Celldex Reports Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update

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. “This is underscored by the completion of enrollment in our Phase 3 CSU studies six months ahead of guidance and strong interest from clinical trial sites in our recently initiated Phase 3 study in cold urticaria and symptomatic dermographism.”

“During 2026, we are excited for multiple important data readouts across our pipeline, including topline data from our barzolvolimab Phase 3 studies in CSU, Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622,” continued Mr. Marucci. “We continue to prepare for the planned BLA filing and commercialization of barzolvolimab in CSU, which has the potential to transform the treatment landscape and position Celldex as a pioneering immunology company—leading in mast cell biology and delivering groundbreaking therapies for patients who are waiting for better treatment options.”

Recent Program Highlights

Barzolvolimab - KIT Inhibitor Program

Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease.

Chronic Urticarias

Prurigo Nodularis and Atopic Dermatitis

Novel Bispecific Antibody Platform

CDX-622 – Bispecific SCF & TSLP

CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders. CDX-622 has been engineered to disable effector function (AQQ) and enhance half-life (YTE).

Fourth Quarter and Twelve Months 2025 Financial Highlights and 2026 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $518.6 million compared to $583.2 million as of September 30, 2025. The decrease was primarily driven by fourth quarter cash used in operating activities of $63.9 million. The increase in cash used in operating activities in the fourth quarter was primarily driven by higher clinical expenses, including the accelerated enrollment completion of the Phase 3 CSU program, and manufacturing barzolvolimab expenses. At December 31, 2025, Celldex had 66.5 million shares outstanding.

Revenues: Total revenue was $0.1 million in the fourth quarter of 2025 and $1.5 million for the year ended December 31, 2025, compared to $1.2 million and $7.0 million for the comparable periods in 2024. The decrease in revenue was primarily due to a decrease in services performed under our manufacturing and research and development agreements with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $75.3 million in the fourth quarter of 2025 and $245.1 million for the year ended December 31, 2025, compared to $46.9 million and $163.6 million for the comparable periods in 2024. The increase in R&D expenses was primarily due to an increase in barzolvolimab clinical trial and contract manufacturing expenses and an increase in employee headcount.

G&A Expenses: General and administrative (G&A) expenses were $11.9 million in the fourth quarter of 2025 and $43.8 million for the year ended December 31, 2025, compared to $10.3 million and $38.5 million for the comparable periods in 2024. The increase in G&A expenses was primarily due to an increase in employee headcount and an increase in barzolvolimab commercial planning expenses.

Net Loss: Net loss was $81.3 million, or ($1.22) per share, for the fourth quarter of 2025, and $258.8 million, or ($3.90) per share, for the year ended December 31, 2025, compared to a net loss of $47.1 million, or ($0.71) per share, for the fourth quarter of 2024, and $157.9 million, or ($2.45) per share, for the year ended December 31, 2024.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2025 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com.

Forward-Looking Statement

This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact

Sarah Cavanaugh

Senior Vice President, Corporate Affairs & Administration

(508) 864-8337

scavanaugh@celldex.com

Patrick Till

Meru Advisors

(484) 788-8560

ptill@meruadvisors.com