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]

Financial Performance - Celldex Therapeutics reported a quarterly loss of $0.64 per share, which was better than the Zacks Consensus Estimate of a loss of $0.69, and an improvement from a loss of $0.81 per share a year ago, indicating a 20.99% year-over-year improvement [1] - The company posted revenues of $3.19 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 121.60%, compared to revenues of $1.52 million in the same quarter last year [2] - Over the last four quarters, Celldex has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Stock Performance - Celldex shares have declined approximately 35.9% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.73 on revenues of $1.41 million, and for the current fiscal year, it is -$2.50 on revenues of $4.45 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Celldex belongs, is currently ranked in the top 38% 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 be tracked by investors [5]

Clinical Development - Barzolvolimab (CDX-0159) is currently in Phase 3 studies for chronic spontaneous urticaria (CSU), with a Phase 2 study achieving primary efficacy endpoints and demonstrating a statistically significant mean change from baseline to week 12[75]. - The company initiated a Phase 2 study in prurigo nodularis (PN) in April 2024, following positive data from a Phase 1b study reported in November 2023[90]. - A Phase 2 study in eosinophilic esophagitis (EoE) was initiated in June 2023, with enrollment ongoing[76]. - The company plans to initiate a Phase 2 study for atopic dermatitis (AD) by the end of 2024, targeting patients who have received prior biologics[76]. - The company initiated two Phase 3 studies of barzolvolimab in Chronic Spontaneous Urticaria (CSU) in July 2024, enrolling approximately 915 patients per trial across 250 sites in about 40 countries[113]. - In a Phase 1b trial for Cold Urticaria (ColdU) and Symptomatic Dermographism (SD), a complete response was achieved in 95% (n=19/20) of patients treated with a single dose of 3 mg/kg barzolvolimab[118]. - In a Phase 2 study for Chronic Inducible Urticaria (CIndU), 196 patients were randomized to receive barzolvolimab at either 150 mg every 4 weeks or 300 mg every 8 weeks, with the primary endpoint being the percentage of patients with a negative provocation test at week 12[128]. - The company has expanded clinical development of barzolvolimab into Prurigo Nodularis (PN), a chronic skin disease with an estimated 154,000 patients in the U.S. who have undergone treatment in the last 12 months[134]. Financial Performance - The total research and development expenses for the nine months ended September 30, 2024, amounted to $116.6 million, compared to $87.6 million for the same period in 2023, reflecting a year-over-year increase of approximately 33%[86]. - The total revenues for the three months ended September 30, 2024, were $3.191 million, a 110% increase from $1.517 million in the same period in 2023[151]. - Research and development expenses increased by 31% to $45.263 million for the three months ended September 30, 2024, compared to $34.535 million in the prior year[151]. - The net loss for the three months ended September 30, 2024, was $42.121 million, a 10% increase from $38.260 million in the same period in 2023[152]. - Revenue from product development and licensing agreements for the three months ended September 30, 2024, was $5.8 million, a 112% increase compared to $2.8 million for the same period in 2023[161]. - Investment and other income increased by 236% to $10.005 million for the three months ended September 30, 2024, compared to $2.979 million in the prior year[151]. - Investment and other income, net, for the nine months ended September 30, 2024, increased by $19.5 million, or 222%, totaling $28.3 million compared to $8.8 million for the same period in 2023[168]. Research and Development Expenses - The company incurred an aggregate of $338.8 million in research and development expenses over the past five years through December 31, 2023[86]. - Product development expenses for the nine months ended September 30, 2024, rose by $19.4 million, or 43%, reaching $64.7 million compared to $45.3 million for the same period in 2023[169]. - General and administrative expenses increased by $6.2 million, or 28%, totaling $28.3 million for the nine months ended September 30, 2024, compared to $22.1 million for the same period in 2023[167]. Cash Flow and Financing - Net cash used in operating activities was $125.3 million for the nine months ended September 30, 2024, compared to $74.8 million for the same period in 2023[174]. - Net cash used in investing activities was $314.2 million for the nine months ended September 30, 2024, compared to net cash provided of $65.4 million for the same period in 2023[176]. - Net cash provided by financing activities was $441.1 million for the nine months ended September 30, 2024, compared to $1.1 million for the same period in 2023[177]. - In March 2024, the company issued 9,798,000 shares of common stock, resulting in net proceeds of $432.3 million after deducting underwriting fees and offering expenses[178]. Clinical Efficacy and Safety - Barzolvolimab demonstrated a mean reduction from baseline in weekly urticaria activity score (UAS7) of 67% at week 12 for both the 1.5 mg/kg and 3.0 mg/kg dose groups, and 82% for the 4.5 mg/kg dose group[94]. - At week 12, complete response (UAS7=0) was achieved by 57% of patients in the 1.5 mg/kg group, 44% in the 3.0 mg/kg group, and 67% in the 4.5 mg/kg group[95]. - Well-controlled disease (UCT≥12) at week 12 was reported in 75% of the 1.5 mg/kg group, 63% of the 3.0 mg/kg group, and 89% of the 4.5 mg/kg group[96]. - At week 12, barzolvolimab achieved a statistically significant mean change from baseline in UAS7 compared to placebo across all dose levels, with a mean difference of -13.41 for 300 mg Q8W[105]. - 71% of patients treated with barzolvolimab 150 mg Q4W and 52% treated with 300 mg Q8W had a complete response (UAS7=0) at week 52[110]. - 74% of patients treated with barzolvolimab 150 mg Q4W and 68% treated with 300 mg Q8W had well-controlled disease (UAS7<6) at week 52[111]. - Barzolvolimab was well tolerated, with most adverse events being mild to moderate; common events included hair color changes (9%) and neutropenia (8%)[100]. - Approximately 72% of patients had angioedema at baseline, with significant improvements in angioedema activity score (AAS7) observed across all doses at week 12[108]. - Patients in the 300 mg cohort experienced angioedema-free days 77% of the time over the 12-week period[108]. - The studies confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell burden and clinical activity in inducible urticaria[122]. - The Phase 1b study of barzolvolimab showed a 57% reduction in Worst Itch Numerical Rating Scale (WI-NRS) at week 8 for the 3.0 mg/kg dose, compared to 25% for placebo[137]. - At week 8, 29% of patients in the 3.0 mg/kg group achieved clear or almost clear skin according to Investigator Global Assessment (IGA), with no patients in the 1.5 mg/kg or placebo groups achieving this[138]. Future Outlook - The ongoing clinical trials and development programs are subject to various uncertainties, including regulatory approvals and the ability to raise sufficient capital for continued operations[72]. - The company expects revenue to decrease over the next twelve months primarily due to a decrease in services under contract manufacturing and research agreements[153]. - The company anticipates that cash used in operating activities will increase over the next twelve months due to expanded development of barzolvolimab[174]. - The company plans to initiate a Phase 1 study of CDX-622, a bispecific antibody, in healthy volunteers by the end of 2024[147]. - The company successfully scaled up the barzolvolimab manufacturing process to produce larger cGMP batches in support of late-stage trials[144].

Financial Performance - Total revenue for Q3 2024 was $3.2 million, up from $1.5 million in Q3 2023, representing a 113.3% increase[15] - Net loss for Q3 2024 was $42.1 million, or ($0.64) per share, compared to a net loss of $38.3 million, or ($0.81) per share in Q3 2023[18] - Research and development expenses increased to $45.3 million in Q3 2024 from $34.5 million in Q3 2023, a rise of 31.8%[16] - General and administrative expenses rose to $10.1 million in Q3 2024 compared to $8.2 million in Q3 2023, an increase of 23.2%[17] Cash and Assets - Cash, cash equivalents, and marketable securities as of September 30, 2024, were $756.0 million, down from $802.3 million as of June 30, 2024[14] - Total assets increased to $823,179 million as of September 30, 2024, up from $465,627 million on December 31, 2023, representing a growth of 76.7%[25] - Cash, cash equivalents, and marketable securities reached $755,999 million, significantly up from $423,598 million, marking an increase of 78.5%[25] - Intangible and other assets grew to $40,107 million, up from $29,874 million, which is an increase of 34.1%[25] - Other current assets increased to $22,843 million from $8,095 million, representing a substantial growth of 182.5%[25] - Property and equipment, net, saw a slight increase to $4,230 million from $4,060 million, reflecting a growth of 4.2%[25] Liabilities and Equity - Current liabilities slightly increased to $32,093 million from $31,125 million, reflecting a rise of 3.1%[25] - Long-term liabilities decreased marginally to $5,181 million from $5,331 million, showing a decline of 2.8%[25] - Stockholders' equity rose to $785,905 million, compared to $429,171 million at the end of 2023, indicating an increase of 83.2%[25] - Total liabilities and stockholders' equity remained consistent at $823,179 million, matching the total assets[25] Clinical Developments - Barzolvolimab demonstrated a 71% complete response rate at Week 52 in the Phase 2 CSU study, the highest rate observed in a controlled study[7] - In the Phase 2 CIndU study, 53.1% of patients with cold urticaria achieved a complete response compared to 12.5% in the placebo group (p=0.0011)[8] - The company plans to initiate a global Phase 3 program in chronic inducible urticaria (CIndU) in 2025[5] - Celldex expects to initiate a Phase 2 study in atopic dermatitis (AD) by the end of 2024[11] Financial Outlook - The company believes its cash position is sufficient to fund operations through 2027[19] - The overall financial position indicates strong growth and improved liquidity, positioning the company favorably for future investments and expansions[25]

Core Insights - Celldex Therapeutics reported significant progress in its clinical trials for barzolvolimab, demonstrating its potential as a transformative treatment for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) [2][4][6] Clinical Development - Enrollment is ongoing in Phase 3 trials for CSU, with two trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to evaluate the efficacy and safety of barzolvolimab in patients who remain symptomatic despite antihistamine treatment [4] - A global Phase 3 program for CIndU is planned to initiate in 2025 [5] - Barzolvolimab met all primary and secondary endpoints in Phase 2 studies for both CSU and CIndU, with results showing high statistical significance [6] - Long-term data from the Phase 2 CSU study indicated a complete response rate of 71% at Week 52 for patients receiving 150 mg Q4W [7] - In the Phase 2 CIndU study, barzolvolimab was the first drug to show clinical benefit in cold urticaria, with complete response rates of 53.1% and 57.6% for cold urticaria and symptomatic dermographism, respectively [8] Pipeline Expansion - A Phase 2 study for eosinophilic esophagitis (EoE) is ongoing, with data expected in the second half of 2025 [9] - A Phase 2 study for prurigo nodularis (PN) is also in progress, targeting approximately 120 patients [10] - Atopic dermatitis (AD) has been selected as a new indication for barzolvolimab, with a Phase 2 study set to begin by the end of 2024 [11] - Celldex's first bispecific antibody, CDX-622, is expected to enter clinical trials by the end of 2024, targeting chronic inflammation pathways [12][13] Financial Performance - As of September 30, 2024, Celldex reported cash, cash equivalents, and marketable securities of $756 million, down from $802 million as of June 30, 2024, primarily due to operating cash usage of $55.3 million [15] - Total revenue for Q3 2024 was $3.2 million, an increase from $1.5 million in Q3 2023, attributed to enhanced services under manufacturing and research agreements [16] - Research and development expenses rose to $45.3 million in Q3 2024 from $34.5 million in Q3 2023, driven by increased clinical trial costs [17] - General and administrative expenses increased to $10.1 million in Q3 2024 from $8.2 million in Q3 2023, mainly due to higher stock-based compensation [18] - The net loss for Q3 2024 was $42.1 million, compared to a net loss of $38.3 million in Q3 2023 [19]

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 developmentCompany to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticari ...

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company's Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024. Presenta ...

Shares of Celldex Therapeutics (CLDX) lost 12.1% on Wednesday due to unsatisfactory 52-week safety data from a mid-stage study of its investigational candidate, barzolvolimab, which is being developed for treating chronic spontaneous urticaria (CSU).CSU is a type of skin disease, characterized by the sudden appearance of hives (raised, itchy welts) without an identifiable trigger. The exact cause is often unknown, but it can be linked to immune system dysfunction, where the body mistakenly triggers allergic ...

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Am ...