protocols, we utilize a double-blind, placebo-controlled food challenge procedure.

This consists of giving the offending food protein to patients to assess the sensitivity of

their food allergy, and thus evaluate the safety and efficacy of our product candidates versus placebo.

The food challenge protocol is meant to induce objective symptoms of an allergic reaction.

These oral food challenge procedures can potentially trigger anaphylaxis or potentially life-threatening systemic allergic reactions.

these procedures are well-controlled, standardized and performed in highly specialized centers with intensive care units, there are inherent risks in conducting a trial of this nature.

An uncontrolled allergic reaction could potentially lead to

serious or even fatal reactions.

Even though these procedures are well-controlled, standardized and performed in highly specialized centers with intensive care units, there are inherent risks in conducting a trial of this nature.

An uncontrolled allergic reaction could potentially lead to serious or even fatal reactions.

Any such serious clinical event could potentially adversely affect our clinical development timelines, including a complete clinical hold on our food allergy clinical trials.

We may also become liable to patients who

participate in our clinical trials and experience any such serious or fatal reactions.

We may also become liable to patients who participate in our clinical trials and experience any such serious or fatal reactions.

Any of the foregoing could have a material adverse effect on our business, prospects, stock price or financial condition.

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Human clinical trials are very expensive, time-consuming, and difficult to design, implement and complete.

The completion of trials for Viaskin

Peanut or our other product candidates may be delayed for a variety of reasons, including delays in:

The completion of trials for Viaskin Peanut or our other product candidates may be delayed for a variety of reasons, including delays in:

demonstrating sufficient safety and efficacy to obtain regulatory approval to commence a clinical trial;

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manufacturing sufficient quantities of a product candidate;

obtaining permission to proceed from the FDA under an investigational new drug, or IND, application, or foreign

equivalent approval from regulatory authorities outside the United States;

obtaining institutional review board, or IRB, or independent ethics committee approval to conduct a clinical

trial at a prospective clinical trial site;

obtaining permission to proceed from the FDA under an investigational new drug, or IND, application, or foreign equivalent approval from regulatory authorities outside the United States;

obtaining institutional review board, or IRB, or independent ethics committee approval to conduct a clinical trial at a prospective clinical trial site;

determining dosing and clinical design and making related adjustments;

patient enrollment, which is a function of many factors, including the size of the patient population, the nature

of the protocol, the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial, and which has been impacted by the ongoing COVID-19 pandemic.

The commencement and completion of clinical trials for our product candidates may

be delayed, suspended or terminated due to a number of factors, including:

patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical trial sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial, and which has been impacted by the ongoing COVID-19 pandemic.

The commencement and completion of clinical trials for our product candidates may be delayed, suspended or terminated due to a number of factors, including:

lack of effectiveness of product candidates during clinical trials;

adverse events, safety issues or side effects relating to the product candidates or their formulation;

serious adverse events relating to the double-blind, placebo-controlled food challenge procedure when testing

patients for the sensitivity of their allergies;

inability to raise additional capital in sufficient amounts to continue clinical trials or development programs,

which are very expensive;

serious adverse events relating to the double-blind, placebo-controlled food challenge procedure when testing patients for the sensitivity of their allergies;

inability to raise additional capital in sufficient amounts to continue clinical trials or development programs, which are very expensive;

the need to sequence clinical trials as opposed to conducting them concomitantly in order to conserve resources;

our inability to enter into collaborations relating to the development and commercialization of our product

our inability to enter into collaborations relating to the development and commercialization of our product candidates;

failure by us or our collaborators to conduct clinical trials in accordance with regulatory requirements;

our inability or the inability of our collaborators to manufacture or obtain from third parties materials

sufficient for use in pre-clinical studies and clinical trials;

governmental or regulatory delays and changes in regulatory requirements, policy and guidelines, including

mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results;

our inability or the inability of our collaborators to manufacture or obtain from third parties materials sufficient for use in pre-clinical studies and clinical trials;

governmental or regulatory delays and changes in regulatory requirements, policy and guidelines, including mandated changes in the scope or design of clinical trials or requests for supplemental information with respect to clinical trial results;

failure of our collaborators to advance our product candidates through clinical development;

delays in patient enrollment, variability in the number and types of patients available for clinical trials, and

lower-than anticipated retention rates for patients in clinical trials;

difficulty in patient monitoring and data collection due to failure of patients to maintain contact after

a regional disturbance where we or our collaborative partners are enrolling patients in our clinical trials, such

as the ongoing COVID-19 pandemic or any other pandemic, terrorist activities or war, or a natural disaster;

varying interpretations of our data, and regulatory commitments and requirements by the FDA and similar foreign

regulatory agencies.

Many of these factors may also ultimately lead to denial of our marketing applications for our product

If we experience delay, suspensions or terminations in a clinical trial, the commercial prospects for the related product candidate will be harmed, and our ability to generate product revenues will be delayed or such revenues could be

reduced or fail to materialize.

In addition, we may encounter delays or product candidate rejections based on new governmental regulations, future

legislative or administrative actions, or changes in FDA or other similar foreign regulatory agency policy or interpretation during the period of product development.

delays in patient enrollment, variability in the number and types of patients available for clinical trials, and lower-than anticipated retention rates for patients in clinical trials;

difficulty in patient monitoring and data collection due to failure of patients to maintain contact after treatment;

a regional disturbance where we or our collaborative partners are enrolling patients in our clinical trials, such as the ongoing COVID-19 pandemic or any other pandemic, terrorist activities or war, or a natural disaster;

varying interpretations of our data, and regulatory commitments and requirements by the FDA and similar foreign regulatory agencies.

Many of these factors may also ultimately lead to denial of our marketing applications for our product candidates.

In addition, we may encounter delays or product candidate rejections based on new governmental regulations, future legislative or administrative actions, or changes in FDA or other similar foreign regulatory agency policy or interpretation during the period of product development.

If we obtain required regulatory approvals, such approvals may later be withdrawn.

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diminishment of any competitive advantages that such product candidates may have or attain.

Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we

may encounter or be subject to:

Furthermore, if we fail to comply with applicable FDA and other regulatory requirements at any stage during this regulatory process, we may encounter or be subject to:

diminishment of any competitive advantages that such product candidates may have or attain;

delays or termination in clinical trials or commercialization;

refusal by the FDA or similar foreign regulatory agencies to review pending applications or supplements to

approved applications;

refusal by the FDA or similar foreign regulatory agencies to review pending applications or supplements to approved applications;

product recalls or seizures;

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The FDA must approve any new drug or biologic before it can be commercialized, marketed, promoted or sold in the United States.

We must provide the FDA with

data from pre-clinical studies and clinical trials that demonstrate that, among other things, our product candidates are safe and effective for a defined indication before they can be approved for commercial

distribution.

We must provide the FDA with data from pre-clinical studies and clinical trials that demonstrate that, among other things, our product candidates are safe and effective for a defined indication

before they can be approved for commercial distribution.

Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.

We must provide data to ensure the identity, strength, quality and purity of the drug

substance and drug product.

We must provide data to ensure the identity, strength, quality and purity of the drug substance and drug product.

Also, we must assure the FDA that the characteristics and performance of the clinical batches will be replicated consistently in the commercial batches.

We will not obtain approval for a product candidate unless and until

the FDA approves a BLA, if at all.

The processes by which regulatory approvals are obtained from the FDA to market and sell a new or repositioned product

are complex, require a number of years and involve the expenditure of substantial resources.

We have already experienced several delays in our previously anticipated ability to obtain FDA approval of Viaskin Peanut, and we may experience additional

delays in the future.

We will not obtain approval for a product candidate unless and until the FDA approves a BLA, if at all.

The processes by which regulatory approvals are obtained from the FDA to market and sell a new or repositioned product are complex, require a number of years and involve the expenditure of substantial resources.

We have already experienced several setbacks and delays in our previously anticipated ability to obtain FDA approval of Viaskin Peanut, and we may experience additional delays in the future.

We cannot assure you that any of our product candidates will receive FDA approval in the future, and the time for receipt of any such approval is currently incapable of estimation.

A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and it does not increase the

likelihood that our product candidates will receive marketing approval.

We have obtained fast track designation from the FDA for the development

of Viaskin Peanut and Viaskin Milk in pediatric populations, and we may pursue that designation for other product candidates as well.

If a product is

intended for the treatment of a serious or life-threatening condition and nonclinical or clinical data demonstrate the potential to address unmet medical needs for this condition, the sponsor may

apply for FDA fast track designation.

The FDA has broad discretion whether or not to grant this designation, and even if we believe our product candidates are eligible for this designation, we cannot be sure that the FDA would decide to grant it.

Even if we do have fast track designation, we may not experience a faster development process, review or

approval compared to conventional FDA procedures.

A fast track designation affords the possibility of rolling review, enabling the FDA to review portions of our marketing application before submission of a complete application, and priority review if supported by clinical data at the time of our

BLA submission.

A fast track designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

We have obtained fast track designation from the FDA for the development of Viaskin Peanut and Viaskin Milk in pediatric populations, and we may pursue that designation for other product candidates as well.

If a product is intended for the treatment of a serious or life-threatening condition and nonclinical or clinical data demonstrate the potential to address unmet medical needs for this condition, the sponsor may apply for FDA fast track designation.

The FDA has broad discretion to grant this designation, and even if we believe our product candidates are eligible for this designation, we cannot be sure that the FDA would decide to grant it.

Even if we do have fast track designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures.

The FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

The approval process outside the United States varies among countries and may limit our ability to develop, manufacture and sell our products

internationally.

The approval process outside the United States varies among countries and may limit our ability to develop, manufacture and sell our products internationally.

Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.

In order to market and sell our product candidates in the European Union and many other jurisdictions, we, and our collaborators, must obtain separate

marketing approvals and comply with numerous and varying regulatory requirements.

In order to market and sell our product candidates in the European Union and many other jurisdictions, we, and our collaborators, must obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries and may involve additional testing.

On November 2, 2020, we announced that our Marketing Authorization Application, or MAA, for Viaskin Peanut had been validated by the European Medicines

Agency, or EMA.

The validation of the MAA confirmed that the submission was sufficiently complete to begin the formal review process for Viaskin Peanut to treat peanut allergies in children ages 4 to 11 years.

Following the MAA validation, the

We may, in the future, conduct clinical trials for, and seek regulatory approval to market, other product candidates in countries other than the United

Depending on the results of clinical trials and the process for obtaining regulatory approvals in other countries, we may decide to first seek regulatory approvals of a product candidate in countries other than the United States, or we may

simultaneously seek regulatory approvals in the United States and other countries.

If we or our collaborators seek marketing approvals for a product candidate outside the United States, we will be subject to the regulatory requirements of health

authorities in each country in which we seek approvals.

With respect to marketing authorizations in Europe, we will be required to submit an MAA to the EMA which conducts a validation and scientific approval process in evaluating a product for

safety and efficacy.

We may, in the future, conduct clinical trials for, and seek regulatory approval to market, product

candidates in countries other than the United States.

If we or our collaborators seek marketing approvals for a product candidate outside the United States, we will be subject to the regulatory requirements of health authorities in each country in which we seek approvals.

With respect to marketing authorizations in Europe, we will be required to submit an MAA to the EMA which conducts a validation and scientific approval process in evaluating a product for safety and efficacy.

The approval procedure varies among regions and countries and may involve additional testing, and the time required to obtain approvals may differ from that required to obtain FDA approval.

Pursuing regulatory approvals from health authorities in countries outside the United States is likely to subject us to all of the risks associated with

pursuing FDA approval described above.

In addition, marketing approval by the FDA does not ensure approval by the health authorities of any other country, and approval by foreign health authorities does not ensure marketing approval by the FDA.

Even if we, or our collaborators, obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our products

may limit how we or they market our products, which could materially impair our ability to generate revenue.

Even if we receive regulatory

approval for Viaskin Peanut or any of our other product candidates, this approval may carry conditions that limit the market for the product or put the product at a competitive disadvantage relative to alternative therapies.

For instance, a

regulatory approval may limit the indicated uses for which we can market a product or the patient population that may utilize the product or may be required to carry a warning in its labeling and on its packaging.

Products with boxed warnings are

subject to more restrictive advertising regulations than products without such warnings.

These restrictions could make it more difficult to market any

product candidate effectively.

Accordingly, assuming we, or our collaborators, receive marketing approval for Viaskin Peanut or any of our other product candidates, we and our collaborators will

continue to expend time, money and effort in all areas of regulatory compliance.

Any of our product candidates for which we, or our collaborators,

obtain marketing approval in the future could be subject to post-marketing restrictions or withdrawal from the market and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements

or if we, or they, experience unanticipated problems with our products following approval.

Any of our product candidates for which we, or our

collaborators, obtain marketing approval in the future, as well as the manufacturing processes, post-marketing requirements and commitments, labeling, advertising and promotional activities for such products, among other things, will be subject to

continual requirements of and review by the FDA and other regulatory authorities.

These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, requirements relating to

manufacturing, quality control, quality assurance and corresponding maintenance of records and documents and requirements regarding the distribution of samples to physicians and recordkeeping.

Even if marketing approval of a product candidate is

granted, the approval will be subject to limitations on the indicated uses for which the product may be marketed or may be subject to other conditions of approval, including the FDA requirement to implement a REMS to ensure that the benefits of a

drug or biological product outweigh its risks.

The FDA or foreign regulatory authorities may also impose requirements for costly post-marketing studies

or clinical trials and surveillance to monitor the safety or efficacy of a product, such as long-term observational studies on natural exposure.

The FDA and other agencies, including the Department of Justice, closely regulate and monitor the

post-approval marketing and promotion of products to ensure that they are manufactured, marketed and distributed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA imposes stringent restrictions

on manufacturers communications regarding off-label use and if we, or our collaborators, market any of our product candidates for which we, or they, receive marketing approval for treatment other than

their approved indications, we, or they, may be subject to warnings or enforcement action for off-label marketing.

Violation of the Federal Food, Drug, and Cosmetic Act, or FDCA, and other statutes, including

the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations or allegations of violations of federal and state health care fraud and abuse laws and state consumer protection laws.

If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our

product candidates may be delayed, and our business will be harmed.

We sometimes estimate the timing of the accomplishment of various scientific,

clinical, regulatory and other product development objectives for planning purposes.

These milestones may include our expectations regarding the commencement or completion of scientific studies, clinical trials, the submission of regulatory filings,

or commercialization objectives.

From time to time, we may publicly announce the expected timing of some of these milestones, such as the completion of an ongoing clinical trial, the initiation of other clinical programs, receipt of marketing

approval, or a commercial launch of a product.

Pursuing regulatory approvals from health authorities in countries outside the United States is likely to subject us to all of the risks associated with pursuing FDA approval described above.

In addition, marketing approval by the

FDA does not ensure approval by the health authorities of any other country, and approval by foreign health authorities does not ensure marketing approval by the FDA.

Even if we, or our collaborators, obtain marketing approvals for our product candidates, the terms of approvals and ongoing regulation of our products may limit how we or they market our products, which could materially impair our ability to generate revenue.

Even if we receive regulatory approval for Viaskin Peanut or any of our other product candidates, this approval may carry conditions that limit the market for the product or put the product at a competitive disadvantage relative to alternative therapies.

For instance, a regulatory approval may limit the indicated uses for which we can market a product or limit the patient population that may utilize the product or require a product to carry a warning in its labeling and on its packaging.

Products with boxed warnings are subject to more restrictive advertising regulations than products without such warnings.

These restrictions could make it more difficult to market any product candidate effectively.

Accordingly, assuming we, or our collaborators, receive marketing approval for Viaskin Peanut or any of our other product candidates, we and our collaborators will continue to expend time, money and effort in all areas of regulatory compliance.

Any of our product candidates for which we, or our collaborators, obtain marketing approval in the future could be subject to post-marketing restrictions or withdrawal from the market and we, and our collaborators, may be subject to substantial penalties if we, or they, fail to comply with regulatory requirements or if we, or they, experience unanticipated problems with our products following approval.

Any of our product candidates for which we, or our collaborators, obtain marketing approval in the future, as well as the manufacturing processes, post-marketing requirements and commitments, labeling, advertising and promotional activities for such products, among other things, will be subject to continual requirements of and review by the FDA and other regulatory authorities.

These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents and requirements regarding the distribution of samples to physicians and recordkeeping.

Even if marketing approval of a product candidate is granted, the approval will be subject to limitations on the indicated uses for which the product may be marketed or may be subject to other conditions of approval, including the FDA requirement to implement a REMS to ensure that the benefits of a drug or biological product outweigh its risks.

The FDA or foreign regulatory authorities may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of a product, such as long-term observational studies on natural exposure.

The FDA and other agencies, including the Department of Justice, closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed, and distributed only for the approved indications and in accordance with the provisions of the approved labeling.

The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we, or our collaborators, market any of our product candidates for which we, or they, receive marketing approval for treatment other than their approved indications, we, or they, may be subject to warnings or enforcement action for off-label marketing.

Violation of the Federal Food, Drug, and Cosmetic Act, or FDCA, and other statutes, including the False Claims Act, relating to the promotion and advertising of prescription drugs may lead to investigations or allegations of violations of federal and state health care fraud and abuse laws and state consumer protection laws.

If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of our product candidates may be delayed, and our business will be harmed.

We sometimes estimate the timing of the accomplishment of various scientific, clinical, regulatory, and other product development objectives for planning purposes.

These milestones may include our expectations regarding the commencement or completion of scientific studies, clinical trials, the submission of regulatory filings, or

commercialization objectives.

The achievement of many of these milestones may be outside of our control.

All of these milestones are based on a variety of assumptions which may cause the timing of achievement of the milestones to

vary considerably from our estimates, including:

All of these milestones are based on a variety of assumptions which may cause the timing of achievement of the milestones to vary considerably from our estimates, including:

our available capital resources or capital constraints we experience;

our receipt of approvals, if any, by the FDA and other regulatory agencies and the timing thereof;

the rate of progress, costs and results of our clinical trials and research and development activities, including

the extent of scheduling conflicts with participating clinicians and collaborators, and our ability to identify and enroll patients who meet clinical trial eligibility criteria;

the rate of progress, costs and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators, and our ability to identify and enroll patients who meet clinical trial eligibility criteria;

other actions, decisions or rules issued by regulators;

our ability to access sufficient, reliable and affordable supplies of compounds used in the manufacture of our

product candidates;

our ability to access sufficient, reliable and affordable supplies of compounds used in the manufacture of our product candidates;

the efforts of our collaborators with respect to the commercialization of our products;

the securing of, costs related to, and timing issues associated with, product manufacturing, as well as sales and

marketing activities;

the securing of, costs related to, and timing issues associated with, product manufacturing, as well as sales and marketing activities;

impacts of the ongoing COVID-19 pandemic.

If we fail to achieve announced milestones in the timeframes we expect, the commercialization of our product candidates may be delayed, our business and

results of operations may be harmed, the trading price of the ADSs or ordinary shares may decline.

For example, immediately following our August 3, 2020 announcement of our receipt of the CRL from the FDA related to our BLA for Viaskin Peanut,

the trading price of our ADSs declined 43%.

Access to raw materials and products necessary for the conduct of clinical trials, for

commercialization, if approved, and manufacturing of our product candidates and product, if any, is not guaranteed.

We are dependent on third

parties for the supply of various materials, chemical or biological products that are necessary to produce patches for our clinical trials or diagnosis patches, and will be necessary to produce patches for our commercial supply, if Viaskin Peanut is

If we fail to achieve announced milestones in the timeframes we expect, the commercialization of our product candidates may be delayed, our business and results of operations may be harmed, the trading price of the ADSs or ordinary shares may decline.

Access to raw materials and products necessary for the conduct of clinical trials, for commercialization, if approved, and manufacturing of our product candidates and product, if any, is not guaranteed.

We are dependent on third parties for the supply of various materials, chemical or biological products that are necessary to produce patches for our clinical trials or diagnosis patches, and will be necessary to produce patches for our commercial supply, if Viaskin Peanut is approved.

The supply of these materials could be reduced or interrupted at any time, including as a result of shelter-in-place, stay-at-home or similar orders or other impacts due to the ongoing COVID-19 pandemic.

In such case, we may not be able to find other suppliers of acceptable materials

in appropriate quantities at an acceptable cost.

If key suppliers or manufacturers are lost or the supply of materials is diminished or discontinued, we may not be able to continue to develop, manufacture and market our product candidates or

products, if any, in a timely and competitive manner.

In such case, we may not be able to find other suppliers of acceptable materials in appropriate quantities at an acceptable cost.

If key suppliers or manufacturers are lost or the supply of materials is diminished or discontinued, we may not be able to continue to develop, manufacture and market our product candidates or products, if any, in a timely and competitive manner.

In addition, these materials are subject to stringent manufacturing processes and rigorous testing.

Delays in the completion and validation of facilities and manufacturing processes of these

materials could adversely affect our ability to complete trials and commercialize our products, if any, in a cost-effective and timely manner.

To prevent such situations, we intend to diversify our supply sources by identifying at a minimum a second

source of supply for critical raw materials and materials, such as natural protein and polymer film with a titanium coating.

If we encounter difficulties in the supply of these materials, chemicals or biological products, if we were not able to

maintain our supply agreements or establish new agreements to develop and manufacture our products in the future, our business, prospects, financial condition, results and development could be significantly affected.

Delays in the completion and validation of facilities and manufacturing processes of these materials could adversely affect our ability to complete trials and commercialize our products, if any, in a cost-effective and timely manner.

To prevent such situations, we intend to diversify our supply sources by identifying at a minimum a second source of supply for critical raw materials and materials, such as natural protein and polymer film with a titanium coating.

If we encounter difficulties in the supply of these materials, chemicals or biological products, if we were not able to maintain our supply agreements or establish new agreements to develop and manufacture our products in the future, our business, prospects, financial condition, results and development could be significantly affected.

Relying on third-party manufacturers may result in delays in our clinical development or commercialization efforts.

Developing and commercializing new medicines entails significant risks and expenses.

Our clinical trials may be delayed if third-party manufacturers are

unable to assure a sufficient quantity of the drug product to meet our study needs.

Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the active pharmaceutical ingredients, or API, used in our Viaskin product candidates, including

Viaskin Peanut, such as peanut protein extract and unmodified allergen milk extract.

In February 2020, Sanofi announced that it plans to create a new company dedicated to the production and marketing to third parties of API, which will consolidate

Sanofis API commercial and development activities currently conducted in six of its European API production sites.

While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be

no assurances that this transition will not adversely impact our supply of API from Sanofi.

If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely

basis and our commercialization efforts and clinic trials may be delayed.

Further, we are aware that Sanofi has entered into a clinical collaboration with Regeneron and Aimmune Therapeutics, to evaluate treatment with Palforzia in combination with

Dupilumab in peanut allergic patients, and commenced a

Phase II clinical trial in October 2018 under this collaboration.

This potential competitive dynamic may make Sanofi less inclined to continue or renew their manufacturing arrangement with us on

commercially reasonable terms or at all and, notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.

We also expect to rely on Sanofi or other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other

product for which we obtain regulatory approval.

Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we

may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms.

Even if Sanofi is able to meet our

commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

Our clinical trials may be delayed if third-party manufacturers are unable to assure a sufficient quantity of the drug product to meet our study needs.

Currently, we have only one manufacturer, Sanofi S.A., or Sanofi, of the active pharmaceutical ingredients, or API, used in our Viaskin product candidates, including Viaskin Peanut, such as peanut protein extract and unmodified allergen milk extract.

In February 2020, Sanofi announced that it plans to create a new

company dedicated to the production and marketing to third parties of API, which will consolidate Sanofi’s API commercial and development activities currently conducted in six of its European API production sites.

While those API sites do not include the site in which the API used in our Viaskin product candidates is produced, there can be no assurances that this transition will not adversely impact our supply of API from Sanofi.

If Sanofi does not continue to manufacture the API as required by us in a timely manner, we may not be able to find a substitute manufacturer on a timely basis and our commercialization efforts and clinic trials may be delayed.

Further, we are aware that Sanofi has entered into a clinical collaboration with Regeneron and Aimmune Therapeutics, to evaluate treatment with Palforzia in combination with Dupilumab in peanut allergic patients, and commenced a Phase II clinical trial in October 2018 under this collaboration.

This potential competitive dynamic may make Sanofi less inclined to continue or renew their manufacturing arrangement with us on commercially reasonable terms or at all and, notwithstanding contractual protections, Sanofi may be able to utilize knowledge gained through their relationship with us in furtherance of their development of competitive therapies.

We also expect to rely on Sanofi or other third-party manufacturers for the manufacturing of commercial supply of Viaskin Peanut, if approved, and any other product for which we obtain regulatory approval.

Sanofi may not be able to effectively scale its manufacturing capacity of our API to meet our commercialization needs and we may be unable to establish any agreements with other third-party manufacturers or to do so on acceptable terms.

Even if Sanofi is able to meet our commercialization needs or if we are able to establish agreements with other third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

reliance on the third party for regulatory compliance and quality assurance;

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the possible misappropriation of our proprietary information, including our trade secrets and know-how;

the possible termination or non-renewal of the agreement by the third

party at a time that is costly or inconvenient for us.

Once regulatory approval is obtained, a marketed product and its manufacturer

are subject to continual review.

the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us.

Once regulatory approval is obtained, a marketed product and its manufacturer are subject to continual review.

The discovery of previously unknown problems with a product or manufacturer may result in restrictions on the product, manufacturer or manufacturing facility, including withdrawal of the product from the market.

manufacturers with which we contract are required to operate in accordance with FDA-mandated current good manufacturing practices, or cGMPs.

A failure of any of our contract manufacturers to establish and

follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch of products based on our product candidates into the market.

Moreover, the constituent parts of a combination product retain their regulatory

status (as a biologic or device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the Quality System Regulation, or QSR, applicable to medical devices, such as design controls, purchasing

controls, and corrective and preventive action.

Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, revocation or suspension of

marketing approval for any products granted pre-market approvals, seizures or recalls of products, operating restrictions, and criminal prosecutions.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our

future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

product candidates may not be able to be manufactured profitably on a large enough scale to support commercialization.

To date, our Viaskin

product candidates have only been manufactured at a scale which is adequate to supply our research activities and clinical trials.

There can be no assurance that the procedures currently used to manufacture our product candidates will work at a

scale which is adequate for commercial needs and we may encounter difficulties in the production of Viaskin patches due to our or our partners manufacturing capabilities.

For example, in large-scale use, there is a possibility that our

electrospray manufacturing tool, ES GEN4.0, may have issues related to maintenance of production quality, protein stability, and allergenicity.

Additionally, during production, the containment of the electrospray function and the use of the allergen

in liquid form keep the environment from being contaminated by the allergens.

However, if there is a malfunction in the handling or storage phases or during the production phases, allergens could be released into the atmosphere and sensitize anyone

present in the environment.

Any manufacturers with which we contract are required to operate in accordance with FDA-mandated current good manufacturing practices, or cGMPs.

A failure of any of our contract manufacturers to establish and follow cGMPs and to document their adherence to such practices may lead to significant delays in the launch of products based on our product candidates into the market.

Moreover, the constituent parts of a combination product retain their regulatory status (as a biologic or device, for example) and, as such, we or our contract manufacturers may be subject to additional requirements in the Quality System Regulation, or QSR, applicable to medical devices, such as design controls, purchasing controls, and corrective and preventive action.

Failure by third-party manufacturers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, revocation or suspension of marketing approval for any products granted pre-market approvals, seizures or recalls of products, operating restrictions, and criminal prosecutions.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or products, if approved, may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

Our Viaskin product candidates may not be able to be manufactured profitably on a large enough scale to support commercialization.

To date, our Viaskin product candidates have only been manufactured at a scale which is adequate to supply our research activities and clinical trials.

There can be no assurance that the procedures currently used to manufacture our product candidates will work at a scale which is adequate for commercial needs and we may encounter

difficulties in the production of Viaskin patches due to our or our partners’ manufacturing capabilities.

For example, in large-scale use, there is a possibility that our electrospray manufacturing tool, ES GEN4.0, may have issues related to maintenance of production quality, protein stability, and allergenicity.

Additionally, during production, the containment of the electrospray function and the use of the allergen in liquid form keep the environment from being contaminated by the allergens.

However, if there is a malfunction in the handling or storage phases or during the production phases, allergens could be released into the atmosphere and sensitize anyone present in the environment.

We have not built commercial-scale manufacturing facilities, and we have limited manufacturing experience with Viaskin patches.

Additionally, while the production process was developed in strict compliance with current regulations, due

to the originality of the product, we cannot predict if European or U.S.

regulatory authorities will make new regulations applicable to our production process, or if we will have any future disagreements with such regulatory authorities regarding

our interpretation of the regulatory requirements.

We rely on a single supplier to produce, or contract for the production of, active ingredients for our

clinical trials and for our commercial supplies of any future approved products.

Even if we were to obtain access to quantities of active ingredients sufficient to allow us otherwise to expand our Viaskin manufacturing capabilities, we may not be

able to produce sufficient quantities of the product at an acceptable cost, or at all.

In the event our Viaskin product candidates cannot be manufactured in sufficient quantities for commercialization, our future prospects could be significantly

impacted and our financial prospects would be materially harmed.

We or the third parties upon whom we depend may be adversely affected by

earthquakes, other natural disasters or outbreaks of contagious diseases and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Earthquakes, other natural disasters or an outbreak of a contagious disease, such as COVID-19, could severely disrupt

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

If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of

our facilities or infrastructure, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for

us to continue our business for a substantial period of time.

Additionally, while the production process was developed in strict compliance with current regulations, due to the originality of the product, we cannot predict if European or U.S.

regulatory authorities will make new regulations applicable to our production process, or if we will have any future disagreements with such regulatory authorities regarding our interpretation of the regulatory requirements.

We rely on a single supplier to produce, or contract for the production of, active ingredients for our clinical trials and for our commercial supplies of any future approved products.

Even if we were to obtain access to quantities of active ingredients sufficient to allow us otherwise to expand our Viaskin manufacturing capabilities, we may not be able to produce sufficient quantities of the product at an acceptable cost, or at all.

In the event our Viaskin product candidates cannot be manufactured in sufficient quantities for commercialization, our future prospects could be significantly impacted and our financial prospects would be materially harmed.

We or the third parties upon whom we depend may be adversely affected by earthquakes, other natural disasters or outbreaks of contagious diseases and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Earthquakes, other natural disasters or an outbreak of a contagious disease, such as COVID-19, could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects.

If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our facilities or infrastructure, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.

The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event.

We may incur substantial expenses as a

result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.

We rely, and will rely in the future, on third parties to conduct our clinical trials and perform data collection and analysis, which may result in

costs and delays that prevent us from successfully commercializing product candidates.

We rely, and will rely in the future, on medical

institutions, clinical investigators, CROs, contract laboratories and collaborators to perform data collection and analysis and others to carry out our clinical trials.

Our development activities or clinical trials conducted in reliance on third

parties may be delayed, suspended, or terminated if:

the third parties do not successfully carry out their contractual duties or fail to meet regulatory obligations

or expected deadlines;

We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.

We rely, and will rely in the future, on third parties to conduct our clinical trials and perform data collection and analysis, which may result in costs and delays that prevent us from successfully commercializing product candidates.

We rely, and will rely in the future, on medical institutions, clinical investigators, CROs, contract laboratories and collaborators to perform data collection and analysis and others to carry out our clinical trials.

Our development activities or clinical trials conducted in reliance on third parties may be delayed, suspended, or terminated if:

the third parties do not successfully carry out their contractual duties or fail to meet regulatory obligations or expected deadlines;

we replace a third party;

the quality or accuracy of the data obtained by third parties is compromised due to their failure to adhere to

clinical protocols, regulatory requirements, or for other reasons.

Third party performance failures may increase our development costs,

delay our ability to obtain regulatory approval, and delay or prevent the commercialization of our product candidates.

While we believe that there are numerous alternative sources to provide these services, in the event that we seek such alternative

sources, we may not be able to enter into replacement arrangements without incurring delays or additional costs.

Even if collaborators with which

we contract in the future successfully complete clinical trials of our product candidates, those candidates may not be commercialized successfully for other reasons.

Even if we contract with collaborators that successfully complete clinical trials for one or more of our product candidates, those candidates may not be

commercialized for other reasons, including:

the quality or accuracy of the data obtained by third parties is compromised due to their failure to adhere to clinical protocols, regulatory requirements, or for other reasons.

Third party performance failures may increase our development costs, delay our ability to obtain regulatory approval, and delay or prevent the commercialization of our product candidates.

While we believe that there are

numerous alternative sources to provide these services, in the event that we seek such alternative sources, we may not be able to enter into replacement arrangements without incurring delays or additional costs.

Even if collaborators with which we contract in the future successfully complete clinical trials of our product candidates, those candidates may not be commercialized successfully for other reasons.

Even if we contract with collaborators that successfully complete clinical trials for one or more of our product candidates, those candidates may not be commercialized for other reasons, including:

failing to receive regulatory approval to market them as drugs;

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Currently, we do not have commercial-ready marketing and sales infrastructure .

If we are unable to establish effective sales or marketing capabilities

or enter into agreements with third parties to sell or market our product candidates, we may not be able to effectively sell or market our product candidates, if approved, or generate product revenues.

If we are unable to establish effective sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be able to effectively sell or market our product candidates, if approved, or generate product revenues.

We currently have a limited commercial infrastructure.

To achieve commercial success for any approved product candidate for which we retain sales and

marketing responsibilities, we must build our sales, marketing, managerial, and other non-technical capabilities or make arrangements with third parties to perform these services.

For example, we are planning

to hire sales representatives for the marketing of Viaskin Peanut in the United States, if approved.

There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to

perform these services.

To achieve commercial success for any approved product candidate for which we retain sales and marketing responsibilities, we must build our sales, marketing, managerial, and other non-technical capabilities or make arrangements with third parties to perform these services.

For example, we are planning to hire sales representatives for the marketing of Viaskin Peanut in the United States, if approved.

There are risks involved with both establishing our own sales and marketing capabilities and entering into arrangements with third parties to perform these services.

For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch.

If the commercial launch of a product candidate for which we recruit a sales force and establish marketing

capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses.

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

marketing personnel.

If the commercial launch of a product candidate for which we recruit a sales force and establish marketing capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses.

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

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

our inability to recruit, hire, retain and incentivize adequate numbers of effective sales and marketing

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to

prescribe any future products;

the lack of complementary products to be offered by sales personnel, which may put us at a competitive

disadvantage relative to companies with more extensive product lines;

our inability to recruit, hire, retain and incentivize adequate numbers of effective sales and marketing personnel;

the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future products;

the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;

unforeseen costs and expenses associated with establishing an independent sales and marketing organization.

If we enter into arrangements with third parties to perform sales, marketing and distribution services, as we are currently exploring

for the marketing of Viaskin Peanut in the United States or the European Union, if approved, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market and sell any product candidates

that we develop ourselves.

In addition, we may not be successful in entering into arrangements with third parties to sell and market Viaskin Peanut or any of our other product candidates or may be unable to do so when needed or on terms that are

favorable to us.

promotional requirements for prescription products that could render our products misbranded in violation of government regulations and thus potentially subject to enforcement.

If we do not establish sales and marketing capabilities successfully,

either on our own or in collaboration with third parties, we will not be successful in commercializing Viaskin Peanut or any of our other product candidates that receive marketing approval, or any such commercialization may experience delays or

If we are not successful in commercializing Viaskin Peanut or any of our other product candidates, either on our own or through collaborations with one or more third parties, our business, results of operations, financial condition and

prospects will be materially and adversely affected.

Our product candidates are regulated as biological products, or biologics, which may subject them to

competition sooner than anticipated.

The Biologics Price Competition and Innovation Act, or BPCIA, established an abbreviated licensure pathway

for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

Biosimilarity means that the biological product is highly similar to the

reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product.

To meet the higher standard of interchangeability, an applicant must provide sufficient information to show biosimilarity and demonstrate that the biological product can be expected to produce the same clinical result as the reference

product in any given patient and, if the biological product is administrated more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference

product is not greater than the risk of using the reference product without such alternation or switch.

Under the BPCIA, an application for a biosimilar

or interchangeable product cannot be approved by the FDA until 12 years after the reference product was first licensed, and the FDA will not even accept an application for review until four years after the date of first licensure.

evolving, complex and is still being interpreted and implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning are subject to uncertainty and could have a material adverse effect on the future commercial prospects for our

biological products.

If we enter into arrangements with third parties to perform sales, marketing and distribution services for the commercialization of Viaskin Peanut in the United States or the European Union, if approved, our product revenues or the profitability of these product revenues to us are likely to be lower than if we were to market and

sell any product candidates that we develop ourselves.

We likely will have more limited control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our product candidates effectively, or they may fail to comply with promotional requirements for prescription products that could render our products misbranded in violation of government regulations and thus potentially subject to enforcement.

If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing Viaskin Peanut or any of our other product candidates that receive marketing approval, or any such commercialization may experience delays or limitations.

Our product candidates are regulated as biological products, or biologics, which may subject them to competition sooner than anticipated.

The Biologics Price Competition and Innovation Act, or BPCIA, established an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

“Biosimilarity” means that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product.

To meet the higher standard of “interchangeability,” an applicant must provide sufficient information to show biosimilarity and demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administrated more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.

Under the BPCIA, an application for a biosimilar or interchangeable product cannot be approved by the FDA until 12 years after the reference product was first licensed, and the FDA will not even accept an application for review until four years after the date of first licensure.

The law is evolving, complex and is still being interpreted and implemented by the FDA.

As a result, its ultimate impact, implementation, and meaning are subject to uncertainty and could have a material adverse effect on the future commercial prospects for our biological products.

We believe that any of our product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity.

However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, potentially creating the opportunity for biosimilar or interchangeable

competition sooner than anticipated.

However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, potentially creating the opportunity for biosimilar or interchangeable competition sooner than anticipated.

Moreover, the process by which an interchangeable product, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biological products ( i.e.

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Even if any of our product candidates are commercialized, they may not be accepted by physicians, patients, or the medical community in general.

we, or our collaborators, are able to commercialize our product candidates, the products may become subject to market conditions that could harm our business.

Even if the medical community accepts a product as safe and efficacious for its indicated use, physicians may choose to restrict the use of the product if we

or any collaborator is unable to demonstrate that, based on experience, clinical data, side-effect profiles and other factors, our product is preferable to any existing drugs or treatments.

We cannot predict the degree of market acceptance of any

product candidate that receives marketing approval, which will depend on a number of factors, including, but not limited to:

Even if we, or our collaborators, are able to commercialize our product candidates, the products may become subject to market conditions that could harm our business.

Even if the medical community accepts a product as safe and efficacious for its indicated use, physicians may choose to restrict the use of the product if we or any collaborator is unable to demonstrate that, based on experience, clinical data, side-effect profiles and other factors, our product is preferable to any existing drugs or

We cannot predict the degree of market acceptance of any product candidate that receives marketing approval, which will depend on a number of factors, including, but not limited to:

the demonstration of the clinical efficacy and safety of the product;

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the advantages and disadvantages of the product compared to alternative treatments;

our and any collaborators ability to educate the medical community about the safety and effectiveness of

the coverage and reimbursement policies of government and commercial third-party payors pertaining to the

our and any collaborator’s ability to educate the medical community about the safety and effectiveness of the product;

the coverage and reimbursement policies of government and commercial third-party payors pertaining to the product;

the market price of our product relative to competing treatments;

our ability to effectively implement a scientific publication strategy.

We face substantial competition from companies with considerably more resources and experience than we

have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us.

We face substantial competition from companies with considerably more resources and experience than we have, which may result in others discovering, developing, receiving approval for, or commercializing products before or more successfully than us.

The biopharmaceuticals industry is highly competitive.

Numerous biopharmaceutical laboratories, biotechnology companies, institutions, universities and other

research entities are actively involved in the discovery, research, development and marketing of therapeutic responses to treat allergies, making it a highly competitive field.

We have competitors in a number of jurisdictions, many of which have

substantially greater name recognition, commercial infrastructures and financial, technical and personnel resources than we have.

Although we believe we are currently in a unique position with respect to the testing and treatment of food allergies

in young children, established competitors may invest heavily to quickly discover and develop novel compounds that could make the Viaskin patch products obsolete or uneconomical.

Any new product that competes with an approved product may need to

demonstrate compelling advantages in efficacy, convenience, tolerability and safety to be commercially successful.

Numerous biopharmaceutical and biotechnology companies, universities and other research entities are actively involved in the discovery, development and commercialization of therapeutic options to treat allergies, making it a highly competitive field.

We have competitors in several jurisdictions, many of which have substantially greater name recognition, commercial infrastructures and financial, technical and personnel resources than we have.

Although we believe we are currently in a unique position with respect to the testing and treatment of food allergies in children, established competitors may invest heavily to quickly discover and develop novel compounds that could make any of our product candidates obsolete or uneconomical.

Any new product that competes with an approved product may need to demonstrate compelling advantages in efficacy, convenience, tolerability and safety to be commercially successful.

Other competitive factors, including generic competition, could force us to lower prices or could result in reduced sales.

addition, new products developed by others could emerge as competitors to Viaskin patch products.

If we are not able to compete effectively against our current and future competitors, our business will not grow and our financial condition and

operations will suffer.

In the case of food allergies, we are aware of several academic studies that are currently being conducted in major centers and

hospitals worldwide.

These studies are evaluating sublingual, subcutaneous, intranasal or other forms of desensitization or products using synthetic allergens, denatured allergens or combinations of medicines or methods, or medicines using

traditional methods such as Chinese herbs.

We are not aware of any pharmaceutical development in conjunction with these academic efforts at this time.

expect studies combining other methods of immunotherapy, such as oral immunotherapy, or OIT, with anti-IgE treatments will be conducted.

These types of

co-administrations may significantly improve the safety of specific immunotherapies administered orally or subcutaneously, and may become significant competitors with our products.

To our knowledge, other pharmaceutical and biotechnology companies are also seeking to develop or have received marketing approval for food allergy

For example, Aimmune Therapeutics, Inc.

Nestlé

Health Science in October 2020, received FDA and EMA approvals of its OIT

product candidate, Palforzia, in peanut allergic patients in January and December 2020.

To our knowledge, Palforzia uses a formulation of peanut flour for oral administration intended for oral desensitization to peanut.

We are also aware of other

companies developing OIT product candidates, as well as other companies that are working on recombinant peanut proteins capable of initiating an attenuated immune response of using subcutaneous administration.

Aimmune also announced a clinical

collaboration with Regeneron Pharmaceuticals, Inc.

and Sanofi to study Palforzia treatment with dupilumab in peanut allergic patients, and commenced a Phase II clinical trial in October 2018 under this collaboration.

Regeneron and Sanofi are

currently recruiting patients in a Phase II study of dupilumab as a monotherapy in the treatment of peanut allergic patients.

In August 2018, Genentech, Inc.

and Novartis Pharmaceuticals Corporation announced that the FDA granted breakthrough

designation for Xolair (omalizumab) for the prevention of severe allergic reactions following accidental exposure to one Xolair or more foods in people with allergies.

In July 2019, NIAID started a Phase III clinical trial studying omalizumab as

monotherapy and as adjunct therapy to multi-allergen OIT in multiple food allergies.

Government restrictions on pricing and reimbursement, as well

as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues if we obtain regulatory approval to market a product.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare costs to contain or reduce costs of

healthcare may adversely affect one or more of the following:

In addition, new products developed by others could emerge as competitors to any of our product candidates.

If we are not able to compete effectively against our current and future competitors, our business will not grow and our financial condition and operations will suffer.

In the case of food allergies, we are aware of several food allergy academic studies and pharmaceutical developmental efforts connected with such studies that are currently being conducted in major medical centers and hospitals worldwide.

These studies are evaluating forms of allergen desensitization treatments such as oral, or OIT, sublingual or SLIT, subcutaneous, or SCIT;

or intranasal immunotherapy, or products using synthetic allergens, or denatured allergens, medicinal herbs, or combinations of medicines or methods, or medicines using traditional methods such as Chinese herbs.

Studies combining other methods of allergen immunotherapy, such as OIT, with anti-IgE monoclonal antibodies treatments are being conducted currently.

These types of co-administrations may significantly improve the safety of specific allergen immunotherapies administered orally or subcutaneously.

In addition, the use of monoclonal antibodies as monotherapy for certain food allergies, including peanut allergy, is being studied in clinical trials.

Monoclonal antibodies, used alone or in combination with allergen immunotherapy, may become significant competitors with to our products.

There is one FDA- and EMA-approved treatment for peanut allergy:

Palforzia, a formulation of peanut flour developed by Aimmune Therapeutics, Inc., or Aimmune.

Nestlé S.A., with whom we have an existing license and collaboration agreement, acquired Aimmune in October 2020.

Aimmune continues to function as a stand- alone business unit that will manage all of Nestlé’s global pharmaceutical business.

Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues if we obtain regulatory approval to market a product.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare costs to contain or reduce costs of healthcare may adversely affect one or more of the following:

our ability or our collaborators’ ability to set a price we believe is fair for our products, if approved;

our ability or our collaborators ability to obtain and maintain market acceptance by the medical community

and patients;

our ability or our collaborators’ ability to obtain and maintain market acceptance by the medical community and patients;

our ability to generate revenues and achieve profitability;

the availability of capital.

Sales of our products, when and if approved for marketing, will depend, in part, on the extent to which our products will be covered by third-party payors,

such as federal, state, and foreign government health care programs, commercial insurance and managed healthcare organizations.

There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be

more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities.

Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that

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

Sales of our products, when and if approved for marketing, will depend, in part, on the extent to which our products will be covered by third-party payors, such as federal, state, and foreign government health care programs, commercial insurance and managed healthcare organizations.

There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the drug is approved by the FDA or comparable foreign regulatory authorities.

Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sales and distribution.

Third-party payors are increasingly reducing reimbursements for medical products, drugs and services.

In addition, the U.S.

government, state legislatures and

foreign governments have continued implementing cost containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution

of generic products.

Adoption of price controls and cost containment measures, and adoption of more restrictive policies in jurisdictions with existing

controls and measures, could further limit our net revenue and results.

Limited third-party reimbursement for our product candidates or a decision by a third-party payor not to cover our product candidates could reduce physician usage of our

products once approved and have a material adverse effect on our sales, results of operations and financial condition.

Various provisions of the Patient

Protection and Affordable Care Act and the Health Care and Education Reconciliation Act, or ACA, were designed to impact the provision of, or payment for, health care in the United States, including expanded Medicaid eligibility, subsidized

insurance premiums, provided incentives for businesses to provide health care benefits, prohibited denials of coverage due to pre-existing conditions, established health insurance exchanges, and provided

additional support for medical research.

With regard to biopharmaceutical products, among other things, the ACA expanded and increased industry rebates for drugs covered under Medicaid programs and made changes to the coverage requirements under the

Medicare prescription drug benefit.

government, state legislatures and foreign governments have continued implementing cost containment programs, including price controls, restrictions on coverage and reimbursement and requirements for substitution of generic products.

Adoption of price controls and cost containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results.

Limited third-party reimbursement for our product candidates or a decision by a third-party payor not to cover our product candidates could reduce physician usage of our products once approved and have a material adverse effect on our sales, results of operations and financial condition.

Various provisions of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, were designed to impact the provision of, or payment for, health care in the United States, including expanded Medicaid eligibility, subsidized insurance premiums, provided incentives for businesses to provide health care benefits, prohibited denials of coverage due to pre- existing conditions, established health insurance exchanges, and provided additional support for medical research.

However, there have been executive, judicial and Congressional challenges to certain aspects of the ACA.

For example, on December 22, 2017, President Trump signed into law The Tax Cuts and Jobs Act of 2017,

or Tax Act, which includes a provision repealing the individual mandate to maintain health insurance coverage under the ACA effective January 1, 2019.

In addition, the 2020 federal spending package permanently eliminated, effective

January 1, 2020, the ACA-mandated Cadillac tax on high-cost employer-sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health insurer

On December 14, 2018, a U.S.

District Court Judge in the Northern District of Texas ruled that the individual mandate is a critical and inseverable feature of the ACA, and because it was repealed as part of the Tax Act, the remaining

provisions of the ACA are invalid as well.

Additionally, on December 18, 2019, the U.S.

Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the

District Court to determine whether the remaining provisions of the ACA are invalid as well.

Supreme Court is currently reviewing the case, although it is unknown when a decision will be made.

Further, although the U.S.

Supreme Court has

not yet ruled on the constitutionality of the ACA, on January 28, 2021, President Biden issued an executive order to initiate a special enrollment period from February 15, 2021 through May 15, 2021 for purposes of obtaining health

insurance coverage through the ACA marketplace.

The executive order also instructs certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid

demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

It is unclear how the Supreme Court ruling, other

such litigation, and the healthcare reform measures of the Biden administration will impact the ACA.

We continue to evaluate how the ACA and recent efforts to limit the implementation of the ACA will impact our business.

Following ACA, both the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012, or the

ATRA, include, among other things, mandatory reductions in Medicare payments to certain providers.

Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to,

among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

At the federal level, the Trump

administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives.

For example, on July 24, 2020 and September 13, 2020, the Trump

administration announced several executive orders related to prescription drug pricing that seek to implement several of the administrations proposals.

As a result, the FDA released a final rule on September 24, 2020, effective

November 30, 2020, providing guidance for states to build and submit importation plans for drugs from Canada.

Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from

pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The implementation of the rule has been delayed by the Biden administration

from January 1, 2022 to January 1, 2023 in response to ongoing litigation.

The rule also creates a new safe harbor for price reductions reflected at the

point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which have also

been delayed pending review by the Biden administration until March 22, 2021.

On November 20, 2020, CMS issued an interim final rule implementing the Trump administrations Most Favored Nation executive order, which would tie Medicare

Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021.

On December 28, 2020, the U.S.

District Court in Northern California issued a nationwide

preliminary injunction against implementation of the interim final rule.

It is unclear whether the Biden administration will work to reverse these measures or pursue similar policy initiatives.

At the state level, legislatures have increasingly

passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure

and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

It is also possible that additional governmental action is taken in response to the

COVID-19 pandemic.

Additional legislative proposals to reform healthcare and government insurance programs, along

with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce demand and prices for our products, if approved.

This could harm our or our collaborators ability to market any products and

generate revenues.

the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.

In some foreign countries, the proposed pricing

for a drug must be approved before it may be lawfully marketed.

For example, on December 22, 2017, President Trump signed into law The Tax Cuts and Jobs Act of 2017, or Tax Act, which includes a provision repealing the individual mandate to maintain health insurance coverage under the ACA effective January 1, 2019.

In addition, the 2020 federal spending package permanently eliminated, effective January 1, 2020, the ACA-mandated “Cadillac” tax on high-cost employer- sponsored health coverage and medical device tax and, effective January 1, 2021, also eliminates the health insurer tax.

On June 17, 2021 the U.S.

Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress.

Thus, the ACA will remain in effect in its current form.

Prior to the U.S.

Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace.

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA.

It is possible that the ACA will be subject to judicial or

Congressional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the Biden administration will impact the ACA.

Following ACA, both the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012, or the ATRA, include, among other things, mandatory reductions in Medicare payments to certain providers.

Additionally, in the United States, there have been several recent Congressional inquiries and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives.

For example, on July 24, 2020 and September 13, 2020, the Trump administration announced several executive orders related to prescription drug pricing that seek to implement several of the administration’s proposals.

As a result, the FDA concurrently released a final rule and guidance in September 2020 providing pathways for states to build and submit importation plans for drugs from Canada.

Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law.

The implementation of the rule has been delayed by the Biden administration from January 1, 2022 to January 1, 2023.

The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers, the implementation of which have also been delayed until January 1, 2023.

On November 20, 2020, CMS issued an interim final rule implementing the Trump administration’s Most Favored Nation executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021.

As a result of litigation challenging the Most Favored Nation model, on December 27, 2021, CMS published a final rule that rescinded the Most Favored Nation model interim final rule.

In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs.

In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

No legislation or administrative actions have been finalized to implement these principles.

It is unclear whether these or similar policy initiatives will be implemented in the future.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

It is also possible that additional governmental action is taken in response to the COVID-19 pandemic.

Additional legislative proposals to reform healthcare and government insurance programs, along with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce demand and prices for our products, if approved.

This could harm our or our collaborators’ ability to market any products and generate revenues.

Cost containment measures that healthcare payors and providers are instituting and the effect of further healthcare reform could significantly reduce potential revenues from the sale of any of our product candidates approved in the future, and could cause an increase in our compliance, manufacturing, or other operating expenses.

In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

In addition, in certain foreign markets, the pricing of prescription drugs is subject to government control and reimbursement may in some cases be unavailable.

The requirements

governing drug pricing vary widely from country to country.

For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement

and to control the prices of medicinal products for human use.

A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the

medicinal product on the market.

The requirements governing drug pricing vary widely from country to country.

For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.

A member state may approve a specific price for a medicinal

product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market.

There can be no assurance that any country that has price controls or reimbursement limitations for biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products.

Historically, biopharmaceutical products launched in the European Union do not follow price structures of the United States and generally tend to have significantly lower prices.

We believe that pricing pressures at the federal and state levels in the United States, as well as

internationally, will continue and may increase, which may make it difficult for us to sell our potential products that may be approved in the future at a price acceptable to us or any of our future collaborators.

We believe that pricing pressures at the federal and state levels in the United States, as well as internationally, will continue and may increase, which may make it difficult for us to sell our potential products that may be approved in the future at a price acceptable to us or any of our future collaborators.

Guidelines and recommendations published by various organizations may impact the use or reimbursement of Viaskin Peanut, if approved.

Government agencies promulgate regulations and guidelines that may be directly applicable to us and any approved products.

However, professional societies,

practice management groups, insurance carriers, physicians groups, private health and science foundations and organizations involved in various diseases also publish guidelines and recommendations to healthcare providers, administrators and

payers, as well as patient communities.

Recommendations by government agencies or other groups and organizations may relate to such matters as usage,

dosage, route of administration and use of related therapies, and a growing number of organizations are providing assessments of the value and pricing of pharmaceutical products.

These assessments may come from private organizations, such as the

Institute for Clinical and Economic Review, or ICER, which publish their findings and offer recommendations relating to the products reimbursement by government and private payers.

In July 2019, ICER published its final report assessing the

comparative clinical effectiveness and value of treatments for peanut allergy, including Viaskin Peanut and a competitor product candidate.

The results of this or future ICER report or any similar recommendations or guidelines may affect our

reputation, and any

recommendations or guidelines that result in decreased use or reimbursement of Viaskin Peanut, if approved, could have a material

adverse effect on our results of operations and financial condition.

In addition, the occurrence of any of the foregoing, or the perception by the investment community or shareholders that such recommendations or guidelines will result in decreased

use or reimbursement of Viaskin Peanut, if approved, could adversely affect the market price of our securities.

Our product candidates may cause

undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

Our product candidates are being developed to address the needs of severely allergic patients, for some of whom coming into contact with even minute amounts

of an allergen can have a profound and life-threatening adverse reaction.

However, professional societies, practice management groups, insurance carriers, physicians’ groups, private health and science foundations and organizations involved in various diseases also publish guidelines and recommendations to healthcare providers, administrators and payors, as well as patient communities.

Recommendations by government agencies or other groups and organizations may relate to such matters as usage, dosage, route of administration and use of related therapies, and a growing number of organizations are providing assessments of the value and pricing of pharmaceutical products.

These assessments may come from private organizations, such as the Institute for Clinical and Economic Review, or ICER, which publish their findings and offer recommendations relating to the products’ reimbursement by government and private payors.

In July 2019, ICER published its final report assessing the comparative clinical effectiveness and value of treatments for peanut allergy, including Viaskin Peanut and a competitor product candidate.

The results of this or future ICER report or any similar recommendations or guidelines may affect our reputation, and any recommendations or guidelines that result in decreased use or reimbursement of Viaskin Peanut, if approved, could have a material adverse effect on our results of operations and financial condition.

In addition, the occurrence of any of the foregoing, or the perception by the investment community or shareholders that such recommendations or guidelines will result in decreased use or reimbursement of Viaskin Peanut, if approved, could adversely affect the market price of our securities.

Our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.

Our product candidates are being developed to address the needs of severely allergic patients, for some of whom they can have a profound and life-threatening adverse reaction if exposed to even minute amounts of an allergen.

Accordingly, safety is of paramount importance in developing these product candidates.

To date, more than ten clinical trials of Viaskin Peanut and Viaskin Milk product

candidates have been conducted both outside and inside of the United States in over 1,000 human patients to evaluate the safety and efficacy of these product candidates for the treatment of peanut allergies and milk allergies, respectively.

events observed in these clinical trials have primarily involved general disorders such skin and subcutaneous tissue, immune system and administration site conditions, such as erythema, pruritus, edema and urticaria.

However, in clinical trials to

date, one case of mild to moderate anaphylaxis has been reported, and it is possible that anaphylaxis or other systemic reactions may occur in the future.

It is worth noting that, as a desensitization patch bringing the allergen into contact with

the skin, reactions, which are a source of itching and discomfort for the patient, are common.

To date, more than ten clinical trials of Viaskin Peanut and Viaskin Milk product candidates have been conducted both outside and inside of the United States in over 1,000 human patients to evaluate the safety and efficacy of these product candidates for the treatment of peanut allergies and milk allergies, respectively.

Adverse events observed in these clinical trials have primarily involved general disorders such skin and subcutaneous tissue, immune system and administration site conditions, such as erythema, pruritus, edema and urticaria.

However, in clinical trials to date, one case of mild to moderate anaphylaxis has been reported, and it is possible that anaphylaxis or other systemic reactions may occur in the future.

It is worth noting that, as a desensitization patch bringing the allergen into contact with the skin, reactions, which are a source of itching and discomfort for the patient, are common.

This reaction is typically temporary in duration and fades after a few weeks of use.

In addition, during daily administration of the patches during

treatments, depending on the severity of the allergies and patient response to treatment, precautionary measures are necessary when handling the patches after use due to risk of contamination.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay, halt or terminate clinical trials and

could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities.

Further, if our Viaskin patch product candidates receive marketing approval and we or others identify undesirable side

effects caused by the products (or any

other similar products) after the approval, a number of potentially significant negative consequences could result, including:

In addition, during daily administration of the patches during treatments, depending on the severity of the allergies and patient response to treatment, precautionary measures are necessary when handling the patches after use due to risk of contamination.

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay, halt or terminate clinical trials and could result in a more restrictive label or the delay or denial of regulatory

approval by the FDA or other regulatory authorities.

Further, if our Viaskin patch product candidates receive marketing approval and we or others identify undesirable side effects caused by the products (or any other similar products) after the approval, a number of potentially significant negative consequences could result, including:

regulatory authorities may withdraw or limit their approval of the products;

regulatory authorities may require the addition of labeling statements, such as a boxed warning or a

contraindication;

we may be required to change the way the products are distributed or administered, conduct additional clinical

trials or change the labeling of the products;

regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication;

we may be required to change the way the products are distributed or administered, conduct additional clinical trials or change the labeling of the products;

we may decide to remove the products from the marketplace;

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our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected products and could substantially increase the costs of

commercializing our products and significantly impact our ability to successfully commercialize our products and generate revenues.

growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future profitability will depend, in part, on our ability to commercialize product candidates based on our Viaskin technology platform in markets within

and without the United States and Europe.

Any of these events could prevent us from achieving or maintaining market acceptance of the affected products and could substantially increase the costs of commercializing our products and significantly impact our ability to successfully commercialize our products and generate revenues.

Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.

Our future profitability will depend, in part, on our ability to commercialize product candidates based on our Viaskin technology platform in multiple markets, including but not limited to those within the United States and Europe.

If we commercialize product candidates based on our Viaskin technology platform in foreign markets, we would be subject to additional risks and uncertainties, including:

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language barriers for technical training;

reduced protection of intellectual property rights in some foreign countries, and related prevalence of generic

alternatives to therapeutics;

reduced protection of intellectual property rights in some foreign countries, and related prevalence of generic alternatives to therapeutics;

foreign currency exchange rate fluctuations;

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the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

Foreign sales of Viaskin patch products could also be adversely affected by the imposition of governmental controls, political and

economic instability, trade restrictions and changes in tariffs.

We are subject to healthcare laws and regulations, which could expose us to criminal sanctions, civil

penalties, integrity obligations, exclusion from government healthcare programs, individual imprisonment, contractual damages, reputational harm and diminished profits and future earnings, among other consequences.

Foreign sales of Viaskin patch products could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs.

We are subject to healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, integrity obligations, exclusion from government healthcare programs, individual imprisonment, contractual damages, reputational harm and diminished profits and future earnings, among other consequences.

Healthcare providers, physicians and others will play a primary role in the recommendation and prescription of Viaskin patch products, if approved.

arrangements with such persons and third-party payors will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we

research, market, sell and distribute Viaskin patch products, if we obtain marketing approval.

Our arrangements with such persons and third-party payors will expose us

to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we research, market, sell and distribute Viaskin patch products, if we obtain marketing approval.

Restrictions under applicable federal, state and foreign healthcare laws and regulations include but are not limited to the following:

The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and

willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for or the

purchase, lease, order or recommendation of any item, good, facility or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid.

Although there are a number of statutory exceptions and regulatory safe

harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly.

Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject

to scrutiny if they do not qualify for an exception or safe harbor.

The intent standard under the federal Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity no longer needs to have actual knowledge of

the statute or specific intent to violate it in order to have committed a violation.

Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or

fraudulent claim for purposes of the federal civil False Claims Act.

The federal civil and criminal false claims laws, including the civil False Claims Act, impose criminal and civil

penalties, including those from civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or

making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal

and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters.

The federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for or the purchase, lease, order or recommendation of any item, good, facility or service for which payment may be made under federal healthcare programs such as Medicare and Medicaid.

Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly.

Practices that involve remuneration that may be alleged to be intended to induce prescribing, purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor.

The intent standard under the federal Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.

The federal civil and criminal false claims laws, including the civil False Claims Act, impose criminal and civil penalties, including those from civil whistleblower or qui tam actions, and civil monetary penalties laws, which prohibit, among other things, knowingly presenting, or causing to be presented, claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters.

Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its

implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and

transmission of individually identifiable health information.

The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that

require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Childrens Health Insurance Program, with specific exceptions, to track and annually

report to CMS payments and other transfers of value provided to physicians (defined to

include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members

in the applicable manufacturer, and disclosure of such information will be made by CMS on a publicly available website.

Beginning in 2022, applicable manufacturers will also be required to report information regarding payments and other transfers of

value provided during the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives.

Analogous state, local or foreign laws and regulations, such as state anti-kickback and false claims laws, which

may apply to items or services reimbursed by any third-party payor, including commercial insurers;

state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws

that require biopharmaceutical companies to comply with the biopharmaceutical industrys voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require licensure or

registration of pharmaceutical sales representatives;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, which impose certain requirements on covered entities and their business associates, and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information.

The federal transparency requirements under the Physician Payments Sunshine Act, enacted as part of the ACA, that require applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of value provided to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members in the applicable manufacturer, and disclosure of such information will be made by CMS on a publicly available website.

Analogous state, local or foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers;

state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the federal requirements, state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, state and local laws that require

licensure or registration of pharmaceutical sales representatives;

state laws that require disclosure of information related to drug pricing;

and state and foreign laws governing the privacy and security of health information in certain circumstances, many of

which differ from each other in significant ways and may not have the same effect as HIPAA.

Ensuring that our business arrangements

with third parties comply with applicable healthcare laws and regulations could be costly.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our current and/or

future business activities could be subject to challenge under one or more of these laws.

If our operations were found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to

significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity obligations, contractual damages, reputational harm,

diminished profits and future earnings, and curtailment of operations, any of which could substantially disrupt our operations.

Defending against any such actions can be costly, time-consuming and may require significant financial and personnel

and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect as HIPAA.

Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations could be costly.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our current and/or future business activities could be subject to challenge under one or more of these laws.

If our operations were found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, integrity obligations, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of operations, any of which could substantially disrupt our operations.

Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources.

Even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

If the physicians or other providers or entities with

whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative

sanctions, including exclusion from government funded healthcare programs.

Changes in regulatory requirements, FDA guidance or guidance from

certain European regulatory authorities or unanticipated events during our clinical trials of Viaskin patch products may occur, which may result in changes to clinical trial protocols or additional clinical trial requirements, which could result in

increased costs to us and could delay our development timeline.

Changes in regulatory requirements, FDA guidance or guidance from certain

European regulatory authorities or unanticipated events during our clinical trials may force us to amend clinical trial protocols or the FDA or certain European regulatory authorities may impose additional clinical trial requirements.

with regulatory authorities have caused us to adjust certain trial protocols.

Amendments to our clinical trial protocols would require resubmission to the FDA and IRBs for review and approval, which may adversely impact the cost, timing or

successful completion of a clinical trial.

If we experience delays completing, or if we terminate, any of our clinical trials, or if we are required to conduct additional clinical trials, the commercial prospects for the Viaskin patch product

candidates, or any other product candidates, may be harmed and our ability to generate product revenue will be delayed.

For example, in August 2020, the

FDA identified concerns regarding the impact of patch-site adhesion on efficacy for Viaskin Peanut and indicated the need for patch modifications, and subsequently a new human factor

Following subsequent interactions with the FDA, order to confirm the consistency of efficacy data between the existing and a modified patch, FDA has requested an assessment comparing the

uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11.

The FDA also recommended conducting a 6-month, well-controlled safety and

adhesion trial to assess a modified Viaskin Peanut patch in the intended patient population.

We intend to submit the protocols for the safety and adhesion study and the allergen uptake study to the FDA for review and comments in the second quarter

of 2021 before initiating the trials.

If the physicians or other providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusion from government funded healthcare programs.

Changes in regulatory requirements, FDA guidance or guidance from certain European regulatory authorities or unanticipated events during our clinical trials of Viaskin patch products may occur, which may result in changes to clinical trial protocols or additional clinical trial requirements, which could result in increased costs to us and could delay our development timeline.

Changes in regulatory requirements, FDA guidance or guidance from certain European regulatory authorities or unanticipated events during our clinical trials may force us to amend clinical trial protocols or the FDA or certain European regulatory authorities may impose additional clinical trial requirements.

Discussions with regulatory authorities have caused us to adjust certain trial protocols.

Amendments to our clinical trial protocols would require resubmission to the FDA and IRBs for review and approval, which may adversely impact the cost, timing or successful completion of a clinical trial.

If we experience delays completing, or if we terminate, any of our clinical trials, or if we are required to conduct additional clinical trials, the commercial prospects for the Viaskin patch product candidates, or any other product candidates, may be harmed and our ability to generate product revenue will be delayed.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If we are found to have improperly promoted off-label uses, we may become subject to significant liability.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as Viaskin patch products,

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as Viaskin patch products, if approved.

In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies, as reflected in the product’s approved labeling.

If we receive marketing approval for Viaskin patch products

as a treatment for a particular allergy, physicians, in their professional medical judgment, may nevertheless prescribe Viaskin patch products to their patients in a manner that is inconsistent with the approved label.

Additionally, it is

permissible to share in certain circumstances truthful and non-misleading information that is consistent with, but not contained in, the products approved labeling.

If we receive marketing approval for Viaskin patch products as a treatment for a particular allergy, physicians, in their professional medical judgment, may nevertheless prescribe Viaskin patch products to their patients in a manner that is inconsistent with the approved label.

Additionally, it is permissible to share in certain circumstances truthful and non-misleading information that is consistent with, but not contained in, the product’s approved labeling.

If we are found to have promoted such off-label uses, we may become subject to significant liability under the FDCA and other statutory authorities, such as laws prohibiting false claims for reimbursement.

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.

If we cannot successfully manage the marketing of Viaskin patch products, if approved, by restricting off-label

promotion, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

product development programs for candidates other than Viaskin patch products may require substantial financial resources and may ultimately be unsuccessful.

The success of our business depends primarily upon our ability to identify, develop and commercialize products to treat common food allergies.

In addition to

the commercialization of Viaskin Peanut, if approved, we may pursue development of our other development programs, including Viaskin Milk, Viaskin Egg and Viaskin rPT.

None of our other potential product candidates has commenced any clinical trials,

we have scaled down our research and clinical development efforts related to these product candidates in order to focus on Viaskin Peanut, and there are a number of FDA requirements that we must satisfy before we can commence clinical trials.

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.

If we cannot successfully manage the marketing of Viaskin patch

products, if approved, by restricting off-label promotion, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

Our product development programs may require substantial financial resources and may ultimately be unsuccessful.

The success of our business depends primarily upon our ability to identify, develop and commercialize products to treat food allergies.

In addition to Viaskin Peanut, we may pursue development of our other development programs, including Viaskin Milk, Viaskin Egg and Viaskin rPT.

None of our other product candidates and potential product candidates has commenced any clinical trials since we scaled down our research and clinical development efforts in 2020 and 2021 to focus on Viaskin Peanut.

There are a number of FDA requirements that we must satisfy before we can commence clinical trials.

Satisfaction of these requirements will entail substantial time, effort and financial resources.

We may never satisfy these requirements.

Any time, effort and financial resources we expend on our other development programs may adversely affect our

ability to continue the commercialization of Viaskin Peanut, if approved, and the clinical development and commercialization of other Viaskin product candidates and we may never commence clinical trials of such development programs despite expending

significant resources in pursuit of their development.

We may never commence clinical trials of such development programs despite expending significant resources in pursuit of their development.

If we do commence clinical trials of our other potential product candidates, such product candidates may never be approved by the FDA.

If any of these events occur, we may be forced to abandon

our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations.

If we do not secure collaborations with strategic partners to test, commercialize and manufacture certain product candidates outside of food allergies,

we may not be able to successfully develop products and generate meaningful revenues.

A key aspect of our current strategy is to selectively

enter into collaborations with third parties to conduct clinical testing, as well as to commercialize and manufacture product candidates outside of food allergies.

Our ability to

generate revenues from these arrangements will depend on our collaborators abilities to successfully perform the functions assigned to them in these arrangements.

We currently have multiple

collaboration agreements in effect, including collaborations for the development of applications in the field of respiratory allergies or autoimmune disease, as well as other therapeutic domains, such as vaccines.

Collaboration agreements, such as

our exclusive global collaboration with Nestlé

Health Science, typically call for milestone payments that depend on successful demonstration of efficacy and safety, obtaining regulatory approvals and clinical trial results.

Collaboration

revenues are not guaranteed, even when efficacy and safety are demonstrated.

The current economic environment may result in potential collaborators electing to reduce their external spending, which may prevent us from developing our product

Even if we succeed in securing collaborators, the collaborators may fail to develop or effectively commercialize products using our product

If any of these events occur, we may be forced to abandon our development efforts for a program or programs, which would have a material adverse effect on our business and could potentially cause us to cease operations.

If we do not secure collaborations with strategic partners to test, commercialize and manufacture certain product candidates outside of food allergies, we may not be able to successfully develop products and generate meaningful revenues.

A key aspect of our current strategy is to selectively enter into collaborations with third parties to conduct clinical testing, as well as to commercialize and manufacture product candidates outside of food allergies.

Our ability to generate revenues from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

We currently have multiple collaboration agreements in effect, including collaborations for the development of applications in the field of respiratory allergies or autoimmune disease, as well as other therapeutic domains, such as vaccines.

Collaboration agreements, such as our exclusive global collaboration with Nestlé Health Science, typically call for milestone payments that depend on successful demonstration of efficacy and safety, obtaining regulatory approvals and clinical trial results.

Collaboration revenues are not guaranteed, even when efficacy and safety are demonstrated.

The current economic environment may result in potential collaborators electing to reduce their external spending, which may prevent us from developing our product candidates.

Even if we succeed in securing collaborators, the collaborators may fail to develop or effectively commercialize products using our product candidates.

Collaborations involving our product candidates pose a number of risks, including the following:

collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal

constraints such as budget limitations, lack of human resources, or a change in strategic focus;

collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is

unenforceable or the product candidate infringes on the intellectual property rights of others;

collaborators may dispute their responsibility to conduct development and commercialization activities pursuant

to the applicable collaboration, including the payment of related costs or the division of any revenues;

collaborators may not have sufficient resources or decide not to devote the necessary resources due to internal constraints such as budget limitations, lack of human resources, or a change in strategic focus;

collaborators may believe our intellectual property is not valid, is not infringed by potential competitors or is unenforceable or the product candidate infringes on the intellectual property rights of others;

collaborators may dispute their responsibility to conduct development and commercialization activities pursuant to the applicable collaboration, including the payment of related costs or the division of any revenues;

collaborators may decide to pursue a competitive product developed outside of the collaboration arrangement;

collaborators may not be able to obtain, or believe they cannot obtain, the necessary regulatory approvals;

collaborators may delay the development or commercialization of our product candidates in favor of developing or

commercializing another partys product candidate.

Thus, collaboration agreements may not lead to development or commercialization

of product candidates in the most efficient manner or at all.

collaborators may delay the development or commercialization of our product candidates in favor of developing or commercializing another party’s product candidate.

Thus, collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all.

Collaboration agreements are generally terminable without cause on short notice.

collaboration agreement is signed, it may not lead to commercialization of a product candidate.

Once a collaboration agreement is signed, it may not lead to commercialization of a product candidate.

We also face competition in seeking out collaborators.

If we are unable to secure new collaborations that achieve the collaborators objectives and

meet our expectations, we may be unable to advance our product candidates and may not generate meaningful revenues.

Intellectual Property Risks

Related to Our Business

If we are unable to secure new collaborations that achieve the collaborator’s objectives and meet our expectations, we may be unable to advance our product candidates and may not generate meaningful revenues.

Intellectual Property Risks Related to Our Business

Our ability to compete may decline if we do not adequately protect our proprietary rights.

Our commercial success depends on obtaining and maintaining proprietary rights to our product candidates for the treatment of common food allergies, as well

as successfully defending these rights against third-party challenges.

We will only be able to protect our product candidates, and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively

protected trade secrets, cover them.

Our commercial success depends on obtaining and maintaining proprietary rights to our product candidates for the treatment of common food allergies, as well as successfully defending these rights against third-party challenges.

We will only be able to protect our product candidates, and their uses from unauthorized use by third parties to the extent that valid and enforceable patents, or effectively protected trade secrets, cover them.

Our ability to obtain patent protection for our product candidates is uncertain due to a number of factors, including:

we may not have been the first to make the inventions covered by pending patent applications or issued patents;

we may not have been the first to file patent applications for our product candidates or the compositions we

developed or for their uses;

we may not have been the first to file patent applications for our product candidates or the compositions we developed or for their uses;

others may independently develop identical, similar or alternative products or compositions and uses thereof;

our disclosures in patent applications may not be sufficient to meet the statutory requirements for

patentability;

our disclosures in patent applications may not be sufficient to meet the statutory requirements for patentability;

any or all of our pending patent applications may not result in issued patents;

we may not seek or obtain patent protection in countries that may eventually provide us a significant business

any patents issued to us may not provide a basis for commercially viable products, may not provide any

competitive advantages, or may be successfully challenged by third parties;

we may not seek or obtain patent protection in countries that may eventually provide us a significant business opportunity;

any patents issued to us may not provide a basis for commercially viable products, may not provide any competitive advantages, or may be successfully challenged by third parties;

our compositions and methods may not be patentable;

others may design around our patent claims to produce competitive products which fall outside of the scope of our

others may design around our patent claims to produce competitive products which fall outside of the scope of our patents;

others may identify prior art or other bases which could invalidate our patents.

Even if we have or obtain patents covering our product candidates or compositions, we may still be barred from making, using and selling our product

candidates or technologies because of the patent rights of others.

Even if we have or obtain patents covering our product candidates or compositions, we may still be barred from making, using and selling our product candidates or technologies because of the patent rights of others.

Others may have filed, and in the future may file, patent applications covering compositions or products that are similar or identical to ours.

There are many issued U.S.

patents relating to chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.

and foreign patents relating to chemical compounds and therapeutic products, and some of these relate to compounds we intend to commercialize.

Numerous U.S.

and foreign issued patents and pending patent applications owned by others exist in the allergy

treatment field in which we are developing products.

and foreign issued patents and pending patent applications owned by others exist in the allergy treatment field in which we are developing products.

These could materially affect our ability to develop our product candidates or sell our products if approved.

Because patent applications can take many years to issue, there may be currently

pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe.

Because patent applications can take many years to issue, there may be currently pending applications unknown to us that may later result in issued patents that our product candidates or compositions may infringe.

These patent applications may have priority over patent applications filed by us.

Obtaining and maintaining a patent portfolio entails significant expense and resources.

Part of the expense includes periodic maintenance fees, renewal fees,

annuity fees, various other governmental fees on patents and/or applications due in several stages over the lifetime of patents and/or applications, as well as the cost associated with complying with numerous procedural provisions during the patent

application process.

Part of the expense includes periodic maintenance fees, renewal fees, annuity fees, various other governmental fees on patents and/or

applications due in several stages over the lifetime of patents and/or applications, as well as the cost associated with complying with numerous procedural provisions during the patent application process.

We may or may not choose to pursue or maintain protection for particular inventions.

In addition, there are situations in which failure to make certain payments or noncompliance with certain requirements in the patent process

can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

If we choose to forgo patent protection or allow a patent application or patent to lapse

purposefully or inadvertently, our competitive position could suffer.

Legal actions to enforce our patent rights can be expensive and may involve the

diversion of significant management time.

In addition, there are situations in which failure to make certain payments or noncompliance with certain requirements in the patent process can result in abandonment or lapse of a patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.

If we choose to forgo patent protection or allow a patent application or patent to lapse purposefully or inadvertently, our competitive position could suffer.

Legal actions to enforce our patent rights can be expensive and may involve the diversion of significant management time.

In addition, these legal actions could be unsuccessful and could also result in the invalidation of our patents or a finding that they are unenforceable.

We may or may not choose to pursue litigation or

other actions against those that have infringed on our patents, or used them without authorization, due to the associated expense and time commitment of monitoring these activities.

If we fail to protect or to enforce our intellectual property

rights successfully, our competitive position could suffer, which could harm our results of operations.

Biopharmaceutical patents and patent

applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.

We may or may not choose to pursue litigation or other actions against those that have infringed on our patents, or used them without authorization, due to the associated expense and time commitment of monitoring these activities.

If we fail to protect or to enforce our intellectual property rights successfully, our competitive position could suffer, which could harm our results of operations.

Biopharmaceutical patents and patent applications involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position.

The patent positions of biopharmaceutical companies can be highly uncertain and involve complex legal and factual questions.

The interpretation and breadth of

claims allowed in some patents covering biopharmaceutical

compositions may be uncertain and difficult to determine, and are often affected materially by the facts and circumstances that pertain to the patented compositions and the related patent claims.

The interpretation and breadth of claims allowed in some patents covering biopharmaceutical compositions may be uncertain and difficult to determine, and are often affected materially by the facts and circumstances that pertain to the patented compositions and the related patent claims.

The standards of the United States Patent and Trademark Office, or USPTO, are sometimes uncertain and could change in the future.

Consequently, the issuance and scope of patents cannot be predicted with certainty.

Patents, if issued, may be

challenged, invalidated or circumvented.

Patents, if issued, may be challenged, invalidated or circumvented.

patents and patent applications may also be subject to interference proceedings, and U.S.

patents may be subject to reexamination proceedings, post-grant review and/or inter partes review in the USPTO.

Foreign patents may be subject also to opposition or comparable proceedings in the corresponding foreign patent office, which could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or

more of the claims of the patent or patent application.

In addition, such interference, reexamination, post-grant review, inter partes review and opposition proceedings may be costly.

Accordingly, rights under any issued patents may not provide us

with sufficient protection against competitive products or processes.

In addition, changes in or different interpretations of patent laws in the United

States and foreign countries may permit others to use our discoveries or to develop and commercialize our technology and products without providing any compensation to us, or may limit the number of patents or claims we can obtain.

The laws of some

countries do not protect intellectual property rights to the same extent as U.S.

Accordingly, rights under any issued patents may not provide us with sufficient protection against competitive products or processes.

In addition, changes in or different interpretations of patent laws in the United States and foreign countries may permit others to use our discoveries or to develop and commercialize our technology and products without providing any compensation to us, or may limit the number of patents or claims we can obtain.

The laws of some countries do not protect intellectual property rights to the same extent as U.S.

laws and those countries may lack adequate rules and procedures for defending our intellectual property rights.

If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, we could lose our competitive advantage and

competition we face would increase, reducing any potential revenues and adversely affecting our ability to attain or maintain profitability.

If we fail to obtain and maintain patent protection and trade secret protection of our product candidates, we could lose our competitive advantage and competition we face would increase, reducing any potential revenues and adversely affecting our ability to attain or maintain profitability.

Developments in patent law could have a negative impact on our business.

From time to time, the United States Supreme Court, or the Supreme Court, other federal courts, the United States Congress, the USPTO or similar foreign

authorities may change the standards of patentability and any such changes could have a negative impact on our business.

In addition, the Leahy-Smith

America Invents Act, or the America Invents Act, which was signed into law in 2011, includes a number of significant changes to U.S.

These changes include a transition from a first-to-invent system to a first-to-file system, changes to the way issued patents are challenged, and

changes to the way patent applications are disputed during the examination process.

From time to time, the United States Supreme Court, or the Supreme Court, other federal courts, the United States Congress, the USPTO or similar foreign authorities may change the standards of patentability and any such changes could have a negative impact on our business.

In addition, the Leahy-Smith America Invents Act, or the America Invents Act, which was signed into law in

2011, includes a number of significant changes to U.S.

These changes include a transition from a “first-to-invent” system to a “first-to-file” system, changes to the way issued patents are challenged, and changes

to the way patent applications are disputed during the examination process.

These changes may favor larger and more established companies that have greater resources to devote to patent application filing and prosecution.

The USPTO has

developed new and untested regulations and procedures to govern the full implementation of the America Invents Act, and many of the substantive changes to patent law associated with the America Invents Act, and, in particular, the first-to-file provisions, became effective on March 16, 2013.

Substantive changes to patent law associated with the America Invents Act may affect our ability to obtain

patents, and if obtained, to enforce or defend them.

Accordingly, it is not clear what, if any, impact the America Invents Act will have on the cost of prosecuting our patent applications, our ability to obtain patents based on our discoveries and

our ability to enforce or defend any patents that may issue from our patent applications, all of which could have a material adverse effect on our business.

The USPTO has developed new and untested regulations and procedures to govern the full implementation of the

America Invents Act, and many of the substantive changes to patent law associated with the America Invents Act, and, in particular, the first-to-file provisions, became effective on March 16, 2013.

Substantive changes to patent law associated with the America Invents Act may affect our ability to obtain patents, and if obtained, to enforce or defend them.

Accordingly, it is not clear what, if any, impact the America Invents Act will have on the cost of prosecuting our patent applications, our ability to obtain patents based on our discoveries and our ability

to enforce or defend any patents that may issue from our patent applications, all of which could have a material adverse effect on our business.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to patent protection, because we operate in the highly technical field of development of therapies, we rely in part on trade secret protection in

order to protect our proprietary technology and processes.

In addition to patent protection, because we operate in the highly technical field of development of therapies, we rely in part on trade secret protection in order to protect our proprietary technology and processes.

However, trade secrets are difficult to protect.

We expect to enter into confidentiality and intellectual property assignment agreements with our employees, consultants, outside scientific

collaborators, sponsored researchers, and other advisors.

These agreements generally require that the other party keep confidential and not disclose to third parties all confidential information developed by the party or made known to the party by

us during the course of

the partys relationship with us.

We expect to enter into confidentiality and intellectual property assignment agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors.

These agreements generally require that the other party keep confidential and not disclose to third

parties all confidential information developed by the party or made known to the party by us during the course of the party’s relationship with us.

These agreements also generally provide that inventions conceived by the party in the course of rendering services to us will be our exclusive property.

However, these agreements may not be honored and may not effectively assign intellectual property rights to us.

In addition to contractual measures, we

try to protect the confidential nature of our proprietary information using physical and technological security measures.

Such measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with

authorized access, provide adequate protection for our proprietary information.

Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against

such misconduct may not provide an adequate remedy to protect our interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is

unpredictable.

In addition, courts outside the United States may be less willing to protect trade secrets.

In addition to contractual measures, we try to protect the confidential nature of our proprietary information using physical and technological security measures.

Such measures may not, for example, in the case of misappropriation of a trade secret by an employee or third party with authorized access, provide adequate protection for our proprietary information.

Our security measures may not prevent an employee or consultant from misappropriating our trade secrets and providing them to a competitor, and recourse we take against such misconduct may not provide an adequate remedy to protect our interests fully.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive, and time-consuming, and the outcome is unpredictable.

In addition, courts outside the United States may be less willing to protect trade

Trade secrets may be independently developed by others in a manner that could prevent legal recourse by us.

If any of our confidential or

proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.

We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our

intellectual property rights even in the jurisdictions where we seek protection.

Filing, prosecuting and defending patents on our product

candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States, assuming

that rights are obtained in the United States.

In addition, the laws of some foreign countries do not protect intellectual property rights to the

extent as federal and state laws in the United States.

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.

If any of our confidential or proprietary information, such as our trade secrets, were to be disclosed or misappropriated, or if any such information was independently developed by a competitor, our competitive position could be harmed.

We will not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.

Filing, prosecuting and defending patents on our product candidates in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States could be less extensive than those in the United States, assuming that rights are obtained in the United States.

In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States.

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.

The statutory deadlines for pursuing patent protection in individual foreign jurisdictions are based on the priority dates of each of our patent applications.

Competitors may use our technologies in jurisdictions where we do not pursue and obtain patent protection to develop their own products and further, may

export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States.

These products may compete with our products and our patents or other intellectual property rights

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

Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third

parties from so competing.

The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United

Competitors may use our technologies in jurisdictions where we do not pursue and obtain patent protection to develop their own products and further, may export otherwise infringing products to territories where we have

patent protection, but enforcement is not as strong as that in the United States.

These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Even if we pursue and obtain issued patents in particular jurisdictions, our patent claims or other intellectual property rights may not be effective or sufficient to prevent third parties from so competing.

The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States.

Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions.

The legal systems of some countries, particularly developing countries, do not favor the

enforcement of patents and other intellectual property protection, especially those relating to biopharmaceuticals or biotechnologies.

This could make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation

of our other intellectual property rights.

The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating to biopharmaceuticals or biotechnologies.

This could make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation of our other intellectual property rights.

For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties.

In addition, many countries limit the enforceability of patents against

third parties, including government agencies or government contractors.

In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors.

In these countries, patents may provide limited or no benefit.

Patent protection must ultimately be sought on a

country-by-country basis, which is an expensive and time- consuming process with uncertain outcomes.

Accordingly, we may choose not to seek patent protection in certain

countries, and we will not have the benefit of patent protection in such countries.

Proceedings to enforce our patent rights in foreign jurisdictions

could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or

interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and

the damages or other remedies awarded, if any, may not be commercially meaningful.

In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our

technology and the enforcement of intellectual property.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we

develop or license.

Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time- consuming process with uncertain outcomes.

Accordingly, we may choose not to seek patent protection in certain countries, and we will not have the benefit of patent protection in such countries.

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, could put our patent applications at risk of not issuing and could provoke third parties to assert claims against us.

We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful.

In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our technology and the enforcement of intellectual property.

Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Third parties may assert ownership or commercial rights to inventions we develop.

Third parties may in the future make claims challenging the inventorship or ownership of our intellectual property.

We have written agreements with

collaborators that provide for the ownership of intellectual property arising from our collaborations.

These agreements provide that we must negotiate certain commercial rights with collaborators with respect to joint inventions or inventions made

by our collaborators that arise from the results of the collaboration.

We have written agreements with collaborators that provide for the ownership of intellectual property arising from our collaborations.

These agreements provide that we must negotiate certain commercial rights with collaborators with respect to joint inventions or inventions made by our collaborators that arise from the results

of the collaboration.

In some instances, there may not be adequate written provisions to address clearly the resolution of intellectual property rights that may arise from a collaboration.

cannot successfully negotiate sufficient ownership and commercial rights to the inventions that result from our use of a third-party collaborators materials where required, or if disputes otherwise arise with respect to the intellectual

property developed with the use of a collaborators samples, we may be limited in our ability to capitalize on the market potential of these inventions.

In addition, we may face claims by third parties that our agreements with employees,

contractors, or consultants obligating them to assign intellectual property to us are ineffective, or in conflict with prior or competing contractual obligations of assignment, which could result in ownership disputes regarding intellectual property

we have developed or will develop and interfere with our ability to capture the commercial value of such inventions.

Litigation may be necessary to resolve an ownership dispute, and if we are not successful, we may be precluded from using certain

intellectual property, or may lose our exclusive rights in that intellectual property.

If we cannot successfully negotiate sufficient ownership and commercial rights to the inventions that result from our use of a third-party collaborator’s materials where required, or if disputes otherwise arise with respect to the intellectual property developed with the use of a collaborator’s samples, we may be limited in our ability to capitalize on the market potential of these inventions.

In addition, we may face claims by third parties that our agreements with employees, contractors, or consultants obligating them to assign intellectual property to us are ineffective, or in conflict with prior or competing contractual obligations of assignment, which could result in ownership disputes regarding intellectual property we have developed or will develop and interfere with our ability to capture the commercial value of such inventions.

Litigation may be necessary to resolve an ownership dispute, and if we are not successful, we may be precluded from using certain intellectual property, or may lose our exclusive rights in that intellectual property.

Either outcome could have an adverse impact on our business.

Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.

We employ individuals who were previously employed at universities or other biopharmaceutical companies, including our competitors or potential

Although we try to ensure that our employees and consultants do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our

employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties.

Litigation may be

necessary to defend against these claims.

We employ individuals who were previously employed at universities or other biopharmaceutical companies, including our competitors or potential competitors.

Although we try to ensure that our employees and consultants

do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of a former employer or other third parties.

Litigation may be necessary to defend against these claims.

If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.

Even if we are successful in defending against such claims,

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

A dispute concerning the infringement or

misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.

Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

A dispute concerning the infringement or misappropriation of our proprietary rights or the proprietary rights of others could be time consuming and costly, and an unfavorable outcome could harm our business.

There is significant litigation in the biopharmaceutical industry regarding patent and other intellectual property rights.

While we are not currently subject

to any pending intellectual property litigation, and are not aware of any such threatened litigation, we may be exposed to future litigation by third parties based on claims that our product candidates, technologies or activities infringe the

intellectual property rights of others.

While we are not currently subject to any pending intellectual property litigation, and are not aware of any such threatened litigation, we may be exposed to future litigation by third parties based on claims that our product candidates, technologies or activities infringe the intellectual property rights of others.

If our development activities are found to infringe any such patents, we may have to pay significant damages or seek licenses to such patents.

A patentee could prevent us from using the patented drugs or

compositions.

A patentee could prevent us from using the patented drugs or compositions.

We may need to resort to litigation to enforce a patent issued to us, to protect our trade secrets, or to determine the scope and validity of third-party proprietary rights.

From time to time, we may hire scientific personnel or

consultants formerly employed by other companies involved in one or more areas similar to the activities conducted by us.

From time to time, we may hire scientific personnel or consultants formerly employed by other companies involved in one or more areas similar to the activities conducted by us.

Either we or these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of prior affiliations.

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Any adverse ruling or perception of an adverse ruling in defending ourselves against these claims could have a material adverse impact on our cash position and the price of the ADSs.

action against us or our collaborators could lead to:

payment of damages, potentially treble damages, if we are found to have willfully infringed a partys patent

injunctive or other equitable relief that may effectively block our ability to further develop, commercialize,

and sell products;

us or our collaborators having to enter into license arrangements that may not be available on commercially

acceptable terms, if at all, all of which could have a material adverse impact on our cash position and business and financial condition.

Any legal action against us or our collaborators could lead to:

payment of damages, potentially treble damages, if we are found to have willfully infringed a party’s patent rights;

injunctive or other equitable relief that may effectively block our ability to further develop, commercialize, and sell products;

us or our collaborators having to enter into license arrangements that may not be available on commercially acceptable terms, if at all, all of which could have a material adverse impact on our cash position and business and financial condition.

As a result, we could be prevented from commercializing current or future product candidates.

We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop

us from commercializing or increase the costs of commercializing our product candidates, if approved.

Our success will depend in part on our

ability to operate without infringing the intellectual property and proprietary rights of third parties.

We cannot assure you that our business, products and methods do not or will not infringe the patents or other intellectual property rights of

third parties.

We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates, if approved.

Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties.

We cannot assure you that our business, products and methods do not or will not infringe the patents or other intellectual property rights of third parties.

The biopharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights.

parties may allege that our product candidates or the use of our technologies infringes patent claims or other intellectual property rights held by them or that we are employing their proprietary technology without authorization.

Patent and other

types of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain.

Any claim relating to intellectual property infringement that is successfully asserted against us may require us to pay

substantial damages, including treble damages and attorneys fees if we are found to be willfully infringing another partys patents, for past use of the asserted intellectual property and royalties and other consideration going forward if

we are forced to take a license.

In addition, if any such claim were successfully asserted against us and we could not obtain such a license, we may be forced to stop or delay developing, manufacturing, selling or otherwise commercializing Viaskin

patch products.

Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these

proceedings, which could have a material adverse effect on us.

If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court,

or redesign our products.

Other parties may allege that our product candidates or the use of our technologies infringes patent claims or other intellectual property rights held by them or that we are employing their proprietary technology without authorization.

Patent and other types of intellectual property litigation can involve complex factual and legal questions, and their outcome is uncertain.

Any claim relating to intellectual property

infringement that is successfully asserted against us may require us to pay substantial damages, including treble damages and attorney’s fees if we are found to be willfully infringing another party’s patents, for past use of the asserted intellectual property and royalties and other consideration going forward if we are forced to take a license.

Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us.

If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court, or redesign our products.

Patent litigation is costly and time consuming.

We may not have sufficient resources to bring these actions to a successful conclusion.

In addition, intellectual property litigation or claims could force us to do one or

more of the following:

In addition, intellectual property litigation or claims could force us to do one or more of the following:

cease developing, selling or otherwise commercializing our product candidates;

pay substantial damages for past use of the asserted intellectual property;

obtain a license from the holder of the asserted intellectual property, which license may not be available on

reasonable terms, if at all;

in the case of trademark claims, redesign, or rename, Viaskin or other trademarks we may own, to avoid infringing

the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming.

Any of these risks coming to fruition could have a material adverse effect on our business, results of

operations, financial condition and prospects.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged

If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering our product

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

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are

obtain a license from the holder of the asserted intellectual property, which license may not be available on reasonable terms, if at all;

in the case of trademark claims, redesign, or rename, Viaskin or other trademarks we may own, to avoid infringing the intellectual property rights of third parties, which may not be possible and, even if possible, could be costly and time-consuming.

Any of these risks coming to fruition could have a material adverse effect on our business, results of operations, financial condition and prospects.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.

If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering our product candidate, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable.

In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace.

Grounds for a validity challenge include alleged failures to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement.

Grounds for unenforceability

assertions include allegations that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.

Third parties may also raise similar claims before administrative

bodies in the United States or abroad, even outside the context of litigation.

Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions, e.g., opposition

Grounds for unenforceability assertions include allegations that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution.

Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.

Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings.

Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our product candidates or competitive products.

The outcome following legal assertions of invalidity and unenforceability is

unpredictable.

The outcome following legal assertions of invalidity and unenforceability is unpredictable.

With respect to validity, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution.

If a defendant 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 our product candidates.

If a defendant 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 our product candidates.

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

Risks Related to Our Organization, Structure and Operations

We are in the process of implementing a global restructuring program, and we may not be able to realize the anticipated benefits of this program or any

other efforts to preserve operational flexibility and financial resources.

We initiated a global restructuring plan in June 2020 in order to

provide operational latitude to progress the clinical development and regulatory review of investigational Viaskin Peanut in the United States and European Union.

The full implementation of the restructuring plan will result in a reduction of more

than 200 jobs, and our new organizational structure is designed to generate cost efficiencies, in particular through right-sizing our facilities and gathering our staff in one central office per country.

However, there can be no guarantee that we

will be able fully to implement our restructuring plans or to realize all of the anticipated benefits thereof.

While we are seeking to terminate certain facilities leases and sublet other facilities, we may not be successful in doing so.

unable to fully implement our restructuring plan, we may not have sufficient financial resources to conduct necessary operations or otherwise capitalize on our business opportunities, and our business, financial condition and results of operations

could be materially adversely affected.

We depend on key personnel and attracting qualified management personnel and our business could be harmed

if we lose key personnel and cannot attract new personnel.

Our success depends to a significant degree upon the technical and management skills

of our officers and key personnel.

We depend on key personnel and attracting qualified management personnel and our business could be harmed if we lose key personnel and cannot attract new personnel.

Our success depends to a significant degree upon the technical and management skills of our officers and key personnel.

The loss of the services of any of these individuals would likely have an adverse effect on us.

Our success also will depend upon our ability to attract and retain additional qualified management.

Recruiting and

retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success.

The loss of the services of our key executives could impede the achievement of our research, development and

commercialization objectives and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and key personnel may be difficult and may take an extended period of time because of the limited

number of individuals in our industry with the breadth of skills and experience required to successfully develop, obtain marketing approval of and commercialize products.

Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous

pharmaceutical and biotechnology companies for similar personnel.

success also will depend upon our ability to attract and retain additional qualified management.

Recruiting and retaining qualified scientific, clinical, manufacturing, sales and marketing personnel will also be critical to our success.

The loss of the services of our key executives could impede the achievement of our research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy.

Furthermore, replacing executive officers and key personnel may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, obtain marketing approval of and commercialize products.

Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.

We compete for such personnel against numerous companies, including larger, more established companies with significantly greater financial resources than we possess.

There can be no

assurance that we will be successful in attracting or retaining such personnel and the failure to do so could have a material adverse effect on our business, financial condition, and results of operations.

Our employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements or engaging in

insider trading, which could significantly harm our business.

There can be no assurance that we will be successful in attracting or retaining such personnel and the failure to do so could have a material adverse effect on our business, financial condition, and results of operations.

Our employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements or engaging in insider trading, which could significantly harm our business.

We are exposed to the risk of employee fraud or other misconduct.

Misconduct by

employees could include intentional failures to:

Misconduct by employees could include intentional failures to:

comply with the regulations of the FDA and applicable non-U.S.

regulators, provide accurate information to the FDA and applicable

regulators, comply with fraud and abuse and other healthcare laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities

regulators, provide accurate information to the FDA and applicable non-U.S.

regulators, comply with fraud and abuse and other healthcare laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us.

In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self- dealing and other abusive practices.

These laws and

regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Employee misconduct could also involve the improper use of, including

trading on, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

We have adopted a code of conduct, but it is not always possible to identify and deter employee

misconduct, and the precautions we take to detect and prevent this activity may be ineffective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a

failure to comply with these laws or regulations.

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, including the

imposition of significant fines or other sanctions.

Product liability and other lawsuits could divert our resources, result in substantial

liabilities and reduce the commercial potential of our product candidates.

The risk that we may be sued on product liability claims is inherent

in the development and commercialization of biopharmaceutical products.

These laws and regulations restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Employee misconduct could also involve the improper use of, including trading on, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

We have adopted a code of conduct, but it is not always possible to identify and deter employee misconduct, and the precautions we take to detect and prevent this activity may be ineffective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

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, including the imposition of significant fines or other sanctions.

Product liability and other lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our product candidates.

The risk that we may be sued on product liability claims is inherent in the development and commercialization of biopharmaceutical products.

Side effects of, or manufacturing defects in, products that we develop could result in the deterioration of a patient’s condition, injury or even death.

product liability claims may be brought by patients participating in our clinical trials as a result of unexpected side effects from our product candidates.

Once a product is approved for sale and commercialized, the likelihood of product liability

lawsuits increases.

For example, product liability claims may be brought by patients participating in our clinical trials as a result of unexpected side effects from our product candidates.

Once a product is approved for sale and commercialized, the likelihood of product liability lawsuits increases.

Criminal or civil proceedings might be filed against us by patients, the regulatory authorities, biopharmaceutical companies and any other third party using or marketing our products.

These actions could include claims resulting

from acts by our partners, licensees and subcontractors, over which we have little or no control.

These actions could include claims resulting from acts by our partners, licensees and subcontractors, over which we have little or no control.

These lawsuits may divert our management from pursuing our business strategy and may be costly to defend.

In addition, if we are held liable in any of

these lawsuits, we may incur substantial liabilities and may be forced to limit or forgo further commercialization of the affected products.

incur significant costs from class action litigation.

The market price for our ordinary shares or ADSs may fluctuate for many reasons, including

as a result of public announcements regarding the progress of our development and commercialization efforts or the development and commercialization efforts of our collaborators and/or competitors, the addition or departure of our key personnel,

variations in our operating results and changes in market valuations of pharmaceutical and biotechnology companies.

When the market price of a security has been volatile as the market price for our ordinary shares and ADSs has been, holders of that

security have occasionally brought securities class action litigation against the company that issued the security.

For example, in December 2018, we announced that we voluntarily withdrew our BLA for Viaskin Peanut

following correspondence with the FDA regarding additional data needs on manufacturing procedures and quality controls, and our ADS price declined significantly as a result.

Following this announcement, on January 15, 2019, Travis Ito-Stone individually and on behalf of all others similarly situated, filed a class action complaint for violation of federal securities laws against us, our former Chief Executive Officer, our current Chief

Executive Officer, our former Deputy Chief Executive Officer and our former Chief Business Officer in the United States District Court for the District of New Jersey.

Subsequently, Ruth Pruitt and Asdrubal Delgado were appointed as lead plaintiffs

and an amended complaint was filed on January 24, 2020 and a second amended complaint was filed on June 5, 2020.

The operative complaint purports to bring a federal securities class action on behalf of a class of persons who acquired our

securities between February 14, 2018 and March 16, 2020 and seeks to recover damages caused by defendants alleged violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Exchange Act and

Rule 10b-5 promulgated thereunder.

The complaint alleges, among other things, that the defendants made materially false and/or misleading statements related to our business, operational and compliance

We believe that the allegations contained in the complaint are without merit and intend to defend the case vigorously.

In addition, if we are held liable in any of these lawsuits, we may incur substantial liabilities and may be forced to limit or forgo further commercialization of the affected products.

We may incur significant costs from class action litigation.

The market price for our ordinary shares or ADSs recently has and may continue to fluctuate for many reasons, including as a result of public announcements regarding the progress of our development and commercialization efforts or the development and commercialization efforts of our collaborators and/or competitors, the addition or departure of our key personnel, variations in our operating results and changes in market valuations of pharmaceutical and biotechnology companies.

When the market price of a security has been volatile as the market price for our ordinary shares and ADSs has been, holders of that security have occasionally brought securities class action litigation against the company that issued the security.

For example, in December 2018, we announced that we voluntarily withdrew our BLA for Viaskin Peanut following correspondence with the FDA regarding additional data needs on manufacturing procedures and quality controls, and our ADS price declined significantly as a result.

Following this announcement, a class action complaint was filed on January 15, 2019 in the United States District Court for the District of New Jersey.

The complaint, as amended, alleged that we and our former Chief Executive Officer, our current Chief Executive Officer, our former Deputy Chief Executive Officer, and our former Chief Business officer violated certain federal securities laws, specifically under Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5 promulgated thereunder.

The plaintiffs seek unspecified damages on behalf of a purported class of persons that purchased our securities between February 14, 2018 and August 4, 2020 and also held our securities on December 20, 2018 and/or March 16, 2020 and/or August 4, 2020.

See the section of this Annual Report titled “Legal Proceedings” for additional information on this matter.

Whether or not the plaintiffs claims are successful, this type of litigation is often expensive and diverts managements attention and

resources, which could adversely affect the operation of our business.

Whether or not the plaintiff’s claims are successful, this type of litigation is often expensive and diverts management’s attention and resources, which could adversely affect the operation of our business.

If we are ultimately required to pay significant defense costs, damages or settlement amounts, such payments could adversely affect our operations.

We may be the target of similar litigation in the future.

Any future litigation could result in substantial costs and divert our managements attention

and resources, which could cause serious harm to our business, operating results and financial condition.

Any future litigation could result in substantial costs and divert our management’s attention and resources, which could cause serious harm to our business, operating results and financial condition.

We maintain liability insurance;

however, if any costs or expenses associated with this or any other litigation exceed our insurance coverage,

we may be forced to bear some or all of these costs and expenses directly, which could be substantial.

We may be subject to legal or administrative

proceedings and litigation other than product liability lawsuits which may be costly to defend and could materially harm our business, financial condition and operations.

Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could

prevent or inhibit the commercialization of product candidates we develop.

We currently carry product liability insurance coverage for our clinical trials with a 15.0 million (equivalent to $18.4 million using closing exchange rate)

annual aggregate coverage limit.

however, if any costs or expenses associated with this or any other litigation exceed our insurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.

We may be subject to legal or administrative proceedings and litigation other than product liability lawsuits which may be costly to defend and could materially harm our business, financial condition and operations.

Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of product candidates we develop.

We currently carry product liability insurance coverage for our clinical trials with a €15.0 million (equivalent to $18.4 million using closing exchange rate) annual aggregate coverage limit.

Although we maintain such insurance, our insurance coverage may be insufficient to reimburse us for any expenses or losses we may suffer.

In addition, in the future, we may not be able to obtain or maintain

sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial

production and sale of any of our product candidates that receive regulatory approval, which could adversely affect our business.

Product liability claims could also harm our reputation, which may adversely affect our collaborators ability to

commercialize our products successfully.

Our failure to maintain certain tax benefits applicable to French technology companies may adversely

affect our results of operations.

As a French technology company, we have benefited from certain tax advantages, including, for example, the

French research tax credit ( crédit dimpôt recherche) , or CIR.

The CIR is a French tax credit aimed at stimulating research and development.

The CIR can be offset against French corporate income tax due and the portion in

excess (if any) may be refunded at the end of a three fiscal-year period.

The CIR is calculated based on our claimed amount of eligible research and development expenditures in France and represented $10.9 million and $9.9 million, as of

December 31, 2019 and 2020 respectively.

The French tax authority with the assistance of the

Research and Technology Ministry may audit each research and development program in respect of which a CIR benefit has been claimed and assess whether such program qualifies in its view for the

may be liable to additional corporate income tax, and penalties and interest related thereto, which could have a significant impact on our results of operations and future cash flows.

Furthermore, if the French Parliament decides to eliminate, or

reduce the scope or the rate of, the CIR benefit, either of which it could decide to do at any time, our results of operations could be adversely affected.

We may be forced to repay conditional advances prematurely if we fail to comply with our contractual obligations under the applicable innovation grant

Since inception through December 31, 2020, we have received multiple conditional advances totaling around 5 million dollars

for innovation granted by OSEO, the French Agency for Innovation and part of the Banque Publique dInvestissement.

If we fail to comply with our contractual obligations under the applicable innovation grant agreements, including if we lose our

exclusive right to commercially develop our product candidates, we could be forced to repay the sums advanced ahead of schedule.

In addition, in the future, we may not be able to obtain or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product or other legal or administrative liability claims by us or our partners, licensees or subcontractors, which could prevent or inhibit the commercial production and sale of any of our product candidates that receive regulatory approval, which could adversely affect our business.

Product liability claims could also harm our reputation, which may adversely affect our collaborators’ ability to commercialize our products successfully.

Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our results of operations.

As a French technology company, we have benefited from certain tax advantages, including, for example, the French research tax credit ( credit d’impôt recherche

The CIR is a French tax credit aimed at stimulating

research and development.

Beginning in the fiscal year ending December 31, 2021, the Company recovered its Small and Medium-sized Enterprises, or SMEs, status under EU law, and became therefore eligible again for the immediate reimbursement of the Research Tax Credit.

The Company will request the immediate reimbursement of the 2021 fiscal year CIR, as well as former tax credit receivables, which were originally refundable three years after the tax declaration in case the Company wouldn’t have been able to offset it against corporate income tax due.

The CIR is calculated based on our claimed amount of eligible research and development expenditures in France and represented $7.5 million and $9.9 million, as of December 31, 2021 and 2020 respectively.

The French tax authority with the assistance of the Research and Technology Ministry may audit each research and development program in respect of which a CIR benefit has been claimed and assess whether such program qualifies in its view for the CIR benefit.

The French tax authorities may challenge our eligibility to, or our calculation of certain tax reductions and/or deductions in respect of our research and development activities and, should the French tax authorities be successful, we may be liable to additional corporate income tax, and penalties and interest related thereto, which could have a significant impact on our results of operations and future cash flows.

Furthermore, if the French Parliament decides to eliminate, or reduce the scope or the rate of, the CIR benefit, either of which it could decide to do at any time, our results of operations could be adversely affected.

We may be forced to repay conditional advances prematurely if we fail to comply with our contractual obligations under the applicable innovation grant agreements.

Since inception through December 31, 2021, we have received multiple conditional advances totaling around $5 million for innovation granted by OSEO, the French Agency for Innovation and part of the Banque Publique d’Investissement.

If we fail to comply with our contractual obligations under the applicable innovation grant agreements, including if we lose our exclusive right to commercially develop our product candidates, we could be forced to repay the sums advanced ahead of schedule.

Such premature repayment could adversely affect our ability to finance our research and development projects.

addition, we cannot ensure that we will then have the additional financial means needed, the time or the ability to replace these financial resources with others.

In addition, we cannot ensure that we will then have the additional financial means needed, the time or the ability to replace these financial resources with others.

We may be exposed to significant foreign exchange risk.

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We incur portions of our expenses, and may in the future derive revenues, in currencies other than the euro, in particular, the U.S.

result, we are exposed to foreign currency exchange risk as our results of operations and cash flows are subject to fluctuations in foreign currency exchange rates.

We currently do not engage in hedging transactions to protect against uncertainty in

future exchange rates between particular foreign currencies and the euro.

As a result, we are exposed to foreign currency exchange risk as our results of operations and cash flows are subject to fluctuations in foreign currency exchange rates.

We currently do not engage in hedging transactions to protect against uncertainty in future exchange rates between particular foreign currencies and the euro.

Therefore, for example, an increase in the value of the euro against the U.S.

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dollar revenue and earnings, if any, would be translated into euros at a reduced value.

We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition,

results of operations and cash flows.

We cannot predict the impact of foreign currency fluctuations, and foreign currency fluctuations in the future may adversely affect our financial condition, results of operations and cash flows.

The ADSs are quoted in U.S.

1 unchanged sentence

Our financial statements are prepared in euros.

Fluctuations in the exchange

rate between euros and the U.S.

Fluctuations in the exchange rate between euros and the U.S.

dollar will affect, among other matters, the U.S.

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We may use hazardous chemicals and biological materials in our business.

Any claims relating to improper handling, storage or disposal of these

materials could be time consuming and costly.

Our research and development processes may involve the controlled use of hazardous materials,

including chemicals and biological materials.

Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.

Our research and development processes may involve the controlled use of hazardous materials, including chemicals and biological materials.

We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from these materials.

For example, in production, the confinement of the electrospray function and the use

of the allergen in liquid form make it possible to prevent the allergens from contaminating the environment.

However, we cannot assure you that in case of malfunction during the handling, storage or production process, allergen would not be released

into the atmosphere and sensitize the persons present in the environment.

We may be sued for any injury or contamination that results from our use or the use by third parties of these materials, and our liability may exceed any insurance coverage

and our total assets.

Federal, state, local or foreign laws and regulations govern the use, manufacture, storage, handling and disposal of these hazardous materials and specified waste products, as well as the discharge of pollutants into the

environment and human health and safety matters.

For example, in production, the confinement of the electrospray function and the use of the allergen in liquid form make it possible to prevent the allergens from contaminating the environment.

However, we cannot assure you that in case of malfunction during the handling, storage or

production process, allergen would not be released into the atmosphere and sensitize the persons present in the environment.

We may be sued for any injury or contamination that results from our use or the use by third parties of these materials, and our liability may exceed any insurance coverage and our total assets.

Compliance with environmental laws and regulations may be expensive and may impair our research and development efforts.

If we fail to comply with these requirements, we could incur substantial costs,

including civil or criminal fines and penalties, clean-up costs or capital expenditures for control

equipment or operational changes necessary to achieve and maintain compliance.

In addition, we cannot predict the impact on our business of new or amended environmental laws or regulations or any

changes in the way existing and future laws and regulations are interpreted and enforced.

Our internal computer systems, or those of our

third-party contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.

Despite the implementation of security measures, our internal computer systems and those of our third-party contractors and consultants are vulnerable to

damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures.

While we do not believe that we have experienced any such system failure, accident or security breach to date,

including cybersecurity incidents, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs.

For example, the loss of clinical trial data for our product candidates 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, including cybersecurity incidents, results in a loss of or damage to our

data or applications or other data or applications relating to our technology or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product

candidates could be delayed.

As these threats continue to evolve, particularly around cybersecurity, we may be required to expend significant resources to enhance our control environment, processes, practices and other protective measures.

these efforts, such events could materially adversely affect our business, financial condition or results of operations.

We may acquire businesses

or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.

At this stage, our strategy

does not involve plans to acquire companies or technologies facilitating or enabling us to access to new medicines, new research projects or new geographical areas, or enabling us to express synergies with our existing operations.

However, if such

acquisitions were to become necessary in future, we may not be able to identify appropriate targets or make acquisitions under satisfactory conditions, in particular, satisfactory price conditions.

In addition, we may unable to obtain the financing

for these acquisitions under favorable conditions, and could be led to finance these acquisitions using cash that could be allocated to other purposes in the context of existing operations.

If we acquire businesses with promising markets or

technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture.

We may encounter numerous difficulties in developing,

manufacturing and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

We cannot assure you that, following any such acquisition, we

will achieve the expected synergies to justify the transaction, which could have a material adverse effect on our business, financial conditions, earnings and prospects.

European data collection is governed by restrictive regulations governing the use, processing, and cross-border transfer of personal information.

The collection and use of personal health data in the European Union is governed by the provisions of the General Data Protection Regulation

((EU) 2016/679), or GDPR.

This legislation imposes requirements relating to having legal bases for processing personal information relating to identifiable individuals and transferring such information outside the European Economic Area including to

the United States, providing details to those individuals regarding the processing of their personal information, keeping personal information secure, having data processing agreements with third parties who process personal information, responding

to individuals requests to exercise their rights in respect of their personal information, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data

protection officers, conducting data protection impact assessments and record-keeping.

The GDPR imposes additional responsibilities and liabilities in relation to personal data that we process, and we may be required to

put in place additional mechanisms ensuring compliance with the new data protection rules.

Failure to comply with the requirements of the GDPR and related national data protection laws of the

member states of the European Union may result in substantial fines, other administrative penalties and civil claims being brought against us, which could have a material adverse effect on our business, results of operations and financial condition.

If we fail to comply with these requirements, we could incur substantial costs, including civil or criminal fines and penalties, clean-up costs or capital expenditures for control equipment or operational changes necessary to achieve and maintain compliance.

In addition, we cannot predict the impact on our business of new or amended environmental laws or regulations or any changes in the way existing and future laws and regulations are interpreted and enforced.

We are subject to stringent and changing obligations related to data privacy and security.

Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions;

fines and penalties;

disruptions of our business operations;

reputational harm;

loss of revenue or profits;

and other adverse business consequences.

In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, and sensitive third-party data.

Our data processing activities subject us to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contracts, and other obligations that govern the processing of personal data by us and on our behalf.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws.

For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health information.

In addition, the California Consumer Privacy Act of 2018, or CCPA, imposes obligations on covered businesses.

These obligations include, but are not limited to, providing specific disclosures in privacy notices and affording California residents certain rights related to their personal data.

The CCPA allows for statutory fines for noncompliance (up to $7,500 per violation).

Although the CCPA exempts some data processed in the context of clinical trials, the CCPA may increase compliance costs and potential liability with respect to other personal data we maintain about California residents.

In addition, it is anticipated that the California Privacy Rights Act of 2020, CPRA, effective January 1, 2023, will expand the CCPA.

The CPRA establishes a new California Privacy Protection Agency to implement and enforce the CPRA, which could increase the risk of enforcement.

Other states have enacted data privacy laws.

For example, Virginia passed the Consumer Data Protection Act, and Colorado passed the Colorado Privacy Act, both of which become effective in 2023.

In addition, data privacy and security laws have been proposed at the federal, state, and local levels in recent years, which could further complicate compliance efforts.

Outside the United States, an increasing number of laws, regulations, and industry standards apply to data privacy and security.

For example, the European Union’s General Data Protection Regulation, or EU GDPR, and the United Kingdom’s GDPR, or UK GDPR, impose strict requirements for processing personal data.

For example, under the EU GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines of up to 20 million euros or 4% of annual global revenue, whichever is greater.

Further, individuals may initiate litigation related to processing of their personal data.

Certain jurisdictions have enacted data localization laws and cross-border personal data transfer laws, which could make it more difficult to transfer information across jurisdictions (such as transferring or receiving personal data that originates in the EU or in other foreign jurisdictions).

Existing mechanisms that facilitate cross-border personal data transfers may change or be invalidated.

For example, absent appropriate safeguards or

other circumstances, the EU GDPR generally restricts the transfer of personal data to countries outside of the European Economic Area, or EEA, such as the United States, that the European Commission does not consider to provide an adequate level of data privacy and security.

The European Commission released a set of “Standard Contractual Clauses,” or SCCs, that are designed to be a valid mechanism to facilitate personal data transfers out of the EEA to these jurisdictions.

Currently, these SCCs are a valid mechanism to transfer personal data outside of the EEA, but there exists some uncertainty regarding whether the SCCs will remain a valid mechanism.

Additionally, the SCCs impose additional compliance burdens, such as conducting transfer impact assessments to determine whether additional security measures are necessary to protect the at-issue personal data.

In addition, Switzerland and the UK similarly restrict personal data transfers outside of those jurisdictions to countries, such as the United States, that do not provide an adequate level of personal data protection, and certain countries outside Europe (e.g., Russia, China, Brazil) have also passed or are considering laws requiring local data residency or otherwise impeding the transfer of personal data across borders, any of which could increase the cost and complexity of doing business.

If we cannot implement a valid compliance mechanism for cross-border data transfers, we may face increased exposure to regulatory actions, substantial fines, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions.

The inability to import personal data to the United States could significantly and negatively impact our business operations;

limiting our ability to collaborate with parties that are subject to such cross-border data transfer or localization laws;

or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significant expense.

Our obligations related to data privacy and security are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective future legal framework.

Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.

Preparing for and complying with these obligations requires significant resources and may necessitate changes to our information technologies, systems, and practices and to those of any third parties that process personal data on our behalf.

Although we endeavor to comply with all applicable data privacy and security obligations, we may at times fail (or be perceived to have failed) to do so.

Moreover, despite our efforts, our personnel or third parties upon whom we rely may fail to comply with such obligations, which could negatively impact our business operations and compliance posture.

For example, any failure by a third-party processor to comply with applicable law, regulations, or contractual obligations could result in adverse effects, including inability to or interruption in our ability to operate our business and proceedings against us by governmental entities or others.

If we fail, or are perceived to have failed, to address or comply with data privacy and security obligations, we could face significant consequences.

These consequences may include, but are not limited to, government enforcement actions (e.g., investigations, fines, penalties, audits, inspections, and similar);

litigation (including class-related claims);

additional reporting requirements and/or oversight;

bans on processing personal data;

and orders to destroy or not use personal data.

Any of these events could have a material adverse effect on our reputation, business, or financial condition, including but not limited to:

loss of customers;

interruptions in our business operations (including, as relevant, clinical trials);

inability to process personal data or to operate in certain jurisdictions;

limited ability to develop or commercialize our products;

expenditure of time and resources to defend any claim or inquiry;

adverse publicity;

or revision or restructuring of our operations.

If our information technology systems or sensitive information, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions;

fines and penalties;

disruptions of our business operations;

reputational harm;

loss of revenue or profits;

and other adverse consequences.

In the ordinary course of our business, we may process proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets (collectively, sensitive

information).

We may rely upon third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, third-party providers of cloud-based infrastructure, encryption and authentication technology, employee email, and other functions.

Our ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place.

We may share or receive sensitive information with or from third parties.

Cyberattacks, malicious internet-based activity, and online and offline fraud are prevalent and continue to increase.

These threats come from a variety of sources, including traditional computer “hackers,” threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors.

Some actors now engage and are expected to continue to engage in cyber-attacks, including, without limitation, nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.

During times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks, including cyber-attacks that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute our goods and services.

We and the third parties upon which we rely may be subject to a variety of evolving threats, including, but not limited to, social-engineering attacks (including through phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, and other similar threats.

Ransomware attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of funds.

Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

Similarly, supply-chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to our information technology systems or the third-party information technology systems that support us and our services.

Additionally, the COVID-19 pandemic and our remote workforce poses increased risks to our information technology systems and data, as more of our employees work from home, utilizing network connections outside our premises.

Future or past business transactions (such as acquisitions or integrations) could also expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

Any of the previously identified or similar threats could cause a security incident or other interruption.

A security incident or other interruption could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information.

A security incident or other interruption could disrupt our ability (and that of third parties upon whom we rely) to conduct our business operations.

We may expend significant resources or modify our business activities to try to protect against security incidents.

Certain data privacy and security obligations may require us to implement and maintain specific security measures, industry-standard or reasonable security measures to protect our information technology systems and sensitive information.

While we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective.

We may be unable in the future to detect vulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred.

Despite our efforts to identify and remediate vulnerabilities, if any, in our information technology systems, our efforts may not be successful.

Further, we may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.

Applicable data privacy and security obligations may require us to notify relevant stakeholders of security incidents.

Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences.

If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may experience adverse consequences.

These consequences may include:

government enforcement actions (for example, investigations, fines, penalties, audits, and inspections);

additional reporting requirements and/or oversight;

restrictions on processing sensitive information (including personal data);

litigation (including class claims);

indemnification obligations;

negative publicity;

reputational harm;

monetary fund diversions;

interruptions in our operations (including availability of data);

financial loss;

and other similar harms.

Security incidents and attendant consequences may cause interruptions in our operations and could result in a material disruption of our programs.

For example, the loss of clinical trial data for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.

We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

We may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.

At this stage, our strategy does not involve plans to acquire companies or technologies facilitating or enabling us to access to new medicines, new research projects or new geographical areas, or enabling us to express synergies with our existing operations.

However, if such acquisitions were to become necessary in future, we may not be able to identify appropriate targets or make acquisitions under satisfactory conditions, in particular, satisfactory price conditions.

In addition, we may unable to obtain the financing for these acquisitions under favorable conditions, and could be led to finance these acquisitions using cash that could be allocated to other purposes in the context of existing operations.

If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture.

We may encounter numerous difficulties in developing, manufacturing and marketing any new products resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

We cannot assure you that, following any such acquisition, we will achieve the expected synergies to justify the transaction, which could have a material adverse effect on our business, financial conditions, earnings and prospects.

We are subject to U.S.

and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws

and regulations.

and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations.

Compliance with these legal standards could impair our ability to compete in domestic and international markets.

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Export Administration Regulations, U.S.

Customs regulations, various

economic and trade sanctions regulations administered by the U.S.

Customs regulations, various economic and trade sanctions regulations administered by the U.S.

Treasury Department’s Office of Foreign Assets Controls, the U.S.

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

domestic bribery statute contained in 18

domestic bribery statute contained in 18 U.S.C.

§ 201, the U.S.

Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities.

Anti-corruption laws are interpreted broadly and prohibit

companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.

may engage third parties to sell our products sell our products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

We have direct or indirect

interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and

other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the

loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

We will need to develop implement sales, marketing and distribution capabilities before we are able to bring any product candidate to market, and as a

result, we may encounter difficulties in managing this development and expansion, which could disrupt our operations.

As of December 31,

2020, we had 141 full-time employees.

Before we can commercialize of Viaskin Peanut, if approved, and any of our other product candidates in North America, we will need to implement and improve our managerial, operational and financial systems,

expand our facilities and continue to recruit and train additional qualified personnel.

Also, our management may need to divert a disproportionate amount of its attention away from our

day-to-day activities and devote a substantial amount of time to managing any such development activities we may pursue.

Due to our limited resources, we may not be able

to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

This may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and

reduced productivity among remaining employees.

Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector.

We may engage third parties to sell our products sell our products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals.

direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors, and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities.

Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

We will need to develop and implement sales, marketing and distribution capabilities before we are able to bring any product candidate to market, and as a result, we may encounter difficulties in managing this development and expansion, which could disrupt our operations.

As of December 31, 2021, we had 90 full-time employees.

Also, our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing any such development activities we may pursue.

Due to our limited resources, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel.

This may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.

Any physical expansion of our operations may lead to significant costs and may divert financial resources from other projects, such as the development of our product candidates.

If our management is

unable to effectively manage our expected development and expansion, our expenses may increase more than expected, our ability to generate or increase our revenue could be reduced and we may not be able to implement our business strategy.

financial performance and our ability to commercialize our product candidates, if approved, and compete effectively will depend, in part, on our ability to effectively manage the future development and expansion of our company.

If our management is unable to effectively manage our expected development and expansion, our expenses may increase more than expected, our ability to generate or increase our revenue could be reduced and we may not be able to implement our business strategy.

Our future financial performance and our ability to commercialize our product candidates, if approved, and compete effectively will depend, in part, on our ability to effectively manage the future development and expansion of our company.

Risks Related to Ownership of Our Ordinary Shares and ADSs

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The trading price of our ADSs and ordinary shares has fluctuated, and is likely to continue to fluctuate, substantially.

The trading price of our securities

depends on a number of factors, including those described in this Risk Factors section, many of which are beyond our control and may not be related to our operating performance.

Our ADSs were sold in our initial public offering on Nasdaq in October 2014 at a price of $21.64 per share, and the price per ADS has ranged from as low as

$1.38 and as high as $12.98 during 2020.

During this same period, our ordinary share prices have ranged from as low as 2.40 to as high as 23.52 The market price of our securities may fluctuate significantly in response to numerous

factors, many of which are beyond our control, including:

The trading price of our securities depends on a number of factors, including those described in this “Risk Factors” section, many of which are beyond our control and may not be related to our operating performance.

Our ADSs were sold in our initial public offering on Nasdaq in October 2014 at a price of $21.64 per share, and the price per ADS has ranged from as low as $1.35 and as high as $7.38 during 2021.

During this same period, our ordinary share prices have ranged from as low as €2.87 to as high as €13.69 The market price of our securities may fluctuate significantly in response to numerous factors, many of which are beyond our control, including:

actual or anticipated fluctuations in our financial condition and operating results;

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competition from existing products or new products that may emerge;

regulatory actions with respect to our products or our competitors products, including the potential

resubmission to the FDA of a BLA for Viaskin Peanut;

announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint

ventures, collaborations, or capital commitments;

failure to meet or exceed financial estimates and projections of the investment community or that we provide to

regulatory actions with respect to our products or our competitors’ products, including the potential resubmission to the FDA of a BLA for Viaskin Peanut;

announcements by us, our partners or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations, or capital commitments;

failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;

issuance of new or updated research or reports by securities analysts;

fluctuations in the valuation of companies perceived by investors to be comparable to us;

price and volume fluctuations attributable to inconsistent trading volume levels of the ADSs and/or ordinary

price and volume fluctuations attributable to inconsistent trading volume levels of the ADSs and/or ordinary shares;

additions or departures of key management or scientific personnel;

disputes or other developments related to proprietary rights, including patents, litigation matters, and our

ability to obtain patent protection for our technologies;

disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

changes in the structure of healthcare payment systems;

changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and

any announcements relating to coverage policies or reimbursement levels;

changes to coverage policies or reimbursement levels by commercial third-party payors and government payors and any announcements relating to coverage policies or reimbursement levels;

announcement or expectation of additional debt or equity financing efforts;

sales of our ordinary shares or ADSs by us, our insiders or our other shareholders;

general economic and market conditions, including as a result of the ongoing

COVID-19 pandemic.

These and other market and industry factors may cause the market price and

demand for our securities to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the liquidity of our

ADSs and ordinary shares.

In addition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance

of these companies.

Share ownership is concentrated in the hands of our principal shareholders and management, who will

continue to be able to exercise a direct or indirect controlling influence on us.

As of December 31, 2020, our executive officers,

directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Caisse de Dépots et Consignations, entities affiliated with Baker Bros.

Advisors LP, entities affiliated with Perceptive Advisors

LLC, and entities affiliated with Boxer Capital, LLC together beneficially own approximately 44.8 of our ordinary shares.

As a result, these shareholders, acting together, will have significant influence over all matters that require

approval by our shareholders, including the election of directors and approval of significant corporate transactions.

general economic and market conditions, including as a result of the ongoing COVID-19 pandemic.

These and other market and industry factors may cause the market price and demand for our securities to fluctuate substantially, regardless of our actual operating performance, which may limit or prevent investors from readily selling their ADSs or ordinary shares and may otherwise negatively affect the liquidity of our ADSs and ordinary shares.

Share ownership is concentrated in the hands of our principal shareholders and management, who will continue to be able to exercise a direct or indirect controlling influence on us.

As of December 31, 2021, our executive officers, directors, current 5% or greater shareholders and affiliated entities, including entities affiliated with Caisse de Dépots et Consignations and entities affiliated with Baker Bros.

Advisors LP together beneficially own approximately 29.9% of our ordinary shares.

As a result, these shareholders, acting together, will have significant influence over all matters that require approval by our shareholders, including the election of directors and approval of significant corporate transactions.

Corporate action might be taken even if other shareholders oppose them.

This concentration of ownership might also have the effect

of delaying or preventing a change of control of our company that other shareholders may view as beneficial.

If securities or industry analysts do

not publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and trading volume could decline.

The trading market for our ADSs and ordinary shares depends in part on the research and reports that securities or industry analysts publish about us or our

This concentration of ownership might also have the effect of delaying or preventing a change of control of our company that other shareholders may view as beneficial.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and trading volume could decline.

The trading market for our ADSs and ordinary shares depends in part on the research and reports that securities or industry analysts publish about us or our business.

If no or few securities or industry analysts cover our company, the trading price for our ADSs and ordinary shares would be negatively impacted.

If one or more of the analysts who covers us downgrades our ADSs or ordinary shares or

publishes incorrect or unfavorable research about our business, the price of our ADSs and ordinary shares would likely decline.

If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, or

downgrades our ADSs or ordinary shares, demand for the our ADSs and ordinary shares could decrease, which could cause the price of our ADSs or ordinary shares or trading volume to decline.

If one or more of the analysts who covers us downgrades our ADSs or ordinary shares or publishes incorrect or unfavorable research about our business, the price of our ADSs and ordinary shares would likely decline.

If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, or downgrades our ADSs or ordinary shares, demand for our ADSs and ordinary shares could decrease, which could cause the price of our ADSs or ordinary shares or trading volume to decline.

If we are not able to comply with the applicable continued listing requirements or standards of Nasdaq, our ADSs could be delisted.

Our ADSs are currently listed on The Nasdaq Global Market.

In order to maintain that listing, we must satisfy certain continued listing

requirements and standards.

On January 14, 2021, we received a notice from the Nasdaq Stock Market indicating that, since our bylaws do not require a quorum for shareholders meetings of at least 33 1/3% of the outstanding shares of our

voting ordinary shares, Nasdaq had determined that we do not meet Nasdaqs quorum requirement under Listing Rule 5620(c)(i), or the Nasdaq Quorum Requirement.

Prior to January 1, 2020, we were a foreign private issuer and was exempt,

pursuant to Listing Rule 5615(a)(3), from complying with the Nasdaq Quorum Requirement.

In order to maintain that listing, we must satisfy certain continued listing requirements and standards, including, among others, minimum stockholders’

equity, minimum share price, director independence and independent committee requirements, and certain corporate governance requirements.

There can be no assurances that we will be able to comply with the applicable listing standards.

For instance, on January 14, 2021, we received a notice from Nasdaq indicating that we did not meet Nasdaq’s quorum requirement under Listing Rule 5620(c)(i), or the Nasdaq Quorum Requirement, because our bylaws do not require a quorum for shareholders’ meetings of at least 33 1/3% of the outstanding shares of our voting ordinary shares.

While our ADSs are listed on Nasdaq, our ordinary shares are listed on Euronext Paris.

Applicable French laws and regulations prohibit French listed companies

from having a quorum requirement for shareholders meetings that is higher than the minimums set by French law.

Applicable French laws and regulations prohibit French listed companies from having a quorum requirement for shareholders’ meetings that is higher than the minimums set by French law.

The minimum quorum requirements under French law are lower than the Nasdaq Quorum Requirement.

We have engaged in discussions with Nasdaq regarding our inability to comply simultaneously with the Nasdaq Quorum Requirement and applicable

French laws and regulations.

On December 31, 2020, as a result of these discussions, Nasdaq filed with the SEC a proposed rule change that would modify the Nasdaq Quorum Requirement applicable to a company incorporated outside of the United

States where such companys home country law is in direct conflict with the Nasdaq Quorum Requirement.

We believe such rule change, if approved by the SEC, will enable us to regain compliance with all applicable Listing Rules.

However, there

can be no assurance either that the SEC will approve the rule change submitted by Nasdaq or that we will be able to comply with the Quorum Requirement if the SEC does not approve the rule change submitted by Nasdaq.

In the event that our ADSs are delisted from Nasdaq and is not eligible for quotation or listing on another market or exchange, trading of our

ADSs could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC

Bulletin Board.

In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our ADSs, and there would likely also be a reduction in our coverage by securities analysts and the news media, which could

cause the price of our ADSs to decline further.

In April 2021 following our discussions with Nasdaq, Nasdaq modified the Nasdaq Quorum Requirement, such that Nasdaq will accept a quorum requirement of the home country of a non-U.S.

company that is lower than that required by Nasdaq, provided the company fulfill certain requirements.

In April 2021, in accordance with the amended Nasdaq Quorum Requirement, we fulfilled such requirements, including filing with the SEC a Current Report on Form 8-K disclosing that we had submitted a letter from our independent French counsel to Nasdaq stating that the laws of France mandate a lower quorum for shareholders’ meetings than that required by the Nasdaq Quorum Requirement, and that we cannot obtain an exemption or waiver from such requirements.

We also posted a statement regarding our reliance on the exception from the Nasdaq Quorum Requirement on our website.

On April 26, 2021, Nasdaq notified us that we regained compliance with the Nasdaq Quorum Requirement.

Notwithstanding our ability to regain compliance with the Nasdaq Quorum Requirement, we may fail to satisfy one or more Nasdaq requirements for continued listing of our ADSs in the future.

In the event that our ADSs are delisted from Nasdaq and are not eligible for quotation or listing on another market or exchange, trading of our ADSs could be conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board.

Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange.

We do not currently intend to pay dividends on our securities and, consequently, your ability to achieve a return on your investment, if any, will

depend on appreciation in the price of the ADSs.

Such a delisting would also likely have a negative effect on the price of our ADSs and would impair your ability to sell or purchase our ADSs when you wish to do so.

In the event of a delisting, we may take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our ADSs to become listed again, stabilize the market price or improve the liquidity of our ADSs, prevent our ADSs from dropping below Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

We do not currently intend to pay dividends on our securities and, consequently, your ability to achieve a return on your investment, if any, will depend on appreciation in the price of the ADSs.

In addition, French law may limit the amount of dividends we are able to distribute.

never declared or paid any cash dividends on our ordinary shares and do not currently intend to do so for the foreseeable future.

We have never declared or paid any cash dividends on our ordinary shares and do not currently intend to do so for the foreseeable future.

We currently intend to invest our future earnings, if any, to fund our growth.

Therefore, you are not likely to receive

any dividends on your ADSs for the foreseeable future and the success of an investment in ADSs will depend upon any future appreciation in its value.

Consequently, investors may need to sell all or part of their holdings of ADSs after price

appreciation, which may never occur, as the only way to realize any future gains on their investment.

Therefore, you are not likely to receive any dividends on your ADSs for the foreseeable future and the success of an investment in ADSs will depend upon any future appreciation in its value.

Consequently, investors may need to sell all or part of their holdings of ADSs after price appreciation, which may never occur, as the only way to realize any future gains on their investment.

There is no guarantee that the ADSs will appreciate in value or even maintain the price at which our shareholders have purchased the ADSs.

Investors seeking cash dividends should not purchase the ADSs.

Further, under French law, the determination of whether we have been sufficiently

profitable to pay dividends is made on the basis of our annual financial statements.

Further, under French law, the determination of whether we have been sufficiently profitable to pay dividends is made on the basis of our annual financial statements.

Therefore, we may be more restricted in our ability to declare dividends than companies not based in France.

In addition, exchange rate fluctuations may affect the amount of euros that we are able to distribute, and the amount in U.S.

dollars that our shareholders

receive upon the payment of cash dividends or other distributions we declare and pay in euros, if any.

dollars that our shareholders receive upon the payment of cash dividends or other distributions we declare and pay in euros, if any.

These factors could harm the value of the ADSs, and, in turn, the U.S.

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As of December 31, 2021, 55,095,762 ordinary shares were issued and outstanding.

Sales of a substantial number of shares of our ordinary shares or ADSs

in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities.

A substantial number of our shares

are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act.

If holders of these shares sell, or indicate an intent to sell, substantial

amounts of our securities in the public market, the trading price of our securities could decline significantly.

In addition, we have filed a

registration statement with the SEC to register the ordinary shares that may be issued under our equity incentive plans.

The ordinary shares subject to outstanding options under our equity incentive plans, ordinary shares reserved for future

issuance under our equity incentive plans and ordinary shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.

Sales of a large number of the

shares issued under these plans in the public market could have an adverse effect on the market price of our securities.

The dual listing of our

ordinary shares and our ADSs may adversely affect the liquidity and value of the ADSs.

Our ADSs are traded on the Nasdaq Global Select Market,

and our ordinary shares are listed on Euronext Paris.

The dual listing of our ordinary shares and our ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the maintenance of an active trading market for

our ADSs in the United States.

Sales of a substantial number of shares of our ordinary shares or ADSs in the public market, or the perception that these sales might occur, could depress the market price of our securities and could impair our ability to raise capital through the sale of additional equity securities.

A substantial number of our shares are now generally freely tradable, subject, in the case of sales by our affiliates, to the volume limitations and other provisions of Rule 144 under the Securities Act.

If holders of these shares sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of our securities could decline significantly.

In addition, we have filed a registration statement with the SEC to register the ordinary shares that may be issued under our equity incentive plans.

The ordinary shares subject to outstanding options under our equity incentive plans, ordinary shares reserved for future issuance under our equity incentive plans and ordinary shares subject to outstanding warrants will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations.

Sales of a large number of the shares issued under these plans in the public market could have an adverse effect on the market price of our securities.

The dual listing of our ordinary shares and our ADSs may adversely affect the liquidity and value of the ADSs.

Our ADSs are traded on the Nasdaq Global Select Market, and our ordinary shares are listed on Euronext Paris.

The dual listing of our ordinary shares and our ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the maintenance of an active trading market for our ADSs in the United States.

The price of our ADSs could also be adversely affected by trading in our ordinary shares on Euronext Paris, and vice versa.

In addition, currency fluctuations as between the euro and U.S.

dollar may have an adverse

impact on the value of our ADSs.

Our by-laws and French corporate law contain provisions that

may delay or discourage a takeover attempt.

Provisions contained in our by-laws and the corporate laws of

France, the country in which we are incorporated, could make it more difficult for a third-party to acquire us, even if doing so might be beneficial to our shareholders.

In addition, provisions of our by-laws

impose various procedural and other requirements, which could make it more difficult for shareholders to effect certain corporate actions.

dollar may have an adverse impact on the value of our ADSs.

Our by-laws and French corporate law contain provisions that may delay or discourage a takeover attempt.

Provisions contained in our by-laws and the corporate laws of France, the country in which we are incorporated, could make it more difficult for a third-party to acquire us, even if doing so might be beneficial to our shareholders.

In addition, provisions of our by-laws impose various procedural and other requirements, which could make it more difficult for shareholders to effect certain corporate actions.

These provisions include the following:

under French law, a non-French resident as well as any French entity

controlled by non-French residents may have to file a declaration for statistical purposes with the Banque de France , within 20 working days following the date of certain direct foreign investments in

us, including any purchase of our ADSs.

In particular, such filings are required in connection with investments exceeding 15,000,000 that lead to the acquisition of at least 10% of our share capital or voting rights or cross such 10%

under French law, certain investments in a French company relating to certain strategic industries by individuals

or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy;

the owner of 90% of the share capital and voting rights of a public company listed on a regulated market in a

Member State of the European Union or in a state party to the EEA Agreement, including from the main French Stock Exchange, has the right to force out minority shareholders following a tender offer made to all shareholders;

a merger (i.e., in a French law context, a share for share exchange following which our company would be

dissolved into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the European Union would require the approval of our board of directors as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting;

under French law, a cash merger is treated as a share purchase and would require the consent of each

participating shareholder;

our shareholders have granted and may grant in the future our board of directors broad authorizations to

increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for our

our shareholders have preferential subscription rights on a pro rata basis on the issuance by us of any

additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our

shareholders or on an individual basis by each shareholder;

our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death

of a director, subject to the approval by the shareholders of such appointment at the next shareholders meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors;

our board of directors can only be convened by our chairman or our managing director, if any, or, when no board

meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors;

our board of directors meetings can only be regularly held if at least half of the directors attend either

physically or by way of videoconference or teleconference enabling the directors identification and ensuring their effective participation in the boards decisions;

however, this mode of participation (by way of videoconference or

teleconference) does not

apply to the adoption of decisions taken for the closing of the accounts for the fiscal year, including the consolidated financial statements;

under French law, a non-French resident as well as any French entity controlled by non-French residents may have to file a declaration for statistical purposes with the Banque de France

, within 20 working days following the date of certain direct foreign investments in us, including any purchase of our ADSs.

In particular, such filings are required in connection with investments exceeding €15,000,000 that lead to the acquisition of at least 10% of our share capital or voting rights or cross such 10% threshold;

under French law, certain investments in a French company relating to certain strategic industries by individuals or entities not residents in a Member State of the EU are subject to prior authorization of the Ministry of Economy;

the owner of 90% of the share capital and voting rights of a public company listed on a regulated market in a Member State of the European Union or in a state party to the EEA Agreement, including from the main French Stock Exchange, has the right to force out minority shareholders following a tender offer made to all shareholders;

a merger (i.e., in a French law context, a share for share exchange following which our company would be dissolved into the acquiring entity and our shareholders would become shareholders of the acquiring entity) of our company into a company incorporated in the European Union would require the approval of our board of directors as well as a two-thirds majority of the votes held by the shareholders present, represented by proxy or voting by mail at the relevant meeting;

under French law, a cash merger is treated as a share purchase and would require the consent of each participating shareholder;

our shareholders have granted and may grant in the future our board of directors’ broad authorizations to increase our share capital or to issue additional ordinary shares or other securities (for example, warrants) to our shareholders, the public or qualified investors, including as a possible defense following the launching of a tender offer for our shares;

our shareholders have preferential subscription rights on a pro rata basis on the issuance by us of any additional securities for cash or a set-off of cash debts, which rights may only be waived by the extraordinary general meeting (by a two-thirds majority vote) of our shareholders or on an individual basis by each shareholder;

our board of directors has the right to appoint directors to fill a vacancy created by the resignation or death of a director, subject to the approval by the shareholders of such appointment at the next shareholders’ meeting, which prevents shareholders from having the sole right to fill vacancies on our board of directors;

our board of directors can only be convened by our chairman or our managing director, if any, or, when no board meeting has been held for more than two consecutive months, by directors representing at least one-third of the total number of directors;

our board of directors meetings can only be regularly held if at least half of the directors attend either physically or by way of videoconference or teleconference enabling the directors’ identification and ensuring their effective participation in the board’s decisions;

however, this mode of participation (by way of videoconference or teleconference) does not apply to the adoption of decisions taken for the closing of the accounts for the fiscal year, including the consolidated financial statements;

our shares are nominative or bearer, if the legislation so permits, according to the shareholder’s choice.

Shares issued are registered in individual accounts opened by us or any authorized intermediary, in the name of each shareholder and kept according to the terms and conditions laid down by the legal and regulatory provisions;

approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by

mail at the relevant ordinary shareholders general meeting is required to remove directors with or without cause;

advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at

a shareholders meeting, except that a vote to remove and replace a director can be proposed at any shareholders meeting without notice;

approval of at least a majority of the votes held by shareholders present, represented by a proxy, or voting by mail at the relevant ordinary shareholders’ general meeting is required to remove directors with or without cause;

advance notice is required for nominations to the board of directors or for proposing matters to be acted upon at a shareholders’ meeting, except that a vote to remove and replace a director can be proposed at any shareholders’ meeting without notice;

our by-laws can be changed in accordance with applicable laws;

the crossing of certain thresholds has to be disclosed and can impose certain obligations;

transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the

Market Abuse Directive and Regulation dated April 16, 2014;

pursuant to French law, the sections of the by-laws relating to the

number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.

transfers of shares shall comply with applicable insider trading rules and regulations and in particular with the Market Abuse Directive and Regulation dated April 16, 2014;

pursuant to French law, the sections of the by-laws relating to the number of directors and election and removal of a director from office may only be modified by a resolution adopted by at least a two thirds majority vote of our shareholders present, represented by a proxy or voting by mail at the meeting.

You may not be able to exercise your right to vote the ordinary shares underlying your ADSs.

Holders of ADSs may exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the provisions of the deposit

The deposit agreement provides that, upon receipt of notice of any meeting of holders of our ordinary shares, the depositary will fix a record date for the determination of ADS holders who shall be entitled to give instructions for the

exercise of voting rights.

Upon timely receipt of notice from us, if we so request, the depositary shall distribute to the holders as of the record date (1) the notice of the meeting or solicitation of consent or proxy sent by us and (2) a

statement as to the manner in which instructions may be given by the holders.

You may instruct the depositary of your ADSs to vote the ordinary shares

underlying your ADSs.

Holders of ADSs may exercise voting rights with respect to the ordinary shares represented by the ADSs only in accordance with the provisions of the deposit agreement.

You may instruct the depositary of your ADSs to vote the ordinary shares underlying your ADSs.

If the depositary timely receives voting instructions from you, it will endeavor to vote the securities (in person or by proxy) represented by the ADSs in accordance with such voting instructions.

If the depositary receives

voting instructions which fail to specify the manner in which the depositary is to vote the deposited securities, you will be deemed to have instructed the depositary to vote in favor of all resolutions endorsed by our board of directors.

you will not be able to exercise your right to vote, unless you withdraw the ordinary shares underlying the ADSs you hold.

If the depositary receives voting instructions which fail to specify the manner in which the depositary is to vote the deposited securities, you will be deemed to have instructed the depositary to vote in favor of all resolutions endorsed by our board of directors.

Otherwise, you will not be able to exercise your right to vote, unless you withdraw the ordinary shares underlying the ADSs you hold.

However, you may not know about the meeting far enough in advance to withdraw those ordinary shares.

If we ask for your

instructions, the depositary, upon timely notice from us, will notify you of the upcoming vote and arrange to deliver our voting materials to you.

We cannot guarantee you that you will receive the voting materials in time to ensure that you can

instruct the depositary to vote your ordinary shares or to withdraw your ordinary shares so that you can vote them yourself.

If the depositary does not receive timely voting instructions from you, it may give a proxy to a person designated by us to

vote the ordinary shares underlying your ADSs.

If we ask for your instructions, the depositary, upon timely notice from us, will notify you of the upcoming vote and arrange to deliver our voting materials to you.

We cannot guarantee you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your ordinary shares or to withdraw your ordinary shares so that you can vote them yourself.

If the depositary does not receive timely voting instructions from you, it may give a proxy to a person designated by us to vote the ordinary shares underlying your ADSs.

In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions.

This means that you may not be able to

exercise your right to vote, and there may be nothing you can do if the ordinary shares underlying your ADSs are not voted as you requested.

Your right as a holder of ADSs to participate in any future preferential subscription rights or to

elect to receive dividends in shares may be limited, which may cause dilution to your holdings.

According to French law, if we issue additional

securities for cash, current shareholders will have preferential subscription rights for these securities on a pro rata basis, transferable during a period starting two days prior to the opening of the subscription period or, if that day is not a

trading day, the preceding trading day;

and ending two days prior to the closing of the subscription period or, of that day is not a trading day, the preceding trading day, unless they waive those rights at an extraordinary meeting of our

shareholders (by a two-thirds majority vote) or individually by each shareholder.

However, the ADS holders in the United States will not be entitled to exercise or sell such rights unless we register the

rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available.

In addition, the deposit agreement provides that the depositary will not make rights available to you

unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act or exempted from registration under the Securities Act.

Further, if we offer holders of our ordinary shares the

option to receive dividends in either cash or shares, under the deposit agreement the depositary may require satisfactory assurances from us that extending the offer to holders of ADSs does not require registration of any securities under the

Securities Act before making the option available to holders of ADSs.

We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared

This means that you may not be able to exercise your right to vote, and there may be nothing you can do if the ordinary shares underlying your ADSs are not voted as you requested.

Your right as a holder of ADSs to participate in any future preferential subscription rights or to elect to receive dividends in shares may be limited, which may cause dilution to your holdings.

According to French law, if we issue additional securities for cash, current shareholders will have preferential subscription rights for these securities on a pro rata basis, transferable during a period starting two days prior to the opening of the subscription period or, if that day is not a trading day, the preceding trading day;

and ending two days prior to the closing of the subscription period or, of that day is not a trading day, the preceding trading day, unless they waive those rights at an extraordinary meeting of our shareholders (by a two-thirds majority vote) or individually by each shareholder.

However, the ADS holders in the United States will not be entitled to exercise or sell such rights unless we register the rights and the securities to which the rights relate under the Securities Act or an exemption from the registration requirements is available.

In addition, the deposit agreement provides that the depositary will not make rights available to you unless the distribution to ADS holders of both the rights and any related securities are either registered under the Securities Act or exempted from registration under the Securities Act.

Further, if we offer holders of our ordinary shares the option to receive dividends in either cash or shares, under the deposit agreement the depositary may require satisfactory assurances from us that extending the offer to holders of ADSs does not require registration of any securities under the Securities Act before making the option available to holders of ADSs.

We are under no obligation to file a registration statement with respect to any such rights or securities or to endeavor to cause such a registration statement to be declared effective.

Moreover, we may not be able to establish an exemption from registration under the Securities Act.

Accordingly, ADS holders may be unable to participate in our rights offerings or to elect to receive dividends in shares and may experience

dilution in their holdings.

In addition, if the depositary is unable to sell rights that are not exercised or not distributed or if the sale is not lawful or reasonably practicable, it will allow the rights to lapse, in which case you will receive

no value for these rights.

Accordingly, ADS holders may be unable to participate in our rights offerings or to elect to receive dividends in shares and may experience dilution in their holdings.

You may be subject to limitations on the transfer of your ADSs and the withdrawal of the underlying ordinary shares.

Your ADSs, which may be evidenced by ADRs, are transferable on the books of the depositary.

However, the depositary may close its books at any

time or from time to time when it deems expedient in connection with the performance of its duties.

The depositary may refuse to deliver, transfer or register transfers of your ADSs generally when our books or the books of the depositary are closed,

or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason subject to your right to cancel your

ADSs and withdraw the underlying ordinary shares.

Temporary delays in the cancellation of your ADSs and withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books,

the transfer of ordinary shares is blocked to permit voting at a shareholders meeting or we are paying a dividend on our ordinary shares.

In addition, you may not be able to cancel your ADSs and withdraw the underlying ordinary shares when you

owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.

However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties.

The depositary may refuse to deliver, transfer or register transfers of your ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason subject to your right to cancel your ADSs and withdraw the underlying ordinary shares.

Temporary delays in the cancellation of your ADSs and withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares.

In addition, you may not be able to cancel your ADSs and withdraw the underlying ordinary shares when you owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities.

Investors may have difficulty enforcing civil liabilities against our company and directors and senior management.

Certain members of our board of directors and senior management, and those of our subsidiary, are non-residents of the

United States, and all or a substantial portion of our assets and the assets of such persons are located outside the United States.

As a result, it may not be possible to serve process on such persons or us in the United States or to enforce

judgments obtained in U.S.

Certain members of our board of directors and senior management, and those of our subsidiary, are non-residents of the United States, and all or a substantial portion of our assets and the assets of such persons are located outside the United States.

As a result, it may not be possible to serve process on such persons or us in the United States or to enforce judgments obtained in U.S.

courts against them or us based on civil liability provisions of the securities laws of the United States.

Additionally, it may be difficult to assert U.S.

securities law claims in actions originally instituted outside of

the United States.

securities law claims in actions originally instituted outside of the United States.

Foreign courts may refuse to hear a U.S.

securities law claim because foreign courts may not be the most appropriate forums in which to bring such a claim.

Even if a foreign court agrees to hear a claim, it may determine that the

law of the jurisdiction in which the foreign court

resides, and not U.S.

Even if a foreign court agrees to hear a claim, it may determine that the law of the jurisdiction in which the foreign court resides, and not U.S.

law, is applicable to the claim.

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law is found to be applicable, the content of applicable U.S.

law must be proved as a fact, which can be a time-consuming

and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.

In particular, there is some doubt as to whether French courts would recognize and enforce certain civil

liabilities under U.S.

law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by the law of the jurisdiction in which the foreign court resides.

In particular, there is some doubt as to whether French courts would recognize and enforce certain civil liabilities under U.S.

securities laws in original actions or judgments of U.S.

courts based upon these civil liability provisions.

In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in

In addition, awards of punitive damages in actions brought in the United States or elsewhere may be unenforceable in France.

An award for monetary damages under the U.S.

securities laws would be considered punitive if it does not seek to compensate the claimant for loss or damage suffered but is intended to punish the defendant.

The enforceability of any judgment

in France will depend on the particular facts of the case as well as the laws and treaties in effect at the time.

The United States and France do not currently have a treaty providing for recognition and enforcement of judgments (other than

arbitration awards) in civil and commercial matters.

The rights of shareholders in companies subject to French corporate law differ in material

respects from the rights of shareholders of corporations incorporated in the United States.

The enforceability of any judgment in France will depend on the particular facts of the case as well as the laws and treaties in effect at the time.

The United States and France do not currently have a treaty providing for recognition and enforcement of judgments (other than arbitration awards) in civil and commercial matters.

The rights of shareholders in companies subject to French corporate law differ in material respects from the rights of shareholders of corporations incorporated in the United States.

We are a French company with limited liability.

corporate affairs are governed by our by-laws and by the laws governing companies incorporated in France.

The rights of shareholders and the responsibilities of members of our board of directors are in many

ways different from the rights and obligations of shareholders in companies governed by the laws of U.S.

Our corporate affairs are governed by our by-laws and by the laws governing companies incorporated in France.

The rights of shareholders and the responsibilities of members of our board of directors are in many ways different from the rights and obligations of shareholders in companies governed by the laws of U.S.

jurisdictions.

For example, in the performance of its duties, our board of directors is required by French law to consider the interests of our

company, our shareholders, employees and other stakeholders, rather than solely our shareholders and/or creditors.

It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a

We are a smaller reporting company, and the reduced disclosure requirements applicable to smaller reporting companies may

make our ADSs less attractive to investors.

We are currently a smaller reporting company as defined in the Securities

Exchange Act of 1934, as amended, or the Exchange Act.

For example, in the performance of its duties, our board of directors is required by French law to consider the interests of our company, our shareholders, employees and other stakeholders, rather than solely our shareholders and/or creditors.

It is possible that some of these parties will have interests that are different from, or in addition to, your interests as a shareholder.

We are a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make our ADSs less attractive to investors.

We are currently a “smaller reporting company” as defined in the Securities Exchange Act of 1934, as amended, or the Exchange Act.

We may continue to be a smaller reporting company even after we are no longer an emerging growth company.

We will be a smaller reporting company and may take advantage of the scaled disclosures

available to smaller reporting companies for so long as (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than

$250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

We are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are

not smaller reporting companies.

We will be a smaller reporting company and may take advantage of the scaled disclosures available to smaller reporting companies for so long as (i) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter or (ii) (a) our annual revenue is less than $100.0 million during the most recently completed fiscal year and (b) the market value of our voting and non-voting ordinary shares held by non-affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.

We are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not smaller reporting companies.

These scaled disclosure requirements include, but are not limited to, the following:

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley

Act, or Section 404;

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404;

reduced disclosure obligations regarding financial information;

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We may choose to take advantage of some, but not all, of the available exemptions.

We cannot predict whether investors will find our ADSs less

attractive if we rely on certain or all of these exemptions.

We cannot predict whether investors will find our ADSs less attractive if we rely on certain or all of these exemptions.

If some investors find our ADSs less attractive as a result, there may be a less active trading market for our ADSs and our ADS price may be more volatile.

Holders Of ADSs May Suffer Adverse Tax Consequences If We Are Characterized As A Passive Foreign

Investment Company.

Holders May Suffer Adverse Tax Consequences If We Are Characterized As A Passive Foreign Investment Company.

Under the U.S.

Internal Revenue Code of 1986, as amended, or Code, we will be a passive foreign investment company, or PFIC,

for any taxable year in which, after the application of certain look-through rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of passive income, or (ii) 50% or more of the average

quarterly value of our assets, including cash, consists of assets that produce, or are held for the production of, passive income. Passive income generally includes interest, dividends, rents, certain

non-active royalties and capital gains.

Whether we will be a PFIC in any year depends on the composition of our income and assets, and the relative fair market value of our assets from time to time, which we

expect may vary substantially over time.

Based on the composition of our gross income and gross assets for our 2020 taxable year, we believe that we were likely a PFIC for the taxable year ending December 31, 2020, and we are not able to

provide any assurance as to whether we will, or will not be classified as a PFIC for the taxable year ending December 31, 2021.

Because the determination of our PFIC status is based on complicated provisions of the Code and applicable

administrative authorities, there can be no assurance that our conclusions concerning our PFIC status for the taxable year ending December 31, 2020 are accurate and will not be successfully challenged by applicable tax authorities, and we cannot

provide any assurance regarding our PFIC status for the current taxable year or any future taxable year.

If we are a PFIC for any taxable year during

Holder (as defined below) holds ADSs, a U.S.

Holder may be subject to adverse tax consequences if a mark-to-market election or a qualified electing fund, or

QEF, election has not been made with respect to its ADSs.

Internal Revenue Code of 1986, as amended, or Code, we will be a passive foreign investment company, or PFIC, for any taxable year in which, after the application of certain “look-through” rules with respect to subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets, including cash, consists of assets that produce, or are held for the production of, “passive income.” Passive income generally includes interest, dividends, rents, certain non-active royalties and capital gains.

Whether we will be a PFIC in any year depends on the composition of our income and assets, and the relative fair market value of our assets from time to time, which we expect may vary substantially over time.

Based on the composition of our gross income and gross assets, we believe that we are likely not a PFIC for the taxable year ending December 31, 2021.

We are not able to provide any assurance as to whether we will, or will not be classified as a PFIC for the current taxable year ending December 31, 2022.

Because the determination of our PFIC status is based on complicated provisions of the Code and applicable administrative authorities, there can be no assurance that our conclusions concerning our PFIC status for the taxable year ending December 31, 2021 are accurate and will not be successfully challenged by applicable tax authorities, and we cannot provide any assurance regarding our PFIC status for the current taxable year or any future taxable year.

If you are a U.S.

Holder (as defined below) during the taxable year when the Company is considered a PFIC, then you may be subject to adverse tax consequences if a mark-to-market election or a qualified electing fund, or QEF, election has not been made with respect to its ADSs.

Holder may incur significant additional U.S.

federal income taxes on income resulting from certain distributions on, or any gain from the disposition of, such ADSs, as such income

generally would be allocated over the U.S.

Holders holding period for its ADSs.

federal income taxes on income resulting from certain distributions on, or any gain from the disposition of, such shares including ADSs, as such income generally would be allocated over the U.S.

Holder’s holding period for its shares.

The amount allocated to the current taxable year ( i.e.

, the year in which the distribution occurs or the gain is recognized) and any year prior to the first

taxable year in which we are a PFIC would be subject to tax as ordinary income earned in the current year, and all other amounts would be subject to tax at the highest rates of U.S.

federal income taxation in effect for such years, with an interest

charge then imposed on the resulting taxes in respect of such income.

, the year in which the distribution occurs or the gain is recognized) and any year prior to the first taxable year in which we are a PFIC would be subject to tax as

ordinary income earned in the current year, and all other amounts would be subject to tax at the highest rates of U.S.

federal income taxation in effect for such years, with an interest charge then imposed on the resulting taxes in respect of such income.

Furthermore, if we are a PFIC for any taxable year during which the U.S.

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Holders that own an interest in a PFIC are required to comply with certain reporting requirements.

may in certain circumstances mitigate the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a QEF, or, if shares of the PFIC are marketable stock for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC.

are strongly urged to consult with, and rely solely upon, their personal tax advisors regarding the implications of the tax provisions applicable to U.S.

persons who own, directly or indirectly, interests in a foreign corporation that is or may

become a PFIC.

Holder may in certain circumstances mitigate the adverse tax consequences of the PFIC rules by filing an election to treat the PFIC as a QEF, or, if shares of the PFIC are “marketable stock” for purposes of the PFIC rules, by making a mark-to-market election with respect to the shares of the PFIC.

For any taxable year in which we are a PFIC, we will determine whether we will provide to U.S.

holders the information required to make a QEF election, provided that there is no assurance that such information will be provided.

Holders are strongly urged to consult with, and rely solely upon, their personal tax advisors regarding the implications of the tax provisions applicable to U.S.

persons who own, directly or indirectly, interests in a foreign corporation that is or may become a PFIC.

Unresolved Staff Comments.

1 unchanged sentence

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

What changed 10-K

Item 1A. Risk Factors