A.History and Development of the Company Our legal and commercial name is Abivax SA. We were incorporated as a société anonyme (limited liability company) under the laws of France on December 4, 2013 for a period of 99 years until December 22, 2112, subject to extension or early dissolution and registered at the Paris Trade and Company Register on December 27, 2013 under the number 799 363 718. Our principal executive offices are located at 7-11 boulevard Haussmann 75009 Paris, France, and our telephone number is +33 (0) 1 53 83 09 63. We have one wholly owned subsidiary, Abivax LLC, a Delaware limited liability company, formed on March 20, 2023. Our agent for service of process in the United States is CT Corporation System, 1015 15th Street N.W., Suite 1000, Washington, D.C. 20005. We have been listed on Euronext Paris since June 2015. In October 2023, we completed the initial public offering of our ordinary shares in the form of ADSs on the Nasdaq Global Market, raising approximately $235.8 million in gross proceeds (equivalent to approximately €223.3 million based on the exchange rate then in effect), inclusive of proceeds from our concurrent private placement of ordinary shares in certain jurisdictions outside of the United States. We did not incur any material capital expenditures for the years ended December 31, 2025, 2024 and 2023 other than in the ordinary course of business, as described below in Item 5—Operating and Financial Review and Prospects. The SEC maintains an Internet site that contains reports, proxy information statements and other information regarding issuers that file electronically with the SEC. The address of that site is http://www.sec.gov. Our website address is www.abivax.com. The reference to our website is an inactive textual reference only and information contained in, or that can be accessed through, our website or any other website cited in this annual report is not part of this annual report. B.Business Overview 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 ("MOA"). 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. 55 Our Pipeline Our lead drug candidate, 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 potential combination therapy opportunities in IBD to pursue. In parallel, we are in the process of strengthening our development portfolio by generating follow-on compounds based on our miR-124 platform and assessing external early drug candidates in IBD. The chart below sets forth details of our pipeline: 1 Under evaluation based on induction and maintenance Phase 3 clinical trials. Our Strategy Our primary goal is to develop and commercialize obefazimod for the treatment of IBD, starting with moderately to severely active UC and CD. We focus on indications with high unmet needs with substantial commercial potential. To achieve our goal, we are pursuing the following key elements of our strategy: •Advance obefazimod through pivotal clinical trials and establish obefazimod as a potential preferred advanced therapy for IBD. We believe that the strength of the induction data we have generated in July 2025 in our Phase 3 clinical trials, with a pooled 16.4% placebo-adjusted clinical remission rate after 8 weeks of treatment, and a highly differentiated placebo adjusted clinical response rate across all lines of bio-naïve and bio-refractory patients, including JAK resistant patients, with no major safety concerns, uniquely positions obefazimod as a potential highly competitive advanced therapy choice for moderately to severely active UC, if approved. We also believe that the strength of the maintenance data demonstrated in our Phase 2b trial (as evidenced by a clinical remission rate of 53%, clinical response rate of 73% and no new adverse safety signals observed from our two-year Phase 2b open label maintenance trial), should they be confirmed in our ongoing Phase 3 maintenance trial, could further position obefazimod as a potential treatment of choice for all UC patient treatment lines. Based on the positive clinical data generated in our UC trials, preclinical studies in dextran sulfate sodium ("DSS") mouse model which provide support for pursuing further development in CD, and underlying biological and mechanistic rationale, we also initiated a Phase 2b clinical trial in patients with CD in the fourth quarter of 2024, with a planned top-line induction data read-out in the fourth quarter of 2026. CD causes long-lasting inflammation and ulcers in the digestive tract, with fibrosis and structuring, playing a key role in disease progression. It differs from UC in that it affects the entire thickness of the bowel wall and all parts of the digestive tract from mouth to anus. However, CD shares many of the underlying pathophysiological processes and clinical manifestations of UC, and, as a result, the current treatment paradigm of CD is similar to UC, as described further below. In addition, we believe that obefazimod’s clinical profile observed to date lends itself to potential combinations with existing or new therapies, which we are exploring. •Potential combination therapy in IBD with obefazimod. Currently available therapies have limited efficacy and durability that wane over time, have extensive pre- initiation requirements, carry significant safety and tolerability challenges (such as black box safety warnings), and many of them are injectable biologics. We believe several of obefazimod’s attributes make 56 it a potentially attractive candidate to pair with other advanced treatments. First, the oral route of administration is preferred by a majority of patients, potentially resulting in higher levels of medication adherence. Further, obefazimod’s proposed MOA harnesses the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. The novel MOA of obefazimod potentially lends itself as complementary to other oral or injectable agents with the potential of improving the induction and remission efficacy over monotherapy. We have initiated a formal process evaluating oral and injectable combination therapy candidate with obefazimod in UC. In September 2024, we announced initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index, and a synergistic and statistically significant reduction of several cytokines (TNFa, IL-17, IL-6, IFNg) in the blood compared to each drug alone. Beyond this current S1P opportunity, we are also investigating potential synergies with agents resulting from several other MOAs (a4b7, IL-23, PDE-4 and ahR). Additional preclinical data to support our decision-making on a combination agent, which would also be based on an evaluation of our induction and maintenance data from our Phase 3 clinical trials, is expected in 2026. •Leverage library of miR-124 enhancers to expand our pipeline in chronic inflammatory diseases. Based on the mechanistic concept of obefazimod, we have launched a research and development program to generate new potential drug candidates to strengthen our intellectual property portfolio on the miR-124 platform and to identify additional drug candidates from our proprietary small molecule library that includes additional miR-124 enhancers. We expect to announce an obefazimod follow-on candidate selection in 2026. We may also consider R&D portfolio additions anytime, with compounds resulting from external scientific and medical partnerships in chronic inflammatory diseases.at preclinical or clinical stage. •Opportunistically evaluate strategic partnerships to maximize the value of obefazimod and our therapeutic pipeline. We have discovered and are developing obefazimod as an innovative medicinal product and we currently hold its worldwide rights. We intend to retain worldwide development and commercialization rights for obefazimod. For certain geographies, we may opportunistically enter into strategic partnerships to accelerate development activities in order to realize the commercial potential of obefazimod as well as other assets in our pipeline. In connection with any potential strategic partnership, we plan to pursue and receive upfront funding, milestone payments and future royalties for these agreements. Our Lead Drug Candidate for the Treatment of Inflammatory Diseases: Obefazimod Obefazimod is an oral small molecule drug candidate in clinical development for the treatment of moderately to severely active UC and CD. We believe that obefazimod is the only small molecule drug candidate in clinical development with a mechanism of action that 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. Our Market Opportunity: UC and CD The estimated market opportunity for UC was approximately $9.2 billion in worldwide sales in 2025 and is expected to reach $21.8 billion in worldwide sales in 2032. In the United States, UC sales were approximately $6.0 billion in 2025 and are expected to reach $14.9 billion by 2032. The UC market has seen tremendous growth which is expected to continue. From 2020 to 2025, U.S. advanced therapy usage has increased by approximately 96% from approximately 138,000 advanced therapy patients in 2020 to approximately 271,000 advanced therapy patients in 2025. Recent and future anticipated growth stems from recent launches in UC, increased advanced therapy use, and differentiated MOA currently in the pipeline. We currently estimate that approximately 300,000 moderate-to-severe UC patients in the United States, out of an estimated 500,000 patients, are on conventional therapy or steroids only, and a safe, efficacious, oral therapy will have the unique ability to further penetrate this patient segment. We believe the potential for oral agents to gain significant market share is supported by physician and patient preference for the convenience of oral administration over injectable agents, increasing demand for therapies with long-term efficacy profiles and the opportunity for potent and well-tolerated oral agents to expand the overall segment of the moderately to severely active UC population undergoing treatment. The estimated market opportunity for CD was approximately $15.2 billion in worldwide sales in 2025 and is expected to reach $19.4 billion in worldwide sales in 2032. In 2025, approximately $10.5 billion of sales were generated from the United States. Similar to the UC market, we believe oral agents represent a significant commercial opportunity, particularly if such therapeutics can provide long-term safety and efficacy profiles 57 comparable to injectable agents. We currently estimate that there are approximately 480,000 moderate-to-severe CD patients in the United States, out of an estimated 800,000 patients. Summary of Obefazimod’s Mechanism of Action We believe our lead drug candidate, obefazimod, is differentiated from competing approaches for the treatment of IBD via its novel MOA. It has been demonstrated that obefazimod enhances 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. Once expressed, micro-RNA interact with specific mRNA targets and decrease their translation into proteins to regulate specific pathways. miR-124 is known to have an effect on two key immune cells, Th17 cells and macrophages, which causes reductions in both cell populations in the gut, as well as decreases in key related cytokines such as IL-17 and IL-6. IL-23, and TNFα. In addition, we now have pre-clinical evidence that obefazimod has an effect on fibroblasts and other fibrosis-related cell types. We know that miR-124 can target both TGF-β pathways and matrix metalloproteinases ("MMPs"), and this can potentially have an anti-fibrotic effect, as illustrated in the images below. 58 As further support of our understanding of obefazimod's MOA, in both ABTECT Phase 3 induction trials, we observed that obefazimod significantly reduced IL-17A and IL-6 levels in serum in patients at week 8 compared with placebo as seen in the image below. IL-17A and IL-6 reflect effects on the Th17 and inflammatory macrophage populations, which are all drivers of mucosal inflammation in both UC and CD. 59 Overview of Our Completed Phase 3 ABTECT Induction Trials and Ongoing Phase 3 ABTECT Maintenance Trial We initiated our pivotal Phase 3 clinical trials of obefazimod for the treatment of moderately to severely active UC in October 2022, which consists of two induction trials (ABTECT-1 and ABTECT-2) and one ABTECT maintenance trial. In July 2025, we announced the top-line data from the two ABTECT induction trials. Overall, 1,275 patients were randomized and 1,272 patients were treated in ABTECT-1 (N=636) and ABTECT-2 (N=636). Below are the trial designs of our ABTECT induction and maintenance trials. In both trials, baseline demographics and disease characteristics were similar between groups; 45% and 49% of patients had inadequate response to one or more advanced therapies. A slightly more severe and refractory population were randomized to the 25 mg group in ABTECT-2 compared to ABTECT-1. Overall this was a highly refractory patient population with approximately 21% of advanced therapy inadequate responders having previously failed a JAK inhibitor. In the pooled analysis of ABTECT trials, a significantly higher proportion of patients receiving obefazimod 50 mg (20.8%) or obefazimod 25 mg (17.6%) versus placebo (4.4%) achieved clinical remission (obefazimod 50 mg- placebo difference: 16.4%, p<0.0001; obefazimod 25 mg-placebo difference: 13.2%, p<0.0001) and met all key secondary endpoints in both trials. A significantly higher proportion of patients receiving obefazimod 50 mg (ABTECT-1: 21.7%, ABTECT-2: 19.8%) versus placebo (2.5% and 6.3%) achieved clinical remission (obefazimod 50 mg-placebo difference: ABTECT-1: 19.3%, p<0.0001; ABTECT-2: 13.4%, p=0.0001) and met all key secondary endpoints in both trials. In ABTECT-1, a significantly higher proportion of patients receiving obefazimod 25 mg versus placebo achieved clinical remission (obefazimod 25 mg -placebo difference: 21.4%, p<0.0001) and met all key secondary endpoints. These results are shown in the charts below. 60 Notes: (a) % Difference is for ABX464 minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: inadequate response to advanced therapies (yes/no), Baseline oral corticosteroids usage (yes/no). P- values are two sided. NRI is used for subjects with missing outcome at Week 8 and subjects reporting any IE prior to Week 8. (b) Clinical remission is defined as SFS = 0 or 1, and RBS = 0 and MES = 0 or 1 (MES of 1 modified to exclude friability). Endoscopic improvement is defined as MES = 0 or 1 (MES of 1 modified to exclude friability). Clinical response is defined as a reduction from Baseline in MMS >= 2 points and a relative reduction from Baseline in MMS >= 30%, and a reduction from Baseline in RBS >= 1 point and/or RBS = 0 or 1. HEMI is defined as MES = 0 or 1 and Geboes Index score <3.1 The overall rates of serious adverse events and treatment emergent adverse events ("TEAEs") leading to study drug discontinuation for patients treated with obefazimod were similar to placebo. Proportions of patients who reported at least one TEAE in ABTECT-1 were 59.4%, 46.9%, and 53.2% for obefazimod 50 mg, obefazimod 25 mg, and placebo, respectively. For ABTECT-2, TEAEs occurred in 61.0%, 50.9%, and 48.4% for obefazimod 50 mg, obefazimod 25 mg, and placebo, respectively. The most frequent TEAE was headache (obefazimod 50 mg: 20.8-25.8%; obefazimod 25 mg: 14.5-15.6%; placebo: 5.7%). The headaches were mild, transient, short in duration and not a barrier to treatment, as evidenced by a low discontinuation rate of 1.6%. No signal was observed for serious, severe, or opportunistic infections or malignancies. No clustering of serious TEAEs was observed; only worsening of UC and pneumonia were reported more than once in any individual treatment arm. Obefazimod’s tolerability profile indicates potentially important clinical differentiation. As of the data cutoff date (September 30, 2025), 1,372 patients have received obefazimod in all completed and ongoing clinical trials across all indications, including 324 patients for longer than one year. Additionally, 1,163 patients have received only blinded obefazimod or placebo in the ABTECT program or Phase 2b clinical trial in CD. We also conducted sub-group analyses for efficacy endpoints at week 8 for patients with and without prior inadequate response to advanced therapies (AT-IR-Yes, AT-IR-No). In a pooled analysis of ABTECT-1 and ABTECT-2, a higher proportion of the AT-IR-Yes subgroup receiving obefazimod 50 mg achieved all efficacy measures relative to placebo including clinical remission (obefazimod 50 mg – placebo difference: 10.1%). In the AT-IR-Yes subgroup, the difference from placebo across all efficacy measures was lower for patients receiving obefazimod 25 mg relative to obefazimod 50 mg. In the AT-IR-No subgroup, larger proportions achieved all efficacy measures relative to placebo including clinical remission (obefazimod 50 mg – placebo difference: 22.4%). In the AT-IR-No subgroup, obefazimod 50 mg and obefazimod 25 mg performed similarly in the pooled analysis across efficacy measures. In the subset of patients who failed JAKi, higher proportions of patients receiving obefazimod 50 mg or obefazimod 25 mg achieved clinical response vs. placebo. The difference from placebo in clinical response for obefazimod 50 mg was >25% across lines of treatment, from AT-IR-No through 4+ AT-IRs as seen below. 61 Notes: (a) % Difference is for ABX464 minus placebo and is based on estimated common risk difference using the Mantel-Haenszel weights adjusting for the randomization stratification factors: inadequate response to advanced therapies (yes/no), Baseline oral corticosteroids usage (yes/no). P- values are two sided. NRI is used for subjects with missing outcome at Week 8 and subjects reporting any IE prior to Week 8. (b) Clinical response is defined as a reduction from Baseline in MMS >= 2 points and a relative reduction from Baseline in MMS >= 30%, and a reduction from Baseline in RBS >= 1 point and/or RBS = 0 or 1 We expect to report top-line data from our Phase 3 ABTECT maintenance trial in late second quarter of 2026. Subject to positive data, we currently expect to submit our NDA with the FDA in the fourth quarter of 2026. Overview of Our Completed Maintenance Phase 2b Clinical Trial of Obefazimod for the Treatment of UC Of the 222 patients who completed our 16-week Phase 2b induction trial, 217 patients (98%) enrolled in the subsequent open-label maintenance trial to evaluate the long-term safety and efficacy profile of obefazimod for up to two years, irrespective of treatments or treatment outcome during the induction phase. At week 48, of those 217 patients who received a 50 mg once-daily oral dosing with obefazimod, 178 patients (82%) had clinical response, 119 patients (55%) were in clinical remission, 133 patients (61%) had endoscopic improvement and 72 patients (33%) had endoscopic remission. Among the 98 bio-refractory patients, 66 patients (67%) had a clinical response, 38 patients (39%) were in clinical remission, 46 patients (47%) had endoscopic improvement and 20 patients (20%) had endoscopic remission at week 96. These results demonstrate potential for long-term clinical remission and clinical response of obefazimod in patients who were refractory to conventional treatments, as well as patients who had previously failed treatment with biologics and/or JAK inhibitors. Of the patients included in the maintenance trial, 164 patients (76%) completed two years of once-daily oral dosing with 50 mg obefazimod. Thirty patients dropped out during the first year of treatment. Six patients did not qualify for the second year due to non-response after the first year of treatment, and 17 patients dropped out during the second year. These patients were all considered as treatment failures in the intent-to-treat analysis. Of all 217 patients who entered the Phase 2b open-label maintenance trial, regardless of their status at the end of the 8-week induction period, 119 patients (55%) achieved clinical remission at week 48 and 114 patients (53%) achieved clinical remission at week 96. Among the 124 patients who achieved clinical response at the end of the 8- week induction period of the double-blind trial, 82 patients (66%) achieved clinical remission at week 48, mimicking the re-randomization of responders approach typically utilized in Phase 3 maintenance trials, and 74 patients (60%) achieved clinical remission at week 96. This comparison is shown below: 62 Notes: 1. 217/222 eligible patients enrolled into open-label maintenance trial. 2. Irrespective of the outcome at the end of the 8-week induction phase. 3. n = Number of patients that met the respective endpoint. 4. N = Number of patients in the relevant analysis set. 5. 124 patients achieved clinical response at end of the 8-week induction phase. 6. 93 patients did not achieve clinical response at end of the 8-week induction phase. Overview of Our Completed Phase 2 Open-Label Trial to Evaluate Long-Term Safety and Efficacy of Obefazimod at 25 mg in UC In this open-label maintenance trial, patients who had completed the four-year Phase 2a or 2-year Phase 2b open label maintenance trials, where they had received 50 mg of once-daily obefazimod, were given the opportunity to continue receiving obefazimod at a reduced dose of 25 mg daily for up to five additional years (provided they met the eligibility criteria of Mayo Endoscopic Subscore = 0 or 1). A total of 130 patients entered the trial, as of September 11, 2024, the data cut-off date, 113 patients have been evaluated out to 48 weeks and 74 patients have undergone the full 96-week evaluation. At study baseline, 89% (116/130) of patients were in clinical remission. At weeks 48 and 96 of treatment, 84% (95/113) and 87% (64/74) of patients evaluated were in clinical remission, respectively. Similarly, 92% (119/130) of patients were in symptomatic remission at study baseline. At weeks 48 and 96, 91% (103/113) and 92% (68/74) of patients evaluated were in symptomatic remission, respectively. Similar trends were observed with other efficacy analyses. The safety results were consistent with previous trials, with no new safety signals detected. Patient retention rates were high, with only 12% (16/130) of patients discontinuing in the first year and 5% (6/114) discontinuing during the second year of treatment. Thirty-three patients had not reached week 96 as of September 11, 2024, the data cutoff date. 63 Overview of Our Ongoing Phase 2b Crohn's Disease Trial (ENHANCE-CD) We have also initiated a Phase 2b clinical trial of obefazimod in patients with CD. Our Investigational New Drug ("IND") application for a Phase 2b clinical trial in patients with CD (trial design shown below) was cleared by the FDA in the fourth quarter of 2023, and we initiated enrollment in October 2024. We intend to announce Phase 2b induction trial top-line results in the fourth quarter of 2026 with the objective to demonstrate clinical response and a tolerability profile consistent with that already observed in our clinical trials for moderately to severely active UC. Based on the results from this Phase 2b clinical trial, if positive, we intend to proceed to a Phase 3 clinical trial. Below is the design of our Phase 2b trial: Existing UC Therapies and Their Limitations The current UC treatment approach is influenced by multiple factors, including disease severity, previous response to treatment, side effects and co-morbidities. Both existing conventional therapies as well as advanced therapies, including approved products and drug candidates in development, face significant room for improvement in efficacy, safety and tolerability, and convenience from dosing and route of administration standpoints as discussed below. Conventional Therapies for UC Aminosalicylates (5-ASAs) are used as a first-line therapy in mildly to moderately active UC. Corticosteroids are used primarily during induction therapy and are effective for reducing symptoms, but do not address mucosal healing which limit their ability to modify and improve the underlying cause of disease. In addition, there are safety considerations with extended corticosteroid use, including lowered quality of life, bone loss, weight gain and cardiovascular complications. As a result, corticosteroids are used primarily as a bridge to manage symptoms until immunomodulators or biologic agents become effective and enable mucosal healing. Oral immunosuppressants (e.g. azathioprine, 6-mercatopurine and methotrexate) have not been effective as induction agents and are generally used for steroid-sparing or as an adjunctive therapy for reducing immunogenicity against biologic agents. Oral immunosuppressants are also associated with known toxicities such as drops in white blood cell counts and increased risk for infection. Given the above insufficiencies of these conventional therapies, patients suffering from mild UC may evolve towards moderate and severe forms requiring the use of advanced therapies. Advanced Therapies for UC Advanced therapies for UC include biological agents as well as emerging oral molecules. Biological agents such as TNF-alpha inhibitors (including infliximab, adalimumab and golimumab), IL-12/23 inhibitors (such as ustekinumab) or IL-23 inhibitors (mirikizumab, guselkumab, risankizumab), specifically block certain inflammatory factors involved in UC. Biological agents also include gut-specific anti-integrin antibodies (such as vedolizumab and natalizumab). Current oral therapies that target inflammatory pathways include JAK inhibitors (such as tofacitinib and upadacitinib), as well as agents that reduce the trafficking of inflammatory cells, such as S1P receptor agonists (e.g., ozanimod and etrasimod). 64 However, these therapies often only have moderate efficacy that may wane over time, as patients stop responding or do not respond at all to these treatments and thus require new therapeutic management options. For patients who do not or no longer respond to treatment, or experience complications, surgical treatment may be necessary. Approximately 10% to 30% of UC patients require surgery over their lifetime. In addition, while TNF-alpha inhibitors and JAK inhibitors and newer biological agents, including anti- integrin antibodies, IL-12/23 inhibitors and IL-23 inhibitors, have generally improved the care of moderate to severely active IBD, these are all anti-inflammatory agents with safety and tolerability concerns. These include increased risks for cancers, infections and blood clots due to their systemic impact and resulting effects on the immune system outside of the GI tract. In addition, prolonged treatment with biological therapies can lead to anti- drug antibody development by patients’ immune systems which may lead to gradual waning of therapeutic efficacy and patients needing to switch to other biological agents. Furthermore, biological agents require injections or intravenous infusions, resulting in patient inconvenience and burden, which often negatively impacts patient compliance. Injections can also lead to injection-related events such as sciatica, neuralgia, neuropathic pain and peripheral neuropathy. In September 2021, the FDA published strict warnings about increased risk of serious heart-related events, cancer, blood clots and death for JAK inhibitors that treat certain chronic inflammatory conditions (including UC). In January 2023, the EMA stated recommendations to minimize the risk of serious side effects with JAK inhibitors used to treat several chronic inflammatory disorders, noting that these side effects include cardiovascular conditions, blood clots, cancer and serious infections which were adopted by the European Commission in March 2023. Recently, there have been efforts to develop drug candidates targeting novel mechanisms, such as S1P receptor agonists and TL1A inhibitors. S1P agonists, while offering convenient oral dosing, have not achieved meaningful commercial adoption. Ozanimod and etrasimod work by blocking the capacity of lymphocytes to egress from lymph nodes, thereby reducing the number of lymphocytes in peripheral blood, which can lead to increased susceptibility to infections. Furthermore, ozanimod, in its UC Study 1 which assessed efficacy during the induction period, achieved 18% clinical remission in all patients compared to 6% for placebo at week 10. For patients with prior exposure to TNF inhibitors, only 10% of patients achieved clinical remission compared to 5% for placebo. TL1A inhibitors have garnered interest from those seeking newer targets and agents with differentiated clinical profiles. Merck-Prometheus and Pfizer-Roivant have generated promising early Phase 2 data in both biologic- experienced and biologic-naïve patients, and have recently initiated Phase 3 clinical trials. In summary, we believe that there is significant unmet medical need in the UC treatment paradigm due to imperfect existing therapies with unfavorable clinical characteristics and limited efficacy that frequently wanes over time. Obefazimod is being developed as a once-daily, oral medication which, combined with its observed tolerability to date, would represent a meaningfully differentiated clinical profile from existing therapies. We believe this may position obefazimod as a potential first-line advanced therapy choice for both prescribers and patients, if approved. Phase 3 Clinical Trials and Regulatory Pathway in UC We are working with IQVIA, a global premier contract research organization, to conduct the Phase 3 clinical trials with obefazimod in moderately to severely active UC, following consultations with regulatory agencies, including FDA, EMA, CDE and PMDA. These pivotal Phase 3 clinical trials consist of two induction trials (ABTECT-1 and ABTECT-2) and the subsequent ABTECT maintenance trial investigating obefazimod at doses of 25 mg and 50 mg across 36 countries in North America, Latin America, Europe and Asia Pacific, involving 1,275 moderately to severely active UC patients in over 600 sites. Each of the trials were randomized, double-blind and placebo-controlled, using independent and central review of the video-taped endoscopies with the primary endpoint of clinical remission according to the Modified Mayo Score assessed at week 8 (induction) and at the end of the 44-week maintenance trial (total 52 weeks), as recommended by the FDA. The Modified Mayo Score evaluates UC disease activity, based on three parameters: stool frequency, rectal bleeding and endoscopic evaluation. Each parameter of the score ranges from zero (normal or inactive disease) to three (severe activity). The patient rates stool frequency score (“SFS”) and rectal bleeding score (“RBS”) daily. The endoscopy subscore is evaluated by a central reader (who is blinded to any clinical information about the patient) from an endoscopy that is performed at the trial site. The inclusion criteria based on FDA guidance for moderately to severely active UC is active disease defined by a Modified Mayo Score ≥ 5 with (RBS) ≥ 1 and endoscopy subscore of 2 or 3 (confirmed by central reader). The primary endpoint for induction and maintenance is clinical remission defined as SFS of 0 or 1 and not greater than baseline and RBS = 0 and endoscopy subscore of 0 or 1. At week 8, secondary endpoints include endoscopic improvement, clinical response, symptomatic remission and histologic- endoscopic mucosal improvement (“HEMI”). At week 44 of the maintenance trial, secondary endpoints include endoscopic improvement, symptomatic remission, corticosteroid-free clinical remission, sustained clinical 65 remission, HEMI and endoscopic remission. After week 44, a long-term extension trial will follow for eligible and willing subjects for an additional for up to 4 years, or until the commercialization of obefazimod, whichever occurs first. Enrollment of the first patient under this program in the United States occurred on October 11, 2022. Top-line data from the ABTECT-1 and ABTECT-2 induction trials were announced in July 2025, and top-line data from the ABTECT maintenance trial is expected to be announced in late second quarter of 2026. Additional Clinical Trials Completed with Obefazimod In addition, three Phase 1 clinical trials have been completed in 2025 to assess the tolerability and safety profile of obefazimod: (i) two drug-drug interaction trials, for the purposes of providing further information on any possible interactions of obefazimod with other drugs, for which we enrolled 24 and 36 healthy volunteers respectively; and (ii) a trial in participants with mild and moderate hepatic impairment compared to matched control normal liver function participants, for the purposes of assessing pharmacokinetics, safety and tolerability in this population, for which we enrolled 30 participants. The results of these Phase 1 clinical trials provide supportive data for our further clinical development and New Drug Application (“NDA”) submission. Furthermore, additional Phase 1 clinical trials to support NDA submission are ongoing. While we have decided not to pursue additional clinical work in rheumatoid arthritis ("RA") at this point, we have completed a Phase 2a clinical trial in patients with RA, where we saw encouraging proof-of-concept data supporting obefazimod’s potential role in addressing inflammatory conditions beyond IBD. Potential Combination Therapy for the Treatment of IBD with Obefazimod as the Cornerstone Despite the development of various advanced targeted therapies for IBD over the past 20 years, a single agent with transformational efficacy remains elusive. Although cross-trial efficacy comparisons must be interpreted with caution, induction of clinical remission rates have currently reached a placebo-adjusted therapeutic ceiling up to 30%. Improved efficacy of combination therapy with thiopurines and TNF-alpha inhibitors has been well described (SONIC and UC-SUCCESS) but did not breach the aforementioned efficacy ceiling. Emerging data utilizing dual advanced targeted therapy affecting complementary mechanisms of action indicate a potential path to higher efficacy rates. The first trial utilizing this strategy (VEGA) randomized patients to three parallel treatment groups: (1) dual combination therapy with guselkumab (IL-23 inhibitor) plus golimumab (TNF-alpha inhibitor); (2) guselkumab alone; or (3) golimumab alone. At the end of the 12-week induction period, a greater proportion of patients randomized to dual combination therapy achieved clinical remission (approximately 47%) compared to either monotherapy treatment arms (guselkumab at approximately 25%; golimumab at approximately 24%). Importantly, adverse events, serious adverse events and infection rates were comparable among treatment groups. J&J has progressed these findings and initiated a fixed-dose combination phase 2 clinical trial of guselkumab plus golimumab (JNJ-4804) in UC/CD. We believe synergistic improvements that may be achieved with advanced combination therapy should be balanced with patient adherence to multiple biologic injections and safety considerations associated with immune suppression. Several of obefazimod’s attributes make it a potentially attractive candidate to pair with other advanced treatments. First, the oral route of administration is preferred by a majority of patients, potentially resulting in higher levels of medication adherence. Further, obefazimod’s proposed mechanism of action harnesses the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. The novel mechanism of action of obefazimod potentially lends itself as complementary to other oral or injectable agents with the potential of improving the induction and remission efficacy over monotherapy. We believe the current clinical results we have observed with obefazimod including a lack of safety signals up to 96 weeks of treatment support development as an agent to be used in potential combination therapy. We have initiated a formal process evaluating oral and injectable combination therapy candidate with obefazimod in UC. In September 2024, we announced results of initial preclinical combination data of obefazimod combined with etrasimod in a mouse model of IBD. The results showed that treatment with the combination improved the response on body weight protection and Disease Activity Index with a synergistic and statistically significant reduction of several cytokines (TNFa, IL-17, IL-6, IFNg) in the blood compared to each drug alone. Additional preclinical data to support our decision-making on a combination agent is expected by the end of 2026. Follow-On Compounds Program Based on the mechanistic concept of obefazimod, a research and development program is currently ongoing to generate new potential drug candidates to strengthen our intellectual property portfolio on the miR-124 platform. The first follow-on drug candidate is expected to be selected in 2026. 66 Additional Ongoing Pre-Clinical Research A major complication of chronic inflammation in IBD is fibrosis, particularly in CD. To date, no efficacious anti-fibrotic treatment for IBD patients is available. As miR-124 is reduced in fibrotic tissue and can suppress TGF- β, a central driver of fibrogenesis, we assessed whether obefazimod-mediated miR-124 induction affects collagen deposition and fibrotic markers in preclinical models. Two sets of experiments were performed to assess the anti-fibrotic effects of obefazimod: (1) in vitro fibrosis was evaluated in the Scar-in-a-Jar ("SiaJ") model using human small-intestinal fibroblasts, stimulated with an IBD- fibrotic cytokine cocktail ("IBD-FC"). Nintedanib, omipalisib and upadacitinib were used as comparators. Readouts included cytotoxicity, PRO-C3, and α-SMA; and (2) in vivo effects were assessed in the chronic TNBS-colitis mouse model, where obefazimod (100 mg/kg) or control (vehicle or thalidomide) were administered orally either from day 5 (anti-inflammatory + fibrosis-preventive effect) or from day 20 (early-onset anti-fibrotic effect). Disease activity, body weight, colon parameters, histology and collagen deposition were analyzed. Our results were as follows: in vitro, obefazimod induced a statistically significant 50% reduction in PRO-C3 at day 12, compared with the IBD-FC condition and upadacitinib (live-cell–adjusted, p<0.0001 vs. IBD-FC). Notably, the IBD-FC SiaJ assay showed pathway specificity: nintedanib showed no activity, while omipalisib did (as shown below). Additionally, cell-number–adjusted analysis showed significant α-SMA reduction by obefazimod indicating a strong inhibition of fibroblast activation (p< 0.0001 vs. IBD-FC, as shown below). In vivo, the known anti-inflammatory effects of obefazimod were confirmed in the chronic colitis model under both dosing schedules. Moreover, results from this initial experiment showed a reduction in the fibrosis score and collagen deposition was reduced by approximately 52% with day 5 dosing and approximately 42% with day 20 dosing in the Sirius Red assay, whereas thalidomide as a positive control achieved approximately 24%. These data support an anti-fibrotic effect of obefazimod in two well-established models, inhibiting collagen deposition and fibroblast activation. Initial in vivo mouse data, aligned with the in vitro findings, indicate that obefazimod may act in a unique way on both intestinal inflammation and fibrosis. We believe these promising results provide a strong rationale to further investigate obefazimod’s anti-fibrotic potential in our ongoing Phase 2b CD trial. These results below were presented at ECCO 2026. 67 Notes: Obefazimod treatment initiated on either day 5 (anti-inflammatory + fibrosis-preventive effect) or from day 20 (early-onset anti-fibrotic effect); ***p<0.001, ****p<0.0001 one-way ANOVA with Tukey’s multiple comparisons test Manufacturing and Supply Obefazimod Our lead compound, obefazimod, is manufactured using commercially available, widely used raw materials and common chemical engineering and synthetic processes. The historical volatility in the prices of these raw materials has not had a material impact on our operating results. Obefazimod is formulated as an oral solid capsule. We have successfully scaled-up active pharmaceutical ingredients and drug product processes, and we have a large supply of active pharmaceutical ingredients and capsules available for clinical trials. We outsource all manufacturing operations and rely on European and North American third-party CMOs to supply clinical trials and finalize the development of obefazimod. These operations are designed to be in compliance with the standards imposed by Good Manufacturing Practice (“GMP”). We believe our outsourcing strategy and internal organization allow us to focus our resources on the development of different drug candidates and the management of third parties, without investing in expensive manufacturing facilities and equipment. All third parties are assessed under our quality system and agreements are in place to compel compliance and we maintain agreements with manufacturers which include confidentiality and intellectual property provisions to protect proprietary rights. We are in the process of further optimizing and scaling up our supply chain for obefazimod to ensure capacity for our expected commercial supply, if the FDA or foreign regulatory authority approved. In addition, we are in process of establishing a second source manufacturer for obefazimod to ensure continuity of product supply. Competition We compete with companies that have drugs on the market or are developing drug candidates for chronic IBD. The biotechnology and pharmaceutical industries are highly competitive and subject to significant and rapid technological change, as researchers learn more about chronic IBD and develop new technologies and treatments. Significant competitive factors in our industry include: (i) product efficacy and safety; (ii) quality and breadth of an organization’s technology; (iii) skill of an organization’s employees and its ability to recruit and retain key employees; (iv) timing and scope of regulatory approvals; (v) government reimbursement rates for, and the average selling price of, pharmaceutical products; (vi) the availability of raw materials and qualified manufacturing capacity; (vii) manufacturing costs; intellectual property and patent rights and their protection; and (viii) sales and marketing capabilities. Our competitors in the chronic inflammatory disease field are primarily large pharmaceuticals companies including, but not limited to, AbbVie, Johnson & Johnson, Takeda, Pfizer and Eli Lilly. Merck, Roche, and Teva/Sanofi are all potential future competitors based on recent acquisitions of TL1A molecules. Several lines of research are being developed to improve the treatment of IBD. Many companies are working to develop new, more effective and better tolerated treatments with more practical formulations, especially small molecules administered orally, better accepted than monoclonal antibodies that require administration by injection or intravenous infusions. 68 The molecules on the market and in development have various mechanisms of action and are primarily: (i) TNF-alpha inhibitors; (ii) IL-12/23 inhibitors; (iii) anti-integrin antibodies; (iv) IL-23 inhibitors; (v) JAK inhibitors; (vi) S1P receptor agonists; or (vii) TL1A inhibitors. In the TNF-alpha treatment class, Remicade® (Janssen) was first approved by the FDA in 1998. In 2012, the European Commission approved AbbVie’s Humira® for the treatment of pediatric patients aged six to 17 years with severe active CD who have an inadequate response, are intolerant or have contraindications to conventional therapy. IL-12/23 inhibitors entered the UC market in 2019 as ustekinumab (Johnson & Johnson’s Stelara®). In 2021, AbbVie filed an authorization application with FDA and EMA for risankizumab (Anti-IL-23—Skyrizi®) for the treatment of moderately to severely active CD and in 2024 it was approved for UC. The anti-integrin class is currently represented by vedolizumab/Entyvio® and natalizumab/Tysabri®. We are also aware of Morphic Therapeutic’s MORF-057 and Protagonist Therapeutics/Johnson & Johnson’s PN-943 currently in development. The anti-integrin drugs work by preventing the leukocytes to move from the blood vessels to sites of inflammation. They block the action of integrin on the surface of circulating immune cells and endothelial cell adhesion molecules, thereby inhibiting the interactions between leukocytes and intestinal blood vessels. Natalizumab and vedolizumab block alpha4-integrin and alpha4beta7-integrin respectively. These drugs are injectable (Humanized mAb). In 2021, Eli Lilly reported that mirikizumab (Anti-IL-23) generated data in a Phase 3 maintenance trial in patients with UC that led to European Commission and FDA approvals for UC. Regulatory filings have also been submitted for CD. All these drugs are injectable (Humanized mAb). Abbvie received FDA approval in moderately to severely active UC for Skyrizi in June 2024 and J&J received FDA approval for Tremfya in September 2024. IL-23 is a regulator of T-helper (Th)-17 cell. IL-23 prevents regulatory T-cell response in the intestine, and therefore increases inflammation in the gut. Anti-interleukins targeting the IL-23 have been shown to be effective for induction and maintenance of remission in patients with moderate-severe UC. The JAK correspond to four intracellular tyrosine kinases: JAK1, JAK2, JAK3 and tyrosine kinase 2. Inhibition of the JAK-STAT signal channel makes it possible to block the production of pro-inflammatory cytokines, including TNF-alpha, to block other pathways of inflammation and to regulate innate and adaptive immunity. Thus, several cytokines and several inflammation pathways are blocked simultaneously, unlike TNF- alpha inhibitors, which only have a single target. In September 2021, FDA published a black box warning, requiring pharmaceutical companies to provide a warning for increased risk of serious cardiac events, cancer, blood clots and death linked to JAK inhibitor treatments used for the treatment of certain IBD, including UC. Consequently, these treatments are only accessible to patients who do not respond to any other available treatment and who have certain well-defined conditions. In the JAK inhibitor class, to our knowledge the following products are authorized or in advanced development: •Pfizer’s tofacitinib (Xeljanz®) is a non-selective JAK inhibitor. It obtained marketing approval in UC in June 2018. In September 2021, the FDA concluded that there was a high risk of serious side effects following a randomized clinical trial conducted to assess the safety of tofacitinib. Consequently, the molecule will be used as a third line treatment in patients who meet specific criteria. •Gilead and Galapagos’ filgotinib (Jyseleca®) is a selective JAK1 inhibitor. Since November 2021, filgotinib has been approved for the treatment of UC in the European Union (the “EU”). Authorization requests have also been submitted to the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) and the Japanese PMDA for the treatment of moderately to severely active UC. In January 2024, Alfasigma acquired the rights to filgotinib from Galapagos. •AbbVie’s upadacitinib (Rinvoq®), which is also a selective JAK1 inhibitor, was approved by the FDA in March 2022 for the treatment of moderately to severely active UC. European Commission authorization for the treatment of moderately to severely active UC was granted in July 2022. Rinvoq was then approved in moderately to severely active CD in 2023. S1P receptor agonists allow sequestration of activated lymphocytes in lymph nodes and thus reduce their circulation in the GI tract. Ozanimod (Zeposia®) is a S1P receptor modulator that is selective for the S1P1 and S1P5 receptors. It was approved by the FDA and European Commission for the treatment of moderately to severely active UC in 2021. In March 2024, BMS announced that ozanimod failed their first Phase 3 induction clinical trial for CD. In October 2023, Pfizer announced approval of Velsipity for moderately to severely active UC. Phase 2/3 CD Velsipity clinical trials are underway. In addition, in October 2023, Ventyx Biosciences announced results from its Phase 2 clinical trial of VTX002 in UC. However, further development is contingent on finding a strategic partner to advance VTX002 to Phase 3 clinical trials. We are also aware of other types of treatments currently under various stages of development, such as NImmune Biopharma’s omilancor (a Lanthionine Synthetase C-Like 2 activator) as well as tyrosine kinase 2 inhibitors from Bristol Myers Squibb’s Sotyktu (deucravacitinib – approved in the EU) and Ventyx Biosciences’ VTX 958. 69 Furthermore, TL1A inhibitors have garnered interest from those seeking newer targets and agents with differentiated clinical profile. Merck-Prometheus and Pfizer-Roivant have generated promising early Phase 2 data in both biologics-experienced and biologics-naïve patients, and have recently initiated Phase 3 clinical trials. Market acceptance of our drug candidates will depend on a number of factors, including: (i) potential advantages over existing or alternative therapies or tests; (ii) the actual or perceived safety of similar classes of products; (iii) the effectiveness of our sales, marketing, and distribution capabilities; and (iv) the scope of any approval provided by the FDA or foreign regulatory authorities. We anticipate that we will face intense and increasing competition as new drugs and therapies enter the market and advanced technologies become available. Government Regulation Companies operating in the pharmaceutical industry are subject to increased scrutiny by the competent authorities and must deal with an ever-changing and increasingly restrictive legal and regulatory environment. The development of drugs involves several stages: research and development, preclinical tests, clinical trials, authorization, manufacturing, commercialization and post-marketing surveillance. All of these stages are subject to specific requirements that impose substantial and onerous constraints, compliance with which is ensured by various national (in France, the ANSM), regional (in the EU, the EMA and the national competent authorities of EU Member States) or federal (in the United States, the FDA) authorities. Failure to comply with these regulations may be subject to fines, to the suspension, variation or withdrawal of the authorizations and certifications required to perform pharmaceutical activities, to the seizure or withdrawal of products from the market, or to partial or total suspension of their manufacturing. Regulatory authorities may also withdraw marketing authorizations (“MAs”) previously granted, reject MA applications (“MAAs”) and initiate legal proceedings whose outcome remains uncertain. Although the regulatory constraints may differ from a country to another, development of therapeutic products for human use must comply with requirements shared by all developed countries. The steps to be completed before obtaining an MA in the EU and in the United States are generally as follows: •conduct of preclinical laboratory tests and studies in animals, in accordance with Good Laboratory Practice (“GLP”); •conduct of clinical trials in humans to demonstrate the safety and efficacy of the product for each considered indication, in accordance with Good Clinical Practice (“GCP”), after authorization by a competent authority and a positive ethics committee opinion; •if trial results are positive, preparation and submission of an MAA to the competent authority, in order to market the product; •inspection by the competent authority of the manufacturing facilities in which the product and/or its ingredients are manufactured to assess compliance with Good Manufacturing Practices (“GMP”); •inspection by the competent authority of establishments distributing medicinal products in order to assess their compliance with Good Distribution Practice (“GDP”); and •if needed, commitment by the applicant to comply with post-MA requirements. Due to these regulatory constraints, the development and approval process of a drug candidate for commercialization, which varies according to its nature, complexity and novelty, usually extends over several years. EU Regulation Preclinical Studies Within all EU Member States, preclinical studies include laboratory evaluation of the composition, purity and stability of the active pharmaceutical ingredient and the formulated product, as well as studies to evaluate the tolerance (toxicological studies), activity and behavior of the product candidate in vitro and in animals (in vivo). The conduct of preclinical studies is subject to legal and regulatory provisions. Non-clinical studies are performed to demonstrate the health or environmental safety of new chemical or biological substances. Non-clinical (pharmaco-toxicological) studies must be conducted in compliance with GLP, as set forth in EU Directive 2004/10/ EC (unless otherwise justified for certain particular medicinal products – e.g., radio-pharmaceutical precursors for radio-labelling purposes). In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which define a set of rules and 70 criteria for a quality system for the organizational process and the conditions for non-clinical studies. These GLP standards reflect the Organization for Economic Co-operation and Development requirements. Preclinical studies are a prerequisite for the initiation of clinical trials in humans: all the results of these trials are submitted to the regulatory authorities at the same time as the application to initiate clinical trials. However, while preclinical tests must be performed prior to conducting clinical trials in humans, certain long-term preclinical tests, such as tests on reproductive toxicity and carcinogenicity, may continue after the submission of an application to initiate clinical trials. Clinical Trials in Humans The various phases of clinical trials in the EU are subject to significant regulatory controls. They must be conducted in accordance with EU and national regulations, the standards adopted by the International Conference on Harmonization (“ICH”) and GCP. Directive no. 2001/20/EC on the conduct of clinical trials sought to harmonize the regulatory framework for clinical trials in the EU, setting out common rules for the monitoring and authorization of clinical trials in the EU. To reduce disparities between the transpositions by the Member States, Regulation 536/2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20/EC, was adopted on April 16, 2014. This regulation aims to further harmonize and streamline the clinical trial authorization process, improve their supervision, simplify adverse event reporting procedures and increase the transparency of clinical trials. This regulation became applicable on January 31, 2022. Following a three-year transition period, all clinical trials (including those ongoing and whose conduct was authorized in accordance with Directive no. 2001/20/EC), are fully subject to the provisions of the Regulation 536/2014 since January 31, 2025 and must have been brought into compliance with the legal framework it provides. Failing this, the trial loses its authorization and must be stopped. Under the clinical trials regulation, the sponsor may submit its application for a clinical trial authorization to one or several Member States, in which case the evaluation of Part I of the dossier (scientific part) is carried out according to a coordinated procedure. In this framework, the sponsor must submit a single application for authorization via the portal associated with the EU database (“CTIS”), comprising a common scientific part evaluated jointly by all the EU Member States in which the trial will be carried out (with one of the Member States concerned acting as rapporteur Member State) and a national part covering the ethical aspects of the trial, evaluated independently by each Member State. The conclusion of the rapporteur Member State with regard to Part I of the assessment report is deemed to be the conclusion of all Member States concerned. However, the Member States concerned may disagree with this conclusion for a number of limited reasons, for example when they consider that participation in the clinical trial would lead to a subject receiving a treatment inferior to that of normal clinical practice on their territory. The Member State concerned may then refuse the conduct of the clinical trial on its territory. A “single” decision covering the conclusions of the Part I and Part II evaluations is issued by each of the Member States concerned and is notified to the sponsor on the dedicated European portal. The sponsor of a clinical trial conducted in the EU notifies through the EudraVigilance database without delay and at the latest within the deadlines set by the clinical trials regulation, of all relevant information on suspected serious and unexpected adverse reactions to the investigational medicinal product. If the competent bodies concerned consider that the adverse effects outweigh the benefits for the participants, they may require the immediate suspension or early termination of the trial at any time. In addition, the sponsor must submit through CTIS once a year, for the duration of the clinical trial, an Annual Safety Report (ASR) for each investigational drug used in the clinical trial. Finally, the EU framework applicable to clinical trials has also been significantly strengthened with Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016, on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation, “GDPR”), which entered into force on May 25, 2018. This regulation has significantly increased EU citizens’ rights by giving them more control over their personal data. Thus, depending on the type of personal data processing carried out during clinical trials and the nature of such trials, it might be necessary to carry out formalities by the local Data Protection Authority, in addition to seeking formal informed consent which must be obtained from each clinical trial subject. Responsibility of the Sponsor and Insurance Obligation of the Sponsor In the EU, the sponsor shall indemnify the subjects of the trial in case of damage arising as a consequence of their participation in the research, unless he proves that the damage does not result from his fault or the fault of any other person intervening in the trial. In the EU, Member States generally require a sponsor to have an insurance 71 covering its civil liability and the liability of any person intervening in the research. In addition, any breach to the provisions concerning clinical trials may lead to significant administrative, criminal and/or reputational penalties. Marketing Approval Within the EU, marketing of medicinal products is governed by EU regulations (including but not limited to Directive 2001/83/EC and Regulation 726/2004/EU). On April 26, 2023, the European Commission issued proposals for a revision of the current legal framework aiming at granting timely access to patients for safe, effective and affordable medicines and at enhancing supply of medicines (namely, the pharma package). On December 11, 2025, the European Parliament and the EU Council reached political agreement on the reform. The new legal framework, which will significantly amend some of the general principles described above, notably timelines and market exclusivity periods, will enter into force in 2026 and will become fully applicable in 2028 after a transition phase. In the EU, medicinal product candidates can only be commercialized after obtaining an MA. To obtain regulatory approval of a product candidate under EU regulatory systems, we must submit an MAA. The process for doing this depends, among other things, on the nature of the medicinal product. There are two types of MAs: •“Centralized MAs” are granted by the European Commission through the centralized procedure based on the opinion of the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA. The MA issued under this procedure is valid in all EU Member States. •The centralized procedure is compulsory for some types of medicinal products such as biotechnology products, designated orphan medicinal products, products containing a new active substance indicated for the treatment of AIDS, cancer, neurodegenerative disorders, diabetes or autoimmune and viral diseases, advanced therapy medicinal products (such as gene therapy, somatic cell therapy and tissue engineered products). The centralized procedure is optional for products containing a new active substance that has not yet been authorized in the EU or for products which present a significant therapeutic, scientific or technical innovation or are of interest for the public health in the EU. •“National MAs” are issued at a national level by the competent authorities of the concerned Member States. They are valid only on their territory. National MAs can be issued for products that do not fall within the mandatory scope of the centralized procedure. Medicinal products which have not received a national MA in any of the Member States, may be authorized through the decentralized procedure. This procedure enables the simultaneous issuance of national MAs in several EU countries. Under the decentralized procedure, an identical dossier is submitted to the competent authorities of each of the Member States in which an MA is sought. One of these Member States is designated by the applicant to act as the Reference Member State (“RMS”). The competent authority of the RMS drafts an assessment report and prepares an SmPC, a package leaflet and a draft labelling, which are sent to the other Member States involved in the procedure, known as the Concerned Member States (“CMS”), for approval. If no CMS raises any objections based on a potential serious risk to public health, a national MA is granted for the product in all Member States involved in the procedure (i.e., in the RMS and the CMS). Where a product has already been authorized for marketing in an EU Member State, this national MA can be recognized in another Member State through the mutual recognition procedure. In this procedure, the Member State which issued the initial MA, known as the RMS, must prepare an assessment report on the medicinal product or update any existing report. This report is sent to the CMS, together with the approved SmPC and the labelling and package leaflet. Unless an objection based on a potential serious risk to public health is raised, the CMS issue(s) a national MA for the product, the terms of which are identical to the MA granted by the RMS. Depending on the procedure used, the EMA or the national competent authority(ies) must, before granting a MA, make an assessment of the benefit/risk ratio of the product based on scientific criteria of quality, safety of use and efficacy. Under the centralized procedure the maximum timeframe for the evaluation of an MAA by the EMA is 210 days, excluding clock stops. In exceptional cases, the CHMP might perform an accelerated review of an MAA in no more than 150 days (not including clock stops). Innovative products that target an unmet medical need and are likely to be of major public health interest may be eligible for a number of expedited development and review programs, such as the Priority Medicines (“PRIME”) scheme, which provides incentives similar to the breakthrough therapy designation in the U.S. This program was launched by the EMA in March 2016, and aims at enhancing the EMA’s support for the development of medicines that target unmet medical needs. It is based on increased interaction through early dialogue with companies developing promising medicines, to optimize their development plans and speed up their evaluation to help them reach patients earlier. More specifically, product developers that benefit from PRIME access can benefit from early and proactive regulatory dialogue with the EMA and frequent discussions on clinical trial designs and other development program elements. Importantly, a dedicated contact and 72 rapporteur from the CHMP is appointed early in the PRIME scheme facilitating increased understanding of the product at EMA’s committee level. A team of multidisciplinary experts at the EMA is also composed to provide guidance on the overall development and regulatory strategies. Thus, PRIME access is intended at speeding up the assessment process of MAAs, without guarantee as to the outcome of the process. Moreover, in the EU, a conditional MA may be granted by the European Commission for a period of one year and is renewable annually. A conditional MA is granted in the absence of sufficient clinical data to obtain an ordinary MA if the following requirements are met: (i) the medicinal product is intended to treat, prevent or diagnose a fatal or seriously debilitating disease, (ii) it fulfils to an unmet medical need, (iii) its benefit/risk ratio is, on the basis of the available data, positive, (iv) it is likely that the applicant will be able to provide the required comprehensive post-MA clinical data and (v) in terms of public health, the benefits of the product’s immediate availability to patients outweigh the risks inherent to the lack of sufficient clinical data. The granting of a conditional MA is accompanied by specific obligations, in particular relating to the completion of clinical trials, the performance of new studies and the collection of pharmacovigilance data in order to confirm the benefit/risk ratio of the product. Once the pending studies are provided, it can become an unconditional MA. MAs may also be granted under exceptional circumstances to medicinal products for which a complete evaluation file cannot be provided when the product’s indication is too rarely encountered and prevents the provision of comprehensive evidence, when the current state of scientific knowledge prevents the provision of such data or when the collection of the necessary data would be unethical. This MA is close to the conditional MA as it is reserved to medicinal products to be approved for severe diseases or unmet medical needs and the applicant does not hold the complete data set legally required for the grant of an ordinary MA. However, unlike the conditional MA, the applicant will not have to provide the missing data later. However, although the MA “under exceptional circumstances” is granted for the standard validity period of 5-year, the risk-benefit balance of the medicinal product is reviewed annually and the MA is withdrawn in case the risk-benefit ratio is no longer favorable. Despite the granting of a MA, both the MA holder and the competent authorities may decide at any time to withdraw (voluntarily or compulsorily) a product from the market or a MA, when it appears that the product presents more risks than benefits for the patients. Data and Marketing Exclusivity In the EU, new products authorized for marketing on the basis of a complete file (i.e., reference products) generally receive eight years of data exclusivity and an additional two years of market exclusivity upon granting of the MA. The data exclusivity period prevents generic and biosimilar applicants from relying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar MA in the EU during a period of eight years from the date on which the reference product was first authorized in the EU. The market exclusivity period prevents generic or biosimilar from being commercialized in the EU until ten years have elapsed from the first MA of the reference product in the EU. The ten-year market exclusivity period can be extended to a maximum of eleven years if, during the first eight years of those ten years, the MA holder obtains an authorization for one or more new therapeutic indications, which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. The pharma package will amend these principles: data exclusivity period will be granted for eight years, and may be extended for one additional year when the product addressed an unmet medical need at the time of the MA or, under specific circumstances, for medicinal products containing new actives substances, and for another additional one year when the MAH obtains a MA for one or more new therapeutic indications, during the regulatory data protection, which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. In addition, the market exclusivity duration will be reduced as a principle to one year after the expiry of the data exclusivity period, and it can also be reduced if the company does not launch the product in all countries which so request. Pediatric Development In the EU, MAAs for new medicinal products must include the results of studies conducted in the pediatric population, in compliance with a Pediatric Investigation Plan (“PIP”) agreed with the EMA’s Pediatric Committee (“PDCO”). The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the medicinal product for which MA is being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO when these data is not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant therapeutic benefit over existing treatments for pediatric patients. Once the MA is obtained in 73 all the EU member states and study results are included in the product information, even when negative, the product is eligible for six months’ supplementary protection certificate extension (if any is in effect at the time of approval) or, in the case of orphan pharmaceutical products, a two-year extension of the orphan market exclusivity is granted. The pharma package removes the possibility to obtain a two-year extension of orphan market exclusivity for conducting research in compliance with a PIP. Manufacturing and Distribution-related Requirements To ensure patients’ safety, the manufacturing, distribution and import of active pharmaceutical ingredients and finished products into the EU are also subject to extensive requirements and both MA holders, manufacturers and distributors of medicinal products are subject to comprehensive regulatory oversight by the EMA, the European Commission and/or the competent regulatory authorities of the Member States. Medicines (including their active substances) must be manufactured in accordance with GMP requirements. These regulations govern manufacturing processes and procedures, and notably provide for requirements relating to the implementation of quality systems to control and ensure the quality of materials and products. Manufacturing activities must be performed only within companies holding valid licenses from the competent regulatory authorities of the Member States which is issued following an inspection of the concerned facilities. In addition, routine inspections are conducted on a regularly basis to ensure that compliance is maintained. Distributors must also comply with very strict requirements, including good distribution practices (“GDP”). These regulations provide for strict requirements including the implementation of an effective quality system and adequate procedures to ensure the quality of the products all over the distribution chain and efficiently respond to claims, recalls, and risks of falsification, or the use of appropriate facilities, equipment and personnel. Similarly to manufacturing, distribution activities are subject to a prior approval from the competent regulatory authorities of the Member States which is issued following an inspection of the concerned facilities which aims at ensuring that the establishment complies with the applicable regulations. Routine inspections are also conducted on a regularly basis. Finally, the import of active pharmaceutical ingredients and medicines into the EU must also be authorized in advance, in order to ensure that the products are manufactured and distributed in accordance with standards at least equivalent to those existing for the EU market. Failure to comply with the above requirements may be sanctioned by the suspension or withdrawal of the manufacturing/distribution/import authorization, civil, criminal or administrative penalties, or the withdrawal of the concerned active ingredients and finished products from the market. Post-Approval Requirements Pharmacovigilance Requirements The MA holder must establish and maintain a pharmacovigilance system and designate a Qualified Person Responsible for Pharmacovigilance (“QPPV”) who is responsible for the establishment and maintenance of that system, and oversees the safety profiles of medicinal products and any emerging safety concerns. The main obligations of the QPPV include prompt reporting of suspected serious adverse reactions to competent authorities and submission of periodic pharmacovigilance update reports (“PSURs”). All new MAA must include a risk management plan (“RMP”) describing the risk management system that the company will put in place and setting out measures to prevent or minimize the risks associated with the medicinal product. The regulatory authorities may also issue an MA subject to the fulfillment of specific obligations. These risk reduction measures or post-authorization obligations may consist, in particular, of reinforced safety monitoring, more frequent submission of PSURs, the conduct of additional clinical trials or the performance of post- authorization safety studies. The pharma package will limit the RMP requirement for generic and biosimilar products, as well as for hybrid and bio-hybrid medicinal products. Advertising Requirements In the EU, the advertising and promotion of medicinal products is also subject to laws concerning promotion of medicinal products, interactions with healthcare professionals, misleading and comparative advertising and unfair commercial practices. The general principles applicable to the advertising of medicines, which is broadly defined as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products, are established by EU directive. Any advertising or promotion of a medicinal product must comply with its approved SmPC. Consequently, any promotion of off-label promotion is prohibited. Indeed, the advertising must encourage the proper use of medicines by presenting them objectively without exaggeration and thus, must not be misleading. Direct-to- consumer advertising of prescription medicines is also prohibited in the EU. Although general requirements for 74 advertising and promotion of medicinal products are established under EU directives, the details are governed by regulations in each Member State and can differ from one country to another. Depending on the Member States, advertising-related regulatory requirements may be sanctioned notably by the suspension or withdrawal of regulatory authorizations, medicinal products recalls, medicinal products seizures, operating restrictions and even criminal and/or civil prosecution and significant financial sanctions. The aforementioned EU rules are generally applicable in the European Economic Area (“EEA”) which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. Coverage and Reimbursement In the EU, pricing and reimbursement systems widely vary from one country to another and remain exclusively the responsibility of the Member States. Thus, Member States may restrict the range of medicines for which their national health insurance system provides reimbursement and control their price, provided that time limits for review of a reimbursement application provided in Directive 89/105/EEC of 21 December 1988 must be complied with. Some Member States use a system of positive and negative lists, whereby medicines can only be marketed after a reimbursement price has been agreed. Others may require additional studies comparing the cost-effectiveness of a medicinal product to existing therapies in order to obtain approval for reimbursement or pricing. Finally, Member States can agree to a set price or, instead, allow companies to set their own prices while having their profits monitored and controlled (e.g., control of the quantity of prescriptions). Over the last few years, many EU Member States have increased the amount of rebates applied to medicinal products, and these efforts may continue as Member States exercise greater control over their healthcare spending due to often large debts. The downward pressure on healthcare costs in general, including medicinal products subject to mandatory prescription, has become considerable. Changing political, economic and regulatory conditions can complicate price negotiations. This price negotiation can continue after reimbursement has been achieved and is generally subject to periodic reviews. Finally, reference prices used by various EU Member States and parallel trade (i.e., arbitrage by distributors between low and high price Member States) may also lead to further price reductions. On December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment (“HTA Regulation”) amending Directive 2011/24/EU, was adopted. While the HTA Regulation entered into force in January 2022 it has only started to apply from January 12, 2025. Implementation is progressive. To date, it only applies to drugs containing new active substances for the treatment of cancer and advanced therapy drugs. This regulation intends to boost cooperation among EU Member States in assessing health technologies, in order to speed up the availability of innovative products on the EU market. The HTA Regulation permits EU Member States to use common HTA tools, methodologies, and procedures across the EU. It also provides for joint clinical assessment of the innovative health technologies at the EU level, joint scientific consultations whereby developers can seek advice from HTA authorities, and identification of emerging health technologies to identify promising technologies early. Nonetheless, individual EU Member States continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement, provided they take into consideration the joint clinical assessment conducted at the EU level. Other Healthcare Laws Relationships between the pharmaceutical industry and healthcare professionals are subject to national restrictions and regulations in order to avoid any incentive to use or prescribe health products that is not exclusively justified by the patient’s state of health and profile. For example, in France, relations between the industry and healthcare professionals practicing in France are governed by the “anti-gift” and “transparency” laws. By way of principle, under the French anti-gift law, persons providing health services, manufacturing or marketing healthcare products, regardless of their nationality and of the effective marketing of their health products on the French market, are prohibited from promising or offering advantages of any kind whatsoever, in cash or in kind, either directly or indirectly, to healthcare professionals practicing in France, students intending to enter such professions or associations of these individuals, including learned societies and national professional councils. The list of benefits that do that do not qualify as “advantages” under the anti-kickback regulation is very limited and includes, for example, benefits that relate to the exercise of the beneficiary’s profession and of negligible value, which may not exceed the amounts provided for by a Ministerial Order. By way of exception, above-mentioned health stakeholders may provide advantages to the healthcare professionals/associations mentioned above, subject to the conclusion of a written agreement and to a prior 75 declaration to or approval from the authority or board to which the concerned beneficiary belongs, depending on the amount of advantages granted. This exception is however limited to specific situations mainly including: •The remuneration, compensation and expenses for research activities, research promotion, scientific evaluation, consultancy, provision of services or commercial promotion, provided that the remuneration is proportionate to the service provided and that the compensation or expenses do not exceed the costs actually incurred by the persons concerned; •Donations and gifts, in cash or in kind, exclusively intended to finance research activities, the promotion of research or scientific evaluation; or •Hospitality offered during events of an exclusively professional or scientific nature, or during events promoting healthcare products or services, provided that this hospitality is of a reasonable level, strictly limited to the main purpose of the event and to healthcare professionals (excluding students); When failing to comply with this regulation, in addition to a significant risk to their reputation, the companies and professionals concerned may be subject to significant criminal penalties and, in the case of the latter, disciplinary penalties. The French transparency provision, for its part, provides citizens with access to certain information on a website so that they can more objectively assess the direct and indirect relationships between health actors (i.e., a broad list including healthcare professionals, associations of healthcare professionals, students, associations of users of the health system, health establishments, academic institutions, foundations, learned societies and societies or advisory bodies involved in the health product or health services sector, etc.) and companies producing or marketing health products or providing services associated with these products. Under the terms of this regulation, the companies concerned must disclose the main information relating to their relationships with healthcare professionals, such as compensation or benefits paid, and agreements entered into. Companies that knowingly fails to disclose such information may be subject to criminal penalties. UK Regulation Since the end of the Brexit transition period on January 1, 2021, Great Britain (“GB”) (England, Scotland and Wales) has not been directly subject to EU laws. However, under the terms of the Ireland/Northern Ireland Protocol, EU laws have generally applied to Northern Ireland. On February 27, 2023, the UK government and the European Commission reached a political agreement on the so-called “Windsor Framework” which is intended to revise the Ireland/Northern Ireland Protocol in order to address some of the perceived shortcomings in its operation. The agreement was adopted at the Withdrawal Agreement Joint Committee on March 24, 2023. If the changes are adopted in the form proposed, medicinal products to be placed on the market in the UK will be authorized solely in accordance with UK laws. Northern Ireland would be reintegrated back into a UK-only regulatory environment under the authority of the MHRA with respect to all medicinal products. The implementation of the Windsor Framework would occur in various stages, with new arrangements relating to the supply of medicines into Northern Ireland anticipated to take effect in 2025. The EU laws that have been transposed into United Kingdom (“UK”) law through secondary legislation remain applicable in Great Britain. However, new EU legislation that was either adopted or entered into application after Brexit such as the EU CTR is not applicable in Great Britain. The UK regulatory framework in relation to clinical trials is derived from previously existing EU legislation (as implemented into UK law, through secondary legislation). On January 17, 2022, the UK MHRA launched an 8-week consultation on reframing the UK legislation for clinical trials. The consultation closed on March 14, 2022, and aims to streamline clinical trial approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality and promote patient and public involvement in clinical trials. The outcome of the consultation is being closely watched and will determine whether the UK chooses to align with the (EU) CTR or diverge from it. Under the terms of the Ireland/Northern Ireland Protocol, provisions of the EU CTR which relate to the manufacture and import of investigational medicinal products and auxiliary medicinal products currently apply in Northern Ireland. Since January 1, 2021, the MHRA has been the sole regulatory of medicines and medical devices in GB and for medicinal products that are not authorized through the centralized procedure in Northern Ireland. The MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will benefit patients, including a 150-day assessment and a rolling review procedure. All existing EU MAs for centrally authorized products were automatically converted or grandfathered into UK MAs, effective in GB (only), free of charge on January 1, 2021, unless the MA holder opted-out. In order to use the centralized procedure to obtain an MA that will be valid throughout the EEA, companies must be established in the EEA. Therefore, since Brexit, companies established in the UK can no longer use the EU centralized procedure for authorization of medicinal products intended to be marketed in the UK. In order to obtain a UK MA to commercialize products in the 76 UK, an applicant must be established in the UK and must follow one of the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures to obtain an MA to commercialize products in the UK. Until December 31, 2023, the MHRA may rely on a decision taken by the European Commission on the approval of a new (centralized procedure) MA when reviewing an application for authorization of a medicinal product to be supplied in GB. Depending on the nature and intended therapeutic purpose of the medicinal product, the MHRA may, alternatively, use its own decentralized or mutual recognition procedures which enable the MHRA to have regard to MAs approved in EU Member States, Iceland, Liechtenstein, and Norway when granting an MA in the UK or GB. From the first quarter of 2024, a new international recognition framework should be in place with an aim to extend the countries whose assessments the MHRA will take into account. The UK government will need to adopt new legislation to introduce this route. There is no pre-MA orphan designation procedure. Applications for orphan designation are made at the same time as an application for MA and the MHRA will review applications for orphan designation in parallel to the corresponding MA application. The criteria are essentially the same, but have been tailored for the market (i.e., the prevalence of the condition in GB, rather than the EU, must not be more than five in 10,000). Should an orphan designation be granted, the period or market exclusivity will be set from the date of first approval of the product in GB. U.S. Government Regulation In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, (“FDCA”) and its implementing regulations. The process of obtaining regulatory approvals and the subsequent compliance with applicable federal, state, and local statutes and regulations requires the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development process, approval process, or after approval, may subject an applicant to a variety of administrative or judicial sanctions, such as the FDA’s refusal to approve pending NDAs, withdrawal of an approval, imposition of a clinical hold on a clinical trial, issuance of warning letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. The process required by the FDA before a drug may be marketed in the United States generally involves the following: •Completion of preclinical laboratory studies, animal studies and formulation studies in compliance with the FDA’s GLP regulations, and other applicable regulations; •Submission to the FDA of an IND which must become effective before human clinical trials may begin; •Approval by the Institutional Review Board (“IRB”) or ethics committee, at each clinical site before each trial may be initiated; •Performance of adequate and well-controlled human clinical trials, in accordance with GCP requirements to establish the safety and effectiveness of the proposed drug product for each indication; •Submission to the FDA of an NDA; •Satisfactory completion of an FDA advisory committee review, if applicable; •Satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice (“cGMP”) requirements and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, and of potential inspection of selected clinical investigation sites to assess compliance with GCPs; and •FDA review and approval of the NDA. Preclinical Studies and INDs Preclinical studies include laboratory evaluation of product chemistry, toxicity and formulation, as well as animal studies to assess potential safety and efficacy. An IND sponsor must submit the results of the preclinical studies, together with manufacturing information, analytical data and any available clinical data or literature, among other things, to the FDA as part of an IND. Some preclinical studies may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. 77 Clinical Trials Clinical trials involve the administration of the investigational drug to human patients under the supervision of qualified investigators in accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, the IRB(s) competent for the institution(s) participating in the clinical trial must review and approve the plan for any clinical trial before it commences. Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination on their www.clinicaltrials.gov website. While the IND is active, progress reports detailing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure. Furthermore, the FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug has been associated with unexpected serious harm to patients. In addition, some clinical trials are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or committee. Depending on its charter, this group may determine whether a trial may move forward at designated check points based on access to certain data from the trial. For purposes of FDA approval, human clinical trials are generally conducted in three sequential phases that may overlap or be combined: •Phase 1: The drug candidate is initially introduced into healthy human subjects and tested for safety, dosage tolerance, absorption, metabolism, distribution and excretion and, if possible, to gain an early indication of its effectiveness. •Phase 2: The drug candidate is administered to a limited patient population with a specified disease or condition to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the drug candidate for specific targeted diseases and to determine dosage tolerance and appropriate dosage. •Phase 3: The drug candidate is administered to an expanded patient population to further evaluate dosage, to provide substantial evidence of efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites. These clinical trials are intended to establish the overall risk-benefit ratio of the drug candidate and provide an adequate basis for product labeling. Post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to, among other things, gain additional experience from the treatment of patients in the intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA. Concurrent with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance with GMPs. The manufacturing process must be capable of consistently producing quality batches of the drug candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final drug. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life. Marketing Approval Assuming successful completion of the required clinical testing, the results of the preclinical studies and clinical trials, together with detailed information relating to the product’s chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA requesting approval to market the product for one or more indications. In most cases, the submission of an NDA is subject to a substantial application user fee. Under the Prescription Drug User Fee Act guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission. This review typically takes twelve months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision. 78 In addition, under the Pediatric Research Equity Act of 2003, as amended and reauthorized, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the pediatric data requirements. The FDA also may require submission of a Risk Evaluation and Mitigation Strategy (“REMS”) plan to ensure that the benefits of the drug outweigh its risks. The REMS plan could include Medication Guides (FDA approved patient labeling to be provided to patients when the drug is dispensed), physician communication plans, assessment plans, or Elements to Assure Safe Use, such as restricted distribution methods, patient registries, or other risk minimization tools. The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing, to determine whether they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the application must be resubmitted with the additional information. The resubmitted application is also subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA reviews an NDA to determine, among other things, whether the drug is safe and effective and whether the facility in which it is manufactured, processed, packaged or held meets standards designed to assure the product’s continued safety, quality and purity. The FDA may refer an application for a novel drug to an Advisory Committee. An Advisory Committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an Advisory Committee, but it considers such recommendations carefully when making decisions. Before approving an NDA, the FDA typically will inspect the facility or facilities where the commercial product would be manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. Additionally, before approving an NDA, the FDA may inspect one or more clinical trial sites to verify the clinical data submitted in the NDA, and to assure compliance with GCP requirements. After evaluating the NDA and all related information, including the Advisory Committee recommendation, if any, and inspection reports regarding the manufacturing facilities and clinical trial sites, the FDA may issue an approval letter, or, in some cases, a Complete Response Letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. A Complete Response Letter indicates that the review cycle of the application is complete, and the application will not be approved in its present form, and describes the specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional clinical trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies or manufacturing. If a CRL is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter, or withdraw the application. Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval. Even if the FDA approves a product, it may limit the approved indications for use of the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies, including Phase 4 clinical trials, be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution and use restrictions or other risk management mechanisms under a REMS, which can materially affect the potential market and profitability of the product. The FDA may at any time prevent or limit further marketing of a product based on the results of post-marketing studies or surveillance programs. After initial approval, some types of changes to the approved product, such as adding new indications, manufacturing changes, and additional labeling claims, are subject to further testing requirements and FDA review and approval. Post-Approval Requirements Drugs manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping, periodic reporting, product sampling and distribution, the submission of advertising and promotion, and reporting of adverse experiences with the product. After approval, most changes to the approved product, such as adding new indications or other labeling claims are subject to prior FDA review and approval. There also are continuing, annual program user fee requirements for any marketed products, as well as new application fees for certain supplemental applications. 79 The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example, the FDA may require post-marketing testing, including Phase 4 clinical trials, and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization. In addition, drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are required to register their establishments with the FDA and state agencies, and are subject to periodic unannounced inspections by the FDA and these state agencies for compliance with cGMP requirements. Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations also require manufacturers to investigate and correct of any deviations from cGMP requirements and impose reporting and documentation requirements upon the sponsor and any third-party manufacturers that the sponsor may decide to use. Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMP compliance. Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Other potential consequences include, among other things: •Restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls; •Fines, warning letters or holds on post-approval clinical trials; •Refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals; •Product seizure or detention, or refusal to permit the import or export of products; or •Injunctions or the imposition of civil or criminal penalties. The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of unapproved uses (“off-label” uses), and a company that is found to have improperly promoted off-label uses may be subject to significant liability. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products. Marketing Exclusivity Market exclusivity provisions under the FDCA can delay the submission or the approval of certain marketing applications. The FDCA provides a five-year period of non-patent data exclusivity within the United States to the first applicant to obtain approval of an NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the FDA may not accept for review an abbreviated new drug application (“ANDA”), or an NDA submitted under Section 505(b)(2) (“505(b)(2) NDA”) submitted by another company for another drug based on the same active moiety, regardless of whether the drug is intended for the same indication as the original innovative drug or for another indication, where the applicant does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after four years if it contains a certification of patent invalidity or non-infringement to one of the patents listed with the FDA by the innovator NDA holder. The FDCA alternatively provides three years of marketing exclusivity for an NDA, or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the modification for which the drug received approval on the basis of the new clinical investigations and does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for drugs containing the active agent for the original indication or condition of use. Five-year and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant 80 submitting a full NDA would be required to conduct, or obtain a right of reference to, all of the preclinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness. Pediatric exclusivity is another type of marketing exclusivity available in the United States. Pediatric exclusivity provides for an additional six months of marketing exclusivity attached to another period of exclusivity if a sponsor conducts clinical trials in children in response to a written request from the FDA. The issuance of a written request does not require the sponsor to undertake the described clinical trials. Coverage and Reimbursement Sales of our drug candidates, if approved, will depend, in part, on the extent to which such products will be covered by third-party payors, such as government health care programs, commercial insurance and managed healthcare organizations. These third-party payors determine which medications they will cover and establish reimbursement levels. In addition, these third-party payors are increasingly limiting coverage or reducing reimbursements for medical products and services. In the United States, no uniform policy of coverage and reimbursement for products exists among third-party payors. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. In addition, the U.S. government and state legislatures have continued implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. For example, the U.S. Department of Health and Human Services (“HHS”) imposes rebates on Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis. HHS has also been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven (7) years under Medicare as part of the Medicare Drug Price Negotiation Program. Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program. Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis. Patients who are prescribed medications for the treatment of their conditions, and their prescribing physicians, generally rely on third-party payors to reimburse all or part of the costs associated with their prescription drugs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover all or a significant portion of the cost of our products. As a result, adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. Decreases in third-party reimbursement for our drug candidates or a decision by a third-party payor to not cover our drug candidates could reduce physician usage of our drug candidates, once approved, and have a material adverse effect on our sales, results of operations and financial condition. Additionally, we or our collaborators may develop companion diagnostic tests for use with our drug candidates. We or our collaborators will be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our drug candidates, once approved. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics. Other Healthcare Laws We will also be subject to other healthcare regulation and enforcement by the U.S. federal government and the states in which we will conduct our business once our drug candidates are approved. Failure to comply with these laws, where applicable, can result in the imposition of significant administrative, civil, and criminal penalties. The laws that may affect our ability to operate in the United States include: •The federal healthcare programs’ Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; •Federal false claims act laws, including the civil False Claims Act, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; •The federal health care fraud statutes, which created additional federal criminal statutes that impose criminal and civil liability for, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters; •The Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies to report annually to the Centers for Medicare & Medicaid Services, information related to payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, as well as and ownership and investment interests held by physicians and their immediate family members; 81 •The U.S. federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which created additional federal criminal statutes that impose criminal and civil liability for, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or knowingly and willingly falsifying, concealing or covering up a material fact or making false statements relating to healthcare matters; and •HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), which governs the conduct of covered entities, business associates, and their covered subcontractors regarding certain electronic healthcare transactions and protects the security and privacy of protected health information. In addition, many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. Further, certain states require certain regulatory licenses to manufacture or distribute products commercially and/or the registration of pharmaceutical sales representatives in the jurisdiction, state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and the reporting of information related to drug pricing. Certain states have also enacted legislation to govern the privacy and security of health information, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. Additionally, to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws. Violation of any of these laws or any other governmental regulations, may result in significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, possible exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, and diminished profits and future earnings. Healthcare Reform The enactment of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the (“ACA”) has substantially changed healthcare financing and delivery by both governmental and private insurers, and significantly impacted the pharmaceutical industry. Since its enactment, there have been judicial and congressional challenges to certain aspects of the ACA. For example, on July 4, 2025, the One Big Beautiful Bill Act, or OBBBA, was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies. Other legislative changes have been proposed and adopted since the ACA was enacted. For example, on August 2, 2011, the Budget Control Act of 2011 was signed into law which among other things, led to aggregate reductions in Medicare payments to providers. These reductions went into effect on April 1, 2013, and, due to subsequent legislative amendments, will remain in effect until 2032 unless additional Congressional action is taken. In addition, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. For example, there have been several U.S. presidential executive orders, congressional inquiries and proposed and enacted legislation at the federal and state designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. The current U.S. presidential administration is pursuing policies to reduce regulations and expenditures across government. These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business. For example, the current administration has announced agreements with pharmaceutical companies that require the drug manufacturers to offer, through a direct- to-consumer platform (TrumpRx), U.S. patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues. Other recent actions and proposals include, for example (1) reducing agency workforce and cut programs; (2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives; (3) imposing tariffs on imported pharmaceutical products; and (4) as part of the Make America Healthy Again Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager 82 payment methodologies, among other things. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks. In June 2024, in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. We expect that additional U.S. healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our drug candidates or additional pricing pressures. Intellectual Property Our success will depend upon our ability to obtain and maintain patents and other intellectual property for our drug candidates in the United States and internationally, including composition-of-matter, pharmaceutical composition, synthesis process, method of manufacture and method of treatment for an obefazimod's intellectual property protection in the United States to 2039, as well as patent and other intellectual property and proprietary protection for our novel discoveries and other important technology inventions and know-how. One of our strategies is also to generate new intellectual property through the protection of potential follow-on compounds. In addition to patents, we rely upon unpatented trade secrets, know-how, and continuing technological innovation to develop and maintain our competitive position. We protect our proprietary information, in part, using confidentiality agreements with our commercial partners, collaborators, employees and consultants and invention assignment agreements with our employees. We also have confidentiality agreements or invention assignment agreements with our commercial partners and selected consultants. Despite these measures, any of our intellectual property and proprietary rights could be challenged, invalidated, circumvented, infringed or misappropriated, or such intellectual property and proprietary rights may not be sufficient to permit us to take advantage of current market trends or otherwise to provide competitive advantages. In addition, such confidentiality agreements and invention assignment agreements can be breached and we may not have adequate remedies for any such breach. For more information, please see “Risk Factors—Risks Related to Intellectual Property.” The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we are seeking patent protection for our drug candidates, the patent term is 20 years from the earliest date of filing a non-provisional patent application. In the United States, the term of a patent may be lengthened by a patent term adjustment, which provides for term extension in the case of administrative delays at the United States Patent and Trademark Office in granting a patent, or may be shortened if a patent is terminally disclaimed over another patent with an earlier expiration date. Furthermore, in the United States, the term of a patent covering an FDA approved drug may be eligible for patent term extension (“PTE”) under the Hatch- Waxman Amendments as compensation for the loss of patent term during the FDA regulatory review process. The period of extension may be up to five years beyond the expiration of the patent but cannot extend the term of a patent beyond a total of 14 years from the date of product approval. Only one patent covering a single FDA- approved product among those eligible for an extension may be extended. In the future, if any of our drug candidates receives FDA approval, we expect to apply for a PTE, if available, to extend the term of a patent covering such approved drug product. We also expect to seek PTEs in any jurisdictions where they are available, however, there is no guarantee that the applicable authorities, including the FDA, will agree with our assessment of whether such an extension should be granted, and even if granted, the length of such an extension. See “Item 3.D. Risk Factors— Risks Related to Intellectual Property — Our ability to 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." Patents All the patents and patent applications covering obefazimod are co-owned with the French National Centre for Scientific Research (the “CNRS”), the University of Montpellier, and the Institut Curie, except U.S. patent 10,464,903, U.S. patent 10,745,357, U.S. patent applications 18/729,018, U.S. patent application 18/893,339, U.S. patent application 18/832,670 and U.S. patent application 19/149,308, as described below. 83 Obefazimod As of December 31, 2025, the principal patent rights related to obefazimod, include: •U.S. patent 10,017,498, which is directed to the composition of matter of obefazimod generically and specifically and to a pharmaceutical composition comprising it. This patent is also granted in Europe and several other countries (Australia, Brazil, Canada, China, Hong Kong, India, Japan, South Korea, Mexico, Russia, South Africa) and has an expiry date of 2030, not including patent term adjustment or any potential PTE. •U.S. patent 10,975,063, which is directed specifically to obefazimod (composition of matter), free base and salts of obefazimod, a pharmaceutical composition comprising it, a process for preparing it and a method for treating HIV infection. This patent has an expiry date of 2030, not including patent term adjustment or any potential PTE. •U.S. patent 10,435,370, which is directed to methods of treating inflammatory diseases including UC and CD by obefazimod generically and specifically. This patent is also granted in Europe and several other countries (Australia, Brazil, Canada, China, Hong Kong, India, Japan, South Korea, Mexico, Russia, South Africa). •U.S. continuation patent 11,649,211 is directed to the method of treating inflammatory diseases including UC and CD by obefazimod specifically. Divisional U.S. patents protect methods of treating additional inflammatory diseases (U.S. patent 10,981,874 and U.S. patent 11,649,210). These patents have an expiry date of 2035, not including patent term adjustment or any potential PTE. •U.S. patent 10,464,903 and U.S. patent 10,745,357, which are directed to a synthesis process for manufacturing obefazimod and derivatives thereof, a polymorphic form of the free base of obefazimod and crystalline forms of various salts of obefazimod. These patents have an expiry date of 2037, not including patent term adjustment or any potential PTE. A corresponding European patent has also been granted. These patents are solely owned by us. •Further indications are also protected by other patents: U.S. patent 9,145,367, which is directed to the method of treating AIDS by obefazimod generically and specifically. This patent is also granted in Europe and several other countries and has an expiry date of 2030. U.S. patent 9,108,919, which is directed to the method of treating cancer by obefazimod generically and specifically. This patent is also granted in Europe and several other countries and has an expiry date of 2030. Another patent application published under US2019/17416679, directed to a method of treating cancer, has been filed worldwide in 2019, with patents granted or patent applications pending in other countries. U.S. patent 10,806,729, which is directed to the method of treating HIV resistant patients by obefazimod generically and specifically. This patent is also granted in some countries in Europe and has an expiry date of 2036. •U.S. patent applications 17/416,856, now granted under U.S. 11,992,499, continuation application 18/635,542 and divisional application 18/635,693, which are respectively directed to the method of treating other inflammatory diseases by obefazimod specifically and generically or its N-glucuronide metabolite have been filed in 2019, as well as counterpart applications and granted patents in other countries. •U.S. patent application 17/796,834, which is directed to the amorphous solid dispersion (ASD) of obefazimod, its method of preparation, pharmaceutical composition and method of treating inflammatory disease, cancer and viral diseases therewith has been filed in 2021, as well as counterpart applications in other countries. •U.S. patent application 17/793,133, which is directed to co-crystals and salts of obefazimod, pharmaceutical composition and method of treating inflammatory disease, cancer and viral diseases therewith has been filed in 2021, as well as counterpart applications in other countries. •U.S. patent application 18/284,253, which is directed to a synthesis process for manufacturing obefazimod and derivatives thereof and was filed in 2022, as well as counterpart applications in other countries. •U.S. patent applications 18/729,018 and continuation in part application 18/893,339, which are directed to combinations products with obefazimod and etrasimod or ozanimod were respectively filed in 2023 and 2024, as well as counterpart applications in other countries. •U.S. patent application 18/832,670, which is directed to combinations products with obefazimod and Rinvoq, filed in 2023, as well as counterpart applications in other countries. •U.S. patent application 19/149,308, which is directed to obefazimod for treatment of ulcerative colitis, was filed in 2024, as well as counterpart applications in other countries. 84 Trademarks and Domain Names We own a number of registered and pending trademarks and registered domain names. The URL for our website, as well as a number of domain names including the wording “abivax” or “obefazimod.” “Abivax” is a registered trademark of our company in Australia, Brazil, Canada, Cuba, the EU, France, India, South Africa, the United Kingdom and the United States. The “Abivax” trademark is pending in Canada, China, India, Japan, Mexico, South Africa, South Korea and the United States. C.Organizational Structure Abivax SA is the parent company of Abivax, LLC, a wholly-owned subsidiary organized in Delaware, United States. D.Property, Plants and Equipment. Our corporate headquarters is located in Paris, France, where we occupy approximately 850 square meters of office space that we sublease and we lease 150 square meters of office space in Jacou, Region of Occitanie in the south of France. We lease an additional 279 square meters of office space in Boston, Massachusetts. We believe our existing facilities meet our current needs.