Core Insights - Celldex will present data from its Phase 2 study of barzolvolimab for chronic spontaneous urticaria at the EAACI Congress 2025 in Glasgow, Scotland [1][2] - A webcast will be hosted by Celldex on June 12 at 6:00 pm ET to discuss the study data [1][2] - Key presentations include sustained disease control following withdrawal of barzolvolimab and improvement in angioedema in CSU patients [3] Company Information - Celldex is focused on developing novel antibody-based therapies that engage the human immune system to treat allergic, inflammatory, and autoimmune disorders [4] - The company emphasizes its commitment to pioneering advancements in immunology to improve patient outcomes [4] Event Details - The EAACI presentation session for the late-breaking oral presentation will occur on June 13 at 9:12 am BST [3] - The oral presentation on angioedema data will take place on June 14 at 3:48 pm BST [3] - The webcast will be accessible through the Investor Relations page of Celldex's website [2]

Core Insights - Celldex Therapeutics, Inc. has elected Denice M. Torres to its Board of Directors, bringing extensive leadership experience from the pharmaceutical and consumer healthcare sectors [1][2] - Torres expressed enthusiasm about joining Celldex at a pivotal time, highlighting the company's progress with barzolvolimab and its potential to improve treatment standards for patients [2] Company Overview - Celldex is a clinical stage biotechnology company focused on developing therapeutics that engage the human immune system to treat severe inflammatory, allergic, autoimmune, and other diseases [3]

Financial Performance - Celldex Therapeutics reported a quarterly loss of $0.81 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.75, and compared to a loss of $0.56 per share a year ago, indicating a decline in performance [1] - The company posted revenues of $0.7 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 62.29%, while revenues a year ago were $0.16 million [2] - Over the last four quarters, Celldex has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - Celldex shares have declined approximately 25.2% since the beginning of the year, contrasting with the S&P 500's decline of 4.3% [3] - The current Zacks Rank for Celldex is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.81 on revenues of $1.84 million, and for the current fiscal year, it is -$3.38 on revenues of $7.33 million [7] - The estimate revisions trend for Celldex is mixed, and future earnings expectations will depend on management's commentary during the earnings call [3][4] Industry Context - The Medical - Biomedical and Genetics industry, to which Celldex belongs, is currently in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Celldex's stock performance [5]

Clinical Trials and Efficacy - 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[65]. - The company initiated Phase 3 studies in CSU in July 2024, following successful Phase 2 results, and plans to present follow-up data through week 76 in 2025[81]. - Ongoing Phase 2 studies for Barzolvolimab include eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD), with enrollment ongoing for AD initiated in December 2024[73][82]. - The Phase 2 study in chronic inducible urticaria (CIndU) achieved all secondary endpoints, which were highly statistically significant and clinically meaningful[81]. - Barzolvolimab demonstrated a statistically significant mean change from baseline to week 12 in UAS7 compared to placebo at all dose levels, with a mean change of -23.87 for 300 mg Q8W, -23.02 for 150 mg Q4W, and -17.06 for 75 mg Q4W[92]. - At week 12, 37.5% of patients in the 300 mg group achieved complete control (UAS7=0), compared to 51.1% in the 150 mg group and 22.9% in the 75 mg group, while only 6.4% in the placebo group achieved the same[92]. - Approximately 72% of patients had angioedema at baseline, with barzolvolimab showing significant improvements in AAS7 across all doses at week 12, achieving a >8 point improvement compared to placebo[95]. - Long-term treatment data presented indicated sustained and deepening disease efficacy over a 52-week treatment period, with improved urticaria control and reduced disease impact on quality of life[96]. - The primary endpoint of the Phase 3 studies will evaluate the clinical effect of barzolvolimab in reducing urticaria activity (UAS7) at week 12[97]. - Barzolvolimab demonstrated a complete response in 71% of patients treated with 150 mg Q4W and 52% of patients treated with 300 mg Q8W at Week 52[98]. - 74% of patients treated with barzolvolimab 150 mg Q4W and 68% of patients treated with 300 mg Q8W had well-controlled disease (UAS7<6) at Week 52[98]. - In a Phase 1b trial, 95% of patients with ColdU and SD achieved a complete response with a single dose of 3 mg/kg[103]. - The median duration of complete response for ColdU patients was 77+ days, while for SD patients it was 57+ days[103]. - At Week 12, 46.9% of patients receiving 150 mg Q4W and 53.1% receiving 300 mg Q8W had a negative provocation test compared to 12.5% in the placebo group[108]. - The study reported a statistically significant improvement in Critical Temperature Threshold (CTT) of -8.82°C for 150 mg Q4W and -9.61°C for 300 mg Q8W[108]. - 58.6% of patients in the 150 mg Q4W group and 68.8% in the 300 mg Q8W group achieved Urticaria Control Test scores >12 at Week 12[108]. - In a Phase 1b study for Prurigo Nodularis (PN), 57% of patients receiving 3.0 mg/kg barzolvolimab achieved a ≥4-point decrease in Worst Itch-Numerical Rating Scale (WI-NRS) at week 8, compared to 25% in the placebo group[114]. - The study showed that 29% of patients on the 3.0 mg/kg dose achieved clear or almost clear skin according to Investigator Global Assessment (IGA) at week 8, with no patients in the placebo or 1.5 mg/kg groups achieving this[114]. - The company has initiated a Phase 2 study for Eosinophilic Esophagitis (EoE) with approximately 160,000 patients in the U.S. estimated to have undergone treatment in the last 12 months, of which about 48,000 are biologic-eligible[119]. - A Phase 2 study for Atopic Dermatitis (AD) has been initiated, targeting a population where two-thirds of patients do not achieve complete control with first-line systemic therapy, indicating a significant unmet need[121]. - The company plans to present data from the EoE study in the second half of 2025, with a focus on reducing esophageal intraepithelial mast cell count as the primary endpoint[120]. Financial Performance - Total research and development expenses for the three months ended March 31, 2025, were $52.614 million, compared to $31.661 million for the same period in 2024, reflecting a 66% increase[79]. - The company incurred an aggregate of $459.7 million in research and development expenses over the past five years through December 31, 2024[78]. - Total revenues for the three months ended March 31, 2025, were $695,000, a 346% increase compared to $156,000 for the same period in 2024[131]. - The net loss for the three months ended March 31, 2025, was $53.8 million, representing a 64% increase from a net loss of $32.8 million for the same period in 2024[132]. - Cash, cash equivalents, and marketable securities totaled $673.3 million as of March 31, 2025, sufficient to meet estimated working capital requirements through 2027[143]. - Net cash used in operating activities was $54.4 million for the three months ended March 31, 2025, compared to $40.6 million for the same period in 2024[145]. - Investment and other income increased by $1.1 million to $8.9 million for the three months ended March 31, 2025, compared to $7.8 million for the same period in 2024[140]. - Product development expenses surged by 107% to $32.2 million for the three months ended March 31, 2025, compared to $15.5 million for the same period in 2024[138]. - General and administrative expenses rose by 19% to $10.8 million for the three months ended March 31, 2025, compared to $9.1 million for the same period in 2024[139]. - The company expects revenue to decrease over the next twelve months due to a reduction in services under existing agreements[133]. - The company plans to raise additional capital through various means, including licensing drug candidates and possible business combinations[144]. Strategic Development - The company is focusing on developing a next-generation bispecific antibody platform, with CDX-622 as the first candidate targeting chronic inflammation pathways[73]. - The company emphasizes the importance of raising sufficient capital to fund ongoing clinical studies and meet long-term liquidity needs[64]. - The company plans to explore strategic partnerships to maximize the value of its technology and product portfolio while ensuring the expeditious development of each product[69]. - Barzolvolimab's manufacturing process has been successfully scaled up to produce larger cGMP batches in support of late-stage trials and potential commercialization[125]. - The company is developing CDX-622, a bispecific antibody targeting TSLP and SCF, which is expected to offer enhanced therapeutic benefits in inflammatory and fibrotic disorders[128]. - In the Phase 2 PN study, patients are being randomized to receive barzolvolimab injections of 150 mg or 300 mg every 4 weeks, with a total enrollment of approximately 120 patients[118]. - The Phase 2 study for AD will include up to 120 patients, with a primary endpoint of evaluating clinical efficacy using the Peak Pruritus Numerical Rating Scale (PP-NRS) at week 16[124]. - The company has expanded clinical development of barzolvolimab into PN, addressing a significant unmet need as there is currently only one FDA-approved therapy for this condition[112].

[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]