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]

Company Overview - WellTheory, a health technology startup focused on autoimmune care, has secured $14 million in Series A funding led by General Catalyst, with participation from several other investors [1][2] - The company was founded by Ellen Rudolph in 2022, aiming to transform traditional care models for autoimmune diseases through holistic and personalized programs [2] Market Opportunity - The autoimmune disease market is significant, with over 50 million Americans affected by conditions such as rheumatoid arthritis, lupus, and multiple sclerosis, a number that has more than doubled in the last 30 years [3] - The economic burden of autoimmune diseases is projected to reach $180 billion by 2025, with costs expected to double in the next 15 years if new treatments do not emerge [4] Business Model and Services - WellTheory offers personalized care plans for over 100 distinct autoimmune diagnoses, focusing on the root causes of symptoms rather than treating them in isolation [4] - The company utilizes proprietary AI tools, including Care Hub and Care Scribe, to streamline treatment plans and improve operational efficiency [5] Team and Support Structure - Members of WellTheory work with a human care team that includes a registered dietitian, a certified health coach, and a care coordinator, providing one-on-one sessions and unlimited messaging [6] Funding Significance - The recent funding round is notable as all institutional investors involved were female partners, highlighting the rarity of female-led startups receiving venture capital, which accounts for less than 2% of total funding [6]

Core Insights - argenx SE is set to present pivotal data for its therapies VYVGART and empasiprubart at the upcoming AANEM Annual Meeting and MGFA Scientific Session, highlighting its commitment to addressing severe autoimmune diseases [1][2] Group 1: VYVGART Developments - VYVGART is being expanded into new patient populations, with data showcasing its potential to treat a broad set of myasthenia gravis patients, including those who are anti-acetylcholine receptor antibody negative [6][7] - The Phase 3 ADAPT SERON study results indicate clinically meaningful improvements in disease activity across all subtypes of generalized myasthenia gravis [7] - Real-world evidence and long-term data reinforce VYVGART's sustained impact on patient outcomes, with over 40 abstracts presented across various neuromuscular diseases [6][7] Group 2: Empasiprubart Progress - Empasiprubart is being evaluated in multiple studies, including Phase 3 trials EMVIGORATE and EMNERGIZE for chronic inflammatory demyelinating polyneuropathy (CIDP), demonstrating argenx's commitment to innovative therapies [7][31] - The Phase 2 ARDA study highlights the clinical efficacy and safety of empasiprubart in multifocal motor neuropathy (MMN), with a Phase 3 study design (EMPASSION) planned to compare its efficacy against intravenous immunoglobulin [7][31] Group 3: Conference Presentations - The AANEM and MGFA sessions will feature oral and poster presentations detailing the clinical development programs for VYVGART and empasiprubart, emphasizing their potential benefits for patients with autoimmune and neuromuscular diseases [6][9] - Key presentations will include results from the ADAPT Jr study investigating VYVGART in juvenile generalized myasthenia gravis and real-world data on glucocorticoid use reduction following efgartigimod initiation [8][9]

Core Insights - Vor Bio announced positive results from a Phase 3 study of telitacicept in primary Sjögren's disease, achieving significant improvements in disease activity compared to placebo [1][2][4] - The study demonstrated a favorable safety profile and sustained efficacy over 48 weeks, indicating potential for telitacicept to be a leading treatment option in this area [2][4] - The company is considering the timing for a global Phase 3 clinical study to expand the treatment's availability [2] Company Overview - Vor Bio is a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, particularly through the development of telitacicept [9] - Telitacicept is designed to inhibit key cytokines involved in B cell survival, addressing the underlying causes of autoimmune conditions rather than just managing symptoms [7][9] - The company has previously achieved approval for telitacicept in China for conditions such as systemic lupus erythematosus and rheumatoid arthritis, and is currently conducting a global Phase 3 trial for generalized myasthenia gravis [8] Study Details - The Phase 3 trial was randomized, double-blind, and placebo-controlled, involving 381 patients with active, anti-SSA-positive primary Sjögren's disease [2][3] - Key endpoints included changes in ESSDAI and ESSPRI at multiple time points, with significant improvements noted at both 24 and 48 weeks [3][4] - At week 24, 71.8% of patients receiving telitacicept 160mg achieved a ≥3-point reduction in ESSDAI compared to 19.3% on placebo, with similar results at week 48 [1][4] Disease Context - Primary Sjögren's disease is a chronic autoimmune condition characterized by inflammation and damage to moisture-producing glands, leading to symptoms such as dry eyes and mouth, fatigue, and systemic complications [5][6] - The disease is underdiagnosed, with a significant unmet need for effective therapies, as current treatments primarily focus on symptom management [6] - Telitacicept's dual-target mechanism may provide a novel approach to treating this condition by reducing autoreactive B cells and autoantibody production [7]

Awards & Recognition - Immunology field sees three immunologists receive the 2025 award for pioneering discoveries [1] - Discoveries are related to the immune system and autoimmune diseases [1]