A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants With Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

The purpose of this Phase 3, randomized, double-blind, placebo-controlled study is to assess the activity and safety of barzolvolimab compared to placebo in participants with cold induced urticaria or symptomatic dermographism who remain symptomatic despite the use of H1-antihistamines.

Start Date15 Jan 2026

Sponsor / Collaborator

Celldex Therapeutics, Inc.

NCT07256392

/ RecruitingPhase 3

A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13

The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials.
This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.

Start Date25 Nov 2025

Sponsor / Collaborator

Celldex Therapeutics, Inc.

NCT06727552

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of barzolvolimab in adults with Atopic Dermatitis

Start Date18 Dec 2024

Sponsor / Collaborator

Celldex Therapeutics, Inc.

100 Clinical Results associated with Barzolvolimab

100 Translational Medicine associated with Barzolvolimab

100 Patents (Medical) associated with Barzolvolimab

Literatures (Medical) associated with Barzolvolimab

01 Dec 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Safety and efficacy of barzolvolimab, an anti–KIT monoclonal antibody, in adults with moderate-to-severe prurigo nodularis: A randomized phase 1b intravenous single dose study

Article

Author: Lu, Yufang ; Bili, Androniki ; Meltzer-Podolske, Michelle ; Alvarado, Diego ; Moiin, Ali ; Yosipovitch, Gil ; Rogalski, Mark ; Hawthorne, Thomas ; Bloom, Bradley ; Ständer, Sonja ; Nattkemper, Leigh ; Metz, Martin

01 Nov 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Depletion of mast cells with barzolvolimab, an anti‐KIT antibody, does not affect mast cell progenitors

Letter

Author: Metz, Martin ; Kiefer, Lea Alice ; Siebenhaar, Frank ; Alvarado, Diego ; Mahnke, Niklas Amadeus ; Terhorst‐Molawi, Dorothea ; Maurer, Marcus ; Moñino‐Romero, Sherezade ; Scheffel, Jörg ; Grekowitz, Eva Maria

01 Nov 2025·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Emerging IgE and non-IgE targeted therapies for chronic urticaria

Review

Author: Chhiba, Krishan D ; Saini, Sarbjit S

Chronic urticaria affects a significant percent of the global population and carries a higher burden of unmet medical need. Current standard-of-care includes antihistamines and omalizumab, but omalizumab is not effective in all patients and has not been found to induce long-term disease remission. This review evaluates the diverse therapeutic pipeline spanning IgE-based and non-IgE-based mast cell targeting strategies, including recent clinical data. The therapeutic landscape has expanded rapidly with multiple mechanisms under investigation. IgE-targeted approaches include omalizumab biosimilars, with CT-P39 having received Food and Drug Administration (FDA) approval. Dupilumab received FDA approval for antihistamine-refractory chronic spontaneous urticaria supporting the targeting of type 2 cytokines, interleukin-4, and interleukin-13, in this disease. Bruton's tyrosine kinase inhibitors have promise, with remibrutinib receiving FDA approval and demonstrating significant reductions in UAS7 in phase 3 trials. c-Kit (c-Kit or KIT) inhibition with barzolvolimab demonstrates robust efficacy with sustained effects post-treatment. Finally, Janus kinase inhibitors, Mas-related G protein-coupled receptor X2 antagonists, and other novel mechanisms are advancing through clinical trials. Although some programs have been discontinued due to safety concerns or lack of efficacy such as fenebrutinib (Bruton's tyrosine kinase inhibitor), THB001 (c-Kit inhibitor), EP262 (Mas-related G protein-coupled receptor X2 antagonist), tezepelumab (anti-TSLP), and lirentelimab and AK006 (sialic acid binding immunoglobulin-like lectin-targeting agents), these studies have informed many of the other positive studies. In summary, in the last year, we have seen the chronic urticaria pipeline mature with multiple phase 3 programs and new approvals representing diverse mechanisms of action. Nevertheless, significant therapeutic gaps persist for omalizumab-refractory disease and chronic-inducible urticaria.

106

News (Medical) associated with Barzolvolimab

25 Feb 2026

·www.biospace.com

Celldex Completes Enrollment in Global Phase 3 Studies (EMBARQ-CSU1 and EMBARQ-CSU2) of Barzolvolimab in Chronic Spontaneous Urticaria

Enrollment completed six months ahead of guidance, driven by significant unmet need for better treatments in CSU Topline data expected Q4 2026 BLA submission planned for 2027 HAMPTON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the completion of enrollment in the Company’s global Phase 3 program of barzolvolimab in chronic spontaneous urticaria (CSU), which consists of two Phase 3 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. “Completing enrollment in these large Phase 3 CSU studies 6 months ahead of guidance highlights the significant unmet need in CSU and speaks to the excitement from patients and physicians about barzolvolimab and its potential as a best-in-disease treatment,” said Anthony S. Marucci, Co-founder, President and Chief Executive Officer of Celldex. “We are extremely grateful to these patients, their families and their treating physicians for their enthusiasm and participation in the EMBARQ-CSU1 and EMBARQ-CSU2 studies. We look forward to reporting topline results later this year and remain focused on completing preparations to support bringing this much needed treatment to more than 1.8 million patients in the United States suffering from CSU.” Barzolvolimab uniquely targets the root cause of CSU—the mast cell—and has the potential to transform the CSU treatment landscape by providing rapid, profound and durable efficacy that is unparalleled in CSU, offering new hope for the patients suffering from this often severe and debilitating disease. Based on results from the completed Phase 2 study of barzolvolimab in CSU, barzolvolimab has the potential to deliver a best-in-class and best-in-disease clinical pro free complete control and dramatic improvements in quality of life and angioedema. Up to 51% of patients on study had a complete response and were symptom free (UAS7=0; no itch/no hives) at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. This profound clinical benefit continued even after patients were off therapy with up to 41% of patients reporting complete response seven months after receiving their last dose. Patients also reported dramatic improvements in angioedema control and quality of life. At 12 weeks, up to 65% of barzolvolimab treated patients were angioedema free (AAS7=0), which increased to up to 77% at Week 52 and remained at up to 64% seven months after last dose. At 12 weeks, up to 67% of patients treated with barzolvolimab reported their CSU had no impact on their quality of life (DLQI 0/1), which increased to up to 82% at Week 52 and remained at up to 48% seven months after last dose. The Phase 3 Program is designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. Both Phase 3 trials are randomized, double-blind, placebo-controlled, parallel group, global studies. 1,939 patients were randomized (n=963 EMBARQ-CSU1; n=976 EMBARQ-CSU2) evenly to barzolvolimab 150 mg every 4 weeks (following 300 mg loading dose), barzolvolimab 300 mg every 8 weeks (following 450 mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo are re-randomized to active treatment across both dosing groups. The primary endpoint of the study will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (weekly urticaria activity score; UAS7) at Week 12 . The study is designed to detect a clinically meaningful difference between each of the active arms vs placebo in the overall population as well as in the subpopulation of omalizumab refractory participants. The primary endpoint analysis will be performed when all patients have completed the placebo controlled portion of the study at 24 weeks. A global Phase 3b long term extension study (LTE) has been established and is ongoing, which patients can enter following completion of the EMBARQ-CSU Phase 3 trials. Please visit clinicaltrials.gov for additional information on EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202 ) . About Barzolvolimab 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. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. About Chronic Spontaneous Urticaria (CSU) CSU is an underdiagnosed disease of misery marked by spontaneous hives, unbearable itch, and unpredictable episodes of disfiguring swelling (angioedema) that causes substantial mental health burden, profound impact on quality of life and is associated with a 1.7-fold increase in all cause mortality at 5 years. Mast cell activation plays a central role in the onset and progression of CSU. While the goal of CSU treatment is the complete absence of symptoms, the vast majority of patients today, even those receiving the most advanced approved and available therapies, continue to suffer from itch, hives, swelling, sleep disruption, and unrelenting anxiety about when the next flare up will occur. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit . Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560 ptill@meruadvisors.com

Phase 3Phase 2Clinical ResultImmunotherapy

25 Feb 2026

·ir.celldex.com

Celldex Reports Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update

Enrollment completed in both Phase 3 chronic spontaneous urticaria global registration studies (EMBARQ-CSU 1 and 2) six months ahead of guidance; Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively accruing Enrollment completed in Phase 2 prurigo nodularis and atopic dermatitis studies with topline data expected in 2026 Phase 1 CDX-622 Proof of Mechanism study in asthma initiated Company prepares for landmark year of clinical readouts in 2026 HAMPTON, N.J. , Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2025 and provided a corporate update. "The enthusiasm for barzolvolimab continues to build, driven by unparalleled efficacy data across multiple indications,” said Anthony Marucci , Co-founder, President and Chief Executive Officer of Celldex. “This is underscored by the completion of enrollment in our Phase 3 CSU studies six months ahead of guidance and strong interest from clinical trial sites in our recently initiated Phase 3 study in cold urticaria and symptomatic dermographism.” “During 2026, we are excited for multiple important data readouts across our pipeline, including topline data from our barzolvolimab Phase 3 studies in CSU, Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622,” continued Mr. Marucci . “We continue to prepare for the planned BLA filing and commercialization of barzolvolimab in CSU, which has the potential to transform the treatment landscape and position Celldex as a pioneering immunology company—leading in mast cell biology and delivering groundbreaking therapies for patients who are waiting for better treatment options.” 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 This morning, Celldex announced that 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 Q4 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 recently completed 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). Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD have been accepted for multiple presentations at the 2026 AAAAI Annual Meeting ( February 27 – March 2 ). This includes a late breaking poster presentation on new data from the Phase 2 ColdU and SD study entitled “Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria” on Sunday, March 1, 2026 . Prurigo Nodularis and Atopic Dermatitis Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026. 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. Novel Bispecific Antibody Platform CDX-622 – Bispecific SCF & TSLP CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE). Enrollment is complete in the Phase 1 study in healthy volunteers. The Phase 1a clinical trial is a three-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 80 healthy participants (Part 1: single intravenous (IV) dose, Part 2: 4 IV doses, Part 3: single subcutaneous (SubQ) dose). Positive data from the single ascending dose portion of the study was presented in October 2025 . Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. In January 2026 , we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated. Fourth Quarter and Twelve Months 2025 Financial Highlights and 2026 Guidance Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $518.6 million compared to $583.2 million as of September 30, 2025 . The decrease was primarily driven by fourth quarter cash used in operating activities of $63.9 million . The increase in cash used in operating activities in the fourth quarter was primarily driven by higher clinical expenses, including the accelerated enrollment completion of the Phase 3 CSU program, and manufacturing barzolvolimab expenses. At December 31, 2025 , Celldex had 66.5 million shares outstanding. Revenues: Total revenue was $0.1 million in the fourth quarter of 2025 and $1.5 million for the year ended December 31, 2025 , compared to $1.2 million and $7.0 million for the comparable periods in 2024. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University . R&D Expenses: Research and development (R&D) expenses were $75.3 million in the fourth quarter of 2025 and $245.1 million for the year ended December 31, 2025 , compared to $46.9 million and $163.6 million for the comparable periods in 2024. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount. G&A Expenses: General and administrative (G&A) expenses were $11.9 million in the fourth quarter of 2025 and $43.8 million for the year ended December 31, 2025 , compared to $10.3 million and $38.5 million for the comparable periods in 2024. The increase in G&A expenses was primarily due to an increase in employee headcount and an increase in barzolvolimab commercial planning expenses. Net Loss: Net loss was $81.3 million , or ( $1.22 ) per share, for the fourth quarter of 2025, and $258.8 million , or ( $3.90 ) per share, for the year ended December 31, 2025 , compared to a net loss of $47.1 million , or ( $0.71 ) per share, for the fourth quarter of 2024, and $157.9 million , or ( $2.45 ) per share, for the year ended December 31, 2024 . Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2025 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027. About CelldexCelldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward-Looking StatementThis release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration(508) 864-8337scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560ptill@meruadvisors.com Source: Celldex Therapeutics, Inc.

Phase 2Phase 1Phase 3Financial StatementImmunotherapy

23 Feb 2026

·www.biospace.com

Celldex Announces Multiple Upcoming Presentations at AAAAI 2026 Supporting Barzolvolimab’s First-in-Class and Best-in-Disease Profile

HAMPTON, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that multiple presentations from the Company’s Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) have been accepted for presentation at the 2026 American Academy of Allergy, Asthma & Immunology's (AAAAI) Annual Meeting being held in Philadelphia, February 27 – March 2. New data from the Phase 2 ColdU and SD Open Label Extension (OLE) will be presented as a late breaker, highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence. All presentations will be posted on the Celldex website at the dates/times listed below. Presentation details are as follows: Trial: Phase 2 ColdU and SD Study Presentation: Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria Session Date / Time: 2/27/2026, 2:45 pm - 3:45 pm Title: Allergic Skin Diseases Type: Poster Session Poster Number: 072 Location: Convention Center, Level 2, Hall E Trial: Phase 2 CSU Study Presentation: Prolonged Off-Treatment Efficacy of Barzolvolimab in Chronic Spontaneous Urticaria Session Date / Time: 2/27/2026, 2:45 pm - 3:45 pm Title: Allergic Skin Diseases Type: Poster Session Poster Number: 075 Location: Convention Center, Level 2, Hall E Trial: Phase 2 ColdU and SD Study Presentation: Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria Session Date / Time: 3/1/2026, 9:45 am - 10:45 am Title: Late Breaking Poster Session II Type: Poster Session LB Poster Number: L41 Location: Convention Center, Level 2, Hall E About Barzolvolimab Barzolvolimab is a humanized monoclonal antibody with a completely 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. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first in class and best in disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit . Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560 ptill@meruadvisors.com

Phase 2ImmunotherapyPhase 3

100 Deals associated with Barzolvolimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatographic urticaria	Phase 3	United States	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Germany	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Lithuania	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Poland	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	South Africa	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	Spain	Celldex Therapeutics, Inc.	15 Jan 2026
Dermatographic urticaria	Phase 3	United Kingdom	Celldex Therapeutics, Inc.	15 Jan 2026
Chronic Urticaria	Phase 3	United States	Celldex Therapeutics, Inc.	11 Jul 2024
Chronic Urticaria	Phase 3	Argentina	Celldex Therapeutics, Inc.	11 Jul 2024
Chronic Urticaria	Phase 3	Belgium	Celldex Therapeutics, Inc.	11 Jul 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05774184 (PipelineReview) Manual	Phase 2	Eosinophilic Esophagitis	65	BarzolvolimabBarzolvolimab 300mg Q4W	jgubolavao(hmnjrdnlxz) = xpdhkmzqqa bkgxhqugig (oxkwxnhenp ) Met	Negative	20 Aug 2025
				Placebo	jgubolavao(hmnjrdnlxz) = symclgncua bkgxhqugig (oxkwxnhenp ) Met
NCT05368285 (GlobeNewswire) Manual	Phase 2	Chronic Urticaria \| Angioedema	-	Barzolvolimab 150 mg Q4W	kvvtxblzql(klfdlbvjxb) = tuotgjdtsp hycptncdoz (uhxlnxsyjf ) View more	Positive	14 Jun 2025
				Barzolvolimab 300 mg Q8W	kvvtxblzql(klfdlbvjxb) = ohoaqsaaxn hycptncdoz (uhxlnxsyjf ) View more
NCT05405660 (Company_Website) Manual	Phase 2	Chronic Urticaria	-	Barzolvolimab	lpbwzvkqxp(hibziggpbo) = wnjseiqpkq doyfnnntnc (nhhihdyltl ) View more	Positive	01 Mar 2025
				Barzolvolimab (patients with SD)	lpbwzvkqxp(hibziggpbo) = stwekfjebi doyfnnntnc (nhhihdyltl )
Company_Website Manual	Phase 2	Chronic Urticaria	-	Barzolvolimab	klxtdksucv(lelubkatwe) = bzpaevvnby lyrbhusahc (gnbaiuyanc ) View more	Positive	01 Mar 2025
NCT05405660 (phase II, ACAAI2024)	Phase 2	Chronic Urticaria	196	Barzolvolimab 150 mg every 4 weeks	letvsgfikn(bvfgraspwx) = with grade I to II neutropenia being the most common adverse events rrswkpwdep (gvwiajgqgd )	Positive	24 Oct 2024
				Barzolvolimab 300 mg every 8 weeks
NCT05368285 (Biospace) Manual	Phase 2	Chronic Urticaria	-	Barzolvolimab 75 mg	-	Positive	25 Sep 2024
				Barzolvolimab 150 mg	xdrywdulnw(xekuuldogq) = dbbfhogkdj svlboszzzd (rohtndzdbi ) View more
NCT05405660 (GlobeNewswire) Manual	Phase 2	Chronic Urticaria	196	BarzolvolimabBarzolvolimab 150 mg q4w (Cold Urticaria)	isyxbpclti(eghilejyye) = voqvwoeoil rtlsrdnynm (alecjamlrz ) Met View more	Positive	29 Jul 2024
				BarzolvolimabBarzolvolimab 300 mg q8w (Cold Urticaria)	isyxbpclti(eghilejyye) = yiffbgsvlv rtlsrdnynm (alecjamlrz ) Met View more
NCT04944862 (AAD2024)	Phase 1	prurigo nodularis	24	Barzolvolimab 1.5 mg/kg	dvburatghz(qvqwmwlvam) = No adverse event was reported in more than one barzolvolimab treated patient. One patient (3.0 mg/kg) had anaphylaxis that resolved without sequelae. wfxwawbuim (vvsqvnosbw )	Positive	08 Mar 2024
				Placebo
NCT05368285 (Corporate Publications) Manual	Phase 2	Chronic Urticaria	208	Barzolvolimab 300 mg q8w	noewlwmlvd(iabzkircri) = htfwvvtoqb pnpboriuzg (zxnlbdbmxg ) Met View more	Positive	06 Nov 2023
				Barzolvolimab 150 mg q4w	noewlwmlvd(iabzkircri) = ssodihefsm pnpboriuzg (zxnlbdbmxg ) Met View more
NCT04944862 (Corporate Publications) Manual	Phase 1	prurigo nodularis	24	Barzolvolimab 1.5 mg/kg	ummekqkoic(bigtfbzqxm) = ohhdcdqywr wojnipjefa (anktnltcxn ) View more	Positive	05 Nov 2023
				Barzolvolimab 3.0 mg/kg	ummekqkoic(bigtfbzqxm) = poplmjtwnj wojnipjefa (anktnltcxn ) View more

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