Celldex Therapeutics, Inc. (NASDAQ:CLDX) is a biopharmaceutical company dedicated to exploring the science of mast cell biology and developing therapeutic antibodies that have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases.
Business Overview
Celldex's drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated diseases for which available treatments are inadequate. The company is focusing its efforts and resources on the continued research and development of barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, as well as its next generation bispecific antibody platform to support pipeline expansion with additional candidates for inflammatory diseases and oncology.Barzolvolimab: Targeting Mast Cell-Driven Diseases
Barzolvolimab is currently being studied across multiple mast cell driven diseases including chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), prurigo nodularis (PN), and eosinophilic esophagitis (EoE). In November 2023, the company announced positive topline results from a Phase 2 study of barzolvolimab in CSU, where the primary efficacy endpoint was met with a statistically significant mean change from baseline to week 12 in urticaria activity score compared to placebo. The company plans to initiate two Phase 3 studies of barzolvolimab in CSU in summer 2024. Additionally, the company recently initiated a Phase 2 study of barzolvolimab in PN and has an ongoing Phase 2 study in EoE.Financials
For the full year 2023, Celldex reported annual revenue of $6.9 million and a net loss of $141.4 million. The company's annual operating cash flow was -$107.3 million, and annual free cash flow was -$109.1 million.In the first quarter of 2024, the company reported total revenues of $156,000, a net loss of $32.8 million, and net cash used in operating activities of $40.6 million. The increase in net loss and cash used in operations was primarily due to higher research and development and general and administrative expenses related to the expanded development of barzolvolimab.
Liquidity
As of March 31, 2024, Celldex had cash, cash equivalents, and marketable securities of $823.8 million. The company believes this cash position will be sufficient to meet estimated working capital requirements and fund current planned operations through 2027. However, the company may need to raise additional capital in the future to support the continued development of its pipeline, potentially through licensing agreements, collaborations, debt financing, or equity offerings.Barzolvolimab Clinical Development
Chronic Spontaneous Urticaria (CSU)
In the positive Phase 2 CSU study, barzolvolimab demonstrated rapid, durable, and clinically meaningful responses in patients with moderate to severe CSU refractory to antihistamines, including those with prior omalizumab treatment. At the 1.5 mg/kg, 3.0 mg/kg, and 4.5 mg/kg dose levels, barzolvolimab resulted in mean reductions from baseline in weekly urticaria activity score (UAS7) of 67%, 67%, and 82% at week 12, respectively. Complete response (UAS7=0) at week 12 was achieved by 57%, 44%, and 67% of patients in these dose groups, respectively. Well-controlled disease (UCT≥12) at week 12 was reported in 75%, 63%, and 89% of patients, respectively.Chronic Inducible Urticaria (CIndU)
In a Phase 1b study, a single dose of barzolvolimab at 3 mg/kg resulted in rapid and durable responses in patients with cold urticaria and symptomatic dermographism, including those refractory to prior omalizumab treatment. A complete response was achieved in 95% of patients, with the median duration of complete response through the 12-week observation period ranging from 57 to 77 days. The company is currently conducting a Phase 2 study in CIndU.Prurigo Nodularis (PN)
In a Phase 1b study, a single dose of barzolvolimab at 3.0 mg/kg resulted in rapid and durable reductions in itch and healing of skin lesions in patients with moderate to severe PN. The company recently initiated a Phase 2 study in PN.Eosinophilic Esophagitis (EoE)
Celldex is also evaluating barzolvolimab in a Phase 2 study in EoE, a chronic inflammatory disease of the esophagus characterized by the infiltration of eosinophils. Enrollment is ongoing in this study.Bispecific Antibody Platform
In addition to barzolvolimab, Celldex is advancing its next generation bispecific antibody platform to support pipeline expansion with additional candidates for inflammatory diseases and oncology. The company's lead bispecific candidate, CDX-585, combines proprietary PD-1 blockade and anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells, respectively. CDX-585 has successfully completed IND-enabling studies and the first patient was dosed in a Phase 1 study in late May 2023.