EpiCept Corp.

First immune thrombocytopenia (ITP) plenary selection in 15 years underscores significant unmet need in this rare, serious autoimmune bleeding disease VYVGART showed rapid, clinically and statistically significant improvements in platelet counts compared with placebo; safety profile consistent with previous trials Topline data from ADVANCE-SC trial of subcutaneously (SC) administered VYVGART for ITP expected in second half of 2023 Amsterdam, the Netherlands – December 10, 2022 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADVANCE trial will be presented during the plenary session at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition in New Orleans, LA (Sunday, December 11, 2022, 2-4pm CT). The ADVANCE study is the first of two registrational trials evaluating the efficacy, safety and tolerability of VYVGART® (efgartigimod alfa-fcab) for the treatment of adult patients with primary ITP. “We are very excited to present our ITP data during the plenary session at ASH, giving us the opportunity to highlight the potential of a new approach to treating this rare, complex disease. People living with ITP need more treatment options with new mechanisms of action that target the underlying biology of the disease, and we look forward to sharing our findings in helping to address this gap with the broader ITP community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “ADVANCE is the second Phase 3 clinical trial in which VYVGART has demonstrated a strong clinical benefit, underscoring our belief in the breadth of potential for this asset in a range of high-need IgG-mediated autoimmune diseases.” Topline data from ADVANCE were reported in May 2022. The trial met its primary endpoint demonstrating a significantly higher proportion (p=0.0316) of VYVGART-treated chronic ITP patients achieved a sustained platelet response (17/78; 21.8%) compared to placebo (2/40; 5%). Sustained platelet response was defined as having platelet counts greater than or equal to 50x109/L on at least four of the last six scheduled visits between weeks 19 and 24 of treatment. Key platelet-derived secondary endpoints (first two secondary endpoints) were also met. VYVGART was well-tolerated in this 24-week chronic dosing study and the observed safety and tolerability profile was consistent with previous clinical trials. Highlights From ASH Plenary Session Early, sustained platelet count increase: 38% of VYVGART-treated participants reached a platelet count of 30x109/L platelets at week 1 compared to 11.1% placeboSustained response across all subgroups: subgroup analyses (including on prior ITP therapy, time since diagnosis, baseline platelet count and age/region demographics) of patients who achieved the primary endpoint all favored VYVGART over placeboInternational Working Group (IWG) responder status: VYVGART resulted in higher responses than placebo on analysis of IWG response criteria 51.2% (44/86) of VYVGART-treated patients achieved an IWG response compared to 20% placeboIWG responders were defined as having a platelet count of at least 30x109/L, a two-fold increase in platelet count from baseline, and the absence of bleeding for two separate, consecutive weekly visits Extent of disease control: VYVGART-treated patients experienced substantially more weeks with disease control, with 44% sustaining response for at least 5-9 weeks (12% placebo), 28% for at least 10-14 weeks (0% placebo), and 17% for at least 15-19 weeks (0% placebo) Sustained platelet count response was achieved in 90% (9/10) of VYVGART responders who switched from weekly to every other week dosing (after surpassing platelet counts of 100x109/L for three out of four consecutive visits); one placebo patient switched to biweekly dosing but did not achieve a sustained platelet count response Key pharmacodynamic parameters: total IgG levels were reduced in VYVGART-treated patients throughout observation period, supporting proposed mechanism of action Mean IgG levels decreased steadily over the first 4 weeks of treatment; baseline remained >60% throughout the trial Consistent safety profile: continuous weekly or biweekly dosing was well-tolerated and did not result in any new safety signals from those reported from previous trials “I am honored to deliver this oral presentation on behalf of my co-investigators at ASH, one of the most prestigious hematology meetings, to provide my peers with additional details on the promising results from the ADVANCE study," stated Catherine Broome, M.D., Associate Professor of Medicine at Georgetown University Lombardi Comprehensive Cancer Center, and Principal Investigator in the ADVANCE trial. "Along with the previously reported positive efficacy, safety and tolerability data from the trial, further analyses show efgartigimod demonstrated rapid and sustained reduction in IgG autoantibodies, which correlated with platelet count response, as well as consistent improvement over placebo across each evaluated weekly timepoint. The data generated to date give us optimism that this therapy could provide a new tool in the treatment of ITP, and we look forward to seeing results from the subcutaneous study in 2023." The Phase 3 ADVANCE IV trial is the first of two registrational trials being conducted as part of the ongoing ITP development program. ADVANCE-SC is evaluating SC VYVGART for the treatment of primary ITP. Topline data from the ADVANCE-SC study are expected in the second half of 2023. Phase 3 ADVANCE Trial DesignThe Phase 3 ADVANCE trial was a randomized, double-blind, placebo-controlled, multicenter, global trial evaluating the efficacy and safety of VYVGART in adult patients with chronic or persistent primary ITP. ​A total of 131 adult patients with primary ITP in North America, Europe and Japan enrolled in the trial and received VYVGART or placebo for a total of 24 weeks as part of the primary trial. Enrolled patients had a confirmed ITP diagnosis and a mean entry platelet count of less than 30x109/L. Patients were on a stable dose of at least one ITP treatment prior to randomization and had received at least one prior therapy. Concomitant medications permitted included corticosteroids, nonsteroidal immunosuppressive drugs, fostamatinib or TPO-RAs. If patients were on 'watch and wait' at baseline, they had to have received at least 2 prior treatments for ITP. ​ Patients were randomized in a 2:1 ratio to receive VYVGART or placebo for a total of 24 weeks as part of the primary trial. Randomized patients received weekly infusions from weeks 1-4 and were eligible to adjust frequency to bi-weekly depending on platelet count. Administration frequency was fixed from study visits 16-24. ​The primary endpoint was measured by the proportion of patients with chronic ITP with a sustained platelet count response defined as achieving platelet counts of greater than or equal to 50x109/L for at least four of the last six scheduled visits between weeks 19 and 24. Patients who received rescue therapy at week 12 or later, or for whom dose and/or frequency of concurrent ITP therapies increased at week 12 or later, were considered non-responders. ​Key secondary endpoints included extent of disease control over 24-week treatment period, proportion of overall population with sustained platelet count response, incidence and severity of WHO-classified bleeding events and an extended primary endpoint analysis between weeks 17 and 24. See the full Prescribing Information for VYVGART in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp. Important Safety Information for VYVGART® (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. prescribing information) What is VYVGART® (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). What is the most important information I should know about VYVGART? VYVGART may cause serious side effects, including: Infection. VYVGART may increase the risk of infection. In a clinical study, the most common infections were urinary tract and respiratory tract infections. More patients on VYVGART vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and blood side effects were mild to moderate in severity. Your health care provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART. Tell your health care provider if you have any history of infections. Tell your health care provider right away if you have signs or symptoms of an infection during treatment with VYVGART such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Undesirable immune reactions (hypersensitivity reactions). VYVGART can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to VYVGART discontinuation. Your health care provider should monitor you during and after treatment and discontinue VYVGART if needed. Tell your health care provider immediately about any undesirable reactions. Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you: Have a history of infection or you think you have an infection.Have received or are scheduled to receive a vaccine (immunization). Discuss with your health care provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART. The use of vaccines during VYVGART treatment has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART.Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed. Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the common side effects of VYVGART?The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. About American Society of Hematology (ASH) Annual Meeting and ExpositionThe 64th ASH Annual Meeting and Exposition is scheduled to take place December 10-13, 2022 at the Ernest N. Morial Convention Center in New Orleans, Louisiana. This in-person event will be broadcast virtually. The ASH 2022 Annual Meeting abstracts are available at: https://www.hematology.org/meetings/annual-meeting/abstracts. About Immune Thrombocytopenia (ITP)Immune thrombocytopenia (ITP) is an autoimmune disorder where immunoglobulin G (IgG) autoantibodies destroy platelets and reduce platelet production, which can lead to an increased risk of excessive bleeding and bruising. In severe cases, frequent bleeding events can cause anemia or even brain hemorrhage in rare cases. ITP is also associated with debilitating fatigue and significant impacts on mental health, including anxiety, fear and depression. Many ITP patients are inadequately controlled on current therapies so there remains a significant unmet need for additional treatment options. About VYVGART® (efgartigimod alfa-fcab)VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). VYVGART is being studied in adults with primary immune thrombocytopenia (ITP) and other IgG autoantibody-mediated diseases. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and- only approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan and the EU. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, Twitter, and Instagram. Media: Kelsey Kirkkkirk@argenx.com Investors: Beth DelGiaccobdelgiacco@argenx.com Forward Looking StatementsThe contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “hope,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning the potential of VYVGART® (efgartigimod alfa-fcab) for the treatment of adult patients with ITP; the intended results of its strategy and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; and the timing and outcome of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

Sanofi to present new clinical data reinforcing novel therapies across rare blood disorders at ASH 2022 Quality of life data for efanesoctocog alfa supports its potential as a transformative, best-in-class therapy for hemophilia A Data across hemophilia A, hemophilia B, cold agglutinin disease (CAD), and other conditions featured in 16 presentations Paris , November 30 , 2022 . Data from across Sanofi’s rare blood disorders franchise will be featured in 16 presentations at the 64 th American Society of Hematology (ASH) Annual Meeting & Exposition from December 10-13, 2022. Karin Knobe, MD , PhD Global Head of Clinical Development for Rare Diseases and Rare Blood Disorders at Sanofi “ The Phase 3 results presented at ASH across hemophilia and cold agglutinin disease underscore our ambition to launch four rare blood disorder therapies in four years. We started this year strong and look forward to c arrying th is momentum into 2023 and beyond, with potential treatment advancements we hope will help transform the lives of people living with rare blood disorders . ” Quality of life data from the pivotal XTEND-1 Phase 3 study will be presented at ASH evaluating the effect of investigational therapy efanesoctocog alfa on pain and physical functioning for people with hemophilia A. These findings build on key results that were first presented at the 30th International Society of Thrombosis and Haemostasis (ISTH) Congress. Data from the XTEND-1 study supported the biologics licence application (BLA) for efanesoctocog alfa, which is currently under FDA priority review with a target action date of February 28, 2023. New data to be presented from the ATLAS program for fitusiran, an investigational therapy for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors, will showcase for the first time the hemostatic equivalency of antithrombin lowering in hemophilia A. Hemostatic equivalency is used to better understand how non-factor therapies, such as fitusiran, can help correct the clotting defect in hemophilia. Fitusiran is designed to work by targeting antithrombin, a protein that helps maintain hemostatic balance. Additional fitusiran data will exhibit improvements in health-related quality of life with reduced treatment burden. Qualitative data will outline treatment expectations for people with hemophilia to live an active lifestyle. In an oral presentation, results from the CADENZA phase 3 study, which supported a supplemental BLA currently under FDA priority review for Enjaymo ® (sutimlimab-jome), will review the effect of Enjaymo on patient-reported outcomes and quality of life. Presentations will also report long-term clinical data from the CADENZA study as well as information on the COVID-19 vaccine response among people living with cold agglutinin disease (CAD) being treated with Enjaymo. Data from the pivotal CADENZA and CARDINAL Phase 3 studies recently supported the European Commission approval of Enjaymo. Additional presentations at ASH will highlight other rare blood disorders. Two posters will explore the prevalence and burden of immune thrombocytopenia (ITP), including cognitive impairment. Data evaluating the response to rilzabrutinib, an investigational therapy, when used as an early treatment option for ITP patients will also be shown. Presentations on acquired thrombotic thrombocytopenic purpura (aTTP) include an analysis of the HERCULES Phase 3 study and a presentation of the MAYARI study design that will assess the efficacy and safety profile of Cablivi ® (caplacizumab-yhdp) without plasma exchange in an investigational setting. Cablivi is approved in several geographies in combination with plasma exchange and immunosuppression for the treatment of aTTP in adults. Hemophilia A and B Abstract #2468: Efficacy of Efanesoctocog Alfa on Physical Functioning: Results from the XTEND-1 Phase 3 Clinical Trial in Previously Treated Patients with Hemophilia A Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #2474: Efficacy of Efanesoctocog Alfa on Pain in Patients with Hemophilia A: Results from the XTEND-1 Phase 3 Clinical Trial in Previously Treated Patients with Hemophilia A Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #3788: A Population Pharmacokinetic (PopPK) Model to Characterize Efanesoctocog Alfa (BIVV001) Factor VIII Activity Levels in Patients with Severe Hemophilia A Poster Presentation: 6-8 pm CT, Monday, December 12, 2022 Abstract #2472: Development of a Quantitative Systems Pharmacology Model to Explore Hemostatic Equivalency of Antithrombin Lowering Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #3559: Fitusiran Prophylaxis Improves Health-Related Quality of Life in People with Hemophilia A or B, with or without inhibitors: Results of ATLAS-PPX study Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #3565: Fitusiran Reaches People’s with Hemophilia and Their Caregivers’ Treatment Expectations: Qualitative Semi-Structured Interviews of Participants of ATLAS-OLE Trial (Interim analysis) Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #3566: Patients with Hemophilia and Their Caregivers Prefer Treatment Attributes That Enable a More Active Lifestyle with Lower Risk of Inhibitor Development Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Cold Agglutinin Disease Abstract #31: Sutimlimab Provides Sustained Improvements in Patient-Reported Outcomes and Quality of Life in Patients with Cold Agglutinin Disease: Open-Label Extension of the Randomized, Phase 3 CADENZA Study Oral Presentation: 9:30-11 am CT, Saturday, December 10, 2022 Abstract #1201: Sustained Complement C1s Inhibition with Sutimlimab in Patients With Cold Agglutinin Disease Results in Continued Efficacy During Part B of the Randomized Placebo-Controlled Phase 3 CADENZA Study (NCT03347422) Poster Presentation: 5:30-7:30 pm CT, Saturday, December 10, 2022 Abstract #1208: Concomitant Use Of Sutimlimab and COVID-19 Vaccines In Patients With Cold Agglutinin Disease from the Phase 3 CARDINAL and CADENZA Studies Poster Presentation: 5:30-7:30 pm CT, Saturday, December 10, 2022 Abstract #2325: Hemolytic Markers, Mortality, and Thromboembolic Events in Cold Agglutinin Disease (CAD): A Retrospective Analysis of the OPTUM Electronic Health Record Database in the United States Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Immune Thrombocytopenia Abstract #2449: Multirefactory Primary Immune Thrombocytopenia in Adults: Prevalence and Burden. Results from the Carmen-France Registry Poster Presentation: 6-8pm CT, Sunday, December 11, 2022 Abstract #2450: Clinical Predictors of Response to Rilzabrutinib Therapy in Patients With Immune Thrombocytopenia: Exploratory Analysis of a Phase 1/2 Study Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abstract #3773: Cognitive Impairment Among Patients With Chronic Immune Thrombocytopenia Poster Presentation: 6-8 pm CT, Monday, December 12, 2022 Acquired Thrombotic Thrombocytopenic Purpura Abstract #1174: A Phase 3 Study to Evaluate the Efficacy and Safety of Caplacizumab Without First-Line Therapeutic Plasma Exchange in Adults With Immune-Mediated Thrombotic Thrombocytopenic Purpura Poster Presentation: 5:30-7:30 pm CT, Saturday, December 10, 2022 Abstract #2493: The Role of ADAMTS13 Activity Levels on Disease Exacerbation or Relapse in Patients With Immune-Mediated Thrombotic Thrombocytopenic Purpura: Post Hoc Analysis of the Phase 3 HERCULES and Post-HERCULES Studies Poster Presentation: 6-8 pm CT, Sunday, December 11, 2022 Abo ut efanesoctocog alf a Efanesoctocog alfa is a novel and investigational recombinant factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for people with hemophilia A. It builds on the innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN ® polypeptides to extend its time in circulation. It is the first investigational factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies. ALTUVIIIO ® is the intended trade name of efanesoctocog alfa in the US. Efanesoctocog alfa is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Efanesoctocog alfa is currently under FDA review with a target action date of February 28, 2023. The FDA also granted efanesoctocog alfa Breakthrough Therapy designation in May 2022, – the first factor VIII therapy to receive this recognition – Fast Track designation in February 2021, and Orphan Drug designation in August 2017. Sanofi and Sobi ® collaborate on the development of efanesoctocog alfa. About fitusiran Fitusiran is an investigational, subcutaneously administered small interference RNA (siRNA) therapeutic in development for the prophylactic treatment of people with hemophilia A or B, with or without inhibitors. Fitusiran is designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds. Fitusiran utilizes Alnylam Pharmaceutical Inc.’s ESC-GalNAc conjugate technology, which enables subcutaneous dosing with increased potency and durability. Fitusiran is currently under clinical investigation and has not been evaluated by any regulatory authority. About Enjaym o ® ( sutimlimab -jome ) Enjaymo is a humanized monoclonal antibody that is designed to selectively target and inhibit C1s in the classical complement pathway, which is part of the innate immune system. By blocking C1s, Enjaymo inhibits the activation of the complement cascade in the immune system and inhibits C1-activated hemolysis in cold agglutinin disease (CAD) to prevent the abnormal destruction of healthy red blood cells. Enjaymo does not inhibit the lectin and alternative pathways. Enjaymo was approved by the U.S. Food and Drug Administration (FDA) in February 2022 as the first and only treatment indicated to decrease the need for red blood cell transfusion due to hemolysis in adults with CAD. Sanofi has filed for an sBLA to add CADENZA (BIVV009-04) clinical data into the label and was granted priority review by the FDA in September 2022. About Cablivi ® ( caplacizumab -yhdp ) Cablivi is a von Willebrand Factor (vWF) antibody fragment, which inhibits the interaction between ultra-large vWF multimers and platelets and, therefore, stops the formation of the micro-clots that can form during an acute episode of acquired thrombotic thrombocytopenia purpura. Cablivi was approved in the European Union in August 2018 and in the United States in February 2019. Use of Cablivi without plasma exchange is currently investigational and has not been evaluated by any regulatory authority. About rilzabrutinib Rilzabrutinib is an oral Bruton’s tyrosine kinase (BTK) inhibitor incorporating Sanofi’s TAILORED COVALENCY ® technology being investigated for the treatment of immune-mediated diseases, including immune thrombocytopenia (ITP). BTK is an intracellular signaling molecule involved in innate and adaptive immune responses related to certain immune-mediated diseases. By inhibiting BTK, rilzabrutinib has the potential to target the underlying disease pathogenesis. Rilzabrutinib is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Kate Conway | + 1 508 364 4931 | kate.conway@sanofi.com Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 6 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri | + 1 617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This document contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. Attachment PDF

EpiCept Corp says that European regulators have given the green light to Ceplene, the US firm’s treatment for adults with acute myeloid leukaemia. The European Commission has granted a full marketing authorisation in the form of a positive Commission Decision, for Ceplene (histamine dihydrochloride) for the remission maintenance and prevention of relapse in adult patients with AML in first remission. The drug is to be administered in conjunction with low-dose interleukin-2. The approval is based in part on the results of a 320-patient Phase III trial for Ceplene in conjunction with IL-2 which showed that treatment significantly reduced the occurrence of relapse among AML patients in complete remission. The improvement of long-term leukaemia-free survival in patients receiving Ceplene/IL-2 exceeded 50% and the drug was well tolerated. The approval allows Ceplene to be marketed in the 27 member states of the European Union, as well as in Iceland, Liechtenstein and Norway. EpiCept has been granted 10 years of market exclusivity in the EU for the treatment, which has orphan drug status. EpiCept chief executive Jack Talley noted that Ceplene is now the first approved therapy “demonstrated to produce a clear benefit in prolonging leukaemia-free survival and preventing relapse among AML patients”. He added that “several potential commercial partners with established sales infrastructures in haematology and oncology in Europe” have expressed interest in marketing Ceplene and are in "various stages of due diligence". There are 40,000 AML patients in the EU, with 16,000 new cases occurring each year. Once diagnosed, patients typically receive induction and consolidation chemotherapy, with the majority achieving complete remission. However, about 70%-80% of patients who achieve first remission will relapse, within 12 months. Less than 15% of relapsed patients survive long-term. As for the North American market, a pre-New Drug Submission meeting with Health Canada for Ceplene has been scheduled during the fourth quarter and will be followed in the first quarter of 2009 by a meeting with the US Food and Drug Administration.