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Celldex Therapeutics(CLDX) - 2025 Q2 - Quarterly Report

Part I — Financial Information This section presents the company's unaudited financial statements and management's discussion and analysis for the reporting period Item 1. Unaudited Financial Statements Celldex Therapeutics, Inc. presents its unaudited condensed consolidated financial statements for the period ended June 30, 2025, including balance sheets, statements of operations and comprehensive loss, and cash flows, along with detailed notes on accounting policies, segment information, fair value measurements, and specific financial line items. The company reported a net loss of $110.4 million for the six months ended June 30, 2025, and maintains sufficient liquidity to fund operations through 2027 Condensed Consolidated Balance Sheets This section presents the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheet Highlights (In thousands) | Item | June 30, 2025 | December 31, 2024 | Change ($) | Change (%) | | :-------------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $23,044 | $28,356 | $(5,312) | -18.7% | | Marketable securities | $607,293 | $696,925 | $(89,632) | -12.9% | | Total current assets | $648,404 | $747,159 | $(98,755) | -13.2% | | Total assets | $692,407 | $792,340 | $(99,933) | -12.6% | | Total current liabilities | $32,963 | $39,501 | $(6,538) | -16.5% | | Total liabilities | $37,001 | $45,335 | $(8,334) | -18.4% | | Total stockholders' equity | $655,406 | $747,005 | $(91,599) | -12.3% | Condensed Consolidated Statements of Operations and Comprehensive Loss This section outlines the company's financial performance over specific periods, including revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $730 | $2,498 | $1,424 | $2,654 | | Research and development expenses | $54,196 | $39,687 | $106,810 | $71,348 | | General and administrative expenses | $10,391 | $9,128 | $21,211 | $18,231 | | Total operating expenses | $64,587 | $48,815 | $128,021 | $89,579 | | Operating loss | $(63,857) | $(46,317) | $(126,597) | $(86,925) | | Investment and other income, net | $7,257 | $10,475 | $16,201 | $18,275 | | Net loss | $(56,600) | $(35,842) | $(110,396) | $(68,650) | | Basic and diluted net loss per common share | $(0.85) | $(0.54) | $(1.66) | $(1.10) | | Comprehensive loss | $(56,829) | $(36,306) | $(110,371) | $(70,178) | Condensed Consolidated Statements of Cash Flows This section details the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flow (In thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(98,377) | $(69,965) | | Net cash provided by (used in) investing activities | $92,800 | $(361,934) | | Net cash provided by financing activities | $265 | $439,824 | | Net (decrease) increase in cash and cash equivalents | $(5,312) | $7,925 | | Cash and cash equivalents at end of period | $23,044 | $42,739 | Notes to Unaudited Condensed Consolidated Financial Statements The notes provide critical context to the financial statements, detailing the basis of presentation, significant accounting policies, segment information, fair value measurements, and specific financial line items. They also cover stock-based compensation, revenue recognition, income taxes, net loss per share, and the settlement agreement related to the Kolltan acquisition (1) Basis of Presentation This note explains the foundational principles and assumptions underlying the preparation of the financial statements - At June 30, 2025, the Company had cash, cash equivalents and marketable securities of $630.3 million15 - The Company incurred a net loss of $110.4 million and used $98.4 million in cash from operations for the six months ended June 30, 202515 - The Company believes current liquidity is sufficient to meet estimated working capital requirements and fund planned operations for at least the next twelve months, but may need to raise additional capital for long-term liquidity needs through licensing, business combinations, debt, or equity issuance1516 (2) Significant Accounting Policies This note details the key accounting principles and methods used in preparing the financial statements - Significant accounting policies are consistent with those discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 202417 - The Company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation Disclosures), effective for fiscal years beginning after December 15, 2024, and December 15, 2026, respectively1920 (3) Segment Information This note provides financial data and insights into the company's operating segments and their performance - The Company is managed as a single operating and reportable segment focused on the development, manufacturing, and commercialization of novel therapeutics21 Research and Development Expenses by Program (In thousands) | Program | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Barzolvolimab/Anti-KIT Program | $42,645 | $30,472 | $82,348 | $54,250 | | CDX-622 | $3,838 | $3,126 | $9,289 | $6,547 | | Other Programs | $7,713 | $6,089 | $15,173 | $10,551 | | Total R&D Expense | $54,196 | $39,687 | $106,810 | $71,348 | Research and Development Expenses by Nature (In thousands) | Expense Type | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Personnel | $14,129 | $11,881 | $27,729 | $23,321 | | Laboratory supplies | $1,544 | $1,615 | $3,712 | $2,923 | | Facility | $1,398 | $1,250 | $2,803 | $2,536 | | Product development | $33,536 | $22,667 | $65,702 | $38,192 | | Other expenses | $3,589 | $2,274 | $6,864 | $4,376 | | Total R&D Expense | $54,196 | $39,687 | $106,810 | $71,348 | (4) Fair Value Measurements This note describes the valuation techniques and inputs used to measure financial assets and liabilities at fair value - The Company's financial assets, primarily money market funds, cash equivalents, and marketable securities, are classified as Level 2 within the valuation hierarchy, totaling $620.1 million at June 30, 2025, and $706.9 million at December 31, 202426 - Contingent consideration liabilities measured at fair value using Level 3 inputs were $0.0 million at both June 30, 2025, and December 31, 2024, with no gain or loss on fair value remeasurement recorded2728 (5) Marketable Securities This note details the company's investment in marketable debt securities, including fair values and unrealized gains/losses Marketable Debt Securities (Available-for-Sale, In thousands) | Item | June 30, 2025 Fair Value | December 31, 2024 Fair Value | | :----------------------------------- | :----------------------- | :----------------------- | | U.S. government and municipal obligations | $254,348 | $288,358 | | Corporate debt securities | $352,945 | $408,567 | | Total marketable securities | $607,293 | $696,925 | Unrealized Loss Position (In thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------------------ | :------------ | :---------------- | | Aggregate fair value of marketable securities in unrealized loss position | $153,200 | $142,500 | - Unrealized losses are generally attributable to changes in interest rates, and the Company has the intent and ability to hold these securities until recovery, determining no material credit loss at June 30, 202530 (6) Intangible Assets This note provides information on the company's intangible assets, primarily acquired in-process research and development - The carrying value of indefinite-lived intangible assets, primarily acquired in-process research and development (IPR&D) related to the anti-KIT program (including barzolvolimab), remained at $27.2 million at June 30, 2025, and December 31, 202432 - Barzolvolimab is in Phase 3 development, and the IPR&D asset has not yet reached technological feasibility nor had alternative future uses32 (7) Other Assets This note describes other non-current assets held by the company, such as long-term advance payments - Advance payments for services not performed within one year, recorded as other assets, were $9.2 million at June 30, 2025, down from $9.6 million at December 31, 202434 (8) Other Long-Term Liabilities This note details the company's long-term obligations, including deferred tax liabilities and deferred revenue Other Long-Term Liabilities (In thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Net deferred tax liabilities related to IPR&D | $1,613 | $1,613 | | Deferred income from sale of tax benefits | $1,860 | $2,790 | | Deferred revenue | $— | $12 | | Total | $3,473 | $4,415 | | Less current portion | $(930) | $(942) | | Long-term portion | $2,543 | $3,473 | - The Company recognized $0.9 million in other income from the sale of New Jersey tax benefits for both the six months ended June 30, 2025, and June 30, 202435 (9) Stockholders' Equity This note outlines changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit - Total stockholders' equity decreased from $747.0 million at December 31, 2024, to $655.4 million at June 30, 202540 - Common stock shares outstanding increased from 66,374,549 at December 31, 2024, to 66,394,241 at June 30, 20257 - In March 2024, the Company issued 9,798,000 shares of common stock in an underwritten public offering, resulting in net proceeds of $432.3 million38 (10) Stock-Based Compensation This note explains the accounting for stock options and other equity awards granted to employees and directors Stock-Based Compensation Expense (In thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $4,882 | $3,884 | $9,467 | $7,577 | | General and administrative | $4,309 | $3,756 | $9,040 | $7,265 | | Total stock-based compensation expense | $9,191 | $7,640 | $18,507 | $14,842 | - Options outstanding at June 30, 2025, were 9,290,328, with a weighted average exercise price of $26.55 and a remaining contractual term of 7.5 years41 - Total unrecognized compensation cost related to non-vested stock options was approximately $81.9 million as of June 30, 2025, expected to be recognized over a weighted average period of 2.9 years42 (11) Accumulated Other Comprehensive Income This note details the components of comprehensive income not included in net income, such as unrealized gains or losses - Accumulated other comprehensive income increased from $3.31 million at December 31, 2024, to $3.34 million at June 30, 2025, primarily due to an unrealized gain on marketable securities of $25 thousand44 (12) Revenue This note provides a breakdown of the company's revenue sources and the factors influencing their changes Contracts and Grants Revenue (In thousands) | Period | 2025 | 2024 | | :------------------------------- | :--- | :--- | | Three Months Ended June 30, | $723 | $2,498 | | Six Months Ended June 30, | $1,367 | $2,652 | - The decrease in contracts and grants revenue was primarily due to a decrease in services performed under agreements with Rockefeller University45 (13) Income Taxes This note explains the company's income tax position, including deferred tax assets and liabilities and valuation allowances - The Company maintains a full valuation allowance on its net deferred tax assets due to a history of recurring losses47 - A net deferred tax liability of $1.6 million at June 30, 2025, and December 31, 2024, relates to IPR&D intangible assets acquired in previous business combinations48 - The Company will evaluate the impact of the newly enacted One Big Beautiful Bill Act (OBBBA) on its forecasted annual effective tax rate in subsequent periods49 (14) Net Loss Per Share This note details the calculation of basic and diluted net loss per common share, considering outstanding equity instruments - Basic and diluted net loss per common share were $(1.66) for the six months ended June 30, 2025, and $(1.10) for the same period in 20249 - Potentially dilutive common shares (stock options) were 9,290,328 in 2025 and 7,533,223 in 2024, but were excluded from diluted net loss per share calculations as their effect would have been anti-dilutive due to the net loss50 (15) Kolltan Acquisition This note describes the settlement agreement related to the Kolltan acquisition, including milestone payments - A definitive settlement agreement in July 2022 replaced the original contingent consideration of up to $172.5 million from the Kolltan acquisition5455 - The Company paid $15.0 million upon execution of the Settlement Agreement and $12.5 million upon successful completion of a Phase 2 Clinical Trial of barzolvolimab in November 20235456 - A future milestone payment of $52.5 million is due upon the first regulatory approval of a Surviving Company Product, payable at the Company's sole election in cash, stock, or a combination5457 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section discusses Celldex's financial condition and results of operations, highlighting its focus on developing therapeutic antibodies for inflammatory, allergic, and autoimmune diseases. It details the progress of key clinical programs, including barzolvolimab in multiple urticaria and dermatological conditions, and the bispecific antibody CDX-622. The company reported increased net losses and R&D expenses due to expanded clinical development, while also outlining its liquidity position and future capital needs Overview This section provides a strategic overview of Celldex's business, therapeutic focus, and development goals - Celldex is a biopharmaceutical company focused on mast cell biology and developing therapeutic antibodies for severe inflammatory, allergic, autoimmune, and other devastating diseases62 - The Company's primary drug candidates include Barzolvolimab (CDX-0159) for mast cell-driven diseases (Chronic Urticarias, Prurigo Nodularis, Eosinophilic Esophagitis, Atopic Dermatitis) and CDX-622, a bispecific antibody for inflammatory diseases6469 - The Company's goal is to build a fully integrated, commercial-stage biopharmaceutical company, with strategic options to retain full economic rights or seek advantageous commercial partnerships for its innovative therapies66 Clinical Development Programs Celldex is actively advancing its clinical pipeline, with barzolvolimab progressing into Phase 3 for Chronic Spontaneous Urticaria (CSU) and showing promising Phase 2 results in Chronic Inducible Urticaria (CIndU), Prurigo Nodularis (PN), Eosinophilic Esophagitis (EoE), and Atopic Dermatitis (AD). The company is also developing CDX-622, a bispecific antibody, with a Phase 1 study initiated in healthy volunteers Barzolvolimab (CDX-0159) This section details the clinical development progress of barzolvolimab across various inflammatory and autoimmune conditions Chronic Spontaneous Urticaria (CSU) This section outlines the clinical trial progress and results for barzolvolimab in treating Chronic Spontaneous Urticaria - Initiated two Phase 3 studies (EMBARQ-CSU1 and EMBARQ-CSU2) in CSU in July 2024, with enrollment expected to be completed in summer 202697 - Phase 2 study in CSU achieved the primary efficacy endpoint (statistically significant mean change from baseline to Week 12 of UAS7 compared to placebo) and demonstrated sustained, deepening disease efficacy and a well-tolerated long-term safety profile through 76 weeks post-dosing78909599 Phase 2 CSU: Summary of Clinical Activity Assessments at Week 12 (UAS7, HSS7, ISS7 Changes) | Metric | 300 mg Q8W (n=51) | 150 mg Q4W (n=52) | 75 mg Q4W (n=53) | Placebo (n=51) | | :-------------------------------- | :---------------- | :---------------- | :--------------- | :------------- | | Baseline UAS7 (mean) | 31.33 | 30.75 | 30.30 | 30.09 | | LS Mean change at Week 12 (UAS7) | -23.87 (p<0.0001) | -23.02 (p<0.0001) | -17.06 (p=0.0017) | -10.47 | | UAS7=0 (Complete Control) at Week 12 | 37.5% | 51.1% | 22.9% | 6.4% | | UAS7≤6 (Well-controlled) at Week 12 | 62.5% | 59.6% | 41.7% | 12.8% | Phase 2 CSU: Summary of Clinical Activity Assessments at Week 76 (Post-Dosing) | Metric | 150 mg Q4W | 300 mg Q8W | | :-------------------------------- | :--------- | :--------- | | UAS7 mean change from baseline | -20.42 | -21.10 | | UAS7=0 (Complete Control) | 41% | 35% | | UAS7≤6 (Well-controlled) | 56% | 47% | | No impact on quality of life (DLQI) | 48% | 40% | Chronic Inducible Urticaria (CIndU) This section presents the clinical trial progress and results for barzolvolimab in treating Chronic Inducible Urticaria - Phase 2 study in CIndU achieved the primary efficacy endpoint in July 2024, showing a statistically significant difference in the percentage of patients with a negative provocation test compared to placebo at Week 1278108 - All secondary endpoints, including improvements in Critical Temperature and Critical Friction Thresholds, and Urticaria Control Test, were also met and were highly statistically significant and clinically meaningful78108109 - The Company plans to advance CIndU into Phase 3 registrational development based on these results112 Phase 2 CIndU: Summary of Clinical Assessments at Week 12 | Metric | Cold Urticaria 150 mg q4w (n=32) | Cold Urticaria 300 mg q8w (n=32) | Cold Urticaria Placebo (n=32) | Symptomatic Dermographism 150 mg q4w (n=33) | Symptomatic Dermographism 300 mg q8w (n=33) | Symptomatic Dermographism Placebo (n=31) | | :------------------------------------------ | :------------------------------- | :------------------------------- | :---------------------------- | :------------------------------------------ | :------------------------------------------ | :---------------------------------------- | | % of patients with negative provocation test | 46.9% (p=0.0023) | 53.1% (p=0.0011) | 12.5% | 57.6% (p<0.0001) | 42.4% (p=0.0003) | 3.2% | | Improvement in Critical Temperature (CTT) / Critical Friction (CFT) Thresholds | -8.82°C (p<0.0001) | -9.61°C (p<0.0001) | -0.30°C | -2.46 pins (p<0.0001) | -2.27 pins (p=0.0002) | -0.82 pins | | % of patients with Urticaria Control Test >12 | 58.6% (p=0.0048) | 68.8% (p<0.0001) | 31.0% | 54.8% (p=0.0015) | 65.5% (p<0.0001) | 32.0% | Prurigo Nodularis (PN) This section details the clinical trial progress and results for barzolvolimab in treating Prurigo Nodularis - Initiated a Phase 2 subcutaneous study in PN in April 2024, evaluating two dose levels of barzolvolimab against placebo in approximately 120 patients119 - Phase 1b study showed a single IV dose of 3.0 mg/kg barzolvolimab resulted in rapid and durable reductions in itch (57% of patients with ≥4-point decrease in WI-NRS at Week 8) and healing of skin lesions (29% achieved clear or almost clear skin by IGA at Week 8)115116 - Clinical activity in PN was associated with profound serum tryptase reduction, indicative of mast cell depletion117 Eosinophilic Esophagitis (EoE) This section outlines the clinical trial progress and results for barzolvolimab in treating Eosinophilic Esophagitis - A Phase 2 study in EoE, initiated in June 2023, is fully enrolled, with data planned for presentation in the second half of 202569121 - The protocol was amended to dose 300 mg every 4 weeks to optimize potential efficacy, with the primary endpoint being the reduction of esophageal intraepithelial infiltration of mast cells121 Atopic Dermatitis (AD) This section presents the clinical trial progress and results for barzolvolimab in treating Atopic Dermatitis - A Phase 2 study in moderate to severe AD was initiated in December 2024, with enrollment ongoing69122123 - The study evaluates the efficacy and safety of subcutaneous barzolvolimab (150 mg or 300 mg every 4 weeks) compared to placebo, with the primary endpoint being the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16123 Additional Barzolvolimab Development Activities This section covers manufacturing and toxicology updates for barzolvolimab, supporting its continued development - Successfully transferred manufacturing process to a CDMO and scaled up drug substance production for late-stage trials and potential commercialization, with drug product manufacturing into pre-filled syringes completed124 - A six-month chronic toxicology study in non-human primates showed full recovery of spermatogenesis after a one-year recovery period, supporting continued development125 Bispecific Platform This section introduces the company's bispecific antibody platform and its lead candidate, CDX-622 CDX-622 This section details the preclinical and early clinical development of CDX-622, a bispecific antibody for inflammatory diseases - CDX-622 is a bispecific antibody targeting TSLP and depleting mast cells via SCF starvation, designed to reduce tissue mast cells and inhibit Type 2 inflammatory responses127 - A Phase 1a dose-escalation study in healthy volunteers was initiated in November 2024, with enrollment ongoing and data from Part 1 expected in the second half of 2025128 - Preclinical studies showed CDX-622 inhibits TSLP and SCF with similar potency to parental mAbs, was well tolerated in toxicology studies, and led to profound mast cell depletion127 Critical Accounting Policies and Estimates This section highlights the key accounting policies and estimates that require significant management judgment - There have been no material changes to the Company's critical accounting policies or estimates since the Annual Report on Form 10-K for the year ended December 31, 2024129 - Key critical accounting policies include accounting for contingent consideration, revenue recognition, intangible and long-lived assets, research and development expenses, and stock-based compensation expense129 Results of Operations Celldex experienced a significant increase in net loss for both the three and six months ended June 30, 2025, primarily driven by higher research and development expenses related to the expanded barzolvolimab clinical program. Revenue from contracts and grants decreased, while investment income also declined due to lower cash balances Three Months Ended June 30, 2025 Compared with Three Months Ended June 30, 2024 - Net loss increased by $20.8 million (58%) to $(56.6) million, primarily due to increased research and development expenses and decreased investment and other income, net130131 - Total revenues decreased by $1.8 million (71%) to $0.73 million, mainly due to a decrease in contracts and grants revenue from Rockefeller University130132 - Research and development expenses increased by $14.5 million (37%) to $54.2 million, primarily driven by higher personnel expenses (19% increase) and product development expenses (48% increase) due to barzolvolimab clinical trial and contract manufacturing130133136 - General and administrative expenses increased by $1.3 million (14%) to $10.4 million, due to higher stock-based compensation and increased employee headcount130137 - Investment and other income, net, decreased by $3.2 million (31%) to $7.3 million, primarily due to lower levels of cash and investment balances130138 Six Months Ended June 30, 2025 Compared with Six Months Ended June 30, 2024 - Net loss increased by $41.7 million (61%) to $(110.4) million, primarily due to an increase in research and development expenses related to barzolvolimab139141 - Total revenues decreased by $1.2 million (46%) to $1.42 million, mainly due to a decrease in contracts and grants revenue from Rockefeller University139142 - Research and development expenses increased by $35.5 million (50%) to $106.8 million, driven by higher personnel (19% increase), laboratory supplies (27% increase), facility (11% increase), and product development (72% increase) costs, primarily for barzolvolimab clinical trials and manufacturing139143144145146 - General and administrative expenses increased by $3.0 million (16%) to $21.2 million, due to higher stock-based compensation and increased employee headcount139147 - Investment and other income, net, decreased by $2.1 million (11%) to $16.2 million, primarily due to lower levels of cash and investment balances139148 Liquidity and Capital Resources Celldex's liquidity at June 30, 2025, was $630.3 million in cash, cash equivalents, and marketable securities, which is deemed sufficient to fund operations through 2027. However, the company anticipates increased cash usage in operating activities due to expanded R&D and may seek additional capital through various means, including licensing, debt, or equity, which could be dilutive Operating Activities This section details the cash flows generated from or used in the company's primary business operations - Net cash used in operating activities was $98.4 million for the six months ended June 30, 2025, an increase from $70.0 million in the prior year, primarily due to increases in research and development and general and administrative expenses153 - The Company expects cash used in operating activities to increase over the next twelve months due to the expanded development of barzolvolimab153 Investing Activities This section describes the cash flows related to the purchase and sale of long-term assets and investments - Net cash provided by investing activities was $92.8 million for the six months ended June 30, 2025, a significant change from net cash used of $361.9 million in the prior year155 - This increase was primarily due to net sales and maturities of marketable securities of $93.8 million in 2025, compared to net purchases of $361.3 million in 2024155 Financing Activities This section outlines the cash flows from activities involving debt, equity, and dividend payments - Net cash provided by financing activities decreased significantly to $0.3 million for the six months ended June 30, 2025, from $439.8 million in the prior year156 - The decrease was primarily due to the absence of a large public offering in 2025, compared to $432.3 million in net proceeds from a common stock offering in March 2024156 Item 3. Quantitative and Qualitative Disclosures About Market Risk Celldex's investment portfolio, primarily in money market funds and high-grade marketable securities, is managed to preserve capital and maintain liquidity. Due to the short-term nature of these investments, the company believes its exposure to market risk, particularly from interest rate changes, is not material, and it does not use derivative financial instruments - The Company's investment portfolio consists primarily of money market mutual funds, municipal bond securities, U.S. government agency securities, and high-grade corporate bonds, managed to preserve principal and maintain adequate liquidity157 - Due to the short-term nature of these investments, the Company believes it does not have material exposure to market risk, and the impact from likely changes in interest rates is not material157 - The Company does not utilize derivative financial instruments158 Item 4. Controls and Procedures As of June 30, 2025, Celldex's management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - The Company's disclosure controls and procedures were evaluated and concluded to be effective at the reasonable assurance level as of June 30, 2025159 - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting160 Part II — Other Information This section covers other required disclosures including risk factors, other information, and exhibits Item 1A. Risk Factors Celldex refers readers to the comprehensive discussion of risk factors in its Annual Report on Form 10-K for the year ended December 31, 2024. The company states that there were no material changes to these previously disclosed risk factors during the period covered by this quarterly report - No material changes to the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024163 Item 5. Other Information During the reporting period, no director or officer of Celldex Therapeutics, Inc. adopted or terminated any Rule 10b5-1 trading arrangements or non-Rule 10b5-1 trading arrangements - No director or officer of the Company adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the period covered by this Quarterly Report on Form 10-Q164 Item 6. Exhibits This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, which are incorporated by reference. These include certifications, XBRL documents, and an amendment to the equity incentive plan - Exhibits filed include Amendment No. 3 to Celldex Therapeutics, Inc. 2021 Omnibus Equity Incentive Plan, Certification of President and Chief Executive Officer, Certification of Senior Vice President and Chief Financial Officer, Section 1350 Certifications, and various Inline XBRL documents167 Signatures The Quarterly Report on Form 10-Q was duly signed on August 7, 2025, by Anthony S. Marucci, President and Chief Executive Officer, and Sam Martin, Senior Vice President and Chief Financial Officer, affirming compliance with the Securities Exchange Act of 1934 - The report was signed by Anthony S. Marucci, President and Chief Executive Officer, and Sam Martin, Senior Vice President and Chief Financial Officer171 - The signing date for the report was August 7, 2025171