Celldex Reports Third Quarter 2024 Financial Results and Provides Corporate Update

About this update from Celldex Therapeutics, Inc.

Enrollment continues in Phase 3 barzolvolimab CSU studies; Phase 3 program in CIndU under development All primary and secondary endpoints met with high statistical significance in global Phase 2 CIndU study Long term 52 week treatment data in landmark, global Phase 2 CSU study demonstrated deepening of response and a favorable safety profile Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start in Q4 Celldex’s first bispecific for inflammatory diseases, CDX-622, to enter the clinic in Q4 HAMPTON, N.J. , Nov. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. "Celldex recently presented best-in-disease data across both our Phase 2 studies of barzolvolimab in CSU and CIndU,” said Anthony Marucci , Co-founder, President and Chief Executive Officer of Celldex Therapeutics . “The data demonstrated barzolvolimab’s unique potential to provide a rapid, durable treatment option and complete disease control for patients suffering from these severe, debilitating diseases. These are transformative results for patients with CSU, many whom do not see meaningful benefit from the current standard of care, and CIndU, where there are currently no approved therapies other than antihistamines. We continue to make strong progress across our entire pipeline, with enrollment ongoing in global Phase 3 CSU trials and our Phase 2 PN and EOE studies. As we look to the end of this year, we remain excited for our Phase 2 study in AD to initiate and our first bispecific for inflammatory diseases, CDX-622, to enter the clinic.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. Chronic Urticarias Phase 3 Development A global Phase 3 program in chronic spontaneous urticaria (CSU) was initiated in July, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. The studies will enroll approximately 915 patients each across 40 countries and 500 sites and are actively enrolling patients. The Company is currently planning a global Phase 3 program in chronic inducible urticaria (CIndU), which is expected to initiate in 2025. Phase 2 Development Barzolvolimab met all primary and secondary endpoints at 12 weeks across the Company’s Phase 2 studies in CSU and CIndU. Results were highly statistically significant and clinically meaningful. Patients continue to be followed on both studies. 52 week long term follow up data from the Phase 2 study in CSU (n=208) were presented in a late breaking oral presentation at the EADV Congress 2024 in September. A deepening of response was observed over the 52 week treatment period and barzolvolimab demonstrated the highest rate of complete response observed in a well controlled study in CSU with 71% of patients (150 mg Q4W) achieving a complete response at Week 52. Importantly, barzolvolimab was also well tolerated through 52 weeks. 12 week primary endpoint data from the Phase 2 study in CIndU (n=196) were presented in a late breaking oral presentation at ACAAI 2024 in October. Barzolvolimab is the first drug to demonstrate clinical benefit in patients with cold urticaria (ColdU) in a large, randomized, placebo-controlled study. Per provocation test, up to 53.1% of patients with ColdU and 57.6% of patients with symptomatic dermographism (SD) treated with barzolvolimab experienced a complete response compared to placebo rates of only 12.5% (p=0.0011) in ColdU and 3.2% (p

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