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You should read the following discussion of our financial condition and results of operations in conjunction
with our financial statements and the related notes thereto included elsewhere in this Annual Report on Form 20-F.
In addition to historical information, the following discussion and analysis contains forward-looking statements that
reflect our plans, estimates and beliefs. Our actual results and the timing of events could differ materially from those
anticipated in the forward-looking statements. Factors that could cause or contribute to these differences include
those discussed below and elsewhere in this annual report, particularly in the sections titled “Item 3.D—Risk
Factors” and “Special Note Regarding Forward-Looking Statements.”
Overview
We are a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s
natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases.
We focus on indications where existing treatments have left patients with significant unmet needs, and where
we believe our investigational agents have the potential to be meaningfully differentiated from currently available
therapies. Our initial focus is on inflammatory bowel diseases (“IBD”), chronic conditions involving inflammation
of the gastrointestinal tract, of which the two most common forms are ulcerative colitis ("UC") and Crohn's disease
("CD").
We believe our lead drug candidate, obefazimod, is differentiated from competing approaches for the
treatment of IBD via its novel mechanism of action. Obefazimod was demonstrated to specifically enhance the
expression of a single micro-RNA, miR-124, which plays a critical role in the regulation of the inflammatory
response. In the context of inflammation, miR-124 is a natural regulator of the inflammatory response, controlling
progression of inflammation and restoring homeostasis of the immune system, without causing broader
immunosuppression. In contrast to currently available advanced therapies, prescribed post-conventional therapies,
some of which target only a single cytokine or pathway, miR-124 modulates the expression of several key cytokines
and pathways. Modulating multiple inflammatory pathways simultaneously may lead to more durability of efficacy
results over the long-term, which is critical in lifelong conditions such as IBD, potentially differentiating
obefazimod from currently available IBD treatments.
Obefazimod is currently in Phase 3 clinical development for the treatment of moderately to severely active
UC. We are continuing to develop obefazimod for the treatment of CD and are evaluating additional potential
inflammatory indications to pursue, subject to the availability of necessary resources and funding. In parallel, we are
in the process of generating follow-on compounds based on our miR-124 platform.
We were incorporated as a société anonyme on December 4, 2013 and, in 2014, we acquired Splicos,
Wittycell and Zophis by means of a universal transfer of assets and liabilities (Transmission Universelle du
Patrimoine (“TUP”)). We have been listed on Euronext Paris since June 26, 2015, and on the Nasdaq Global Market
since October 24, 2023.
On March 20, 2023, our United States-based subsidiary Abivax LLC (the “Subsidiary”) was formed as a
limited liability company under the laws of the State of Delaware. The Subsidiary hosts our operations in the United
States. We have prepared audited consolidated statements of financial position of the Company and the Subsidiary
as of December 31, 2025, 2024 and 2023, and the related consolidated statements of income (loss), comprehensive
income (loss), changes in shareholders’ equity and cash flows for each of the three years in the period ended
December 31, 2025, including the related notes (collectively referred to as the “consolidated financial statements”).
As of December 31, 2025, the Subsidiary’s contribution to our consolidated results of operations was a net operating
loss of €(246.1) million.
Since our inception in 2013, we have devoted substantially all of our efforts to organizing and staffing our
company, business planning, raising capital, establishing our intellectual property portfolio, acquiring or discovering
drug candidates, research and development activities for obefazimod and other compounds, establishing
arrangements with third parties for the manufacture of our drug candidates and component materials, and providing
general and administrative support for these operations. We do not have any products approved for sale and have not
generated any revenue from product sales or otherwise. We do not expect to generate significant revenue from
product sales or royalties unless and until our drug candidates are approved for marketing and successfully
commercialized.
We have incurred significant operating losses since inception, and we expect to continue to incur significant
expenses and operating losses for the foreseeable future. Our ability to generate product revenue sufficient to
achieve profitability will depend heavily on the successful development and eventual commercialization of
obefazimod and any future drug candidates. For the years ended December 31, 2025, 2024 and 2023 we reported net
losses of €336.1 million, €176.2 million and €147.7 million, respectively. As of December 31, 2025, we carried
forward accumulated tax losses of €912.9 million. We expect to continue to incur net operating losses for at least the
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next several years, and we do not anticipate achieving profitability in the future unless we obtain regulatory
approvals necessary to commercialize obefazimod and any additional drug candidates that we may pursue in the
future. We expect that our research and development expenses, general and administrative expenses, and capital
expenditures will increase substantially in connection with our ongoing activities, particularly if and as we:
•continue to advance our existing drug candidates through clinical development;
•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 regulatory and marketing approval for which we have not entered into a collaboration with
a third-party;
•seek to discover, identify and validate additional drug candidates;
•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;
•manufacture, or have manufactured, non-clinical, clinical and potentially commercial supplies of
obefazimod and any future drug candidates;
•attract new and retain existing clinical, scientific, operational, financial and management personnel;
and
•incur additional legal, accounting, and other costs associated with operating as a dual-listed French and
U.S. public company.
Our net losses may fluctuate significantly from period to period, depending on the timing of expenditures
related to our research and development activities.
We will not generate revenue from product sales unless and until we successfully complete clinical
development and obtain regulatory approval for a drug candidate. In particular, 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 would 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. In addition, if we obtain regulatory approval for a drug candidate and
do not enter into a third-party commercialization partnership, we expect to incur significant expenses related to
developing our commercialization capability to support product sales, marketing, manufacturing and distribution
activities.
As a result, we will need substantial additional funding to support our continuing operations and pursue our
growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to
finance our operations through equity offerings, debt financings or other capital sources, which could include
collaborations, strategic alliances or additional licensing arrangements. We may be unable to raise additional funds
or enter into such arrangements when needed, on favorable terms, or at all. Our failure to raise capital or enter into
such agreements as, and when, needed, could have a material adverse effect on our business, results of operations
and financial condition, including requiring us to have to delay, reduce or eliminate product development or future
commercialization efforts. The amount and timing of our future funding requirements will depend on many factors,
including the successful advancement of obefazimod or any future drug candidates. Our ability to raise additional
funds may also be adversely impacted by potential worsening global economic conditions and disruptions to and
volatility in the credit and financial markets in the United States and worldwide, such as those resulting from the
ongoing war in Ukraine.
Due to the numerous risks and uncertainties associated with development of treatment of chronic
inflammatory diseases, we are unable to predict the timing or amount of increased expenses or when or if we will be
able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become
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profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be
unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
Principal Factors Affecting Our Results of Operations
The following factors have affected, and we expect will continue to affect, our results of operations.
Research and Development Activities
Research and development activities are central to our business. Since our inception, most of our resources
have been allocated to research and development and it accounts for the majority of our operating expenses. For the
year ended December 31, 2025, research and development expenses accounted for 71% of our total operating
expenses, as compared to 79% and 78% for the years ended December 31, 2024 and 2023 respectively. Drug
candidates in later stages of clinical development generally have higher development costs than those in earlier
stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
Accordingly, we expect that our research and development expenses to remain in line with current spending in the
foreseeable future as we seek to advance the development of our drug candidates. The successful development of
our drug candidates remains highly uncertain.
At this time, we cannot accurately determine or estimate the nature, timing and costs of the research and
development activities that will be necessary to complete the remainder of the development of obefazimod, and we
may never succeed in obtaining regulatory approval for obefazimod or any future drug candidates we may develop.
The duration, costs and timing of clinical trials and the development of our drug candidates will depend on
numerous risks and uncertainties associated with clinical development, including risks and uncertainties related to:
•the scope, progress, outcome and expenses of our clinical trials and other research and development
activities;
•the length of time required to enroll suitable patients and successful patient enrollment in, and the
initiation and completion of, clinical trials;
•the results of our clinical trials;
•the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;
•the establishment of commercial manufacturing capabilities or making arrangements with third-party
manufacturers;
•the expense of filing, prosecuting, maintaining, defending and enforcing patent claims and other
intellectual property rights;
•changing government regulation;
•launching commercial sales of our drug candidates, if and when approved, whether alone or in
collaboration with others;
•maintaining a continued acceptable safety profile of the drug candidates following regulatory approval;
•the ability to market, commercialize and achieve market acceptance for obefazimod or any other drug
candidate that we may develop in the future; and
•significant competition and rapidly changing technologies within the biopharmaceutical industry.
A change in the outcome of any of these variables with respect to the development of any of our drug
candidates could significantly change the costs and timing associated with the development of that drug candidate.
The actual probability of success for our drug candidates will be affected by a variety of factors, including the safety
and efficacy of our drug candidates, investment in our clinical programs, manufacturing capability and competition
with other products and drug candidates. As a result of these variables, we are unable to determine the duration and
completion costs of our research and development projects or when and to what extent we may generate revenue
from the commercialization and sale of our drug candidates.
Marketing Approval and Market Acceptance of our Drug Candidates
We may never succeed in achieving marketing approval for any of our drug candidates. We may obtain
unexpected and/or negative results from our clinical trials. We may elect to discontinue, delay or modify the
development plan and clinical trials of some drug candidates or focus on others. A change in the outcome of any of
these factors with respect to the development of drug candidates that we are developing could result in a significant
change in the costs and timing associated with the development of such drug candidates. For example, if the EMA or
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the FDA or other regulatory authority were to require us to conduct non-clinical studies and clinical trials beyond
those that we currently anticipate will be required for the completion of clinical development, or if we experience
significant delays in enrollment in any clinical trials, we could be required to spend significant additional financial
resources and time on the completion of clinical development of our drug candidates.
Equity and Debt Financing
At this stage, we have not generated any revenue from sales of products or otherwise, and we do not expect to
do so unless and until we successfully complete development of, obtain marketing approval for, and successfully
commercialize, one or more of our drug candidates. Until such time that we can generate substantial revenue from
sales of products, if ever, we expect to finance our operating activities through a combination of equity offerings,
debt financings and government or other third-party funding. However, we may be unable to raise additional funds
or enter into such arrangements when needed on favorable terms, or at all, which would have a negative impact on
our financial condition and could force us to delay, limit, reduce or terminate our development programs or
commercialization efforts or grant to others the rights to develop or market drug candidates that we would otherwise
prefer to develop and market ourselves. Failure to receive additional funding could cause us to cease operations, in
part or in full.
Acquisition of Prosynergia
On April 1, 2022, we acquired 100% of the share capital of Prosynergia with the aim of strengthening our
research and development portfolio, for an amount of €3.25 million. On December 12, 2022, we completed the
merger with Prosynergia through a TUP and all of Prosynergia’s assets and liabilities were transferred to us.
Following the merger, Prosynergia was dissolved. Accordingly, as Prosynergia was dissolved in December 2022, we
did not prepare consolidated financial statements as of December 31, 2022.
Impact of the Russia-Ukraine War on our Business
The Russia-Ukraine war continues. The conflict has already had major implications for the global economy
and the rate of inflation, particularly in relation to the supply of energy, raw materials and food products. It has also
caused intense volatility on the financial markets.
Given these developments, we have decided not to include Russia and Belarus in our global Phase 3 clinical
trials for obefazimod in UC. However, the global scale of this conflict cannot be predicted at this stage. We,
therefore, cannot rule out an adverse impact of this conflict on our business, including in terms of access to raw
materials, logistics, the performance of clinical trials and in relation to any future financing we may seek.
The long-term safety and efficacy extension of the Phase 2b maintenance trial of obefazimod in moderately to
severely active UC is our only clinical trial with patients currently enrolled in Ukraine. The Phase 2b 12-month
assessment was carried out in all the Ukrainian patients before the war broke out and these patients are therefore
included in the one-year maintenance results that were reported on April 6, 2022. Ukrainian patients who completed
the two-year Phase 2b maintenance trial have been transitioned to the long-term safety and efficacy trial that is still
on-going. None of these sites are located in the Crimea Region of Ukraine, the so-called Donetsk People’s Republic,
or the so-called Luhansk People’s Republic. We have a few sites active in the western part of Ukraine in the
ABTECT Phase 3 clinical trials.
Together with our CRO, we are making considerable efforts to ensure the follow-up of patients who are
unable to come to the study centers. Monitoring takes place through a remote monitoring system that was
established and used successfully during the COVID-19 pandemic.
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A.Operating Results
Comparison of Years Ended December 31, 2023, 2024 and 2025
The following table sets forth our results of operations for the years ended December 31, 2023, 2024 and
2025.
(In thousands of euros) . . . . . . . . . . Year ended December 31, 2023 Year ended December 31, 2024 Year ended December 31, 2025 2024 vs 2023 Change 2025 vs 2024 Change
Other operating income . . . . 4,621 12,449 4,570 169% (63)%
Total operating income . . . . 4,621 12,449 4,570 169% (63)%
Sales and marketing expenses (6,431) (5,954) (5,194) (7)% (13)%
Research and development expenses . . . . . . . . . . . . . . . . (103,176) (146,532) (177,761) 42% 21%
General and administrative expenses . . . . . . . . . . . . . . . . (22,390) (32,946) (67,670) 47% 105%
Total Operating expenses . . (131,997) (185,433) (250,626) 40% 35%
Operating loss . . . . . . . . . . . (127,376) (172,984) (246,056) 36% 42%
Financial expenses . . . . . . . . (27,875) (16,991) (112,307) (39)% 561%
Financial income . . . . . . . . . 7,511 13,732 28,110 83% 105%
Financial loss . . . . . . . . . . . . (20,364) (3,258) (84,198) (84)% 2484%
Net loss before tax . . . . . . . . (147,740) (176,242) (330,254) 19% 87%
Income Tax . . . . . . . . . . . . . . — — (5,848) —% —%
Net loss for the period . . . . . (147,740) (176,242) (336,102) 19% 91%
Total Operating Income
For the year ended December 31, 2025, our total operating income was €4.6 million, as compared to €12.4
million for the year ended December 31, 2024, a decrease of €(7.9) million, or (63)%, as detailed below.
For the year ended December 31, 2024, our total operating income was €12.4 million, as compared to €4.6
million for the year ended December 31, 2023, an increase of €7.8 million, or 169%, as detailed below.
Other Operating Income
The following table sets forth our other operating income for the years ended December 31, 2023, 2024 and
2025.
(In thousands of euros) . . . . . Year ended December 31, 2023 Year ended December 31, 2024 Year ended December 31, 2025 2024 vs 2023 Change 2025 vs 2024 Change
CIR (Research Tax Credits) . . . 4,493 6,651 3,061 48% (54)%
Subsidies . . . . . . . . . . . . . . . . . 81 4,140 — 5017% (100)%
Depositary service fees . . . . . . . — 1,634 1,509 —% (8)%
Other . . . . . . . . . . . . . . . . . . . . . 47 23 — (52)% (100)%
Total other operating income 4,621 12,449 4,570 169% (63)%
For the year ended December 31, 2025, our other operating income was €4.6 million, as compared to €12.4
million for the year ended December 31, 2024, a decrease of €(7.9) million, or (63)%. This variation is primarily
due to a decrease in subsidies by €(4.1) million and a decrease in research tax credits by €(3.6) million or (54)%.
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For the year ended December 31, 2024, our other operating income was €12.4 million, as compared to €4.6
million for the year ended December 31, 2023, an increase of €7.8 million, or 169%. This increase was primarily
due to an increase in subsidies of €4.1 million or 5,017%, an increase in research tax credits of €2.2 million or 48%,
and an increase in depositary service fees of €1.63 million.
Research Tax Credits ("CIR")
For the year ended December 31, 2025, we recognized research tax credits for our research and development
projects of €3.1 million, as compared to €6.7 million for the year ended December 31, 2024, a decrease of €(3.6)
million, or (54)%. Although research and development expenses for the year ended December 31, 2025 increased by
21% as compared to the year ended December 31, 2024, the €(3.6) million decrease in research tax credits was
mainly driven by (i) the maximum amount of eligible outsourced research and development expenses being capped,
(ii) a decrease in internal research and development costs (for €2.6 million), (iii) the reimbursement of the CARENA
and RNP-VIR conditional advances, deducted from the 2024 CIR calculation (for €0.6 million) and (iv) a change in
the CIR regulation related to eligible expenses (for €0.4 million).
For the year ended December 31, 2024, we recognized research tax credits for our research and development
projects of €6.7 million, as compared to €4.5 million for the year ended December 31, 2023, an increase of
€2.2 million, or 48%. The increase corresponds to an additional CIR payment received in 2024 related to the 2021
tax year, for an amount of €1.0 million, and an increase in the CIR for the tax year 2024 as compared to the tax year
2023 of €1.1 million, or 26%. This increase is mainly due to the reimbursements of conditional advances and
overpayment of conditional advances made to Bpifrance in relation to the RNP-VIR and CARENA projects,
following the termination of both projects (see Bpifrance - Conditional Advances and Subsidies within the
"Liquidity and Capital Resources" section).
Subsidies
For the year ended December 31, 2025, our subsidy income was nil, as compared to €4.1 million for the year
ended December 31, 2024. The subsidy income recognized in 2024 was related to the RNP-VIR and CARENA
conditional advances granted by Bpifrance between 2013 and 2019. Following the termination of both projects, in
June 2024, Bpifrance agreed to waive 60% of the remaining conditional advances and accrued interests, resulting in
a non-cash subsidy income of €4.1 million (see Bpifrance - Conditional Advances and Subsidies within the
"Liquidity and Capital Resources" section).
For the year ended December 31, 2024, our subsidy income was €4.1 million as compared to €0.1 million for
the year ended December 31, 2023. The increase is related to the RNP-VIR and CARENA conditional advances
granted by Bpifrance between 2013 and 2019, as explained above.
Depositary Service Fees
As part of our depositary agreement with Citibank (which is acting as our exclusive depositary for our
publicly listed ADSs), we are entitled to receive a portion of the fees collected by Citibank on ADS transactions
(e.g., issuance, cancellation and depositary service fees).
For the year ended December 31, 2025, our income related to depositary service fees was €1.5 million, as
compared to €1.6 million for the year ended December 31, 2024, a decrease of €(0.1) million, or (8)%. The 2025
fees mainly reflect the large number of transactions that occurred over the second half of 2025, following the
announcement of the results from our Phase 3 ABTECT trials and the completion of our follow-on offering of
ordinary shares in the form of ADSs on the Nasdaq Global Market in July 2025 (the “July 2025 Nasdaq Offering”).
The 2024 fees were related to the higher number of transactions following our U.S. initial public offering on the
Nasdaq Global Market completed in October 2023.
We did not recognize any income related to depositary service fees for the year ended December 31, 2023.
Total Operating Expenses
For the year ended December 31, 2025, our total operating expenses were €250.6 million, as compared to
€185.4 million for the year ended December 31, 2024, an increase of €65.2 million, or 35%. This increase was
primarily due to an increase in research and development expenses of €31.2 million, or 21.3% and an increase in
general and administrative expenses of €34.7 million, or 105.4%, each as described below.
For the year ended December 31, 2024, our total operating expenses were €185.4 million, as compared to
€132.0 million for the year ended December 31, 2023, an increase of €53.4 million, or 40%. This increase was
primarily due to an increase in research and development expenses of €43.4 million, or 42% and an increase in
general and administrative expenses of €11 million, or 47%, each as described below.
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Sales and Marketing Expenses
Sales and marketing expenses consist primarily of personnel expenses, including share-based compensation
expenses, for employees engaged in sales and marketing activities, as well as consulting costs associated with
market research in preparation for our potential future sales and commercialization efforts in the U.S.
For the year ended December 31, 2025, our total sales and marketing expenses were €5.2 million, as compared
to €6.0 million for the year ended December 31, 2024, a decrease of €(0.8) million, or (13)%. The decrease is driven
by one-time costs of €1.8 million that were incurred in 2024 for our corporate re-branding, including its new
website, largely offset by an increase in personnel costs of €1.0 million, of which €0.3 million relate to employer
taxes and social contributions related to our AGAs, resulting predominantly from the increase in our share price
during the second half of 2025.
For the year ended December 31, 2024, our total sales and marketing expenses were €6.0 million as compared
to €6.4 million for the year ended December 31, 2023, a decrease of €(0.5) million, or (7)%. The decrease was
primarily driven by the reduction in the headcount of our Sales and Marketing department part-way through 2024.
Research and Development Expenses
The following table sets forth our research and development expenses by drug candidate and therapeutic
indication for the years ended December 31, 2025, 2024 and 2023.
(In thousands of euros) . . . . . . . . . Year ended December 31, 2023 Year ended December 31, 2024 Year ended December 31, 2025 2024 vs 2023 Change 2025 vs 2024 Change
OBEFAZIMOD . . . . . . . . . 97,490 142,678 171,574 46% 20%
Ulcerative Colitis . . . . . 83,788 115,818 117,405 38% 1%
Crohn's Disease . . . . . . 2,735 7,354 17,554 169% 139%
Obefazimod Other Indications . . . . . . . . . . 169 474 4,596 181% 870%
Transversal Activities . . 10,798 19,032 32,018 76% 68%
Others . . . . . . . . . . . . . . . . . 5,686 3,854 6,187 (32)% 61%
Research and Development expenses. . . . . . . . . . . . . . . . 103,176 146,532 177,761 42% 21%
For the year ended December 31, 2025, our research and development expenses were €177.8 million, as
compared to €146.5 million for the year ended December 31, 2024, an increase of €31.2 million, or 21%. This
increase was primarily due to a €13.0 million, or 68%, increase in transversal activities related to increased
chemistry, manufacturing and controls ("CMC") and supply chain costs related to the progression of clinical trials
and anticipation of future commercial launch, a €10.2 million, or 139%, increase in expenses related to our CD
clinical program, resulting from the progression of our Phase 2b CD trial, a €1.6 million, or 1%, increase in expenses
related to our UC clinical program resulting from our continued progression of our UC clinical program and the
Phase 3 induction trials data read-out during the second half of 2025, and a €4.1 million, or 870%, increase in
expenses related to new indications (including the combination therapy) for obefazimod. In addition, a sharp rise in
employer tax and social contributions related to our stock-based compensation ("AGAs"), in turn predominantly
attributable to the increase in our share price during the second half of 2025, contributed to the overall increase in
research and development expenses across all destinations for the year ended December 31, 2025 as compared to
year ended December 31, 2024, in an amount of €20.1 million.
For the year ended December 31, 2024, our research and development expenses were €146.5 million, as
compared to €103.2 million for the year ended December 31, 2023, an increase of €43.4 million, or 42%. This
increase was primarily due to a €32.0 million, or 38%, increase in expenses related to our UC clinical program,
driven by the progression of Phase 3 clinical trials for obefazimod in UC (where Phase 3 clinical trial costs were
significantly higher than in Phase 2), a €8.2 million, or 76%, increase in transversal activities related to the overall
expansion of the research and development headcount to support our organizational growth and the issuance of new
equity awards to officers and employees in research and development and a €4.6 million increase in expenses related
to our CD clinical program, driven by planning costs incurred for the Phase 2b CD trial.
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General and Administrative Expenses
The following table sets forth our operating expenses for the years ended December 31, 2023, 2024 and 2025.
(In thousands of euros) Year ended December 31, 2023 Year ended December 31, 2024 Year ended December 31, 2025 2024 vs 2023 Change 2025 vs 2024 Change
Personnel costs . . . . . . . . . . . 13,104 19,434 52,817 48% 172%
Consulting and professional fees . . . . . . . . . . . . . . . . . . . . 6,393 7,990 9,984 25% 25%
Other general and administrative expenses . . . . 2,893 5,522 4,870 91% (12)%
General and administrative expenses . . . 22,390 32,946 67,670 47% 105%
For the year ended December 31, 2025, our general and administrative expenses were €67.7 million, as
compared to €32.9 million for the year ended December 31, 2024, an increase of €34.7 million, or 105%. This
increase was primarily due to an increase in personnel costs of €33.4 million, or 172%, mainly explained by the
increase in employer taxes and social contributions related to our AGAs by €27.3 million resulting predominantly
from the increase in our share price during the second half of 2025 and to a lesser degree by an increase in
consulting and professional fees of €2.0 million, or 25%, driven by an increase in legal and professional fees and
costs associated with building our infrastructure to support future growth in our operations.
For the year ended December 31, 2024, our general and administrative expenses were €32.9 million, as
compared to €22.4 million for the year ended December 31, 2023, an increase of €10.6 million, or 47%. This
increase was primarily due to an increase in personnel costs of €6.3 million, or 48%. This increase in personnel costs
represents the full year impact of the build out of our G&A organization (increased headcount and equity-based
compensation costs) which started in late 2023 to support the expansion of the company, as well as increased legal
and professional fees and other costs associated with operating as a dual-listed public company.
Operating Income (Loss)
For the year ended December 31, 2025, our operating loss was €246.1 million, as compared to an operating
loss of €173.0 million for the year ended December 31, 2024, an increase of €73.1 million, or 42%. This increase
was primarily due to an increase of €31.2 million in research and development expenses and an increase of
€34.7 million in general and administrative expenses. There expenses were offset, to a lesser degree, by a €(0.8)
million decrease in sales and marketing expenses.
For the year ended December 31, 2024, our operating loss was €173.0 million, as compared to an operating
loss of €127.4 million for the year ended December 31, 2023, an increase of €45.6 million, or 36%. This increase
was primarily due to an increase of €43.4 million in research and development expenses and an increase of €10.6
million in general and administrative expenses. These expenses were offset, to a lesser degree, by a €(0.5) million
decrease in sales and marketing expenses.
Financial Income (Loss)
For the year ended December 31, 2025, our financial loss was €84.2 million, as compared to a financial loss of
€3.3 million and a €20.4 million for the years ended December 31, 2024 and 2023, respectively.
For the year ended December 31, 2025, our financial loss was mainly driven by (i) increases in the fair values
of the senior convertible notes (the "Heights Convertible Notes") issued pursuant to the subscription agreement
entered into in August 2023 with entities affiliated with Heights Capital Management (the "Heights Financing") and
the warrants issued in August 2023 to Kreos Capital and Claret European Growth Capital (the “Kreos / Claret
BSA") of €36.0 million and €29.9 million, respectively (predominantly driven by the increase in our share price and
the remeasurement of these instruments prior to their conversion into ordinary shares), (ii) foreign exchange losses
of €13.4 million (including the €9.6 million non-cash impact of the revaluation of U.S. dollar-denominated cash and
cash equivalents as of December 31, 2025), (iii) interests of €17.2 million in relation to our royalty certificates, (iv)
interest expenses of €11.1 million in relation to the first tranche of senior secured convertible bonds with warrants
attached in the Kreos / Claret Financing (the “Kreos / Claret OCABSA”), the second and third tranches of senior
secured bonds in the Kreos / Claret Financing and the senior convertible notes in the Heights Financing (the
"Heights Convertible Notes") and (v) a €3.8 million loss on derecognition on the Kreos / Claret Tranches B and C.
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These costs were partially offset mainly by (i) foreign exchange gains of €11.9 million (including the €10.7
million gain related to our July 2025 Nasdaq Offering), (ii) interest income of €5.6 million and fair value changes of
€4.7 million in relation to the invested proceeds from our U.S. initial public offering and listing on Nasdaq and (iii) a
decrease in derivatives fair value by €3.6 million.
For the year ended December 31, 2024, our financial loss was mainly driven by (i) interest expenses of €11.5
million in relation to the first tranche of senior secured convertible bonds with warrants attached in the Kreos /
Claret Financing (the “Kreos / Claret OCABSA”), the second and third tranches of senior secured bonds in the
Kreos / Claret Financing (drawn on March 28, 2024 and June 21, 2024, respectively) and the senior convertible
notes in the Heights Financing (the "Heights Convertible Notes"), (ii) a €1.5 million increase in the fair value of the
Kreos / Claret Minimum Return Indemnifications and (iii) transaction costs amounting to €1.6 million.
These costs were partially offset mainly by (i) an interest income of €8.2 million in relation to the invested
proceeds from our U.S. initial public offering and listing on Nasdaq, and (ii) foreign exchange gains of €2.7 million
(including the €1.7 million non-cash impact of the revaluation of U.S. dollar-denominated cash and cash equivalents
as of December 31, 2024).
For the year ended December 31, 2023, our net financial loss was mainly driven by (i) interest expenses of
€3.9 million in relation to the Kreos / Claret OCABSA and the Heights Convertible Notes, (ii) a €8.9 million
expense in relation to our royalty certificates, a (iii) €3.0 million increase in the fair value of derivatives, transaction
costs amounting to €1.9 million, (iv) a net €3.2 million loss on derecognition of the OCEANE bonds and the
recognition of the Heights convertible notes, and (v) and foreign exchange losses of €5.6 million (including the €3.2
million non-cash impact of the year-end revaluation of U.S. dollar-denominated cash and cash equivalents).
These costs were partially offset by (i) an interest income of €2.4 million in relation to the invested proceeds
from our U.S. initial public offering and listing on Nasdaq, (ii) a decrease in the fair value of the Heights
Convertible Notes by €3.2 million and a (iii) decrease in derivatives fair value by €1.0 million.
Income Taxes
For the year ended December 31, 2025, our deferred income tax charge was €(5.8) million, as compared to
€— for the years ended December 31, 2024 and 2023.
This increase is explained by the net deferred tax liability of €5.8 million recognized in our consolidated
statements of financial position as of December 31, 2025.
The deferred tax liability resulted from the significant taxable temporary difference arising from our royalty
certificates as of December 31, 2025, which in turn resulted from the difference between (i) the amount already
deducted from our taxable income as of December 31, 2025 (based on the certificates' fair value minus their
subscription price) and (ii) the amount of the related financial liability recognized in our Statements of Financial
Position at that date (measured at amortized cost using the original effective interest rate).
Further explanation on the calculation of the deferred tax liability is disclosed in Note 22 to our financial
statements as of and for the year ended December 31, 2025, appearing elsewhere in this Annual Report on Form 20-
F.
The deferred tax expense is non-cash for the year ended December 31, 2025.
Net Loss
For the year ended December 31, 2025, our net loss for the period was €336.1 million, as compared to
€176.2 million for the year ended December 31, 2024, an increase of €159.9 million, or 91%.
For the year ended December 31, 2024, our net loss for the period was €176.2 million, as compared to
€147.7 million for the year ended December 31, 2023, an increase of €28.5 million, or 19%.
B.Liquidity and Capital Resources
Sources of Liquidity
We have incurred substantial operating losses since inception and expect to continue to incur significant
operating losses for the foreseeable future and may never become profitable. For the years ended December 31,
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2025, 2024 and 2023, we reported net losses of €336.1 million, €176.2 million and €147.7 million, respectively. As
of December 31, 2025, we carried forward accumulated tax losses of €912.9 million.
Since inception, we have financed our operations primarily through the issuance of ordinary shares, as well as
bank borrowings and loans, receipt of research tax credits and subsidiaries, and sales of royalty certificates, for gross
aggregate proceeds of €1,194.7 million, of which €130.0 million of gross proceeds were from our offerings of
ordinary shares on Euronext Paris in February 2023, €223.3 million of gross proceeds were from our offering of
ordinary shares in the form of ADSs on the Nasdaq Global Market in our U.S. initial public offering as well as
ordinary shares in Europe (including France) and countries outside of the United States in a concurrent private
placement in October 2023, €637.5 million of gross proceeds were from our offering of ordinary shares in the form
of ADSs on the Nasdaq Global Market in the July 2025 Nasdaq Offering, bank borrowings and structured loans of
€175.0 million, reimbursements of CIR in an amount of €41.2 million, subsidies received from Bpifrance (including
€21.3 million of subsidies and €1.8 million of conditional advances) and royalty certificates in an amount of
€2.9 million.
In addition, on November 19, 2024, we entered into an equity distribution agreement with Piper Sandler & Co.
(“Piper Sandler”) allowing us to issue and sell from time to time, in one or more "at the market" offerings through
Piper Sandler acting as sales agent, ordinary shares in the form of ADSs, with aggregate gross sales proceeds of up
to $150.0 million (the "ATM Program"). To date, we have not sold any ADSs pursuant to the ATM Program.
Based on our existing cash and cash equivalents and other short-term investments of €530.4 million as of
December 31, 2025, we expect, as of the date of issuance of the consolidated financial statements included in this
Annual Report on Form 20-F, to be able to fund our forecasted cash flow requirements into the fourth quarter of
2027, allowing us to reach 12 months of expected cash runway following the planned new drug application ("NDA")
submission of obefazimod for UC, assuming positive results from its Phase 3 maintenance trial. Our forecasted cash
flow requirements take into account our assumption of continued R&D expenditure related to the continuation of the
Phase 3 clinical trials of obefazimod in UC, progression of the Phase 2b clinical trials for CD and the initial stages of
the scale up of the commercial organization as we prepare for a potential launch of obefazimod in UC.
Based on the above, management has concluded that its existing cash, cash equivalents and other short-term
investments are sufficient to fund its operating and capital expenditure requirements for a period greater than 12
months from the date of issuance of the financial statements accompanying this annual report, and the
accompanying financial statements have been prepared on a going concern basis.
Capital Increases
Our operations have been financed primarily by capital increases from our founders and investors, net
proceeds from the initial public offering of our ordinary shares on Euronext Paris in France in 2015, and additional
follow-on capital increases, including the initial public offering of our ordinary shares in the form of ADSs on the
Nasdaq Global Market in 2023 and our July 2025 Nasdaq Offering. We have not yet commercialized any of our
drug candidates, which are in various phases of clinical development, and we do not expect to generate revenue from
sales of any products in 2026, if at all. Until such time as we can generate significant revenue from product sales, if
ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources,
including potential collaborations with other companies or other strategic transactions.
The following table sets forth our main capital increases carried out during the years ended December 31,
2023, 2024 and 2025:
(In thousands of euros) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gross proceeds amount
Capital increase from issuance of ordinary shares - February 23, 2023 . . . . . . . . . . . . . . . . . . . . 130,000
Initial Public Offering (Nasdaq) - October 24, 2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223,300
Capital increase from issuance of ordinary shares - July 24, 2025 . . . . . . . . . . . . . . . . . . . . . . . . 637,500
On March 1, 2023, we received gross proceeds of €130.0 million from the issuance of 20,000,000 ordinary
shares at a subscription price of €6.50 per share. The proceeds were primarily used to finance the progress of
obefazimod clinical trials in chronic inflammatory diseases and for general corporate purposes (research and
development expenses and loans maturities payments).
On October 24, 2023, we received gross proceeds of €223.3 million from the issuance of 20,325,500 ordinary
shares (including ordinary shares in the form of ADSs) at a price of €10.99 per share in connection with our U.S.
initial public offering. The proceeds were primarily used to finance the progress of obefazimod clinical trials in
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chronic inflammatory diseases and for general corporate purposes (research and development expenses and loans
maturities payments).
On July 28, 2025, we received gross proceeds of €637.5 million from the issuance of 11,679,400 ADSs at a
price of $64.00 per ADS (corresponding to €54.58 per ordinary share, based on the exchange rate of €1.00 =
$1.1726 as published by the European Central Bank on July 23, 2025) in connection with our July 2025 Nasdaq
Offering. The proceeds were primarily used to finance the progress of obefazimod clinical trials in chronic
inflammatory diseases and for general corporate purposes (research and development expenses and loans maturities
payments).
Research Tax Credits
From our inception to December 31, 2025, we have benefited from refunds of CIRs in a total amount of €41.2
million. In November 2024, we received CIRs of €4.5 million with respect to the year ended December 31, 2023. In
June 2025, we received CIRs of €5.7 million with respect to the year ended December 31, 2024.
Bpifrance—Conditional Advances and Subsidies
We have received several conditional advances and subsidies from Bpifrance since our inception. Funds
received from Bpifrance in the form of conditional advances are recognized as financial liabilities, as we have a
contractual obligation to reimburse Bpifrance for such conditional advances in cash based on a repayment schedule.
Each award of an advance is made to help fund a specific development milestone. Subsidies are non-repayable
grants, which are recognized in the financial statements when there exists reasonable assurance that we will comply
with the conditions attached to the subsidies and the subsidies will be received.
The following table sets forth the funds received from Bpifrance as of December 31, 2025, in relation to
contracts that were ongoing or terminated during the years ended December 31, 2023 and 2024:
As of December 31, 2025
(In thousands of euros) Contract status Amount collected
Conditional advances ....................... €1,802
Carena (1) .......................................... Stopped €234
RNP-VIR (2) ....................................... Stopped €1,178
Ebola ................................................. Stopped €390
Subsidies ............................................ €5,875
Carena (1) .......................................... Stopped €3,140
RNP-VIR (2) ....................................... Stopped €2,735
Ebola .................................................. Stopped €—
Total ................................................... €7,677
(1)Following termination of the project due to technical failure in June 2024, the repayment of an amount of conditional advance of €2.0
million (excluding accrued interests) was waived by Bpifrance and therefore reclassified as a subsidy.
(2)Following the termination of the project due to technical failure in June 2024, the repayment of an amount of conditional advance of
€1.8 million (excluding accrued interests) was waived by Bpifrance and therefore reclassified as a subsidy.
Bpifrance—CARENA Contract
As part of the development of therapeutic and diagnostic solutions targeting alternative splicing and RNA
interference in the fields of virology (HIV-AIDS, HTLV-1) and metabolism (obesity), SPLICOS, which we acquired
in October 2014, entered into a Master Support Agreement and a conditional advance contract on December 2013
for the “CARENA” Strategic Industrial Innovation Project (“CARENA project”), with Bpifrance. Under this
contract, we were eligible to receive up to €3.8 million in conditional advances to develop a therapeutic HIV
treatment program with obefazimod. As of December 31, 2024, we had received €3.4 million of conditional
advances and subsidies.
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In June 2024, the Company and Bpifrance agreed to terminate the project due to technical failure. Bpifrance
granted an additional amount of €1.1 million payable to the Company to reimburse additional expenses incurred as
part of the project, and agreed to waive 60% of the remaining conditional advance of €3.3 million and accrued
interests, for which we recognized a subsidy income of €2.3 million in the aggregate. We repaid the outstanding
amounts during the second half of 2024.
Bpifrance—RNP-VIR Contract
As part of the CARENA project, focused on the clinical development of a drug molecule and demonstrating
the validity of an innovative therapeutic approach targeting viral RNPs, we entered into a Master Support
Agreement with Bpifrance, as well as a beneficiary agreement dated March 21, 2017, with conditional advances for
the “RNP-VIR” structuring research and development project for competitiveness. Under the RNP-VIR contract, we
were eligible to receive up to €6.3 million in conditional advances to develop methods for the discovery of new
molecules for the treatment of viral infectious diseases through the development of the “Modulation of RNA
biogenesis” platform. As of December 31, 2024, we had received €3.9 million of conditional advances and
subsidies.
In June 2024, the Company and Bpifrance agreed to terminate the project due to technical failure. Bpifrance
claimed the reimbursement of €1.2 million corresponding to overpayments of conditional advances and subsidies
(for which we had not incurred the corresponding R&D expenses) and agreed to waive 60% of the remaining
advances of €3.0 million and accrued interests, for which the we recognized a subsidy income of €1.9 million in the
aggregate. We repaid the outstanding amounts during the second half of 2024.
Bpifrance—Ebola
The Bpifrance and Occitanie Region joint support agreement was entered into on June 2, 2017 and provides
for conditional advances for a total amount of €0.4 million (€0.1 million from the Languedoc Roussillon Midi
Pyrénées Region and €0.3 million from Bpifrance) for the Ebola program. All funds under this contract were
received. In September 2019, we terminated this program due to the imminent licensing of a competing vaccine for
this indication, as well as changes in the macroeconomic climate for public funding. The reimbursement of the
conditional advance was spread over the period from September 2019 to June 2024.
Indebtedness
For a description of material financing agreements, see "Item 10.C. Material Contracts."
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Historical Changes in Cash Flows
The following table sets forth our cash inflows and outflows for the years ended December 31, 2023, 2024 and
2025.
(In thousands of euros) . . . . . . . . . . . . . . . . . . . . . . Year ended December 31, 2023 Year ended December 31, 2024 Year ended December 31, 2025 2024 vs 2023 Change 2025 vs 2024 Change
Net cash flows used in operating activities . . . . . . . . . . . . . . . . . . . . . . . . . (97,130) (154,072) (161,129) 59% 5%
Net cash flows (used in) provided by investing activities . . . . . . . . . . . . . . . . . . (8,095) 15,762 (8,193) (295)% (152)%
Net cash flows provided by financing activities . . . . . . . . . . . . . . . . . . . . . . . . . . 335,290 28,207 547,307 (92)% 1840%
Effect of movements in exchange rates on cash held . . . . . . . . . . . . . . . . . . . . . . . (5,072) 2,382 (10,251) (147)% (530)%
Revaluation of cash equivalents measured at fair value . . . . . . . . . . . . . . . — — 4,730 —% —%
Net increase (decrease) in cash and cash equivalents . . . . . . . . . . . . . . . . . . 224,992 (107,720) 372,464 (148)% (446)%
Cash and cash equivalents at the beginning of the period . . . . . . . . . . . . 26,950 251,942 144,221 835% (43)%
Cash and cash equivalents at the end of the period . . . . . . . . . . . . . . . . . . . . . 251,942 144,221 516,685 (43)% 258%
Operating Activities
For the year ended December 31, 2025, cash used in operating activities was €(161.1) million, as compared to
€(154.1) million for the year ended December 31, 2024, a decrease of €7.1 million, or 5%.
For the year ended December 31, 2024, cash used in operating activities was €(154.1) million, as compared to
€(97.1) million for the year ended December 31, 2023, an increase of €(56.9) million, or 59%.
For the year ended December 31, 2025, cash used in operating activities was predominantly related to
payments for the progression of our UC and CD trials and personnel, legal, professional and infrastructure costs
associated with operating as a dual-listed public company. The increase was mostly driven by the increase in our
operating loss (as explained above), partly offset by changes in our working capital requirements, from €0.5 million
for the year ended December 31, 2024 to €4.1 million for the year ended December 31, 2025.
For the year ended December 31, 2024, cash used in operating activities is attributable to increased R&D
spend driven by the progression of the UC Phase 3 clinical trial and the initiation of the Phase 2b CD trial, the full
year impact of increased legal and professional fees and other infrastructure costs associated with operating as a
dual-listed public company and changes in working capital.
For the year ended December 31, 2023, cash used in operating activities is attributable to increased R&D
spend driven by the progression of the UC Phase 3 clinical trial, increased headcount to support the expansion of the
overall organization, including a newly created sales and marketing department, increased legal and professional
fees and other infrastructure costs associated with operating as a dual-listed public company and changes in working
capital.
Investing Activities
For the year ended December 31, 2025, cash used in investing activities was €8.2 million and was mainly due
to an investment in 9- and 12-month term deposits, partially offset by the interests received from our cash and cash
equivalents and short-term investments of €5.5 million.
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For year ended December 31, 2024, cash from investing activities was €15.8 million and was mainly due to
the payment of the our 6-month term deposit of €9.0 million and from interests received from cash, cash equivalents
and short-term investments of €8.2 million.
For the year ended December 31, 2023, cash used in investing activities was €8.1 million and was mainly due
to a €9.0 million investment in a 6-month term deposit and the payment of additional long-term CRO advances
amounting to €1.6 million, partially offset by interests received amounting to €2.4 million.
Financing Activities
For the year ended December 31, 2025, cash from financing activities was €547.3 million, which mainly
consisted of net proceeds from our July 2025 Nasdaq Offering of €607.2 million as well as cash received from
exercises of share warrants of €5.8 million, partially offset by debt repayments of €59.6 million (of which €2.1
million related to tranche A of the Kreos / Claret Financing and €53.9 million related to tranches B and C (of which
€33.8 million correspond to the full prepayment of the outstanding balance and related fees as of December 23,
2025), €2.2 million related to the Heights convertible notes and €2.5 million related to the State-guaranteed loan
(Prêt garanti par l'Etat, or "PGE")), and interest payments of €6.5 million.
For the year ended December 31, 2024, cash from financing activities was €28.2 million, which mainly
consisted of drawdowns on tranche B (in an amount of €25 million) and tranche C (in an amount of €25 million) of
the senior secured non-convertible bonds from the Kreos / Claret Financing, net of disbursed transaction costs and
deposits (in an amount of €2.6 million in the aggregate), partially offset by repayments of €13.2 million (of which
€8.8 million related to the Heights convertible notes and €2.7 million related to conditional advances) and interest
payments of €7.7 million.
For the year ended December 31, 2023, cash from financing activities was €335.3 million, which consisted of
net proceeds from our offering of ordinary shares on Euronext Paris of €123.3 million (after deducting transaction
costs of €6.7 million), net proceeds from our offering of ordinary shares and ADSs of €202.0 million (after
deducting transaction costs of €21.3 million) from our U.S. initial public offering and listing on Nasdaq and
concurrent private placement (after deducting transaction costs and underwriting commissions of €28.1 million), net
proceeds from the August 2023 drawdown of the first tranches of the Kreos / Claret Financing and the Heights
Financing, collectively amounting to €27.2 million (net of repayments of all outstanding amounts that remained due
under the 2018 venture loan agreement with Kreos Capital ("First KC Agreement"), the 2020 bonds issue agreement
with Kreos Capital ("Second KC Agreement") and the OCEANE bonds), partially offset by repayments under the
notes issued under the First KC Agreement and Second KC Agreement (in an amount of €5.0 million), PGE (in an
amount of €1.3 million) and interest paid (in an amount of €5.3 million).
Material Cash Requirements
Contractual Obligations and Loans
The following table sets forth aggregate information about material contractual obligations as of December 31,
2025.
The commitment amounts in the table below are associated with contracts that are enforceable and legally
binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum or
variable price provisions, and the approximate timing of the actions under the contracts. Future events could cause
actual payments to differ from these estimates. All amounts except the retirement benefits in the table below are
presented gross and are undiscounted.
As of December 31, 2025 As of December 31, 2025 As of December 31, 2025
Less than More than
(In thousands of euros) . . . . . . . . . . . . . . . . . . . . . 1 year 1 year Total
Lease obligations . . . . . . . . . . . . . . . . . . 1,340 566 1,906
Retirement benefits . . . . . . . . . . . . . . . . . — 627 627
Off-balance sheet obligations . . . . . . . . . 205,131 — 205,131
Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206,471 1,193 207,664
In the ordinary course of our business, we regularly use the services of subcontractors and enter into research
and partnership arrangements with various CROs and with public-sector partners or subcontractors, who conduct
clinical trials and studies in relation to the drug candidates. Off-balance sheet obligations in the table above are
commitments related to these research and partnership agreements. They are classified at less than one year maturity
in the absence of a fixed schedule in contracts, in case of multiple-year contracts, such as CRO contracts. CRO
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contracts include payments that are conditional to the completion of future development milestones. The majority of
the commitments with our CROs are cancellable under certain circumstances such as insolvency, study put on hold
by competent authorities, breach in regulations or negligence in the provision of the services.
Our material cash requirements in the above table do not include potential future royalty payments related to
the royalty certificates, amounting to 2% of the future net sales of obefazimod (worldwide and for all indications).
The amount of royalties that may be paid under the royalty certificates is capped at €172.0 million in the aggregate.
Royalty payments are expected to take place before the expiry date of the certificates, which is 15 years after their
issuance date (September 2, 2037).
As of December 31, 2025, our contractual obligations were €207.7 million comprising off-balance sheet
obligations of €205.1 million with respect to purchase obligations, lease obligations of €1.9 million and retirement
benefits obligations of €0.6 million.
Operating Capital and Capital Expenditures Requirements
We have incurred substantial operating losses since inception and expect to continue to incur significant
operating losses for the foreseeable future and may never become profitable. For the year ended December 31, 2025,
we recorded a net loss of €336.1 million. Until such time as we can generate significant revenue from product sales,
if ever, we expect to continue to finance our operations from the sale of additional equity or debt financings, or other
capital which comes in the form of strategic collaborations, licensing, or other arrangements.
Our present and future funding requirements will depend on many factors, including, among other things:
•the size, progress, timing, and completion of our preclinical studies and clinical trials;
•the number of potential new drug candidates we identify and decide to develop;
•the costs involved in filing patent applications and maintaining and enforcing patents or defending
against claims or infringements raised by third parties;
•the time and costs involved in obtaining regulatory approval for our drug candidates and any delays we
may encounter as a result of evolving regulatory requirements or adverse results with respect to any of
these drug candidates;
•selling and marketing activities undertaken in connection with the anticipated commercialization of
obefazimod and any other current or future drug candidates and costs involved in the creation of an
effective sales and marketing organization;
•the amount of revenue, if any, we may derive either directly or in the form of milestones or royalty
payments from our existing or future partnership or collaboration agreements; and
•the severity, duration and impact of the Russia/Ukraine war, which may continue to adversely impact
our business and clinical trials.
See “Risk Factors—Risks Related to our Financial Position and Need for Additional Capital” for additional
risks associated with our substantial capital requirements.
C.Research and Development, Patents and Licenses, Etc.
For a discussion of our research and development activities, see “Item 4.B—Business Overview” and “Item
5.A—Operating Results.”
D.Trend Information
For a discussion of trends, see “Item 4.B—Business Overview,” “Item 5.A—Operating Results” and “Item
5.B—Liquidity and Capital Resources.”
E.Critical Accounting Estimates
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Our audited financial statements as of, and for the years ended, December 31, 2025, 2024 and 2023 were
prepared in accordance with International Financial Reporting Standards (“IFRS”), as issued by the International
Accounting Standards Board (“IASB”), and IFRS as adopted by the European Union ("EU") regulation n°1606/2022
of July 19, 2022.
A description of accounting policies and estimates along with a description of the recently-issued accounting
pronouncements that may potentially impact our financial position and results of operations is disclosed in Notes 4
and 2 respectively to our financial statements as of and for the year ended December 31, 2025, appearing elsewhere
in this Annual Report on Form 20-F. We applied the amendment to IAS 21 The Effects of Changes in Foreign
Exchange Rates – Lack of Exchangeability that is effective as of December 31, 2025.
We did not have to change our accounting policies or make retrospective adjustments as a result of adopting
this standard. The impacts resulting from the application of this amendment are described in Note 2 to our financial
statements as of and for the year ended December 31, 2025, appearing elsewhere in this Annual Report on Form 20-
F.
We did not elect for early application of the new standards, amendments and interpretations, which were
issued but not mandatory as of December 31, 2025. Our assessment of the impacts resulting from the application of
these recently issued accounting pronouncements is described in Note 2 to our financial statements as of and for the
year ended December 31, 2025, appearing elsewhere in this Annual Report on Form 20-F.
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