Celldex Announces Q3 2024 Financial Results and Corporate Update

Celldex Therapeutics, Inc. has provided an update on its financial results for the third quarter of 2024, highlighting significant progress in its ongoing clinical studies and pipeline development.

The company has made notable advancements in its clinical trials for barzolvolimab, a humanized monoclonal antibody that targets the KIT receptor. This receptor is involved in various inflammatory responses, including hypersensitivity and allergic reactions. The KIT receptor's inhibition by barzolvolimab is being investigated for its potential to treat chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). The global Phase 3 program for CSU, initiated in July, includes two trials aimed at evaluating the efficacy and safety of barzolvolimab in patients who continue to exhibit symptoms despite antihistamine treatment, with around 915 patients being enrolled in each trial across 40 countries. Additionally, a Phase 3 program for CIndU is planned to commence in 2025.

In Phase 2 trials, barzolvolimab achieved all primary and secondary endpoints with high statistical significance, demonstrating clinically meaningful results. In the CSU study, 52-week data revealed a deepening of response over the treatment period, with 71% of patients achieving complete response at Week 52. Similarly, in the CIndU study, significant clinical benefits were observed in patients with cold urticaria and symptomatic dermographism, with response rates significantly higher than the placebo group.

The company is also progressing with Phase 2 trials for eosinophilic esophagitis (EoE) and prurigo nodularis (PN), both of which are ongoing. The EoE study, initiated in July 2023, is evaluating the efficacy and safety of barzolvolimab in 75 patients, with results expected in the second half of 2025. The PN study, initiated in early 2024, involves 120 patients and is also assessing the drug's efficacy and safety.

Celldex has selected atopic dermatitis (AD) as the fifth indication for barzolvolimab. A Phase 2 trial for AD is set to start by the end of the year, focusing on patients who do not achieve complete disease control with current therapies.

The company is also advancing its bispecific antibody platform, with CDX-622 targeting chronic inflammation pathways. CDX-622, a bispecific antibody, neutralizes thymic stromal lymphopoietin (TSLP) and depletes mast cells via stem cell factor (SCF) starvation. Preclinical studies have shown that CDX-622 is well tolerated and effective in reducing inflammation. A Phase 1 study in healthy volunteers is expected to begin by the end of 2024.

Celldex’s financial results for the third quarter of 2024 show a decrease in cash and cash equivalents from $802.3 million to $756.0 million, primarily due to operating expenses. The company reported total revenues of $3.2 million for the quarter, an increase from the previous year. Research and development expenses rose to $45.3 million, while general and administrative expenses increased to $10.1 million. The net loss for the quarter was $42.1 million, or $0.64 per share.

Celldex remains confident in its financial position, with sufficient cash reserves to fund operations through 2027. The company continues to focus on developing transformative therapeutics for patients with severe inflammatory, allergic, and autoimmune diseases.