Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.81 per share versus the Zacks Consensus Estimate of a loss of $0.75. This compares to loss of $0.56 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.75 per share when it actually produced a loss of $0.71, delivering a surprise of 5.33%.Over the last four quarters, the c ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 000-15006 CELLDEX THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware No. 13-3191702 (I.R.S. Employer Identification No.) (State or other jurisdiction of incorporation or organization) Perryville III Building, 53 Frontage Road, Suite 220, Hampton, New Jersey 08827 ☒ ...

HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2025 and provided a corporate update. "In the first quarter of 2025, we presented data from our Phase 2 studies in chronic spontaneous and chronic inducible urticaria that demonstrated that barzolvolimab greatly improved quality of life for patients," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Ba ...

Strong execution and progress across pipeline with multiple key data read outs expected in 2025Late breaking oral presentation on Phase 2 CSU program at EAACI 2025 in JunePhase 3 barzolvolimab CSU studies enrollment ongoing; Phase 3 program in CIndU under developmentPhase 2 EOE study enrollment complete; ongoing enrollment in Phase 2 PN and AD studiesCelldex’s first bispecific for inflammatory diseases, CDX-622, Phase 1 study ongoing HAMPTON, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. ...

HAMPTON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Celldex announced today the presentation of histology data from the Company’s ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). Biopsies taken during screening demonstrate the presence of high numbers of intraepithelial mast cells in participants with active EoE and correlate with eosinophil counts, supporting the hypothesis that treating EoE with barzolvolimab—a mast cell depleting agent—could provide promising therapeutic benefit. The ...

- CDX-622 inhibits SCF and TSLP-dependent inflammatory signatures in human skin -- Phase 1 study in healthy volunteers ongoing - HAMPTON, N.J., March 03, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive preclinical data from CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—thymic stromal lymphopoietin (TSLP) and mast cell depletion via stem cell factor (SCF) starvation. The data demon ...

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].