Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Barzolvolimab Phase 2 CSU 76 Week Data 7 MONTHS POST ACTIVE THERAPY 2 01 Introduction Anthony Marucci, President & CEO 3 Barzolvolimab Best in Disease for All Patients1 EAACI 2025 Safe Harbor Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our us ...

Summary of Celldex Therapeutics (CLDX) Conference Call Company Overview - **Company**: Celldex Therapeutics (CLDX) - **Focus**: Development of Barzolumab for chronic spontaneous urticaria (CSU) Key Industry Insights - **Industry**: Biopharmaceuticals, specifically targeting chronic spontaneous urticaria (CSU) - **Current Treatment Landscape**: Existing treatments are inadequate for many patients, highlighting the need for new options Core Findings from the Conference Call 1. **Barzolumab Phase II Study Results**: - Barzolumab shows the highest reported complete response rate in CSU treatment at every time point [7][12][30] - Complete response rates reached 51% at 12 weeks and 71% at 52 weeks, with 41% maintaining a complete response at 76 weeks post-treatment [30][31] - 93% of patients experienced a clinically meaningful reduction in disease burden during the active treatment period [12] 2. **Patient Quality of Life**: - 92% of patients report CSU impacts all aspects of their daily lives, with significant correlations between complete response and improved quality of life [11][36] - 48% of patients reported no impact on their daily quality of life seven months after treatment [35] 3. **Safety Profile**: - Barzolumab has a well-tolerated safety profile with no new safety signals identified during the follow-up period [20][28] - Common adverse events include mild decreases in neutrophil counts and subtle pigmentation changes, which are reversible [21][24] 4. **Market Potential**: - The drug is positioned as a potential first-line treatment for patients with antihistamine-refractory moderate to severe CSU [39] - High excitement among physicians regarding Barzolumab's efficacy and safety profile, which may influence treatment decisions [39] 5. **Ongoing Research and Development**: - Phase III studies are underway, with enrollment expected to complete by summer 2026 [39] - The company is focused on confirming the efficacy and safety of Barzolumab in larger patient populations [39] Additional Important Insights - **Patient Demographics**: The study included patients with severe CSU, with 70% having a UAS7 score greater than 28 at baseline [17] - **Long-term Efficacy**: The sustained response after treatment cessation suggests potential normalization of mast cell activity in patients [44] - **Physician Perspectives**: Physicians are optimistic about the potential for Barzolumab to change treatment paradigms for CSU, particularly for patients who have not responded to existing therapies [42][46] Conclusion - Celldex Therapeutics is making significant strides in the treatment of chronic spontaneous urticaria with Barzolumab, demonstrating promising efficacy and safety data that could redefine treatment standards in this area. The ongoing Phase III studies will be crucial in validating these findings and expanding treatment options for patients suffering from this debilitating condition.

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]

Company to host webcast on Thursday, June 12 at 6:00 pm ETHAMPTON, N.J., June 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that data from the Company’s Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland. Abstracts will be available on the meeting website Thursday, June 12th at 6:01 pm ET/ Friday, June 13th at 12:01 am CEST. Celldex will host a webcast on Thursday, June 12th at 6:00 pm ET to discus ...

Core Insights - Celldex Therapeutics, Inc. has elected Denice M. Torres to its Board of Directors, bringing extensive leadership experience from the pharmaceutical and consumer healthcare sectors [1][2] - Torres expressed enthusiasm about joining Celldex at a pivotal time, highlighting the company's progress with barzolvolimab and its potential to improve treatment standards for patients [2] Company Overview - Celldex is a clinical stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, autoimmune, and other diseases [3]

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.81 per share versus the Zacks Consensus Estimate of a loss of $0.75. This compares to loss of $0.56 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.75 per share when it actually produced a loss of $0.71, delivering a surprise of 5.33%.Over the last four quarters, the c ...

Clinical Trials and Efficacy - Barzolvolimab (CDX-0159) achieved primary efficacy endpoints in Phase 2 studies for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), with statistically significant mean changes from baseline to week 12 compared to placebo[65]. - The company initiated Phase 3 studies in CSU in July 2024, following successful Phase 2 results, and plans to present follow-up data through week 76 in 2025[81]. - Ongoing Phase 2 studies for Barzolvolimab include eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD), with enrollment ongoing for AD initiated in December 2024[73][82]. - The Phase 2 study in chronic inducible urticaria (CIndU) achieved all secondary endpoints, which were highly statistically significant and clinically meaningful[81]. - Barzolvolimab demonstrated a statistically significant mean change from baseline to week 12 in UAS7 compared to placebo at all dose levels, with a mean change of -23.87 for 300 mg Q8W, -23.02 for 150 mg Q4W, and -17.06 for 75 mg Q4W[92]. - At week 12, 37.5% of patients in the 300 mg group achieved complete control (UAS7=0), compared to 51.1% in the 150 mg group and 22.9% in the 75 mg group, while only 6.4% in the placebo group achieved the same[92]. - Approximately 72% of patients had angioedema at baseline, with barzolvolimab showing significant improvements in AAS7 across all doses at week 12, achieving a >8 point improvement compared to placebo[95]. - Long-term treatment data presented indicated sustained and deepening disease efficacy over a 52-week treatment period, with improved urticaria control and reduced disease impact on quality of life[96]. - The primary endpoint of the Phase 3 studies will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (UAS7) at week 12[97]. - Barzolvolimab demonstrated a complete response in 71% of patients treated with 150 mg Q4W and 52% of patients treated with 300 mg Q8W at Week 52[98]. - 74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well-controlled disease (UAS7<6) at Week 52[98]. - In a Phase 1b trial, 95% of patients with ColdU and SD achieved a complete response with a single dose of 3 mg/kg[103]. - The median duration of complete response for ColdU patients was 77+ days, while for SD patients it was 57+ days[103]. - At Week 12, 46.9% of patients receiving 150 mg Q4W and 53.1% receiving 300 mg Q8W had a negative provocation test compared to 12.5% in the placebo group[108]. - The study reported a statistically significant improvement in Critical Temperature Threshold (CTT) of -8.82°C for 150 mg Q4W and -9.61°C for 300 mg Q8W[108]. - 58.6% of patients in the 150 mg Q4W group and 68.8% in the 300 mg Q8W group achieved Urticaria Control Test scores >12 at Week 12[108]. - In a Phase 1b study for Prurigo Nodularis (PN), 57% of patients receiving 3.0 mg/kg barzolvolimab achieved a ≥4-point decrease in Worst Itch-Numerical Rating Scale (WI-NRS) at week 8, compared to 25% in the placebo group[114]. - The study showed that 29% of patients on the 3.0 mg/kg dose achieved clear or almost clear skin according to Investigator Global Assessment (IGA) at week 8, with no patients in the placebo or 1.5 mg/kg groups achieving this[114]. - The company has initiated a Phase 2 study for Eosinophilic Esophagitis (EoE) with approximately 160,000 patients in the U.S. estimated to have undergone treatment in the last 12 months, of which about 48,000 are biologic-eligible[119]. - A Phase 2 study for Atopic Dermatitis (AD) has been initiated, targeting a population where two-thirds of patients do not achieve complete control with first-line systemic therapy, indicating a significant unmet need[121]. - The company plans to present data from the EoE study in the second half of 2025, with a focus on reducing esophageal intraepithelial mast cell count as the primary endpoint[120]. Financial Performance - Total research and development expenses for the three months ended March 31, 2025, were $52.614 million, compared to $31.661 million for the same period in 2024, reflecting a 66% increase[79]. - The company incurred an aggregate of $459.7 million in research and development expenses over the past five years through December 31, 2024[78]. - Total revenues for the three months ended March 31, 2025, were $695,000, a 346% increase compared to $156,000 for the same period in 2024[131]. - The net loss for the three months ended March 31, 2025, was $53.8 million, representing a 64% increase from a net loss of $32.8 million for the same period in 2024[132]. - Cash, cash equivalents, and marketable securities totaled $673.3 million as of March 31, 2025, sufficient to meet estimated working capital requirements through 2027[143]. - Net cash used in operating activities was $54.4 million for the three months ended March 31, 2025, compared to $40.6 million for the same period in 2024[145]. - Investment and other income increased by $1.1 million to $8.9 million for the three months ended March 31, 2025, compared to $7.8 million for the same period in 2024[140]. - Product development expenses surged by 107% to $32.2 million for the three months ended March 31, 2025, compared to $15.5 million for the same period in 2024[138]. - General and administrative expenses rose by 19% to $10.8 million for the three months ended March 31, 2025, compared to $9.1 million for the same period in 2024[139]. - The company expects revenue to decrease over the next twelve months due to a reduction in services under existing agreements[133]. - The company plans to raise additional capital through various means, including licensing drug candidates and possible business combinations[144]. Strategic Development - The company is focusing on developing a next-generation bispecific antibody platform, with CDX-622 as the first candidate targeting chronic inflammation pathways[73]. - The company emphasizes the importance of raising sufficient capital to fund ongoing clinical studies and meet long-term liquidity needs[64]. - The company plans to explore strategic partnerships to maximize the value of its technology and product portfolio while ensuring the expeditious development of each product[69]. - Barzolvolimab's manufacturing process has been successfully scaled up to produce larger cGMP batches in support of late-stage trials and potential commercialization[125]. - The company is developing CDX-622, a bispecific antibody targeting TSLP and SCF, which is expected to offer enhanced therapeutic benefits in inflammatory and fibrotic disorders[128]. - In the Phase 2 PN study, patients are being randomized to receive barzolvolimab injections of 150 mg or 300 mg every 4 weeks, with a total enrollment of approximately 120 patients[118]. - The Phase 2 study for AD will include up to 120 patients, with a primary endpoint of evaluating clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at week 16[124]. - The company has expanded clinical development of barzolvolimab into PN, addressing a significant unmet need as there is currently only one FDA-approved therapy for this condition[112].

HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2025 and provided a corporate update. "In the first quarter of 2025, we presented data from our Phase 2 studies in chronic spontaneous and chronic inducible urticaria that demonstrated that barzolvolimab greatly improved quality of life for patients," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Ba ...

Strong execution and progress across pipeline with multiple key data read outs expected in 2025Late breaking oral presentation on Phase 2 CSU program at EAACI 2025 in JunePhase 3 barzolvolimab CSU studies enrollment ongoing; Phase 3 program in CIndU under developmentPhase 2 EOE study enrollment complete; ongoing enrollment in Phase 2 PN and AD studiesCelldex’s first bispecific for inflammatory diseases, CDX-622, Phase 1 study ongoing HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ...