[Corporate Update and CEO Remarks](index=1&type=section&id=Corporate%20Update%20and%20CEO%20Remarks) CEO Anthony Marucci highlighted barzolvolimab's best-in-class efficacy in chronic urticaria, anticipating 2025 as a pivotal year with key data readouts, including 76-week CSU study results exploring sustained disease control - Barzolvolimab demonstrated **best-in-class efficacy** in chronic urticaria, showing high complete response rates and significant improvements in patient quality of life[2](index=2&type=chunk) - **2025** is anticipated to be a year of strong execution with key data readouts from barzolvolimab's Phase 2 studies (CSU, CIndU, EOE) and CDX-622's Phase 1 study[2](index=2&type=chunk)[6](index=6&type=chunk) - Upcoming **76-week data** from the Phase 2 CSU study, focusing on sustained disease control after treatment withdrawal, will be presented at the EAACI conference in June[2](index=2&type=chunk)[7](index=7&type=chunk) [Program Highlights](index=1&type=section&id=Program%20Highlights) Celldex is advancing its clinical pipeline, with barzolvolimab progressing in Phase 3 for CSU and planned for CIndU, alongside ongoing Phase 2 studies and active enrollment for CDX-622's Phase 1 study [Barzolvolimab - KIT Inhibitor Program](index=1&type=section&id=Barzolvolimab%20-%20KIT%20Inhibitor%20Program) Barzolvolimab, a KIT inhibitor, is advancing with global Phase 3 trials for CSU, a planned Phase 3 for CIndU in 2025, and ongoing Phase 2 studies for EoE, PN, and AD with data expected in 2025 - Global Phase 3 program for CSU (EMBARQ-CSU1 and EMBARQ-CSU2) is ongoing, with each trial enrolling approximately **915 patients**[7](index=7&type=chunk) - A global Phase 3 program in CIndU is expected to initiate in **2025**[7](index=7&type=chunk) - Positive quality of life data from Phase 2 CSU and CIndU studies showed up to **82% of CSU patients** at Week 52 reported no symptom impact on quality of life[13](index=13&type=chunk) - Enrollment is complete for the Phase 2 EoE study with data expected in **2025**, while Phase 2 studies for PN and AD are ongoing[13](index=13&type=chunk) [Bispecific Antibody Platform (CDX-622)](index=2&type=section&id=Bispecific%20Antibody%20Platform%20(CDX-622)) CDX-622, a bispecific antibody targeting TSLP and SCF to reduce mast cells and inhibit Type 2 inflammation, is undergoing a Phase 1 study in healthy volunteers with initial data expected in 2025 - CDX-622 is a bispecific antibody designed to neutralize **TSLP** and deplete mast cells by targeting **SCF**[10](index=10&type=chunk) - A Phase 1 study in healthy volunteers is ongoing, with single ascending dose data expected in **2025**[10](index=10&type=chunk) [First Quarter 2025 Financial Highlights](index=2&type=section&id=First%20Quarter%202025%20Financial%20Highlights) Celldex reported a net loss of $53.8 million in Q1 2025, driven by increased R&D expenses, concluding the quarter with a strong cash position of $673.3 million, sufficient to fund operations through 2027 [Financial Performance (Q1 2025 vs Q1 2024)](index=2&type=section&id=Financial%20Performance%20(Q1%202025%20vs%20Q1%202024)) Q1 2025 saw total revenue of $0.7 million, with R&D expenses rising to $52.6 million due to barzolvolimab costs, resulting in a net loss of $53.8 million or ($0.81) per share | Financial Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $0.7 million | $0.2 million | | R&D Expenses | $52.6 million | $31.7 million | | G&A Expenses | $10.8 million | $9.1 million | | Net Loss | $53.8 million | $32.8 million | | Net Loss per Share | ($0.81) | ($0.56) | - The increase in R&D expenses was primarily driven by higher costs for **barzolvolimab clinical trials**, contract manufacturing, and personnel[12](index=12&type=chunk)[14](index=14&type=chunk) [Financial Position and Guidance](index=2&type=section&id=Financial%20Position%20and%20Guidance) As of March 31, 2025, Celldex held $673.3 million in cash, cash equivalents, and marketable securities, a decrease from year-end 2024, with current reserves projected to fund operations through 2027 | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $673.3 million | $725.3 million | - The company believes its cash position is sufficient to meet working capital requirements and fund planned operations through **2027**[15](index=15&type=chunk) - As of March 31, 2025, Celldex had **66.4 million shares outstanding**[11](index=11&type=chunk) [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) The unaudited consolidated financial statements detail the company's Q1 2025 performance, showing a net loss of $53.8 million and a financial position with total assets of $739.5 million and stockholders' equity of $703.0 million **Consolidated Statements of Operations (Unaudited, in thousands)** | | Three Months Ended March 31, | | :--- | :--- | :--- | | | **2025** | **2024** | | Total revenues | $695 | $156 | | Total operating expenses | $63,434 | $40,764 | | Operating loss | $(62,739) | $(40,608) | | Net loss | $(53,796) | $(32,808) | | Basic and diluted net loss per common share | $(0.81) | $(0.56) | **Condensed Consolidated Balance Sheet Data (Unaudited, in thousands)** | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $673,291 | $725,281 | | Total assets | $739,471 | $792,340 | | Total liabilities | $36,490 | $45,335 | | Stockholders' equity | $702,981 | $747,005 |

Core Viewpoint - Celldex Therapeutics reported positive Phase 2 study results for barzolvolimab, indicating significant improvements in the quality of life for patients with chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [2][14] Financial Highlights - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $673.3 million, down from $725.3 million at the end of 2024, primarily due to $54.4 million used in operating activities during the first quarter [10][15] - Total revenue for the first quarter of 2025 was $0.7 million, an increase from $0.2 million in the same period of 2024, attributed to increased services under manufacturing and research agreements [11] - Research and development expenses rose to $52.6 million in Q1 2025 from $31.7 million in Q1 2024, mainly due to costs associated with barzolvolimab clinical trials [12] - General and administrative expenses increased to $10.8 million in Q1 2025 from $9.1 million in Q1 2024, primarily due to higher stock-based compensation [13] - The net loss for the first quarter of 2025 was $53.8 million, or ($0.81) per share, compared to a net loss of $32.8 million, or ($0.56) per share, in the same period of 2024 [15] Pipeline and Clinical Development - Barzolvolimab is a humanized monoclonal antibody targeting the KIT receptor, showing best-in-class efficacy in chronic urticaria with high complete response rates [3][2] - A global Phase 3 program for CSU is ongoing, with two trials (EMBARQ-CSU1 and EMBARQ-CSU2) enrolling approximately 915 patients each across 40 countries [7] - The company is planning a global Phase 3 program for chronic inducible urticaria (CIndU) expected to start in 2025 [7] - Data from the Phase 2 CSU study, including 76-week follow-up results, will be presented at the EAACI Congress 2025 [6][7] Additional Indications and Studies - Enrollment is complete for the Phase 2 study in eosinophilic esophagitis (EoE), with data expected in 2025 [14] - Ongoing enrollment in Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) [14] - CDX-622, a bispecific antibody targeting SCF and TSLP, is in Phase 1 study with data expected in 2025 [9]

Core Insights - Celldex announced histology data from its ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating a potential therapeutic benefit due to the correlation between intraepithelial mast cells and eosinophil counts [1][2] - The Phase 2 "EvolvE" study aims to test the hypothesis that barzolvolimab can deplete esophageal mast cells and lead to clinical improvement in EoE, a condition with limited treatment options [3][5] Study Details - The ongoing 28-week, randomized, double-blind, placebo-controlled study evaluates 300 mg of barzolvolimab or placebo administered every 4 weeks to participants with known EoE [3] - The primary endpoint is the reduction in peak esophageal epithelial mast cell count at 12 weeks, with key secondary endpoints including reduction in peak eosinophil count and dysphagia symptom scores [3] - Screening data from 151 participants show high numbers of intraepithelial mast cells in active EoE cases, correlating with eosinophil counts [3] Eosinophilic Esophagitis (EoE) Overview - EoE is characterized by chronic inflammation of the esophagus due to eosinophil infiltration, leading to symptoms such as difficulty swallowing and chest pain [5] - Current treatment options for EoE are limited, highlighting the importance of developing effective therapies like barzolvolimab [5] Barzolvolimab Profile - Barzolvolimab is a humanized monoclonal antibody targeting the receptor tyrosine kinase KIT, which is involved in mast cell activity and inflammatory responses [6] - The drug is also being studied for other conditions, including chronic spontaneous urticaria and atopic dermatitis, indicating its broader therapeutic potential [6] Company Background - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the immune system and target critical pathways for severe inflammatory and allergic diseases [7]

Core Insights - Celldex Therapeutics announced positive preclinical data for CDX-622, a bispecific antibody targeting TSLP and SCF pathways involved in inflammation and fibrosis [1][2][3] Group 1: CDX-622 Mechanism and Efficacy - CDX-622 neutralizes both SCF and TSLP, leading to reduced tissue mast cells and inhibition of Type 2 inflammatory responses, suggesting enhanced clinical activity compared to single-target therapies [2][5] - The bispecific antibody is designed to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses, potentially offering significant therapeutic benefits in inflammatory and fibrotic disorders [5][8] Group 2: Clinical Development - A Phase 1 randomized, double-blind, placebo-controlled study is currently ongoing to assess the safety, pharmacokinetics, and pharmacodynamics of CDX-622 in up to 56 healthy participants [5][3] - Initial data from the Phase 1 study is expected to be presented later this year, following the initiation of the study in November [3][5] Group 3: Preclinical Findings - Preclinical studies show that CDX-622 exhibits similar potency to its parental monoclonal antibodies and other treatments like tezepelumab and barzolvolimab [8] - The antibody preferentially inhibits the soluble form of SCF, which may have a differential impact on KIT-dependent processes [8] - CDX-622 was well tolerated in a GLP toxicology study at all dose levels, including the highest tested dose of 75 mg/kg, resulting in significant mast cell depletion in various tissues [8]

Core Insights - Celldex Therapeutics, Inc. announced positive results from Phase 2 studies of barzolvolimab, showing significant improvements in disease control and quality of life for patients with chronic urticaria [1][2][3] Group 1: Study Results - In the Phase 2 CSU study, 82% of patients reported that symptoms no longer impacted their quality of life at Week 52 [1][7] - In the Phase 2 CIndU study, 60% of patients reported that symptoms no longer impacted their quality of life at Week 12 [1][7] - Up to 71% of CSU patients achieved complete response (UAS7 = 0) at Week 52, the highest rate observed in a well-controlled study [7] - Up to 95% of CSU patients reported meaningful improvement in quality of life based on the Dermatology Life Quality Index (DLQI) at Week 52 [7] - Up to 82% of CSU patients reported well-controlled urticaria based on the Urticaria Control Test (UCT) at Week 52 [7] - In the CIndU study, up to 60% of patients reported that symptoms no longer impacted their quality of life at Week 12, with 69% reporting well-controlled urticaria based on UCT [7] Group 2: Treatment Implications - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function and survival [1][14] - The treatment has the potential to change the treatment paradigm for chronic urticaria, allowing patients to live normally again [3] - Current clinical guidelines emphasize complete disease control as the treatment goal, with studies showing minimal or no impact on quality of life when this is achieved [3] Group 3: Future Developments - Global Phase 3 studies for barzolvolimab in patients with CSU are actively enrolling, with plans to advance into Phase 3 development for CIndU in 2025 [6]

Group 1 - Celldex Therapeutics reported a quarterly loss of $0.71 per share, which was better than the Zacks Consensus Estimate of a loss of $0.75, but worse than the loss of $0.57 per share from a year ago, indicating a 24.56% increase in loss year-over-year [1] - The company posted revenues of $1.18 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 24.19%, and down from $4.13 million in the same quarter last year [2] - Celldex shares have declined approximately 18.4% since the beginning of the year, contrasting with the S&P 500's gain of 1.3% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $1.3 million, and for the current fiscal year, it is -$3.32 on revenues of $7.5 million [7] - The Medical - Biomedical and Genetics industry, to which Celldex belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Clinical Development - Barzolvolimab (CDX-0159) achieved primary efficacy endpoints in Phase 2 studies for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), with statistically significant mean changes from baseline to week 12 compared to placebo [335]. - In the Phase 1b study for CSU, barzolvolimab demonstrated an 82% mean reduction in baseline UAS7 at week 12 for the 4.5 mg/kg dose group, indicating significant symptom improvement [352]. - The ongoing Phase 2 studies for eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD) are part of the expanded development of barzolvolimab into additional indications [348]. - The company initiated Phase 3 studies in CSU in July 2024, following successful Phase 2 results that showed sustained efficacy and a well-tolerated long-term safety profile [335]. - The first bispecific candidate, CDX-622, targeting chronic inflammation pathways, entered a Phase 1a dose-escalation study in November 2024, with enrollment ongoing [335]. - The Phase 2 study in chronic inducible urticaria (CIndU) achieved its primary efficacy endpoint, with a statistically significant difference in the percentage of patients with a negative provocation test compared to placebo at week 12 [335]. - The company plans to present follow-up data from the CSU study through week 76 in 2025, indicating ongoing commitment to data transparency and patient outcomes [347]. - The Phase 1b trial for chronic inducible urticaria (CIndU) showed a complete response in 95% of patients treated with a single dose of 3 mg/kg of barzolvolimab [369]. - Patients on barzolvolimab experienced rapid responses, with 100% achieving well-controlled disease (UCT>12) by week 4 post-treatment in the ColdU cohort [369]. - The Phase 2 study for EoE will enroll approximately 75 patients, with a primary endpoint of reducing esophageal intraepithelial mast cell count, and data is expected to be presented in the second half of 2025 [386]. - A Phase 2 study for atopic dermatitis (AD) was initiated in December 2024, with approximately 120 patients enrolled to evaluate the efficacy of barzolvolimab at doses of 150 mg and 300 mg [387]. - The primary endpoint for the AD study is the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, with secondary endpoints including various patient-reported outcomes [387]. Financial Performance - The total research and development expenses incurred over the past five years amounted to $459.7 million, with $163.6 million spent in 2024, up from $118.0 million in 2023 [344]. - Total revenues for the year ended December 31, 2024, increased by $137,000, or 2%, to $7,020,000 compared to $6,883,000 in 2023 [409]. - Product development and licensing agreements revenue decreased by $265,000, or 95%, to $13,000 in 2024, while contracts and grants revenue increased by $402,000, or 6%, to $7,007,000 [409]. - The net loss for the year ended December 31, 2024, was $157,863,000, an increase of $16,434,000, or 12%, compared to the net loss of $141,429,000 in 2023 [410]. - Investment and other income, net, increased by $24,102,000, or 184%, to $37,215,000 in 2024, attributed to higher cash levels from public offerings [409]. - General and administrative expenses increased by $7,634,000, or 25%, to $38,548,000 in 2024, primarily due to higher stock-based compensation [409]. - The company expects a decrease in revenue over the next twelve months due to reduced services under contracts with Rockefeller University [411]. - The company incurred a net loss of $157.9 million for the year ended December 31, 2024, with net cash used in operations amounting to $157.8 million, an increase from $107.3 million in 2023 [437][439]. - Total revenues for the year ended December 31, 2024, were $7.02 million, a 2% increase from $6.88 million in 2023 [473]. - The net loss for the year ended December 31, 2024, was $157.86 million, compared to a net loss of $141.43 million in 2023, representing an increase of 11.6% [473]. Research and Development Expenses - Research and development expenses rose by $45,539,000, or 39%, to $163,550,000 in 2024, driven by increased personnel and product development costs [409]. - Personnel expenses within research and development increased by $11,785,000, or 29%, to $51,906,000 in 2024, due to higher stock-based compensation and increased headcount [413]. - Product development expenses surged by $31,285,000, or 53%, to $90,604,000 in 2024, mainly due to barzolvolimab clinical trial expenses [416]. - Total research and development (R&D) expenses for the year ended December 31, 2024, were $163,550,000, an increase of 38.5% from $118,011,000 in 2023 [488]. - The Barzolvolimab/Anti-KIT Program accounted for $123,750,000 of the total R&D expenses in 2024, up from $79,913,000 in 2023, representing a 54.8% increase [488]. Capital and Liquidity - As of December 31, 2024, the company's liquidity sources included cash, cash equivalents, and marketable securities totaling $725.3 million [437]. - The company plans to raise additional capital through various means, including licensing drug candidates, business combinations, and issuing debt or equity [438]. - The company issued 8,538,750 shares in November 2023, resulting in net proceeds of $216.2 million, and 9,798,000 shares in March 2024, yielding net proceeds of $432.3 million [448][450]. - The company maintains that its cash, cash equivalents, and marketable securities are sufficient to meet working capital requirements through 2027, barring any significant changes [437]. - The company believes its cash and marketable securities will be sufficient to meet working capital requirements for at least the next twelve months [482]. Manufacturing and Operations - In 2023, the company successfully scaled up the barzolvolimab manufacturing process to produce larger cGMP batches in support of late-stage trials [388]. - The Company relies on contract development and manufacturing organizations (CDMOs) for the manufacturing of drug substances and products, as well as for future commercial supplies [498]. - The Company operates a cGMP manufacturing facility in Fall River, Massachusetts, to produce drug substance for clinical trials, utilizing excess capacity through contract manufacturing and research arrangements [511]. - Research and development expenses include clinical trial costs, manufacturing of clinical material, and personnel costs, with expenses recognized as incurred [514].

Financial Performance - Total revenue for Q4 2024 was $1.2 million, a decrease from $4.1 million in Q4 2023, while total revenue for the year was $7.0 million compared to $6.9 million in 2023[13]. - The net loss for Q4 2024 was $47.1 million, or ($0.71) per share, compared to a net loss of $43.3 million, or ($0.83) per share, in Q4 2023; for the year, the net loss was $157.9 million, or ($2.45) per share, compared to $141.4 million, or ($2.92) per share, in 2023[17]. Expenses - Research and development (R&D) expenses increased to $46.9 million in Q4 2024 from $30.4 million in Q4 2023, and for the year, R&D expenses were $163.6 million compared to $118.0 million in 2023[14]. - General and administrative (G&A) expenses rose to $10.3 million in Q4 2024 from $8.8 million in Q4 2023, with annual G&A expenses totaling $38.5 million compared to $30.9 million in 2023[15]. Cash and Assets - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $725.3 million, down from $756.0 million as of September 30, 2024, primarily due to $32.5 million used in operating activities during Q4[11]. - Total assets increased to $792,340 million in December 2024, up from $465,627 million in December 2023, representing a growth of 70%[25]. - Cash, cash equivalents, and marketable securities rose to $725,281 million, compared to $423,598 million in the previous year, indicating a 71% increase[25]. - Stockholders' equity grew significantly to $747,005 million, up from $429,171 million, reflecting a 74% increase year-over-year[25]. - Current liabilities increased to $39,501 million from $31,125 million, marking a rise of 27%[25]. - Long-term liabilities slightly increased to $5,834 million from $5,331 million, showing a growth of 9%[25]. - Other current assets surged to $21,878 million, compared to $8,095 million, which is an increase of 170%[25]. - Intangible and other assets, net, rose to $40,835 million from $29,874 million, representing a 37% increase[25]. - Property and equipment, net, increased to $4,346 million from $4,060 million, showing a growth of 7%[25]. Clinical Development - Barzolvolimab demonstrated a 71% complete response rate at Week 52 in a Phase 2 study for chronic spontaneous urticaria (CSU), marking the highest rate observed in a controlled study[12]. - The global Phase 3 program for CSU is enrolling approximately 915 patients across 40 countries and 500 sites, with ongoing enrollment in the Phase 3 barzolvolimab studies[8]. - A Phase 1 study for CDX-622, a bispecific candidate targeting SCF and TSLP, was initiated in November 2024, with enrollment ongoing in a two-part randomized, double-blind, placebo-controlled study[10]. - The company anticipates multiple important data readouts in 2025, including results from barzolvolimab Phase 2 studies in CSU, CIndU, and eosinophilic esophagitis[7]. Future Outlook - Celldex expects its cash position to be sufficient to meet estimated working capital requirements and fund current planned operations through 2027[18].

Core Insights - Celldex Therapeutics reported strong efficacy data for barzolvolimab in chronic urticarias, with ongoing Phase 3 studies in chronic spontaneous urticaria (CSU) and plans to initiate a Phase 3 program in chronic inducible urticaria (CIndU) in 2025 [2][7][12] - The company has initiated two new programs, including advancing barzolvolimab into atopic dermatitis and introducing a bispecific candidate, CDX-622, targeting inflammatory pathways [2][10] - Financial results showed a net loss of $47.1 million for Q4 2024, with total revenues of $1.2 million for the quarter and $7.0 million for the year, reflecting a decrease in revenue primarily due to reduced services under agreements [11][12][17] Pipeline Developments - Barzolvolimab is a humanized monoclonal antibody targeting the KIT receptor, crucial for mast cell activity, with significant results in Phase 2 studies for CSU and CIndU [3][6] - The Phase 3 program for CSU includes two trials enrolling approximately 915 patients each across 40 countries, aiming to establish the drug's efficacy and safety [7] - CDX-622, a bispecific antibody, is designed to neutralize TSLP and deplete mast cells, with a Phase 1 study in healthy volunteers initiated in November 2024 [10][13] Financial Performance - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $725.3 million, down from $756.0 million at the end of Q3 2024 [11][25] - Research and development expenses increased to $46.9 million for Q4 2024 and $163.6 million for the year, driven by clinical trial costs for barzolvolimab [14] - General and administrative expenses rose to $10.3 million for Q4 2024, attributed to higher stock-based compensation and commercial planning expenses [15]

Core Viewpoint - Celldex Therapeutics has initiated a Phase 2 study of barzolvolimab for atopic dermatitis, addressing a significant unmet need in the treatment of this common chronic inflammatory skin disease [1][2][3] Group 1: Study Details - The Phase 2 study is randomized, double-blind, and placebo-controlled, evaluating the efficacy and safety of subcutaneous barzolvolimab in patients with moderate to severe atopic dermatitis [2] - Approximately 120 patients will be enrolled, receiving either 150 mg or 300 mg of barzolvolimab or a placebo every 4 weeks after an initial loading dose [2] - The primary endpoint is to assess clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at Week 16, with secondary endpoints including various patient-reported outcomes [2][3] Group 2: Disease Background - Atopic dermatitis affects up to 20% of the US population, with a significant impact on quality of life, as many patients experience severe itching and skin breakdown [1][3] - Up to 50% of adult patients have moderate to severe disease, and 86% experience daily pruritus, with 61% reporting severe or unbearable itching [3] Group 3: Barzolvolimab Overview - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function and survival [4] - The drug is also being studied for other conditions, including chronic spontaneous urticaria and eosinophilic esophagitis, indicating its potential versatility in treating mast cell-related diseases [4] Group 4: Company Background - Celldex Therapeutics is a clinical-stage biotechnology company focused on developing therapeutics that engage the immune system and target critical pathways for severe inflammatory and allergic diseases [5]