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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ 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 (State or other jurisdiction of incorporati ...

EXHIBIT 99.1 Celldex Reports Second Quarter 2024 Financial Results and Provides Corporate Update Phase 3 CSU studies initiated July 2024 Positive topline Phase 2 CIndU 12 week data reported July 2024 supporting Phase 3 advancement 52 week Phase 2 CSU data and full 12 week Phase 2 CIndU data to be reported 2H 2024 Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start YE 2024 Celldex's first bispecific for inflammatory diseases, CDX-622, to enter the clinic this year HAMPTON, N.J., Aug ...