Group 1 - Celldex will participate in upcoming investor conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, TD Cowen Immunology & Inflammation Summit on November 13, and the 8th Annual Evercore Healthcare Conference on December 2 [1][3] - Live webcasts of the presentations will be available on the "Events & Presentations" page of the Celldex website, with replays accessible for 90 days following each event [1] Group 2 - Celldex is focused on pioneering new therapies in immunology, particularly through novel antibody-based treatments aimed at improving the lives of patients with allergic, inflammatory, and autoimmune disorders [2]

Core Insights - Celldex announced new data on barzolvolimab's efficacy in chronic spontaneous urticaria (CSU) at the ACAAI Annual Scientific Meeting, highlighting its potential to transform treatment for patients suffering from this debilitating condition [1][2] Study Results - The Phase 2 study met its primary endpoint, showing significant improvement in UAS7 scores compared to placebo at 12 weeks across all dose groups [4] - Barzolvolimab achieved rapid complete response rates (UAS7=0) in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks [4] - Seven months post-treatment, 41% of patients reported a complete response, and 48% indicated their quality of life was no longer affected by the disease [4] - Patients on barzolvolimab experienced an average improvement of 8.6 points in UCT7 scores from baseline at Week 12, compared to 2.5 points for placebo [7] - At Week 52, 71% of patients achieved complete disease control (UCT7=16) and 86% achieved well-controlled disease (UCT7>12) at the 150 mg Q4W dose [7] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile, with mild side effects such as hair color changes and skin hypopigmentation being reversible after treatment discontinuation [4][7] Ongoing Research - The company is currently enrolling patients in a global Phase 3 Program for barzolvolimab, consisting of two trials aimed at establishing its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [5][10] Background on CSU - Chronic spontaneous urticaria (CSU) is characterized by hives or wheals lasting six weeks or longer without identifiable triggers, often leading to significant patient discomfort and reduced quality of life [11]

Core Insights - Celldex announced positive data from the Phase 1 study of CDX-622, a bispecific antibody targeting inflammation and fibrosis pathways [1][2] - The study demonstrated good tolerability, a favorable pharmacokinetic profile, and significant reductions in serum tryptase levels, indicating effective mast cell inhibition [1][6] - The company plans to advance the study to the next phase, testing multiple ascending doses and initiating a Phase 1b study in asthma patients [2][4] Study Design and Results - The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 [4][7] - Part 1 enrolled 32 participants across 4 cohorts, receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) over a 12-week observation period [4][6] - Data from Part 1 were presented, and enrollment for Part 2 is ongoing, with results from Parts 2 and 3 expected in Q3 2026 [4][6] Mechanism and Therapeutic Potential - CDX-622 targets two validated pathways: neutralizing TSLP and depleting mast cells via SCF starvation, potentially offering enhanced therapeutic benefits for inflammatory and fibrotic disorders [5][6] - The antibody showed a serum half-life of approximately 18 days at 9 mg/kg, with no evidence of immunogenicity or dose-limiting toxicities observed [6][2] - A single dose led to a rapid and sustained decrease of about 50% in circulating tryptase, consistent with systemic mast cell inhibition [6]

Core Viewpoint - Celldex Therapeutics, Inc. (NASDAQ:CLDX) is viewed as a small-cap stock with potential upside, but Barclays has initiated coverage with an Underweight rating and a $25 price target due to safety concerns and competitive pressures [1][3]. Group 1: Company Overview - Celldex Therapeutics, Inc. develops, manufactures, and commercializes novel therapeutics for human health care, with a pipeline that includes Varlilumab, CDX-1140, CDX-301, and CDX-3379 [3]. Group 2: Investment Analysis - Barclays highlighted that while there is binary risk associated with small and mid-cap biotechnology stocks, investments backed by de-risked mechanisms of action and prior clinical data present a favorable risk-reward profile [2]. - The firm noted that the market is currently favorable towards new mechanisms and modes of action that could enhance dosing frequency and patient compliance [2]. Group 3: Clinical Data and Market Position - Despite the encouraging clinical data for Celldex's lead molecule barzolvolimab, the shares are not expected to provide significant upside through 2026 due to safety liabilities and a competitive landscape [3].

Group 1 - Celldex Therapeutics, Inc. (NASDAQ: CLDX) shares have increased over 70% from their 60-month low in April 2025, which was attributed to high discontinuation rates for their lead asset, barzolvolimab [2] - The company is involved in mast cell therapy and has faced challenges with its primary asset, impacting its stock performance [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates [2]

Core Insights - Celldex announced new data showing the efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), demonstrating significant improvement regardless of baseline immunoglobulin E (IgE) levels [1][3][5] Group 1: Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - Complete response rates (UAS7=0) were observed in up to 51% of patients at 12 weeks, increasing to 71% at 52 weeks, with 41% of patients reporting a complete response at 76 weeks [5][8] - The study demonstrated similar efficacy in patients with low (<40) and normal/high (>40) IgE levels, reinforcing the role of mast cells in CSU [8][9] Group 2: Mechanism and Treatment Potential - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The drug shows promise as a treatment for all patients with moderate to severe CSU, particularly those with low IgE levels who typically respond poorly to existing therapies [3][8] Group 3: Ongoing Research and Development - Celldex is currently enrolling patients in a global Phase 3 program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] - The ongoing studies also include patients who have not responded to biologic treatments, indicating a broad potential application for barzolvolimab [6][10] Group 4: Background on CSU - Chronic spontaneous urticaria (CSU) is characterized by hives or wheals lasting for 6 weeks or longer without identifiable triggers, often leading to significant patient discomfort and reduced quality of life [11] - Current therapies provide only symptomatic relief for some patients, highlighting the need for more effective treatments like barzolvolimab [11]

Core Insights - Celldex announced new data showing rapid and strong efficacy of barzolvolimab in treating chronic spontaneous urticaria (CSU), regardless of baseline immunoglobulin E (IgE) levels [1][3][8] Study Results - The Phase 2 study of barzolvolimab met its primary endpoint, showing significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [5][9] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks; 41% of patients reported a complete response at 76 weeks [5][8] - The study demonstrated a well-tolerated safety profile throughout the treatment period [5] Mechanism of Action - Barzolvolimab targets mast cells by binding to the receptor tyrosine kinase KIT, inhibiting its activity, which is crucial for mast cell function and survival [1][7] - The data reinforces the role of mast cells as key drivers of CSU, indicating that barzolvolimab could be a meaningful treatment for all patients, including those with low IgE levels [3][8] Ongoing Research - Celldex is currently enrolling patients in a global Phase 3 Program for barzolvolimab, consisting of two trials designed to establish its efficacy and safety in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment [6][10] About Chronic Spontaneous Urticaria (CSU) - CSU is characterized by hives or wheals lasting 6 weeks or longer without identifiable triggers, often resulting from mast cell activation [11]

Core Viewpoint - The session at the Morgan Stanley Global Healthcare Conference features the Celldex team, focusing on their company background and lead asset [1][2]. Company Background - Celldex is being introduced to attendees who may not be familiar with the company and its operations [2]. Lead Asset - The discussion will include details about Celldex's lead asset, which is a significant focus for the company [2].

Group 1 - The session is part of the Morgan Stanley Global Healthcare Conference, focusing on the biotech sector [1] - Judah Frommer serves as an equity analyst specializing in SMid biotech [1] - The Celldex team is being welcomed to present their company and lead asset [2] Group 2 - The conference aims to provide insights for those less familiar with Celldex and its offerings [2]

Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Industry**: Biotech, specifically in immunoinflammatory diseases - **Lead Asset**: Barzolvolimab (CDX-0159), an antibody targeting KIT (CD117) [2][4] Key Points and Arguments Clinical Development - **Current Studies**: - Two Phase III studies in Chronic Spontaneous Urticaria (CSU) with 1,830 patients across 480 sites in over 40 countries [2] - Two indications in urticaria: cold urticaria and symptomatic dermographism, with 12-week data meeting all endpoints [2][3] - Upcoming 20-week data readout expected in Q4 2025 and 44-week data in early 2026 [3] - Phase II studies ongoing for Prurigo Nodularis (PN) and atopic dermatitis [3][4] Efficacy and Safety Data - **76-week Data**: 41% of patients had a sustained complete response seven months after stopping Barzolvolimab, significantly higher than the expected <10% spontaneous remission rate [8][10] - **Safety Profile**: Adverse events (AEs) related to KIT were reversible, with no long-term clinical impact observed [10][17] - **KOL Reactions**: Positive feedback from Key Opinion Leaders (KOLs) regarding the long-term efficacy and safety data [14][15] Market Positioning - **Market Opportunity**: Barzolvolimab is positioned to treat a wide range of patients, including those refractory to antihistamines and those with varying IgE levels [30][31] - **Competition**: Focus on standard of care rather than competing with other KIT programs, as Barzolvolimab is in Phase III while competitors are further behind [41] Financials and Runway - **Cash Position**: $630 million at the end of the quarter, expected to last through 2027 and into 2028 [47] - **Upcoming Milestones**: Key readouts include Phase III for CSU, Sindu study, and Phase II studies for AV and PN [47] Additional Insights - **Mast Cell Role**: The importance of mast cells in various indications is being validated, particularly in chronic itch and atopic dermatitis [6][7] - **Bispecific Pipeline**: CDX-622, a bispecific targeting TSLP and stem cell factor, is in early studies with potential applications in asthma and other pulmonary conditions [42][43] - **Regulatory Environment**: No significant changes noted with the FDA; however, the company is monitoring potential impacts from tariffs and pricing strategies [56][60] Conclusion Celldex Therapeutics is advancing its lead asset, Barzolvolimab, through critical clinical trials with promising efficacy and safety data. The company is well-positioned in the market with a strong cash runway and a focus on expanding its therapeutic pipeline.