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UNITED STATES
SECURITIES AND EXCHANGE COMMISSIONb
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
      REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES
EXCHANGE ACT OF 1934
OR
      ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended December 31, 2023
OR
      TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
OR
      SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
Date of event requiring this shell company report
Commission file number: 001-41842
Abivax SA
(Exact name of Registrant as specified in its charter and translation of Registrant’s name into English)
France
(Jurisdiction of incorporation or organization)
7-11 boulevard Haussmann
75009 Paris, France
(Address of principal executive offices)
Marc de Garidel
Chief Executive Officer
7-11 boulevard Haussmann
75009 Paris, France
Tel: +33 (0) 1 53 83 09 63
info@abivax.com
(Name, Telephone, Email and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
American Depositary Shares, each representing
one ordinary share, nominal value €0.01 per share
ABVX
The Nasdaq Global Market
Ordinary shares, nominal value €0.01 per share*
*
The Nasdaq Global Market*
*Not for trading, but only in connection with the registration of the American Depositary Shares.
Securities registered or to be registered pursuant to Section 12(g) of the Act. None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None
1
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close
of the period covered by the annual report.
Ordinary shares: 62,928,818 shares outstanding as of December 31, 2023, including 11,339 treasury shares
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes
No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be
submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for
such shorter period that the registrant was required to submit such files). Yes No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer,
or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging
growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Emerging growth company
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 13(a) of the Exchange Act.
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting
Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of
the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15
U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial
statements of the registrant included in the filing reflect the correction of an error to previously issued financial
statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of
incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery
period pursuant to §240.10D-1(b).
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements
included in this filing:
U.S. GAAP
International Financial Reporting Standards as issued by the International Accounting Standards Board Other
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement
item the registrant has elected to follow. Item 17 Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes No
2
TABLE OF CONTENTS
Page
INTRODUCTION ........................................................................................................................................
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS ..............................................
PART I .........................................................................................................................................................
Item 1.Identity of Directors, Senior Management and Advisers ................................................
Item 2.Offer Statistics and Expected Timetable .........................................................................
Item 3.Key Information ..............................................................................................................
Item 4.Information on the Company. ..........................................................................................
Item 4A. Unresolved Staff Comments. ...........................................................................................
Item 5.Operating and Financial Review and Prospects ..............................................................
Item 6.Directors, Senior Management and Employees ..............................................................
Item 7.Major Shareholders and Related Party Transactions .......................................................
Item 8.Financial Information ......................................................................................................
Item 9.The Offer and Listing ......................................................................................................
Item 10.Additional Information. ...................................................................................................
Item 12.Description of Securities Other than Equity Securities ...................................................
PART II ........................................................................................................................................................
Item 13.Defaults, Dividend Arrearages and Delinquencies ..........................................................
Item 15.Controls and Procedures ..................................................................................................
Item 16.[Reserved] ........................................................................................................................
Item 16A.Audit Committee Financial Expert ..................................................................................
Item 16B.Code of Ethics .................................................................................................................
Item 16C.Principal Accountant Fees and Services ..........................................................................
Item 16F.Change in Registrant’s Certifying Accountant ................................................................
Item 16G.Corporate Governance .....................................................................................................
Item 16H.Mine Safety Disclosure ...................................................................................................
Item 16J.Insider Trading Policies ...................................................................................................
Item 16K.Cybersecurity ...................................................................................................................
PART III .......................................................................................................................................................
Item 17.Financial Statements ........................................................................................................
Item 18.Financial Statements ........................................................................................................
Item 19.Exhibits ............................................................................................................................
SIGNATURES .............................................................................................................................................
INDEX TO THE CONSOLIDATED FINANCIAL STATEMENTS.........................................................
F-1
3
INTRODUCTION
Unless otherwise indicated or the context otherwise requires, “Abivax,” “the company,” “our company,” “we,” “us”
and “our” refer to Abivax SA and its consolidated subsidiary, taken as a whole.
“Abivax” and the Abivax logo and other trademarks or service marks of Abivax SA appearing in this Annual Report
on Form 20-F are the property of Abivax SA. Solely for convenience, the trademarks, service marks and trade
names referred to in this annual report are listed without the ® and symbols, but such references should not be
construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their
right thereto. All other trademarks, trade names and service marks appearing in this annual report are the property of
their respective owners. We do not intend to use or display other companies’ trademarks and trade names to imply
any relationship with, or endorsement or sponsorship of us by, any other companies.
This Annual Report on Form 20-F includes our audited financial statements as of and for the years ended December
31, 2023, 2022 and 2021 prepared in accordance with International Financial Reporting Standards (“IFRS”), as
issued by the International Accounting Standards Board (“IASB”). None of our financial statements were prepared
in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Our financial statements are
presented in euros and, unless otherwise stated, all monetary amounts are in euros. All references in this annual
report to “$”, “U.S. dollars” and “dollars” mean U.S. dollars, and all references to “€”, “EUR” and “euros” mean
European Monetary Union euros, unless otherwise noted. Throughout this annual report, references to ADSs mean
ADSs or ordinary shares represented by such ADSs, as the case may be.
4
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 20-F, or annual report, contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as
amended ("Exchange Act"), that are based on our management’s beliefs and assumptions and on information
currently available to our management. All statements other than present and historical facts and conditions
contained in this annual report, including statements regarding our future results of operations and financial
positions, business strategy, plans and our objectives for future operations, are forward-looking statements. When
used in this annual report, the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is
designed to,” “may,” “might,” “plan,” “will,” “would,” “potential,” “predict,” “objective,” “should,” or the negative
of these and similar expressions identify forward-looking statements. Forward-looking statements include, but are
not limited to, statements about:
the prospects of attaining, maintaining and expanding marketing authorization for our drug candidates;
the potential attributes and clinical advantages of our drug candidates;
the initiation, timing, progress and results of our preclinical and clinical trials (and those conducted by third
parties) and other research and development programs;
the timing of the availability of data from our clinical trials;
the timing of and our ability to advance drug candidates through clinical development;
the timing or likelihood of regulatory meetings and filings;
the timing of and our ability to obtain and maintain regulatory approvals for any of our drug candidates;
our ability to identify and develop new drug candidates from our preclinical studies;
our ability to develop sales and marketing capabilities and transition into a commercial-stage company;
the effects of increased competition as well as innovations by new and existing competitors in our industry;
our ability to enter into strategic relationships or partnerships;
our ability to obtain, maintain, protect and enforce our intellectual property rights and propriety technologies
and to operate our business without infringing the intellectual property rights and proprietary technology of
third parties;
our expectations regarding our cash requirements;
our estimates regarding expenses, future revenues, capital requirements and the need for additional
financing;
the impact of government laws and regulations;
our competitive position;
unfavorable conditions in our industry, the global economy or global supply chain, including financial and
credit market fluctuations, international trade relations, political turmoil, natural catastrophes, warfare (such
as the Russia-Ukraine war and the Israel-Hamas war), and terrorist attacks; and
other risks and uncertainties, including those listed in this annual report under the caption “Risk Factors.”
You should refer to the section of this annual report titled “Item 3.D-Risk Factors” for a discussion of important
factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking
statements. As a result of these factors, we cannot assure you that the forward-looking statements in this annual
report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the
inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should
not regard these statements as a representation or warranty by us or any other person that we will achieve our
objectives and plans in any specified time frame or at all. We undertake no obligation to publicly update any
forward-looking statements, whether as a result of new information, future events or otherwise, except as required
by law.
You should read this annual report and the documents that we reference in this annual report and have filed as
exhibits to this annual report completely and with the understanding that our actual future results may be materially
different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
This annual report contains market data and industry forecasts that were obtained from industry publications. These
data involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such
estimates. We have not independently verified any third-party information. While we believe the market position,
market opportunity and market size information included in this annual report is generally reliable, such information
is inherently imprecise.
5
Summary Risk Factors
We are a clinical-stage company with a limited operating history and no approved products and no
historical product revenues, which makes it difficult to assess our future prospects and financial results.
We have incurred considerable losses historically, which we anticipate will continue and may increase in
the future.
We will require substantial additional funding, which may not be available on acceptable terms or at all,
and failure to obtain this necessary capital may force us to delay, limit or terminate our product
development efforts or other operations.
We have significant debt commitments, which require us to meet certain operating covenants, and if we fail
to comply with those covenants the bondholders would be able to accelerate our repayment obligations.
Additionally, the conversion of some or all of our bonds into ordinary shares would dilute the ownership
interests of existing shareholders.
Our principal tangible and intangible assets serve as collateral under the terms of debt agreements for the
Kreos / Claret Financing. If we default on these debt obligations, the Secured Lenders could foreclose on
those assets, and we would be unable to continue our business and operations.
Drug candidates under development must undergo costly, rigorous and highly regulated preclinical studies
and clinical trials, whose time of completion, number and outcomes are uncertain.
We are heavily dependent on the success of our drug candidates, in particular obefazimod, and we cannot
be certain that obefazimod or any of our other current or future drug candidates will receive regulatory
approval, and, without regulatory approval, we will not be able to market our drug candidates.
Clinical failure can occur at any stage of clinical development. The results of earlier clinical trials as well as
data from any interim analysis of ongoing trials are not necessarily predictive of future results and any drug
candidate we advance through clinical trials may not have favorable results in later clinical trials.
Our future may depend on our most advanced clinical development program, obefazimod, since our other
drug candidates are in a less advanced stage of development.
We expect to expand our organization, and as a result, we may encounter difficulties in managing our
growth, which could disrupt our operations.
We rely on a small number of third-party suppliers, and in certain cases a single-source supplier, and we
may be in a position of dependence with respect to our subcontractors.
Our future success depends on our ability to retain our key executives and to attract, retain and motivate
qualified personnel.
There are material weaknesses in our internal controls over financial reporting and if we are unable to
maintain effective internal controls over financial reporting, the accuracy and timeliness of our financial
reporting may be adversely affected, which could adversely affect our business, investor confidence and the
market price of our securities.
Our ability to exclusively commercialize our drug candidates may decrease if we are unable to protect our
intellectual property rights or if these rights are insufficient for our purposes.
6
PART I
Item 1.Identity of Directors, Senior Management and Advisers
Not applicable.
7
Item 2.Offer Statistics and Expected Timetable
Not applicable.
8
Item 3.Key Information
A.[Reserved]
Not applicable.
B.Capitalization and Indebtedness
Not applicable.
C.Reasons for the Offer and Use of Proceeds
Not applicable.
D.Risk Factors
Our business faces significant risks. You should carefully consider all of the information set forth in this
annual report and in our other filings with the United States Securities and Exchange Commission, or the SEC,
including the following risk factors which we face and which are faced by our industry. Our business, financial
condition or results of operations could be materially adversely affected by any of these risks. This report also
contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from
those anticipated in these forward-looking statements, as a result of certain factors including the risks described
below and elsewhere in this annual report and our other SEC filings. See “Special Note Regarding Forward-
Looking Statements” above.
Risks Related to our Financial Position and Need for Additional Capital
We are a clinical-stage company with a limited operating history and no approved products and no historical
product revenues, which makes it difficult to assess our future prospects and financial results.
We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can
evaluate our business and prospects. We were incorporated as a société anonyme (limited liability company) on
December 4, 2013 and, to date, we have focused primarily on organizing and staffing our company, business
planning, raising capital, identifying, acquiring and in-licensing our drug candidates, establishing our intellectual
property portfolio, conducting research, preclinical studies and clinical trials, establishing arrangements with third
parties for the manufacture of our drug candidates and related raw materials and providing general and
administrative support for these operations. Investment in product development in the healthcare industry, including
of biopharmaceutical products, is highly speculative because it entails substantial upfront capital expenditures and
significant risk that any potential drug candidate will fail to demonstrate adequate effect or an acceptable safety
profile, gain regulatory approval or become commercially viable. As a result, our ability to reduce our losses and
reach consistent profitability from product sales is unproven, and we may never sustain profitability. We have no
products approved for commercial sale and have not generated any revenue from product sales to date.
Our ability to generate revenue from product sales and achieve and maintain profitability depends on our
ability, alone or with any future collaborators, to successfully complete the development of, and obtain the
regulatory approvals necessary to commercialize, our lead drug candidate, obefazimod. Our prospects, including our
ability to finance our operations and generate revenue from product sales, therefore will depend substantially on the
development and commercialization of obefazimod, as other programs in our preclinical portfolio are still in earlier
stages of development. Since our inception in 2013, the majority of our operating income has been derived from our
reliance on research collaborations unrelated to obefazimod, and we do not anticipate generating revenue from
product sales for the next several years, if ever. Our ability to generate revenue from product sales depends heavily
on our or any future collaborators’ success in:
timely and successful completion of clinical development of obefazimod, our lead drug candidate;
obtaining and maintaining regulatory and marketing approval for obefazimod and any future drug
candidates for which we successfully complete clinical trials;
launching and commercializing any drug candidates for which we obtain regulatory and marketing
approval by establishing a sales force, marketing and distribution infrastructure or, alternatively,
collaborating with a commercialization partner;
9
obtaining coverage and adequate reimbursement from government and third-party payors for our
current or any future drug candidates, if approved, both in the United States and internationally, and
reaching acceptable agreements with foreign government and third-party payors on pricing terms;
 
developing, validating and maintaining a commercially viable, sustainable, scalable, reproducible and
transferable manufacturing process for obefazimod or any future drug candidates that are compliant
with current good manufacturing practices;
establishing and maintaining supply and manufacturing relationships with third parties that can provide
an adequate amount and quality of drugs and services to support our planned clinical development, as
well as the market demand for obefazimod and any future drug candidates, if approved;
obtaining market acceptance, if and when approved, of obefazimod or any future drug candidates as a
viable treatment option by physicians, patients, third-party payors and others in the medical
community;
effectively addressing any competing technological and market developments;
implementing additional internal systems and infrastructure, as needed;
negotiating favorable terms in any collaboration, licensing or other arrangements into which we may
enter, and performing our obligations pursuant to such arrangements;
maintaining, protecting and expanding our portfolio of intellectual property rights, including patents,
trade secrets and know-how;
avoiding and defending against third-party interference or infringement claims; and
attracting, hiring and retaining qualified personnel.
We have incurred considerable losses historically, which we anticipate will continue and may increase in the
future.
Since our inception, we have incurred net losses. For the years ended December 31, 2023, 2022 and 2021, we
reported net losses of €147.7 million, €60.7 million and €42.5 million, respectively. As of December 31, 2023, we
carried forward accumulated tax losses of €459.8 million.
We have devoted most of our financial resources to research and development, including our clinical and
preclinical development activities. Even if we obtain regulatory approval to market a drug candidate, our future
revenues will depend upon the size of any markets in which our drug candidates have received approval and our
ability to achieve sufficient market acceptance, reimbursement from third-party payors and adequate market share
for our drug candidates in those markets. There can be no assurance that we will ever earn any revenues or revenues
sufficient to offset past, current and future losses or achieve profitability, which would impair our ability to sustain
our operations. Moreover, even if we achieve profitability, such profitability may not be sustainable. Any inability to
generate sustained profits could have a material adverse effect on our business, prospects, financial condition, cash
flows and results of operations.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. We do not
anticipate achieving profitability in the future unless we obtain the regulatory approvals necessary to commercialize
obefazimod and any additional drug candidates that we may pursue in the future. We anticipate that our expenses
will increase substantially if, and as, we:
timely and successfully complete clinical development of obefazimod, our clinical-stage drug
candidate;
seek and maintain regulatory and marketing approvals for obefazimod and any future drug candidates
for which we successfully complete clinical trials;
continue the preclinical and clinical development of our drug candidates;
expand the scope of our current clinical trials for our drug candidates;
 
begin new clinical trials for our drug candidates;
develop, scale and validate our commercial manufacturing capabilities for our drug candidates;
establish a sales, marketing and distribution infrastructure to commercialize any drugs for which we
may obtain marketing approval for which we have not entered into a collaboration with a third-party;
seek to discover, identify and validate additional drug candidates;
10
acquire or in-license other drug candidates and technologies;
make milestone, royalty or other payments under in-license or collaboration agreements;
obtain, maintain, protect, enforce and expand our intellectual property portfolio;
attract new and retain existing skilled personnel; and
create additional infrastructure to support our operations as a U.S. public company.
In addition, following the issuance of royalty certificates in September 2022 and other royalties that may
become payable under our royalty agreements, the payment of royalties in the event of commercialization of
obefazimod will result in a decrease in cash flows generated by sales of the product, which could have an
unfavorable impact on our financial position, particularly at the beginning of the commercialization phase.
The net losses we incur may fluctuate significantly from quarter-to-quarter and year-to-year, such that a
period-to-period comparison of our results of operations may not be a good indication of our future performance. In
any particular period or periods, our operating results could be below the expectations of securities analysts or
investors, which could cause the price of the ordinary shares (which may be in the form of ADSs) to decline. An
increase in operational losses would have a material adverse effect on our business, financial position, income,
growth and outlook.
We will require substantial additional funding, which may not be available on acceptable terms or at all, and
failure to obtain this necessary capital may force us to delay, limit or terminate our product development efforts
or other operations.
Our operations have consumed substantial amounts of cash since inception. We are currently advancing
obefazimod through clinical development and conducting preclinical studies with respect to other programs.
Developing drug candidates is expensive, lengthy and risky, and we expect our research and development expenses
to increase substantially in connection with our ongoing activities, particularly as we seek to advance obefazimod
toward commercialization. If our clinical trials are successful and we obtain regulatory approval for drug candidates
that we develop, we will incur commercialization expenses before these drug candidates are marketed and sold.
Based on (a) our existing cash and cash equivalents of €251.9 million and other short-term investments of €9.0
million as of December 31, 2023, (b) drawdown of the second tranche of the Kreos / Claret Financing, amounting to
€25.0 million in gross proceeds received on March 28, 2024, and (c) the expected reimbursement of the CIR from
2023 in the second half of 2024 amounting to €4.5 million, we expect to be able to fund our forecasted cash flow
requirements into the fourth quarter of 2025. Under these assumptions and based on our current clinical plan, we
would have sufficient funds to finance our operations through the announcement of our top-line data from the Phase
3 ABTECT-1 and ABTECT-2 induction trials for UC.
This takes into account our assumption that R&D expenditure will be substantially increased in 2024 driven
by the progression of the Phase 3 clinical trials of obefazimod in UC and the initiation of the Phase 2b trial for CD in
2024. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available
capital resources sooner than we expect. For instance, there is no guarantee that we would be able to meet our
conditions to be able to draw down on the remaining tranches of the Kreos / Claret Financing and the Heights
Financing. We anticipate that we will require additional capital as we seek regulatory approval of our drug
candidates. We intend to assess and plan for any such funding requirements and aim to regularly update the market
on our financing need projections.
Until we can generate sufficient product or royalty revenue to finance our cash requirements, which we may
never do, we may seek additional financing in the form of public or private equity or debt financings, government or
other third-party funding, marketing and distribution arrangements and collaborations, strategic alliances and
licensing arrangements or a combination of these sources.
The amount and timing of our funding needs will depend on factors that are largely outside of our control,
such as:
higher costs and slower-than-expected progress on our research and development programs and
clinical trials;
costs related to preparing, filing, enforcing and maintaining our patents and other intellectual property
rights;
11
the scope of the research required and time needed to sign licensing agreements with industrial
partners;
the expenses needed to respond to technological and market developments;
higher costs and longer-than-expected lead times obtaining regulatory authorizations, including time
for preparing application dossiers for the relevant authorities; and
new opportunities for developing new products or acquiring technologies, products or companies.
Any additional fundraising efforts may divert our management from their day-to-day activities, which may
adversely affect our ability to develop and, if approved, commercialize our drug candidates. In addition, we cannot
guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Under
French law, our share capital may be increased only with shareholders’ approval at an extraordinary general
shareholders’ meeting on the basis of a report from the board of directors. In addition, the French Commercial Code
imposes certain limitations on our ability to price certain offerings of our share capital without preferential
subscription rights (droit préférentiel de souscription), which limitation may prevent us from successfully
completing any such offering. To the extent that we raise additional capital, the terms of any financing may
adversely affect the holdings or the rights of our shareholders and the issuance of additional securities, whether
equity or debt, by us, or the possibility of such issuance, may cause the market price of our ordinary shares (which
may be in the form of ADSs) to decline. The sale of additional equity or convertible securities will dilute our
shareholders ownership interest. The incurrence of indebtedness would result in increased fixed payment obligations
and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional
debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions
that could adversely impact our ability to conduct our business. To the extent that we raise additional funds through
arrangements with research and development partners or otherwise, we may be required to relinquish some of our
technologies, drug candidates or revenue streams, license our technologies or drug candidates on unfavorable terms,
or otherwise agree to terms unfavorable for us. If we are unable to obtain adequate financing, we may be required to
delay, reduce or eliminate the number or scope of our projects and drug candidates (including our preclinical studies
and clinical trial programs). In order to obtain financing, we may be required to relinquish rights to some of our
technologies or drug candidates or otherwise agree to terms unfavorable to us. If we are unable to obtain funding on
a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or
development programs or the commercialization of any drug candidate or be unable to expand our operations or
otherwise capitalize on our business opportunities, as desired, which could impair our prospects.
Our financial statements contain a footnote describing management’s assumption regarding our ability to
continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all.
For the years ended December 31, 2023 and 2022, we reported net losses of €147.7 million and €60.7 million,
respectively. As of December 31, 2023, we carried forward accumulated tax losses of €459.8 million. Recurring
losses may cast significant doubt or raise substantial doubt about our ability to continue as a going concern.
There cannot be any assurance that we will be successful in obtaining necessary financing in the future to
continue as a going concern or achieve profitability. We expect that we will need to raise additional capital in order
to complete the necessary trials to achieve commercial viability of some or all of our drug candidates. If funds are
not available, we may be required to delay, reduce the scope of, or eliminate research or development plans or
commercialization efforts with respect to our products. The sale of additional equity may dilute existing
shareholders and newly issued shares may contain senior rights and preferences compared to currently outstanding
ordinary shares. Issued debt securities may contain covenants and limit our ability to pay dividends or make other
distributions to our shareholders. If we are unable to obtain such additional financing, future operations (such as our
clinical development programs) would need to be scaled back or discontinued. These factors may raise substantial
doubt about our ability to continue as a going concern.
There are material weaknesses in our internal controls over financial reporting and if we are unable to maintain
effective internal controls over financial reporting, the accuracy and timeliness of our financial reporting may be
adversely affected, which could adversely affect our business, investor confidence and the market price of our
securities.
Internal control over financial reporting is a process designed to provide reasonable assurance regarding the
reliability of financial reporting for external purposes in accordance with international financial reporting standards.
Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly
reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of
our financial statements; providing reasonable assurance that receipts and expenditures of our assets are made in
accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use
12
or disposition of our assets that could have a material effect on the financial statements would be prevented or
detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not
intended to provide absolute assurance that a misstatement of our financial statements would be prevented or
detected.
We must maintain effective internal controls 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 controls over
financial reporting at the end of each fiscal year, starting with the end of the first full fiscal year after the completion
of our initial public offering of our ADSs in the United States. However, our independent registered public
accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting for
so long as we are an “emerging growth company,” which may be up to five fiscal years following our initial public
offering of our ADSs in the United States. An independent assessment of the effectiveness of our internal controls
could detect problems that our management’s assessment might not.
Our management has not completed an assessment of the effectiveness of our internal controls over financial
reporting, and our independent registered public accounting firm has not conducted an audit of our internal controls
over financial reporting. In conjunction with preparing our financial statements as of and for the years ended
December 31, 2023 and 2022, material weaknesses in our internal controls over financial reporting were identified.
The material weaknesses related to a lack of risk assessment as well as formal, documented and implemented
processes, controls and review procedures, specifically due to a lack of a sufficient number of professionals with an
appropriate level of internal control knowledge, training and experience. These material weaknesses did not result in
a material misstatement to our financial statements included herein, however these material weaknesses could result
in material inaccuracies in our financial statements and impair our ability to comply with applicable financial
reporting requirements and related regulatory filings on a timely basis.
We have developed a remediation plan to address these material weaknesses and strengthen our controls in
these areas. In this regard, we have started to reorganize our finance and accounting function by hiring additional
experienced employees to provide more review and oversight over our financial processes. While we are working to
remediate the material weaknesses as quickly and efficiently as possible, we cannot at this time provide the expected
timeline in connection with implementing our remediation. As of December 31, 2023, we had not yet completed
remediation of these material weaknesses. These remediation measures may be time-consuming and costly and
might place significant demands on our financial and operational resources. There is no assurance that the actions
we may take in the future will be sufficient to remediate the control deficiencies that led to these material
weaknesses in our internal control over financial reporting or that they will prevent or avoid potential future material
weaknesses.
The rules governing the standards that will have to be met for our management to assess our internal controls
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 controls over financial reporting. We have begun
the process of designing, implementing, and testing the internal controls over financial reporting required to comply
with this obligation. This process is time-consuming, costly, and complicated. 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 controls 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 ordinary shares and ADSs may decline. In addition,
undetected material weaknesses in our internal controls over financial reporting could lead to restatements of
financial statements and require us to incur the expense of remediation. Any of these developments could result in
investor perceptions of us being adversely affected, which could cause a decline in the market price of our securities.
Our management is responsible for establishing and maintaining adequate internal control over financial
reporting. Our growth will place significant additional pressure on our system of internal control over financial
reporting. Any failure to maintain an effective system of internal control over financial reporting could limit our
ability to report our financial results accurately and timely or to detect and prevent fraud.
 
Significant impairment of our goodwill could materially impact our financial position and results of our
operations.
We carry a goodwill balance, which is allocated to obefazimod and ABX196 cash generating units, on our
balance sheet as a result of past business acquisitions, including with respect to obefazimod and ABX196. We are
required to review our goodwill for impairment on an annual basis or more frequently if events or changes in
circumstances indicate evidence of impairment. We did not record any goodwill impairment loss for the year ended
December 31, 2023. For the year ended December 31, 2022, we recorded a goodwill impairment loss of €13.6
million. The goodwill impairment loss was related to an impairment test conducted with respect to the ABX196
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cash-generating unit as a result of significant external changes in the hepatocellular carcinoma treatment landscape,
which are expected to require a new, lengthy, heavy and risky internal development process (use of a combination of
compounds). As such, due to the lack of progress made in the negotiation of a development partnership, we made
the decision to freeze the development program for ABX196 in the treatment of hepatocellular cancer, which led to
full impairment of ABX196 goodwill. In July 2023, we have decided to completely stop our ABX196 program,
which will be reflected in our next financial statements. After full impairment of the goodwill allocated to ABX196,
we continue to carry a goodwill balance allocated to obefazimod amounting to €18.4 million in the aggregate as of
December 31, 2023. We have not currently identified reasons to impair the goodwill allocated to obefazimod.
However, there can be no assurance that, based on the results of our annual goodwill impairment tests, we will not
be required to identify further goodwill impairment losses, which could have a material adverse effect on our results
of operations.
We have significant debt commitments, which require us to meet certain operating covenants, and if we fail to
comply with those covenants the bondholders would be able to accelerate our repayment obligations.
Additionally, the conversion of some or all of our bonds into ordinary shares would dilute the ownership interests
of existing shareholders.
On August 20, 2023, we entered into a framework subscription agreement (the "Framework Subscription
Agreement") with entities affiliated with Kreos Capital ("Kreos") and entities affiliated with Claret European
Growth Capital ("Claret"), as the Secured Lenders (the "Kreos / Claret Financing"). Under this Framework
Subscription Agreement, we may draw up to €75 million in structured debt financing, in three tranches of €25
million in aggregate principal amount each. The first and second tranches were drawn on August 22, 2023 and
March 28, 2024, respectively. The Kreos / Claret Financing provides for certain restrictive covenants (subject to
customary exceptions), which include, among other things, restrictions on the incurrence of indebtedness, cross-
default, the distribution of dividends and the grant of security interests. As security for the Kreos / Claret Financing,
the Secured Lenders benefit from the grant of first-ranking collateral on our principal tangible and intangible assets,
including pledges over our business (fonds de commerce) as a going concern and intellectual property rights in our
lead drug candidate, as well as pledges over our bank accounts and receivables. Such securities apply to all tranches
of the Kreos / Claret Financing.
In addition, on August 20, 2023, we entered into a subscription agreement with entities affiliated with Heights
Capital Management ("Heights", and such agreement, the "Heights Subscription Agreement"). Under the Heights
Subscription Agreement, we may draw up to €75 million in amortizing senior convertible notes, in two tranches of
€35 million and €40 million, respectively, as further described below. The first tranche in aggregate principal
amount of €35 million was drawn on August 24, 2023. The terms and conditions of the Heights Convertible Notes
include a negative pledge providing that any security granted in favor of other borrowed debt or debt instruments
should also be granted in favor of the Heights Convertible Notes on an equal basis (with the exception of the
securities issued pursuant to the Kreos / Claret Financing).
In June 2020, we obtained a non-dilutive financing in the form of a State-guaranteed loan of €5.0 million. The
loan was structured with an initial maturity of 12 months at 0.25% and a five-year extension option. In March 2021,
we exercised the five-year extension option with a one-year deferral of principal repayment, with the following
conditions: (i) a revised interest rate of 0.58% per annum, excluding insurance and State-guaranteed premium; and
(ii) a State-guaranteed premium of €0.1 million to be paid by installments over the contract period starting in June
2021.
The loan includes certain customary covenants and prepayment provisions. The negative covenants include an
undertaking not to dispose of all or part of our assets for more than 50% of the gross value of our fixed assets.
There is also no guarantee that we will have sufficient cash to pay the bonds issued to the Secured Lenders or
Heights at maturity, which could have a negative impact on our business as security interests have been granted on
our principal tangible and intangible assets: in particular, on our goodwill, intellectual property rights relating to our
lead drug candidates, as well as a pledge of our bank accounts and claims. There is also no guarantee that we will
have sufficient cash to make the scheduled payments on the Kreos / Claret Financing, the Heights Financing or the
State-guaranteed loan, which could have a material adverse effect on our business, financial position and results of
operations. Any failure to make scheduled payments or trigger for early repayment of the loan could have a material
adverse effect on our business, financial position, income, growth and outlook. If we breach our obligations under
any of these agreements, it could result in default and trigger an early repayment of the bonds. There is no guarantee
that we would have the necessary resources to fund an advance repayment of the bonds.
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Our principal tangible and intangible assets serve as collateral under the terms of debt agreements for the Kreos /
Claret Financing. If we default on these debt obligations, the Secured Lenders could foreclose on those assets,
and we would be unable to continue our business and operations.
In August 2023, we entered into the Kreos / Claret Financing. In connection with the financing, we have
granted the Secured Lenders with first-ranking collateral on our principal tangible and intangible assets, including
pledges over our business (fonds de commerce) as a going concern and intellectual property rights in our lead drug
candidate, as well as pledges over our bank accounts and receivables until our debt obligations thereunder are repaid
in full. There can be no assurance that we will not breach the covenants or other terms of, or that an event of default
will not occur under, the debt agreements for the Kreos / Claret Financing. If a breach or event of default occurs,
there can be no assurance that we will be able to cure the breach within the time permitted. In the event of any
failure to pay our obligations when due, any breach or default of our covenants or other obligations, or any other
event that causes an acceleration of payment at a time when we do not have sufficient resources to meet these
obligations, the Secured Lenders could foreclose on the collateral. If the Secured Lenders were to be successful, we
would lose our intellectual property rights in our lead drug candidate and be unable to commercialize our lead drug
candidate and conduct our business. Any of these consequences would have a material adverse effect on our
business, financial condition and share price.
We rely on grants and subsidies, which may not continue to be available and we may be forced to repay
conditional advances prematurely if we fail to comply with our contractual obligations under certain innovation
grant agreements.
We have received various grants and conditional advances from Bpifrance under various development
programs, in a total amount of 20.1 million as of December 31, 2023. In the event that we do not comply with the
contractual conditions stipulated in the aid agreements we have entered into, we may have to repay the sums
advanced early. Such premature repayment could deprive us of the necessary financial resources for our research
and development projects and we cannot guarantee that we will find necessary additional financial resources, the
timeline for or the possibility of replacing these financial resources with others. We cannot guarantee that we will
have the necessary resources to cope with an early repayment. A material repayment would result in a material
adverse effect on our business, operations, financial position, income, growth, and outlook.
In addition, the amount and date of payment of current and future grants and subsidies depend on many factors
that are not in our control, including possible non-distribution decisions or the freezing of funds, as well as the
achievement of key milestones previously agreed on with Bpifrance. Delays or failure in obtaining or replacing
these grants and subsidies in the future could have a material adverse effect on our business, financial position,
income, growth and outlook.
Current equity agreements and convertible debt instruments may dilute our equity resulting in dilution to our
shareholders.
Since our incorporation, we have issued and granted founder’s share warrants (BCE) and share warrants
(BSA) and granted free shares (AGA) to persons linked to us and financing entities. We have also issued convertible
bonds. See "Item 5.B—Liquidity and Capital Resources.”
The theoretical exercise of all the founder’s share warrants (BCE) and share warrant (BSA) instruments giving
access to our capital issued and outstanding as of December 31, 2023, excluding securities held by financing entities,
would allow for the subscription of 638,643 potential new ordinary shares, resulting in a hypothetical dilution equal
to 1.01% based on our existing share capital as of December 31, 2023.
Our general meeting of June 5, 2023 delegated authority to the board of directors (the “Board”) to carry out
one or more capital increases and/or issues of securities giving access to our capital subject to the following
limitations:
a total maximum nominal amount of the capital increases set at €500,000 (or the equivalent value of
that amount in the event of an issue in another currency) with a total maximum nominal amount of the
debt securities that may be issued set at €150,000,000 (or the equivalent value of that amount in the
event of an issue in another currency); and