Celldex Therapeutics(CLDX) - 2025 Q1 - Quarterly Results

Corporate Update and CEO Remarks CEO Anthony Marucci highlighted barzolvolimab's best-in-class efficacy in chronic urticaria, anticipating 2025 as a pivotal year with key data readouts, including 76-week CSU study results exploring sustained disease control - Barzolvolimab demonstrated best-in-class efficacy in chronic urticaria, showing high complete response rates and significant improvements in patient quality of life[2] - 2025 is anticipated to be a year of strong execution with key data readouts from barzolvolimab's Phase 2 studies (CSU, CIndU, EOE) and CDX-622's Phase 1 study[2][6] - Upcoming 76-week data from the Phase 2 CSU study, focusing on sustained disease control after treatment withdrawal, will be presented at the EAACI conference in June[2][7] Program Highlights Celldex is advancing its clinical pipeline, with barzolvolimab progressing in Phase 3 for CSU and planned for CIndU, alongside ongoing Phase 2 studies and active enrollment for CDX-622's Phase 1 study Barzolvolimab - KIT Inhibitor Program Barzolvolimab, a KIT inhibitor, is advancing with global Phase 3 trials for CSU, a planned Phase 3 for CIndU in 2025, and ongoing Phase 2 studies for EoE, PN, and AD with data expected in 2025 - Global Phase 3 program for CSU (EMBARQ-CSU1 and EMBARQ-CSU2) is ongoing, with each trial enrolling approximately 915 patients[7] - A global Phase 3 program in CIndU is expected to initiate in 2025[7] - Positive quality of life data from Phase 2 CSU and CIndU studies showed up to 82% of CSU patients at Week 52 reported no symptom impact on quality of life[13] - Enrollment is complete for the Phase 2 EoE study with data expected in 2025, while Phase 2 studies for PN and AD are ongoing[13] Bispecific Antibody Platform (CDX-622) CDX-622, a bispecific antibody targeting TSLP and SCF to reduce mast cells and inhibit Type 2 inflammation, is undergoing a Phase 1 study in healthy volunteers with initial data expected in 2025 - CDX-622 is a bispecific antibody designed to neutralize TSLP and deplete mast cells by targeting SCF[10] - A Phase 1 study in healthy volunteers is ongoing, with single ascending dose data expected in 2025[10] First Quarter 2025 Financial Highlights Celldex reported a net loss of $53.8 million in Q1 2025, driven by increased R&D expenses, concluding the quarter with a strong cash position of $673.3 million, sufficient to fund operations through 2027 Financial Performance (Q1 2025 vs Q1 2024) Q1 2025 saw total revenue of $0.7 million, with R&D expenses rising to $52.6 million due to barzolvolimab costs, resulting in a net loss of $53.8 million or ($0.81) per share | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $0.7 million | $0.2 million | | R&D Expenses | $52.6 million | $31.7 million | | G&A Expenses | $10.8 million | $9.1 million | | Net Loss | $53.8 million | $32.8 million | | Net Loss per Share | ($0.81) | ($0.56) | - The increase in R&D expenses was primarily driven by higher costs for barzolvolimab clinical trials, contract manufacturing, and personnel[12][14] Financial Position and Guidance As of March 31, 2025, Celldex held $673.3 million in cash, cash equivalents, and marketable securities, a decrease from year-end 2024, with current reserves projected to fund operations through 2027 | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $673.3 million | $725.3 million | - The company believes its cash position is sufficient to meet working capital requirements and fund planned operations through 2027[15] - As of March 31, 2025, Celldex had 66.4 million shares outstanding[11] Consolidated Financial Statements The unaudited consolidated financial statements detail the company's Q1 2025 performance, showing a net loss of $53.8 million and a financial position with total assets of $739.5 million and stockholders' equity of $703.0 million Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | | :--- | :--- | :--- | | | 2025 | 2024 | | Total revenues | $695 | $156 | | Total operating expenses | $63,434 | $40,764 | | Operating loss | $(62,739) | $(40,608) | | Net loss | $(53,796) | $(32,808) | | Basic and diluted net loss per common share | $(0.81) | $(0.56) | Condensed Consolidated Balance Sheet Data (Unaudited, in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $673,291 | $725,281 | | Total assets | $739,471 | $792,340 | | Total liabilities | $36,490 | $45,335 | | Stockholders' equity | $702,981 | $747,005 |