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As filed with the Securities and Exchange Commission on January 19, 2021.

Registration No. 333-          


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM F-1

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933



Biophytis S.A.

(Exact Name of Registrant as Specified in Its Charter)



Not Applicable
(Translation of Registrant's name into English)

France
(State or Other Jurisdiction of
Incorporation or Organization)
  2834
(Primary Standard Industrial
Classification Code Number)
  Not Applicable
(I.R.S. Employer
Identification Number)

Biophytis S.A.
Sorbonne University—BC 9, Bâtiment A 4ème étage
4 place Jussieu
75005 Paris, France
+33 1 44 27 23 00
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)

Puglisi & Associates
850 Library Avenue, Suite 204
Newark, Delaware 19711
(302)738-6680
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)



Copies to:

Aron Izower
Wendy Grasso
Reed Smith LLP
599 Lexington Avenue, 26nd Floor
New York, NY 10022
+1 (212) 521-5400

 

Linda Hesse
Jones Day
2 rue Saint-Florentin
75001 Paris
France
+33 1 56 59 39 39

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

           If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box.    o

           If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.    o

           Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.

           Emerging Growth Company    ý

           If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act.    o

CALCULATION OF REGISTRATION FEE

       
 
Title of each class of securities
to be registered

  Proposed maximum
aggregate offering
price(1)

  Amount of
registration fee

 

Ordinary shares, €0.20 nominal value per share(2)(3)(4)

  $14,950,000   $1,632

 

(1)
Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended, or the Securities Act.

(2)
Consists of ordinary shares to be offered in the form of American Depositary Shares, or ADSs (including ADSs that the underwriter has the option to purchase).

(3)
Each ADS represents the right to receive            ordinary shares. The ADSs issuable upon deposit of the ordinary shares registered hereby are being registered under a separate registration statement on Form F-6 (File No. 333-232305).

(4)
Pursuant to Rule 416 under the Securities Act, the ordinary shares registered hereby also include an indeterminate number of additional ordinary shares as may from time to time become issuable by reason of stock splits, stock dividends, recapitalizations or similar transactions.



           The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said Section 8(a), may determine.

   


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The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

Subject to Completion, dated January 19, 2021

P R O S P E C T U S

American Depositary Shares

LOGO

Representing            Ordinary Shares

        We are offering            American Depositary Shares, or ADSs, referred to herein as the offering. Each ADS represents the right to receive             ordinary shares. The ADSs may be evidenced by American Depositary Receipts, or ADRs.

        This is our initial public offering of ADSs. Prior to this offering there has been no public market for the ADSs. Our ordinary shares are listed on the Euronext Growth Paris market.

        We intend to apply for the listing of the ADSs on the Nasdaq Capital Market under the symbol "BPTS." The offering is subject to our receipt of gross proceeds of at least $             million in order to satisfy applicable Nasdaq listing requirements.

        The offering price is expected to be between $            and $            per ADS. The final offering price per ADS in U.S. dollars will be determined through negotiations between us and H.C. Wainwright & Co., LLC, or Wainwright, as underwriter, and by reference to the prevailing market prices of our ordinary shares on the Euronext Growth Paris after taking into account market conditions and other factors. On            , 2021, the last reported sale price of our ordinary shares on the Euronext Growth Paris market was €            per ordinary share, corresponding to a price of $            per ADS, assuming an exchange rate of €            per U.S. dollar, the Banque de France exchange rate on            , 2021, and based on an assumed ratio of                    ordinary shares for each ADS.

        We are an "emerging growth company" as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

        Investing in the ADSs involves risks. See "Risk Factors" beginning on page 19.

        Neither the Securities and Exchange Commission nor any U.S. state or other securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

       
 
 
  Per ADS
  Total
 

Public Offering Price

  $               $            
 

Underwriting Discounts and Commissions(1)

  $               $            
 

Proceeds to us, before expenses

  $               $            

 

(1)
See "Underwriting" beginning on page 241 of this prospectus for additional information regarding underwriting compensation.

        Wainwright may also exercise its option to purchase up to an additional            ADSs from us in the offering, at the public offering price, less underwriting discounts and commissions, within 30 days after the date of this prospectus. If Wainwright exercises this option in full, the total underwriting commissions payable by us will be $            and the total proceeds to us, before expenses, will be $            , based on the Banque de France exchange rate on                        , 2021.

        The underwriter expects to deliver the ADSs to purchasers in the offering on or about                        , 2021 through the book-entry facilities of The Depository Trust Company.

Sole Book-Running Manager

H.C. Wainwright & Co.

   

The date of this prospectus is                        , 2021.


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TABLE OF CONTENTS

 
  Page

PROSPECTUS SUMMARY

  1

RISK FACTORS

 
19

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 
79

USE OF PROCEEDS

 
81

DIVIDEND POLICY

 
83

CAPITALIZATION

 
84

DILUTION

 
87

SELECTED FINANCIAL AND OTHER DATA

 
91

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 
93

BUSINESS

 
115

MANAGEMENT

 
172

RELATED PARTY TRANSACTIONS

 
185

PRINCIPAL SHAREHOLDERS

 
189

DESCRIPTION OF SHARE CAPITAL AND ARTICLES OF ASSOCIATION

 
191

LIMITATIONS AFFECTING SHAREHOLDERS OF A FRENCH COMPANY

 
217

DESCRIPTION OF AMERICAN DEPOSITARY SHARES

 
219

SHARES ELIGIBLE FOR FUTURE SALE

 
228

MATERIAL UNITED STATES FEDERAL INCOME TAX AND FRENCH TAX CONSIDERATIONS

 
230

ENFORCEMENT OF CIVIL LIABILITIES

 
240

UNDERWRITING

 
241

EXPENSES OF THE OFFERING

 
250

LEGAL MATTERS

 
251

EXPERTS

 
251

WHERE YOU CAN FIND MORE INFORMATION

 
251

INDEX TO THE FINANCIAL STATEMENTS

 
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        You should rely only on the information contained in this prospectus and any related free-writing prospectus that we authorize to be distributed to you. We and the underwriter have not authorized any person to provide you with information different from that contained in this prospectus or any related free-writing prospectus that we authorize to be distributed to you. This prospectus is not an offer to sell, nor is it seeking an offer to buy, these securities in any state or jurisdiction where the offer or sale is not permitted. The information in this prospectus speaks only as of the date of this prospectus unless the information specifically indicates that another date applies, regardless of the time of delivery of this prospectus or of any sale of the securities offered hereby.

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        For investors outside of the United States: Neither we nor the underwriter have taken any action in any jurisdiction outside the United States to permit a public offering of the ADSs in that jurisdiction. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions as to this offering and the distribution of the prospectus applicable to that jurisdiction.

        We are incorporated in France, and a majority of our outstanding securities are owned by non-U.S. residents. Under the rules of the U.S. Securities and Exchange Commission, or SEC, we are currently eligible for treatment as a "foreign private issuer." As a foreign private issuer, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as domestic registrants whose securities are registered under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

        The financial statements included in this prospectus are presented in euros. All references in this prospectus to "$," "US$," "U.S.$," "U.S. dollars," "dollars" and "USD" mean U.S. dollars and all references to "€" and "euros," mean euros, unless otherwise noted. Throughout this prospectus, references to ADSs mean ADSs or ordinary shares represented by ADSs, as the case may be.


MARKET, INDUSTRY AND OTHER DATA

        Unless otherwise indicated, information contained in this prospectus concerning our industry and the markets in which we operate, including our general expectations and market position, market opportunity and market size estimates, is based on information from independent industry analysts, third-party sources and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us based on such data and our knowledge of such industry and market, which we believe to be reasonable. Although we are responsible for all of the disclosures contained in this prospectus, we have not independently verified any of the data from third-party sources, nor have we ascertained the underlying economic assumptions relied upon therein. In addition, while we believe the market opportunity information included in this prospectus is generally reliable and is based on reasonable assumptions, such data involves risks and uncertainties, including those discussed under the heading "Risk Factors."


TRADEMARKS AND SERVICE MARKS

        This prospectus may contain references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork and other visual displays, may appear without the ® or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies' trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other company.

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PROSPECTUS SUMMARY

        The following summary highlights information contained elsewhere in this prospectus and does not contain all of the information you should consider before investing in the ADSs. You should read the entire prospectus carefully, including "Risk Factors" and our financial statements and the related notes appearing elsewhere in this prospectus. You should carefully consider, among other things, the matters discussed in the sections of this prospectus titled "Business," and "Management's Discussion and Analysis of Financial Condition and Results of Operations" before making an investment decision. Unless otherwise indicated, "Biophytis," "the company," "our company," "we," "us" and "our" refer to Biophytis S.A. and its consolidated subsidiary.

Overview

        We are a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Our goal is to become a leader in the emerging field of aging science by delivering life-changing therapies to the growing number of patients in need. To accomplish this goal, we have assembled an experienced and skilled group of industry professionals, scientists, clinicians and key opinion leaders from leading industry and academic institutions from around the world.

        A number of degenerative diseases associated with aging have been characterized in the last century, including sarcopenia and age-related macular degeneration, or AMD. The pathophysiology of these and many other age-related diseases is not yet well understood, and effective treatment options are lacking. The global population of people over the age of 60 is expected to double from approximately 962 million in 2017 to 2.1 billion by 2050, according to estimates from the United Nations' World Population Prospects: the 2017 Revision. We believe that the need for effective therapeutics for age-related diseases will continue to grow throughout the 21st century. In addition, healthcare costs, including costs associated with treatments and long-term care for age-related diseases associated with this demographic shift, are expected to rise proportionally, as effective treatment options are currently lacking. We believe that developing treatments to slow disease progression and reduce the risk of severe disability associated with age-related diseases is of the utmost importance.

        As we age, our physical, respiratory, visual and cognitive performances gradually decline due, in part, to the cumulative deleterious effect of multiple biological and environmental stresses, including current and emerging viral infections, to which we are exposed during our lifetime. The functional decline can be much faster in some individuals as a consequence of, among other things, the degenerative processes affecting specific cells, tissues and organs. Through evolution, cells, tissues and organisms have developed natural means or pathways to counteract and balance the effects of the many stresses they face. This natural ability to compensate for stress and remain functional, called biological resilience, degrades over time. The decline in biological resilience contributes to the acceleration of these degenerative processes and the impairment of functional performance, which, in turn, can lead to severe disability, reduced health-span and ultimately death. This occurs as we age, but can occur at a younger age, when genetic mutations exist, or in the case of infection and inflammation.

        The 2019 coronavirus outbreak due to SARS-CoV-2, or COVID-19, was first identified in Wuhan, in the Hubei Province in China in December 2019. It was recognized as a worldwide pandemic by the World Health Organization, or WHO, in March 2020. There are many ongoing clinical studies to develop medical responses to COVID-19. A few anti-viral agents (including Veklury (remdesivir) and bamlanivimab (LY-CoV55)) have already received authorizations in the United States and the European Union, or EU; in addition, certain anti-inflammatory agents (including Il-6 antagonists and dexamethasone) have been shown to be effective in patients who are on a respirator. Moreover, a few vaccines have now been authorized around the globe; while many more remain in development. Age, co-morbidities, heavy smoking, male gender and several ethnic backgrounds are associated with worse

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outcomes. Our therapeutic approach is aimed at targeting and activating key biological resilience pathways that can protect against and counteract the effects of the multiple biological and environmental stresses, including inflammatory, oxidative, metabolic and viral stresses that lead to age-related diseases.

        Our lead drug candidate, Sarconeos (BIO101), is an orally administered small molecule in development for the treatment of neuromuscular diseases. Sarconeos (BIO101) is a plant-derived pharmaceutical-grade purified 20-hydroxyecdysone. We have completed preclinical studies, including chronic toxicology and safety pharmacology studies, and a Phase 1 clinical trial in healthy human volunteers, which are necessary for pursuing further clinical development of Sarconeos (BIO101). Our early data suggests that Sarconeos (BIO101) stimulates biological resilience and muscle metabolism in cellular models, and preserves strength, mobility and respiratory capacity in animal models of certain neuromuscular diseases. While we are still in the early stages of development, we believe that these results support further investigation and clinical development of Sarconeos (BIO101) in patients with certain neuromuscular and respiratory diseases.

        The initial indication we are seeking approval for is sarcopenia, an age-related degeneration of skeletal muscle, which is characterized by a loss of muscle mass, strength and function in elderly people (adults 65 years of age and older) leading to reduced mobility, or mobility disability, and increased risk of adverse health events and hospitalization, and potential death resulting from falls, fractures, and physical disability. There is currently no approved medication for sarcopenia, which is present in the elderly with an estimated prevalence range between six to 22% worldwide. We are currently testing the safety and efficacy of Sarconeos (BIO101) in an ongoing global, randomized, double-blind, placebo-controlled clinical study (SARA-INT) with 233 elderly patients with sarcopenia at risk of mobility disability. The enrollment to this study was completed in March 2020. The COVID-19 pandemic has resulted in the closure of study sites and changes to the protocol for this study. Such changes and revisions were submitted to and reviewed by the applicable institutional review boards, or IRBs. Despite the interruption of in-office visits and other disruptions that were imposed due to the COVID-19 pandemic, we were able to retain most of the study participants. The last patient completed his final on-treatment visit in December 2020. Currently, we are conducting final assessment on the last patients in this clinical trial. We expect to announce top-line results from this study during the second quarter of 2021.

        Sarconeos (BIO101) is also in development to treat patients who suffer from severe respiratory manifestations of COVID-19. We are currently testing the safety and efficacy of Sarconeos (BIO101) in an ongoing global, multicenter, double-blind, placebo-controlled, group-sequential, and adaptive two-part Phase 2-3 study (COVA) in patients with SARS-CoV-2 pneumonia. COVID-19 is an infectious disease caused by a newly discovered coronavirus. Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease and cancer are more likely to develop serious illness. Part 1 of COVA is a Phase 2 exploratory proof of concept, or PoC, study to provide preliminary data on the activity, safety and tolerability of Sarconeos (BIO101) in the target population, which is hospitalized patients with severe respiratory manifestations. Part 2 of COVA will be a Phase 3 pivotal randomized study to provide further evidence of safety and efficacy of Sarconeos (BIO101) after 28 days of dosing. The study has regulatory approvals to take place in the United States, Brazil, France, Belgium and the United Kingdom. The first COVA participant was enrolled in August 2020, in Belgium. On January 8, 2021, the independent Data Monitoring Committee, or DMC, of COVA reviewed the safety data analysis from the first 20 patients who were enrolled in the study, and recommended beginning recruitment for Part 2 of COVA. Pursuant to this recommendation, recruitment for Part 2 of COVA will begin as soon as we receive approvals or permissions from regulatory authorities in each jurisdiction, and from IRBs and Ethics Committees that oversee the clinical trial sites. Enrollment for Parts 1 and 2 of the study are expected to be completed in the first quarter of 2021. The first interim analysis, or IA, is

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anticipated to occur in the first quarter of 2021, subject to any COVID-19 related delays and the impact of the current pandemic on our operational capabilities, with results of the study and submission for emergency use authorization, or EUA, with the U.S. Food and Drug Administration, or FDA, and conditional marketing authorization with the European Medicines Agency, or EMA, expected in the second quarter of 2021.

        We are also developing Sarconeos (BIO101) for Duchenne muscular dystrophy, or DMD, a rare genetic neuromuscular disease in male children and young adults, which is characterized by accelerated degeneration of muscle and is responsible for a loss of mobility, respiratory failure and cardiomyopathy, leading to premature death. There is currently no cure and limited treatment options for DMD, which affects approximately 2.8 out of 100,000 people worldwide (approximately 20,000 new cases annually worldwide), based on our estimates from publicly available information, resulting in premature death. In 2018, we received orphan drug designation for Sarconeos (BIO101) in DMD from the FDA and the EMA. In December 2019, we received an Investigational New Drug, or IND, "may proceed" letter from the FDA (USA) and we received a Clinical Trials Application, or CTA, approval from the Federal Agency for Medicines and Health Products (Belgium), or FAMHP, to start the MYODA study, and to investigate Sarconeos (BIO101) in non-ambulatory patients with signs of respiratory deterioration. In the "may proceed" letter, the FDA noted that it had significant concerns with the design of the study, and, that the results of the study, as originally designed to enroll ambulatory and non-ambulatory patients and measure muscle function deterioration through a composite score, would not be capable of providing interpretable data sufficient to support a marketing application. In its letter, the FDA recommended that we revise the study population and primary endpoint. We have incorporated the FDA's recommendations and revised the protocol to focus on non-ambulatory patients with signs of respiratory deterioration and changed the primary endpoint to respiratory function. The revised protocol will be submitted as an amendment to the FDA and other regulatory authorities for review. While the FDA has not reviewed these changes yet, we do not expect the FDA to object to the revised protocol, given that we made the changes that the FDA requested. We hope to start this study, which will be a global, double-blind, placebo-controlled, group-sequential, Phase 1-3 seamless study, in the first half of 2021, subject to any COVID-19-related delays and the impact of the pandemic on our operational capabilities.

        Our second drug candidate, Macuneos (BIO201), is an orally administered small molecule in development for the treatment of diseases of the retina, or retinopathies. It is a plant-derived pharmaceutical-grade purified 9 cis-norbixin, or norbixin. We have completed preclinical cellular and animal studies of Macuneos (BIO201) for the treatment of retinopathies. While we are still in the early stages of development, we believe that the results from our preclinical studies support continued investigation into whether Macuneos (BIO201) may stimulate biological resilience and protect the retina against phototoxic damage that leads to vision loss. The initial indication we plan to seek approval for is dry AMD, a common eye disorder among people over the age of 50 that affects central vision, impairing functions such as reading, driving, and facial recognition, and has a major impact on quality of life and the ability to live independently. There are currently no approved drugs for dry AMD. Based on our estimates from publicly available information, AMD affects approximately 8.5% of the global population (ages 45 to 85) and is expected to increase over time as the population ages. We plan to commence a Phase 1 clinical trial (MACA-PK) in healthy volunteers in the second half of 2021, subject to regulatory review and approval, which is pending, any COVID-19-related delays and the impact of the pandemic on our operational capabilities.

        We are also exploring Macuneos (BIO201) as a potential treatment for Stargardt disease, which shares many of the characteristics of dry AMD. Stargart disease is the most common form of inherited macular degeneration that typically develops in childhood and leads to vision loss and, in some cases, blindness. We plan to explore clinical development of Macuneos (BIO201) for Stargardt disease in early 2022 following our MACA-PK Phase 1 clinical trial, subject to any COVID-19-related delays and the impact of the pandemic on our operational capabilities.

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        We hold exclusive commercialization rights through licenses for each of our drug candidates. We currently plan to develop our drug candidates through clinical PoC (typically Phase 2), and then seek licensing and/or partnership opportunities for further clinical development through regulatory approval and commercialization.

        We have developed our lead drug candidate Sarconeos (BIO101), preclinical drug candidate Macuneos (BIO201), and a preclinical pipeline of life-cycle extension products, consisting of BIO103 and BIO203, through a drug discovery platform in collaboration with Sorbonne University in Paris, France based on work with medicinal plants. Plants are major sources of small molecules, called secondary metabolites, which they produce as a defense mechanism to various environmental stresses, including attack from predatory and pathogenic species (e.g., insects, bacteria and fungi). Our drug discovery platform is based on a reverse pharmacology approach that tests a collection of bioactive secondary metabolites along with chemical analogs that we have synthesized in phenotypic screens of various age-related diseases. Our long-term goal is to advance the field of aging science with the continued discovery and development of new drug candidates that treat age-related diseases by stimulating biological resilience pathways that are involved in the aging process and/or age-related diseases.

        We have assembled an executive team of scientific, clinical, and business leaders with broad expertise in biotechnology and clinical drug development. Stanislas Veillet, our co-founder, Chairman and Chief Executive Officer, has held positions in the biotechnology, pharmaceutical and nutritional industries for the last 25 years. He holds a Ph.D. in genetics and has authored more than a dozen patents. Our other co-founder and Scientific Advisor, René Lafont, is a biochemist (Ecole Normale Supérieure), Professor Emeritus and former Dean of the Department of Life Sciences at Sorbonne University. He has authored over 250 scientific publications and a dozen patents and is also notably a Laureate of Karlson Foundation in Germany and the recipient of the Jaroslay Heyrovsky medal of the Czech Academy of Sciences. Dr. Samuel Agus, our Chief Medical Officer, holds a Doctor in Medicine, is a board-certified neurologist with academic training in biostatistics and bioinformatics, and has over 15 years of clinical development experience in the pharmaceutical industry. Waly Dioh, our Chief Operating Officer holds a doctorate in phytopathology (Paris XI), and spent most of his career with research and development teams in Monsanto Company, initially in France to set up a genoptyping platform, and then in the United States. Pierre Dilda, our Chief Scientific Officer holds a doctorate in pharmacology from the University of Paris V, Faculty of Medicine, Paris. He has 25 years' experience in advancing small molecule drug candidates in pharma, biotech and academic environments. Evelyne Nguyen, our Chief Financial Officer, graduated from the Institut de Gestion (France). She has over 30 years of corporate finance and business development experience with biotech and pharma companies (i.e., Bristol Myers Squibb, LFB and Nicox SA), and led numerous cross border transactions.

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Our Clinical Pipeline

        We are developing a portfolio of programs targeting biological resilience pathways that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases. Our current pipeline of drug candidates is illustrated below.

GRAPHIC

Sarconeos (BIO101)

        We are developing Sarconeos (BIO101) for the treatment of certain neuromuscular diseases, including sarcopenia and DMD. Both are diseases of muscular degeneration, but with different causes and pathophysiologies (i.e., age-related versus genetic). However, similar key muscular processes are impaired in each of these diseases as well as other muscle wasting conditions, including metabolism, mitochondrial function, stem cell proliferation and loss of biological resilience, which are mediated through multiple signaling pathways. Early cellular and animal model data suggest that Sarconeos (BIO101) directly targets muscle tissue and cells, and improves several key muscle cell functions, including protein syntheses, regeneration and energy production. Additional studies suggest it may have a positive impact on Acute Lung Injury, or ALI, which may evolve towards Acute Respiratory Distress Syndrome, or ARDS, in COVID-19 patients. We believe that Sarconeos (BIO101) may have the potential to improve muscle and respiratory function and preserve strength, mobility and respiratory capacity in various muscle wasting and COVID-19-related ALI/ARDS.

Sarcopenia (the SARA clinical program)

        Sarcopenia is an age-related degeneration of skeletal muscle. It is a major cause of mobility disability in the elderly, characterized by a loss of muscle mass, strength, balance and the ability to stand and/or walk, resulting in a loss of independence, increased risk of adverse health events and hospitalization, and potential death resulting from falls, fractures, and physical disability. We have observed activity of Sarconeos (BIO101) on cellular function and muscle performance in several cellular and animal models of various age-related and muscular wasting conditions. Based on the Phase 1 study (SARA-PK), with 54 healthy young and elderly adult subjects in 2017, we identified the two dosing levels (175 and 350 mg b.i.d.) for our ongoing SARA-INT trial. We are currently testing the safety and efficacy of the oral adult formulation of Sarconeos (BIO101) in an ongoing global, randomized, double-blind, placebo-controlled study (SARA-INT) with 233 elderly participants with sarcopenia at risk of mobility disability. Recruitment was completed in March 2020. The COVID-19 pandemic has resulted in the closure of study sites and changes to the protocol. Such changes and revisions were submitted to and reviewed by the applicable IRBs. Despite these interruptions of in-office study visits and other disruptions that were imposed due to the COVID-19 pandemic, we were able to retain most of the study participants. The last patient completed his final on-treatment visit in

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December 2020. Currently, we are conducting final assessment on the last patients in this clinical trial. We expect to announce top-line results during the second quarter of 2021.

        If approved by regulatory authorities for commercial use, we believe there is market potential for Sarconeos (BIO101) in sarcopenia, which is highly present in the elderly (greater than 65 years old) with an estimated prevalence range of between six to 22% worldwide. There is currently no approved medication for sarcopenia and no therapeutic agents are currently being tested in confirmatory or Phase 3 clinical trials. Based on our review of research in this area, we believe Sarconeos (BIO101) is currently the only drug candidate being tested in an interventional Phase 2 clinical trial for the treatment of sarcopenia. To our knowledge, there is currently no widely accepted standard of care for sarcopenia. Current non-medicinal treatment recommendations primarily focus on moderate physical activity, such as 30 minutes of walking per day or resistance-based (strength) training, as they exert effects on both the nervous and muscular systems that are critical to positive physiological and functional adaptations in older adults, and nutritional intervention. Other potential drug modalities that have been tested in the clinic for sarcopenia have yet to demonstrate effectiveness on clinically meaningful outcomes (strength and mobility) and/or safety in larger clinical trials and/or have not progressed through the clinic. Based on our understanding and discussions with regulatory agencies, including the FDA and EMA, functional mobility endpoints must be achieved in order to obtain marketing approval for sarcopenia. We believe that based on our potential mechanism-of-action and preclinical cellular and animal model data that Sarconeos (BIO101) directly targets muscle tissue and cells, and improves key muscle cell functions.

COVID-19 (the COVA clinical program)

        COVID-19 was declared as a worldwide pandemic by WHO in March 2020. As of the date of this prospectus, the number of worldwide cases is approximately 94 million, with more than 2.0 million confirmed deaths. At this stage, many countries in Europe are experiencing a second wave of cases, while the number of new cases per day in the United States is at an all-time high. COVA is a global, multicentric, double-blind, placebo-controlled, group-sequential, and adaptive two-part Phase 2-3 study with a total of 310 hospitalized patients in both parts. Part 1 will include the first 50 patients and the data from all study participants will be analyzed together at the end of Part 2. We are using the adult oral formulation of Sarconeos (BIO101) at 350 mg b.i.d. During the study, two IAs will be performed by the DMC, with the first one from the first 50 participants and the second IA on the safety and efficacy data from 155 participants, which will be used to re-assess the final sample size. The study was approved in the following countries: the United States, Brazil, France, Belgium and the United Kingdom. The first participant in Part 1 of the study was enrolled in August 2020 in Belgium. On January 8, 2021, the independent DMC of COVA reviewed the safety data analysis from the first 20 patients who were enrolled in the study, and recommended beginning recruitment for Part 2 of COVA. Pursuant to this recommendation, recruitment for Part 2 of COVA will begin as soon as we receive approvals or permissions from regulatory authorities in each jurisdiction, and from IRBs and Ethics Committees that oversee the clinical trial sites. Enrollment for Parts 1 and 2 of the study are expected to be completed in the first quarter of 2021. The first IA is anticipated to occur in the first quarter of 2021, subject to any COVID-19-related delays and the impact of the current pandemic on our operations, with results of the study and submission for EUA with the FDA and conditional marketing authorization with the EMA expected in the second quarter of 2021.

        Due to the global pandemic, the rising number of COVID-19 cases, and the need for new treatments, especially for patients who are hospitalized with severe respiratory manifestations such as COVID-19 related ALI/ARDS, regulatory authorities are applying emergency approval programs. These programs include EUA in the United States, and the EMA conditional marketing authorization, under the guidance of the COVID-19 task-force, and similar programs in other countries. If an EUA is achieved, a separate regulatory process will be needed in order to obtain a full marketing authorization

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(i.e., non-emergency authorization and conditional marketing authorization) for the use of Sarconeos (BIO101) in respiratory failure linked to COVID-19.

        If authorized by regulatory authorities for commercial use, we believe there is market potential for Sarconeos (BIO101) in hospitalized patients with COVID-19 who are not yet in Intensive Care Units, or ICUs. To our knowledge, there are currently only a few drugs approved for COVID-19 treatments (such as Veklury (remdesivir), which was approved for certain patient populations, and bamlanivimab (LY-CoV55)) and based on our research, none are specifically targeting the modulation of the Renin—Angiotensin System, or RAS, to restore respiratory function. However, there have been multiple clinical trials testing repositioned drugs and new drug candidates or vaccines in 2020. A few vaccines have now been authorized around the globe; while many more remain in development.

DMD (the MYODA clinical program)

        DMD is rare neuromuscular genetic disease in male children and young adults, which is characterized by accelerated degeneration of muscle and is responsible for a loss of mobility, respiratory failure and cardiomyopathy, leading to premature death. It is the most common form of muscular dystrophy in children. DMD is caused by mutations in the dystrophin gene that result in the absence or very low levels of functional dystrophin, a cytoskeletal protein that protects muscle cells.

        We have observed a positive effect on muscle function, mobility, and respiratory capacity (a major disability in later stage DMD disease progression) in mdx mice models of DMD that were treated with Sarconeos (BIO101). In June 2018, we received orphan drug designation from the FDA and EMA for Sarconeos (BIO101) in DMD. We received an IND "may proceed" letter from the FDA in the United States and CTA approval from the FAMHP in Belgium in the second half of 2019 to initiate clinical development with our MYODA clinical program, which is based on a global, double-blind, placebo-controlled, group-sequential, Phase 1-3 seamless study, in non-ambulatory DMD patients, with signs of respiratory deterioration. We will use the pediatric oral formulation of Sarconeos (BIO101) to test the safety and efficacy of the product on respiratory functions, as measured by Peak Expiratory Flow, or PEF, as the primary endpoint. In the "may proceed" letter from the FDA, the FDA noted that it had significant concerns with the design of our study, and that the results of the study, as originally designed to enroll ambulatory and non-ambulatory patients and measure muscle function deterioration through a composite score, would not be capable of providing interpretable data sufficient to support a marketing application. In its letter, the FDA recommended that we revise the study population and primary endpoint. We have incorporated the FDA's recommendations and revised the protocol to focus on non-ambulatory patients with signs of respiratory deterioration and changed the primary endpoint to respiratory function. The revised protocol will be submitted as an amendment to the FDA and other regulatory authorities for review. We hope to initiate the study in the first half of 2021, subject to any COVID-19-related delays and the impact of the pandemic on our operational capabilities.

        If approved by regulatory authorities for commercial use, we believe there is market potential for Sarconeos (BIO101) in DMD, which affects approximately 2.8 out of 100,000 people worldwide (approximately 20,000 new cases annually worldwide), based on our estimates from publicly available information, resulting in premature death. There is currently no cure for DMD and there are only limited treatment options that aim to control the symptoms and slow the disease progression. In many countries, corticosteroids are the standard drug therapy. However, corticosteroids typically only slow the progression of muscle weakness and delay the loss of ambulation by up to two years, and their benefit for non-ambulatory boys with signs of respiratory deterioration, is not clear. Corticosteroids have also been associated with adverse side effects and are generally not suitable for long-term administration. There are three targeted therapies (i.e., therapies targeting a specific dystrophin mutation by exon skipping or with stop codons) available on the market (two in the United States and one in Europe). As these therapies each target a specific gene mutation, they can only address the approximately 20% of the overall DMD patient population with those genetic mutations. In addition, there are only a few

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treatments that are in clinical development that target treatment of ambulatory children. There are very few early stage programs that target treatment of non-ambulatory patients with signs of respiratory deterioration.

        We believe that Sarconeos (BIO101) directly targets muscle tissue and cells, increases key muscle cell functions that are impaired independent of the genetic mutation that causes the disease, and has the potential to be used complementarily with corticosteroids, current targeted therapies and other gene therapies under development. We also believe that because Sarconeos (BIO101) targets various impaired muscle tissues and cells relevant to muscle strength, mobility and respiratory function, it has the potential to be used in all stages of DMD progression, including both ambulatory and non-ambulatory patients. Due to the high unmet need, specifically in the population of non-ambulatory patients, with signs of respiratory deterioration, we decided to focus on this sub-population, at this stage.

Macuneos (BIO201)

Dry AMD (the MACA clinical program)

        AMD is an age-related degeneration of the macula, the central part of the retina. It is one of the leading causes of irreversible vision loss and blindness in people over the age of 50 worldwide, according to the Bright Focus Foundation's Age-Related Macular Degeneration: Facts & Figures Fact Sheet. Approximately 85 to 90% of AMD patients suffer from the dry (atrophic) form, called dry AMD, according to estimates provided by the American Macular Degeneration Foundation. Based on our estimates from publicly available information, we believe that dry AMD affects approximately 170 million people worldwide and is expected to increase over time as the population ages. Dry AMD affects central vision and impairs many functions affecting quality of life and independent living such as reading, driving, and facial recognition. The prevalence of dry AMD increases significantly with advancing age.

        We have observed that Macuneos (BIO201) appears to potentially protect the retina against phototoxic damage caused by A2E (a by-product of the visual pigment cycle) accumulation that leads to vision loss in several cellular and animal models of dry AMD and Stargardt disease. We are conducting chronic and acute animal toxicology studies to support IND and CTAs. We plan to commence a Phase 1 clinical trial (MACA-PK) in healthy volunteers in the second half of 2021, subject to regulatory review and approval, which is pending, any COVID-19-related delays and the impact of the current pandemic on our operational capabilities. We expect the MACA-PK Phase 1 clinical trial will assess the safety, pharmacokinetics, or PK, and pharmacodynamics, or PD of Macuneos (BIO201).

        If approved by regulatory authorities for commercial use, we believe that there is market potential for Macuneos (BIO201) in dry AMD. Therapeutic options for dry AMD have proven challenging with no currently approved drugs that can slow or reverse the disease progression.

        We intend to investigate whether Macuneos (BIO201) may also be an effective treatment for Stargardt disease, the most common form of inherited juvenile macular degeneration. The pathophysiology of Stargardt disease is similar to that of AMD, in that it may also be characterized by accelerated retinal degeneration.

Our Strategy

        We are focused on the development of therapeutics that improve functional outcomes for patients suffering from age-related diseases. Our goal is to build Biophytis into a leading biotechnology company focused on targeting biological resilience pathways that slow the degenerative processes associated with age-related disease progression in order to improve the lives of millions of patients that have limited or no treatment options. We currently plan to develop our drug candidates through

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clinical PoC (Phase 2/3) and then seek licensing and/or partnership opportunities for further clinical development through regulatory approval and commercialization. To achieve our goal, we are pursuing the following strategies:

    Demonstrate clinical proof of concept (PoC) of Sarconeos (BIO101) in sarcopenia.  Our resources and business efforts are primarily focused on advancing the clinical development of Sarconeos (BIO101) for the treatment of neuromuscular disorders, with an initial focus on sarcopenia. Our goal is to demonstrate clinical PoC safety and efficacy of Sarconeos (BIO101) to treat sarcopenia in our ongoing SARA-INT Phase 2 clinical trial. Upon successful completion, we plan to pursue licensing and/or partnership opportunities to advance Sarconeos (BIO101) into a confirmatory or Phase 3 clinical trial necessary to secure marketing approval. We believe this indication has significant value and that establishing clinical PoC may help attract partners for further clinical development and commercialization.

    Demonstrate the therapeutic benefit and obtain conditional approval of Sarconeos (BIO101) for COVID-19 patients.  Complete a two-part Phase 2/3 trial in hospitalized COVID-19 patients with severe respiratory manifestations and file for an EUA in the United States. We will also seek to obtain a conditional marketing authorization in the EU by using expedited procedures implemented at the EU level to support the development and evaluation of treatments for COVID-19, and apply for similar fast-track measures in other countries, such as Brazil. In parallel, we will work to make Sarconeos (BIO101) ready for launch, through manufacturing and supply-chain upscaling and market-access preparations. We plan for a commercial launch in these countries, upon EUA or traditional regulatory approval, by licensing the product to global or regional pharmaceutical companies. An EUA differs from a traditional approval in that, among other things, it may be revoked at the conclusion of a public health emergency, and there may be limitations to its uses. However, EUAs can be effective for quickly supplying medical countermeasures needed during public health emergencies. We also plan to conduct additional studies, as needed, to obtain regulatory approval for commercial distribution.

    Initiate clinical development of Sarconeos (BIO101) in DMD.  Our efforts are also focused on leveraging our knowledge and the development of Sarconeos (BIO101) in sarcopenia to commence and advance the clinical development of Sarconeos (BIO101) for the treatment of non-ambulatory DMD patients with signs of respiratory deterioration, independent of genetic mutation and across the disease spectrum. We have already received an IND "may proceed" letter from the FDA in the United States and a CTA approval from FAMHP in Belgium. In the "may proceed" letter from the FDA, the FDA noted that it had significant concerns with the design of the study, and that the results of the study, as originally designed to enroll ambulatory and non-ambulatory patients and measure muscle function deterioration through a composite score, would not be capable of providing interpretable data sufficient to support a marketing application. In its letter, the FDA recommended that we revise the study population and primary endpoint. We have incorporated the FDA's recommendations and revised the protocol to focus on non-ambulatory patients with signs of respiratory deterioration and changed the primary endpoint to respiratory function. The revised protocol will be submitted as an amendment to the FDA and other regulatory authorities for review. We hope to initiate this study in the first half of 2021, subject to any COVID-19-related delays and the impact of the pandemic on our operational capabilities. The pandemic may also pose limitations on starting a study in a very vulnerable population.

    Advance the development of our second drug candidate, Macuneos (BIO201).  We are also working on continuing the preclinical development of our second drug candidate, Macuneos (BIO201), for the treatment of retinopathies, with an initial focus on dry AMD. We plan to start a Phase 1 clinical trial (MACA-PK) in healthy volunteers, in the second half of 2021, subject to regulatory

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      review and approval, which is pending, any COVID-19-related delays and the impact of the pandemic on our operation capabilities.

    Expand our presence in the United States to support co-development in Europe and the United States.  We plan to continue the expansion of our company in the United States and Europe. In 2018, we opened offices in Cambridge, Massachusetts to support our growing clinical, regulatory, and operational efforts, and we hired a U.S.-based Chief Medical Officer. Our goal is to continue to build our clinical and regulatory operations to support further clinical trials and, if successful, apply for regulatory approval in both the United States and Europe. We plan to work with patient associations, regulatory agencies, government and third-party payors and other key constituencies in both regions.

    Expand our pipeline and explore potential strategic partnerships and alliances to maximize the value of our development programs.  We plan to continue to leverage our collaborations with leading scientific and academic institutions in order to pursue new INDs for our existing drug candidates, including Sarconeos (BIO101), BIO103, Macuneos (BIO201) and BIO203. We believe that our drug candidates may be applicable for additional age-related disease research and potential application. We plan to explore the commercial potential of our drug candidates after establishing clinical PoC through Phase 2/3.

Impact of COVID-19

        We are closely monitoring how the spread of COVID-19 is affecting our employees, business, preclinical and clinical studies. As part of our COVID-19 pandemic response, most of our employees have transitioned to working remotely and travel has been restricted. During the pandemic, we instructed our employees to work remotely as much as possible except for essential and required activities that needed to be performed in laboratories. Such access and work must comply with social distancing and other local government and facility requirements and policies were implemented during initial and subsequent waives of COVID-19. While we have substantially completed enrollment dosing of Sarconeos (BIO101) in our SARA-INT study, limitations on in-office visits due to study site closures during the initial COVID-19 wave required adaptation of the study protocol including closing on-site activities, organizing patient follow-ups to take place at home, and expanding treatment from six to nine months for some patients. All such changes to the protocol were submitted to, reviewed and approved by reviewing IRBs. Despite these impediments, the last patient completed his final on-treatment visit in December 2020. However, the impact of continued and prolonged disruptions caused by the COVID-19 pandemic may result in further difficulties or delays in initiating, enrolling, conducting or completing our ongoing and planned clinical trials, which could result in additional unforeseen costs. The impact of COVID-19 on our future clinical research and development progress will largely depend on future developments of the pandemic. These future COVID-19 developments are highly uncertain and cannot be predicted with confidence, and include issues such as: the rate and ultimate geographic spread of the disease; the duration of the pandemic; travel restrictions and social distancing requirements in the U.S., Brazil, the UK, France and other countries; business disruptions and closures; impact on financial markets and the global economy; and the effectiveness of actions taken to contain, treat and prevent the disease.

Risks Associated with Our Business

        Our business is subject to a number of risks of which you should be aware before making an investment decision. These risks are discussed more fully in the "Risk Factors" section of this

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prospectus immediately following this prospectus summary. These risks include, but are not limited to, the following:

    Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current outbreak of COVID-19 and future coronavirus outbreaks, and in particular in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.

    We are a clinical-stage biotechnology company, with no products approved for commercial sale. We have incurred significant losses since inception and anticipate that we will continue to incur losses for the foreseeable future.

    We will require substantial additional financing to achieve our goals and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our drug development or other operations.

    We have benefited from certain reimbursable financial advances and non-reimbursable subsidiaries from the French government that if terminated or reduced may restrict our ability to successfully develop, manufacture and commercialize our drug candidates.

    Our indebtedness could restrict our operations and make us more vulnerable to adverse economic conditions.

    Our business is dependent on the successful development, conduct of clinical trials, supporting data, regulatory approval, manufacture and commercialization of our drug candidates, each of which is in the early stages of development.

    The denial or delay of regulatory approval for our drug candidates would preclude or delay the commercialization of our drug candidates and adversely impact our potential to generate revenue and/or raise financing, our business and our results of operations.

    Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials, especially preclinical data and early phase clinical trial data, may not be predictive of future trial results.

    We rely on third parties to provide the raw materials necessary for our drug candidates and to manufacture preclinical and clinical supplies of our drug candidates and we intend to rely on third parties to produce commercial supplies of any approved drug candidate. We have not currently engaged a supplier for long-term, commercial manufacture. The loss of these suppliers or manufacturers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially affect future studies, commercial launch if approval is received, and adversely affect our business.

    We rely on third parties in the conduct of all of our preclinical studies and clinical trials and intend to rely on third parties in the conduct of all of our future clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our drug candidates.

    Our existing collaborations as well as additional collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our drug candidates.

    Our ability to compete may decline if we do not adequately protect our proprietary rights.

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    We have a significant number of outstanding warrants and convertible debt, which may cause significant dilution to our shareholders, have a material adverse impact on the market price of our ordinary shares and make it more difficult for us to raise funds through future equity offerings.

    The requirements of being a U.S. public company may strain our resources, divert management's attention and affect our ability to attract and retain executive management and qualified board members.

    There has been no market for the ADSs prior to the offering and an active and liquid market for our securities may fail to develop, which could harm the market price of the ADSs.

    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.

    As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of ADSs.

    We are an "emerging growth company" under the JOBS Act (as defined below) and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make the ADSs less attractive to investors.

    Our research and development activities may be adversely impacted depending on the evolution of the COVID-19 pandemic, mostly in countries where our clinical trials are ongoing and/or to be launched (e.g., the United States, France, Belgium and Brazil).

Corporate Information

        We were incorporated as a société anonyme, or SA, on September 27, 2006. We are registered at the Paris Registre du Commerce et des Sociétés under the number 492 002 225. Our principal executive offices are located at Sorbonne University—BC 9, Bâtiment A 4ème étage, 4 place Jussieu 75005 Paris, France and our telephone number is +1 44 27 23 00. Our website address is www.biophytis.com. Our agent for service of process in the United States is Puglisi & Associates. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website is not a part of this prospectus.

Implications of Being an "Emerging Growth Company"

        We qualify as an "emerging growth company," as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and regulatory requirements in contrast to those otherwise applicable generally to public companies. These provisions include:

    the requirement to have only two years of audited financial statements and only two years of related Management's Discussion and Analysis of Financial Condition and Results of Operations disclosure; and

    exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to Section 404 the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act.

        We may take advantage of these reduced reporting and other regulatory requirements for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, have more than

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$700 million in market value of our ordinary shares held by non-affiliates or issue more than $1.0 billion of non-convertible debt over a three-year period.

Implications of Being a Foreign Private Issuer

        Upon consummation of the offering, we will report under the Exchange Act as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

    the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act;

    the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and

    the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K upon the occurrence of specified significant events.

        We intend to take advantage of these exemptions as a foreign private issuer.

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The Offering

ADSs offered by us

              ADSs, each representing            ordinary shares.

Ordinary shares to be outstanding immediately after the offering

 

            ordinary shares (or            ordinary shares if Wainwright exercises its option to purchase an additional            ADSs in full).

Option to purchase additional ADSs in the offering

 

We have granted Wainwright an option, which is exercisable within 30 days from the date of this prospectus, to purchase up to an additional            ADSs (representing            ordinary shares) from us at the offering price, less the underwriting discounts and commissions, solely to cover over-allotments, if any.

The ADSs

 

Each ADS represents            ordinary shares, nominal value €0.20 per share. The ADSs may be evidenced by ADRs. Purchasers of ADSs in the offering will have the rights of an ADS holder as provided in the deposit agreement among us, the depositary and all owners and holders of ADSs issued thereunder. To better understand the terms of the ADSs, you should carefully read the section in this prospectus titled "Description of American Depositary Shares." We also encourage purchasers of ADSs to read the deposit agreement, which is filed as an exhibit to the registration statement that includes this prospectus.

Depositary

 

The Bank of New York Mellon

Minimum Gross Proceeds

 

$            million

Use of proceeds

 

We estimate that the net proceeds to us from the offering will be approximately $            million, based on the assumed initial public offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

 

We intend to use the net proceeds we receive from the offering to finalize part 2 of our COVA trial of Sarconeos (BIO101) in respiratory failure linked to COVID-19, to finalize our Phase 2 clinical trial (SARA-INT) of Sarconeos (BIO101) in sarcopenia with top line results, to commence development of Sarconeos (BIO101) in DMD following IND approval from the FDA and EMA, subject to better control of COVID-19 in Europe and the United States, and to continue to build our preclinical research and development platform on retinopathies and for other new and on-going research and development activities, working capital and other general corporate purposes. See the section of this prospectus titled "Use of Proceeds."

Dividend policy

 

We do not expect to pay any dividends on ordinary shares or ADSs in the foreseeable future.

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Risk factors

 

You should read the "Risk Factors" section of this prospectus for a discussion of factors to consider carefully before deciding to invest in the ADSs or ordinary shares.

Proposed Nasdaq trading symbol for the ADSs

 

"BPTS"

        The number of our ordinary shares (including ordinary shares represented by ADSs) that will be outstanding immediately following the completion of the offering is based on 54,834,978 ordinary shares outstanding and zero ADSs outstanding as of June 30, 2020.

        After June 30, 2020, the following ordinary shares were issued:

    an aggregate of 30,840,328 ordinary shares that were issued in two private placements in July and October 2020, or the H2 2020 Private Placements;

    an aggregate of 13,990,411 ordinary shares issued upon the conversion of bonds, or the H2 2020 Bond Conversions; and

    an aggregate of 1,091,380 ordinary shares issued upon the conversion of share subscription warrants and founders' warrants, or the H2 2020 Warrant Conversions.

        The number of ordinary shares outstanding as of June 30, 2020 excludes:

    3,615,566 ordinary shares issuable upon the exercise of warrants issued to investors outstanding as of January 4, 2021, with a weighted-average exercise price of €0.27 per ordinary share;

    3,455,610 ordinary shares issuable upon the exercise of warrants issued pursuant to equity incentive awards and outstanding as of January 4, 2021, with a weighted average exercise price of €0.61 per ordinary share;

    585,936 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Negma Group Limited, or NEGMA, and outstanding as of January 4, 2021, with a weighted average exercise price of €0.64 per ordinary share;

    442,477 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Kreos Capital V (UK) Ltd., or Kreos, and outstanding as of January 4, 2021, with a weighted average exercise price of €2.67 per ordinary share as part of a financing that is described elsewhere in this prospectus;

    431,184 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Bracknor Fund Ltd., or Bracknor, and outstanding as of January 4, 2021, with a weighted average exercise price of €3.48 per ordinary share as part of a financing that has been fully repaid and terminated; and

    2,500,911 free ordinary shares that were granted to our two founders on December 22, 2020 and will be delivered to them on December 22, 2022, after a two-year vesting period.

        Unless otherwise indicated, all information contained in this prospectus assumes no exercise of Wainwright's option to purchase up to an additional            ADSs (representing             ordinary shares) from us in the offering.

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Summary Consolidated Financial Data

        The following tables summarize our consolidated financial data for the periods and as of the dates indicated below. We derived the summary statement of consolidated operations data for the years ended December 31, 2018 and 2019 and statement of consolidated financial position data as of December 31, 2018 and 2019 from our audited consolidated financial statements included elsewhere in this prospectus. Our audited consolidated financial statements have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The following summary statement of consolidated operations data for the six months ended June 30, 2019 and 2020 and statement of consolidated financial position data as of June 30, 2020 have been derived from our unaudited interim condensed consolidated financial statements as of June 30, 2020 and for the six months ended June 30, 2019 and 2020 included elsewhere in this prospectus. The unaudited interim condensed consolidated financial statements as of June 30, 2020 and for the six months ended June 30, 2019 and 2020 were prepared in accordance with IAS 34, Interim Financial Reporting, the standard of the IFRS applicable to interim financial statements.

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        Our historical results are not necessarily indicative of the results that may be expected in the future. You should read these data together with our consolidated financial statements and related notes beginning on page F-1, as well as the sections of this prospectus titled "Selected Financial and Other Data" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the other financial information included elsewhere in this prospectus.

 
  Year Ended December 31,   Six Months Ended June 30,  
 
  2018   2019   2019   2020  
 
          U.S. $(1)  
 
  (in thousands, except share and per share data)
 

Statement of Consolidated Operations Data:

                               

Operating expenses:

                               

Research and development, net(3)

    9,513     9,089     4,828     5,192     5,815  

General and administrative expenses

    4,348     6,593     4,789     2,269     2,541  

Total operating expenses

    13,861     15,682     9,617     7,461     8,356  

Operating loss

    (13,861 )   (15,582 )   (9,617 )   (7,461 )   (8,356 )

Financial expenses

    (215 )   (2,878 )   (595 )   (4,289 )   (4,804 )

Financial income

    17     18     14     1     1  

Change in fair value of derivative instruments

        726         2,289     2,564  

Net financial expense

    (198 )   (2,134 )   (581 )   (1,999 )   (2,239 )

Net loss before taxes

    (14,059 )   (17,816 )   (10,198 )   (9,460 )   (10,595 )

Income tax benefit

    72     28              

Net loss

    (13,987 )   (17,788 )   (10,198 )   (9,460 )   (10,595 )

Earnings (losses) per share(2)

                               

Basic

    (1.05 )   (1.05 )   (0.76 )   (0.25 )   (0.28 )

Diluted

    (1.05 )   (1.05 )   (0.76 )   (0.25 )   (0.28 )

Weighted average number of ordinary shares outstanding used for computing Basic

    13,374,426     16,882,661     13,366,218     37,211,432     37,211,432  

Weighted-average number of ordinary shares outstanding used for computing Diluted

    13,374,426     16,882,661     13,366,218     37,211,432     37,211,432  

(1)
Translated solely for convenience into dollars at an exchange rate of €1.00=US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.

(2)
See Notes 2.22 and 19 to our audited consolidated financial statements and Note 18 to our unaudited interim condensed consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share.

(3)
Research and development expenses excluding research tax credits and subsidies amounted to €12,691 thousand and €11,937 thousand for the years ended as of December 31, 2018 and 2019, respectively. They amounted to €6,567 thousand and €6,953 thousand (or $7,787 thousand translated solely for convenience into dollars at an exchange rate of €1.00=1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020) for the six months periods ended June 30, 2019 and 2020, respectively.

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  As of June 30, 2020
 
  Actual   Pro Forma(1)   Pro Forma As
Adjusted(2)(3)
 
    US$(4)     US$(4)     US$(4)
 
  (in thousands)

Statement of Consolidated Financial Position Data:

                               

Cash and cash equivalents

    12,183     13,645     31,260     35,011        

Total assets

    18,848     21,110     37,925     42,476        

Non-controlling interests

    (32 )   (36 )   (32 )   (36 )      

Total shareholders' equity

    (4,438 )   (4,971 )   18,247     20,437        

Total non-current liabilities

    3,872     4,337     3,872     4,337        

Total current liabilities

    19,414     21,744     17,034     19,078        

(1)
Pro forma basis gives effect as of January 4, 2021 to (i) the issuance of 30,840,328 ordinary shares in the H2 2020 Private Placements and the receipt of proceeds therefrom in the amount of €16,139,916; (ii) the issuance of 13,990,411 ordinary shares in the H2 2020 Bond Conversions representing a total impact on shareholders' equity of €6,250,000; (iii) the issuance of 1,091,380 ordinary shares in the H2 2020 Warrant Conversions and the receipt of proceeds therefrom in the amount of €294,673; (iv) the issuance of €3 million of convertible notes to Atlas Special Opportunities LLC, or ATLAS, or the H2 2020 Convertible Note Financing, and the receipt of proceeds therefrom (€2,885 thousand) recorded for both cash and cash equivalents and current liabilities with a redemption value in the amount of €3 million; (v) the repayment in cash of €863 thousand corresponding to the remaining 30 convertible notes that were issued to ATLAS at redemption value in the amount of €750 thousand; (vi) the proceeds of the CIR receivable financing in the amount of €1,953,518 and (vii) the repayment of €1,562 thousand of the carrying amount of the Kreos loan.

(2)
Pro forma as adjusted basis gives effect to the issuance and sale of                        ADSs (representing                        ordinary shares) in the offering at an assumed offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and the application of net proceeds from the offering described under "Use of Proceeds."

(3)
Each $1.00 increase or decrease in the assumed offering price of $            per ADS in the offering, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease each of pro forma as adjusted cash and cash equivalents, total assets and total shareholders' equity by $             million, assuming that the number of ADSs offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting commissions and estimated offering expenses payable by us and applying the net proceeds from the offering. Subject to applicable law, we may also increase or decrease the number of ADSs we are offering in the offering. Each increase or decrease of 100,000 ADSs offered by us would increase or decrease each of pro forma as adjusted cash and cash equivalents, total assets and total shareholders' equity by $             million, assuming that the assumed offering price per ordinary share remains the same, and after deducting estimated underwriting commissions and offering expenses payable by us and applying the net proceeds from the offering.


The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price, the actual number of ADSs offered by us, and other terms of the offering determined at pricing.

(4)
Translated solely for convenience into dollars at an exchange rate of €1.00=US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020, except as it relates to the impact of the assumed proceeds, which are translated into U.S. dollars at an exchange rate of €1.00=US$            , the exchange rate of the Banque de France on                        .

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RISK FACTORS

        Investing in our ADSs involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this prospectus, including our consolidated financial statements and related notes, before deciding whether to purchase our securities. Many of the following risks and uncertainties are, and will be, exacerbated by COVID-19 and any worsening of the global business and economic environment as a result. If any of the following risks are realized, our business, financial condition, operating results and prospects could be materially and adversely affected. In that event, the market price of our securities could decline, and you could lose part or all of your investment.

Risks Related to Our Limited Operating History, Financial Condition, and Capital Requirements

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current outbreak of COVID-19 and future coronavirus outbreaks, and in particular in regions where we or third parties on which we rely have significant manufacturing facilties, concentrations of clinical trial sites or other business operations.

        Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current outbreak of COVID-19, which the WHO declared a global pandemic and which has prompted severe lifestyle and commercial restrictions aimed at reducing the spread of the disease. Since March 2020, the U.S. federal and state and non-U.S. governments have implemented restricted travel and shelter-in-place orders, which, among other things, directed individuals to shelter at their places of residence, directed businesses and governmental agencies to cease non-essential operations at physical locations, prohibited certain non-essential gatherings, and ordered cessation of non-essential travel. As a result of these developments, we implemented work-from-home policies for most of our employees. We also implemented social distancing and sanitary measures. Some of our clinical study sites had to be closed, and we had to revise the protocols and obtain IRB review and approval to continue our clinical trials. With the second wave of COVID-19, governments have imposed and may impose further quarantines or other restrictions, which 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, the potential impact of changing government orders in response to the spread of COVID-19 cases and other limitations on our ability to conduct our business in the ordinary course. Although we do not anticipate any impacts to our clinical programs, these and similar, and perhaps more severe, disruptions in our operations could negatively impact our business operating results and financial condition in the future.

        Quarantines, shutdowns and shelter-in-place and similar government orders related to COVID-19 or other infectious diseases, or the perception that such events, orders or other restrictions on the conduct of business operations could occur, could impact personnel at third-party supplier, manufacturing or packaging facilities in the United States and other countries, or the availability or costs of materials, which could disrupt our supply chain. Although we do not anticipate any clinical supply issues or concerns for our planned clinical trials, restrictions resulting from the COVID-19 outbreak may disrupt our supply chain in the future and delay or limit our ability to obtain sufficient materials for our drug candidates.

        In addition, our current clinical trial and planned clinical trials may be affected by the ongoing COVID-19 pandemic. Site initiation and patient enrollment may be delayed due to prioritization of hospital resources toward the COVID-19 pandemic, and sites conducting potential patient enrollment may not be able or willing to comply with clinical trial protocols whether due to quarantines impeding patient movement or interrupting healthcare services, or due to potential patient concerns regarding interactions with medical facilities or staff. Similarly, our ability to recruit and retain principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19,

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may be delayed or disrupted, which may adversely impact our clinical trial operations. Furthermore, when the primary endpoint of one of our studies is a site-based assessment, there is a risk that participants will not be able to or want to undergo this required in person assessment for safety reasons, resulting in a delay to our studies and potentially compromising the timing and results of our study. COVID-19 may also lead to increased costs, due to a prolonged study timeframe, resulting in the need to add study staff and the need to utilize additional technological tools, such as remote monitoring, remote source-data verification and remote audits.

        Regulatory authorities may also experience a significantly increased workload, with requirements and demands for short review timelines for COVID-19 studies on the one hand and the need to amend study protocols to address COVID-19-related limitations in study conduct on the other hand. This can prolong review timelines and reduce the availability to run expedited programs which put a high demand on regulatory staff. There is also a risk that the changes to protocols of ongoing clinical trials (other than for COVID-19 indications) that were made to address restrictions imposed in the context of the coronavirus pandemic will negatively impact the review conducted by the relevant regulatory agencies. In which case, such agencies may consider the data to be insufficient to support acceptance of the data and the statistical plan. For example, changing in-office and in-person checks and visits to phone contacts may not be sufficient for regulatory review. We will not know until we complete our ongoing studies, complete analysis, and submit such data what, if any, limitations and effects could result.

        In addition, the global COVID-19 pandemic has adversely affected, and any future significant outbreak of contagious diseases could similarly adversely affect, the economics and financial markets of many countries, including the United States, resulting in an economic downturn that could reduce our ability to access capital, which could negatively affect our liquidity and ability to process our clinical trials and business operations and suppress demand for our future products. Any of these events could have a material adverse effect on our business, financial condition, results of operations or cash flow. In addition, a recession, down-turn or market correction resulting from the COVID-19 pandemic could materially adversely affect the value of our ADS and ordinary shares.

We are a clinical-stage biotechnology company with no products approved for commercial sale. We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.

        Biotechnology product development is a highly speculative undertaking because it entails substantial upfront capital expenditures and significant risk that any potential drug candidate will not demonstrate adequate effectiveness in the targeted indication or an acceptable safety profile, gain regulatory approval or become commercially viable. We have incurred significant losses since our inception in 2006, and we anticipate that we will continue to incur losses for the foreseeable future, which, together with our limited operating history, may make it difficult to assess our future viability.

        We incurred losses of €14.0 million, €17.8 million and €9.5 million ($10.5 million) for the years ended December 31, 2018 and 2019 and the six months ended June 30, 2020, respectively. Substantially all of our losses have resulted from expenses incurred in connection with our preclinical and clinical programs and other research and development activities and from general and administrative costs associated with our operations. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase as we continue to develop our drug candidates, conduct clinical trials and pursue research and development activities. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our shareholders' equity and working capital.

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We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development or other operations.

        Since our inception, we have invested a significant portion of our efforts and financial resources on our preclinical studies and clinical trials and other research and development activities. We believe that we will continue to expend substantial resources for the foreseeable future in connection with the preclinical and clinical development of our current drug candidates and the discovery and development of any other drug candidates we may choose to pursue. These expenditures will include costs associated with conducting preclinical studies and clinical trials and obtaining regulatory approvals, and any expenses associated with commercializing, marketing and selling products approved for sale that we elect to commercialize ourselves. In addition, other unanticipated costs may arise. Because the outcome of any preclinical study or clinical trial is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of our current drug candidates or any future drug candidates we may choose to pursue.

        We estimate that the net proceeds from the offering will be approximately $             million, based on an assumed public offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us. As of June 30, 2020, we had capital resources consisting of cash, cash equivalents, and marketable securities of €12.2 million ($13.6 million) (translated solely for convenience into dollars at an exchange rate of €1.00=$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020). Since that date and as of January 4, 2021, we have issued (i) €3 million of convertible notes in the H2 2020 Convertible Note Financing, (ii) 13,990,411 ordinary shares in the H2 2020 Bond Conversions, (iii) 1,091,380 ordinary shares in the H2 Warrant Conversions and (iv) 30,840,328 ordinary shares in the H2 2020 Private Placements totaling €16.1 million. We also (i) repaid €863 thousand in cash for the remaining 30 convertible notes that were issued to ATLAS for a redemption value of €750,000, (ii) received the proceeds of the CIR receivable financing in the amount of €1,953,518 and (iii) repaid €1,562 thousand of the carrying amount of the Kreos loan. We expect our existing capital resources, including our ability to draw down on our credit facility with ATLAS (as described in further detail in the section of this prospectus titled "Management's Discussion and Analysis of Financial Condition and Results of Operations"), together with the proceeds from the offering, will be enough to fund our planned operating expenses for the next 12 months. However, our current operating plans may change as a result of many factors currently unknown to us, and we may need to seek additional funds even sooner than planned, through public or private equity or debt financings or other sources, such as strategic collaborations. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans.

        Our future capital requirements depend on many factors, including:

    the scope, progress, data and costs of researching and developing our current drug candidates and any other drug candidates we may choose to pursue in the future, and conducting preclinical studies and clinical trials;

    the timing of, and the costs involved in, obtaining regulatory approvals for our current drug candidates or any future drug candidates we may choose to pursue;

    the number and characteristics of any additional drug candidates we develop or acquire;

    any costs associated with manufacturing our current drug candidates and any future drug candidates;

    the cost of sourcing purified extracts and a supply chain in sufficient quantity and quality to meet our needs;

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    the cost of commercialization activities associated with any of our current drug candidates or any future drug candidates that are approved for sale and that we choose to commercialize ourselves, including marketing, sales and distribution costs;

    our ability to maintain existing, and establish new, strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;

    any product liability or other lawsuits related to any current or future drug candidates that are approved for sale;

    the expenses needed to attract, hire and retain skilled personnel;

    the costs associated with being a public company;

    the costs that become required as a result of modified or revised clinical protocols for our clinical trials;

    the costs that become required due to necessity of having to perform additional clinical trials;

    the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing our intellectual property portfolio; and

    the timing, receipt and amount of sales of any future approved products, if any.

        Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis on terms acceptable to us, we may be required to:

    delay, limit, reduce or terminate preclinical studies, clinical trials or other development activities for our current drug candidates or any future drug candidate;

    seek corporate partners for our drug candidates when we would otherwise develop our drug candidates on our own, or at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;

    delay, limit, reduce or terminate our research and development activities; or

    delay, limit, reduce or terminate any efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize our current drug candidates or any future drug candidates.

        We do not expect to realize revenue from sales of products or royalties from licensed products in the foreseeable future, if at all, unless and until our drug candidates are clinically tested, approved for commercialization and successfully marketed. To date, we have primarily financed our operations through the sale of debt and equity securities, as well as public aid for innovation and reimbursement of the French research tax credit, described elsewhere in this prospectus. We will need to seek additional funding in the future and currently intend to do so through collaborations, public or private equity offerings or debt financings, credit or loan facilities, public funding, or a combination of one or more of these funding sources. Our ability to raise additional funds will depend on financial, economic and other factors, many of which are beyond our control. Additional funds may not be available to us on acceptable terms or at all. If we enter into arrangements with collaborators or others, we may be required to relinquish rights to some of our drug candidates that we would otherwise pursue on our own. If we raise additional funds by issuing equity securities, our shareholders will suffer dilution and the terms of any financing may adversely affect the rights of our shareholders. In addition, as a condition to providing additional funds to us, future investors may demand, and may be granted, rights superior to those of existing shareholders. Debt financing, if available, is likely to involve restrictive covenants limiting our flexibility in conducting future business activities, and, in the event of insolvency,

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debt holders would be repaid before holders of our equity securities received any distribution of our corporate assets.

We have benefited from certain reimbursable financial advances and non-reimbursable subsidies from the French government that if terminated or reduced may restrict our ability to successfully develop, manufacture and commercialize our drug candidates.

        We have benefited from certain reimbursable advances and non-reimbursable subsidies from the French government and intend to continue to seek advances and/or subsidies from these agencies in the future in order to accelerate the development of our drug candidates. There is no assurance that these benefits will continue to be available to us in the future. If such benefits and programs were to be terminated or reduced, it could have an adverse effect on our business, operating results and financial condition and could deprive us of financial resources necessary for research and development of our drug candidates. Furthermore, the advances and subsidies are generally subject to contractual conditions, including our compliance with agreed upon preliminary budgets and scientific programs, informing the lender of any deviations from such agreed upon budgets and programs, and our compliance with certain financial ratios to ensure our solvency. In the event that we do not comply with the contractual conditions of the subsidies, we may be required to reimburse the French government for any outstanding payments (currently €886 thousand) on an accelerated basis and could be liable for any damages incurred by such agencies resulting from the breach of contract.

Due to the significant resources required for the development of our drug candidates, we must prioritize development of certain drug candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

        We plan to develop a pipeline of drug candidates to treat age-related diseases and diseases whose progression and symptoms are similar to those associated with aging. Due to the significant resources required for the development of drug candidates, we must focus our attention and resources on specific diseases and disease pathways and decide which drug candidates to pursue and the amount of resources to allocate to each.

        Our decisions concerning the allocation of research, development, collaboration, management and financial resources toward particular drug candidates or therapeutic areas may not lead to the development of any viable commercial product and may divert resources away from better opportunities. Similarly, any decision to delay, terminate or collaborate with third parties in respect of certain programs may subsequently prove to be suboptimal and could cause us to miss valuable opportunities. If we make incorrect determinations regarding the viability or market potential of any of our programs or drug candidates or misread trends in the aging or healthspan, or biotechnolgy industry, our business, financial condition and results of operations could be materially adversely affected. As a result, we may fail to capitalize on viable commercial products or profitable market opportunities, be required to forego or delay pursuit of opportunities with other drug candidates or other diseases and disease pathways that may later prove to have greater commercial potential than those we choose to pursue, or relinquish valuable rights to such drug candidates through collaboration, licensing or other royalty arrangements in cases in which it would have been advantageous for us to invest additional resources to retain development and commercialization rights.

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Our operating results may fluctuate significantly, which may make our future operating results difficult to predict.

        Our operating results may fluctuate significantly, which may make it difficult for us to predict our future operating results. These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:

    the timing and cost of, and level of investment in, research, development and, if approved, any commercialization activities relating to our drug candidates, which may change from time to time;

    the timing and status of enrollment for our clinical trials;

    the cost of manufacturing our drug candidates, as well as building out our supply chain, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;

    expenditures that we may incur to acquire, develop or commercialize additional drug candidates;

    the timing and amount of any future milestone, royalty or other payments due under any collaboration or license agreement;

    future accounting pronouncements or changes in our accounting policies;

    the timing and success or failure of preclinical studies and clinical trials for our drug candidates and/or redesign, delays and/or change of scope of our preclinical or clinical trials;

    the timing of receipt of approvals for our drug candidates from regulatory authorities in the United States and internationally;

    the timing and success of competing drug candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;

    coverage and reimbursement policies with respect to our drug candidates, if approved; and

    the level of demand for our products, if approved, which may vary significantly over time.

        The cumulative effects of these factors could result in large fluctuations and unpredictability in our annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past results as an indication of our future performance.

        This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our ordinary shares and ADSs could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated revenue or earnings guidance we may provide.

Our indebtedness could restrict our operations and make us more vulnerable to adverse economic conditions.

        On September 10, 2018, we entered into a Venture Loan Agreement and Bonds Issue Agreement with Kreos, which provides for up to €10 million in financing to us. Pursuant to the terms of the agreements, Kreos agreed to subscribe for up to €10 million in non-convertible bonds, to be issued by us in up to four tranches of €2.5 million each. The first two tranches were issued in September 2018, a third tranche was issued in December 2018, and the final tranche was issued on March 1, 2019. Each tranche bears a 10% annual interest rate and must be repaid in 36 monthly installments, with monthly payments of €320,004 commencing in April 2019. In connection with the first tranche, we issued a

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warrant to Kreos giving them the right to purchase 442,477 new ordinary shares at an exercise price of €2.67 per share over a 7-year period from the issue date.

        If we are unable to make the required payments, we may need to refinance all or a portion of our indebtedness, sell assets, delay capital expenditures or seek additional equity. The terms of our existing or future debt agreements may also restrict us from affecting any of these alternatives. Any refinancing of our debt could be at higher interest rates and may require us to comply with more onerous covenants, which could further restrict our business operations. Further, changes in the credit and capital markets, including market disruptions and interest rate fluctuations, may increase the cost of financing, make it more difficult to obtain favorable terms, or restrict our access to these sources of future liquidity. In addition, any failure to make scheduled payments of interest and principal on our outstanding indebtedness would likely result in a reduction of our credit rating, which could harm our ability to incur additional indebtedness on commercially reasonable terms or at all. Our inability to generate sufficient cash flow to satisfy our debt service obligations, or to refinance or restructure our obligations on commercially reasonable terms or at all, could have a material adverse effect on our business, financial condition and results of operations, as well as on our ability to satisfy our obligations in respect of our indebtedness.

        Pursuant to the terms of the agreements, we have the right, at any time but with no less than 30 days prior notice to Kreos, to prepay or purchase the bonds, exclusively in full. The prepayment will be equal to (i) the principal amount outstanding, plus (ii) the sum of all interest repayments which would have been paid throughout the remainder of the term of the relevant tranche discounted by 10% per annum.

Our debt agreements contain restrictions that limit our flexibility in operating our business.

        Our Venture Loan Agreement and Bonds Issue Agreement with Kreos and our convertible notes agreement with ATLAS, impose certain operating and financial restrictions. These covenants may limit our ability and the ability of our subsidiaries, under certain circumstances, to, among other things:

    incur additional indebtedness;

    create or incur liens;

    sell or transfer assets; and

    pay dividends and distributions.

        These agreements also contain certain customary affirmative covenants and events of default, including a change of control.

        As a result of the covenants and restrictions contained in our existing debt agreements, we are limited in how we conduct our business, and we may be unable to raise additional debt to compete effectively or to take advantage of new business opportunities. The terms of any future indebtedness we may incur could include more restrictive covenants. We cannot guarantee that we will be able to maintain compliance with these covenants in the future and, if we fail to do so, that we will be able to obtain waivers from Kreos and ATLAS, and/or amend the covenants.

        Our failure to comply with the restrictive covenants described above as well as others contained in our future debt instruments from time to time could result in an event of default, which, if not cured or waived, could result in our being required to repay these borrowings before their maturity dates. In addition, any event of default or declaration of acceleration under one debt instrument could also result in an event of default under one or more of our other debt instruments. If we are unable to repay, refinance or restructure our indebtedness under our secured debt, the holders of such debt could proceed against the collateral securing that indebtedness. If we are forced to refinance these

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borrowings on less favorable terms or if we are unable to repay, refinance or restructure such indebtedness, our financial condition and results of operations could be adversely affected.

Risks Related to Our Business

Our business is dependent on the successful development, regulatory approval, manufacture and commercialization of our drug candidates, both of which are in the early stages of development.

        We have no products approved for sale. Our lead drug candidate, Sarconeos (BIO101), is in clinical development and our second drug candidate, Macuneos (BIO201) is still in the preclinical phase. Our life-cycle extension drug candidates, BIO103 and BIO203, are still in the preclinical development phase. To secure marketing approval for our lead drug candidates, we will need to meet endpoints satisfactory to the FDA and EMA in larger confirmatory clinical trials. The success of our business, including our ability to finance our company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization of drug candidates. However, given our early stage of development, it may be many years, if we succeed at all, before we have demonstrated the safety and efficacy of a drug candidate sufficient to warrant approval for commercialization.

        In the future, we may also become dependent on other drug candidates that we may develop or acquire. The clinical and commercial success of our current drug candidates and any future drug candidates will depend on a number of factors, including the following:

    our ability to raise any additional required capital on acceptable terms, or at all;

    our ability to complete IND-enabling studies and successfully submit IND or comparable applications;

    timely completion of our preclinical studies and clinical trials, which may be significantly slower or cost more than we currently anticipate and will depend substantially upon the performance of third-party contractors;

    whether we are required by the FDA, EMA or similar regulatory agencies to conduct additional clinical trials or other studies beyond those planned to support the approval and commercialization of our drug candidates or any future drug candidates;

    acceptance of our proposed indications and primary endpoint assessments relating to the proposed indications of our drug candidates by the FDA, the EMA and similar foreign regulatory authorities;

    our ability to demonstrate to the satisfaction of the FDA, EMA and similar foreign regulatory authorities the safety, efficacy and acceptable risk to benefit profile of our drug candidates or any future drug candidates;

    our ability to perform clinical trials according to modified clinical trial protocols and to adapt to work environments that are changing due to the COVID-19 pandemic (e.g., a significant number of our employees who are working from home);

    the prevalence, duration and severity of potential side effects or other safety issues experienced with our drug candidates or future approved products, if any;

    the timely receipt of necessary marketing approvals from the FDA, EMA and similar foreign regulatory authorities;

    achieving and maintaining, and, where applicable, ensuring that our third-party contractors achieve and maintain compliance with our contractual obligations and with all regulatory

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      requirements applicable to our drug candidates or any future drug candidates or approved products, if any;

    the ability of any third parties with whom we contract to manufacture adequate clinical trial and commercial supplies, if approved, of our current drug candidates or any future drug candidates, remain in good standing with regulatory agencies and develop, validate and maintain commercially viable manufacturing processes that are compliant with current good manufacturing practices, or cGMP;

    with respect to any approved drug candidates that we elect to commercialize ourselves, our ability to successfully develop a commercial strategy and thereafter commercialize such drug candidates, whether alone or in collaboration with others;

    the convenience of our treatment or dosing regimen;

    our sourcing of purified extracts and a supply chain in sufficient quantity and quality to meet product needs for clinical development and commercialization;

    acceptance by physicians, payors and patients of the benefits, safety and efficacy of our drug candidates or any future drug candidates, if approved, including relative to alternative and competing treatments;

    patient demand for our drug candidates, if approved;

    our ability to maintain adequate drug diversion controls for Sarconeos (BIO101), which has a potential for misuse/abuse among body builders and other sportsmen as a result of its intended anabolic effect;

    lifestyle and commercial restrictions as a result of the current outbreak of COVID-19;

    the potential impact of changing government orders in response to upticks in COVID-19 cases and other limitations on our ability to conduct our business in the ordinary course;

    prioritization of hospital resources toward the COVID-19 pandemic which would otherwise be used for clinical studies;

    the ability of our participants to safely follow clinical trial protocols because of quarantines impeding patient movement or interrupting healthcare services, or due to potential patient concerns regarding interactions with medical facilities or staff as a result of the COVID-19 pandemic;

    our ability to recruit and retain principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, may be delayed or disrupted, which may be adversely impact our clinical trial operations;

    delays due to the COVID-19 pandemic, including due to reduced workforce productivity as a result of our implementation of a temporary work-from-home policy or illness among personnel, or due to delays at our third-party contract research organizations throughout the world for similar reasons or due to restirctions imposed by applicable governmental authorities;

    the impact, if any on the data from ongoing studies that have been impacted by the initial and subjequent waves of the coronavirus pandemic effect, and whether changes that were made to accommodate the pandemic will allow regulatory acceptance of the resulting data or whether the data will be sufficient for regulatory review—the effect of such changes will not be known until we complete ongoing studies, data analysis, and submit the data for regulatory review;

    our ability to establish and enforce intellectual property rights in and to our current drug candidates and any future drug candidates we may develop;

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    our ability to avoid third-party patent interference, intellectual property challenges or intellectual property infringement claims; and

    risks related to COVID-19, the status of the ongoing pandemic, availability of vaccines, and pattern of spread (which may depend on persistence, or lack thereof, of antibodies which, as of the date of this prospectus, is suspected to be no longer than six to 12 months).

        These factors, many of which are beyond our control, could cause us to experience significant delays or an inability to obtain regulatory approvals or commercialize or license our drug candidates. Even if regulatory approvals are obtained, we may never be able to successfully commercialize or license any of our drug candidates. Accordingly, we cannot provide assurances that we will be able to generate sufficient revenue through the sale of our drug candidates or any future drug candidates we may develop to continue our business or achieve profitability.

We may not be able to obtain regulatory approval for our drug candidates under applicable regulatory requirements. The denial, delay or imposed limitations of or on any such approval would preclude, delay or limit the commercialization of our drug candidates and adversely impact our potential to generate revenue and/or raise financing, our business and our results of operations.

        To gain approval to market our drug candidates, we must provide the FDA, EMA and other foreign regulatory authorities with clinical data that adequately demonstrate the safety and efficacy of the drug candidate for the intended indication applied for in the applicable regulatory filing. It is not currently known what effect, if any, modificiation of ongoing non-COVID-19 related studies resulting from the COVID-19 pandemic, will have on the acceptability of data from such revised studies. Product development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical development programs. A number of companies in the biotechnology and pharmaceutical industries have suffered significant setbacks in clinical trials, even after promising data in preclinical studies or earlier phase clinical trials. These setbacks have been caused by, among other things, new preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. Success in preclinical testing and early phase clinical trials does not ensure that later phase clinical trials will be successful, and the results of clinical trials conducted by other parties may not be indicative of the results in trials we may conduct.

        The research, testing, manufacturing, packaging, labeling, approval, sale, marketing and distribution of drug and biologic products are subject to extensive regulation by the FDA, EMA and other foreign regulatory authorities, and such regulations differ from country to country. We are not permitted to market our investigational drug candidates in the EU, the United States or any other country until they receive the requisite approval from the applicable regulatory authorities of such jurisdictions.

        Separately, in response to the global pandemic of COVID-19, on March 10, 2020, the FDA announced its intention to postpone most foreign inspections of manufacturing facilities and products through April 2020. Subsequently, on July 10, 2020, the FDA announced its intention to resume certain on-site inspections of domestic manufacturing facilities subject to a risk-based prioritization system. The FDA intends to use this risk-based assessment system to identify the categories of regulatory actitivty that can occur within a given geographic area, ranging from mission-critical inspections to resumption of all regulatory activities. With the second wave of COVID-19, if global health concerns prevent the FDA, EMA and other foreign regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA, EMA or other foreign regulatory authorities to timely review and process regulatory submissions, which could have a material adverse effect on our business.

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        The FDA, EMA or any foreign regulatory bodies can delay, limit or deny approval of our drug candidates for many reasons, including:

    our inability to demonstrate to the satisfaction of the agency that a drug candidate is safe and effective for the requested indication;

    the agency's disagreement with our trial protocol or the interpretation of data from preclinical studies or clinical trials, including studies impacted by the coronavirus pandemic;

    the agency's refusal to accept the data that is produced from modified protocols (e.g., data collected from phone contacts instead of in-office and in-person checks and visits may not be sufficient for regulatory approval or clearance);

    our inability to demonstrate that the clinical and other benefits of a drug candidate outweigh any safety or other perceived risks;

    the agency's requirement for additional preclinical studies or clinical trials;

    the agency's non-approval of the formulation, labeling or specifications of a drug candidate;

    the agency's failure to approve the manufacturing processes or facilities of third-party manufacturers upon which we rely;

    our inability to demonstrate to the satisfaction of the agency the sourcing of purified extracts and that our supply chain is in sufficient quantity and quality to meet product specifications; or

    the potential for approval policies or regulations of the FDA, EMA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

        In addition, the legal and regulatory basis for expedited and emergency programs related to COVID-19 may be revoked and withdrawn if the public health assessment warrants the removal of the pandemic and emergency status.

        Of the large number of biotechnology and pharmaceutical products in development, only a small percentage successfully complete the applicable regulatory approval processes and are commercialized.

        Even if we eventually complete clinical testing and receive approval from the FDA, EMA or applicable foreign agencies for any of our drug candidates, the applicable agency may grant approval contingent on the performance of costly additional clinical trials, which may be required after approval. The FDA, EMA or the applicable foreign regulatory agency also may approve our drug candidates for a more limited indication or a narrower patient population than we originally requested, and the applicable agency, may not approve our drug candidates with the labeling that we believe is necessary or desirable for the successful commercialization of such drug candidates.

        Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of our drug candidates and would materially adversely impact our business and prospects.

Clinical development is a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.

        Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure or delay can occur at any time during the different phases, or stages, of the clinical trial process. Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful. A number of companies in the biotechnology, biopharmaceutical and pharmaceutical industries have suffered significant setbacks in clinical trials, even after positive results in earlier preclinical studies or earlier phase clinical trials. These setbacks have been caused by, among

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other things, new preclinical findings made while clinical trials were underway and safety or efficacy observations made in clinical trials, including previously unreported adverse events. The results of our preclinical studies or in vivo and in vitro studies provide very limited data in diseases whose physiopathology is not well understood and may not be predictive of the results of study outcomes in human clinical trials. Drug candidates in later stages of clinical trials may fail to show the desired pharmacological properties or safety and efficacy traits despite having progressed through preclinical studies and early phase clinical trials. Notwithstanding any promising results in earlier studies, we cannot be certain that we will not face setbacks and receive less promising results in later studies. Even if we are able to initiate and complete clinical trials, including studies underway during the initial coronavirus pandemic, the safety and efficacy data may not be sufficient to obtain regulatory approval for our drug candidates.

        We may experience delays in obtaining the necessary regulatory authorization for our MYODA and COVA clinical program of Sarconeos (BIO101) and/or our MACA clinical trial program for Macuneos (BIO201), completing our SARA-INT Phase 2 clinical trial of Sarconeos (BIO101), and initiating other planned studies and trials. Additionally, we cannot be certain that studies or trials for our drug candidates will begin on time, not require redesign, enroll an adequate number of subjects on time or be completed on schedule, if at all. Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to:

    the FDA, EMA or comparable foreign regulatory authorities disagreeing as to the design or implementation of our clinical trials;

    delays in obtaining regulatory approval to commence a trial;

    reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

    IRB approval at each trial site;

    recruiting an adequate number of suitable patients to participate in a trial;

    having subjects complete a trial or return for post-treatment follow-up;

    clinical sites deviating from trial protocol or dropping out of a trial;

    inability to access sites for initiation and patient monitoring and enrollment due to travel or quarantine restrictions imposed by national, federal, state or local governance;

    addressing subject safety concerns that arise during the course of a trial;

    adding a sufficient number of clinical trial sites;

    sourcing of purified extracts and a supply chain in sufficient quantity and quality to meet product needs;

    safety issues that are discovered in preclinical studies that will be conducted concurrently with the COVA clinical trial;

    supply chain and sourcing may be slow or significantly delayed as the result of COVID-19 restrictions on movement suspensions of service, and temporary global border closings; or

    obtaining sufficient product supply of drug candidate for use in preclinical studies, clinical trials, or during industrial scale up from third-party suppliers.

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        We may experience numerous adverse or unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our drug candidates, including:

    we may receive feedback from regulatory authorities that requires us to modify the design of our clinical trials;

    clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs;

    patient screening, new patient enrollment, monitoring and data collection may be affected or delayed as a result of restrictions imposed by national, federal, state or local governments due to COVID-19;

    the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate;

    our third-party contractors may fail to comply with regulatory requirements, fail to maintain adequate quality controls, or be unable to source or provide us with sufficient purified extracts for product supply to conduct and complete preclinical studies or clinical trials of our drug candidates in a timely manner, or at all;

    we or our investigators might have to suspend or terminate clinical trials of our drug candidates for various reasons, including non-compliance with regulatory requirements, inability to comply with applicable study protocol as a result of COVID-19 restrictions, a finding that our drug candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;

    limitations occurring as a result of public health emergencies, such as COVID-19;

    the impact, if any on the data from ongoing studies that have been impacted by the initial and subjequent waves of the coronavirus pandemic effect and whether changes to accommodate the pandemic will impact regulatory acceptance of the data or whether it will be sufficient for regulatory review, the effect of which will not be known until we complete ongoing studies, data analysis and submit the data for regulatory review;

    the cost of clinical trials of our drug candidates may be greater than we anticipate;

    the quality of our drug candidates or other materials necessary to conduct preclinical studies or clinical trials of our drug candidates may be insufficient or inadequate;

    regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; and

    future collaborators may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us.

        If we are required to conduct additional clinical trials or other testing of our drug candidates beyond those that we currently contemplate, if we are unable to successfully complete clinical trials of our drug candidates or other testing, if the results of these trials or tests are not positive or are only moderately positive or if there are safety concerns, we may:

    incur unplanned costs;

    be delayed in obtaining marketing approval for our drug candidates or, in due course, not obtain marketing approval at all;

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    obtain marketing approval in some countries and not in others;

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

    obtain marketing approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

    be subject to additional post-marketing testing requirements; or

    have the treatment removed from the market after obtaining marketing approval.

        We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by the Data Safety Monitoring Board, or DSMB, for such trial or by the FDA, EMA or other regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA, EMA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

        Further, conducting clinical trials in foreign countries presents additional risks that may delay completion of our clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries, including foreign countries' enforcement of COVID-19 restrictions on movement and lifestyle.

        Principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or a regulatory authority concludes that the financial relationship may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection of the marketing application we submit. Any such delay or rejection could prevent or delay us from commercializing our current or future drug candidates.

        If we experience delays in the completion, or termination, of any preclinical study or clinical trial of our drug candidates, the commercial prospects of our drug candidates may be harmed, and our ability to generate revenues from any of these drug candidates will be delayed or not realized at all. In addition, any delays in completing our clinical trials may increase our costs, slow down our drug candidate development and approval process and jeopardize our ability to commercialize our products and generate revenues. Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our drug candidates. If one or more of our drug candidates prove to be ineffective, unsafe or commercially unviable, our entire platform and pipeline would have little, if any, value, which would have a material and adverse effect on our business, financial condition, results of operations and prospects.

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If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

        The timely completion of clinical trials in accordance with their protocols depends on, among other things, our ability to enroll a sufficient number of patients who remain in the study until its conclusion. We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The enrollment of patients depends on many factors, including:

    the patient eligibility criteria defined in the protocol;

    the size of the patient population required for analysis of the trial's primary endpoints;

    the proximity of patients to trial sites;

    the ability of patients to be assessed in study sites, given potential lock-downs due to the COVID-19 pandemic;

    the design of the trial;

    patient enrollment may be delayed due to quarantines impeding patient movement or patient concerns regarding interaction and monitoring with medical facilities and staff;

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

    clinicians' and patients' perceptions as to the potential advantages of the drug candidate being studied in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating; and

    our ability to obtain and maintain patient consents.

        In addition, our clinical trials may compete with other clinical trials for drug candidates that are in the same therapeutic areas as our drug candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we may conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site.

        Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our drug candidates.

Our drug candidates may cause undesirable side effects or have other properties 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.

        Undesirable side effects caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA or comparable foreign regulatory authorities. For example, one of our drug products, Sarconeos (BIO101), has been identified as having potential for misuse/abuse of the intended anabolic effect by body builders and sportsmen. Participants in clinical studies with Sarconeos (BIO101) are advised not to allow anyone access to the trial medication and the investigators specifically instruct subjects not to share their medicine. This risk is likely to become more significant after marketing authorization is granted, and the label for the drug, if it becomes approved, may have warnings and restrictions on the use and distribution of the product.

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        If unacceptable side effects arise in the development of our drug candidates, we, the FDA, EMA, the IRBs at the institutions in which our studies are conducted, or the DSMB could suspend or terminate our clinical trials or the FDA, EMA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our drug candidates for any or all targeted indications. Treatment-related side effects could also affect patient recruitment or the ability of enrolled patients to complete any of our clinical trials or result in potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Failure to recognize or manage the potential side effects of our drug candidates could result in patient injury. Any of these occurrences may harm our business, financial condition and prospects significantly.

        If our drug candidates are used in combination with other drugs or treatments, they may interact negatively with those other drugs or treatments. We plan to conduct studies in order to assess the risks of interactions of our drug candidates with other drugs and treatments taken together. However, there can be no guarantee that our drug candidates will not interact negatively with other drugs or treatments not covered by our studies or that such interactions will not be revealed until after the products have been commercialized. These interactions could have adverse, unacceptable or undetected side effects, or could reduce or destroy the effectiveness of our drug candidates, which could diminish the commercial potential of our drug candidates, slow their development and consequently, have a material adverse effect on our business, financial condition and prospects.

        Even if we successfully advance any of our drug candidates into and through clinical trials, such trials will likely only include a limited number of subjects and limited duration of exposure to our drug candidates. As a result, we cannot be assured that adverse effects of our drug candidates will not be uncovered when a significantly larger number of patients are exposed to the drug candidate. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of taking our drug candidates over a multi-year period. Certain clinical trial protocols that are revised because of the current COVID-19 pandemic may also make it more difficult to identify potential safety concerns early on.

        If any of our drug candidates receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result, including:

    regulatory authorities may withdraw their approval of the product;

    we may be required to recall a product or change the way such product is administered to patients;

    additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;

    regulatory authorities may require the addition of labeling statements, such as a "black box" warning or other warnings, including a potential for abuse warning;

    we may be required to implement a Risk Evaluation and Mitigation Strategy, or REMS, or create a Medication Guide outlining the risks of such side effects for distribution to patients;

    we could be sued and held liable for harm caused to patients;

    the sales of our product may decrease significantly and the product may become less competitive; and

    our reputation may suffer.

        Any of the foregoing events could prevent us from achieving or maintaining market acceptance of the particular drug candidate, if approved, and result in the loss of significant revenues to us, which would materially and adversely affect our results of operations and business. In addition, if one or more

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of our drug candidates prove to be unsafe, our entire platform and pipeline could be affected, which would have a material and adverse effect on our business, financial condition, results of operations and prospects.

Even if our current drug candidates or any future drug candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.

        Even if one or more of our drug candidates receives the necessary regulatory approvals, the commercial success of any of our current or future drug candidates will depend significantly on the broad adoption and use of the resulting product by physicians and patients for approved indications. Our drug candidates may not be commercially successful. For a variety of reasons, including among other things, competitive factors, pricing or physician preference, reimbursement by insurers, the degree and rate of physician and patient adoption of our current or future drug candidates, if approved, will depend on a number of factors, including:

    the clinical indications for which the product is approved and patient demand for approved products that treat those indications;

    the safety and efficacy of our product as compared to other available therapies;

    the feasabilty of adhering to heightened drug diversion protocols for drug product Sarconeos (BIO101) which has the potential for misuse/abuse by body builders and other sportsmen;

    the availability of coverage and adequate reimbursement from managed care plans, insurers and other healthcare payors for any of our drug candidates that may be approved;

    acceptance by physicians, operators of clinics and patients of the product as a safe and effective treatment;

    overcoming any biases physicians or patients may have toward particular therapies for the treatment of approved indications;

    public misperception regarding the use of our therapies, or public bias against "anti-aging" companies;

    patient satisfaction with the administration and effectiveness of our drug candidates and overall treatment experience, including, for example, the convenience of any dosing regimen and storage method;

    the cost of treatment with our drug candidates in relation to alternative treatments and reimbursement levels, if any, and willingness to pay for the product, if approved, on the part of insurance companies and other third-party payers, physicians and patients;

    the timing of market introduction of the drug candidate as well as competitive products;

    the revenue and profitability that our products may offer a physician as compared to alternative therapies;

    the prevalence and severity of side effects;

    limitations or warnings contained in the approved labeling for our products;

    any regulatory agency's requirement to undertake a REMS;

    the effectiveness of our sales, marketing and distribution efforts;

    COVID-19 may be substantially eradicated prior to our development of a successful therapy in the COVA clinical program by one or more of the vaccines that have been or may in the future be authorized for use, or the therapy produced by the COVA clinical program may not be

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      effective against other or future coronaviruses, reducing or eliminating the need for this therapy to treat the disease;

    the SARS-CoV-2 virus could develop resistance to our treatment developed in the COVA clinical program, which could affect any long-term demand or sales potential for our potential therapies;

    adverse publicity about our products or favorable publicity about competitive products; and

    potential product liability claims.

        We cannot assure you that our current or future drug candidates, if approved, will achieve broad market acceptance among physicians and patients. Any failure by our drug candidates that obtain regulatory approval to achieve market acceptance or commercial success would adversely affect our results of operations.

We rely on third parties to provide the raw materials necessary for our drug candidates and to manufacture preclinical and clinical supplies of our drug candidates and we intend to rely on third parties to produce commercial supplies of any approved drug candidate. The loss of these suppliers or manufacturers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.

        We do not have nor do we plan to build or acquire the infrastructure or capability internally to source the raw materials necessary to produce our drug candidates and/or to manufacture our drug candidates on a preclinical, clinical or commercial scale.

        Sarconeos (BIO101) is a pharmaceutical-grade purification of 20-hydroxyecdysone, which is derived from the Cyamnotis sp or Stemmacantha sp, a plant cultivated in China and used for medicinal purposes in traditional Chinese medicine. There are a limited number of growers of this plant and suppliers of the plant material and we must account for the lead time required to grow sufficient quantities of the plant to meet our needs. At this time we rely on one supplier for the plant quantities we require for our clinical trials. We have not entered into a long-term supply agreement with this supplier. We have already obtained GMP batches/GMP-compliant batches/batches produced in compliance with GMP of Sarconeos (BIO101) for our ongoing SARA-INT Phase 2 and COVA Phase 2/3 clinical trials and we believe we can secure sufficient quantities for our SARA, COVA and MYODA clinical programs through our current supply chain up to regulatory approval and/or marketing authorization. If our current supplier is unable to provide sufficient quantities of the plant to produce Sarconeos (BIO101) for future clinical trials, our ability to obtain regulatory approval for Sarconeos (BIO101) would be affected. If we receive regulatory approval, we will likely need substantial quantities of plants to produce Sarconeos (BIO101) for commercial development. If our current supplier is unable to provide sufficient quantities of the plant to produce Sarconeos (BIO101) and if we are unable to find an alternative source, our ability to commercialize Sarconeos (BIO101) would be impaired. In order to address this issue, we are evaluating alternative methods for producing 20-hydroxyecdysone in order to optimize the supply chain to support our projected commercial needs.

        Macuneos (BIO201) is a pharmaceutical-grade purification of norbixin, which is derived from seeds of Bixa orellana L., a plant traditionally used for medicinal purposes in the Amazon and currently used for producing a food color in many countries. Although this plant is more widely available, there are a limited number of suppliers of the plant material that could meet our requirement for quality. At this time we rely on one supplier for the plant quantities we will require for our MACA clinical program. We have not entered into a long-term supply agreement with this supplier. If our current supplier is unable to provide sufficient supply to produce Macuneos (BIO201) for future clinical trials, our ability to obtain regulatory approval Macuneos (BIO201) would be affected. If we receive regulatory approval, we will likely need substantial quantities of plants to produce Macuneos (BIO201) for commercial

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development. If our current supplier is unable to provide sufficient quantities of the plant to produce Macuneos (BIO201) and if we are unable to find an alternative source, our ability to commercialize Macuneos (BIO201) would be impaired. In order to address this issue, we are evaluating alternative methods for producing norbixin in order to optimize the supply chain to support our projected commercial needs.

        Our contract manufacturing partner for both Sarconeos (BIO101) and Macuneos (BIO201) is Patheon, a part of Thermo Fisher Scientific, located in Germany. We have not entered into a long-term manufacturing agreement with Patheon or any other contract manufacturer.

        The facilities used by our contract manufacturer to manufacture our drug candidates are subject to various regulatory requirements and may be subject to the inspection of the FDA, EMA or other regulatory authorities. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partner for compliance with the regulatory requirements, known as cGMPs. If our contract manufacturer cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA, EMA or comparable regulatory authorities in foreign jurisdictions, we may not be able to rely on their manufacturing facilities for the manufacture of our drug candidates. In addition, we have limited control over the ability of our contract manufacturer to maintain adequate quality control, quality assurance and qualified personnel. If the FDA, EMA or a comparable foreign regulatory authority finds these facilities inadequate for the manufacture of our drug candidates or if such facilities are subject to enforcement action in the future or are otherwise inadequate, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our drug candidates. Any significant delay in, or quality control problems with respect to, the supply of a drug candidate, or the raw material components thereof, for an ongoing study or trial could considerably delay completion of our preclinical studies or future clinical trials, product testing and potential regulatory approval of our drug candidates. Moreover, quarantines, shutdowns, shelter-in-place and other restrictions related to COVID-19 or other infectious diseases, or the perception that such events, orders or other restrictions on the conduct of business operations could occur, could impact personnel at manufacturing facilities which could disrupt our supply chain.

        If any of our drug candidates is approved by the FDA, EMA and/or comparable foreign regulatory authorities and we choose to independently commercialize such drug candidate, we will need to engage manufacturers for the commercial supply of such drug candidates. However, we may be unable to enter into any such agreement or do so on commercially reasonable terms, which could have a material adverse impact upon our business. Moreover, if there is a disruption to one or more of our third-party manufacturers' or suppliers' relevant operations, or if we are unable to enter into arrangements for the commercial supply of our drug candidates, we will have no other means of producing our drug candidates until they restore the affected facilities or we or they procure alternative manufacturing facilities or sources of supply. Our ability to progress our preclinical and clinical programs could be materially and adversely impacted if any of the third party suppliers upon which we rely were to experience a significant business challenge, disruption or failure due to issues such as financial difficulties or bankruptcy, issues relating to other customers such as regulatory or quality compliance issues, or other financial, legal, regulatory or reputational issues. Additionally, any damage to or destruction of our third-party manufacturers' or suppliers' facilities or equipment may significantly impair our ability to manufacture our drug candidates on a timely basis.

        In addition, to manufacture our drug candidates in the quantities that we believe would be required to meet anticipated market demand, our third-party manufacturers would likely need to increase manufacturing capacity and, in some cases, we could be required to secure alternative sources of commercial supply, which could involve significant challenges and could require additional regulatory approvals. COVID-19 restrictions create a risk that we may not be able to develop or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels. In addition, the

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development of commercial-scale manufacturing capabilities could require us and our third-party manufacturers to invest substantial additional funds and hire and retain the technical personnel who have the necessary manufacturing experience. Neither we nor our third-party manufacturers may successfully complete any required increase to existing manufacturing capacity in a timely manner, or at all. If our manufacturers or we are unable to purchase the raw materials necessary for the manufacture of our drug candidates on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the commercial launch of our drug candidates or any future drug candidates would be delayed or there would be a shortage in supply, which would impair our ability to generate revenues from the sale of such drug candidates, if approved.

We rely on third parties in the conduct of all of our preclinical studies and clinical trials and intend to rely on third parties in the conduct of all of our future clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our drug candidates.

        We currently do not have the ability to independently conduct preclinical studies that comply with the regulatory requirements known as good laboratory practice, or GLP, requirements. We also do not currently have the ability to independently conduct any clinical trials. The FDA, EMA and regulatory authorities in other jurisdictions require us to comply with regulations and standards, commonly referred to as good clinical practice, or GCP, requirements for conducting, monitoring, recording and reporting the results of clinical trials, in order to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. We rely on medical institutions, clinical investigators, contract laboratories and other third parties, such as CROs to conduct GLP-compliant preclinical studies and GCP-compliant clinical trials on our drug candidates properly and on time. While we have agreements governing their activities, we control only certain aspects of their activities and have limited influence over their actual performance. The third parties with whom we contract for execution of our GLP-compliant preclinical studies and our GCP-compliant clinical studies play a significant role in the conduct of these studies and trials and the subsequent collection and analysis of data. These third parties are not our employees and, except for restrictions imposed by our contracts with such third parties, we have limited ability to control the amount or timing of resources that they devote to our programs. In addition, third parties may have proprietary COVID-19 policies that may create delays or service disruptions, including a temporary work-from-home policy that leads to reduced workforce productivity. Although we rely on these third parties to conduct our GLP-compliant preclinical studies and GCP-compliant clinical trials, we remain responsible for ensuring that each of our GLP preclinical studies and clinical trials is conducted in accordance with its investigational plan and protocol and applicable laws and regulations, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

        Many of the third parties with whom we contract may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities that could harm our competitive position. If the third parties conducting our preclinical studies or our clinical trials do not adequately perform their contractual duties or obligations, experience significant business challenges, disruptions or failures, do not meet expected deadlines, terminate their agreements with us or need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to our protocols or to GCPs, or for any other reason, we may need to enter into new arrangements with alternative third parties. This could be difficult, costly or impossible, and our preclinical studies or clinical trials may need to be extended, delayed, terminated or repeated. As a result we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable drug candidate, our financial results and the commercial prospects for our drug candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed.

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We face significant competition in an environment of rapid technological and scientific change, and our drug candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration. A number of our competitors have significantly greater resources than we do and we may not be able to successfully compete.

        The biotechnology and pharmaceutical industries in particular are characterized by rapidly advancing technologies, intense competition and a strong emphasis on developing proprietary therapeutics. Numerous companies are engaged in the development, patenting, manufacturing and marketing of healthcare products competitive with those that we are developing. We face competition from a number of sources, such as pharmaceutical companies, generic drug companies, biotechnology companies and academic and research institutions, many of which have greater financial resources, marketing capabilities, sales forces, manufacturing capabilities, research and development capabilities, clinical trial expertise, intellectual property portfolios, experience in obtaining patents and regulatory approvals for drug candidates and other resources than we do. Some of the companies that offer competing products also have a broad range of other product offerings, large direct sales forces and long-term customer relationships with our target physicians, which could inhibit our market penetration efforts. Mergers and acquisitions in the biotechnology and pharmaceutical industry may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. In addition, certain of our drug candidates, if approved, may compete with other products that treat age-related diseases, including over-the-counter, or OTC, treatments, for a share of some patients' discretionary budgets and for physicians' attention within their clinical practices.

        We are aware of other companies seeking to develop treatments to prevent or treat aging-related diseases through various biological pathways. For sarcopenia, Sarconeos (BIO101) is currently the most advanced in clinical development given the recent failures of myostatin inhibitors (the last of these is bimagrumab, which was developed by Novartis and has failed in Phase 2 clinical studies). Indeed, the main challenge is to be able to identify the optimal target population given the dynamics in diagnostic criteria. The recent failures, combined with these dynamics, can deter major pharmaceutical companies from re-entering this space. While there are numerous clinical studies with new drug candidates to treat COVID-19, we believe Sarconeos (BIO101) is the most advanced drug candidate for the treatment of respiratory failure associated with COVID-19, specifically targeting the RAS imbalanced by SARS-CoV-2.

        For DMD, our current focus on non-ambulatory patients with evidence of respiratory deterioration, puts us in a position to become one of the more advanced companies that develop medications for this population. Santhera Therapeutics, which was developing idebenone for this indication, has recently stopped their Phase 2/3 study and are no longer investing in this area. For dry AMD, we believe that we will compete with a number of companies that are developing drugs to treat this disease, for example, Allegro Ophthalmics, Apellis Pharmaceuticals, Astellas, Hemera Biosciences, Ionis Pharmaceuticals, Ophthotech Corporation and Roche and Stealth Biotherapeutics.

        Certain alternative treatments offered by competitors may be available at lower prices and may offer greater efficacy or better safety profiles. Furthermore, currently approved products could be discovered to have application for treatment of age-related diseases generally, which could give such products significant regulatory and market timing advantages over any of our drug candidates. Our competitors also may obtain FDA, EMA or other regulatory approval for their products more rapidly than we may obtain approval for ours and may obtain orphan product exclusivity from the FDA or EMA for indications our drug candidates are targeting, which could result in our competitors establishing a strong market position before we are able to enter the market. Newly developed systemic

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or non-systemic treatments that replace existing therapies that are currently only utilized in patients suffering from severe disease may also have lessened side effects or reduced prices compared to current therapies, which make them more attractive for patients suffering from mild to moderate disease. Even if a generic product or an OTC product is less effective than our drug candidates, a less effective generic or OTC product may be more quickly adopted by physicians and patients than our competing drug candidates based upon cost or convenience. For additional information regarding our competition, see the section of this prospectus titled "Business—Competition."

        In addition, another party may be successful in producing a more efficacious therapy for COVID-19 or a therapy with a more convenient or preferred route of administration or in producing a therapy in a more timely manner, which may lead to the diversion of funding away from us and toward other companies or lead to decreased demand for our potential therapies. Further, other therapies that are more affordable than our potential therapies may be used to treat COVID-19, including existing generic drugs, which could also hurt the funding of and demand for our potential therapies.

        Several public and private entities have been working to develop a therapy or vaccine for COVID-19 including: BioNTech SE (together with Pfizer Inc.) and Moderna, Inc., whose COVID-19 vaccines have been authorized for emergency use, and Alexion Pharmaceuticals, Inc., Incyte Corporation, Sanofi S.A., Regeneron Pharmaceuticals, Inc., Amgen Inc. (together with Adaptive Biotechnologies Corporation), Abcellera Biologics, Inc. (together with Eli Lilly and Company), Vir Biotenchonogy, Inc. (together with GSK, Biogen Inc. and WuXi Biologics Ltd.), Altimmune, Inc., AstraZeneca PLC (together with Oxford University), GlaxoSmithKline (GSK) (together with Sanofi S.A.), Hear Biologics, Inc., Inovio Pharmaceuticals, Inc., Johnson & Johnson, Novavax, Inc. and Vaxart, Inc., among others, who are still in the development stage. These entities may be more successful at developing, manufacturing or commercializing a therapy for COVID-19, especially given that several of these other organizations are much larger than we are and have access to larger pools of capital, including U.S. government funding, and broader manufacturing infrastructure. The success or failure of other entities, or perceived success or failure, may adversely impact our ability to obtain any future funding for our development and manufacturing efforts or to ultimately commercialize a therapy for COVID-19, if approved.

Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to generate revenues and become profitable even if we obtain regulatory approval to market a product.

        Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, determine which medications they will cover and establish reimbursement levels. Assuming we obtain coverage for a given product by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the cost of our products. Therefore, coverage and adequate reimbursement is critical to new product acceptance. Coverage decisions may depend upon clinical and economic standards that disfavor new drug products when more established or lower cost therapeutic alternatives are already available or subsequently become available.

        Government authorities and other third-party payors are developing increasingly sophisticated methods of controlling healthcare costs, such as by limiting coverage and the amount of reimbursement

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for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices as a condition of coverage, are using restrictive formularies and preferred drug lists to leverage greater discounts in competitive classes, and are challenging the prices charged for medical products.

        In the United States, federal programs impose penalties on drug manufacturers in the form of mandatory additional rebates and/or discounts if commercial prices increase at a rate greater than the Consumer Price Index-Urban, and these rebates and/or discounts, which can be substantial, may impact our ability to raise commercial prices. Further, no uniform policy requirement for coverage and reimbursement for drug products exists among third-party payors in the United States. Therefore, coverage and reimbursement for drug products can differ significantly from payor to payor. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

        In the EU, coverage and reimbursement possibilities for drug products differ from one Member State to another. Each Member State has the ability to set the prices and restrict the range of medicinal products for which their national health insurance systems provide reimbursement. Factors contributing to price changes between Member States depend on different regulatory approaches and instruments used by each Member State to govern the supply and demand of medicinal products. For example, in France, a pharmaceutical company may freely set a price of a drug after obtaining the National MA. However, in order for the product to be reimbursed under the French Social Security scheme, the pharmaceutical company must follow a specific process and submit an application to the French High Authority for Health, or HAS. The opinion issued by the HAS is then transmitted to the French Economic Committee for Health Products, or CEPS—with which the pharmaceutical company has to negotiate the price of the product. The final decision on reimbursement is issued by the French Minister of Health and can be revised afterwards depending on the cost/benefit balance of the medicinal product over time. Other EU countries may adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. In view of these differences from one Member State to another, there is still a risk that some EU countries do not allow favorable reimbursements and pricing arrangements.

        The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare costs to contain or reduce costs of healthcare may negatively affect our commercialization prospects, including:

    our ability to set a price we believe is fair for our products, if approved;

    our ability to obtain and maintain market acceptance by the medical community and patients;

    our ability to generate revenues and achieve profitability; and

    the availability of capital.

        We cannot be sure that coverage and reimbursement will be available for any potential drug candidate that we may commercialize and, if reimbursement is available, what the level of reimbursement will be. Coverage and reimbursement may impact the demand for, or the price of, any drug candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any drug candidate for which we obtain marketing approval.

        We expect that additional U.S. state and federal healthcare reform measures, as well as similar measures by non-U.S. governments, will be adopted in the future, any of which could limit the amounts that governments will pay for healthcare products and services, which could result in additional pricing

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pressure or reduced demand for any drug candidate we develop. For example, it is possible that additional governmental action (both in the United States and abroad) will be taken to address the COVID-19 pandemic, which could impact our business in an as-yet unknown manner.

In the event we elect to commercialize any of our drug candidates that receive regulatory approval, we will need to establish sales capabilities on our own or through third parties. If we are unsuccessful in our efforts, we may not be able to market and sell our drug candidates effectively in the United States, EU and/or other foreign jurisdictions, if approved, or generate product revenue.

        We currently do not have a marketing or sales organization. In order to commercialize our drug candidates in the United States and foreign jurisdictions, we would need to establish marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in doing so. If any of our drug candidates receive regulatory approval and we elect to independently commercialize such drug candidates, we would expect to establish a sales organization with technical expertise and supporting distribution capabilities to commercialize each such drug candidate, which would be expensive and time consuming. We have no prior experience in the marketing, sale and distribution of pharmaceutical products and there are significant risks involved in building and managing a sales organization, including our ability to hire, retain, and incentivize qualified individuals, generate sufficient sales leads, provide adequate training to sales and marketing personnel, and effectively manage a geographically dispersed sales and marketing team. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact the commercialization of these products. Alternatively, we may choose to collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems. If we are unable to enter into such arrangements on acceptable terms or at all, we may not be able to successfully commercialize our drug candidates. If we are not successful in commercializing our drug candidates or any future drug candidates, either on our own or through arrangements with one or more third parties, and are not otherwise able to license these products to third parties, we may not be able to generate any future product revenue and we would incur significant additional losses.

We will need to increase the size of our organization, and we may experience difficulties in managing growth.

        As of the date of this prospectus, we have 23 full-time employees, 19 of whom are engaged in research and development activities and four of whom are engaged in general and administrative activities. We will need to continue to expand our managerial, operational, finance and other resources in order to manage our operations and clinical trials, continue our development activities and commercialize our drug candidates or any future drug candidates. Our management and personnel, systems and facilities currently in place may not be adequate to support this future growth. Our need to effectively execute our growth strategy requires that we:

    manage our clinical trials effectively;

    identify, recruit, retain, incentivize and integrate additional employees;

    manage our internal development and operational efforts effectively while carrying out our contractual obligations to and/or relations with third parties including regulatory agencies and market authorities;

    continue to improve our operational, financial and management controls, reports systems and procedures; and

    manage our information technology systems and data security.

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If we fail to attract and retain senior management and key scientific personnel, we may be unable to successfully develop our drug candidates or any future drug candidates, conduct our clinical trials and commercialize our current or any future drug candidates.

        We are dependent upon the services of our senior management and the loss of any of these individuals could harm our business. The loss of services of any of our key executive officers or other members of our senior management team, may be disruptive to, or cause uncertainty in, our business and could have a negative impact on our ability to manage and grow our business effectively. Such disruption could have a material adverse impact on our financial performance, financial condition, and the market price of our ordinary shares.

        Our success also depends on our ability to continue to attract, retain and motivate highly qualified clinical and scientific personnel. Competition for qualified personnel in the biotechnology and pharmaceuticals field is intense due to the limited number of individuals who possess the skills and experience required by our industry. We will need to hire additional personnel as we expand our clinical development and if we initiate commercial activities. We may not be able to attract and retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future drug candidates.

        We face an inherent risk of product liability as a result of the clinical testing of our drug candidates and will face an even greater risk if we commercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranty. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our drug candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

    decreased demand for our current or future drug candidates;

    injury to our reputation;

    withdrawal of clinical trial participants;

    costs to defend the related litigation;

    a diversion of management's time and our resources;

    substantial monetary awards to trial participants or patients;

    regulatory investigations, product recalls, withdrawals or labeling, marketing or promotional restrictions;

    loss of revenue; and

    the inability to commercialize our current or any future drug candidates.

        Our inability to obtain and maintain sufficient product liability insurance at an acceptable cost and scope of coverage to protect against potential product liability claims could prevent or inhibit the commercialization of our current or any future drug candidates we develop. We currently carry product

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liability insurance covering our clinical trials. Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient funds to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing any of our drug candidates, we intend to expand our insurance coverage to include the sale of such drug candidate; however, we may be unable to obtain this liability insurance on commercially reasonable terms or at all.

Our existing collaborations as well as additional collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our drug candidates.

        We utilize external collaborations and currently maintain several active early-stage research and discovery focused collaborations. We may seek to partner with pharmaceutical laboratories to conduct clinical trials of our drug candidates. We may also seek additional collaboration arrangements for the commercialization, or potentially for the development, of certain of our drug candidates depending on the merits of retaining commercialization rights for ourselves as compared to entering into collaboration arrangements. To the extent that we decide to enter into additional collaboration agreements in the future, we may face significant competition in seeking appropriate collaborators. Moreover, collaboration arrangements are complex and time-consuming to negotiate, document, implement and maintain and challenging to manage. We may not be successful in our efforts to prudently manage our existing collaborations or to enter new ones should we choose to do so. The terms of new collaborations or other arrangements that we may establish may not be favorable to us.

        The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include risks that:

    collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations;

    collaborators may not perform their obligations as expected;

    collaborators may not pursue development and commercialization of our drug candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive products or their internal development of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

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

    collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or drug candidates;

    a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

    we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

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    collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

    disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future drug candidates or that result in costly litigation or arbitration that diverts management attention and resources;

    collaborations may be terminated, and, if terminated, this may result in a need for additional capital to pursue further development or commercialization of the applicable current or future drug candidates;

    collaborators may own or co-own intellectual property covering products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property;

    disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and

    a collaborator's sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

Significant disruptions of information technology systems or breaches of data security could materially adversely affect our business, results of operations and financial condition.

        We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. We have established physical, electronic and organizational measures to safeguard and secure our systems to prevent a data compromise, and rely on commercially available systems, software, tools, and monitoring to provide security for our information technology systems and the processing, transmission and storage of digital information. We have also outsourced elements of our information technology infrastructure, and as a result a number of third-party vendors may or could have access to our confidential information. Our internal information technology systems and infrastructure, and those of our current and any future collaborators, contractors and consultants and other third parties on which we rely, are vulnerable to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization.

        The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments and cyber-terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. In addition, the prevalent use of mobile devices that access confidential information increases the risk of data security breaches, which could lead to the loss of confidential information or other intellectual property. The costs to us to mitigate network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position. If such an event were to occur and cause interruptions in our operations, it could result in a material

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disruption of our product development programs. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Moreover, if a computer security breach affects our systems or results in the unauthorized release of personally identifiable information, our reputation could be materially damaged.

        In addition, such a breach may require notification to governmental agencies, the media or individuals pursuant to various federal and state privacy and security laws, if applicable, including the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Clinical Health Act of 2009, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws.

        Under the EU regulation and notably the General Data Protection Regulation, or GDPR, No. 2016/679, which entered into force on May 25, 2018 and is applicable personal data that we process in relation to our presence in the EU, the offering of products or services to individuals in the EU or the monitoring of the behavior of individuals in the EU, we have also a legal responsibility to report personal data breaches to the competent supervisory authority. The EU data protection regulation includes a broad definition and a short deadline for the notification of personal data breaches, which may be difficult to implement in practice and requires that we implement robust internal processes. Under this regulation, we have to report personal data breaches to the competent supervisory authority within 72 hours of the time we become aware of a breach "unless the personal data breach is unlikely to result in a risk to the right and freedoms of natural persons" (Article 33 of the GDPR). In addition, the GDPR requires that we communicate the breach to the data subject if the breach is "likely to result in a high risk to the rights and freedoms of natural persons" (Article 34 of the GDPR). In order to fulfil these requirements, we have to implement specific internal processes to be followed in case of a personal data breach, which will allow us to (a) contain and recover the breach, (b) assess the risk to the data subjects, (c) notify, and possibly communicate the breach to the data subjects, (d) investigate and respond to the breach. The performance of these processes involve substantial costs in resources and time.

        Finally, as a consequence of the decision by the European Court of Justice issued on July 16, 2020 (known as the "Schrems II decision"), which invalidated the privacy shield for data transfers between the EU and the United States, a reassessment of both data transfers to and storage of EU data by our U.S. entities or other U.S. companies will be required. To the extent that the U.S. legal system is not considered as providing an adequate level of protection by the European authorities, and that the other safeguards provided by applicable regulation (e.g., Standard Contractual Clause, or SCCs, in their current form) are not deemed to fully address such inadequacies, additional protective measures will have to be assessed on a case-by-case basis, and implemented in order to ensure the compliance of such transfers, based on the new SCCs currently under discussion, prior to adoption.

        Moreover, as we may rely on third parties that will also process as processor the data for which we are a data controller—for example, in the context of the manufacturing of our drug candidates or for the conduct of clinical trials, we must contractually ensure that strict security measures, as well as appropriate obligations including an obligation to report in due delay any security incident are implemented, in order to allow us fulfilling our own regulatory requirements.

        We would also be exposed to a risk of loss or litigation and potential liability for any security breach on personal data for which we are data controller. The costs of above-mentioned processes together with legal penalties, possible compensation for damages and any resulting lawsuits arising from a breach may be extensive and may have a negative impact on reputation and materially adversely affect our business, results of operations and financial condition.

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Our employees and independent contractors, including principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.

        We are exposed to the risk that our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors may engage in misconduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or other unauthorized activities that violate the laws and regulations of the FDA, EMA and other similar regulatory bodies, including those laws that require the reporting of true, complete and accurate information to such regulatory bodies; manufacturing standards; healthcare fraud and abuse, data privacy laws and other similar laws; or laws that require the true, complete and accurate reporting of financial information or data. Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials, the creation of fraudulent data in our preclinical studies or clinical trials, or illegal misappropriation of product, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective 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 be in compliance with such laws or regulations. In addition, we are subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. 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 and financial results, including, without limitation, the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgements, possible exclusion from participation in governmental healthcare programs, individual imprisonment, other sanctions, contractual damages, reputational harm, diminished profits and future earnings and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

        Our research and development activities and our third-party manufacturers' and suppliers' activities involve the controlled storage, use and disposal of hazardous materials owned by us, including the components of our product and drug candidates and other hazardous compounds. We and any third-party manufacturers and suppliers we engage are subject to numerous federal, state and local environmental, health and safety laws, regulations and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment, and disposal of hazardous and regulated materials and wastes; the emission and discharge of hazardous materials into the ground, air and water; and employee health and safety. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers' facilities pending their use and disposal. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.

        Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws

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and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. Under certain environmental laws, we could be held responsible for costs relating to any contamination at our current or past facilities and at third-party facilities. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance.

        Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research, product development and manufacturing efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. Although we maintain workers' compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty, and general liability insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liable for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, results of operations and financial condition.

Risks Related to Intellectual Property

Our ability to compete may decline if we do not adequately protect our proprietary rights.

        Our success depends on obtaining and maintaining proprietary rights to our drug candidates for the treatment of age-related diseases, as well as successfully defending these rights against third-party challenges. We will only be able to protect our drug 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 drug 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 drug 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;

    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 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 patents; or

    others may identify prior art or other bases which could invalidate our patents.

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        Even if we have or obtain patents covering our drug candidates or compositions, we may still be barred from making, using and selling our drug 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. 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. These could materially affect our ability to develop our drug 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 drug 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. 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.

        In addition, it is unclear at this time what Brexit's impact will have on our intellectual property rights and the process for obtaining and defending such rights. It is possible that certain intellectual property rights, such as trademarks, granted by the EU will cease being enforceable in the UK absent special arrangements to the contrary. With regard to existing patent rights, the effect of Brexit should be minimal considering enforceable patent rights are specific to the UK, whether arising out of the European Patent Office or directly through the UK patent office.

        Legal actions to enforce our proprietary rights (including patents and trademarks) 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 trademarks 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 trademarks, 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.

Biotechnology 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 biotechnology companies can be highly uncertain and involve complex legal and factual questions. The interpretation and breadth of claims allowed in some patents covering biotechnology 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. U.S. 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

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patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. For example, Patent No. EP2790706 (protecting Patent family S3 in various European countries) is currently subject to an opposition procedure before the European Patent Office. A decision, which is susceptible to lead to the cancellation of Patent No. EP2790706, is expected in 2021-2022, it being specified that the Chinese patent protecting the same invention (Patent family S3) was invalidated by the Court of Revision of the Chinese Patent Office, further to a motion for invalidation brought by a third party based on similar arguments (including the insufficient description of the animal model used in the patent, the novelty of the patent, the extension beyond the application as filed and the inventive step). 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. laws and those countries may lack adequate rules and procedures for defending our intellectual property rights. This may also result in having the same invention covering differing claims in different countries and provide a different scope of protection in foreign countries.

        If we fail to obtain and maintain patent protection and trade secret protection of our drug 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. patent law. 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.

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. 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

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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. 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 drug candidates and our trademarks 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 or using our trademarks in all countries outside the United States, or from selling or importing products made using our inventions or commercialized under identical or similar trademarks in and into the United States or other jurisdictions. The statutory deadlines for pursuing patent and trademark protection in individual foreign jurisdictions are based on the priority dates of each of our patent and trademark applications.

        Competitors may use our technologies or trademarks in jurisdictions where we do not pursue and obtain patent or trademark protection to develop their own products and further, may export otherwise infringing products to territories where we have patent or trademark 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 and trademarks 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. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties, provided that (as a general rule and subject to local laws) the interests of public health so require (e.g., if the

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treatment is made available to the public in insufficient quantity or quality or at abnormally high prices) and the patent owner is compensated. If the test of the safety and efficacy of Sarconeos (BIO101) in patients with SARS-CoV-2 pneumonia is successful, we could be required to grant compulsory licenses for any patent or patent application protecting such treatment. 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 or other intellectual property 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 or other intellectual property at risk of being invalidated or interpreted narrowly, could put our patent or trademark 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. 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. 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.

        Our Chief Executive Officer, who is a corporate officer (mandataire social) but not an employee of the Company under French law, is involved in our research and development activities. He has contributed to research results for which we have submitted patent applications in which he is listed as a co-inventor and other inventions that we expect may give rise to patent applications in the future for which we expect he will be included as a co-inventor. Under French intellectual property law, inventors who are employees of a company have legal rights that are typically circumscribed in France by a combination of French labor law and contractual arrangements. Because Mr. Veillet is our CEO, and not an employee, we have entered into an assignment agreement with him, pursuant to which he will be entitled to certain payments as consideration for his prior and future contributions to our research projects and inventions. See "Intellectual Property Agreement with Stanislas Veillet" in the "Business" section of this prospectus for additional information.

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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 biotechnology 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.

        There is significant litigation in the biotechnology 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 drug 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. 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. Either we or these individuals may be subject to allegations of trade secret misappropriation or other similar claims as a result of prior affiliations. If we become involved in litigation, it could consume a substantial portion of our managerial and financial resources, regardless of whether we win or lose. We may not be able to afford the costs of litigation. 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. 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; or

    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 drug 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 drug 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 biotechnology industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may allege that our drug candidates or the use of our

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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. 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 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. 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:

    cease developing, selling or otherwise commercializing our drug 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;

    harm our reputation and cause potential partners or academic entities to avoid working with us; and

    in the case of trademark claims, redesign or rename trademarks we 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 drug 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 drug candidate, the defendant could counterclaim that the patent covering our drug 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 proceedings. Such proceedings could result in revocation or amendment of our patents in such a way that they no longer cover our drug candidates or competitive products. 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 drug candidates. Such a loss of patent protection would have a material adverse impact on our business.

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Risks Related to Government Regulation

While a key component of our strategy is achieving an EUA in the United States and conditional marketing authorization in the EU and other countries, the likelihood to be considered for such programs depends on the status of the COVID-19 pandemic.

        Currently, there are a few vaccines in the world authorized for use against SARS-CoV-2. If vaccines become readily available and very efficient, the number of cases will drop significantly and the urgency to develop new treatments will be reduced. Under such conditions, regulatory agencies may be less willing to consider expedited and shortened processes for review and may require submissions to be based on more than one clinical study.

Even if we obtain regulatory approval for a drug candidate, our products will remain subject to regulatory scrutiny.

        If our drug candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

        Manufacturers and manufacturers' facilities are required to comply with extensive FDA, EMA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations. As such, we and our contract manufacturers will be subject to continual review and inspections to assess compliance with cGMP and adherence to commitments made in any approved marketing application. Inspections by regulatory authorities and the potential need for subsequent corrective actions may require additional investment or changes to our manufacturing or suppliers' manufacturing facilities, and may cause delays, interruptions, or complete stoppage of the manufacturing process. If certain drugs have a potential for misuse/abuse, manufacturers and manufacturers' facilities must also comply with certain drug diversion regulatory and compliance programs. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

        Given that we expect to have a global supply chain, our supply chain may also be affected by the FDA's enforcement activity at the U.S. border, such as import detentions, drug diversion oversight or refusals. Despite our investment in regulatory compliance, the FDA may raise issues with our regulatory compliance, and suppliers outside of our direct control may also fail to adhere to the FDA's regulatory requirements, in which case our supply chain and business plans may be interrupted. Further import detentions or holds may also occur while the FDA attempts to verify the imported products' compliance with the law. Such detentions or holds may affect our supply chain and business plans.

        Authorities and policy makers are tightening controls on compliance by suppliers on environmental and social standards. We may be required to further tighten the audit of our suppliers, and to change suppliers in case of non-compliance. Independently, enforcement measures by government authorities such as import bans from suppliers suspected of such non-compliance may impact our supply chain.

        We will have to comply with requirements concerning advertising and promotion for our products. Promotional communications with respect to prescription drugs and biologics are subject to a variety of legal and regulatory restrictions in the United States and the EU (both at EU and national level) and must be consistent with the information in the product's approved label. As such, we may not promote our products for indications or uses for which they do not have approval. The holder of an approved application must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process. We could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of our products in general or in specific

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patient subsets. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval. In addition, under European regulation, certain of our drug candidates could be added to the list of drugs subject to additional monitoring. Such list concerns drugs for which there is no experience due to their recent marketing or a lack of data on their long-term use. This classification would lead to additional requirements regarding post-marketing surveillance measures of our products, which may require more resources on our end.

        If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If we fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

    issue warning letters;

    seek an injunction or impose administrative, civil or criminal penalties;

    suspend or withdraw regulatory approval;

    suspend any of our clinical trials;

    refuse to approve pending applications or supplements to approved applications submitted by us;

    impose restrictions on our operations, including closing our contract manufacturers' facilities;

    seize or detain products, or require a product recall;

    refuse product importation, subject the import shipments to scrutiny, or place us or our suppliers on the Import Alert program; or

    refuse product importation, subject the import shipments to scrutiny, or place us or our suppliers on the Import Alert program.

        Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our products. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of our company and our operating results will be adversely affected.

        Moreover, the policies of the FDA, EMA and of other regulatory authorities may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, in Europe, the United States or elsewhere. For example, the new European regulation on clinical trials on medicinal products for human use published in the Official Journal of the European Union on May 27, 2014 will soon be applicable, upon the implementation of the European portal and database and could impact the administrative procedure that we will have to follow in order to obtain regulatory approval for our drug candidates. Depending on the date of our application for clinical trial authorization, we could be required to adapt quickly to the new requirements and procedures resulting from this new regulation, in particular regarding the new required deadlines that will require us to be reactive in the event of additional requests from the authorities. We are also anticipating further guidance from national regulators of each Member State (such as ANSM for France) as those are involved in the process.

        In addition, certain policies of the Trump administration in the United States may impact our business and industry. Namely, the Trump administration has taken several executive actions, including the issuance of a number of Executive Orders, that could impose significant burdens on, or otherwise materially delay, the FDA's ability to engage in routine oversight activities such as implementing

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statutes through rulemaking, issuance of guidance, and review and approval of marketing applications. It is difficult to predict how these orders will be implemented, and the extent to which they will impact the FDA's ability to exercise its regulatory authority. If these executive actions impose restrictions on the FDA's ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. In addition, if we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability.

If any of our drug candidates obtain regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected products.

        Under the Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, a pharmaceutical manufacturer may file an abbreviated new drug application, or ANDA, seeking approval of a generic version of an approved, small molecule innovator product. Under the Hatch-Waxman Act, a manufacturer may also submit a new drug application, or NDA, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDCA, that references the FDA's prior approval of the innovator product. A 505(b)(2) NDA product may be for a new or improved version of the original innovator product. The Hatch-Waxman Act also provides for certain periods of regulatory exclusivity, which preclude FDA approval (or in some circumstances, FDA filing and review) of an ANDA or 505(b)(2) NDA. In addition to the benefits of regulatory exclusivity, an innovator NDA holder may have patents claiming the active ingredient, product formulation or an approved use of the drug, which would be listed with the product in the FDA publication, "Approved Drug Products with Therapeutic Equivalence Evaluations," known as the Orange Book. If there are patents listed in the Orange Book for a product, a generic or 505(b)(2) applicant that seeks to market its product before expiration of the patents must include in their applications what is known as a "Paragraph IV" certification, challenging the validity or enforceability of, or claiming non-infringement of, the listed patent or patents. Notice of the certification must be given to the patent owner and NDA holder and if, within 45 days of receiving notice, either the patent owner or NDA holder sues for patent infringement, approval of the ANDA or 505(b)(2) NDA is stayed for up to 30 months.

        Accordingly, if any of our drug candidates are approved, competitors could file ANDAs for generic versions of our drug candidates or 505(b)(2) NDAs that reference our small molecule drug products. If there are patents listed for our drug candidates in the Orange Book, those ANDAs and 505(b)(2) NDAs would be required to include a certification as to each listed patent indicating whether the ANDA applicant does or does not intend to challenge the patent. We cannot predict which, if any, patents in our current portfolio or patents we may obtain in the future will be eligible for listing in the Orange Book, how any generic competitor would address such patents, whether we would sue on any such patents, or the outcome of any such suit.

        We may not be successful in securing or maintaining proprietary patent protection for products and technologies we develop or license. Moreover, if any of our owned or in-licensed patents that are listed in the Orange Book are successfully challenged by way of a Paragraph IV certification and subsequent litigation, the affected product could immediately face generic competition and its sales would likely decline rapidly and materially.

We may seek orphan drug designation for certain future drug candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug designation, including market exclusivity, which may cause our revenue, if any, to be reduced.

        We may pursue orphan drug designation for certain of our future drug candidates. In the European Union, the EMA's Committee for Orphan Medicinal Products, or COMP, grants orphan drug designation to promote the development of products that are intended for the diagnosis, prevention, or

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treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union. Additionally, designation is granted for products intended for the diagnosis, prevention, or treatment of a life-threatening, seriously debilitating or serious and chronic condition when, without incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing the drug or biological product or where there is no satisfactory method of diagnosis, prevention, or treatment, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Under the Orphan Drug Act, the FDA may designate a drug or biologic product as an orphan drug if it is intended to treat a rare disease or condition, defined as a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States.

        In the European Union, orphan drug designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval. This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same indication for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity for the orphan patient population.

        Even if we obtain orphan drug designation, we may not be the first to obtain marketing approval for any particular orphan indication due to the uncertainties associated with developing pharmaceutical products. Further, even if we obtain orphan drug exclusivity for a drug candidate, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties can be approved for the same condition. Orphan drug designations are not in any way indicative of a drug's likelihood of receiving the final marketing authorization from FDA. The FDA does not evaluate a drug candidate's safety and effectiveness using the same standard as it would when reviewing a drug candidate's safety and effectiveness prior to granting final marketing approvals. The FDA may grant orphan drug designations to multiple drugs intended for the same indication. Even after an orphan drug is approved, the EMA or FDA can subsequently approve the same drug with the same active moiety for the same condition if the EMA or FDA concludes that the later drug is clinically superior in that it is safer, more effective, or makes a major contribution to patient care. Orphan drug designation neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory review or approval process.

Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug candidates and may affect the prices we may set.

        In the United States, the EU and other jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the Affordable Care Act, was enacted, which substantially changed the way healthcare is financed by both

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governmental and private insurers. Among the provisions of the Affordable Care Act, those of greatest importance to the pharmaceutical and biotechnology industries include the following:

    an annual, non-deductible fee payable by any entity that manufactures or imports certain branded prescription drugs and biologic agents (other than those designated as orphan drugs), which is apportioned among these entities according to their market share in certain government healthcare programs;

    a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer's outpatient drugs to be covered under Medicare Part D;

    new requirements to report certain financial arrangements with physicians and teaching hospitals, including reporting "transfers of value" made or distributed to prescribers and other healthcare providers and reporting investment interests held by physicians and their immediate family members;

    an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;

    a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;

    extension of a manufacturer's Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

    expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer's Medicaid rebate liability;

    a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

    creation of the Independent Payment Advisory Board, which, once empaneled, will have the authority to recommend certain changes to the Medicare program that could result in reduced payments for prescription drugs and those recommendations could have the effect of law unless overruled by a supermajority vote of Congress; and

    establishment of a Center for Medicare Innovation at the Centers for Medicare & Medicaid Services, or CMS, to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

        Since its enactment, there have been judicial and Congressional challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. The current presidential administration and Congress will likely continue to seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the Affordable Care Act. It is uncertain the extent to which any such changes may impact our business or financial condition.

        In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. In August 2011, the Budget Control Act of 2011, among other things, led to aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2025 unless additional action is taken by Congress. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer

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treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

        Individual states in the United States have also become increasingly aggressive in passing legislation and implementing 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. Legally-mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our drug candidates or put pressure on our product pricing. Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products.

        In the EU, similar political, economic and regulatory developments may affect our ability to profitably commercialize our drug candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the EU or at the member state level may result in significant additional requirements or obstacles that may increase our operating costs. The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Generally, pricing negotiations with governmental authorities can take many months after the receipt of regulatory approval and product launch. In some EU Member States, such as in France, we may be required to conduct a clinical trial that compares the cost-effectiveness of our products candidates with available therapies in order to obtain favorable reimbursement for the indications sought or pricing approval. Should reimbursement for our drug candidates be unavailable in any country in which we seek reimbursement, or be limited or subject to additional clinical trials, or should pricing be set at unsatisfactory levels, then this might have an impact on our operating results. Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our drug candidates, restrict or regulate post-approval activities and affect our ability to commercialize our drug candidates, if approved. In markets outside of the United States and EU, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

        We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action in the United States, the EU or any other jurisdiction. If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or such third parties are not able to maintain regulatory compliance, our drug candidates may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

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Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.

        Our business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute our drug candidates, if approved. Such laws include:

    the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or providing any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, 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 good, facility, item or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

    the U.S. federal false claims and civil monetary penalties laws, including the civil False Claims Act, which, among other things, impose criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

    the U.S. federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

    HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, which also imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization by covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information;

    the FDCA, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices and the introduction of such products into interstate commerce;

    the U.S. Public Health Service Act, which prohibits, among other things, the introduction into interstate commerce of a biological product unless a biologics license is in effect for that product;

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    the U.S. Physician Payments Sunshine Act and its implementing regulations, which require certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children's Health Insurance Program to report annually to the government information related to certain payments and other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members;

    analogous U.S. state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry's voluntary compliance guidelines and the relevant compliance guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities; and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and

    similar healthcare laws and regulations in the EU and other jurisdictions, including reporting requirements detailing interactions with and payments to healthcare providers. For example, under French law, the regulation requires strict transparency of the links between the health care industry and other actors such as, but not limited to, health care practioners, and impose reporting on a public record all benefits granted to the various actors involved, in particular health professionals, as well as the existence of agreements concluded with these actors as well as remunerations paid. In addition to financial penalties, any violation of those requirements, such as misleading information or non-publication, could result in additional sanctions that may have harmful effect on the conduct of our business. More generally, as our business activity is heavily regulated and involves a significant interaction with government officials, our dealings with prescriber and authorities are subject to national anti-corruption laws of EU Member States. These laws notably prohibit us and our employees from improperly influencing government officials or commercial parties to obtain or retain business, direct business to any person or gain any advantage and also prohibit our third-party business partner's representatives and agents from engaging in corruption and bribery. Under these applicable anti-corruption laws, we may be held liable for the acts or the corrupt activities of our third-party bunisess partners, intermerdiares, representatives, contractors, channel partners and agents, even if we don't explicitly authorize or have knowledge of such activities. While we have a formal procedure that defines the process to be used to select our third-party partners, collaborate with them and monitor them in accordance with applicable anti-corruption laws, there is a risk that our third-party partners may act in violation of applicable laws, for which we may be ultimately held responsible. Any violation of applicable anti-corruption laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant legal fees, severe criminal, civil and administrative sanctions, suspension or debarment from government contracts, all of which may have an adverse effect on our reputation, business, results of operations and financial condition. In addition, it is possible that as our business grows and evolves, we will become subject to additional compliance requirements, resulting for example from French the Sapin II law, which requires companies concerned by this regulation to implement a general anti-corruption compliance project under the control of the competent supervisory authority such as staff training, compliance documentation, audits and regular monitoring of commercial relationships. As the EU Commission has stated in one of its reports that the health sector is

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      particularly vulnerable, our business may be subject to increased anti-corruption compliance monitoring.

        Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of our operations. Further, defending against any such actions can be costly, time-consuming and may require significant personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.

        In addition, considering that our activity involves the processing of EU personal data, in particular sensitive data such as health data, our business activities are also subject to GDPR and other national data protection laws and guidelines with respect to such data, which implies that we must implement significant and continuous efforts to comply with these data protection regulations, as well as any applicable additional national health care regulations. The GDPR has allowed EU Member States to introduce additional requirements for the processing of health data. This means we must comply with both EU as well as national laws in order to conduct our activities as regards patient data. In particular, our GDPR compliance involves the precise identification of our data processing operations and the risks incurred, the implementation of an organization of our internal processes and the establishment of documentation relating to our compliance. Our GDPR compliance also means being very aware of the fulfilment of our third-party contractors' obligations and their own GPDR compliance, which requires us to impose strict contractual provisions on our third-party contractors as processors. Moreover, the transfer of data from the EU to our U.S. entities or others U.S. companies must be subject to a valid legal mechanism for the lawful transfer of data, which may have to require some of our third-party contractors who process personal data to take additional privacy and security measures. Non-compliance could cause us to incur potential disruption and expense related to our business processes. Any violations of these laws and regulations could also result in substantial penalties and could materially damage our reputation.

        Furthermore, following the ECJ's decision to invalidate the EU—U.S. privacy shield as part of the Schrems II decision, any transfer or storage of EU data by our U.S. entities, other U.S. companies or contractual counterparties will require the implementation of additional safeguards, which given the current status of regulations, will most certainly require further protection measures in order to ensure an adequate level of protection as defined by the European authorities.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business.

        We are subject to the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and possibly other state and national anti-bribery and anti-money laundering laws in countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, third-party intermediaries, joint venture partners and collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector. We engage third-party investigators, CROs, and other

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consultants to design and perform preclinical studies of our drug candidates, and will do the same for any clinical trials. Also, once a drug candidate has been approved and commercialized, we may engage third-party intermediaries to promote and sell our products abroad and/or to obtain necessary permits, licenses, and other regulatory approvals. We or our third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities. We can be held liable for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, collaborators, partners, and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

        Noncompliance with anti-corruption and anti-money laundering laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage, and other collateral consequences. If any subpoenas, investigations, or other enforcement actions are launched, or governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal litigation, our business, results of operations and financial condition could be materially harmed. In addition, responding to any action will likely result in a materially significant diversion of management's attention and resources and significant defense and compliance costs and other professional fees. In certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor which can result in added costs and administrative burdens.

Our failure to maintain certain tax benefits applicable to French technology companies may adversely affect our results of operations.

        As a French biotechnology company, we have benefited from certain tax advantages, including, for example, the research tax credit (Crédit d'Impôt 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 (or, sooner, for smaller companies such as ours). The CIR is calculated based on our claimed amount of eligible research and development expenditures in France and represented €3.1 million and €2.8 million as of December 31, 2018 and 2019, 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 for additional corporate income tax, and penalties and interest related thereto, or we may not obtain the refunds for which we have applied, 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.

Recent U.S. tax legislation and future changes to applicable U.S. tax laws and regulations may have an adverse effect on our business, financial condition and results of operations.

        Changes in laws and policy relating to taxes may have an adverse effect on our business, financial condition and results of operations. For example, at the end of 2017, the U.S. government enacted significant tax reform, with additional guidance from the U.S. tax authority still pending. Changes include, but are not limited to, a federal corporate tax rate decrease to 21% for tax years beginning after December 31, 2017, a reduction to the maximum deduction allowed for net operating losses generated in tax years after December 31, 2017, eliminating carrybacks of net operating losses, and providing for indefinite carryforwards for losses generated in tax years after December 31, 2017. The

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2017 legislation remains unclear in many respects and could be subject to potential amendments and technical corrections or even outright changes, particularly as a possible new U.S. presidential administration and a new U.S. Congress prepares to drive U.S. federal income tax policy starting in 2021. Additionally, current tax laws may continue to be subject to interpretations and implementing regulations by the Treasury and Internal Revenue Service, or IRS, any of which could mitigate or increase certain adverse effects of prior legislation. In addition, it is unclear how future U.S. federal income tax changes will affect state and local taxation. Generally, future changes in applicable U.S. tax laws and regulations, or their interpretation and application could have an adverse effect on our business, financial conditions and results of operations.

Risks Related to the Offering, Ownership of the ADSs and Our Status as a Non-U.S. Company with Foreign Private Issuer Status

The requirements of being a U.S. public company may strain our resources, divert management's attention and affect our ability to attract and retain executive management and qualified board members.

        As a U.S. public company, following the offering, we will incur legal, accounting, and other expenses that we did not previously incur. We will be subject to the Exchange Act, including the reporting requirements thereunder, 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 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 after we are no longer an "emerging growth company" and/or a foreign private issuer. For example, for so long as we remain a foreign private issuer, we will not be required to file with the SEC quarterly reports with respect to our business and results of operations, which are required to be made by domestic issuers pursuant to the Exchange Act.

        Pursuant to Section 404 of the Sarbanes-Oxley Act, we will be required to furnish a report by our management on our internal control over financial reporting, including an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. However, while we remain an emerging growth company, we will not be required to include this attestation report on internal control over financial reporting issued by our independent registered public accounting firm. When our independent registered public accounting firm is required to undertake an assessment of our internal control over financial reporting, the cost of complying with Section 404 will significantly increase and management's attention may be diverted from other business concerns, which could adversely affect our business and results of operations. We may need to hire more employees in the future or engage outside consultants to comply with these requirements, which will further increase our cost and expense. If we fail to implement the requirements of Section 404 in the required timeframe, we may be subject to sanctions or investigations by regulatory authorities, including the SEC and the Nasdaq. Furthermore, if we are unable to conclude that our internal control over financial reporting is effective, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of the ADSs and our ordinary shares could decline, and we could be subject to sanctions or investigations by regulatory authorities. Failure to implement or maintain effective internal control systems required of public companies could also restrict our future access to the capital markets.

        In addition, enhanced legal and regulatory regimes and heightened standards relating to corporate governance and disclosure for public companies result in increased legal and financial compliance costs and make some activities more time consuming. Further, being a U.S. public company and a French public company will have an impact on disclosure of information and require compliance with two sets of applicable rules. This could result in uncertainty regarding compliance matters and higher costs necessitated by legal analysis of dual legal regimes, ongoing revisions to disclosure and adherence to heightened governance practices.

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The Public Company Accounting Oversight Board, or PCAOB, is currently unable to inspect the audit work and practices of auditors operating in France, including our auditor.

        Our auditor, Ernst & Young et Autres, is registered with the Public Company Accounting Oversight Board, or PCAOB, in the United States. The PCAOB's cooperative arrangement with the French audit authority expired in December 2019. The expiration of this cooperation arrangement prevents inspections of registered firms in France until a new arrangement is concluded. Such inspections assess a registered firm's compliance with U.S. law and professional standards in connection with the performance of audits of financial statements filed with the SEC. As a result, our investors may not realize the potential benefits of such inspections until a new cooperative arrangement, which is currently under negotiation, is entered into and inspections in France resume. The current inability of the PCAOB to conduct inspections of auditors in France also makes it more difficult to evaluate the effectiveness of our auditor's audit procedures or quality control procedures as compared to auditors outside France that are subject to PCAOB inspections.

There has been no public market for the ADSs prior to the offering, and an active market may not develop in which investors can resell the ADSs.

        Prior to the offering, there has been no public market for the ADSs. We cannot predict the extent to which an active trading market for the ADSs will develop or be sustained after the offering, or how the development of such a market might affect the market price for the ADSs. The initial public offering price of the ADSs in the offering has been agreed upon between us and the underwriter based on a number of factors, including the trading price of our ordinary shares on the Euronext Growth Paris market as of the date of this prospectus, as well as certain market conditions in effect at the time of the offering, which may not be indicative of the price at which the ADSs will trade following completion of the offering. Investors may not be able to sell their ADSs at or above the initial public offering price. In addition, investors may not be able to successfully withdraw the underlying ordinary shares of the ADSs for the reasons discussed under the risk factor titled "You may not be able to exercise your right to vote the underlying ordinary shares of the ADSs" described below. In connection with any withdrawal of any of our ordinary shares represented by ADSs, the ADSs will be surrendered to the depositary. Unless additional ADSs are issued, the effect of such transactions will be to reduce the number of outstanding ADSs and, if a significant number of transactions are effected, to reduce the liquidity of the ADSs. See the section in this prospectus titled "Description of American Depositary Shares."

The market price of our equity securities may be volatile, and purchasers of the ADSs could incur substantial losses.

        The market price for the ADSs and ordinary shares may be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell the ADSs at or above the price originally paid for the security. The market price for our securities may be influenced by many factors, including:

    actual or anticipated fluctuations in our financial condition and operating results;

    actual or anticipated changes in our growth rate relative to our competitors;

    competition from existing products or new products that may emerge;

    announcements by us 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;

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    share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

    additions or departures of key management or scientific personnel;

    lawsuits threatened or filed against us, disputes or other developments related to proprietary rights, including patents, litigation matters, and our ability to obtain patent protection for our technologies;

    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 ADSs or ordinary shares by us, our insiders or our other holders; and

    general economic and market conditions.

        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 the ADSs and may otherwise negatively affect the liquidity of the trading market for the ADSs.

We may be exposed to significant foreign exchange risk. Exchange rate fluctuations may adversely affect the foreign currency value of the ADSs.

        We incur portions of our expenses and may in the future derive revenues in currencies other than the euro, in particular, the U.S. dollar. 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. dollar could be expected to have a negative impact on our revenue and earnings growth as U.S. 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. The ADSs will be quoted in U.S. dollars on the Nasdaq Capital Market and our ordinary shares are trading in euros on the Euronext Growth Paris. Our financial statements are prepared in euros. Fluctuations in the exchange rate between euros and the U.S. dollar will affect, among other matters, the U.S. dollar value of the ADSs.

If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, our business will be harmed and the price of our securities could decline as a result.

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

    our available capital resources or capital constraints we experience;

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    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;

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

    other actions, decisions or rules issued by regulators;

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

    our ability to license and/or generate revenues other than through independent commercialization of our products;

    the efforts of our collaborators and/or other partners, including licensees, with respect to the commercialization of, in due course, our products; and

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

        If we fail to achieve announced milestones in the timeframes we expect, the commercialization of our drug candidates may be delayed, our business and results of operations may be harmed, and the trading price of our securities may decline as a result.

After the completion of the offering, we may be at an increased risk of securities class action litigation.

        Historically, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and biopharmaceutical companies have experienced significant share price volatility in recent years. If we were to be sued, it could result in substantial costs and a diversion of management's attention and resources, which could harm our business.

We have broad discretion in the use of the net proceeds from the offering and may use them in ways with which you do not agree and in ways that may not increase the value of your investment.

        Our management will have broad discretion in the application of the net proceeds that we receive from the offering. We may spend or invest these proceeds in a way with which our shareholders and ADS holders disagree. The failure by our management to apply these funds effectively could harm our business and financial condition. Pending their use, we may invest the net proceeds from the offering in a manner that does not produce income or that loses value. These investments may not yield a favorable return to our investors.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of the ADSs and their trading volume could decline.

        The trading market for the ADSs 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 the ADSs would be negatively impacted. If one or more of the analysts who covers us downgrades our equity securities or publishes incorrect or unfavorable research about our business, the price of our securities 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 securities, demand for our securities could decrease, which could cause the price of the ADSs or their trading volume to decline.

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We do not currently intend to pay dividends on our ordinary shares and, consequently, your ability to achieve a return on your investment 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.

        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 the ADSs for the foreseeable future and the success of an investment in these securities will depend upon any future appreciation in their 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 investors have purchased them. 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 statutory financial statements prepared and presented in accordance with accounting standards applicable in France. Please see the section of this prospectus titled "Description of Share Capital—Key Provisions of Our Articles of Incorporation and Articles of Association—Rights, Preferences and Restrictions Attaching to Ordinary Shares" for further details on the limitations on our ability to declare and pay dividends imposed by Article 34 of our By-laws and "Material United States Federal Income Tax and French Considerations" the taxes that may be imposed on you if we elect to pay a dividend. 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. These factors could harm the value of the ADSs, and, in turn, the U.S. dollar proceeds that holders receive from the sale of the ADSs.

If you purchase ADSs in the offering, you will experience substantial and immediate dilution.

        If you purchase ADSs in the offering, you will experience substantial and immediate dilution of $            per ADS in net tangible book value as of June 30, 2020, after giving effect to the offering at the assumed offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, because the price that you pay will be substantially greater than the net tangible book value per ADS that you acquire. You will experience additional dilution upon exercise of any outstanding warrants to purchase ordinary shares or if we otherwise issue additional ADSs or ordinary shares below the offering price. For a further description of the dilution that you will experience immediately after the offering, see the section of this prospectus titled "Dilution."

We have a significant number of outstanding warrants and convertible debt instruments, which may cause significant dilution to our shareholders, have a material adverse impact on the market price of our common stock and make it more difficult for us to raise funds through future equity offerings.

        As of January 4, 2021, we had 100,757,097 ordinary shares issued and outstanding. In addition, as of that date we had outstanding warrants to acquire up to 8,530,773 ordinary shares and 2,500,911 free ordinary shares that were granted to our two founders on December 22, 2020 and will be delivered to them on December 22, 2022 after a two-year vesting period. The issuance of ordinary shares upon the exercise of warrants and convertible debt instruments would dilute the percentage ownership interest of all shareholders, might dilute the book value per share of our ordinary shares and would increase the number of our publicly traded shares, which could depress the market price of our ordinary shares.

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        We are also subject to outstanding legal proceeding instigated by NEGMA in which they have claimed 7,000,000 ordinary shares should be issued to them. See the section of this prospectus titled "Business—Legal Proceedings."

        In addition to the dilutive effects described above, the perceived risk of dilution as a result of the significant number of outstanding warrants and convertible debt may cause our shareholders to be more inclined to sell their shares, which would contribute to a downward movement in the price of our ordinary shares. Moreover, the perceived risk of dilution and the resulting downward pressure on our share price could encourage investors to engage in short sales of our ordinary shares, which could further contribute to price declines in our ordinary shares. The fact that our shareholders, warrant holders and convertible debt holders can sell substantial amounts of our ordinary shares in the public market, whether or not sales have occurred or are occurring could make it more difficult for us to raise additional funds through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate, or at all.

Future sales, or the possibility of future sales, of a substantial number of the ADSs or our ordinary shares could adversely affect the price of the ADSs.

        Future sales of a substantial number of the ADSs or ordinary shares, or the perception that such sales will occur, could cause a decline in the market price of the ADSs. ADSs sold in the offering may be resold in the public market immediately without restriction, unless purchased by our affiliates. If ADS holders sell substantial amounts of ADSs in the public market, or the market perceives that such sales may occur, the market price of the ADSs and our ability to raise capital through an issuance of equity securities in the future could be adversely affected.

        Approximately        % of our ordinary shares outstanding after the offering (including                        ordinary shares represented by ADSs) will be subject to lock-up agreements described in the "Underwriting" section of this prospectus. If, after the expiration of such lock-up agreements, these shareholders sell substantial amounts of our ordinary shares in the public market, or the market perceives that such sales may occur, the market price of the ADSs could be adversely affected.

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. Our corporate affairs are governed by our bylaws 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, 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 holder of ADSs.

U.S. investors may have difficulty enforcing civil liabilities against our company and directors and senior management and the experts named in this prospectus.

        Certain members of our board of directors and senior management and certain experts named in this prospectus 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. 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

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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. Further, if U.S. 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. 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 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. French law provides that a shareholder, or a group of shareholders, may initiate a legal action to seek indemnification from the directors of a corporation in the corporation's interest if it fails to bring such legal action itself. If so, any damages awarded by the court are paid to the corporation and any legal fees relating to such action may be borne by the relevant shareholder or the group of shareholders.

        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. See the section of this prospectus titled "Enforcement of Civil Liabilities."

ADSs holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action.

        The deposit agreement governing the ADSs representing our ordinary shares provides that, to the fullest extent permitted by law, ADS holders waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares, the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws.

        If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts and circumstances of that case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the United States Supreme Court. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the City of New York, which has non-exclusive jurisdiction over matters arising under the deposit agreement. In determining whether to enforce a contractual pre-dispute jury trial waiver provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a jury trial. We believe that this is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor's negligence in failing to liquidate collateral upon a guarantor's demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs. It is advisable that you consult legal counsel regarding the jury waiver provision before entering into the deposit agreement.

        If you or any other owner or holder of ADSs bring a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under federal securities laws, you or such other owner or holder may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and/or the depositary. If a lawsuit is brought against us and/or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be

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conducted according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action.

        Nevertheless, if this jury trial waiver provision is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any owner or holder of ADSs or by us or the depositary of compliance with any substantive provision of the U.S. federal securities laws and the rules and regulations promulgated thereunder. By agreeing to the jury trial waiver provision in the deposit agreement, investors will not be deemed to have waived our compliance with or the depositary's compliance with the federal securities laws and the rules and regulations promulgated thereunder.

Our Articles of Association and By-laws and French corporate law contain provisions that may delay or discourage a takeover attempt.

        Provisions contained in our Articles of Association and/or French corporate law 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 bylaws 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, the owner of 90% of voting rights of a public company listed on a regulated market in a Member State of the EU or in a state party to the European Economic Area, or EEA, Agreement, including France, has the right to force out minority shareholders following a tender offer made to all shareholders;

    under French law, a non-resident of France as well as any French entity controlled by non-French residents may have to file an administrative notice with French authorities in connection with a direct or indirect investment in us, as defined by administrative rulings; see the section of this prospectus titled "Limitations Affecting Shareholders of a French Company";

    a merger (i.e., in a French law context, a stock for stock 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 EU 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, such as 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, for the remaining duration of such director's term of office, provided that prior to such decision of the board of directors, the number of directors remaining in office exceeds the minimum required by law and our bylaws, and subject to the approval by

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      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 be convened by our chairman (directly or upon request of our managing director), or, when no board meeting has been held for more than three 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;

    our shares are nominative or bearer, if the legislation so permits, according to the shareholder's choice;

    under French law, certain investments in any entity governed by French law relating to certain strategic industries (such as research and development in biotechnologies and activities relating to public health) and activities by individuals or entities not French, not resident in France or controlled by entities not French or not resident in France are subject to prior authorization of the Ministry of Economy; see "Limitations Affecting Shareholders of a French Company";

    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 bylaws 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; and

    pursuant to French law, our bylaws, including the sections relating to the number of directors and election and removal of a director from office, may only be modified by a resolution adopted by two-thirds of the votes 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 agreement. 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 will be entitled to give instructions for the exercise of voting rights. Upon timely receipt of notice from us, if we so request, the depositary will 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.

        Purchasers of ADSs may instruct the depositary of the ADSs to vote the ordinary shares underlying their ADSs. Otherwise, purchasers of ADSs will not be able to exercise voting rights unless they withdraw the ordinary shares underlying the ADSs they hold. However, a holder of ADSs may not know about the meeting far enough in advance to withdraw those ordinary shares. If we ask for a holder of ADSs' instructions, the depositary, upon timely notice from us, will distribute notice of the upcoming vote and arrange to deliver our voting materials to him or her. We cannot guarantee to any

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holder of ADSs that he or she will receive the voting materials in time to ensure that he or she can instruct the depositary to vote his or her ordinary shares or to withdraw his or her ordinary shares so that he or she can vote them. If the depositary does not receive timely voting instructions from a holder of ADSs, it may give a proxy to a person designated by us to vote the ordinary shares underlying his or her 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 a holder of ADSs may not be able to exercise his or her right to vote, and there may be nothing he or she can do if the ordinary shares underlying the ADSs are not voted as he or she requested.

Purchasers of ADSs may not be directly holding our ordinary shares.

        A holder of ADSs will not be treated as one of our shareholders and will not have direct shareholder rights. French law governs our shareholder rights. The depositary will be the holder of the ordinary shares underlying ADSs held by purchasers of ADSs in the offering. Purchasers of ADSs will have ADS holder rights. The deposit agreement among us, the depositary and the owners and holders of ADSs, sets out ADS holder rights, as well as the rights and obligations of the depositary.

The 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 the holdings of purchasers of ADSs in the offering.

        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 unless they waive those rights at an extraordinary meeting of our shareholders (by a two-thirds majority vote) or individually by each shareholder. However, 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 of 1933, as amended, or 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 purchasers of ADSs 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.

Purchasers of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying ordinary shares.

        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 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 a holder of ADSs' right to cancel his or her ADSs and withdraw the underlying

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ordinary shares. Temporary delays in the cancellation of 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, a holder of ADSs may not be able to cancel his or her ADSs and withdraw the underlying ordinary shares when he or she owes 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. See the section of this prospectus titled "Description of American Depositary Shares."

As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of ADSs.

        We are a foreign private issuer, as defined in the SEC's rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to public companies organized within the United States. For example, we are exempt from certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our officers and directors are exempt from the reporting and "short-swing" profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we currently make annual and semi-annual filings with respect to our listing on Euronext Growth Paris and expect to file financial reports on an annual and semi-annual basis, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. public companies and will not be required to file quarterly reports on Form 10-Q or current reports on Form 8-K under the Exchange Act. Accordingly, there will be less publicly available information concerning our company than there would be if we were not a foreign private issuer.

As a foreign private issuer, we are permitted and we expect to follow certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq's corporate governance standards. These practices may afford less protection to shareholders than they would enjoy if we complied fully with the corporate governance standards of Nasdaq.

        As a foreign private issuer listed on the Nasdaq Capital Market, we will be subject to Nasdaq's corporate governance standards. However, Nasdaq rules provide that foreign private issuers are permitted to follow home country corporate governance practices in lieu of Nasdaq's corporate governance standards as long as notification is provided to Nasdaq of the intention to take advantage of such exemptions. We intend to rely on exemptions for foreign private issuers and follow French corporate governance practices in lieu of Nasdaq's corporate governance standards, to the extent possible. Certain corporate governance practices in France, which is our home country, may differ significantly from Nasdaq corporate governance standards. For example, as a French company, neither the corporate laws of France nor our bylaws require a majority of our directors to be independent and we can include non-independent directors as members of our remuneration committee, and our independent directors are not required to hold regularly scheduled meetings at which only independent directors are present.

        We are also exempt from provisions set forth in Nasdaq rules which require an issuer to provide in its bylaws for a generally applicable quorum, and that such quorum may not be less than one-third of the outstanding voting stock. Consistent with French law, our bylaws provide that a quorum requires the presence of shareholders having at least (1) 20% of the shares entitled to vote in the case of an ordinary shareholders' general meeting or at an extraordinary shareholders' general meeting where

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shareholders are voting on a capital increase by capitalization of reserves, profits or share premium, or (2) 25% of the shares entitled to vote in the case of any other extraordinary shareholders' general meeting.

        As a foreign private issuer, we are required to comply with certain Nasdaq rules and Rule 10A-3 of the Exchange Act, relating to audit committee composition and responsibilities. Under French law, the audit committee may only have an advisory role and appointment of our statutory auditors, in particular, must be decided by the shareholders at our annual meeting.

        Therefore, our shareholders may be afforded less protection than they otherwise would have under Nasdaq's corporate governance standards applicable to U.S. domestic issuers.

We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense.

        While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually on the last business day of an issuer's most recently completed second fiscal quarter and, accordingly, the next determination will be made with respect to us on June 30, 2022. In the future, we would lose our foreign private issuer status if we fail to meet the requirements necessary to maintain our foreign private issuer status as of the relevant determination date. We will remain a foreign private issuer until such time that more than 50% of our outstanding voting securities are held by U.S. residents and any of the following three circumstances applies: (i) the majority of our executive officers or directors are U.S. citizens or residents; (ii) more than 50% of our assets are located in the United States; or (iii) our business is administered principally in the United States.

        The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly more than costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP, rather than IFRS, and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion of our financial statements to U.S. GAAP would involve significant time and cost. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers such as the ones described herein and exemptions from procedural requirements related to the solicitation of proxies.

We are an "emerging growth company" under the JOBS Act and will be able to avail ourselves of reduced disclosure requirements applicable to emerging growth companies, which could make the ADSs less attractive to investors.

        We are an "emerging growth company," as defined in the U.S. Jumpstart Our Business Startups Act of 2012, or the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not "emerging growth companies," including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

        We cannot predict if investors will find the ADSs less attractive because we may rely on these exemptions. If some investors find the ADSs less attractive as a result, there may be a less active trading market for the ADSs and the price of the ADSs may be more volatile. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which we have total

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annual gross revenue of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of the date of the completion of the offering; (iii) the date on which we have issued more than $1.0 billion in nonconvertible debt during the previous three years; and (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

U.S. holders of ADSs may suffer adverse tax consequences if we are characterized as a passive foreign investment company.

        Generally, if, for any taxable year, at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest, and gains from the sale or exchange of investment property and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a PFIC, U.S. holders of the ADSs may suffer adverse tax consequences, including having gains realized on the sale of the ADSs treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on the ADSs by individuals who are U.S. holders, and having interest charges apply to certain distributions by us and the proceeds of sales of the ADSs. See the section in this prospectus titled "Material United States Federal Income and French Tax Considerations—Material U.S. Federal Income Tax Considerations—Passive Foreign Investment Company Considerations."

        Our status as a PFIC will depend on the composition of our income (including whether we receive certain non-refundable grants or subsidies and whether such amounts and reimbursements of certain refundable research tax credits will constitute gross income for purposes of the PFIC income test) and the composition and value of our assets, which may be determined in large part by reference to the market value of the ADSs, which may be volatile, from time to time. Our status may also depend, in part, on how quickly we utilize the cash proceeds from the offering in our business. Based on the current composition of our gross income and assets and on reasonable assumptions and projections, we believe that it is more likely than not that we would not have been considered a PFIC for our taxable year ending December 31, 2019; and, based on a similar analysis, we do not expect to be considered a PFIC for our taxable year ending December 31, 2020. However, there can be no assurance that we will or will not be considered a PFIC for these years or any future taxable year.

Investments in our securities may be subject to prior governmental authorization under the French foreign investment control regime.

        Pursuant to the provisions of the French Monetary and Financial Code (code monétaire et financier), any investment by any non-French citizen, any French citizen not residing in France, any non-French entity or any French entity controlled by one of the aforementioned persons or entities that will result in the relevant investor (a) acquiring control of an entity registered in France, (b) acquiring all or part of a business line of an entity registered in France, or (c) for non-EU or non-EEA investors crossing, directly or indirectly, alone or in concert, a 25% threshold of voting rights in an entity registered in France, in each case, conducting activities in certain strategic industries, such as the industry in which we operate, is subject to the prior authorization of the French Ministry of Economy, which authorization may be conditioned on certain undertakings.

        In the context of the ongoing COVID-19 pandemic, the Decree (décret) n°2020-892 dated July 22, 2020 as modified by the Decree (décret) n°2020-1729 dated December 28, 2020, has created, until December 31, 2021, a new 10% threshold of the voting rights for the non-European investments in listed companies, in addition to the 25% abovementioned threshold.

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        The foreign investment control regime described above applies to companies engaged in activities essential to protecting public health as well as biotechnology-related research and development activities.

        Therefore, any investor meeting the above criteria willing to acquire all or part of our business with the effect of crossing the applicable share capital thresholds set forth by the French Monetary and Financial Code will have to request this prior governmental authorization before acquiring our ordinary shares or ADSs. We cannot guarantee that such investor will obtain the necessary authorization in due time. The authorization may also be granted subject to conditions that deter a potential purchaser. The existence of such conditions to an investment in our securities could have a negative impact on our ability to raise the funds necessary to our development. In addition, failure to comply with such measures could result in significant consequences for the investor (including the investment to be deemed null and void). Such measures could also delay or discourage a takeover attempt, and we cannot predict whether these measures will result in a lower or more volatile market price of our ADSs or ordinary shares.

        For more details on the French foreign investment control regime see "Limitations Affecting Shareholders of a French Company—Ownership of ADSs or Shares by Non-French Residents"

We must maintain effective internal control over financial reporting, and if we are unable to do so, the accuracy and timeliness of our financial reporting may be adversely affected, which could hurt our business, lessen investor confidence and depress the market price of our securities.

        We must maintain effective internal control over financial reporting in order to accurately and timely report our results of operations and financial condition. In addition, as a public company listed in the United States, the Sarbanes-Oxley Act will require, among other things, that we assess the effectiveness of our internal control over financial reporting at the end of each fiscal year. We anticipate being first required to issue management's annual report on internal control over financial reporting, pursuant to Section 404 of the Sarbanes-Oxley Act, in connection with issuing our consolidated financial statements as of and for the year ending December 31, 2022 and the filing of our second annual report with the SEC.

        The rules governing the standards that must be met for our management to assess our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act are complex and require significant documentation, testing and possible remediation. These stringent standards require that our audit committee be advised and regularly updated on management's review of internal control over financial reporting. We are in the process of designing, implementing, and testing the internal control over financial reporting required to comply with this obligation. This process is time-consuming, costly, and complicated. In addition, our independent registered public accounting firm will be required to attest to the effectiveness of our internal controls over financial reporting beginning with our annual report following the date on which we are no longer an "emerging growth company," which may be up to five fiscal years following the date of the offering.

        Our management may not be able to effectively and timely implement controls and procedures that adequately respond to the increased regulatory compliance and reporting requirements that will be applicable to us as a public company listed in the United States. If we fail to staff our accounting and finance function adequately or maintain internal control over financial reporting adequate to meet the demands that will be placed upon us as a public company listed in the United States, our business and reputation may be harmed and the price of our ADSs may decline. Furthermore, investor perceptions of us may be adversely affected, which could cause a decline in the market price of our securities.

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

        This prospectus contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the sections of this prospectus titled "Prospectus Summary," "Risk Factors," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Business." All statements, other than statements of historical facts, contained in this prospectus, including statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, our expectations regarding the scope and duration of the COVID-19 pandemic and its potential impact on our clinical trials and operations, and future results of current and anticipated products, are forward-looking statements. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The words "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "goal," "intend," "may," "might," "objective," "plan," "potential," "predict," "project," "positioned," "seek," "should," "target," "will," "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and management's beliefs and assumptions, are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. These forward-looking statements include statements regarding:

    the timing, progress and results of clinical trials for our drug candidates, including statements regarding the timing of initiation and completion of clinical trials, dosing of subjects and the period during which the results of the clinical trials will become available;

    the potential impact of COVID-19 on our clinical trials and our operations generally;

    the timing, scope or likelihood of regulatory filings and approvals for our drug candidates;

    our ability to successfully commercialize our drug candidates;

    potential benefits of the clinical development and commercial experience of our management team;

    our ability to effectively market any drug candidates that receive regulatory approval on our own or through third parties;

    our commercialization, marketing and manufacturing capabilities and strategy;

    our expectation regarding the safety and efficacy of our drug candidates;

    the potential clinical utility and benefits of our drug candidates;

    our ability to advance our drug candidates through various stages of development, especially through pivotal safety and efficacy trials;

    our estimates regarding the potential market opportunity for our drug candidates;

    our expectations related to the use of proceeds from the offering;

    developments and projections relating to our competitors or our industry;

    our ability to become profitable;

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    our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

    our ability to secure additional financing when needed on acceptable terms;

    the impact of government laws and regulations in the United States, France and foreign countries;

    the implementation of our business model, strategic plans for our business, drug candidates and technology;

    our intellectual property position;

    our ability to rely on orphan drug designation for market exclusivity;

    our ability to attract or retain key employees, advisors or consultants; and

    our expectations regarding the time during which we will be an emerging growth company under the JOBS Act.

        Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. As a result, any or all of our forward-looking statements in this prospectus may turn out to be inaccurate. We have included important factors in the cautionary statements included in this prospectus, particularly in the section of this prospectus titled "Risk Factors," that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Moreover, we operate in a highly competitive and rapidly changing environment in which new risks often emerge. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

        You should read this prospectus and the documents that we reference in this prospectus and have filed as exhibits to the registration statement of which this prospectus is a part completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements contained in this prospectus are made as of the date of this prospectus, and we do not assume any obligation to update any forward-looking statements except as required by applicable law.

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USE OF PROCEEDS

        The offering is subject to us raising minimum gross proceeds of $             million in order to satisfy the applicable Nasdaq listing requirements. We estimate that we will receive net proceeds from the offering of approximately $             million, assuming a public offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, and assuming no exercise of the underwriter's option to purchase an additional                        ADSs from us in the offering. If the underwriter exercises in full its option to purchase up to an additional                        ADSs, we estimate that we will receive net proceeds of approximately $             million, assuming a public offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

        Each $1.00 increase or decrease in the assumed offering price of $            per ADS in the offering, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease our net proceeds by approximately $             million, assuming that the number of ADSs as set forth on the cover page of this prospectus remains the same and after deducting underwriting commissions and estimated offering expenses payable by us. Subject to applicable law, we may also increase or decrease the number of ADSs we are offering in the offering. Each increase or decrease of 100,000 ADSs offered by us would increase or decrease our net proceeds by $             million, assuming that the assumed offering price per ADS remains the same, and after deducting estimated underwriting commissions and estimated offering expenses payable by us.

        The actual net proceeds payable to us will be adjusted based on the actual number of ADSs offered by us in the offering, the actual offering price of the ADSs and other terms of the offering determined at pricing.

        We currently expect to use the net proceeds from the offering as follows:

    approximately $             million to finalize part 2 of our COVA trial of Sarconeos (BIO101) in respiratory failures linked to COVID-19 (to be given priority due to the current focus on developing treatments for COVID-19) ;

    approximately $             million to finalize our Phase 2 clinical trial (SARA-INT) of Sarconeos (BIO101) in sarcopenia with top line results;

    approximately $             million to commence our development of Sarconeos (BIO101) in DMD (with enrollment of the first patient in the trial) following IND approval from the FDA and EMA, subject to better control of COVID-19 in Europe and the United States; and

    the remainder to continue to build our preclinical research and development platform on retinopathies and for other new and on-going research and development activities, working capital and other general corporate purposes.

        We expect our existing capital resources, and including our ability to draw down on our credit facility with ATLAS (up to €15 million), together with the proceeds from the offering, will fund our planned operating expenses for at least the next 12 months. However, we will need additional funds to advance our drug candidates beyond the intended uses described above. We currently plan to develop our drug candidates through clinical PoC and seek licensing and/or partnership opportunities for regulatory approval and commercialization. Until then, we may satisfy our future cash needs through public or private equity or debt financings, government or other third-party funding, or a combination of these approaches.

        This expected use of the net proceeds from the offering represents our intentions based upon our current plans and business conditions. As of the date of this prospectus, we cannot predict with

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certainty all of the particular uses for the net proceeds to be received upon the completion of the offering or the amounts that we will actually spend on the uses set forth above. The amounts and timing of our actual expenditures and the extent of clinical development may vary significantly depending on numerous factors, including the progress of our development efforts, the status of and results from preclinical studies and any ongoing clinical trial or any clinical trial we may commence in the future, as well as any collaborations that we may enter into with third parties for our drug candidates and any unforeseen cash needs. As a result, our future financing needs remain uncertain and our management will retain broad discretion over the allocation of the net proceeds from the offering.

        Pending our use of the net proceeds from the offering, we intend to invest the net proceeds in a variety of capital preservation investments, including short-term, investment-grade, interest-bearing instruments.

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DIVIDEND POLICY

        We have never declared or paid any cash dividends on our ordinary shares. We do not anticipate paying cash dividends on our equity securities in the foreseeable future and intend to retain all available funds and any future earnings for use in the operation and expansion of our business.

        Subject to the requirements of French law and our by-laws, dividends may only be distributed from our distributable profits, plus any amounts held in our reserves other than those reserves that are specifically required by law. See the section of this prospectus titled "Description of Share Capital—Key Provisions of Our By-laws and French Law Affecting our Ordinary Shares—Rights, Preferences and Restrictions Attaching to Ordinary Shares" for further details on the limitations on our ability to declare and pay dividends. Dividend distributions, if any, will be made in euros and converted into U.S. dollars with respect to the ADSs, as provided in the deposit agreement.

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CAPITALIZATION

        The following table sets forth our cash and cash equivalents and capitalization as of June 30, 2020 on:

    an actual basis;

    a pro forma basis after giving effect as of January 4, 2021 to (i) the issuance of 30,840,328 ordinary shares in the H2 2020 Private Placements and the receipt of proceeds therefrom in the amount of €16,139,916; (ii) the issuance of 13,990,411 ordinary shares in the H2 2020 Bond Conversions representing a total impact on shareholders' equity of €6,250,000; (iii) the issuance of 1,091,380 ordinary shares in the H2 2020 Warrant Conversions and the receipt of proceeds therefrom in the amount of €294,673; (iv) the issuance of €3 million of convertible notes in the H2 2020 Convertible Note Financing and the receipt of proceeds therefrom (€2,885 thousand) recorded for both cash and cash equivalents and current liabilities with a redemption value in the amount of €3 million; (v) the repayment in cash of €863 thousand corresponding to the remaining 30 convertible notes that were issued to ATLAS at redemption value in the amount of €750 thousand; (vi) the proceeds of the CIR receivable financing in the amount of €1,953,518 and (vii) the repayment of €1,562 thousand of the carrying amount of the Kreos loan.

    a pro forma as adjusted basis to give further effect to the issuance and sale of                        ADSs (representing                        ordinary shares) in the offering at an assumed offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us and the application of net proceeds from the offering described under "Use of Proceeds."

        Our capitalization following the offering will be adjusted based on the actual offering price and offer terms of the offering determined at pricing, including the amount by which actual offering expenses are higher or lower than estimated. You should read this table together with our audited consolidated financial statements and related notes beginning on page F-1, as well as the sections of this prospectus titled "Use of Proceeds," "Selected Financial and Other Data," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the other financial information included elsewhere in this prospectus.

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  As of June 30, 2020  
 
  Actual   Pro Forma   Pro Forma As
Adjusted(1)
 
 
 
  $
 
  $
 
  $
 
 
  (in thousands)
 

Cash and cash equivalents

    12,183     13,645     31,260     35,011                                    

Non-current financial liabilities

    3,733     4,181     3,733     4,181                                    

Current financial liabilities

    7,622     8,537     5,242     5,871                                    

Shareholders' equity

                                     

Ordinary shares, €0.20 nominal value: 54,834,978 shares issued and outstanding, actual; 100,757,097 shares issued and outstanding per pro forma,             shares issued and outstanding, per pro forma as adjusted

    10,967     12,283     20,152     22,570                                    

Premiums related to the share capital

    7,163     8,023     20,663     23,143                                    

Treasury shares

    (42 )   (47 )   (42 )   (47 )                                  

Foreign currency translation adjustment

    (78 )   (87 )   (78 )   (87 )                                  

Accumulated deficit—attributable to our shareholders

    (12,956 )   (14,511 )   (12,956 )   (14,511 )                                  

Net loss—attributable to our shareholders

    (9,460 )   (10,595 )   (9,460 )   (10,595 )                                  

Non-controlling interests

    (32 )   (36 )   (32 )   (36 )                                  

Total shareholders' equity

    (4,438 )   (4,971 )   18,247     20,437                                    

Total capitalization

    6,917     7,747     27,222     30,489                                    

(1)
Each $1.00 increase or decrease in the assumed offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease each of the pro forma as adjusted cash and cash equivalents, total assets and total shareholders' equity by €             million ($             million), assuming that the number of ADSs, as set forth on the cover page of this prospectus, remains the same and after deducting underwriting commissions and estimated offering expenses payable by us. Subject to applicable law, we may also increase or decrease the number of ADSs we are offering in the offering. Each increase or decrease of 100,000 ADSs offered by us would increase or decrease each of the pro forma as adjusted cash and cash equivalents, total assets and total shareholders' equity by €             million ($             million), assuming that the assumed offering price per ordinary share remains the same, and after deducting estimated underwriting commissions and estimated offering expenses payable by us.

        The pro forma as adjusted information discussed above is illustrative only and will change based on the actual offering price, the actual number of ADSs offered by us, and other terms of the offering determined at pricing.

        The number of our ordinary shares (including ordinary shares represented by ADSs) that will be outstanding immediately following the completion of the offering is based on 54,834,978 ordinary shares outstanding and zero ADSs outstanding as of June 30, 2020.

        The following ordinary shares were issued after June 30, 2020:

    an aggregate of 30,840,328 ordinary shares that were issued in the H2 2020 Private Placements;

    an aggregate of 13,990,411 ordinary shares issued upon the H2 2020 Bond Conversions; and

    an aggregate of 1,091,380 ordinary shares issued upon the H2 2020 Warrant Conversions.

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        The number of ordinary shares outstanding as of June 30, 2020 excludes:

    3,615,566 ordinary shares issuable upon the exercise of warrants issued to investors outstanding as of January 4, 2021, with a weighted-average exercise price of €0.27 per ordinary share;

    3,455,610 ordinary shares issuable upon the exercise of warrants issued pursuant to equity incentive awards and outstanding as of January 4, 2021, with a weighted average exercise price of €0.61 per ordinary share;

    585,936 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to NEGMA and outstanding as of January 4, 2021, with a weighted average exercise price of €0.64 per ordinary share;

    442,477 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Kreos and outstanding as of January 4, 2021, with a weighted average exercise price of €2.67 per ordinary share as part of a financing that is described elsewhere in this prospectus;

    431,184 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Bracknor and outstanding as of January 4, 2021, with a weighted average exercise price of €3.48 per ordinary share as part of a financing that has been fully repaid and terminated; and

    2,500,911 free ordinary shares that were granted to our two founders on December 22, 2020 and will be delivered to them on December 22, 2022, after a two-year vesting period.

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DILUTION

        If you invest in our ADSs in this offering, your interest will be immediately diluted to the extent of the difference between the portion of the initial public offering price per ADS in this offering attributable to each underlying ordinary share represented thereby and the net tangible book value per ordinary share after this offering. Dilution results from the fact that the portion of the initial public offering price per ADS attributable to each underlying ordinary share represented thereby is substantially in excess of the net tangible book value per ordinary share.

        As of June 30, 2020, we had a historical net tangible book value of approximately €(7.0) million ($(7.9) million), or €(0.13) ($(0.14)) per ordinary share and $            per ADS (translated solely for convenience into dollars at an exchange rate of €1.00=US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020). Net tangible book value per ordinary share represents the amount of our total tangible assets (total assets less goodwill and other intangible assets) less our total liabilities, divided by the total number of our ordinary shares outstanding as of June 30, 2020.

        Our pro forma net tangible book value as of June 30, 2020 was approximately €14.4 million ($16.2 million), or €0.14 ($0.16) per ordinary share. Pro forma net tangible book value per share represents the amount of our total tangible assets (total assets less goodwill and other intangible assets) less our total liabilities, divided by the number of our ordinary shares outstanding, as of June 30, 2020, after giving effect as of January 4, 2021 to (i) the issuance of 30,840,328 ordinary shares in the H2 2020 Private Placements and the receipt of proceeds therefrom in the amount of €16,139,916; (ii) the issuance of 13,990,411 ordinary shares in the H2 2020 Bond Conversions representing a total impact on shareholders' equity of €6,250,000; (iii) the issuance of 1,091,380 ordinary shares in the H2 2020 Warrant Conversions and the receipt of proceeds therefrom in the amount of €294,673; (iv) the issuance of €3 million of convertible notes in the H2 2020 Convertible Note Financing and the receipt of proceeds therefrom (€2,885 thousand) recorded for both cash and cash equivalents and current liabilities with a redemption value in the amount of €3 million; (v) the repayment in cash of €863 thousand corresponding to the remaining 30 convertible notes that were issued to ATLAS at redemption value in the amount of €750 thousand; (vi) the proceeds of the CIR receivable financing in the amount of €1,953,518 and (vii) the repayment of €1,562 thousand of the carrying amount of the Kreos loan.

        After giving effect to the sale of                        ADSs in this offering at the assumed initial public offering price of $            per ADS, which is the midpoint of the price range on the cover page of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us, and the application of the estimated net proceeds from the offering as described under "Use of Proceeds," our pro forma as adjusted net tangible book value at June 30, 2020 would have been €           ($            ) per ordinary share and €          ($            ) per ADS (translated solely for convenience into dollars at an exchange rate of €1.00=US$            , the noon buying rate of the Federal Reserve Bank of New York on            except as it relates to the impact of the assumed proceeds, which are translated into U.S. dollars at an exchange rate of €1.00=US$            , the exchange rate of the Banque de France on            ). This represents an immediate increase in pro forma as adjusted net tangible book value of €          ($            ) per ordinary share and €           ($            ) per ADS to the existing shareholders and an immediate dilution in pro forma as adjusted net tangible book value of €          ($            ) per ordinary share and €          ($            ) per ADS to investors purchasing ADSs in this offering. The following table illustrates this dilution to new investors purchasing ADSs in this offering:

        The following table illustrates this dilution to new investors purchasing ADSs in the offering.

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  As of June 30, 2020  
 
  Per Ordinary
Share
  Per ADS  
 
  (€)   ($)   (€)   ($)  

Assumed offering price

                                                                     

Historical net tangible book value per ordinary share or ADS as of June 30, 2020

    (0.13 )   (0.14 )                                  

Increase per share due to the H2 2020 Private Placements, the H2 2020 Bond Conversions, the H2 2020 Warrant Conversions, the H2 2020 Convertible Note Financing and the proceeds of the CIR financing and net of the repayment of convertible notes and Kreos loan reimbursement

    0.27     0.30                                    

Pro forma net tangible book value per share as of June 30, 2020

    0.14     0.16                                    

Increase in net tangible book value per ordinary share or ADS attributable to new investors participating in the offering

                                                                     

Pro Forma as adjusted net tangible book value per ordinary share or ADS after the offering

                                                                     

Dilution in pro forma as adjusted net tangible book value per ordinary share or ADS to new investors participating in the offering

                                                                     

        The dilution information discussed above is illustrative only and will change based on the actual offering price and other terms of the offering determined at pricing.

        If the underwriter exercises in full its option to purchase an additional                        ADSs, our pro forma as adjusted net tangible book value per ADS after the offering would be $            , representing a further immediate increase in pro forma as adjusted net tangible book value per ADS of $            , and the immediate dilution to new investors participating in the offering would be $            per ADS, based on the assumed initial public offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus.

        Each $1.00 increase or decrease in the assumed offering price of $            per ADS, which is the midpoint of the price range set forth on the cover page of this prospectus, would further increase or decrease the pro forma as adjusted net tangible book value after the offering by $            per ADS and the dilution to new investors in the offering by $            per ADS, assuming that the number of ADSs offered by us in the offering, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and the application of the estimated net proceeds from the offering as described under "Use of Proceeds."

        An increase or decrease of 100,000 in the number of ADSs offered by us in the offering, as set forth on the cover page of this prospectus, would further increase or decrease the pro forma as adjusted net tangible book value after the offering by $            per ADS and decrease (increase) the dilution to new investors participating in the offering by $            per ADS, assuming no change in the assumed initial public offering price per ADS and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and the application of the estimated net proceeds from the offering as described under "Use of Proceeds."

        The following table summarizes, as of June 30, 2020, on a pro forma as adjusted basis described above, the number of ordinary shares purchased from us (including ordinary shares represented by ADSs), the total consideration paid to us, the average price per ordinary share paid by existing

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shareholders and the price per ADS paid by new investors purchasing ADSs in the offering. The table below and the two paragraphs that follow the table are based on an assumed initial public offering price of $            per ADS in the offering, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and the application of the estimated net proceeds from the offering as described under "Use of Proceeds," and reflect the Banque de France exchange rate on                        , 2021:

 
  Ordinary shares
purchased(1)
  Total
consideration
   
   
 
 
  Average price
per ordinary
Share ($)
  Average price
per ADS
($)
 
 
  Number   Percent   Amount ($)   Percent  

Existing shareholders

                   %                  %                          

New investors

                                     

Total

                 100 %                100 %                          

(1)
Including ordinary shares represented by ADSs.

        Each $1.00 increase or decrease in the assumed offering price of $            per ADS in the offering, which is the midpoint of the price range set forth on the cover page of this prospectus, would increase or decrease the total consideration paid by new investors by $             million, assuming that the number of ADSs offered by us in the offering, as set forth on the cover page of this prospectus, remains the same. An increase or decrease of 100,000 in the number of ADSs offered by us, as set forth on the cover page of this prospectus, would increase or decrease the total consideration paid by new investors by $             million, assuming no change in the assumed initial public offering price per ADS.

        The information described above is illustrative only and will change based on the actual offering price, the actual number of ADSs offered by us and other terms of the offering determined at pricing.

        If the underwriter exercises in full its option to purchase up to an additional                        ADSs (representing                        ordinary shares), the following will occur:

    the percentage of our ordinary shares held by existing shareholders will decrease to        % of the total number of our ordinary shares outstanding after the offering; and

    the percentage of our ordinary shares held by new investors will increase to approximately        % of the total number of our ordinary shares outstanding after the offering.

        The tables and calculations above are based on the number of ordinary shares (including ordinary shares represented by ADSs) that will be outstanding after the offering, which is based on 54,834,978 ordinary shares outstanding as of June 30, 2020.

        The following ordinary shares were issued after June 30, 2020:

    an aggregate of 30,840,328 ordinary shares that were issued in the H2 2020 Private Placements;

    an aggregate of 13,990,411 ordinary shares issued upon the H2 2020 Bond Conversions; and

    an aggregate of 1,091,380 ordinary shares issued upon the H2 2020 Warrant Conversions.

        The number of ordinary shares outstanding as of June 30, 2020 excludes:

    3,615,566 ordinary shares issuable upon the exercise of stock warrants issued to investors outstanding as of January 4, 2021, with a weighted-average exercise price of €0.27 per ordinary share;

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    3,455,610 ordinary shares issuable upon the exercise of warrants issued pursuant to equity incentive awards and outstanding as of January 4, 2021, with a weighted average exercise price of €0.61 per ordinary share;

    585,936 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to NEGMA and outstanding as of January 4, 2021, with a weighted average exercise price of €0.64 per ordinary share;

    442,477 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Kreos and outstanding as of January 4, 2021, with a weighted average exercise price of €2.67 per ordinary share as part of a financing that is described elsewhere in this prospectus;

    431,184 ordinary shares issuable upon the exercise of warrants issued pursuant to warrants issued to Bracknor and outstanding as of January 4, 2021, with a weighted average exercise price of €3.48 per ordinary share as part of a financing that has been fully repaid and terminated; and

    2,500,911 free ordinary shares that were granted to our founders on December 22, 2020 and will be delivered to them on December 22, 2022, after a two-year vesting period.

        It also excludes any potential dilution that may result in the event of a final decision awarding the delivery of shares by the Company to NEGMA in connection with the dispute described in the section of this prospectus titled "Business—Legal Proceedings".

        To the extent that warrants are exercised or we issue additional ADSs or ordinary shares in the future, there will be further dilution to investors participating in the offering. In addition, we may choose to raise additional capital because of market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans. If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our shareholders.

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SELECTED FINANCIAL AND OTHER DATA

        The following tables summarize our consolidated financial data for the periods and as of the dates indicated below. We derived the selected statement of consolidated operations data for the years ended December 31, 2018 and 2019 and statement of consolidated financial position data as of December 31, 2018 and 2019 from our audited consolidated financial statements included elsewhere in this prospectus. Our audited consolidated financial statements have been prepared in accordance with IFRS, as issued by the IASB. The following summary statement of consolidated operations data for the six months ended June 30, 2019 and 2020 and statement of consolidated financial position data as of June 30, 2020 have been derived from our unaudited interim condensed consolidated financial statements as of June 30, 2020 and for the six months ended June 30, 2019 and 2020 included elsewhere in this prospectus. The unaudited interim condensed consolidated financial statements as of June 30, 2020 and for the six months ended June 30, 2019 and 2020 were prepared in accordance with IAS 34, Interim Financial Reporting, the standard of the IFRS applicable to interim financial statements.

        Our historical results are not necessarily indicative of the results that may be expected in the future. You should read these data together with our consolidated financial statements and related notes beginning on page F-1, as well as the sections of this prospectus titled "Selected Financial and Other Data" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the other financial information included elsewhere in this prospectus.

 
  Year Ended
December 31,
  Six Months Ended June 30,  
 
  2018   2019   2019   2020  
 
 
 
 
 
  U.S. $(1)
 
 
  (in thousands, except share and per share data)
 

Statement of Consolidated Operations Data:

                               

Revenue

                     

Operating expenses:

                               

Research and development, net(3)

    9,513     9,089     4,828     5,192     5,815  

General and administrative expenses

    4,348     6,593     4,789     2,269     2,541  

Total operating expenses

    13,861     15,682     9,617     7,461     8,356  

Operating loss

    (13,861 )   (15,582 )   (9,617 )   (7,461 )   (8,356 )

Financial expenses

    (215 )   (2,878 )   (595 )   (4,289 )   (4,804 )

Financial income

    17     18     14     1     1  

Change in fair value of derivative instruments

        726         2,289     2,564  

Net Financial expense

    (198 )   (2,134 )   (581 )   (1,999 )   (2,239 )

Net loss before taxes

    (14,059 )   (17,816 )   (10,198 )   (9,460 )   (10,595 )

Income tax benefit

    72     28              

Net loss

    (13,987 )   (17,788 )   (10,198 )   (9,460 )   (10,595 )

Earnings (losses) per share(2)

                               

Basic

    (1.05 )   (1.05 )   (0.76 )   (0.25 )   (0.28 )

Diluted

    (1.05 )   (1.05 )   (0.76 )   (0.25 )   (0.28 )

Weighted average number of ordinary shares outstanding used for computing Basic

    13,374,426     16,882,661     13,366,218     37,211,432     37,211,432  

Weighted-average number of ordinary shares outstanding used for computing Diluted

    13,374,426     16,882,661     13,366,218     37,211,432     37,211,432  

(1)
Translated solely for convenience into dollars at an exchange rate of €1.00 = US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.

(2)
See Notes 2.22 and 19 to our audited consolidated financial statements and Note 18 to our unaudited interim condensed consolidated financial statements for further details on the calculation of basic and diluted loss per ordinary share.

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(3)
Research and development expenses excluding research tax credits and subsidies amounted to €12,691 thousand and €11,937 thousand for the years ended as of December 31, 2018 and 2019, respectively. They amounted to €6,567 thousand and €6,953 thousand (or $7,787 thousand translated solely for convenience into dollars at an exchange rate of €1.00 = US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020) for the six-months periods ended June 30, 2019 and 2020, respectively.
 
  As of December 31,   As of June 30,  
 
  2018   2019   2020  
 
 
 
 
  US $(1)
 
 
  in thousands
   
 

Statement of consolidated financial position data:

                         

Cash and cash equivalents

    14,406     6,337     12,183     13,645  

Total assets

    21,862     17,672     18,848     21,110  

Non-controlling interests

    (31 )   (31 )   (32 )   (36 )

Total shareholders' equity

    7,006     (7,526 )   (4,438 )   (4,971 )

Total non-current liabilities

    6,572     5,540     3,872     4,337  

Total current liabilities

    8,284     19,658     19,414     21,744  

(1)
Translated solely for convenience into dollars at an exchange rate of €1.00 = US$1.12, the noon buying rate of the Federal Reserve Bank of New York on June 30, 2020.

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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

        You should read the following discussion of our financial condition and results of operations in conjunction with our consolidated financial statements and the notes included elsewhere in this prospectus. The following discussion contains forward-looking statements that involve certain risks and uncertainties. Our actual results could differ materially from those discussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this prospectus, particularly under the "Risk Factors" and "Special Note Regarding Forward-Looking Statements" sections.

Overview

        We are a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Our goal is to become a leader in the emerging field of aging science by delivering life-changing therapies to the growing number of patients in need. To accomplish this goal, we have assembled an experienced and skilled group of industry professionals, scientists, clinicians and key opinion leaders from leading industry and academic institutions from around the world.

        Our therapeutic approach is aimed at targeting and activating key biological resilience pathways that can protect against and counteract the effects of the multiple biological and environmental stresses, including inflammatory, oxidative, metabolic and viral stresses that lead to age-related diseases.

        Our lead drug candidate, Sarconeos (BIO101), is in development for the treatment of neuromuscular diseases, including sarcopenia and DMD, and for the treatment of respiratory diseases, including COVID-19. Our second drug candidate, Macuneos (BIO201), is in development for the treatment of retinopathies, including dry AMD and Stargardt disease.

        We are currently testing the safety and efficacy of Sarconeos (BIO101) in an ongoing global, randomized, double-blind, placebo-controlled clinical study (SARA-INT) with 233 elderly patients with sarcopenia at risk for mobility disability. We are also actively developing Sarconeos (BIO101) in an ongoing global, multicentric, double-blind, placebo-controlled, group-sequential, and adaptive two-part Phase 2-3 study (COVA) with 310 patients 45 years old and older with severe respiratory symptoms of COVID-19. We received an IND "may proceed" letter from the FDA in the United States and CTA approval from the FAMHP in Belgium in the second half of 2019 to initiate clinical development with our MYODA clinical program, which is based on a global, double-blind, placebo-controlled, group-sequential, Phase 1-3 seamless study, in non-ambulatory DMD patients, with signs of respiratory deterioration

        We hold exclusive commercialization rights through licenses for each of our drug candidates. We currently plan to develop our drug candidates through clinical PoC (typically Phase 2), and then seek licensing and/or partnership opportunities for further clinical development through regulatory approval and commercialization.

Financial Operations Overview

        The following discussion sets forth certain components of our statements of operations as well as factors that impact those items.

Revenues

        To date we have not generated any revenues from product sales, or otherwise, and we do not expect to recognize any revenue from the sale of products, even if we obtain regulatory approval for the products, in the near term. Our ability to generate revenue in the future will depend almost entirely

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on our ability to successfully develop, obtain regulatory approval for and then commercialize our drug candidates.

Research and Development Expenses

        Our research and development expenses consist primarily of costs incurred in connection with the development of our drug candidates, including:

    personnel-related costs, such as salaries, bonuses, benefits, travel and other related expenses, including share-based compensation;

    expenses incurred under our agreements with CROs, clinical sites, contract laboratories, medical institutions and consultants that plan and conduct our preclinical studies and clinical trials;

    costs associated with regulatory filings;

    costs of acquiring preclinical study and clinical trial materials, and costs associated with preclinical development formulation and process development;

    depreciation, maintenance and other facility-related expenses; and

    as an offset of our research and development expenses, the CIR.

        To date, we have expensed all research and development costs as incurred, as we do not currently meet the conditions to capitalize expenditures on drug development activities, as provided in IAS 38 Intangible Assets.

        Clinical development expenses for our drug candidates are a significant component of our current research and development expenses as we advance our drug candidates into and through clinical trials. Drug candidates in later stage clinical development generally have higher research and development costs than those in earlier stages of development, primarily due to increased size and duration of the clinical trials. We recognize costs for each grant project, preclinical study or clinical trial that we conduct based on our evaluation of the progress to completion, using information and data provided to us by our research and development vendors and clinical sites.

        We expect our research and development expenses to increase for the foreseeable future as we progress our drug candidates into and through clinical trials. Furthermore, to the extent we undertake to commercialize any drug candidates approved for any indication for sale, our expenses will likely increase even more. The process of conducting the necessary clinical research to obtain regulatory approval of a drug candidate is costly and time consuming. We will require additional funding, beyond any proceeds raised in the offering, to fund our continuing operations. The probability that any of our drug candidates receives regulatory approval and eventually is able to generate revenue depends on a variety of factors, including the quality of our drug candidates, early clinical data, investment in our clinical program and further clinical validation, competition, manufacturing capability and commercial viability. We may never succeed in obtaining regulatory approval for any of our drug candidates. As a result of these uncertainties, we are unable to determine the duration and completion costs of our research and development projects or if, when and to what extent we will generate revenue from the commercialization and sale of any of our drug candidates, if approved.

General and Administrative Expenses

        General and administrative expenses include personnel costs, costs for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, travel and share-based compensation. Outside professional services consist of legal, accounting and audit services, commercial evaluation and strategy services, and other consulting services. We expect general and administrative expenses to increase in the near future with the expansion of our staff and management

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team to include new personnel responsible for finance, legal, information technology and later, sales and business development functions. We also expect to incur additional general and administrative costs in connection with this offering and as a result of operating as a U.S. public company following the offering, including expenses related to compliance with the rules and regulations of the SEC and those of any national securities exchange on which our securities are traded, additional insurance expense, investor relations activities and other administrative and professional services. We also expect to incur additional expenses related to in-licenses, acquisitions or similar transactions that we may pursue as part of our strategy, including legal, accounting and audit services and other consulting fees.

Net Financial Income (Expense)

        Net financial income (expense) includes amortized cost of the reimbursable advances, convertible notes and non-convertible bonds, fair value adjustments on financial instruments, including derivatives, other financial income and expense and the NEGMA financial indemnity (as described in further detail in the paragraph "Results of Operations" below and in Note 14 to the unaudited interim condensed consolidated financial statements). We expect to incur additional financial expenses related to financing agreements or similar transactions that we may enter into to finance our development.

COVID-19 Impact

        We have, like many other companies, experienced disruptions due to the COVID-19 pandemic. Given the rapid changes associated with COVID-19, we have and are continuing to take the necessary precautions to protect our employees, partners and operations. For example, we have encouraged our employees in France and in the United States to work from home and to organize meetings and events in a virtual way whenever possible. We have also imposed restrictions on travel, which is now limited to professional imperatives only.

        Our ongoing and planned clinical studies have been impacted by COVID-19. Our SARA-INT trial in sarcopenia has been impacted by the emergence of COVID-19 and subsequent lockdowns in Belgium and several American states (California and New York in particular). In light of the various measures adopted by governments and health authorities to restrict movement and protect the safety of patients, we have had to adapt our SARA-INT protocol in order to ensure the continuity of the trial, in particular by closing all on-site activities, organizing patient follow-up to take place at home, and expanding the treatment from six to nine months for some patients. Despite these interruptions of in-office study visits and other disruptions that were imposed due to the COVID-19 pandemic, we were able to retain most of the study participants. The last patient completed his final on-treatment visit in December 2020. Currently, we are conducting final assessment on the last patients in this clinical trial. We expect to announce top-line results during the second quarter of 2021.

        In addition, our MYODA program in DMD and MACA program for dry AMD, both planned for 2021, may be delayed as a result of COVID-19.

        Our COVA trial to treat COVID-19 patients will depend strongly upon the evolution of the pandemic.

Critical Accounting Policies and Significant Judgments And Estimates

        Our audited consolidated financial statements and unaudited interim condensed consolidated financial statements have been prepared in accordance with IFRS, as issued by the IASB. Some of the accounting methods and policies used in preparing our financial statements under IFRS are based on complex and subjective assessments by our management or on estimates based on past experience and assumptions deemed realistic and reasonable based on the circumstances. The actual value of our assets, liabilities and shareholders' equity and of our losses could differ from the value derived from these estimates if conditions change and these changes have an impact on the assumptions adopted. We

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believe that the most significant management judgments and assumptions in the preparation of our financial statements are described below. See Note 2.2 to our audited consolidated financial statements as of December 31, 2018 and 2019 and for each of the two years ended December 31, 2018 and 2019.

Founders' warrants and warrants granted to employees and executives

        The fair value measurement of share-based payments is based on the Black-Scholes option valuation model, which makes assumptions about complex and subjective variables. These variables notably include the value of our shares, the expected volatility of the share price over the lifetime of the instrument, and the present and future behavior of holders of those instruments. There is a high inherent risk of subjectivity when using an option valuation model to measure the fair value of share-based payments in accordance with IFRS 2 Share-based Payment.

Convertible Notes and Non-Convertible Bonds

        During the year ended December 31, 2018, we issued non-convertible bonds with warrants attached to Kreos.

        During the year ended December 31, 2019, we issued non-convertible bonds to Kreos and notes convertible into ordinary shares and/or redeemable for cash with warrants attached to NEGMA.

        During the six-month period ended June 30, 2020, we issued notes convertible into ordinary shares and/or redeemable for cash to ATLAS.

        In accordance with IFRS 9 Financial Instruments, we measured the fair value of the equity instrument and the financial derivative instruments (related to the conversion option held by NEGMA and ATLAS) based on the Black-Scholes option valuation model, which makes assumptions about complex and subjective variables. These variables notably include the value of our shares, the expected volatility of the share price over the lifetime of the instrument, and the assumed present and future behavior (including estimated timing of exercise, conversion and other decisions) of holders of those instruments. There is a high inherent risk of subjectivity when using an option valuation model to measure the fair value of financial instruments and equity instruments in accordance with IAS 32 Financial Instruments: presentation, and IFRS 9 Financial Instruments.

        In accordance with IFRS 9 Financial Instruments, initial recognition of the convertible notes was recorded at the fair value of their debt component and subsequently this debt component is accounted for under the amortized cost method.

        The conversion option of the convertible notes was bifurcated and classified in derivative instruments because the conversion price is not fixed and measured at fair value on the date of issuance based on the Black-Scholes option valuation model with recognition of the changes in fair value in profit or loss in each reporting period in accordance with IFRS 9 Financial Instruments.

Non-recognition of deferred tax assets net of deferred tax liabilities

        The determination of the amount of deferred tax assets which can be recognized requires management to make estimates on both the period in which tax losses carried forward will be realizable, and the level of future taxable income.

        As of December 31, 2018 and 2019 and June 30, 2020, no deferred tax asset has been recognized in our financial statements except as a result of the expected taxable income to be derived from deferred tax liabilities.

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        We recognized in 2018:

    a deferred tax liability with respect to the equity component of the non-convertible bonds issued in 2018 for €72 thousand, as a decrease of equity on initial recognition under IAS 12 Income Taxes; and

    a deferred tax asset with respect to net operating losses (NOLs) carried forward as a result of the deferred tax liabilities generated, resulting in deferred tax income of €72 thousand in the statement of consolidated operations.

        We recognized in 2019:

    a deferred tax liability with respect to the equity component of the non-convertible bonds issued in 2019 for €28 thousand, as a decrease of equity on initial recognition under IAS 12 Income Taxes; and

    a deferred tax asset with respect to net operating losses (NOLs) carried forward as a result of the deferred tax liabilities generated, resulting in deferred tax income of €28 thousand in the statement of consolidated operations.

The JOBS Act

        As an "emerging growth company" under the JOBS Act, we can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an "emerging growth company" to delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We will not take advantage of the extended transition period provided under Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. Since IFRS makes no distinction between public and private companies for purposes of compliance with new or revised accounting standards, the requirements for our compliance as a private company and as a public company are the same.

        We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an "emerging growth company", we intend to rely on certain of these exemptions including, without limitation, the exemptions from providing an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act. We will remain an "emerging growth company" until the earliest of: (1) the last day of the fiscal year in which we have total annual gross revenues of $1.07 billion or more; (2) the last day of the fiscal year following the fifth anniversary of the date of the completion of this offering; (3) the date on which we have issued more than $1 billion in non-convertible debt during the previous three years; and (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

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Results of Operations

Comparison for the six-month periods ended June 30, 2019 and 2020

        The following table sets forth our results of operations for the six-month periods ended June 30, 2019 and 2020.

(Amounts in thousands of euros)
  June 30,
2019
  June 30,
2020
 

Revenue

         

Costs of sales

         

Gross margin

         

Research and development, net

    (4,828 )   (5,192 )

General and administrative expenses

    (4,789 )   (2,269 )

Operating loss

    (9,617 )   (7,461 )

Financial expenses

    (595 )   (4,289 )

Financial income

    14     1  

Change in fair value of derivative instruments

        2,289  

Net financial expense

    (581 )   (1,999 )

Loss before taxes

    (10,198 )   (9,460 )

Income taxes

         

Net loss

    (10,198 )   (9,460 )

Research and Development Expenses

        Research and development expenses may be summarized as follows for the six-month periods ended June 30, 2019 and 2020.

(Amounts in thousands of euros)
  June 30,
2019
  June 30,
2020
 

Personnel expenses

    (2,034 )   (1,579 )

Purchases and external expenses

    (4,430 )   (5,255 )

Other

    (103 )   (119 )

Research and development expenses

    (6,567 )   (6,953 )

Research tax credit

    1,705     1,754  

Subsidies

    34     7  

Research tax credit and Subsidies

    1,739     1,761  

Research and development, net

    (4,828 )   (5,192 )

        Research and development expenses primarily relate to activities in connection with conducting clinical trials and non-clinical studies of our drug candidates for the treatment of age-related diseases.

        The decrease of €0.5 million in personnel expenses is primarily related to the downsizing of our structure initiated during the second half of 2019 which continues into 2020.

        The increase of €0.8 million in purchases and external expenses is primarily related to our clinical trials. These expenses consisted primarily of the cost of CROs in conducting the clinical SARA-INT trial, which increased the number of patients and clinical centers.

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        We have benefited from the CIR since our incorporation. The CIR was steady at €1,705 thousand and €1,754 thousand for the six-month periods ended June 30, 2019 and 2020, respectively.

General and Administrative Expenses

        General and Administrative expenses may be summarized as follows for the six-month periods ended June 30, 2019 and 2020.

(Amounts in thousands of euros)
  June 30,
2019
  June 30,
2020
 

Personnel costs

    (1,257 )   (743 )

Purchases and external expenses

    (1,253 )   (1,242 )

Other

    (2,180 )   (284 )

General and administrative expenses

    (4,690 )   (2,269 )

        Personnel expenses, including share-based payments, for general management and administrative staff decreased by €0.5 million due to the reorganization of our administrative and finance function, and the subsequent decrease in personnel from eight people as of June 30, 2019 to four people as of June 30, 2020.

        Other purchases and external expenses consisted primarily of administrative expenses associated with being a public listed company in France, accounting and audit fees, and legal fees.

        The decrease in other expenses is primarily due to the recognition as expenses of the €2,225 thousand in fees related to our 2019 Nasdaq listing application, which was later withdrawn.

Net Financial Expense

        Net financial expense may be summarized as follows for the six-month periods ended June 30, 2019 and 2020.

(Amounts in thousands of euros)
  June 30,
2019
  June 30,
2020
 

Other financial expenses

    (16 )   (163 )

NEGMA financial indemnity

        (1,779 )

Financial interest and amortized cost of the non-convertible bonds and convertible notes

    (576 )   (2,332 )

Changes in fair value of derivative instruments

        2,289  

Other financial income

    4     1  

Foreign exchange gains (losses)

    6     (15 )

Net financial expense

    (581 )   (1,999 )

        Net financial expense was €(581) thousand and €(1,999) thousand for the six-month periods ended June 30, 2019 and 2020, respectively.

        On September 10, 2018, we signed a venture loan agreement and bond issue agreement with Kreos (as described in further detail below). The first and second tranches of non-convertible bonds were issued on September 10, 2018, the third tranche was issued on December 17, 2018, and the last one was issued on March 1, 2019, for total gross proceeds to us of €10 million. In accordance with IFRS 9 Financial instruments, the non-convertible debt component is measured according to the amortized cost method.

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        On August 21, 2019, we signed an agreement with NEGMA providing for up to €24 million in financing to us through the issuance of multiple tranches of convertible notes with attached warrants (ORNANEBSA), at our sole discretion.

        Pursuant to this agreement, the Board of Directors approved the issuance of the following convertible notes and warrants during the year ended December 31, 2019:

    A first tranche on August 21, 2019 of 300 ORNANE plus a commitment fee of 30 ORNANE, with attached warrants to purchase 585,936 shares, resulting in gross proceeds to us of €3 million; and

    A second tranche on December 26, 2019 of 300 ORNANE, of which 50% were paid by NEGMA as of December 31, 2019, resulting in gross proceeds to us of €1.5 million, together with attached warrants to purchase 694,444 shares.

        In accordance with IFRS 9 Financial instruments, initial recognition of the convertible notes was recorded at the fair value of their debt component and subsequently this debt component is accounted for under the amortized cost method. The conversion option of the convertible notes was bifurcated and classified in derivative instruments because the conversion price is not fixed and measured at fair value on the date of issuance based on the Black-Scholes option valuation model with recognition of the changes in fair value in profit or loss in each reporting period in accordance with IFRS 9 Financial instruments.

        Following the termination of the NEGMA contract on April 6, 2020, NEGMA undertook legal action in order to claim damages of €910,900 from us as well as the delivery of 7,000,000 of our ordinary shares that NEGMA considers it was entitled to pursuant to the remaining ORNANES still held by NEGMA, issued in consideration for a loan of €1,400,000 in principal. Pursuant to a summary judgment dated May 7, 2020, NEGMA obtained a decision partially responding to its claims ordering, under penalty (which amounted to €7 thousand), that we pay damages in an amount of €378 thousand, and deliver 2,050,000 ordinary shares to NEGMA. These 2,050,000 shares were valued at €1,394 thousand and were considered as a financial indemnity. The financial indemnity, including damages totaling €1,779 thousand, was then recorded as financial expense during the period (€1,394 thousand against equity and €385 thousand (including the €7 thousand in penalties) paid to NEGMA). The summary judgement does not extinguish the liability due to NEGMA. We appealed the May 7, 2020 summary judgment. By decision dated November 18, 2020, the Court of Appeal reversed the order of May 7, 2020 and ordered NEGMA to pay the costs of the trial and appeal proceedings. As a result, NEGMA was ordered to return the 2,050,000 ordinary shares to us and pay us the amount of €378 thousand. NEGMA has satisfied these obligations as of the date of this prospectus by paying €419 thousand (including penalty interest and legal costs) and delivering 2,050,000 ordinary shares to us. NEGMA has two months to appeal this decision. In addition, NEGMA initiated proceedings on the merits in order to obtain what had not been awarded by the May 7, 2020 court order. Since the decision of the Court of Appeals of Paris dated November 18, 2020, NEGMA has modified its claims on the merits in order to obtain 7,000,000 shares. Further hearings on the merits are expected to occur in early 2021. See the section of this prospectus titled "Business—Legal Proceedings."

        In April 2020, we signed a new convertible bond financing of €24 million with ATLAS to continue the development of Sarconeos (BIO101). We issued a first tranche of €3 million on April 29, 2020, a second tranche of €3 million on June 19, 2020 and a third tranche of €3 million on August 28, 2020. As of the date of this prospectus, there are no outstanding convertible notes issued to ATLAS, following redemption in cash of the remaining 30 notes. In accordance with IFRS 9 Financial instruments, the debt component of the convertible notes was measured according to the amortized cost method. The conversion option of the convertible notes was bifurcated and classified in derivative instruments because the conversion price is not fixed and measured at fair value on the date of issuance (based on

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the Black-Scholes valuation model) with recognition of the changes in fair value in profit or loss in accordance with IFRS 9 Financial instruments.

        Pursuant to the agreement, we may issue up to 600 additional ORNANE to ATLAS, which would provide for additional funding to us of up to €15 million.

        There were 68 NEGMA convertible notes (par value of €10 thousand) and 80 ATLAS convertible notes (par value of €25 thousand) converted during the six-month period ended June 30, 2020, which resulted in the elimination of the related financial instruments and reclassification of the debt to equity upon share issuance with the net impact of the conversion using the nominal value of the debt being reflected in the line "Financial interest and amortized cost of the convertible notes and non-convertible bonds" in the table above.

Income taxes

        No income tax expenses were charged in the six-month periods ended June 30, 2019 and 2020.

Comparison for the years ended December 31, 2018 and 2019

        The following table sets forth our results of operations for the years ended December 31, 2018 and 2019.

(Amounts in thousands of euros)
  December 31,
2018
  December 31,
2019
 

Revenue

         

Costs of sales

         

Gross margin

         

Research and development, net

    (9,513 )   (9,089 )

General and administrative expenses

    (4,348 )   (6,593 )

Operating loss

    (13,861 )   (15,682 )

Financial expenses

    (215 )   (2,878 )

Financial income

    17     18  

Change in fair value of derivative instruments

        726  

Net financial expense

    (198 )   (2,134 )

Loss before taxes

    (14,059 )   (17,816 )

Income taxes

    72     28  

Net loss

    (13,987 )   (17,788 )

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Research and Development Expenses

        Research and development expenses may be summarized as follows for the years ended December 31, 2018 and 2019.

(Amounts in thousands of euros)
  December 31,
2018
  December 31,
2019
 

Personnel expenses

    (2,962 )   (3,063 )

Purchases and external expenses

    (9,539 )   (8,660 )

Other

    (190 )   (214 )

Research and development expenses

    (12,691 )   (11,937 )

Research tax credit

    3,133     2,807  

Subsidies

    45     41  

Research tax credit and Subsidies

    3,178     2,848  

Research and development, net

    (9,513 )   (9,089 )

        Personnel costs, including stock-based payments for engineers and research personnel, were €2,962 thousand and €3,063 thousand for the years ended December 31, 2018 and 2019, respectively.

        Purchases and external expenses related to our research activity were €9,539 thousand and €8,660 thousand for the years ended December 31, 2018 and 2019, respectively. The decrease in purchases and external expenses related to our studies and research costs is mainly due to budgetary constraints on current programs in favor of the development of our SARA-INT study. This decision allowed us to accelerate patient recruitment in the SARA-INT study.

        These expenses consisted primarily of the cost of CROs in conducting clinical trials and non-clinical regulatory studies of our drug candidates.

        We have benefited from the Research Tax Credit (CIR) since our incorporation. The CIR amounted to €3,133 thousand and €2,807 thousand for the years ended December 31, 2018 and 2019, respectively. In December 2019, a portion of the CIR receivables for 2018 and 2019 were prefinanced by FONDS COMMUN DE TITRISATION PREDIREC INNOVATION 2020 with NEFTYS CONSEIL SARL as arranger, or NEFTYS. CIR receivables for 2018 (€3,133 thousand) and 2019 (€3,243 thousand) were subsequently reimbursed by the French Tax Authorities in January 2020 and June 2020, respectively. The prefinanced receivables were then reimbursed directly to NEFTYS.

General and Administrative Expenses

        General and Administrative expenses may be summarized as follows for the years ended December 31, 2018 and 2019.

(Amounts in thousands of euros)
  December 31,
2018
  December 31,
2019
 

Personnel costs

    (1,804 )   (1,998 )

Purchases and external expenses

    (2,428 )   (2,393 )

Other

    (116 )   (2,203 )

General and administrative expenses

    (4,348 )   (6,593 )

        Personnel costs, including share-based payments, for general management and administrative staff were €1,804 thousand and €1,998 thousand for the years ended December 31, 2018 and 2019, respectively, mainly due to the full impact in 2019 of the recruitment of a CFO for our U.S. subsidiary that occurred in late 2018.

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        Other purchases and external expenses were €2,428 thousand and €2,393 thousand for the years ended December 31, 2018 and 2019, respectively. These expenses consisted primarily of administrative expenses associated with being a public listed company in France, accounting and audit fees, and legal fees.

        The overall increase in general and administrative expenses for the year ended December 31, 2019, is primarily due to the recognition as expenses of the €2,225 thousand in fees related to our 2019 Nasdaq listing application, which was later withdrawn.

Net Financial Expense

        Net financial expense may be summarized as follows for the years ended December 31, 2018 and 2019.

(Amounts in thousands of euros)
  December 31,
2018
  December 31,
2019
 

Other financial expenses

    (38 )   (337 )

Financial interest and amortized cost of the convertible notes and non-convertible bonds

    (189 )   (2,526 )

Change in fair value of derivative instruments

        726  

Other financial income

    10     4  

Foreign exchange gains (losses)

    19      

Net financial expense

    (198 )   (2,134 )

        Net financial expense was €(198) thousand and €(2,134) thousand for the years ended December 31, 2018 and 2019, respectively.

        On September 10, 2018, we signed a venture loan agreement and bonds issue agreement with Kreos (as described in further detail below). The first and second tranches of non-convertible bonds were issued on September 10, 2018, the third tranche was issued on December 17, 2018, and the last one was issued on March 1, 2019, for total gross proceeds to us of €10 million. In accordance with IFRS 9 Financial instruments, the non-convertible debt component is measured according to the amortized cost method.

        On August 21, 2019, we signed an agreement with NEGMA providing for up to €24 million in financing to us through the issuance of multiple tranches of convertible notes with attached warrants (ORNANEBSA), at our sole direction.

        Pursuant to this agreement, the Board of Directors approved the issuance of the following convertible notes and warrants during the year ended December 31, 2019:

    A first tranche on August 21, 2019 of 300 ORNANE plus a commitment fee of 30 ORNANE, with attached warrants to purchase 585,936 shares, resulting in gross proceeds to us of €3 million; and

    A second tranche on December 26, 2019 of 300 ORNANE, of which 50% were paid by NEGMA as of December 31, 2019, resulting in gross proceeds to us of €1.5 million, together with attached warrants to purchase 694,444 shares.

        In accordance with IFRS 9 Financial Instruments, initial recognition of the convertible notes was recorded at the fair value of their debt component and subsequenty this debt component is accounted for under the amortized cost method. The conversion option of the convertible notes was bifurcated and classified in derivative instruments because the conversion price is not fixed and measured at fair value on the date of issuance (based on the Black-Scholes valuation model) with recognition of the changes in fair value in each reporting period in the statement of consolidated operations.

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        An aggregate of 242 convertible notes (par value of €10 thousand each) were converted in 2019, which resulted in the elimination of the financial instrument and reclassification of the debt to equity upon share issuance with the net impact of the conversion using the nominal value of the debt being reflected in "Financial interest and amortized cost of the convertible notes and non-convertible bonds" in the table above.

        In April 2020, we signed a new convertible bond financing of €24 million with ATLAS to continue the development of Sarconeos (BIO101). We issued a first tranche of €3 million on April 29, 2020, a second tranche of €3 million on June 19, 2020, and a third tranche of €3 million on August 28, 2020. As of the date of this prospectus, there are no outstanding convertible notes issued to ATLAS, following redemption in cash of the remaining 30 notes.

        Pursuant to the agreement, we may issue up to 600 additional ORNANE to ATLAS, which would provide for additional funding to us of up to €15 million.

    Income taxes

        In 2018 and 2019, a deferred tax asset has been recognized through the consolidated statement of operations to offset the deferred tax liability related to the equity component of the non-convertible bonds and the convertible notes recorded in equity. Management expects that losses on ordinary activities will continue to be offset by unrecognized tax losses.

Liquidity and Capital Resources

        As of December 31, 2019, and June 30, 2020, we had cash and cash equivalents of €6,337 thousand and €12,183 thousand, respectively. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation. Currently, our funds are held in bank accounts and fixed bank deposits primarily in France.

        Our operations have been financed primarily by capital contributions from our founders, capital increases carried out between 2006 and 2019, convertible debt instruments with warrants, non-convertible bonds and net proceeds from the initial public offering of our ordinary shares on the Euronext Growth Market in France in 2015. Our primary uses of capital are, and we expect will continue to be, third-party expenses associated with the planning and conduct of preclinical studies and clinical trials, costs of process development services and manufacturing of our drug candidates, and compensation-related expenses.

        We do not expect to generate significant revenue from product sales unless and until we out-license one or more drug candidates or we obtain regulatory approval for and commercialize our current or any future drug candidates, either directly or through others. We anticipate that we will continue to generate losses for the foreseeable future, and we expect our losses to increase as we continue the development of and seek regulatory approvals for our drug candidates and begin to commercialize any approved products.

        We are subject to numerous risks applicable to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. Upon the closing of the offering, we expect to incur additional costs associated with operating as a public company in the United States and we anticipate that we will need substantial additional funding in connection with our continuing operations.

        Our future funding requirements will depend on many factors, including the following:

    the scope, rate of progress, results and cost of our preclinical studies and clinical trials and other related activities.

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    the cost of formulation, development, manufacturing of clinical supplies and establishing commercial supplies of our drug candidates and any other drug candidates that we may develop, in-license or acquire;

    the cost, timing and outcomes of pursuing regulatory approvals;

    the cost and timing of establishing administrative, sales, marketing and distribution capabilities, to the extent we undertake to commercialize our products directly;

    the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any required milestone and royalty payments thereunder; and

    the emergence of competing technologies and their achieving commercial success before we do or other adverse market developments.

        Our ability to achieve and maintain profitability will depend upon the successful development, regulatory approval and commercialization of our drug candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. If we need to raise additional capital to fund our operations and complete our ongoing and planned clinical trials, funding may not be available to us on acceptable terms, or at all.

        We plan to continue to fund our operations and capital funding needs through a combination of equity offerings, debt financings and collaborations. The sale of additional equity would result in additional dilution to our shareholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that would restrict our operations. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, sell assets where possible or suspend or curtail planned programs. In addition, lack of funding would limit any strategic initiatives to in-license or acquire additional drug candidates or programs.

        As of June 30, 2020, we had capital resources consisting of cash, cash equivalents, and marketable securities of €12.2 million ($13.6 million). Since that date and as of January 4, 2021, we issued €3 million of convertible notes in August 2020 and issued shares through two private placements totaling €16.1 million in July 2020 and October 2020. We also issued an aggregate number of (i) 13,990,411 ordinary shares in the H2 2020 Bond Conversions and (ii) 1,091,380 ordinary shares in the H2 2020 Warrant Conversions. We also (i) repaid €863 thousand in cash for the remaining 30 convertible notes that were issued to ATLAS, at redemption value in the amount of €750 thousand (ii) received the proceeds of the CIR receivable financing in the amount of €1,953,518 and (iii) repaid €1,562 thousand of the carrying amount of the Kreos loan.

        We expect that our existing capital resources as adjusted by the effect of those events, and including our ability to draw down on our credit facility with ATLAS (up to €15 million), together with the proceeds from the offering, will be sufficient to fund our current operations for the next 12 months. However, this estimate is based on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. In any event, we will need additional funding to pursue preclinical and clinical activities, obtain regulatory approval for, and commercialize our drug candidates.

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Cash Flows

 
  Year Ended
December 31,
  Six Months
Ended June 30,
 
(Amounts in thousands of euros)
  2018   2019   2019   2020  

Net cash (used in) provided by:

                         

Operating activities

    (12,057 )   (15,272 )   (10,359 )   76  

Investing activities

    (104 )   (278 )   (283 )    

Financing activities

    6,771     7,500     1,459     5,764  

Effect of exchange rate changes on cash and cash equivalents

    (61 )   (18 )   (16 )   6  

Net increase (decrease) in cash and cash equivalents

    (5,451 )   (8,069 )   (9,199 )   (5,846 )

Operating Activities

        Net cash used in operating activities were €12,057 thousand and €15,272 thousand for the years ended December 31, 2018 and 2019, respectively. The increase in net cash used is mainly related to the €2,225 thousand in fees incurred in connection with our 2019 Nasdaq listing application, which was later withdrawn.

        During the six-month periods ended June 30, net cash used in operating activities decreased from €10,359 thousand in 2019 to a net cash provided by operating activities of €76 thousand in 2020. Net cash used in operating cash flows before change in working capital requirements amounted to €6,829 thousand during the six months period ended June 30, 2020 compared to €8,984 thousand, primarily reflecting the decrease of general and administrative expenses due to the cost incurred in 2019 in connection with our 2019 Nasdaq listing application, which was later withdrawn. Cash provided by the change in working capital requirements during the six-month period ended June 30, 2020 amounted to €6,906 thousand, primarily reflecting the reimbursement of the research tax credit receivables and increase in trade payable, compared to cash used in the change in working capital requirements during the six-month period ended June 30, 2019 of €1,375 thousand, primarily as a result of an increase in the research tax credit receivable in the period.

Investing Activities

        Net cash used in investing activities was €104 thousand and €278 thousand for the years ended December 31, 2018 and 2019, respectively. As part of the Intellectual Property Agreement signed with our CEO, we acquired, in 2019, from our CEO the rights to use patents for €630 thousand, which are amortized over 19 years, €270 thousand of which was paid during the six-month period ended June 30, 2019 and year ended December 31, 2019.

Financing Activities

        Net cash provided by financing activities were €6,771 thousand and €7,500 thousand for the years ended December 31, 2018 and 2019, respectively.

        Between September and December 2018, we issued three tranches of non-convertible bonds to Kreos for €2,500 thousand each for total gross proceeds to us of €7,500 thousand. A guarantee deposit of €240 thousand was withheld by Kreos from the proceeds received by us. The amount withheld will be deducted from the last installment to be repaid by us. In relation to these debt issuances, we incurred costs of €305 thousand.

        On March 1, 2019, we issued one tranche of non-convertible bonds to Kreos for €2,500 thousand. A guarantee deposit of €80 thousand was withheld by Kreos from the proceeds received by us. The amount withheld will be deducted from the last installment to be repaid by us. In relation to these debt issuances, we incurred costs of €50 thousand. In 2019, we repaid €2,292 thousand.

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        On August 21, 2019, we issued one tranche of convertible notes with attached warrants to NEGMA for €3,000 thousand (300 convertible notes), plus a commitment fee of 30 convertible notes. On December 26, 2019, we issued a second tranche out of which 50% were paid by NEGMA, resulting in gross proceeds to us of €1.5 million (150 convertible notes). 242 convertible notes were converted in 2019 resulting in the issuance of 10,499,841 ordinary shares.

        In December 2019, a portion of the research tax credit receivables for 2018 and 2019 were prefinanced by NEFTYS for total gross proceeds of €5,029 thousand. We incurred issuance costs of €62 thousand and amortized costs of €134 thousand. A guarantee deposit of €475 thousand was withheld by NEFTYS from the proceeds received by us.

        We also received net proceeds of €73 thousand from conditional advances in 2019 compared to €329 thousand in 2018, and we paid interest of €1,080 thousand in 2019 compared to €135 thousand in 2018.

        Net cash provided by financing activities were €1,459 thousand and €5,764 thousand for the six-month period ended June 30, 2019 and 2020, respectively.

        We issued an aggregate of 18,454,677 ordinary shares in two capital increases that occurred in February and June 2020 for total gross proceeds to us of €7,346 thousand. In relation to these equity transactions, we incurred costs of €863 thousand.

        Proceeds from the subscription of warrants and the exercise of warrants amounted to €271 thousand and €567 thousand, respectively, during the six-month period ended June 30, 2020. The subscription and the exercise of the investors' warrants by our CEO in April 2020 was settled against the €630 thousand due to our CEO following our acquisition of patents rights (€177 thousand for the subscription of warrants and €453 thousand for the exercise of warrants).

        In April and June 2020, we issued two tranches of convertible notes to ATLAS for €3,000 thousand each. As at June 30, 2020, 80 convertible notes of €25 thousand each were converted resulting in the issuance of 3,188,272 ordinary shares. In relation to these debt issuances, we incurred costs of €414 thousand.

        Pursuant to a summary judgement dated May 7, 2020, we were required to pay damages in an amount of €378 thousand and deliver 2,050,000 ordinary shares to NEGMA.

        We repaid €1,567 thousand of the Kreos non-convertible bonds during the six-month period ended June 30, 2020 compared to €801 thousand during the six-month period ended June 30, 2019.

        We did not receive proceeds from conditional advances during the six-month period ended 2020 compared to €277 thousand for the same period in 2019. We paid interest of €368 thousand and €337 thousand for the six-months period ended June 30, 2019 and 2020, respectively.

Cash and Funding Sources

Research Tax Credit

        We have benefited from the CIR since our incorporation. The CIR is usually payable by the government in the year following its recognition when there is no taxable net income to be offset if certain business size criteria are met. The CIR for 2017 was reimbursed in 2018 for €2,545 thousand. In December 2019, a portion of the CIR receivables for 2018 and 2019 were prefinanced by NEFTYS. CIR receivables for 2018 (€3,133 thousand) and 2019 (€3,243 thousand) were reimbursed by the French Tax Authorities in January 2020 and June 2020, respectively. The prefinanced receivables were then reimbursed directly to NEFTYS. The CIR for 2020 (including the CIR computed for the six-month period ended June 30, 2020 of €1,754 thousand) is expected to be reimbursed in 2021.

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Reimbursable Advances

        A reimbursable advance was granted to us by BPI France on August 7, 2008. This was a non-interest-bearing reimbursable advance of €230 thousand for the clinical development of an extract of quinoa active on metabolic syndrome. Following the successful completion of the project and the extension of the repayment terms granted by BPI France (formerly OSEO), this advance was repaid by means of quarterly payments made between March 31, 2016 and December 31, 2018. As of December 31, 2018, we have fully satisfied this conditional advance.

        A reimbursable advance was granted to us by BPI France on February 4, 2015. This was a non-interest-bearing reimbursable advance of €260 thousand for the "in vitro, in vivo, and pharmacokinetic characterization of a candidate drug." Following the successful completion of the project and the extension of the repayment terms granted by BPI France, this advance is being repaid by means of quarterly payments made between June 30, 2017 and March 31, 2022. The payment schedule has been postponed by six months automatically by BPI France as part of the financial support measures for companies in the management of the COVID-19 crisis. As a result, the last payment will occur in September 30, 2022.

        A reimbursable advance was granted to us by BPI France on November 28, 2016. This is a non-interest-bearing reimbursable advance of €1,100 thousand for the production of clinical batches, in the preclinical regulatory phase and clinical Phase 1 of Sarconeos (BIO101), for the treatment of sarcopenic obesity. The agreement with BPI France provides that the advance would be paid to us in two tranches, with the first of €600 thousand paid at the signing date of the agreement, and the second €500 thousand to be paid at the end of the program. We received €500 thousand during the year ended December 31, 2018 related to the second tranche. Following the successful completion of the project, this advance is being repaid by means of quarterly payments made between December 31, 2018 and September 30, 2023. The payment schedule has been postponed by six months automatically by BPI France as part of the financial support measures for companies in the management of the COVID-19 crisis. As a result, the last payment will occur in March 31, 2024.

        On June 3, 2019, we entered into a collaboration agreement with the French Muscular Dystrophy Association (AFM-Telethon), pursuant to which AFM-Telethon has provided funding of €400,000 to us. This is a non-interest-bearing reimbursable advance of €400,000 for certain preclinical studies and preparations for our MYODA program. Under the terms of the agreement, subject to regulatory approval to conduct the MYODA clinical trial in Europe and conclusive results from the collaboration, we will submit to AFM-Telethon a new research project for further collaboration on the clinical development of Sarconeos (BIO101) in DMD. If funding for the new research project is approved by AFM-Telethon, we will negotiate in good faith the terms of a new collaboration agreement with AFM-Telethon. If entered into, the new collaboration agreement will grant certain rights to AFM-Telethon that may, in the event we later decide to abandon or not pursue the development of Sarconeos (BIO101), entitle AFM-Telethon to continue the development and/or commercialization of Sarconeos (BIO101) and/or any pharmaceutical product derived from Sarconeos (BIO101) for the purpose of guaranteeing the access of such products to DMD patients. The advance will be repaid upon our obtaining authorization to commence a Phase 3 clinical trial of Sarconeos (BIO101) for the treatment of DMD. In addition, we will be required to repay the advance if we are unable to come to an agreement with AFM-Telethon on further funding of our MYODA clinical program or we materially breach the agreement and AFM-Telethon requests reimbursement.

Loans from Lending Institutions

        We signed a loan agreement with BPI France (formerly OSEO) on November 4, 2008 for the partial financing of an innovation program in the amount of €150 thousand. This loan was repaid in

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quarterly installments of €7.5 thousand through August 31, 2018 (term of the loan). We have fully satisfied this loan.

Non-convertible bonds issued to Kreos

        In September 2018, we entered into a venture loan agreement and bonds issue agreement with Kreos providing for up to €10 million in financing to us. Pursuant to the terms of the agreements, Kreos agreed to subscribe for up to €10 million in non-convertible bonds, to be issued by us in up to four tranches of €2.5 million each, with a warrant to purchase 442,477 ordinary shares attached to the first tranche. As required under the terms of the agreements, we pledged a security interest in our assets for the benefit of Kreos. We also granted a security over the business as a going concern (nantissement de fonds de commerce), including a portion of our patents, to Kreos.

        Each tranche of non-convertible bonds bears a 10% annual interest rate and must be repaid in 36 monthly installments of €320,004 per month commencing in April 2019. The first and second tranches were issued to Kreos on September 10, 2018. The third tranche was issued to Kreos on December 17, 2018. The final tranche was issued on March 1, 2019.

        In connection with the first tranche, we issued 442,477 warrants to Kreos giving them the right to purchase 442,477 new ordinary shares at an exercise price of €2.67 per share over a 7-year period from the issue date.

        Pursuant to the terms of the agreements, we have the right, at any time but with no less than 30 days prior notice to Kreos, to prepay or purchase the bonds, exclusively in full. The prepayment will be equal to (i) the principal amount outstanding, plus (ii) the sum of all interest repayments which would have been paid throughout the remainder of the term of the relevant tranche discounted by 10% per annum.

Convertible notes issued to NEGMA

        In August 2019, we signed an agreement with NEGMA providing for up to €24 million in financing to us through the issuance of multiple tranches of convertible notes with attached warrants (ORNANEBSA), at our sole discretion.

        On August 21, 2019, a first tranche of 300 ORNANE plus a commitment fee of 30 ORNANE, with attached warrants to purchase 585,936 ordinary shares (BSAT1), was issued resulting in gross proceeds to us of €3 million. On December 27, 2019, a second tranche of 300 ORNANE, out of which 50% were paid by NEGMA in 2019, with attached warrants to purchase 694,444 ordinary shares (BSAT2), was issued resulting in gross proceeds to us of €1.5 million.

        On April 6, 2020, in the context of the execution of an issuance and subscription agreement with ATLAS, we terminated the contract with NEGMA.

        Following this termination, NEGMA undertook legal action in order to claim damages of €910,900 from us as well as the delivery of 7,000,000 of our ordinary shares that NEGMA considers it was entitled to pursuant to the only Biophytis ORNANES still held by NEGMA, issued in consideration for a loan of €1,400,000 in principal.

        The sum of €910,900 claimed by NEGMA corresponds to the contractual penalties alleged by NEGMA under the terms of the NEGMA contract 2019, which provided for the payment of such penalties in the event of conversion of bonds into shares when the stock price is below the par value of the shares. Biophytis vigorously disputes this legal action and these requests for payment and delivery of shares.

        Pursuant to a summary judgment dated May 7, 2020, NEGMA obtained a decision partially responding to its claims ordering us under penalty (which amounted to €7 thousand), to pay damages

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to NEGMA in an amount of €378 thousand and to deliver to NEGMA 2,050,000 of our ordinary shares. This delivery of 2,050,000 shares to NEGMA were valued at €1,394 thousand and were considered as a financial indemnity. The financial indemnity, including damages totaling €1,779 thousand was then recorded as financial expense during the period (€1,394 thousand against equity and €385 thousand (including €7 thousand in penalties) paid to NEGMA). The summary judgement does not extinguish the potential liability due to NEGMA. We appealed this decision to the Court of Appeals of Paris. By decision dated November 18, 2020, the Court of Appeal reversed the May 7, 2020 order and ordered NEGMA to pay the costs of the trial and appeal proceedings. As a result, NEGMA was ordered to return the 2,050,000 ordinary shares to us and pay us an amount of €378 thousand. NEGMA has satisfied these obligations as of the date of this prospectus by paying €419 thousand (including penalty interest and legal costs) and delivering 2,050,000 ordinary shares to us. NEGMA has two months to appeal this decision. In addition, NEGMA initiated proceedings on the merits in order to obtain what had not been awarded by the May 7, 2020 court order. Since the decision of the Court of Appeals of Paris dated November 18, 2020, NEGMA has modified its claims on the merits in order to obtain 7,000,000 shares. Further hearings on the merits are expected to occur in early 2021.

        In 2019, 242 convertible notes had been converted resulting in the issuance of 10,499,841 ordinary shares. During the first semester 2020, 68 bonds held by NEGMA were converted into ordinary shares generating the issuance of 3,400,000 shares.

        NEGMA also exercised all BSAT2 during the six month period ended June 30, 2020 generating the issuance of 694,444 shares. All BSAT1 are still outstanding as of June 30, 2020.

Convertible bonds issued to ATLAS

        In April 2020, we signed a new convertible bond financing of €24 million from ATLAS to continue the development of Sarconeos (BIO101).

        The 960 3-year note warrants require their holder to exercise them, at our request, in tranches of 120 warrants each. Each warrant grants its holder the right to one ORNANE. Note warrants may not be transferred and will not be subject to a request for admission to trading on the Euronext Growth market.

        The ORNANE have a par value of €25,000 and are issued at a subscription price of 0.97% of the nominal value. They do not bear interest and have a 24-month maturity from issuance. Holders of ORNANE may request at any time to convert them during their maturity period, and at that time, we will be able to redeem the ORNANE in cash. At the end of the maturity period, and if the ORNANE have not yet been converted or redeemed, the holder will have to convert them.

        ORNANE may be transferred by their holders only to Affiliates and will not be subject to a request for admission to trading on the Euronext Growth market.

        We issued a first tranche of €3 million on April 29, 2020, a second tranche of €3 million on June 19, 2020 and a third tranche of €3 million on August 28, 2020. As of the date of this prospectus, there are no outstanding convertible notes issued to ATLAS, following redemption in cash of the remaining 30 notes. A commitment fee of €375 thousand has been withheld from the proceeds received for the first tranche. Other issuance costs were incurred by us for approximately €66 thousand (€16 thousand for the first tranche, €23 thousand for the second tranche and €27 thousand for the third tranche).

        As of June 30, 2020, 80 convertible notes had been converted resulting in the issuance of 3,188,272 ordinary shares.

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Public Offering of Share Subscription Warrants

        On April 3, 2020, we decided to launch a public offering of share subscription warrants. The main objective of the transaction is to allow existing shareholders to participate in the new COVA program and our future development, and eventually to consolidate its equity.

        Upon completion of the public offering, we issued 7,475,708 share subscription warrants, after full exercise of the extension clause.

        The subscription price was €0.06 per warrant. The warrants can be exercised for a period of 5 years from April 30, 2020, at an exercise price of €0.27 per new share.

        Each warrant will give its holder the right to subscribe to one new Biophytis share.

        Total subscriptions amounted to €449 thousand. During the six-month period ended June 30, 2020, warrants were exercised for €833 thousand.

        The subscription and the exercise of the investors warrants by our CEO was settled by the remaining amount of €630 thousand due our CEO as part of the Intellectual Property agreement (€177 thousand for the subscription of warrants and €453 thousand for the exercise of warrants).

Contractual obligations

        The following table discloses aggregate information about material contractual obligations and periods in which payments were due as of December 31, 2019.

        Future events could cause actual payments to differ from these estimates.

(Amounts in thousands of euros)
  Year ended
December 31,
2019 Total
  2020
Less than
1 year
  2021 - 2022
1 - 3 yrs
  2023 - 2024
3 - 5 yrs
  Thereafter
More than
5 yrs
 

Non-convertible bonds(a)

    8,639     3,840     4,799          

Convertible bonds—NEGMA(c)

    2,080     2,080              

Conditional advances

    1,368     136     657     575      

Financial liabilities related to the prefinancing of a portion of the research tax credit receivables

    5,029     5,029              

Bank overdrafts

    15     15              

Lease liability(b)

                     

Operating lease obligations(b)

                     

Licence agreements(d)

    45     15     30     110      

Total

    17,396     11,115     5,486     685      

(a)
The contractual obligations related to non-convertible bonds include the principal repayments and the 10% annual interest payments.

(b)
Given the contractual terms of our main leases (low-value asset leases and short-term agreements of less than 12 months), the mandatory application of IFRS 16 Lease as January 1, 2019 had no impact on our financial statements as of December 31, 2019. Discussions on the lease arrangement with Sorbonne University were not finalized as December 31, 2019. The lease agreement has not yet been renewed as of the date of this prospectus. Therefore, there is no rent commitment.

(c)
The NEGMA contract was terminated in April 2020. Redemption value of the notes issued to NEGMA amounts to €1,400 thousand as of the date of the prospectus. In April 2020, we signed a new convertible note financing of €24 million from ATLAS to continue the development of Sarconeos (BIO101) through the issuance of multiple convertible notes. Holders of ORNANE may

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    request at any time to convert them during their maturity period, and at that time, we will be able to redeem the ORNANE in cash. At the end of the term, and if the ORNANE have not yet been converted or redeemed, the holder will have to convert them. We issued a first tranche of €3 million on April 29, 2020, a second tranche of €3 million on June 19, 2020 and a third tranche of €3 million on August 28, 2020. As of the date of this prospectus, there are no outstanding convertible notes issued to ATLAS, as the Company has repaid €863 thousand for the remaining 30 convertible notes that were issued to ATLAS with a redemption value of €750,000.

(d)
We have signed several agreements to license industrial property to further our research and developments efforts with royalties due to the counterparties that are variable starting the year after the first marketing of a product and royalty arrangements. However, there are certain guaranteed annual minimum amounts due starting in various future years. These guaranteed annual minimum amounts are shown in the table above. Other than these minimum guaranteed amounts (as further described below), amounts of royalties to be paid after 2024 cannot be determined precisely and therefore, no royalties amounts are included in the table above.

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        The following table discloses the commitments given as part of the licensing agreements mentioned above:

Agreements for the exploitation of industrial property
  Commitments given

SARCOB commercialization agreement—SATT Lutech Agreement of January 1, 2016, as amended on April 2, 2019, on November 6, 2020 and on December 17, 2020

  This agreement covers the S1 through S9 patent families. The contractual structure of the consideration payable by us is as follows: firstly, in the year after the first marketing of a product and in any event at the latest, from 2023 onwards, we will pay a guaranteed annual minimum amount of €40 thousand, which will be deducted from the amount of royalties effectively due annually to SATT Lutech. With regard to the direct exploitation, the agreement provides for an annual royalty for a figure based on the net sales of products, distinguishing between sales of nutraceutical and medicinal products. With regards to indirect exploitation, the agreement provides for annual double-digit royalties based on income received from licensees, distinguishing:

 

(i) between the sales of nutraceutical products (double-digit royalties) and drug products (two or one-digit royalties) and (ii) the product development phase (Phase 1, 2 or 3) at the time of the conclusion of the licensing agreement. The royalty payments will end upon termination of the agreement.

MACULIA commercialization agreement—SATT Lutech Agreement of January 1, 2016, as amended on December 17, 2020

 

This agreement covers the MI through MIV patent families. The contractual structure of the consideration payable by us is as follows: firstly, in the year following the first marketing of a nutraceutical product and in any event no later than in 2020, we will pay an annual guaranteed minimum amount of €15 thousand. In the same way, we will pay a guaranteed minimum amount of €50 thousand in the event of marketing of a drug product and in any event no later than from 2026. These amounts will be deducted from the amount of royalties effectively due annually to SATT Lutech. For direct exploitation, the agreement also provides for an annual royalty of a figure based on net sales of products, distinguishing between sales of nutraceutical and medicinal drugs. For indirect exploitation, it also provides for annual double-digit royalties based on income received from licensees, distinguishing (i) between the sales of nutraceuticals (double-digit royalties) and drug products (one or two-digit royalties) and (ii) the product development phase of these products (Phase 1, 2 or 3) at the time of conclusion of the licensing agreement. The royalty payments will end upon termination of the agreement.

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Off-Balance Sheet Arrangements

        We do not have variable interests in variable interest entities or any off-balance sheet arrangements as defined under the SEC rules, such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our statements of financial position.

Quantitative and Qualitative Disclosures About Market Risk

        For our Quantitative and Qualitative Disclosures about Market Risk, see Note 22 "Management and assessment of financial risks" to our audited consolidated financial statements as of and for the two years ended December 31, 2018 and 2019, which appear elsewhere in this prospectus.

Recent Accounting Pronouncements

        For a discussion of the new standards and interpretations adopted and not yet adopted by us, see Note 2 "Accounting principles, rules and methods" to (1) our audited consolidated financial statements as of December 31, 2018 and 2019 and for each of the two years in the period ended December 31, 2018 and 2019 and (2) our unaudited interim condensed consolidated financial statements as of June 30, 2020 and for the six-month periods ended June 30, 2019 and 2020, which appear elsewhere in this prospectus.

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