Celldex Reports First Quarter Financial Results and Provides Corporate Update
Rhea-AI Summary
Celldex (NASDAQ:CLDX) reported Q1 2026 results and an operational update on May 7, 2026. Key points: Phase 3 CSU enrollment finished six months early (1,939 patients), topline CSU data expected Q4 2026, BLA planned for 2027, multiple 2026 readouts expected, and a $345M follow-on financing closed in April 2026.
Cash as of March 31, 2026: $451.5M; net loss Q1 2026: $78.7M (−$1.18/share).
AI-generated analysis. Not financial advice.
Positive
- Phase 3 CSU enrollment completed six months early (1,939 patients)
- Topline Phase 3 CSU data expected in Q4 2026
- Raised $345.0 million gross in April 2026 public offering
- Cash runway expected through 2028 after April offering
Negative
- Net loss of $78.7 million in Q1 2026
- R&D expenses increased to $73.0 million in Q1 2026
- Revenue declined to $0.0 million in Q1 2026
Key Figures
Market Reality Check
Peers on Argus
CLDX gained 1.57% while close biotech peers were mixed: VERA up 4.84%, AUPH and CDTX roughly flat, COGT and ARDX down. Momentum scans only flagged VRDN modestly higher, supporting a stock-specific reaction to CLDX’s earnings and pipeline update.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 25 | Q4 2025 earnings | Positive | +24.1% | Reported Q4/full-year 2025 results, strong cash of $518.6M, and early CSU Phase 3 enrollment. |
| Nov 10 | Q3 2025 earnings | Positive | +7.5% | Q3 2025 results plus positive Phase 2 barzolvolimab data in CSU and ColdU/SD and CDX-622 progress. |
| Aug 07 | Q2 2025 earnings | Positive | -2.6% | Q2 2025 results with strong CSU Phase 2 durability data and sizable $630.3M cash reserves. |
| May 08 | Q1 2025 earnings | Positive | -6.1% | Q1 2025 results highlighting advancing Phase 3 CSU program and multiple Phase 2 studies. |
| Feb 27 | Q4 2024 earnings | Positive | +1.3% | Q4/full-year 2024 results with solid cash, growing urticaria programs, and CDX-622 launch. |
Earnings and corporate updates have generally been received positively, with three out of five recent earnings reports producing upside moves, though negative reactions have also occurred despite constructive operational updates.
Over the last five earnings cycles, Celldex has repeatedly paired financial results with substantial barzolvolimab and CDX-622 updates. Cash balances remained high, with reported runways through 2027, and key milestones included early completion of Phase 3 CSU enrollment and strong Phase 2 urticaria data. Market reactions have often been favorable, highlighted by a 24.07% rise on Feb 25, 2026, but two earlier quarters saw shares decline despite positive clinical and cash runway commentary, underscoring inconsistent trading responses.
Historical Comparison
In the past five earnings updates, CLDX moved on average 4.83%. Today’s 1.57% gain is more muted but directionally consistent with its generally positive reaction pattern to financials plus pipeline updates.
Earnings updates have repeatedly paired rising R&D investment and strong cash runways with advancing barzolvolimab from Phase 2 into large Phase 3 CSU and ColdU/SD programs, while CDX-622 has progressed through early clinical stages with additional data guided for 2026.
Market Pulse Summary
This announcement combines Q1 2026 results with meaningful pipeline milestones, including early completion of Phase 3 CSU enrollment at 1,939 patients and multiple Phase 2 and Phase 1 readouts guided for 2026. Financially, Celldex reported a wider net loss of $78.7M and increased R&D, but bolstered its position with a $345.0M offering and cash projected to fund operations through 2028. Investors may focus on upcoming late-stage barzolvolimab data, CDX-622 biomarker readouts, and ongoing expense trends as key watchpoints.
Key Terms
monoclonal antibody medical
prurigo nodularis medical
atopic dermatitis medical
thymic stromal lymphopoietin (tslp) medical
stem cell factor (scf) medical
fractional exhaled nitric oxide (feno) medical
absolute eosinophil count (aec) medical
AI-generated analysis. Not financial advice.
- Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027
- Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling
- Phase 1 CDX-622 proof of mechanism study in asthma ongoing
- 2026 expected to deliver multiple key data readouts across the pipeline
- Raised
$345 million in gross proceeds from a follow-on public offering, closed in April 2026
HAMPTON, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update.
"We began the year with a significant milestone - the early completion of enrollment in our Phase 3 CSU studies - and we have continued to build on that momentum over the quarter,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “This spring, barzolvolimab was featured in five presentations at leading medical meetings, further reinforcing its potential as a first-in-class, best-in-disease therapy with the ability to transform the treatment landscape for patients in need of better options. This progress enabled the successful completion of a
“As we look ahead, our focus remains on execution—driving strong enrollment across our Phase 3 study in ColdU and SD and advancing towards multiple important data readouts this year,” Mr. Marucci continued. “These include topline data from our Phase 3 barzolvolimab CSU studies, results from Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622.”
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
- 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 were presented at the 2026 AAAAI Annual Meeting (February 27 – March 2) and the 2026 AAD Annual Meeting (March 27 – 31) further demonstrating a first-in-class and best-in-disease profile. Key highlights include:
- Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD
- Sustained off-treatment efficacy despite barzolvolimab clearance and normalization of tryptase, suggesting disease modification in patients with CSU treated for full 52 weeks
- Greatly improved quality of life and reduced disease impact for patients with ColdU/SD at Week 20
- Greatly improved quality of life and reduced disease impact for patients with CSU, ColdU and SD across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment
- Barzolvolimab retreatment achieves similar profound efficacy to first exposure in patients with ColdU and SD; ability to retreat facilitates a real-world paradigm in which treatment may be intermittent for patients with ColdU and SD
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 multi-part Phase 1 study in healthy volunteers. 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.
First Quarter 2026 Financial Highlights and 2026 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 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 March 31, 2026, along with the approximately
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 | ||||||||||
| Consolidated Statements of Operations Data | Ended March 31, | |||||||||
| 2026 | 2025 | |||||||||
| (Unaudited) | ||||||||||
| Revenues: | ||||||||||
| Product development and licensing agreements | $ | - | $ | 50 | ||||||
| Contracts and grants | 15 | 645 | ||||||||
| Total revenues | 15 | 695 | ||||||||
| Operating expenses: | ||||||||||
| Research and development | 73,001 | 52,614 | ||||||||
| General and administrative | 11,449 | 10,820 | ||||||||
| Total operating expenses | 84,450 | 63,434 | ||||||||
| Operating loss | (84,435 | ) | (62,739 | ) | ||||||
| Investment and other income, net | 5,750 | 8,943 | ||||||||
| Net loss | $ | (78,685 | ) | $ | (53,796 | ) | ||||
| Basic and diluted net loss per common share | $ | (1.18 | ) | $ | (0.81 | ) | ||||
| Shares used in calculating basic and diluted net loss per share | 66,566 | 66,383 | ||||||||
| Condensed Consolidated Balance Sheet Data | March 31, | December 31, | ||||||||
| 2026 | 2025 | |||||||||
| (Unaudited) | ||||||||||
| Assets | ||||||||||
| Cash, cash equivalents and marketable securities | $ | 451,458 | $ | 518,573 | ||||||
| Other current assets | 7,764 | 16,091 | ||||||||
| Property and equipment, net | 7,396 | 5,334 | ||||||||
| Intangible and other assets, net | 44,636 | 42,985 | ||||||||
| Total assets | $ | 511,254 | $ | 582,983 | ||||||
| Liabilities and stockholders' equity | ||||||||||
| Current liabilities | $ | 51,472 | $ | 50,991 | ||||||
| Long-term liabilities | 3,556 | 4,827 | ||||||||
| Stockholders' equity | 456,226 | 527,165 | ||||||||
| Total liabilities and stockholders' equity | $ | 511,254 | $ | 582,983 | ||||||
