CLDX

EX-99.1

2 exh_991.htm

PRESS RELEASE

EdgarFiling

EXHIBIT 99.1

Celldex Reports Third Quarter Financial Results and Provides Corporate Update

Best-in-disease results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies showed rapid, profound, sustained efficacy supporting barzolvolimab’s potential to be a transformational therapy in CSU BLA submission for barzolvolimab in CSU anticipated in 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling Excellent progress across all earlier stage pipeline programs HAMPTON, N.J., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2026 and provided a corporate update.

“Barzolvolimab has significant potential to address enormous populations of high unmet need and shift the treatment paradigm goal from symptom improvement to complete symptom resolution, which for patients means no itch, no hives, no swelling,” said Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex. “This quarter we reported best-in-disease results from our two Phase 3 studies in CSU, demonstrating barzolvolimab’s unparalleled ability to deliver complete response to patients—including even in patient populations suffering with severe disease or severe angioedema or with omalizumab refractory disease. We are moving quickly to bring this much needed medicine to patients and physicians. We are also making excellent progress advancing our ongoing Phase 3 study in symptomatic dermographism and cold urticaria and look forward to updating on these programs in 2027.

“Building on our leading science clinically validating the therapeutic potential of KIT inhibition in immune and inflammatory diseases, we will continue to chart the future of mast cell medicine, expanding barzolvolimab and CDX-622 development across a diverse spectrum of immune and inflammatory diseases and adding to our growing mast cell targeted pipeline to bring our science to additional patient populations that could benefit.”

Recent Program Highlights

Barzolvolimab - KIT Inhibitor Program

Barzolvolimab is a first-in-class humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease.

Chronic Urticarias

In September 2026, the Company reported best-in-disease topline results from the Phase 3 EMBARQ-CSU1 and -CSU2 studies of barzolvolimab in patients with CSU whose symptoms are inadequately controlled by H1-antihistamines. The primary and all key secondary endpoints across both studies and both dose groups were met. Results showed rapid, profound, and sustained efficacy, including unprecedented complete response rates, supporting barzolvolimab’s potential to be a transformational therapy in CSU. Efficacy was sustained or deepened from Weeks 12 to 24, and barzolvolimab was well-tolerated with a favorable safety profile through 24 weeks, consistent with prior studies. Statistically significant and clinically meaningful benefit was also seen in antihistamine refractory patients with severe disease or severe angioedema, as well as in patients with CSU refractory to omalizumab. Treatment in both EMBARQ-CSU trials will continue to 52 weeks, and the Company anticipates a BLA submission in 2027.

Data from the Phase 3 studies reported to date are consistent with results from the completed Phase 2 CSU study. In Phase 2, the primary endpoint was met at Week 12 and patients on study continued to receive barzolvolimab for a total of 52 weeks of treatment. Sustained and deepening disease efficacy and a well-tolerated long term safety profile were demonstrated over the 52-week treatment period. In addition, at 76 weeks, 7 months after the completion of dosing with barzolvolimab, over 40% of patients (150mg Q4W) continued to experience profound, sustained complete response and up to 64% of patients treated with barzolvolimab who had angioedema at baseline remained angioedema-free, supporting barzolvolimab’s disease modifying potential.

Enrollment is ongoing in Celldex’s global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the 20-week treatment period. Patients w

EX-99.1

2 exh_991.htm

PRESS RELEASE

EdgarFiling

EXHIBIT 99.1

Celldex Reports Second Quarter Financial Results and Provides Corporate Update

Barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2) ongoing, topline data expected in Sept/Oct 2026; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling; Phase 2 topline data in AD expected in late 2026 Positive results from Phase 1 trial of bispecific CDX-622 showed rapid, profound, dose-dependent reductions in serum tryptase and CDX-622 was well tolerated; Phase 1 CDX-622 proof of mechanism study in asthma ongoing

HAMPTON, N.J., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2026 and provided a corporate update.

“We are leaders in mast cell science with a pipeline of programs that have the potential to dramatically shift treatment paradigms for patients,” said Anthony Marucci, Co-founder, President and Chief Executive Officer at Celldex. “Barzolvolimab, followed by our first bispecific candidate CDX-622, are a powerful portfolio combination targeting inflammatory diseases where mast cells are implicated, with the goal of ultimately bringing our leading science to additional patient populations that could benefit from our medicines. We are looking forward to sharing the topline results from our two Phase 3 trials of barzolvolimab in the early fall and are actively driving towards potential commercialization.”

Recent Program Highlights

Barzolvolimab - KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease.

Chronic Urticarias

Enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU), demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in September/October 2026, supporting a planned BLA filing in 2027.

In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks).

In June 2026, Celldex presented long-term barzolvolimab results that demonstrated sustained off-treatment improvement in patients with CSU at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting. Treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema patients with moderate to severe CSU. 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. Results support the potential of barzolvolimab to shift treatment goals from symptom control to disease modification.

Atopic Dermatitis and Prurigo Nodularis

Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026.

Topline data from the Phase 2 study in prurigo nodularis (PN) were presented in July 2026 and demonstrated that the trial did not meet primary or key secondary endpoints. Barzolvolimab was well-tolerated and demonstrated a favorable safety profile consistent with prior studies. Rapid and profound suppression of circulating tryptase indicative of systemic mast cell depletion was observed. These data suggest that mast cells may not be the key pathogenic

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