Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported an EPS of -$1.22, missing estimates and indicating financial challenges. The company's revenue fell significantly short of expectations, with actual revenue at $121,000 versus an estimated $1.39 million. Despite financial hurdles, Celldex is advancing in clinical trials, with Phase 3 studies for chronic spontaneous urticaria fully enrolled and more studies underway. Celldex Therapeutics, Inc. (NASDAQ:CLDX) is a biotechnology company focused on developing tre ...

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, 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. Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827 (Address of principal executive offi ...

Celldex Reports Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update EXHIBIT 99.1 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. "Thi ...

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 2027Phase 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 initiatedCompany prepares for landmar ...

Enrollment completed six months ahead of guidance, driven by significant unmet need for better treatments in CSUTopline data expected Q4 2026BLA 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 i ...

Core Insights - Celldex announced multiple presentations of Phase 2 clinical trials for barzolvolimab at the 2026 AAAAI Annual Meeting, focusing on chronic spontaneous urticaria (CSU), cold urticaria (ColdU), and symptomatic dermographism (SD) [1][2] Group 1: Clinical Trial Presentations - New data from the Phase 2 ColdU and SD Open Label Extension (OLE) will be presented, indicating that retreatment with barzolvolimab results in rapid improvement in urticaria control after symptom recurrence [2] - The presentations include: - **Phase 2 ColdU and SD Study**: "Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria" on February 27, 2026 [2] - **Phase 2 CSU Study**: "Prolonged Off-Treatment Efficacy of Barzolvolimab in Chronic Spontaneous Urticaria" on February 27, 2026 [2] - **Phase 2 ColdU and SD Study**: "Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria" on March 1, 2026 [2] Group 2: Barzolvolimab Overview - Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action targeting mast cells by binding to a unique part of the KIT receptor, which is critical for mast cell function and survival [3] - The drug shows significant potential as a first-in-class treatment for CSU, ColdU, and SD, based on data from robust Phase 2 studies [3] - Barzolvolimab is currently undergoing Phase 3 studies for CSU and ColdU/SD, as well as Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) [3] Group 3: Company Background - Celldex is focused on pioneering new therapies in immunology, particularly antibody-based treatments that engage the human immune system to address allergic, inflammatory, and autoimmune disorders [4]

Company Project Progress - Barzol drug Phase III clinical trial is expected to complete patient enrollment by July 2026, which is considered the most important event of the year by management. The company also plans to initiate evaluations for new indications such as food allergies and allergic rhinitis [1] - The company plans to announce Phase II clinical trial results for nodular prurigo and atopic dermatitis in 2026, which will be used to determine the dosing regimen for subsequent registration studies [1] - Updates on the bispecific project CDX622 are expected in the third quarter of 2026, with results from a subcutaneous single-dose escalation study also planned for release within the year. Based on these data, the company intends to initiate mechanism validation studies for severe asthma [1] Strategic Advancement - The company is focused on validating its bispecific platform (CDX622) and promoting Barzol as the preferred drug in the field of CSU and other diseases. For commercialization, the company plans to independently advance in the U.S. market while considering partnerships for markets outside the U.S. [2] Institutional Perspectives - On January 7, 2026, Celldex Therapeutics' stock price surged by 5.18%, with 80% of brokerage firms giving a buy recommendation. However, it is important to note that the company is still in the research and development phase, with the latest financial report showing zero revenue and a negative net profit [3]

Summary of Celldex Therapeutics Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Event**: Guggenheim Emerging Outlook Biotech Summit 2026 - **Date**: February 11, 2026 - **Key Executives Present**: Anthony Marucci (President and CEO), Diane Young (Chief Medical Officer), Tibor Keler (Chief Scientific Officer) [1] Key Milestones and Developments - **2025 Achievements**: - Initiated a second Phase 3 study for cold urticaria and symptomatic dermographism in December 2025 [3] - Completed Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) [3] - **Ongoing Studies**: - Two Phase 3 studies for chronic spontaneous urticaria (CSU) are ongoing, with enrollment expected to complete by summer 2026 [4] - Combined enrollment target of at least 1,830 patients across 500 centers in 43 countries [4] Clinical Data and Efficacy - **Cold Urticaria and Symptomatic Dermographism**: - Phase 3 studies involve 240 patients, with results expected in approximately 18 months [5] - **Phase 2 Data**: - Anticipated data from PN and AD studies in the second half of 2026, which will inform future Phase 3 studies [5] - **Physician Feedback**: - Physicians are enthusiastic about the data, noting a 70% complete response rate and 41% persistence of effect seven months post-treatment [9] - Long-term durability data is expected to change treatment paradigms [13] Safety Profile - **Safety Data**: - Consistent safety profile with common side effects being mild and reversible [24] - Investigators are comfortable with the safety data presented so far [24] Commercial Strategy - **Market Dynamics**: - The market for biologically eligible patients is estimated at 750,000, with potential for growth as competitors enter [39] - Pricing strategy will be influenced by competitors like Novartis and Sanofi, with a focus on positioning behind existing treatments [39][41] - **Launch Considerations**: - Additional capital will be needed for product launch and further development [82] Future Indications and Research - **Additional Indications**: - Exploring food allergies, allergic rhinitis, and chronic pruritic itch as potential future indications [6] - **Bispecific Molecule Development**: - CDX-622 targets stem cell factor and TSLP, with promising early results in healthy volunteers [68] - Ongoing studies in asthma to validate the dual mechanism of action [72] Financial Position - **Cash Reserves**: - $583 million at the end of Q3 2025, sufficient to fund operations through 2027 [82] - **Future Funding Needs**: - Additional capital will be required for product launch and ongoing development [84] Conclusion - Celldex Therapeutics is positioned for significant growth with multiple ongoing clinical trials and a strong pipeline. The company is focused on expanding its market presence while ensuring safety and efficacy in its treatments. Future developments in additional indications and bispecific therapies are also being explored, with a solid financial foundation to support these initiatives.

Core Viewpoint - Cedars Medical (CLDX.US) has announced its key R&D plans for 2026, focusing on multiple clinical trial advancements and platform validation [1] Project Advancement - The Phase III clinical trial for CSU: The main drug Barzol targeting chronic spontaneous urticaria (CSU) is expected to complete patient enrollment by July 2026, which is the most anticipated event by management [2] - Update on the bispecific project CDX622: Data from the multi-dose escalation study is expected to be released in the third quarter of 2026. Results from the subcutaneous single-dose escalation study are also planned for release within 2026. The company aims to initiate mechanism validation studies for severe asthma based on these data [4] - Evaluation of new indications: The company will start assessing the potential for expanding Barzol into new indications such as food allergies and allergic rhinitis [5] Product Development Progress - Announcement of Phase II clinical data: Results from the Phase II studies on nodular prurigo and atopic dermatitis are planned for release in 2026. These studies will be used to determine the dosing regimen for subsequent registration studies [3] Strategic Advancement - Mid to long-term strategic focus: The company is committed to validating its bispecific platform (CDX622) and promoting Barzol as the preferred drug in the CSU and other disease areas. In terms of commercialization, the plan is to independently advance in the U.S. market while considering partnerships for markets outside the U.S. [6]

Core Insights - Celldex Therapeutics is focused on developing antibody-based therapies for allergic, inflammatory, and autoimmune diseases, with a market capitalization of $1.76 billion [3] - The lead program, barzolvolimab, has shown promising results in clinical trials for chronic urticaria conditions, with significant efficacy and safety profiles reported [2][5] - The company is currently in a strong financial position with $583.2 million in cash and equivalents, expected to sustain operations until 2027 despite reporting a net loss of $67 million in Q3 [5] Clinical Development - Celldex initiated a global Phase 3 study for barzolvolimab in December, targeting ColdU and SD, with ongoing Phase 2 studies for prurigo nodularis and atopic dermatitis [1] - Positive Phase 2 results for barzolvolimab indicated that 66% of ColdU patients and 49% of SD patients achieved complete responses at 20 weeks, significantly outperforming placebo [2] - The company is also developing CDX-622, a bispecific antibody, with positive Phase 1 data and further results expected in Q3 2026 [1] Market Potential - There are over half a million patients in the U.S. and Europe suffering from various urticaria conditions, indicating a substantial unmet medical need that barzolvolimab could address [7] - Analysts have a favorable outlook on CLDX stock, with 13 out of 17 rating it a "Strong Buy" and an average target price suggesting a potential upside of 104% from current levels [7] Investment Landscape - The biotech sector, particularly for growth stocks like Celldex, is characterized by high risk and potential for significant returns based on clinical trial outcomes and regulatory approvals [4][6] - Celldex's stock performance is closely tied to the success of its clinical trials, typical for clinical-stage biotech companies [6]