Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 11, 2025 - **Key Executives Present**: Tibor Keler (Chief Scientific Officer), Diane Young (Chief Medical Officer), Sarah Cavanaugh (SVP Corporate Affairs) Key Industry Insights - **Urticaria Programs**: 2025 has been a significant year for Celldex, particularly with advancements in their urticaria programs, including chronic spontaneous urticaria (CSU) and inducible urticaria [2][3] - **Data Presentation**: The company presented 76-week data from the CSU program, showcasing high efficacy and off-treatment durability, with a 41% complete response rate seven months post-treatment [5][6] - **Phase Three Studies**: Ongoing phase three studies in CSU and a new phase three study for inducible urticaria set to begin in December [2][10] Core Product Insights - **Barzolimab**: The drug has shown unprecedented off-treatment durability compared to existing treatments like Xolair and Dupixent, which typically see symptom recurrence shortly after discontinuation [6][8] - **Safety Profile**: The safety data from the 76-week study indicates that barzolimab is well tolerated, with mild and reversible side effects [8][9] Pipeline Developments - **CDX-622 Program**: Recent data from the CDX-622 program indicates a promising future for 2026, with a focus on targeting both TSLP and stem cell factor [3][36] - **Inducible Urticaria Study**: The phase two study for inducible urticaria reported that about two-thirds of cold urticaria patients achieved a complete response at 20 weeks [15][16] - **Future Studies**: Plans for phase two studies in prurigo nodularis (PN) and atopic dermatitis (AD) are underway, with expectations for data in the second half of next year [25][26][31] Financial Position - **Cash Position**: The company reported a cash position of $583.2 million, which is expected to fund operations through 2027 [48][49] Competitive Landscape - **Market Dynamics**: The entry of competitors like Novartis with Remibrutinib is expected to expand the market for CSU treatments, which Celldex believes positions barzolimab favorably within this growing market [47] Additional Considerations - **Future Indications**: Celldex is exploring additional indications related to itch and other allergic conditions, leveraging the unique properties of their bispecific antibody portfolio [32][34][45] - **Biomarker Strategy**: The company plans to utilize biomarkers to assess the efficacy of their treatments, particularly in asthma studies [46] This summary encapsulates the key points discussed during the conference call, highlighting the advancements, pipeline developments, and strategic positioning of Celldex Therapeutics in the biopharmaceutical industry.

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations net of tax of $166 million for the quarter [24] - Cash and cash equivalents stood at $4.4 billion with no debt on the balance sheet, indicating a strong capital position [24][25] Business Line Data and Key Metrics Changes - The company highlighted significant progress in its late-stage pipeline, with 11 potentially registrational trials and indications with blockbuster potential [8][9] - Brepocitinib's data in dermatomyositis (DM) hit all 10 ranked endpoints, with an NDA filing planned for the first half of next year [5][10] - The Graves' disease trial for batoclimab demonstrated disease-modifying potential, with a significant portion of patients achieving remission [19][20] Market Data and Key Metrics Changes - The company noted a large patient population for Graves' disease, with approximately 880,000 diagnosed patients in the U.S., of which 330,000 are uncontrolled or intolerant to current therapies [19] - The unmet medical need in the DM landscape is significant, with 75% of patients currently on only steroids or immunosuppressive therapies [11][12] Company Strategy and Development Direction - The company is focused on expanding its pipeline and achieving profitability, with a strong emphasis on the upcoming investor day to discuss future strategies [8][25] - The management expressed excitement about the potential of their therapies in addressing significant unmet needs in various indications, including Graves' disease and DM [9][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the competitive landscape in Graves' disease and expressed confidence in their product's profile and the overall market opportunity [33][60] - The company is optimistic about the upcoming data readouts and the potential for their therapies to transform treatment paradigms in their target indications [16][78] Other Important Information - The company is involved in ongoing litigation related to LNP technology, with a jury trial in the Moderna case scheduled for March 2026 [24] - The company has a favorable marketing ruling in the Pfizer case, which is expected to progress in the near future [24] Q&A Session Summary Question: What should be watched next regarding Pfizer litigation? - Management indicated that the scheduling process for the Pfizer case is underway, and more information about the timeline, including a potential trial date, will be available soon [29] Question: Thoughts on Argenx entering the Graves' market? - Management acknowledged the competitive landscape but expressed confidence in their product's competitive profile and the overall patient population's needs [33][34] Question: What to expect from the investor day? - Management stated that the investor day will provide a comprehensive overview of the company's transformation and future opportunities, with potential new data to be shared [36][38] Question: Insights on remission data for Graves' disease? - Management emphasized that deeper IgG reductions are expected to drive remission rates and that they will learn more from ongoing studies [42][44] Question: Update on the competitive landscape in Graves' disease? - Management noted the increasing competition but expressed confidence in their FcRn mechanism's safety and efficacy, which positions them well in the market [60][62] Question: Status of the overseas study with 1402? - Management confirmed that several large registrational programs are ongoing, and they will share updates as they become available [99]

Stoke Therapeutics Third Quarter 2025 Business Update Webcast for Investors & Analysts November 4, 2025 © COPYRIGHT 2025 | STOKE THERAPEUTICS | 1 Forward-Looking Statements and Other Legal Notices This presentation has been prepared by Stoke Therapeutics, Inc. ("Stoke" or "us") for informational purposes only and not for any other purpose. Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter(s) or Stoke or any officer, director, e ...

Summary of Roivant Sciences (ROIV) Update - Immunovant Graves Disease Data Update Company and Industry Overview - **Company**: Roivant Sciences (specifically focusing on Immunovant) - **Industry**: Biopharmaceuticals, specifically targeting autoimmune diseases such as Graves' disease Key Points and Arguments 1. **Data Presentation**: The call presented follow-up data from a study on Graves' disease, highlighting significant findings from a Phase II trial of birtoclimab, an anti-FcRn antibody [5][31] 2. **Patient Response**: 80% of patients (17 out of 21) remained responders six months after stopping treatment, indicating potential disease-modifying effects [6][20] 3. **Remission Rates**: Nearly 50% of responders (8 out of 17) were off antithyroid drugs (ATDs) while remaining controlled at the six-month follow-up [21][31] 4. **Unmet Need**: Approximately 25-30% of Graves' disease patients in the U.S. are uncontrolled on existing therapies, highlighting a significant market opportunity for new treatments [10][14] 5. **Safety Profile**: Birtoclimab was well tolerated with no new safety signals reported, consistent with previous findings for anti-FcRn antibodies [27] 6. **Phase III Trials**: Two registrational studies for IMBT-1402 are underway, with expectations for improved efficacy due to optimized dosing strategies [28][30] 7. **Long-term Effects**: The company plans to evaluate longer duration off-treatment effects and the potential for sustained benefits in patients [60][61] 8. **Commercial Strategy**: The data suggests a diversity of treatment effects, with some patients potentially requiring chronic therapy while others may achieve remission [61][62] Additional Important Content 1. **Disease Background**: Graves' disease is an autoimmune disorder leading to hyperthyroidism, with significant comorbidities including cardiovascular risks and thyroid cancer [9][12] 2. **Patient Population**: The study focused on patients who were uncontrolled despite standard treatments, emphasizing the severity of the disease [15][31] 3. **Biological Mechanism**: The therapy appears to disrupt feedback loops in Graves' disease, leading to sustained reductions in TRAB levels even after treatment cessation [43][60] 4. **Enrollment and Interest**: There is strong enthusiasm from both patients and physicians regarding the ongoing trials, which may enhance enrollment [44] 5. **Statistical Power**: The Phase III studies are designed with sufficient power to detect significant differences in remission rates, with stringent endpoints [102] This summary encapsulates the critical insights from the conference call regarding the advancements in treatment for Graves' disease and the strategic direction of Roivant Sciences in this therapeutic area.

Core Insights - Immunovant, Inc. presented six-month off-treatment data for batoclimab in uncontrolled Graves' disease patients, indicating potential disease modification and strong durability of response [1][2][3] Study Details - The proof-of-concept study involved a 24-week treatment with batoclimab, followed by a 24-week off-treatment follow-up, focusing on patients with active Graves' disease [3][4] - The key endpoint was the normalization of free triiodothyronine (T3) and free thyroxine (T4) levels without increasing anti-thyroid drug (ATD) doses from baseline [3] Remission Data - Out of 21 patients in the follow-up period, approximately 80% (17/21) maintained normal thyroid function at the end of six months [6][7] - Among the responders, about 50% (8/17) achieved ATD-free remission, while an additional 30% (5/17) were on low ATD doses [6][7] Future Trials - Two potentially registrational trials for Immunovant's lead compound IMVT-1402 in Graves' disease are currently enrolling, with topline readouts expected in 2027 [5][6]

Core Insights - Biogen Inc. and Stoke Therapeutics announced new clinical data for zorevunersen, an investigational treatment for Dravet syndrome, to be presented at the 36th International Epilepsy Congress [1][2] - Zorevunersen is being evaluated in the EMPEROR Phase 3 study, which aims to demonstrate its potential as a disease-modifying therapy [1][8] Company Overview - Biogen is a leading biotechnology company focused on innovative science to deliver new medicines and create shareholder value [9] - Stoke Therapeutics specializes in RNA medicine and is developing zorevunersen to restore protein expression in patients with Dravet syndrome [11] Clinical Data and Study Details - New clinical data show substantial and durable reductions in seizures and improvements in cognition and behavior for patients receiving zorevunersen alongside standard anti-seizure medications [2][4] - The EMPEROR Phase 3 study is a global, double-blind, sham-controlled trial evaluating zorevunersen's efficacy and safety in children with Dravet syndrome [8] Presentation Information - Presentations at the IEC will include data on zorevunersen's potential as a disease-modifying therapy and improvements in seizure-free days and quality of life [2][4] - Key presentations will be made by leading experts in the field, highlighting the significance of zorevunersen in treating Dravet syndrome [5][2]