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.