Celldex Q1 2024 Financial Results and Corporate Update

Celldex Therapeutics Inc. reported its financial results for the first quarter ending March 31, 2024, and provided updates on its various clinical programs. The company highlighted the progress of its key investigational drug, barzolvolimab, and other initiatives.

During the first quarter, Celldex presented promising data from a large Phase 2 study in chronic spontaneous urticaria (CSU), demonstrating the potential of barzolvolimab to treat mast cell-mediated diseases. The company plans to expand the drug's development in 2024, focusing on several indications based on its unique mechanism of action and significant clinical improvements in pruritus.

Celldex is set to initiate Phase 3 CSU studies in summer 2024. The Phase 2 CSU study revealed that barzolvolimab met its primary efficacy endpoint, showing a statistically significant improvement in the weekly urticaria activity score (UAS7) at week 12 compared to placebo. The drug also exhibited rapid and durable responses in patients with moderate to severe CSU who are unresponsive to antihistamines, including those previously treated with omalizumab. Patients will continue receiving treatment for 52 weeks, with results expected in the second half of 2024.

Enrollment in the Phase 2 study for chronic inducible urticaria (CIndU) has been completed, and 12-week data are anticipated in the second half of 2024. This study included 196 patients split between those with cold urticaria and symptomatic dermographism.

In early 2024, Celldex initiated a Phase 2 study for prurigo nodularis (PN), enrolling around 120 patients with moderate to severe PN who did not adequately respond to topical medications or for whom such treatments are inadvisable. The study is evaluating multiple doses of barzolvolimab over a 24-week treatment phase.

For eosinophilic esophagitis (EoE), a Phase 2 study began in July 2023, with ongoing enrollment. The protocol was amended to optimize efficacy by administering 300 mg doses every four weeks instead of every eight weeks.

Barzolvolimab's next development target will be atopic dermatitis (AD), a chronic inflammatory skin condition characterized by severe itching and eczematous lesions. The drug's mechanism could be crucial in treating moderate to severe AD patients who do not achieve disease control with current systemic therapies. A Phase 2 study for AD is expected to begin by the end of 2024.

Celldex's bispecific antibody platform includes CDX-585, which combines PD-1 and ILT4 blockade to counteract immunosuppressive signals in T cells and myeloid cells. The Phase 1 study of CDX-585, which started in May 2023, is enrolling patients with advanced or metastatic solid tumors that have progressed after standard therapies.

Financially, Celldex is on strong footing with over $820 million in cash and equivalents as of March 31, 2024, compared to $423.6 million at the end of 2023. This increase mainly stems from net proceeds of $432.3 million from a public offering in March 2024, offset by operating expenses. The company's revenue for Q1 2024 was $0.2 million, down from $1.0 million in Q1 2023, due to decreased services under agreements with Rockefeller University. Research and development expenses rose to $31.7 million from $26.8 million in the previous year, driven by barzolvolimab clinical trial costs and personnel expenses. General and administrative costs also increased to $9.1 million from $6.6 million, primarily due to stock-based compensation and commercial planning expenses for barzolvolimab. Net loss for Q1 2024 was $32.8 million, or $0.56 per share, compared to $29.4 million, or $0.62 per share, in Q1 2023.

Celldex believes its financial resources are sufficient to support its operations through 2027. The company remains committed to advancing its pipeline of antibody-based therapeutics, targeting severe inflammatory and allergic diseases.