Core Insights - Celldex Therapeutics reported significant progress in its clinical trials for barzolvolimab, demonstrating its potential as a transformative treatment for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [2][4][6] Clinical Development - Enrollment is ongoing in Phase 3 trials for CSU, with two trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to evaluate the efficacy and safety of barzolvolimab in patients who remain symptomatic despite antihistamine treatment [4] - A global Phase 3 program for CIndU is planned to initiate in 2025 [5] - Barzolvolimab met all primary and secondary endpoints in Phase 2 studies for both CSU and CIndU, with results showing high statistical significance [6] - Long-term data from the Phase 2 CSU study indicated a complete response rate of 71% at Week 52 for patients receiving 150 mg Q4W [7] - In the Phase 2 CIndU study, barzolvolimab was the first drug to show clinical benefit in cold urticaria, with complete response rates of 53.1% and 57.6% for cold urticaria and symptomatic dermographism, respectively [8] Pipeline Expansion - A Phase 2 study for eosinophilic esophagitis (EoE) is ongoing, with data expected in the second half of 2025 [9] - A Phase 2 study for prurigo nodularis (PN) is also in progress, targeting approximately 120 patients [10] - Atopic dermatitis (AD) has been selected as a new indication for barzolvolimab, with a Phase 2 study set to begin by the end of 2024 [11] - Celldex's first bispecific antibody, CDX-622, is expected to enter clinical trials by the end of 2024, targeting chronic inflammation pathways [12][13] Financial Performance - As of September 30, 2024, Celldex reported cash, cash equivalents, and marketable securities of $756 million, down from $802 million as of June 30, 2024, primarily due to operating cash usage of $55.3 million [15] - Total revenue for Q3 2024 was $3.2 million, an increase from $1.5 million in Q3 2023, attributed to enhanced services under manufacturing and research agreements [16] - Research and development expenses rose to $45.3 million in Q3 2024 from $34.5 million in Q3 2023, driven by increased clinical trial costs [17] - General and administrative expenses increased to $10.1 million in Q3 2024 from $8.2 million in Q3 2023, mainly due to higher stock-based compensation [18] - The net loss for Q3 2024 was $42.1 million, compared to a net loss of $38.3 million in Q3 2023 [19]

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 developmentCompany to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticari ...

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024. Presenta ...

Shares of Celldex Therapeutics (CLDX) lost 12.1% on Wednesday due to unsatisfactory 52-week safety data from a mid-stage study of its investigational candidate, barzolvolimab, which is being developed for treating chronic spontaneous urticaria (CSU).CSU is a type of skin disease, characterized by the sudden appearance of hives (raised, itchy welts) without an identifiable trigger. The exact cause is often unknown, but it can be linked to immune system dysfunction, where the body mistakenly triggers allergic ...

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 ...