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.

HAMPTON, N.J., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced that management will participate in a fireside chat today, September 9th, 2025, at the Morgan Stanley 23rd Annual Global Healthcare Conference at 3:20 pm ET. A live webcast of the presentation will be available on the "Events & Presentations” page of the "Investors" section of the Celldex website. A replay will be available for 90 days following the event. About CelldexCelldex is pioneering new horizons in i ...

Core Insights - Celldex Therapeutics, Inc. announced topline results from its Phase 2 study of barzolvolimab for eosinophilic esophagitis (EoE), meeting the primary endpoint of mast cell depletion but failing to show clinical improvement in symptoms [1][2][6] Study Results - The study aimed to assess the effect of barzolvolimab on intraepithelial mast cells and clinical outcomes in EoE [1] - The primary endpoint was met with a significant reduction in peak esophageal intraepithelial mast cell count, showing an absolute change from baseline of -36.0 for barzolvolimab compared to -2.7 for placebo at Week 12 [5][6] - Despite the significant mast cell depletion, no improvement in EoE symptoms was observed, with p-values of 0.33 for the Dysphagia Symptom Questionnaire and 0.95 for endoscopic scoring [6][7] Safety Profile - Barzolvolimab exhibited a favorable safety and tolerability profile consistent with previous studies [2][7] - The dosing regimen of 300 mg Q4W was well-tolerated, showing no significant adverse effects compared to less frequent dosing in earlier studies [7] Future Directions - Following these results, Celldex will not pursue further development of barzolvolimab for EoE but will continue to advance its pipeline, including ongoing studies in chronic spontaneous urticaria and plans for a Phase 3 program in inducible urticaria [3][4]

Summary of Celldex Therapeutics (CLDX) Conference Call - August 19, 2025 Company Overview - **Company**: Celldex Therapeutics (CLDX) - **Focus**: Development of therapies targeting mast cell biology, particularly in eosinophilic esophagitis (EOE) and other indications Key Points from the Conference Call Industry and Company Insights - **Phase II Study Results**: The conference discussed the top line results from the Phase II study of bardezolizumab in EOE, highlighting the challenges in treating this disease and the need for effective treatment options [2][5] - **Mast Cell Role**: The study aimed to explore the role of mast cells in EOE, with findings suggesting that mast cells are not the primary drivers of the disease despite significant depletion [5][14] Core Findings and Data - **Study Design**: The study was a randomized, double-blind, placebo-controlled trial involving 65 patients, assessing the impact of bardezolizumab on mast cell counts and clinical outcomes [8][10] - **Primary Endpoint**: The primary endpoint was met, showing a significant reduction in peak mast cell counts from baseline to week twelve, with a decrease of 36 cells per high power field in the treatment group compared to a decrease of 2.7 in the placebo group (p < 0.0001) [12][13] - **Clinical Outcomes**: Despite the significant mast cell depletion, there was no improvement in dysphagia scores or other clinical outcomes compared to placebo, indicating that mast cell depletion does not translate to clinical benefit in EOE [14][15] - **Safety Profile**: Bardezolizumab demonstrated a favorable safety profile, with common adverse events including hair color changes and nasopharyngitis, but no serious adverse events related to treatment [15][16] Future Directions - **Development Plans**: The company will not pursue further development of bardezolizumab in EOE but remains committed to advancing mast cell science and exploring other indications where mast cells may play a role [18][19] - **Ongoing Studies**: Bardezolizumab is being studied in five indications, including chronic spontaneous urticaria and atopic dermatitis, with plans to initiate a Phase III program in cold urticaria [19][20] - **Bispecific Antibody Approach**: The company is considering a bispecific antibody approach to target mast cells alongside other pathways for future indications [38][54] Additional Considerations - **Subgroup Analyses**: There is potential for further analysis of the data to understand varying endotypes of EOE, although the small sample size may limit the significance of such analyses [42][43] - **Indication Expansion**: The company plans to add additional indications to its pipeline, with insights expected in the coming year based on ongoing studies [46][48] Conclusion - **Commitment to Innovation**: Celldex Therapeutics remains focused on driving innovation in mast cell science and delivering therapies that can significantly impact patient care, despite the setbacks in the EOE study [70]

Core Insights - Celldex Therapeutics reported topline results from a Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating that while the primary endpoint of mast cell depletion was met, there was no improvement in EoE symptoms or endoscopic assessments compared to placebo [1][4][5] - The company will not pursue further development of barzolvolimab for EoE but will continue to explore its potential in other gastrointestinal indications [1][2] Study Design and Results - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 65 patients with moderate to severe EoE, assessing the efficacy and safety of subcutaneous barzolvolimab [4][6] - The primary endpoint was the reduction in peak esophageal intraepithelial mast cell count at 12 weeks, which was achieved with a significant reduction of -36.0 in the barzolvolimab group compared to -2.7 in the placebo group (p=<0.0001) [5][6] - Despite the significant mast cell depletion, no clinical improvement was observed in EoE symptoms (p=0.33) or endoscopic scoring (p=0.95) [5][6] Safety Profile - Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with previous studies [5][6] - An unblinded review of data through the full treatment period (28 weeks) showed consistent clinical and safety outcomes [5] Future Development Plans - Celldex is focusing on advancing barzolvolimab's pipeline, with ongoing enrollment in four studies, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis [2][8] - Plans are also being finalized to initiate a Phase 3 program in inducible urticaria, which will include cold urticaria and symptomatic dermographism [2][8]

Company Performance - Celldex Therapeutics reported a quarterly loss of $0.85 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.86, but worse than a loss of $0.54 per share a year ago, indicating a year-over-year decline [1] - The company posted revenues of $0.73 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 56.18%, and down from $2.5 million in the same quarter last year [2] - Over the last four quarters, Celldex has surpassed consensus EPS estimates three times, but has only topped consensus revenue estimates once [2] Stock Performance - Celldex shares have declined approximately 15.2% since the beginning of the year, contrasting with the S&P 500's gain of 7.9% [3] - The current Zacks Rank for Celldex is 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Future Outlook - The consensus EPS estimate for the upcoming quarter is -$0.90 on revenues of $1.63 million, and for the current fiscal year, it is -$3.48 on revenues of $3.7 million [7] - The outlook for the Medical - Biomedical and Genetics industry, where Celldex operates, is currently in the top 41% of over 250 Zacks industries, indicating a favorable environment for potential stock performance [8]