CLDXMEDIUM SIGNALOPERATIONAL10-K

CLDX completed enrollment in Phase 3 CSU studies with topline data expected Q4 2026, while R&D expenses surged 50% and net losses increased 64% as the company advances multiple clinical programs for barzolvolimab.

The completion of Phase 3 enrollment in CSU represents a major operational milestone that moves CLDX closer to potential commercialization of its lead asset, with sustained efficacy data showing over 40% of patients maintaining complete response 7 months post-dosing. However, the company is burning significant cash across multiple concurrent clinical trials in various indications, creating execution risk and increased capital requirements as it approaches critical data readouts.

Comparing 2026-02-25 vs 2025-02-27View on EDGAR →
FINANCIAL ANALYSIS

The financial picture reflects a clinical-stage biotech in heavy investment mode, with R&D expenses jumping 50% to $245M driving net losses up 64% to $259M, while operating cash burn increased 34% to $211M. Current assets declined 28% to $535M and stockholders' equity fell 29% to $527M, indicating substantial cash consumption that will likely require additional financing before the critical Q4 2026 CSU data readout. Revenue doubled but remains immaterial at $1.8M, highlighting the company's complete dependence on successful clinical execution for future value creation.

FINANCIAL STATEMENT CHANGES
Revenue
P&L
+87.5%
$941K$1.8M

Strong top-line growth of 87.5% — accelerating demand or successful expansion into new markets.

Net Income
P&L
-63.9%
-$157.9M-$258.8M

Net income declined 63.9% — review whether driven by operations, interest costs, or non-recurring items.

R&D Expense
P&L
+49.8%
$163.6M$245.1M

R&D investment increased 49.8% — signals commitment to future product development, though near-term margin impact.

Operating Income
P&L
-47.3%
-$195.1M-$287.4M

Operating income deteriorated sharply — investigate whether driven by one-time charges or structural cost issues.

Capital Expenditure
Cash Flow
+41.4%
$1.9M$2.7M

Capital expenditure jumped 41.4% — major investment cycle underway; assess returns on deployment.

Interest Expense
P&L
-41.2%
$1.6M$927K

Interest expense declined — debt repayment or refinancing at lower rates improving earnings quality.

Operating Cash Flow
Cash Flow
-33.7%
-$157.8M-$210.9M

Operating cash flow fell 33.7% — earnings quality concerns; investigate working capital changes and non-cash items.

Stockholders Equity
Balance Sheet
-29.4%
$747.0M$527.2M

Equity decreased 29.4% — buybacks or losses reducing book value, monitor solvency ratios.

Current Liabilities
Balance Sheet
+29.1%
$39.5M$51.0M

Current liabilities rose 29.1% — increased short-term obligations, watch current ratio.

Current Assets
Balance Sheet
-28.4%
$747.2M$534.7M

Current assets declined 28.4% — monitor working capital adequacy and short-term liquidity.

LANGUAGE CHANGES
NEW — 2026-02-25
PRIOR — 2025-02-27
ADDED
We are focusing our efforts and resources on the continued research and development of Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which is currently being studied across multiple mast cell driven diseases including - Chronic Spontaneous Urticaria (CSU): In February 2026, we announced that enrollment is complete in our Phase 3 studies in CSU and that topline data will be available in the fourth quarter of 2026.
In June 2025, Celldex presented longer term follow up data from the study.
At 76 weeks, 7 months after the completion of dosing with barzolvolimab, over 40% of patients (150 mg Q4W) continued to experience profound, sustained complete response and improved quality of life; - Cold Urticaria (ColdU) and Symptomatic Dermographism (SD): We initiated a Phase 3 study in ColdU and SD in December 2025 and enrollment is ongoing.
In July 2024, we announced that our Phase 2 study being conducted in two forms of chronic inducible urticaria (CIndU), ColdU and SD, achieved the primary efficacy endpoint (statistically significant difference between the percent of patients with a negative provocation test compared to placebo at Week 12) and was well tolerated.
Patients on study continued to receive barzolvolimab and, in November 2025, we reported data from 20 weeks of treatment demonstrating sustained efficacy and a well tolerated safety profile over the longer treatment period; - Prurigo Nodularis (PN): In April 2024, we initiated a Phase 2 study in PN and enrollment was completed in December 2025.
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REMOVED
We are focusing our efforts and resources on the continued research and development of Barzolvolimab (also referred to as CDX-0159), a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which is currently being studied across multiple mast cell driven diseases including - Chronic Urticarias: We initiated Phase 3 studies in chronic spontaneous urticaria (CSU) in July 2024.
Patients on study continued to receive barzolvolimab for 20 weeks of treatment; - Prurigo Nodularis (PN): In April 2024, we initiated a Phase 2 study in PN and enrollment is ongoing; positive data from a Phase 1b study in PN was reported in November 2023; - Eosinophilic Esophagitis (EoE): A Phase 2 study in EoE was initiated in June 2023 and is fully accrued; and - Atopic Dermatitis (AD): A Phase 2 study in AD was initiated in December 2024 and enrollment is ongoing.
In November 2024, a Phase 1a dose-escalation study in healthy volunteers was initiated and enrollment is ongoing.
More detail on these programs is provided in the Clinical Development Programs section.
Phase 1 studies in CSU and CIndU were successfully completed and Phase 2 studies are ongoing.
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