Celldex Reports Fourth Quarter and Year End 2025 Financial Results and Provides Corporate Update
Rhea-AI Summary
Celldex (NASDAQ:CLDX) reported Q4 and full-year 2025 results and a clinical update. Cash and marketable securities were $518.6M at year-end; net loss was $258.8M for 2025. Enrollment completed in Phase 3 CSU (1,939 patients) six months early; topline CSU data expected Q4 2026 with a planned BLA in 2027.
Multiple 2026 readouts expected across barzolvolimab Phase 2 and 3 programs and CDX-622 early clinical data; company states cash runway through 2027.
Positive
- Phase 3 CSU enrollment completed early: 1,939 patients
- Enrollment finished six months ahead of guidance
- Company reports cash runway through 2027
- Multiple topline readouts expected in 2026 (CSU, PN, AD, CDX-622)
Negative
- Cash decreased by $64.6M from Sept 30, 2025 to Dec 31, 2025
- Net loss widened to $258.8M in 2025 (vs $157.9M in 2024)
- Revenue declined to $1.5M for 2025 from $7.0M in 2024
News Market Reaction – CLDX
On the day this news was published, CLDX gained 24.07%, reflecting a significant positive market reaction. Argus tracked a peak move of +18.7% during that session. Our momentum scanner triggered 56 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $399M to the company's valuation, bringing the market cap to $2.06B at that time. Trading volume was very high at 4.5x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner shows no sector-wide move. Peers are mixed: COGT up 5.24%, ARDX up 5.64%, VERA up 1.12%, AUPH down 0.68%, CDTX flat at 0.03%, suggesting stock-specific trading in CLDX rather than a broad biotech rotation.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Earnings update | Positive | -1.0% | Q3 2025 results and strong Phase 2 barzolvolimab data across urticarias. |
| Aug 07 | Earnings update | Positive | -2.6% | Q2 2025 results with robust CSU Phase 2 data and large cash reserves. |
| May 08 | Earnings update | Positive | -6.1% | Q1 2025 results and advancement of multiple Phase 2 barzolvolimab studies. |
| Feb 27 | Earnings update | Positive | +1.3% | Q4 and 2024 results with progressing barzolvolimab programs and strong cash. |
| Aug 08 | Earnings update | Positive | +0.6% | Q2 2024 results and initiation of Phase 3 CSU and CIndU data. |
Earnings updates have generally been viewed positively on fundamentals but produced slightly negative average next-day moves, with 3 of 5 prior earnings reactions trading lower.
Across prior earnings releases from Q2 2024 through Q3 2025, Celldex consistently highlighted progress for barzolvolimab and CDX‑622 while reporting rising R&D spend and net losses. Cash positions remained strong, repeatedly guiding runway through 2027. Earlier updates tracked the transition from initiating Phase 3 CSU and CIndU programs to advancing global enrollment. Today’s Q4 and 2025 results extend that narrative with higher R&D tied to accelerated Phase 3 CSU completion and preparation for upcoming 2026 readouts.
Historical Comparison
Over the past five earnings releases, CLDX averaged a -1.55% next-day move. Today’s pre-news gain of 2.14% sits above this typical earnings reaction pattern.
Earnings updates trace barzolvolimab’s path from early Phase 3 initiation to broad global enrollment, while CDX‑622 advanced from preclinical to Phase 1 with expanding clinical biomarker plans.
Market Pulse Summary
The stock surged +24.1% in the session following this news. A strong positive reaction aligns with Celldex’s pattern of using earnings to showcase clinical momentum and balance higher R&D spending with a solid cash runway through 2027. Investors have recently rewarded barzolvolimab advances and broad Phase 3 enrollment. However, rising net losses of $258.8M in 2025 and elevated operating spend could cap enthusiasm if future readouts or financing plans disappoint.
Key Terms
monoclonal antibody medical
randomized, double-blind, placebo-controlled medical
pharmacokinetics medical
pharmacodynamics medical
subcutaneous medical
fractional exhaled nitric oxide (feno) medical
absolute eosinophil count (aec) medical
AI-generated analysis. Not financial advice.
- 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 2027
- Phase 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 initiated
- Company prepares for landmark year of clinical readouts in 2026
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
- This morning, Celldex announced that enrollment was completed six months ahead of guidance in the global Phase 3 program in chronic spontaneous urticaria (CSU)—demonstrating strong interest in barzolvolimab. The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. EMBARQ-CSU1 and EMBARQ-CSU2 are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with advanced therapies. Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027.
- In December 2025, Celldex initiated a global Phase 3 study in cold urticaria (ColdU) and symptomatic dermographism (SD)—EMBARQ-ColdU and -SD. Barzolvolimab is the first drug in development to demonstrate clinical benefit in patients with ColdU and SD in a large, randomized, placebo-controlled study. In the recently completed Phase 2 study, all primary and secondary endpoints were met with high statistical significance at 12 weeks and sustained through the end of the treatment period (20 weeks).
- Data from the Phase 2 studies of barzolvolimab in both CSU and ColdU/SD have been accepted for multiple presentations at the 2026 AAAAI Annual Meeting (February 27 – March 2). This includes a late breaking poster presentation on new data from the Phase 2 ColdU and SD study entitled “Retreatment with Barzolvolimab Leads to Rapid Improvement in Urticaria Control After Symptom Recurrence in Chronic Inducible Urticaria” on Sunday, March 1, 2026.
Prurigo Nodularis and Atopic Dermatitis
- Enrollment is complete in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN. Topline data from this study are expected to be presented in the summer of 2026.
- Enrollment is complete in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. Topline data from this study are expected to be presented in late 2026.
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).
- Enrollment is complete in the Phase 1 study in healthy volunteers. The Phase 1a clinical trial is a three-part, randomized, double-blind, placebo-controlled, dose escalation study designed to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 80 healthy participants (Part 1: single intravenous (IV) dose, Part 2: 4 IV doses, Part 3: single subcutaneous (SubQ) dose). Positive data from the single ascending dose portion of the study was presented in October 2025. Data from the multiple ascending dose portion of the study and SubQ administration are anticipated in the third quarter of 2026. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP.
- In January 2026, we initiated an open-label, single-dose Phase 1 proof of mechanism (POM) study to assess the safety, pharmacodynamics, and pharmacokinetics of CDX-622 in adults with mild to moderate asthma. Participants will receive a single IV infusion of CDX-622 and be followed for 12 weeks. PD effects of CDX-622 on fractional exhaled nitric oxide (FeNO), absolute eosinophil count (AEC) and serum biomarkers, including TSLP- and SCF-related biomarkers, will be evaluated.
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
Revenues: Total revenue was
R&D Expenses: Research and development (R&D) expenses were
G&A Expenses: General and administrative (G&A) expenses were
Net Loss: Net loss was
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
| CELLDEX THERAPEUTICS, INC. | ||||||||||||||||
| (In thousands, except per share amounts) | ||||||||||||||||
| Three Months | Year | |||||||||||||||
| Consolidated Statements of Operations Data | Ended December 31, | Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | ||||||||||||||||
| Revenues: | ||||||||||||||||
| Product development and licensing agreements | $ | 40 | $ | 8 | $ | 97 | $ | 13 | ||||||||
| Contracts and grants | 81 | 1,167 | 1,448 | 7,007 | ||||||||||||
| Total revenues | 121 | 1,175 | 1,545 | 7,020 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 75,333 | 46,939 | 245,074 | 163,550 | ||||||||||||
| General and administrative | 11,941 | 10,263 | 43,838 | 38,548 | ||||||||||||
| Total operating expenses | 87,274 | 57,202 | 288,912 | 202,098 | ||||||||||||
| Operating loss | (87,153 | ) | (56,027 | ) | (287,367 | ) | (195,078 | ) | ||||||||
| Investment and other income, net | 5,836 | 8,935 | 28,610 | 37,215 | ||||||||||||
| Net loss | $ | (81,317 | ) | $ | (47,092 | ) | $ | (258,757 | ) | $ | (157,863 | ) | ||||
| Basic and diluted net loss per common share | $ | (1.22 | ) | $ | (0.71 | ) | $ | (3.90 | ) | $ | (2.45 | ) | ||||
| Shares used in calculating basic and diluted net loss per share | 66,489 | 66,353 | 66,422 | 64,395 | ||||||||||||
| Condensed Consolidated Balance Sheet Data | December 31, | December 31, | ||||||||||||||
| 2025 | 2024 | |||||||||||||||
| Assets | ||||||||||||||||
| Cash, cash equivalents and marketable securities | $ | 518,573 | $ | 725,281 | ||||||||||||
| Other current assets | 16,091 | 21,878 | ||||||||||||||
| Property and equipment, net | 5,334 | 4,346 | ||||||||||||||
| Intangible and other assets, net | 42,985 | 40,835 | ||||||||||||||
| Total assets | $ | 582,983 | $ | 792,340 | ||||||||||||
| Liabilities and stockholders' equity | ||||||||||||||||
| Current liabilities | $ | 50,991 | $ | 39,501 | ||||||||||||
| Long-term liabilities | 4,827 | 5,834 | ||||||||||||||
| Stockholders' equity | 527,165 | 747,005 | ||||||||||||||
| Total liabilities and stockholders' equity | $ | 582,983 | $ | 792,340 | ||||||||||||
FAQ
When will Celldex (CLDX) report topline Phase 3 CSU results and what follows?
How large was the Phase 3 chronic spontaneous urticaria program for CLDX and why is it significant?
What cash runway did Celldex (CLDX) report at year-end 2025 and how long will it fund operations?
What major clinical readouts does Celldex (CLDX) expect in 2026 besides CSU?
How did Celldex's 2025 financials change and what drove the expense increases for CLDX?
