Core Viewpoint - Celldex Therapeutics' shares fell by 12.1% due to disappointing safety data from a mid-stage study of barzolvolimab, an investigational treatment for chronic spontaneous urticaria (CSU) [1] Group 1: Study Results - The phase II study involved 208 CSU patients and compared three dosing regimens of barzolvolimab (75 mg, 150 mg, 300 mg) against a placebo [1] - Statistically significant improvements in UAS7 scores were observed at week 12 and sustained through week 52 for all dose levels [2][3] - A complete response (UAS7 score of 0) was achieved in 71% of patients on the 150 mg dose and 52% on the 300 mg dose at week 52 [3] - 74% of patients on the 150 mg dose and 68% on the 300 mg dose had well-controlled disease (UAS7 score < 6) at week 52 [4] Group 2: Safety Concerns - Despite efficacy data, safety concerns arose as over 10% of barzolvolimab-treated patients experienced treatment-related adverse events, including hair color changes and neutropenia [5] - The company stated that adverse events were mostly mild and not related to dosage levels, with stable neutrophil counts during treatment [5] Group 3: Clinical Pipeline - Celldex has initiated a global phase III program for barzolvolimab, which includes two late-stage studies for adult CSU patients [6] - The company is also exploring barzolvolimab for other inflammatory diseases such as prurigo nodularis and atopic dermatitis [6] - Another candidate, CDX-585, is in phase I development for advanced or metastatic solid tumors [6] Group 4: Market Performance - Year-to-date, Celldex shares have declined by 9.2%, while the industry average decline is 1.9% [3]

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Am ...

HAMPTON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences: 2024 Cantor Global Healthcare Conference on Tuesday, September 17th at 8:35 a.m. ET TD Cowen's Chronic Urticaria Summit on Friday, September 20th at 10:00 a.m. ET Live webcasts of the presentations will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. Replays will ...

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.65 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8.47%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.67 per share when it actually produced a loss of $0.56, delivering a surprise of 16.42%.Over the last four quarters, th ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (State or other jurisdiction of incorporati ...

EXHIBIT 99.1 Celldex Reports Second Quarter 2024 Financial Results and Provides Corporate Update Phase 3 CSU studies initiated July 2024 Positive topline Phase 2 CIndU 12 week data reported July 2024 supporting Phase 3 advancement 52 week Phase 2 CSU data and full 12 week Phase 2 CIndU data to be reported 2H 2024 Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start YE 2024 Celldex's first bispecific for inflammatory diseases, CDX-622, to enter the clinic this year HAMPTON, N.J., Aug ...

Phase 3 CSU studies initiated July 2024 Positive topline Phase 2 CIndU 12 week data reported July 2024 supporting Phase 3 advancement 52 week Phase 2 CSU data and full 12 week Phase 2 CIndU data to be reported 2H 2024 Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start YE 2024 Celldex’s first bispecific for inflammatory diseases, CDX-622, to enter the clinic this year HAMPTON, N.J., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial ...

Clinical Trial Results - Barzolvolimab demonstrated clinically meaningful and statistically significant complete response rates across both dose groups in the Phase 2 clinical trial for chronic inducible urticaria (CIndU) [1] - The study is the first large, randomized, placebo-controlled trial to show success in treating CIndU, specifically cold urticaria (ColdU) and symptomatic dermographism (SD) [1] - Barzolvolimab achieved the primary efficacy endpoint, with 46.9% (150 mg q4w) and 53.1% (300 mg q8w) of ColdU patients showing a negative provocation test at Week 12, compared to 12.5% for placebo [3] - For SD patients, 57.6% (150 mg q4w) and 42.4% (300 mg q8w) achieved a negative provocation test at Week 12, compared to 3.2% for placebo [3] Safety and Tolerability - Barzolvolimab exhibited a favorable safety profile consistent with prior studies, with most adverse events being mild to moderate in severity [3] - The most common treatment-emergent adverse events were hair color changes (13%) and neutropenia (11%) [3] - The rate of infections was similar between barzolvolimab-treated patients and placebo, with no association between neutropenia and infections [3] Study Design and Methodology - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 196 patients with CIndU who remained symptomatic despite antihistamine therapy [4] - Patients were divided into two cohorts: 97 with ColdU and 99 with SD, and were randomized to receive barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo [4] - The primary endpoint was the percentage of patients with a negative provocation test at Week 12, assessed using TempTest® for ColdU and FricTest® for SD [4][5] Future Development - The company plans to advance barzolvolimab into Phase 3 registration development for CIndU [1] - Full 12-week data from the study will be presented at a medical meeting in the fourth quarter of 2024 [2] About Chronic Inducible Urticaria (CIndU) - CIndU is characterized by hives or wheals triggered by specific stimuli, such as cold temperatures in ColdU or skin scratching/rubbing in SD [7] - Approximately 0.5% of the population suffers from chronic inducible urticarias, with mast cell activation being a key driver of symptoms [7] - There are currently no approved therapies for CIndU other than antihistamines, and patients often manage symptoms by avoiding triggers [7] About Barzolvolimab - Barzolvolimab is a humanized monoclonal antibody that binds and inhibits the receptor tyrosine kinase KIT, which is critical for mast cell function and survival [8] - It is being studied in multiple indications, including chronic spontaneous urticaria (CSU), prurigo nodularis (PN), and eosinophilic esophagitis (EOE), with plans for additional indications like atopic dermatitis (AD) [8] Company Overview - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapeutics for severe inflammatory, allergic, and autoimmune diseases [9] - The company’s pipeline includes antibody-based therapeutics targeting mast cell biology and other critical pathways [9]

Met primary endpoint demonstrating clinically meaningful and statistically significant complete response rate across both dose groupsFirst large, randomized, placebo-controlled study to demonstrate success in CIndU Favorable safety and tolerability consistent with prior studies Plans to advance CIndU into Phase 3 registration developmentCompany to host webcast call today at 4:30 pm ET HAMPTON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive topline r ...

Core Viewpoint - Celldex Therapeutics has initiated a global Phase 3 program for barzolvolimab, targeting chronic spontaneous urticaria (CSU) patients who remain symptomatic despite existing treatments [1][4]. Group 1: Clinical Trials - The Phase 3 program includes two trials, EMBARQ-CSU1 and EMBARQ-CSU2, enrolling over 1800 patients with CSU [1]. - Both trials are randomized, double-blind, placebo-controlled studies, with approximately 915 patients randomized to receive either barzolvolimab 150 mg every 4 weeks, 300 mg every 8 weeks, or placebo for 52 weeks [3]. - The primary endpoint is to evaluate the reduction in urticaria activity (UAS7) at Week 12, with a focus on detecting clinically meaningful differences between active arms and placebo [3]. Group 2: Treatment Mechanism and Efficacy - Barzolvolimab is a novel monoclonal antibody that targets mast cells by blocking the receptor tyrosine kinase KIT, which is essential for mast cell function and survival [2][7]. - Previous studies have shown that barzolvolimab can provide rapid, durable, and complete disease control in CSU patients, regardless of their treatment history [3]. - A Phase 2 study indicated that barzolvolimab met its primary endpoint, showing statistically significant improvement in UAS7, along with favorable results in secondary endpoints such as itch severity and hives severity scores [4]. Group 3: Company Overview - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory and allergic diseases [8]. - The company aims to advance barzolvolimab not only for CSU but also for additional indications, including chronic inducible urticaria and atopic dermatitis [7][8].