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 ...

Core Viewpoint - Celldex Therapeutics' shares fell by 12.1% due to disappointing safety data from a mid-stage study of barzolvolimab, an investigational treatment for chronic spontaneous urticaria (CSU) [1] Group 1: Study Results - The phase II study involved 208 CSU patients and compared three dosing regimens of barzolvolimab (75 mg, 150 mg, 300 mg) against a placebo [1] - Statistically significant improvements in UAS7 scores were observed at week 12 and sustained through week 52 for all dose levels [2][3] - A complete response (UAS7 score of 0) was achieved in 71% of patients on the 150 mg dose and 52% on the 300 mg dose at week 52 [3] - 74% of patients on the 150 mg dose and 68% on the 300 mg dose had well-controlled disease (UAS7 score < 6) at week 52 [4] Group 2: Safety Concerns - Despite efficacy data, safety concerns arose as over 10% of barzolvolimab-treated patients experienced treatment-related adverse events, including hair color changes and neutropenia [5] - The company stated that adverse events were mostly mild and not related to dosage levels, with stable neutrophil counts during treatment [5] Group 3: Clinical Pipeline - Celldex has initiated a global phase III program for barzolvolimab, which includes two late-stage studies for adult CSU patients [6] - The company is also exploring barzolvolimab for other inflammatory diseases such as prurigo nodularis and atopic dermatitis [6] - Another candidate, CDX-585, is in phase I development for advanced or metastatic solid tumors [6] Group 4: Market Performance - Year-to-date, Celldex shares have declined by 9.2%, while the industry average decline is 1.9% [3]

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 ...

HAMPTON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences: 2024 Cantor Global Healthcare Conference on Tuesday, September 17th at 8:35 a.m. ET TD Cowen's Chronic Urticaria Summit on Friday, September 20th at 10:00 a.m. ET Live webcasts of the presentations will be available on the "Events & Presentations” page of the "Investors & Media" section of the Celldex website. Replays will ...

Celldex Therapeutics (CLDX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.59. This compares to loss of $0.65 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8.47%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.67 per share when it actually produced a loss of $0.56, delivering a surprise of 16.42%.Over the last four quarters, th ...