Endocrine System Diseases

Visionary healthcare company adds obesity and chronic care management provider to its curated selection of market-tested services NEW CANAAN, Conn., Oct. 31, 2024 /PRNewswire/ -- Muse Health, a care navigation integrator of value-based benefits, has partnered with FlyteHealth to offer its members expert obesity care and chronic condition management. Muse Health's vertically integrated healthcare system is focused on an individual's whole health through interactions with healthcare providers in primary and specialty care. FlyteHealth delivers a comprehensive suite of clinical care, technology and support, reducing the complexity and cost of obesity and comorbid chronic conditions for employers and payers. As Muse Health and its clients identified the growing need for a new way to approach diabetes, hypertension and weight management, they conducted extensive market analysis and determined that FlyteHealth is the ideal partner to service its clients' employees/members. "The more complex the challenges encountered by our stakeholders, the more we require robust solutions. FlyteHealth's best-in-class medical obesity solution and their mission-focused management and operations team made them a perfect partner to optimize lifestyles around food and activity in a culturally concordant manner," said Muse Health CEO Ricardo Johnson II. "We are excited to work alongside FlyteHealth to accomplish this important work." Muse Health partners with payers, pharmacy benefit managers (PBMs), group employers, associations, and other entities to ensure that value-based benefits are cognizant of social determinants of health, racial equalities, gender fairness, and economic stabilization. The company identifies, assesses, and manages a suite of value-based benefit providers that align with its strategic, moral obligations. They also secure claims data from clients, leverage proprietary risk-stratification programs, and steer individuals (Medicare and Medicaid beneficiaries, labor and group employees) to its vendor partners for services. As its portfolio vendor partners deliver their services, Muse Health manages collaborative strategies between its clients and vendor partners to reach individuals where they live in the manner that works best for them. "We are delighted to be part of the Muse Health virtual care ecosystem," said FlyteHealth CEO and co-founder Sloan Saunders. "We like the unique market approach Muse Health is taking to ensure that all individuals, including the most disadvantaged ones, have access to quality healthcare." For more information, contact: Ricardo Johnson II, CEO, Muse Health, [email protected] Gabe Castaneda, Chief Revenue Officer, FlyteHealth, [email protected] About Muse Health Muse Health provides an integrated health solution to our healthcare partners, working exclusively with payers, providers, and service entities to provide transformative solutions focused on underrepresented populations. Muse Health focuses on an individual's whole health and their engagement with healthcare providers in primary, secondary, and tertiary care markets. MUSE HEALTH technology platform is present in over 100 hospital systems and over a dozen payer networks. For more information, please visit About FlyteHealth FlyteHealth is obesity care that empowers you. Delivering a comprehensive suite of clinical care, technology, and support, FlyteHealth reduces the complexity and cost of obesity and its comorbid conditions for employers and payers. Based on the founders' decades of research and clinical care, FlyteHealth clinicians deliver the latest in personalized medication therapy and behavior coaching. The evidence-based treatment protocols enable individuals not only to lose weight and maintain weight loss long-term, but also to achieve significant improvements in outcomes related to diabetes, hypertension, heart disease, and many other weight-related health complications. Through the Flyte Intelligence obesity treatment platform, FlyteHealth empowers healthcare providers with subject matter expertise and care navigation services. Drawing from the largest data set of obesity and chronic disease research, Flyte Intelligence enables delivery of the highest standard of patient care at scale. For more information, please visit . Contact: FlyteHealth Nicole Turgeon [email protected] (206) 295-2060 SOURCE FlyteHealth WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Study Results Position Company to Target Segments of $270B+ Multi-Billion Dollar Drug Delivery Systems Market1 VANCOUVER, BC, Oct. 31, 2024 /PRNewswire/ -- BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") highlights studies showing that its novel immune educating delivery platform, DPX™, recruits and activates unique subsets of antigen presenting cells ("APCs") to drive immunogenicity of antigens, and exhibits superior immune activation compared to aqueous and emulsion-based antigen delivery systems. With cancer vaccines, the successful eradication of tumors relies on the persistent delivery of antigenic APCs to prime potent, antigen specific, cytotoxic T cells. Current peptide antigen delivery methods include using either water-based formulations which provide short exposure of peptides to immune cells, or oil-in-water emulsions that provide longer peptide exposure but that can elicit dysfunctional T cell phenotypes. In contrast, BioVaxys' DPX technology is a non-aqueous, lipid-in-oil, immune-educating therapeutic delivery platform that keeps the antigen cargo at the site of injection, ensuring that uptake of the DPX-encapsulated cargo is an active process driven by the APCs across time. In a study done in collaboration with Dalhousie University of Halifax, Nova Scotia, DPX was compared to aqueous and emulsion-based formulations to evaluate the dynamics of immune cell recruitment to the site of injection, antigen consumption, and trafficking by immune cells. Immune cell composition and antigen uptake at the injection site were assessed by multi-parameter flow cytometry and confocal microscopy using model peptide antigens administered in mice. Antigen-specific immune responses were assessed by interferon-gamma (IFN-γ)-based Enzyme-Linked Immunospot (ELISpot) assay to measure IFN-γ, the presence of which plays a crucial role in activating the immune system. The ELISpot assay is a sensitive method for measuring the number of cells that produce cytokines or antibodies in response to an antigen. "BioVaxys is at the forefront of a significant shift in the drug delivery landscape," James Passin, CEO of BioVaxys, stated, "These groundbreaking study results validate our strategic position in an important segment of the multi-billion drug delivery market. DPX not only outperforms current antigen delivery solutions but also demonstrate inherent immune-activating properties, opening up significant revenue potential across multiple market segments." The study results showed that aqueous formulations were poorly able to retain lymphocytes at the injection site and consequently did not elicit a detectable IFN-γ ELISpot response. Both DPX and the oil emulsion were superior in recruiting APCs to the injection site and inducing antigen-specific immune responses, and with significant increases in immune cell infiltration detected as early as 2 days post DPX injection. However, a significant difference between DPX and oil emulsion was that antigen presentation driven by the DPX platform resulted in activation of more critical markers of T cell subsets than emulsion. An additional and highly significant finding is that recruitment and activation of these T cell subsets by DPX was evident regardless of whether an antigen was contained as cargo in DPX, indicating that DPX on its own has immune system activating properties. Kenneth Kovan, President and Chief Operating Officer at BioVaxys, stated "We know that compared to DPX remaining at the injection site, emulsion-based and aqueous formulations leach cargo into surrounding tissues. These findings further highlight the quantitative, qualitative, and temporal differences in immune cell recruitment by DPX and two common delivery platforms and show the character of the immune response triggered by the DPX platform via activation of T cell subsets with intrinsically higher capacity for antigen uptake, presentation, and activation." BioVaxys is planning to present additional data in early December on the unique characteristics of DPX 1Drug Delivery Devices Market Size, Share & Trends Analysis Report By Application (Oncology, Infectious Diseases), By Route Of Administration (Oral, Transdermal, Injectable), By End-use, By Region, And Segment Forecasts, 2024 – 2030, Grand View Research About BioVaxys Technology Corp. BioVaxys Technology Corp. () is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on its DPX™ immune-educating technology platform and its HapTenix© "neoantigen" tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization for food allergy, and other immunological diseases. Through a differentiated mechanism of action, the DPX™ platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. The Company's clinical stage pipeline includes maveropepimut-S (MVP-S), based on the DPX™ platform, and is in Phase IIB clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant Ovarian Cancer. MVP-S delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers, and also delivers an innate immune activator and a universal CD4 T cell helper peptide. MVP-S has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. BioVaxys is also developing DPX™+SurMAGE, a dual-targeted immunotherapy combining antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously, DPX™-RSV for Respiratory Syncytial Virus, DPX+rPA for peanut allergy prophylaxis, and BVX-0918, a personalized immunotherapeutic vaccine using its proprietary HapTenix© "neoantigen" tumor cell construct platform for refractive late-stage ovarian cancer. BioVaxys common shares are listed on the CSE under the stock symbol "BIOV" and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit and connect with us on X and LinkedIn. ON BEHALF OF THE BOARD Signed "James Passin" James Passin, Chief Executive Officer Phone: +740 358 0555 Email: [email protected] Cautionary Statements Regarding Forward Looking Information This press release includes certain "forward-looking information" and "forward-looking statements" (collectively "forward-looking statements") within the meaning of applicable Canadian and United States securities legislation including the United States Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included herein, without limitation, statements relating the future operating or financial performance of the Company, are forward looking statements. Forward-looking statements are frequently, but not always, identified by words such as "expects", "anticipates", "believes", "intends", "estimates", "potential", "possible", and similar expressions, or statements that events, conditions, or results "will", "may", "could", or "should" occur or be achieved. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those expressed or implied in such forward-looking statements. These forward-looking statements reflect the beliefs, opinions and projections on the date the statements are made and are based upon a number of assumptions and estimates, primarily the assumption that BioVaxys will be successful in developing and testing vaccines, that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social uncertainties and contingencies including, primarily but without limitation, the risk that BioVaxys' vaccines will not prove to be effective and/ or will not receive the required regulatory approvals. With regards to BioVaxys' business, there are a number of risks that could affect the development of its biotechnology products, including, without limitation, the need for additional capital to fund clinical trials, its lack of operating history, uncertainty about whether its products will complete the long, complex and expensive clinical trial and regulatory approval process for approval of new drugs necessary for marketing approval, uncertainty about whether its autologous cell vaccine immunotherapy can be developed to produce safe and effective products and, if so, whether its vaccine products will be commercially accepted and profitable, the expenses, delays and uncertainties and complications typically encountered by development stage biopharmaceutical businesses, financial and development obligations under license arrangements in order to protect its rights to its products and technologies, obtaining and protecting new intellectual property rights and avoiding infringement to third parties and their dependence on manufacturing by third parties. The Company does not assume any obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law. Logo - SOURCE BioVaxys Technology Corp. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

$573 million in third quarter global net product sales CIDP global expansion on track, with decisions on approval under review in Japan, Europe, China, and Canada Management to host conference call today at 1:30 PM CET (8:30 AM ET) Regulated information - Inside information October 31, 2024 7:00AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its third quarter 2024 financial results and provided a business update. “We delivered significant patient impact with VYVGART over the quarter, expanding our gMG footprint and delivering innovation to CIDP patients three months into launch,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We continued to advance our goal of reaching more gMG patients earlier in their treatment journey, supported by VYVGART’s strong safety and efficacy profile, and real-world data showing the ability to meaningfully reduce steroid use. Expanding upon our leadership in gMG, we are now paving the future in CIDP. The strength of our data, combined with execution across the team to reach key stakeholders, contributed to the initial success of our CIDP launch, with more than 300 patients on therapy at the end of the third quarter. There remains significant opportunity ahead as we work towards achieving our Vision 2030, with innovation implemented across our pipeline to deliver transformative outcomes to more patients.” Advancing ‘Vision 2030’ in Third Quarter 2024 Vision 2030 is the next phase in argenx’s long-term commitment to transform the treatment of autoimmune diseases by strengthening its leadership in FcRn biology, investing in its continuous pipeline of differentiated antibody candidates, and scaling in a disciplined way to ensure innovation remains core to the argenx mission. As a part of this vision, argenx plans to reach at least 50,000 patients globally, advance the pipeline to achieve 10 labeled indications, and bring five new molecules into Phase 3 by 2030. Reaching 50,000 Patients Globally by 2030 VYVGART® (efgartigimod alfa-fcab) is a first-in-class antibody fragment targeting FcRn and is now approved for both intravenous use and subcutaneous injection (SC) (efgartigimod alfa and hyaluronidase-qvfc) in three indications, including generalized myasthenia gravis (gMG) globally, primary immune thrombocytopenia (ITP) in Japan (IV only), and chronic inflammatory demyelinating polyneuropathy (CIDP) in the U.S. (SC only). Generated global net product revenues (inclusive of both VYVGART and VYVGART SC) of $573 million in the third quarter of 2024Multiple VYVGART regulatory submissions completed or underway for gMG, including: Swissmedic approved VYVGART for the treatment of gMG in SwitzerlandRegulatory decisions on approval expected in Australia and Saudi Arabia in 2024, and South Korea in 2025 Multiple VYVGART SC regulatory submissions under review or planned for CIDP, including: Regulatory submissions completed in Japan, Europe, and China with decisions on approval expected in 2025Regulatory submission to be completed in Canada by end of 2024 VYVGART now reimbursed in 11 countries in Europe, with new agreements in place in France, Luxembourg, and BelgiumFDA review of VYVGART SC pre-filled syringe (PFS) for gMG and CIDP ongoing with Prescription Drug User Fee Act (PDUFA) target action date of April 10, 2025 Advancing Pipeline to Achieve 10 Labeled Indications by 2030 argenx continues to demonstrate breadth and depth within its immunology pipeline, advancing multiple pipeline-in-a-product candidates. argenx is solidifying its leadership in FcRn biology, with efgartigimod currently in development in 15 indications. argenx is also advancing its first-in-class C2 inhibitor, empasiprubart, which is being evaluated in multifocal motor neuropathy (MMN), delayed graft function (DGF), dermatomyositis (DM), and CIDP. In addition, argenx is evaluating ARGX-119, a muscle-specific kinase (MuSK) agonist in both congenital myasthenic syndrome (CMS) and amyotrophic lateral sclerosis (ALS). Registrational studies ongoing of efgartigimod in thyroid eye disease (TED)Registrational studies ongoing to support label-expansion into broader MG, including ADAPT SERON in seronegative gMG and ADAPT OCULUS in ocular MGRegistrational study in primary Sjögren’s disease (SjD) on track to start by end of 2024Confirmatory study of efgartigimod in primary ITP to start by end of 2024 to enable registration in U.S.Topline data from seamless Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets (immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and DM) expected by end of 2024Update on BALLAD study development plan evaluating efgartigimod in bullous pemphigoid (BP) expected by end of 2024Decision made to discontinue development of efgartigimod in membranous nephropathy (MN); proof-of concept study ongoing with efgartigimod in lupus nephritis (LN)Proof-of-concept study ongoing with efgartigimod in antibody mediated rejection (AMR), with systemic sclerosis (SSc) to start by end of 2024Registrational study of empasiprubart in MMN to start by end of 2024Additional proof-of-concept studies of empasiprubart ongoing, including VARVARA study in DGF and EMPACIFIC study in DMRegistrational study of empasiprubart in CIDP to start in 2025Ongoing Phase 1b/2a studies of ARGX-119 to assess early signal in patients with CMS and ALS Investing in Immunology Innovation Program to Support Five New Molecules in Phase 3 by 2030 argenx continues to invest in its Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates have been nominated, including: ARGX-213, targeting FcRn and further solidifying argenx’s leadership in this new class of medicine; ARGX-121, a first-in-class molecule targeting IgA; ARGX-109, targeting IL-6, which plays an important role in inflammation, and ARGX-220, a first-in-class sweeping antibody for which the target has not yet been disclosed. Phase 1 studies of ARGX-213 and ARGX-121 expected to start in second half of 2025Investigational new drug (IND) applications for ARGX-220 and ARGX-109 on track to be filed by end of 2025 THIRD QUARTER 2024 FINANCIAL RESULTS argenx SE UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF PROFIT OR LOSS Three Months Ended Nine Months Ended September 30 September 30(in thousands of $ except for shares and EPS) 2024 2023 2024 2023Product net sales $ 572,997 $ 329,097 $ 1,448,915 $ 816,432 Collaboration revenue 239 692 2,905 3,047 Other operating income 15,642 10,050 38,999 31,275 Total operating income $ 588,878 $ 339,839 $ 1,490,819 $ 850,754 Cost of sales $ (59,072) $ (35,999) $ (154,633) $ (78,358)Research and development expenses (235,940) (191,755) (686,195) (553,119)Selling, general and administrative expenses (277,698) (191,930) (769,392) (503,079)Loss from investment in a joint venture (1,981) (743) (5,294) (2,623)Total operating expenses $ (574,691) $ (420,427) $ (1,615,514) $ (1,137,179) Operating profit/(loss) $ 14,187 $ (80,588) $ (124,695) $ (286,425) Financial income $ 40,586 $ 30,049 $ 118,414 $ 67,078 Financial expense (676) (231) (1,760) (626)Exchange gains/(losses) 33,927 (32,509) 6,712 (23,345) Profit/(loss) for the period before taxes $ 88,024 $ (83,279) $ (1,329) $ (243,318)Income tax (expense)/benefit $ 3,386 $ 10,637 $ 60,208 $ 47,437 Profit/(loss) for the period $ 91,410 $ (72,642) $ 58,879 $ (195,881)Profit/(loss) for the period attributable to: Owners of the parent $ 91,410 $ (72,642) $ 58,879 $ (195,881)Weighted average number of shares outstanding 60,087,498 58,128,233 59,633,179 56,512,254 Basic profit/(loss) per share (in $) 1.52 (1.25) 0.99 (3.47)Diluted profit/(loss) per share (in $) 1.39 (1.25) 0.91 (3.47)Net increase in cash, cash equivalents and current financial assets compared to year-end 2023 and 2022 $ 194,523 $ 993,035 Cash and cash equivalents and current financial assets at the end of the period $ 3,374,367 $ 3,185,583 DETAILS OF THE FINANCIAL RESULTS Total operating income for the third quarter and year-to-date in 2024 was $589 million and $1,491 million, respectively, compared to $340 million and $851 million for the same periods in 2023, and mainly consists of: Product net sales of VYVGART for the three months ended and nine months ended September 30, 2024, were $573 million and $1,449 million, compared to $329 million and $816 million for the same periods in 2023.Other operating income for the third quarter and year-to-date in 2024 was $16 million and $39 million, respectively, compared to $10 million, and $31 million for the same periods in 2023. The other operating income for the three and nine months ended September 30, 2024 primarily relates to research and development tax incentives and payroll tax rebates. Total operating expenses for the third quarter and year-to-date in 2024 were $575 million and $1,616 million, respectively, compared to $420 million and $1,137 million for the same periods in 2023, and mainly consists of: Cost of sales for the third quarter and year-to-date in 2024 was $59 million and $155 million, respectively, compared to $36 million and $78 million for the same periods in 2023. The cost of sales was recognized with respect to the sale of VYVGART and VYVGART Hytrulo.Research and development expenses for the third quarter and year-to-date in 2024 were $236 million and $686 million, respectively, compared to $192 million and $553 million for the same periods in 2023. The research and development expenses mainly relate to external research and development expenses and personnel expenses incurred in the clinical development of efgartigimod in various indications and the expansion of other clinical and preclinical pipeline candidates.Selling, general and administrative expenses for the third quarter and year-to-date in 2024 were $278 million and $769 million, respectively, compared to $192 million and $503 million for the same periods in 2023. The selling, general and administrative expenses mainly relate to professional and marketing fees linked to global commercialization of VYVGART and VYVGART Hytrulo, and personnel expenses. Financial income for the third quarter and year-to-date in 2024 was $41 million and $118 million, respectively, compared to $30 million and $67 million for the same periods in 2023. The increase in financial income is mainly due to an increase in interest income on current financial assets and cash and cash equivalents. Exchange gains for the third quarter and year-to-date in 2024 were $34 million and $7 million respectively, respectively, compared to $(33) million and $(23) million of exchange losses for the same periods in 2023. Exchange gains/losses are mainly attributable to unrealized exchange rate gains or losses on the cash, cash equivalents and current financial assets position in Euro. Income tax for the third quarter and year-to-date in 2024 was $3 million and $60 million of tax benefit, respectively, compared to $11 million and $47 million of tax benefit for the same periods in 2023. Tax benefit for the nine months ended September 30, 2024 consists of $29 million of income tax expense and $89 million of deferred tax income, compared to $24 million of income tax expense and $71 million of deferred tax income for the comparable prior period. Net income for the three and nine month periods ended September 30, 2024, was $91 million and $59 million, respectively, compared to a net loss of $(73) million and $(196) million over the prior year periods. On a per weighted average share basis, the earnings per share was $0.99 for the nine months ended September 30, 2024 and a net loss per share of $(3.47) for the nine months ended September 30, 2023. Cash, cash equivalents and current financial assets totaled $3.4 billion as of September 30, 2024, compared to $3.2 billion as of December 31, 2023. The increases in cash and cash equivalents and current financial assets over the period was from financing activities due to the exercise of stock options which is offset by net cash flows used in operating and investing activities. FINANCIAL GUIDANCE With the increase in cash, cash equivalents and current financial assets in the quarter and year-to-date, the previously issued cash guidance no longer applies. The financial guidance on the combined selling, general and administrative expenses and research and development expenses remains unchanged at approximately $2 billion. EXPECTED 2024 FINANCIAL CALENDAR February 27, 2025: Full-year 2024 financial results and 4Q 2024 business update CONFERENCE CALL DETAILS The third quarter 2024 financial results and business update will be discussed during a conference call and webcast presentation today at 1:30 pm CET/8:30 am ET. A webcast of the live call and replay may be accessed on the Investors section of the argenx website at argenx.com/investors. Dial-in numbers: Please dial in 15 minutes prior to the live call. Belgium 32 800 50 201France 33 800 943355Netherlands 31 20 795 1090United Kingdom 44 800 358 0970United States 1 888 415 4250Japan 81 3 4578 9081Switzerland 41 43 210 11 32 About argenx argenx 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 approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, China and Canada. 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, X/Twitter, Instagram, Facebook, and YouTube. For further information, please contact: Media: Ben Petokbpetok@argenx.com Investors:Alexandra Roy (US)aroy@argenx.com Lynn Elton (EU)lelton@argenx.com Forward-looking Statements The 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 “aim,” “achieve,” “advance,” “bring,” “complete,” “expect,” “initiate,” “plan,” “reach,” “start,” “support,” “to be,” or “will,” and include statements argenx makes regarding its goal to reach more gMG patients in an early-line setting; its growth opportunity; its Vision 2030 plan, including (1) transforming the treatment of autoimmune diseases by strengthening its leadership in FcRn biology, (2) investing in its continuous pipeline of differentiated antibody candidates, (3) scaling in a disciplined way to ensure innovation, and (4) reaching 50,000 patients globally with an argenx medicine, 10 labeled indications across all approved assets, and five new molecules in Phase 3 development; the advancement of anticipated clinical development, data readouts and regulatory milestones and plans, including (1) the anticipated timing of additional VYVGART regulatory decisions on approval for gMG in Australia, Saudi Arabia, and South Korea, (2) the anticipated timing of VYVGART SC regulatory submissions for CIDP, including decisions on approval in China, Japan, and Europe and an anticipated regulatory submission filing in Canada, (3) the anticipated timing of the initiation of a registrational study for efgartigimod in primary SjD, (4) the anticipated timing of a confirmatory study of efgartigimod in primary ITP, (5) the anticipated timing of topline data from Phase 2/3 ALKIVIA study evaluating efgartigimod across three myositis subsets, (6) the anticipated timing of an update on the BALLAD study development plan evaluating efgartigimod in BP, (7) the anticipated timing of proof-of-concept study data for efgartigimod in LN, (8) the anticipated timing of the initiation of a study on efgartimod in SSc, (9) the anticipated timing of the initiation of a registrational study of empasiprubart for MMN, (9) the anticipated timing of the initiation of a registrational study of empasiprubart in CIDP, (10) the anticipated timing of the initiation of Phase 1 studies of ARGX-213 and ARGX-121, (11) the anticipated timing of the filing of investigational new drug applications for ARGX-220 and ARGX-109; the advancement of empasiprubart; its 2024 selling, general and administrative expenses and research and development expenses; the anticipated timing of releases of future financial results and business updates; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. 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, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third parties suppliers, service provides and manufacturing; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. 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 to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.