Celldex Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported no material revenue for the three months ended September 30, 2026, compared to $0.0 million in the same period in 2025; total revenue for the nine months ended September 30, 2026, was $37,000, down from $1.4 million in the prior year period.
• Research and development expenses were $67.4 million for the quarter (up from $62.9 million in Q3 2025) and $208.0 million for the nine months (up from $169.7 million year-to-date).
• General and administrative expenses were $14.8 million for the quarter (up from $10.7 million in Q3 2025) and $39.4 million for the nine months (up from $31.9 million year-to-date).
• Net loss was $75.6 million, or $0.96 per share, for the quarter, compared to a net loss of $67.0 million, or $1.01 per share, in Q3 2025; for the nine months, net loss was $227.7 million, or $3.06 per share, compared to $177.4 million, or $2.67 per share, in the prior year period.
• Cash, cash equivalents, and marketable securities totaled $650.3 million as of September 30, 2026, a decrease from $717.6 million as of June 30, 2026, driven by $65.0 million in cash used in operating activities during the quarter.
• Total assets were $721.5 million as of September 30, 2026, compared to $583.0 million as of December 31, 2025.
• Total liabilities were $72.1 million as of September 30, 2026, compared to $55.8 million as of December 31, 2025.

Guidance and Future Outlook:

• Management anticipates a Biologics License Application (BLA) submission for barzolvolimab in chronic spontaneous urticaria (CSU) in 2027.
• The company believes its cash position is sufficient to fund current planned operations and meet working capital requirements through 2028.
• Enrollment is ongoing in the Phase 3 EMBARQ-ColdU and EMBARQ-SD studies for barzolvolimab, with updates expected in 2027.
• Topline data from the Phase 2 study in atopic dermatitis is expected to be presented in late 2026.
• Additional indications for barzolvolimab are expected to be announced by year-end.

Business Segments and Product Lines:

• Barzolvolimab Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies reported best-in-disease results, meeting all primary and key secondary endpoints with rapid, profound, and sustained efficacy, including complete response rates.
• Barzolvolimab demonstrated efficacy in antihistamine-refractory patients with severe disease, severe angioedema, and omalizumab-refractory disease.
• In the Phase 2 CSU study, over 40% of patients treated with 150mg Q4W maintained complete response 76 weeks after dosing completion, and up to 64% of patients with baseline angioedema remained angioedema-free.
• The Phase 2 study in prurigo nodularis (PN) was discontinued after topline data suggested mast cells are not the key pathogenic driver, though the drug was well-tolerated.
• CDX-622, a novel bispecific antibody targeting SCF and TSLP, showed rapid, profound, dose-dependent reductions in serum tryptase in Phase 1 healthy volunteer trials and is currently being evaluated in an open-label Phase 1 proof-of-mechanism study in adults with mild to moderate asthma.
• CDX-622 is planned for expansion into additional indications including allergic rhinitis and food allergy.

Market and Competitive Landscape:

• Barzolvolimab is described as the first drug in development to demonstrate clinical benefit in patients with cold urticaria and symptomatic dermographism in a large, randomized, placebo-controlled study.
• Celldex is the first company to directly demonstrate that neutralizing soluble stem cell factor (SCF) can selectively inhibit KIT signaling in mast cells.
• The company aims to shift the treatment paradigm for chronic urticarias from symptom improvement to complete symptom resolution.

Risks and Challenges:

• Risks include the ability to successfully complete research, development, and commercialization of drug candidates, including barzolvolimab and CDX-622.
• Uncertainties exist regarding clinical testing, patient accrual, and the limited experience in bringing programs through Phase 3 trials.
• Potential risks involve the availability, cost, and quality of clinical materials from contract manufacturers or the company's own facility.
• Regulatory approval timing and cost remain uncertain, as does the potential failure of the market for the company's programs to develop.
• Risks also include the loss of key personnel, competition, changes in the regulatory landscape, and the ability to obtain additional capital.

Management Commentary and Tone:

• CEO Anthony Marucci stated barzolvolimab has significant potential to address large populations with high unmet need and described the Phase 3 results as demonstrating "unparalleled ability to deliver complete response."
• Management expressed confidence in advancing the pipeline, noting "excellent progress" across earlier-stage programs and plans to expand barzolvolimab and CDX-622 development across diverse immune and inflammatory diseases.
• The tone emphasized moving quickly to bring the medicine to patients and physicians while continuing to validate the therapeutic potential of KIT inhibition.

Other Key Points:

• Shares outstanding were 78.5 million as of September 30, 2026.
• The decrease in revenue was attributed to a decrease in services performed under manufacturing and R&D agreements with Rockefeller University.
• Increases in R&D and G&A expenses were driven by increased barzolvolimab clinical trial and contract manufacturing expenses, commercial planning expenses, and increased employee headcount.
• Barzolvolimab retreatment in the ColdU and SD Phase 2 Open Label Extension achieved similar profound efficacy to first exposure.
• CDX-622 exhibited monoclonal antibody-like pharmacokinetics with extended half-life and good exposure via subcutaneous administration.