Celldex Reports Second Quarter Financial Results and Provides Corporate Update

(NASDAQ:CLDX) Celldex reported financial results for the second quarter ended June 30, 2026, with cash, cash equivalents and marketable securities of $717.6 million as of June 30, 2026, compared to $451.5 million as of March 31, 2026. The company completed enrollment of 1,939 patients in its global Phase 3 program in chronic spontaneous urticaria (CSU), the largest program conducted in antihistamine refractory CSU, across 43 countries and over 500 sites. Net loss was $73.5 million, or ($0.94) per share, for the second quarter of 2026, and $152.2 million, or ($2.11) per share, for the six months ended June 30, 2026. Research and development expenses were $67.5 million in Q2 2026 and $140.5 million for the six months ended June 30, 2026. Topline data from the Phase 3 barzolvolimab CSU studies are anticipated in September/October 2026, with a planned BLA filing in 2027. Celldex believes its cash position is sufficient to fund current planned operations through 2028. The company discontinued its Phase 2 prurigo nodularis study after not meeting primary or key secondary endpoints.

Celldex Reports Results from Phase 2 Study of Barzolvolimab in Prurigo Nodularis

(NASDAQ:CLDX) Celldex reported topline results from its Phase 2 study of barzolvolimab delivered subcutaneously in prurigo nodularis (PN), stating that the study did not meet the primary endpoint or key secondary endpoints at Week 12 at either dose level evaluated. The primary endpoint was the proportion of patients who achieve a four point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12, which was not met, and the percentage of patients with IGA-CPNG-S 0/1 did not differentiate from placebo. The study enrolled 140 patients who were randomly assigned to receive barzolvolimab 150mgQ4W after an initial loading dose of 450mg, 300mgQ4W after an initial loading dose of 450mg, or placebo during a 24-week Treatment Phase, with follow-up for an additional 16 weeks. Barzolvolimab demonstrated a favorable safety and tolerability profile, with rapid and profound suppression of circulating tryptase observed, indicative of systemic mast cell depletion. The study was conducted at 48 centers across six countries, including the United States. Celldex is discontinuing the Phase 2 study in PN based on these results. The company projects that Phase 3 CSU topline data is expected in Sept/Oct 2026, Phase 3 SD and ColdU enrollment is on track, and Phase 2 topline data in AD will be available in late 2026.

Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU at the European Academy of Allergy and Clinical Immunology Annual Meeting

(NASDAQ:CLDX) Celldex announced the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. Seven months after the completion of dosing (Week 76), up to 64% of patients treated with barzolvolimab who had angioedema at baseline remained angioedema-free. Two Phase 3 trials of barzolvolimab in CSU are ongoing and enrollment is complete, with 1,939 patients enrolled across 43 countries and 500 sites. The randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated 208 patients with CSU who remain symptomatic despite antihistamine therapy. Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to Week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels. Topline data are anticipated in Q4 2026, supporting a planned BLA submission in 2027. Angioedema occurs in 55% of people with CSU and patients report a mean of 7.7 angioedema episodes annually.

Celldex Presents Positive First-in-Human Results from Phase 1 Study of Novel Bispecific CDX-622 at the European Academy of Allergy and Clinical Immunology Annual Meeting

(NASDAQ:CLDX) Celldex presented positive results from the Phase 1 healthy participant study of CDX-622, a novel, bispecific antibody that targets soluble SCF and TSLP, at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. The Phase 1 trial enrolled 32 participants in Part 1, 24 participants in Part 2, and 24 participants in Part 3, with dosing regimens including single ascending intravenous doses (0.3, 1.0, 3.0, and 9.0 mg/kg), multiple ascending intravenous doses (1.0, 3.0, and 9.0 mg/kg at weeks 2, 4, and 6), and single ascending subcutaneous doses (290, 580, and 870 mg). CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, was well-tolerated at all dose levels, and showed no dose-limiting toxicities or related serious adverse events. Biopsy data indicated a greater impact on mucosal mast cells than skin mast cells, and there was no evidence of immunogenicity at any dose. The most commonly reported adverse event was Grade 1 headache, and there were no changes in hair or skin pigmentation or meaningful impact on hematologic parameters. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma, and Celldex plans to initiate additional proof of concept studies in allergic rhinitis and food allergy. The company projects that combined TSLP neutralization and mast cell depletion with CDX-622 may result in broad efficacy in inflammatory diseases where both pathways play a pathogenic role.