Summary of Celldex Therapeutics Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 13, 2025 - **Key Speakers**: Anthony Marucci (CEO), Tibor Keler (CSO), Diane Young (CMO) Key Points Industry and Product Focus - The discussion primarily revolves around Celldex's ongoing clinical trials and data related to their drug Barzolvolimab, particularly in the context of Chronic Spontaneous Urticaria (CSU), Prurigo Nodularis (PN), and Atopic Dermatitis (AD) [3][4][34] Clinical Data Highlights - **CSU Phase Two Data**: - A 76-week phase two study showed a **41% complete response rate** seven months after stopping Barzolvolimab, indicating a durable remission [3][4] - This response rate is comparable to Xolair and higher than Dupixent, suggesting significant efficacy [3][4] - **Competitor Comparison**: - Xolair's effects diminish within weeks after cessation, while Ruxolitinib's long-term effects remain unclear. Dupixent shows modest efficacy [4][5] - **Mast Cell Dynamics**: - Data indicates that mast cells return to normal levels after treatment, but the long-term effects on disease modification are still being evaluated [6] Future Studies and Trials - **OLE (Open Label Extension)**: - The OLE is designed to gather additional follow-up data and explore retreatment options post-approval [7][8] - **Upcoming Trials**: - Ongoing phase two studies for PN and AD are expected to yield results in the second half of 2026. The PN trial involves 120 patients and focuses on itch reduction and lesion healing [17][21][34] - **CDX-622 Development**: - CDX-622, a bispecific targeting mast cells and TSLP, is in phase one trials with promising pharmacokinetics and no immunogenicity observed [28][29] Market Position and Strategy - **Competitive Landscape**: - Celldex aims to position Barzolvolimab as a competitive option against existing treatments like Dupixent, focusing on improving itch reduction and lesion healing [19][20] - **Pipeline Expansion**: - The company is considering various indications for CDX-622, including severe asthma and food allergies, based on ongoing data [31][32] Upcoming Catalysts - Key upcoming milestones include: - Phase three study initiation for cold urticaria and symptomatic dermographism by the end of 2025 - Phase two readouts for cold urticaria and symptomatic dermographism in Q1 2026 - Completion of CSU phase three accrual by summer 2026 - Data releases for AD and PN in the second half of 2026 [34][36] Enrollment and Study Progress - Enrollment for the ongoing EMBARK studies is proceeding well, with expectations to complete by summer 2026 [36][37] Additional Insights - The discussion emphasizes the importance of understanding mast cell roles in various conditions, which could lead to innovative treatment strategies and improved patient outcomes [20][22]

Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 11, 2025 - **Key Executives Present**: Tibor Keler (Chief Scientific Officer), Diane Young (Chief Medical Officer), Sarah Cavanaugh (SVP Corporate Affairs) Key Industry Insights - **Urticaria Programs**: 2025 has been a significant year for Celldex, particularly with advancements in their urticaria programs, including chronic spontaneous urticaria (CSU) and inducible urticaria [2][3] - **Data Presentation**: The company presented 76-week data from the CSU program, showcasing high efficacy and off-treatment durability, with a 41% complete response rate seven months post-treatment [5][6] - **Phase Three Studies**: Ongoing phase three studies in CSU and a new phase three study for inducible urticaria set to begin in December [2][10] Core Product Insights - **Barzolimab**: The drug has shown unprecedented off-treatment durability compared to existing treatments like Xolair and Dupixent, which typically see symptom recurrence shortly after discontinuation [6][8] - **Safety Profile**: The safety data from the 76-week study indicates that barzolimab is well tolerated, with mild and reversible side effects [8][9] Pipeline Developments - **CDX-622 Program**: Recent data from the CDX-622 program indicates a promising future for 2026, with a focus on targeting both TSLP and stem cell factor [3][36] - **Inducible Urticaria Study**: The phase two study for inducible urticaria reported that about two-thirds of cold urticaria patients achieved a complete response at 20 weeks [15][16] - **Future Studies**: Plans for phase two studies in prurigo nodularis (PN) and atopic dermatitis (AD) are underway, with expectations for data in the second half of next year [25][26][31] Financial Position - **Cash Position**: The company reported a cash position of $583.2 million, which is expected to fund operations through 2027 [48][49] Competitive Landscape - **Market Dynamics**: The entry of competitors like Novartis with Remibrutinib is expected to expand the market for CSU treatments, which Celldex believes positions barzolimab favorably within this growing market [47] Additional Considerations - **Future Indications**: Celldex is exploring additional indications related to itch and other allergic conditions, leveraging the unique properties of their bispecific antibody portfolio [32][34][45] - **Biomarker Strategy**: The company plans to utilize biomarkers to assess the efficacy of their treatments, particularly in asthma studies [46] This summary encapsulates the key points discussed during the conference call, highlighting the advancements, pipeline developments, and strategic positioning of Celldex Therapeutics in the biopharmaceutical industry.

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, 2025 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. Securities registered pursuant to Section 12(b) of the Act: | Title of each class | Trading Symbol(s) | Name of each ...

EXHIBIT 99.1 Celldex Reports Third Quarter 2025 Financial Results and Provides Corporate Update HAMPTON, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2025 and provided a corporate update. "This quarter, Celldex continued to demonstrate our leadership in the field of mast cell biology, presenting exciting data across our pipeline programs," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Cel ...

Strong execution and continued progress across pipeline Positive Phase 2 barzolvolimab data in Chronic Spontaneous Urticaria (CSU) demonstrating rapid, profound improvement in UCT7 scores with sustained disease control post treatment and strong efficacy regardless of baseline IgE levels Positive Phase 2 barzolvolimab data in Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) demonstrating sustained efficacy and favorable safety profile at 20 weeks; first large, randomized, placebo-controlled study to ...

Core Insights - Celldex has appointed Teri Lawver as Senior Vice President and Chief Commercial Officer, succeeding Richard Wright who is retiring after over a decade of service [1][2] - Teri Lawver brings 30 years of experience in global healthcare, particularly in biopharmaceuticals and medical technology, with a strong background in immunology and inflammation [2][3] - Lawver's previous roles include Chief Commercial Officer at Dexcom, where she managed $4 billion in annual revenue, and significant positions at Johnson & Johnson, including Worldwide Vice President for Janssen Immunology [2] Company Overview - Celldex is focused on advancing immunology to develop novel antibody-based therapies aimed at improving outcomes for patients with allergic, inflammatory, and autoimmune disorders [3] - The company is preparing for the potential launch of barzolvolimab and is advancing its broader pipeline of therapies [2][3]

Group 1 - Celldex will participate in upcoming investor conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, TD Cowen Immunology & Inflammation Summit on November 13, and the 8th Annual Evercore Healthcare Conference on December 2 [1][3] - Live webcasts of the presentations will be available on the "Events & Presentations" page of the Celldex website, with replays accessible for 90 days following each event [1] Group 2 - Celldex is focused on pioneering new therapies in immunology, particularly through novel antibody-based treatments aimed at improving the lives of patients with allergic, inflammatory, and autoimmune disorders [2]

HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab’s ability to improve urticaria control from the Company’s recently completed Phase 2 study in chronic spontaneous urticaria (CSU). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting (ACAAI) in Orlando, Florida by Dr. Steven Greenberg, Vice President of Clinical Sci ...

Core Insights - Celldex announced positive data from the Phase 1 study of CDX-622, a bispecific antibody targeting inflammation and fibrosis pathways [1][2] - The study demonstrated good tolerability, a favorable pharmacokinetic profile, and significant reductions in serum tryptase levels, indicating effective mast cell inhibition [1][6] - The company plans to advance the study to the next phase, testing multiple ascending doses and initiating a Phase 1b study in asthma patients [2][4] Study Design and Results - The Phase 1 trial is a randomized, double-blind, placebo-controlled, dose escalation study assessing safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CDX-622 [4][7] - Part 1 enrolled 32 participants across 4 cohorts, receiving single ascending intravenous doses of CDX-622 (0.3, 1.0, 3.0, and 9.0 mg/kg) over a 12-week observation period [4][6] - Data from Part 1 were presented, and enrollment for Part 2 is ongoing, with results from Parts 2 and 3 expected in Q3 2026 [4][6] Mechanism and Therapeutic Potential - CDX-622 targets two validated pathways: neutralizing TSLP and depleting mast cells via SCF starvation, potentially offering enhanced therapeutic benefits for inflammatory and fibrotic disorders [5][6] - The antibody showed a serum half-life of approximately 18 days at 9 mg/kg, with no evidence of immunogenicity or dose-limiting toxicities observed [6][2] - A single dose led to a rapid and sustained decrease of about 50% in circulating tryptase, consistent with systemic mast cell inhibition [6]

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