Core Insights - Celldex Therapeutics has made significant advancements in the development of barzolvolimab, particularly in treating mast cell-mediated diseases, with positive data reported from various clinical studies [2][4]. Clinical Development - Phase 3 studies for chronic spontaneous urticaria (CSU) are expected to begin in summer 2024, following positive Phase 2 data [1][4]. - The Phase 2 CSU study reported a statistically significant mean change in the weekly urticaria activity score (UAS7) at 12 weeks, demonstrating the drug's efficacy [4][5]. - Enrollment is nearing completion for the Phase 2 chronic inducible urticaria (CIndU) study, with data anticipated in the second half of 2024 [1][5]. - A Phase 2 study for prurigo nodularis (PN) is set to start in early 2024, building on positive Phase 1 data [1][6]. Financial Performance - As of December 31, 2023, the company reported cash, cash equivalents, and marketable securities totaling $423.6 million, a significant increase from $235.3 million at the end of Q3 2023 [8]. - Total revenue for Q4 2023 was $4.1 million, up from $1.6 million in Q4 2022, driven by increased services under manufacturing and research agreements [9]. - Research and development expenses rose to $30.4 million in Q4 2023, compared to $22.9 million in Q4 2022, primarily due to barzolvolimab clinical trials [9][10]. - The net loss for Q4 2023 was $43.3 million, or ($0.83) per share, compared to a net loss of $26.5 million, or ($0.56) per share, in Q4 2022 [12]. Pipeline and Future Plans - Celldex is expanding its barzolvolimab program into additional mast cell-mediated diseases and plans to introduce a bispecific antibody for inflammatory diseases [2][3]. - The company is also conducting a Phase 2 study in eosinophilic esophagitis (EoE), with protocol amendments to optimize dosing [6].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 13-3191702 State or other jurisdiction of incorporat ...

EXHIBIT 99.1 Celldex Reports Fourth Quarter and Year End 2023 Financial Results and Provides Corporate Update - Phase 3 CSU studies expected to initiate in summer 2024 - - Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 - - Enrollment nearing completion in Phase 2 CIndU study; Data expected 2H 2024 - - Phase 2 PN study expected to start in early 2024; Positive Phase 1 PN data reported in oral presentation at WCI 2023 - HAMPT ...

- Primary and secondary endpoints met with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups -- Sustained activity with rapid onset within 2 weeks -- Similar improvement in omalizumab-experienced/refractory and omalizumab-naïve disease consistent with unique mechanism of action -- Favorable safety profile -- 52 week results and Phase 3 CSU trial initiations anticipated in 2024 -- Company to host webcast February 25th at 9:45 am ET- HAMPTO ...

HAMPTON, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that management will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 9:00 a.m. ET. A webcast of the presentation will be available on the "Events & Presentations" of the "Investors & Media" section of the Celldex website. A replay will be available for 30 days following the event. About Celldex Therapeutics, Inc.Cell ...

Core Insights - Celldex Therapeutics, Inc. announced that an abstract detailing the 12-week results from its Phase 2 clinical trial of barzolvolimab for chronic spontaneous urticaria (CSU) has been accepted for presentation at the AAAAI Annual Meeting 2024 [1] - The trial aims to evaluate the efficacy and safety of barzolvolimab in patients with CSU who are resistant to antihistamines, with a total of 208 patients participating [2] Group 1 - The abstract titled "Barzolvolimab Significantly Decreases Chronic Spontaneous Urticaria Disease Activity and is Well Tolerated: Top Line Results from a Phase 2 Trial" will be presented by Dr. Marcus Maurer on February 24, 2024 [1] - The study is a randomized, double-blind, placebo-controlled trial assessing multiple dosing regimens of barzolvolimab, with patients assigned to receive either 75 mg, 150 mg, 300 mg, or placebo [2] - The primary endpoint of the study is the mean change in Urticaria Activity Score over 7 days (UAS7) from baseline to Week 12, with secondary endpoints including other safety and clinical activity assessments [2] Group 2 - A webcast presentation of the data will be hosted by the company on February 25, 2024, at 9:45 AM ET, accessible via the Celldex Therapeutics website [3] - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, and autoimmune diseases [4]

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 September 30, 2023 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 incorp ...

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, 2023 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 ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $.001 CLDX Nasdaq Capital Market 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 March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THE ...

Barzolvolimab Phase 1b Multiple Ascending Dose Chronic Spontaneous Urticaria Updated Study Results AAAAI 2023 Presentation – San Antonio February 26, 2023 Safe Harbor Statement This communication contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are st ...