Galapagos and Gilead Enter into Binding Agreement to Collaborate on Advancing First in Class T Cell Engager Program for Autoimmune Diseases Conference Call March 31, 2026 Forward-Looking Statements This presentation contains forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "believe," "anticipate," "expect," "intend," "plan," "seek," "upcoming," "future," "estimate," "may," "will, ...

Core Insights - Argenx SE will present data for VYVGART and pipeline candidates at the 2026 American Academy of Neurology Annual Meeting, highlighting advancements in treatments for severe autoimmune diseases [1][2][36] Group 1: VYVGART Developments - New Phase 3 results in ocular myasthenia gravis (oMG) will demonstrate VYVGART's potential as a targeted treatment option for patients [2][6] - Positive results from the Phase 3 ADAPT OCULUS study confirm VYVGART's therapeutic potential in adults with oMG, marking a significant advancement in treatment options [5][6] - Data from the ADAPT SERON study supports VYVGART's efficacy across broader patient populations, including generalized myasthenia gravis (gMG) patients without detectable anti-acetylcholine receptor antibodies [6][38] Group 2: Pipeline Candidates - Argenx will share results from the ARGX-119 Phase 1b trial evaluating adimanebart in patients with DOK7 congenital myasthenic syndromes, showing a favorable safety profile and functional improvements [4][38] - Empasiprubart is being evaluated for multiple severe autoimmune indications, including chronic inflammatory demyelinating polyneuropathy (CIDP) and delayed graft function following kidney transplant [28][36] Group 3: CIDP Insights - Results from an ADHERE post hoc analysis will highlight VYVGART Hytrulo's impact in treatment-naïve CIDP patients, supporting its earlier use in treatment paradigms [3][38] - Real-world insights will illustrate physician approaches to transitioning patients from intravenous immunoglobulin (IVIg) to VYVGART Hytrulo, aiming to enhance patient outcomes [3][38]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $77.1 million, up 29% from $59.9 million in Q4 2024 [4] - Net product sales of LUPKYNIS for Q4 2025 were $74.2 million, up 29% from $57.6 million in Q4 2024 [4] - Net income for Q4 2025 was $210.8 million, up 14,957% from $1.4 million in Q4 2024, primarily due to a significant income tax benefit [4] - Diluted earnings per share for Q4 2025 was $1.53, up 15,200% from $0.01 in Q4 2024 [5] - Total revenue for the year ended December 31, 2025, was $283.1 million, up 20% from $235.1 million in 2024 [6] - Net income for the year ended December 31, 2025, was $287.2 million, up 4,852% from $5.8 million in 2024 [6] Business Line Data and Key Metrics Changes - Net product sales of LUPKYNIS for the year ended December 31, 2025, were $271.3 million, up 25% from $216.2 million in 2024 [6] - Cash flows from operating activities for Q4 2025 were $45.7 million, up 52% from $30.1 million in Q4 2024 [5] - Cash flows from operating activities for the year ended December 31, 2025, were $135.7 million, up 206% from $44.4 million in 2024 [7] Market Data and Key Metrics Changes - The company expects net product sales of $305 million to $315 million for 2026, representing a 12%-16% increase compared to 2025 [3][8] - The company repurchased 12.2 million common shares for $98.2 million, reducing fully diluted shares outstanding from 149.8 million to 139.7 million [7] Company Strategy and Development Direction - The company is focused on the growth of LUPKYNIS while advancing the clinical development of aritinercept, a novel biologic for autoimmune diseases [9][10] - The strategy includes leveraging data on the efficacy of LUPKYNIS and promoting early diagnosis and treatment of lupus nephritis [14][27] - The company aims to change the treatment paradigm by emphasizing the importance of early identification and aggressive treatment of proteinuria [14][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of LUPKYNIS, citing strong adherence and persistency among patients [24] - The management acknowledged the competitive landscape but emphasized the unique benefits of LUPKYNIS, particularly its speed in reducing proteinuria [36][38] - The company does not expect significant contributions from international markets compared to the U.S. due to varying pricing and reimbursement structures [42][43] Other Important Information - The company terminated the phase 3 VOCAL study due to recruitment challenges and plans to negotiate with the FDA regarding pediatric commitments [16][17] - Management is optimistic about the potential of aritinercept and plans to initiate clinical studies in additional autoimmune diseases in 2026 [10][22] Q&A Session Summary Question: Guidance for 2026 seems conservative; what are the underlying assumptions? - Management explained that the guidance is based on historical growth patterns and current market conditions, with no extraordinary trends observed in early 2026 [12][15] Question: Clarification on the termination of the VOCAL study and FDA's stance? - The study was terminated due to recruitment difficulties, and management plans to discuss pediatric commitments with the FDA [16][17] Question: Update on AURINIAcept development? - Management confirmed that updates will be provided in the second quarter of 2026, with no preferential indication currently identified [20][50] Question: Impact of Gazyva's approval on LUPKYNIS? - Management stated that there has been no immediate impact on LUPKYNIS sales, and the guidance incorporates various competitive factors [34][35] Question: Are doctors combining B-cell and T-cell therapies? - Management noted that there is potential for combining therapies, and discussions are ongoing regarding the efficacy of such combinations [45][46]

Core Insights - OneMedNet Corporation has announced a strategic partnership with ViuHealth to enhance its Real-World Data (RWD) offerings, particularly in the autoimmune disease sector [1][2] Group 1: Partnership Details - The partnership will integrate ViuHealth's longitudinal autoimmune disease data into OneMedNet's iRWD™ platform, which is powered by Palantir Foundry, thereby increasing the scale and diversity of regulatory-grade RWD [2][6] - ViuHealth will provide ongoing data that captures patient journeys, treatment adherence, flares, and outcomes, which will support pharmaceutical partners in drug discovery and market strategies [3][4] Group 2: Market Opportunity - The autoimmune therapeutics market is projected to exceed $166 billion globally in 2026, indicating a significant opportunity for pharmaceutical and biotechnology companies to leverage the enriched datasets for drug development and regulatory evidence [3][14] - Autoimmune diseases affect approximately 8% of the U.S. population, representing tens of millions of individuals, creating strong demand for longitudinal real-world data in life sciences and digital health [5][14] Group 3: Revenue Growth Strategy - This partnership is expected to drive OneMedNet's subscription revenue growth by integrating high-value, disease-specific data into the iRWD™ platform, making it more attractive for ongoing subscriptions rather than one-time sales [4][14] - The collaboration aims to create predictable Annual Recurring Revenue (ARR) and enhance customer retention through expanded data feeds [14] Group 4: Company Positioning - OneMedNet is positioning itself as a trusted data infrastructure provider in specialty disease areas, reinforcing its role in the rapidly growing real-world data and AI-enabled healthcare markets [7][8] - The company aims to build repeatable, subscription-oriented data partnerships that generate continuous data flows, enhancing its ability to deliver relevant cohorts reflecting real-world patient journeys [7][14]

Summary of Climb Bio's Conference Call Company Overview - **Company**: Climb Bio - **Focus**: Autoimmune diseases with two antibodies in clinical development Key Points Upcoming Milestones - Climb Bio has five clinical data readouts scheduled for this year - Monoclonal antibody targeting CD19: - Data on subcutaneous (subQ) formulation in healthy volunteers expected in the first half of the year - Initial data from Phase 1b studies in Immune Thrombocytopenic Purpura (ITP) and Systemic Lupus Erythematosus (SLE) in the second half - Initial data from Phase 2 study in Primary Membranous Nephropathy (PMN) also expected in the second half - Second antibody, an APRIL-only antibody for IgA nephropathy, will have data available mid-year [2][3][4] Competitive Landscape - UPLIZNA is currently the only approved CD19 antibody, focusing on rare neuro diseases - Climb Bio's CD19 antibody is believed to have greater affinity and a subQ formulation option, which UPLIZNA lacks [5][7][11] PMN Indication - No approved therapies currently exist for PMN; standard care includes off-label use of rituximab - Rituximab achieves complete renal remission in only 10% of patients after one year and 35% after two years - Climb Bio's Phase 1b study showed a 60% complete remission rate and 100% serological remission in PLA2R antibody-positive patients [14][15][32] Market Opportunity - Approximately 70,000 patients in the U.S. have PMN, with two-thirds requiring therapeutic intervention - Regulatory strategy involves one Phase 3 study with around 150 patients, focusing on proteinuria as the primary endpoint [32][34] ITP and SLE Indications - ITP has a strong rationale for CD19 targeting, with only 20% of refractory patients achieving a durable platelet response - SLE is viewed as a more complex indication, requiring larger pivotal trials; Climb Bio is conducting a parallel study in China for lupus nephritis patients [39][40][41] APRIL Antibody Development - Climb Bio's APRIL-only antibody (CLYM116) features a unique sweeper mechanism, allowing for high-affinity binding and potential for longer half-life - Early studies indicate a two- to threefold longer half-life compared to existing therapies, with better activity in IgA suppression [48][56][60] Financial Position - Climb Bio reported $176 million in cash at the end of Q3, with a runway extending into 2028, covering all planned readouts for the year [93][95] Future Indications - Climb Bio is exploring additional indications for the APRIL antibody, including Sjögren's syndrome, to maximize asset potential [90][91] Conclusion - Climb Bio is positioned to address significant unmet needs in autoimmune diseases with promising clinical data and a strong financial foundation, paving the way for potential market success in the coming years [2][93][95]

Core Insights - Kyverna Therapeutics has appointed Mayo Pujols as Chief Technology Officer, effective February 9, 2026, to support the launch of its CAR T-cell therapy, miv-cel [1][2][3] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel (mivocabtagene autoleucel, KYV-101) [7] - The company aims to revolutionize treatment for B-cell-driven autoimmune diseases and is advancing its neuroimmunology franchise with ongoing registrational trials [7] Leadership Transition - Mayo Pujols brings over 30 years of experience in technical operations, particularly in cell and gene therapies, succeeding Karen Walker, who is retiring but will assist in the transition [2][3] - Pujols has held significant roles in various biopharmaceutical companies, including COO at Castle Creek Biosciences and CTO at Rocket Pharmaceuticals, where he guided gene therapy programs through regulatory milestones [3][4] Miv-cel Therapy - Miv-cel is a fully human, autologous CAR T-cell therapy targeting CD19, designed for potency and tolerability, and is under investigation for B-cell-driven autoimmune diseases [6] - The therapy has the potential to achieve deep B-cell depletion and reset the immune system, aiming for durable, drug-free remission in autoimmune conditions [6] Inducement Grant - In connection with Pujols' appointment, Kyverna will grant him an option to purchase 300,000 shares of common stock, which will vest over four years [5]

Core Insights - Teva Pharmaceuticals has entered a funding agreement with Royalty Pharma to receive up to $500 million for the development of its anti-IL-15 antibody, TEV-'408, which is in early-stage development for vitiligo and other autoimmune diseases [1][2] Funding Agreement Details - The agreement includes $75 million for R&D co-funding of a phase IIb vitiligo study expected to start in 2026, with an option for an additional $425 million to co-fund phase III development based on phase IIb results [2] - Teva will retain rights to the drug while being responsible for milestone payments and ongoing royalties on global net sales if the drug is approved [5][11] Strategic Benefits for Teva - The collaboration with Royalty Pharma strengthens Teva's immunology pipeline, reduces financial exposure, and accelerates the development of TEV-'408, allowing for faster clinical progression [3][4] - Teva's shares have increased by 95% over the past six months, outperforming the industry growth of 54.1% [4] Market Potential - Vitiligo is a chronic autoimmune condition with a global prevalence of 0.5% to 2%, representing a significant unmet medical need due to limited treatment options [7] - TEV-'408 aims to address both the physical and psychosocial burdens of vitiligo by targeting the IL-15 pathway responsible for immune-driven melanocyte destruction [7] Ongoing Research and Development - Teva is also evaluating TEV-'408 in a phase IIa study for celiac disease, which received Fast Track designation from the FDA in 2025 [8] - The current collaboration with Royalty Pharma marks Teva's second agreement, following a previous deal for the development of TEV-'749 for schizophrenia [9]

Core Insights - Jade Biosciences, Inc. is focused on developing therapies for autoimmune diseases and has outlined its strategic priorities for 2026, including key milestones ahead of the J.P. Morgan Healthcare Conference [1][2] Key Program Updates - JADE101 is a fully human monoclonal antibody targeting APRIL, currently in Phase 1 trials, showing high binding affinity and engineered for extended half-life, aiming for patient-friendly dosing [3][4] - JADE201, an anti-BAFF-R monoclonal antibody, is set to enter first-in-human studies in rheumatoid arthritis patients in Q2 2026, with interim data expected in 2027 [5][8] - JADE301, a newly nominated development candidate, is in preclinical development with a Phase 1 trial expected to start in the first half of 2027 [6][14] Upcoming Milestones - Interim results from the JADE101 Phase 1 trial are expected in the first half of 2026, which will inform dose selection for subsequent trials [7] - The Phase 2 clinical trial for JADE101 in IgA nephropathy patients is anticipated to begin mid-2026, with preliminary data expected in 2027 [6][7] - JADE201's first-in-human study is expected to begin in Q2 2026, with interim data anticipated in 2027 [14] Financial Update - As of December 31, 2025, Jade expects to report approximately $336 million in cash and equivalents, providing operational runway into the first half of 2028 [9][10]

Core Insights - Orelabrutinib is the first BTK inhibitor to show significant clinical activity in a Phase 2 clinical trial for Systemic Lupus Erythematosus (SLE) [1] - Zenas BioPharma has acquired exclusive rights to develop, manufacture, and commercialize orelabrutinib for Multiple Sclerosis (MS) globally, and for non-oncology fields outside Greater China and Southeast Asia [1][5] Clinical Trial Results - In the Phase 2b study, 187 patients were randomized into three groups: orelabrutinib 75 mg once-daily, orelabrutinib 50 mg once-daily, and placebo [2] - The primary endpoint, SLE Response Index-4 (SRI-4) response rate at week 48, was met with the 75 mg group showing a response rate of 57.1% compared to 34.4% for placebo (p < 0.05) [2] - Secondary endpoints, including SRI-6 and British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response rates, were also significantly higher in the 75 mg group compared to placebo (p < 0.05) [3] Safety and Tolerability - Orelabrutinib was well tolerated, exhibiting a safety profile consistent with BTK inhibition and the disease biology of SLE [3] Development Pipeline - Zenas is advancing orelabrutinib into a Phase 3 trial for Primary Progressive MS (PPMS) and plans to initiate a Phase 3 trial for Secondary Progressive MS (SPMS) in Q1 2026 [6] - Orelabrutinib is already approved for B cell malignancies in mainland China and Singapore, marketed by InnoCare [6] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [7] - The company is advancing two late-stage molecules: obexelimab and orelabrutinib, with obexelimab being a bifunctional monoclonal antibody targeting CD19 and FcγRIIb [7][8]

Summary of Vor Biopharma FY Conference Call Company Overview - Vor Biopharma (NasdaqGS:VOR) has in-licensed telitacicept, a BAFF/APRIL inhibitor, from RemeGen, targeting autoimmune diseases with a focus on Myasthenia Gravis (MG) and Sjögren's syndrome as initial indications [3][4] Key Points Industry and Market Potential - The market for MG is projected to reach $10 billion by 2030, indicating significant growth and unmet medical needs [11] - Sjögren's syndrome is described as an underserved and untapped market, with potential comparable to lupus in terms of opportunity [19] Clinical Data and Efficacy - RemeGen's data showed a MG-ADL delta change of approximately four versus placebo, which is double the effect seen with other mechanisms in the MG space [6] - The QMG data demonstrated a substantial effect size, indicating confidence in the drug's efficacy [6] - The 48-week data showed continued improvement in MG-ADL and QMG scores, suggesting long-term durability of the treatment [16][17] Mechanism of Action - The drug works by inhibiting BAFF and APRIL, leading to selective depletion of autoreactive B cells, which is believed to contribute to its broader efficacy [13][14] - The mechanism is expected to provide a more durable and disease-modifying treatment compared to existing therapies [18] Competitive Landscape - The competitive landscape for MG is described as highly competitive but with significant unmet needs that Vor Biopharma aims to address [12][19] - The company is aware of the challenges faced by competitors regarding high placebo response rates in clinical trials and plans to implement strategies to mitigate this in their own studies [20][22] Development Strategy - Vor Biopharma plans to start Phase 3 trials for Sjögren's syndrome next year, leveraging insights from previous trials to optimize their approach [19][21] - The company has a cash runway of approximately $300 million, sufficient to fund the upcoming MG global trial and part of the Sjögren's study [28] Commercialization Plans - Vor Biopharma intends to commercialize the drug independently to maximize value, supported by an experienced medical affairs team [28] Additional Insights - The company has a strong focus on training investigators and patients to minimize variability and placebo responses in clinical trials [22][23] - Vor Biopharma is positioned as a first mover in both MG and Sjögren's with its BAFF/APRIL inhibitor, differentiating itself from competitors targeting other indications [26][27]