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Core Insights - Celldex has initiated a global Phase 3 trial (EMBARQ-ColdU and SD) to evaluate the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who are symptomatic despite H1 antihistamine treatment [1][2] - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function, which is a key driver in ColdU and SD [1][7] - The trial aims to enroll approximately 240 participants across 75 clinical sites in 7 countries, with a primary endpoint focused on the percentage of patients achieving a complete response at Week 12 [2][3] Study Design and Objectives - The EMBARQ-ColdU and SD trial will include two cohorts: one for ColdU and one for SD, with participants randomized in a 1:1 ratio to receive either barzolvolimab or placebo for 24 weeks [2][3] - The primary endpoint will assess the complete response rate using TempTest® for ColdU and FricTest® for SD at Week 12, with follow-up for 16 weeks post-treatment [2][5] Clinical Background and Need - ColdU and SD affect over 533,000 patients in the U.S. and Europe, with no advanced therapies currently approved, leading to inadequate disease control for over 80% of patients [3][4] - Patients often experience severe itching and hives, significantly impacting their mental and emotional well-being, daily activities, and social interactions [3][4] Previous Study Results - A Phase 2 study showed that barzolvolimab met its primary endpoint, demonstrating a statistically significant difference in negative provocation tests compared to placebo at Week 12, with up to 75% of ColdU patients and 67% of SD patients achieving a partial or complete response [3][5] - Secondary endpoints also showed strong support for the primary results, with sustained effects through the end of the treatment period [5] Future Directions - Barzolvolimab is being studied across five indications, including chronic spontaneous urticaria, with ongoing Phase 3 studies and plans for additional indications [3][7] - The initiation of the EMBARQ-ColdU and SD trial represents a significant advancement in treatment options for patients suffering from these conditions [4][5]

Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Current Status**: Late-stage company in phase three development for CSU program and planning to initiate phase three for CIndU program by the end of December 2025 [5][6] Key Programs and Developments - **CSU Program**: Expected to complete accrual by July 2026, with significant data anticipated [5] - **CIndU Program**: Phase three initiation planned by the end of December 2025 [5] - **Prurigo Nodularis and Atopic Dermatitis**: Phase two studies expected to read out in 2026 [5] - **CDX-622**: First bispecific program targeting stem cell factor (SCF) and TSLP, currently in healthy volunteer studies with multiple ascending dose (MAD) study ongoing [6][18] Scientific Insights - **SCF-248 vs. SCF-220**: CDX-622 targets the soluble form SCF-248, which is believed to be more relevant in inflammation contexts, potentially avoiding adverse effects associated with other KIT functions [8][10] - **Tryptase Reduction**: Current maximum inhibition achieved is 50%, with ongoing studies to determine if further reductions can be achieved [10][12] - **Biomarkers**: Skin punch biopsies are being performed to assess mast cell populations and their responses [11][13] Market and Commercial Strategy - **Pricing Strategy**: Anticipated pricing for Barzal is expected to be higher than $40,000 per year, potentially aligning with other immunology treatments priced around $59,000 [21][24] - **Patient Population**: Initial use of Barzal is expected to be among patients who are refractory to existing treatments, with a focus on both antihistamine refractory and biologically experienced populations [19][23] Future Considerations - **Additional Indications**: Potential exploration of food allergies, chronic urticaria, and allergic rhinitis as future indications for Barzal [32] - **Partnership Opportunities**: Considering partnerships outside the U.S. while focusing on self-commercialization in the U.S. [33] - **Next Steps for CDX-622**: Plans to conduct randomized phase 2 trials following the MAD data expected in Q3 2026 [34] Conclusion - **Outlook**: The company is optimistic about the upcoming data from CSU and other programs, indicating a bright future with multiple indications being explored [37]

Summary of Celldex Therapeutics Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 13, 2025 - **Key Speakers**: Anthony Marucci (CEO), Tibor Keler (CSO), Diane Young (CMO) Key Points Industry and Product Focus - The discussion primarily revolves around Celldex's ongoing clinical trials and data related to their drug Barzolvolimab, particularly in the context of Chronic Spontaneous Urticaria (CSU), Prurigo Nodularis (PN), and Atopic Dermatitis (AD) [3][4][34] Clinical Data Highlights - **CSU Phase Two Data**: - A 76-week phase two study showed a **41% complete response rate** seven months after stopping Barzolvolimab, indicating a durable remission [3][4] - This response rate is comparable to Xolair and higher than Dupixent, suggesting significant efficacy [3][4] - **Competitor Comparison**: - Xolair's effects diminish within weeks after cessation, while Ruxolitinib's long-term effects remain unclear. Dupixent shows modest efficacy [4][5] - **Mast Cell Dynamics**: - Data indicates that mast cells return to normal levels after treatment, but the long-term effects on disease modification are still being evaluated [6] Future Studies and Trials - **OLE (Open Label Extension)**: - The OLE is designed to gather additional follow-up data and explore retreatment options post-approval [7][8] - **Upcoming Trials**: - Ongoing phase two studies for PN and AD are expected to yield results in the second half of 2026. The PN trial involves 120 patients and focuses on itch reduction and lesion healing [17][21][34] - **CDX-622 Development**: - CDX-622, a bispecific targeting mast cells and TSLP, is in phase one trials with promising pharmacokinetics and no immunogenicity observed [28][29] Market Position and Strategy - **Competitive Landscape**: - Celldex aims to position Barzolvolimab as a competitive option against existing treatments like Dupixent, focusing on improving itch reduction and lesion healing [19][20] - **Pipeline Expansion**: - The company is considering various indications for CDX-622, including severe asthma and food allergies, based on ongoing data [31][32] Upcoming Catalysts - Key upcoming milestones include: - Phase three study initiation for cold urticaria and symptomatic dermographism by the end of 2025 - Phase two readouts for cold urticaria and symptomatic dermographism in Q1 2026 - Completion of CSU phase three accrual by summer 2026 - Data releases for AD and PN in the second half of 2026 [34][36] Enrollment and Study Progress - Enrollment for the ongoing EMBARK studies is proceeding well, with expectations to complete by summer 2026 [36][37] Additional Insights - The discussion emphasizes the importance of understanding mast cell roles in various conditions, which could lead to innovative treatment strategies and improved patient outcomes [20][22]

Summary of Celldex Therapeutics FY Conference Call Company Overview - **Company**: Celldex Therapeutics (NasdaqCM:CLDX) - **Date**: November 11, 2025 - **Key Executives Present**: Tibor Keler (Chief Scientific Officer), Diane Young (Chief Medical Officer), Sarah Cavanaugh (SVP Corporate Affairs) Key Industry Insights - **Urticaria Programs**: 2025 has been a significant year for Celldex, particularly with advancements in their urticaria programs, including chronic spontaneous urticaria (CSU) and inducible urticaria [2][3] - **Data Presentation**: The company presented 76-week data from the CSU program, showcasing high efficacy and off-treatment durability, with a 41% complete response rate seven months post-treatment [5][6] - **Phase Three Studies**: Ongoing phase three studies in CSU and a new phase three study for inducible urticaria set to begin in December [2][10] Core Product Insights - **Barzolimab**: The drug has shown unprecedented off-treatment durability compared to existing treatments like Xolair and Dupixent, which typically see symptom recurrence shortly after discontinuation [6][8] - **Safety Profile**: The safety data from the 76-week study indicates that barzolimab is well tolerated, with mild and reversible side effects [8][9] Pipeline Developments - **CDX-622 Program**: Recent data from the CDX-622 program indicates a promising future for 2026, with a focus on targeting both TSLP and stem cell factor [3][36] - **Inducible Urticaria Study**: The phase two study for inducible urticaria reported that about two-thirds of cold urticaria patients achieved a complete response at 20 weeks [15][16] - **Future Studies**: Plans for phase two studies in prurigo nodularis (PN) and atopic dermatitis (AD) are underway, with expectations for data in the second half of next year [25][26][31] Financial Position - **Cash Position**: The company reported a cash position of $583.2 million, which is expected to fund operations through 2027 [48][49] Competitive Landscape - **Market Dynamics**: The entry of competitors like Novartis with Remibrutinib is expected to expand the market for CSU treatments, which Celldex believes positions barzolimab favorably within this growing market [47] Additional Considerations - **Future Indications**: Celldex is exploring additional indications related to itch and other allergic conditions, leveraging the unique properties of their bispecific antibody portfolio [32][34][45] - **Biomarker Strategy**: The company plans to utilize biomarkers to assess the efficacy of their treatments, particularly in asthma studies [46] This summary encapsulates the key points discussed during the conference call, highlighting the advancements, pipeline developments, and strategic positioning of Celldex Therapeutics in the biopharmaceutical industry.

Clinical Trials and Efficacy - Barzolvolimab (CDX-0159) achieved the primary efficacy endpoint in the Phase 2 study for Chronic Spontaneous Urticaria (CSU), showing a statistically significant mean change from baseline to Week 12 compared to placebo[67]. - In the CSU study, over 40% of patients continued to experience a profound, sustained complete response at 76 weeks after treatment with barzolvolimab[67]. - The Phase 2 study for Cold Urticaria and Symptomatic Dermographism achieved its primary efficacy endpoint, with all secondary endpoints also met and statistically significant[67]. - Barzolvolimab demonstrated rapid and durable responses in patients with moderate to severe Chronic Spontaneous Urticaria (CSU), with a mean reduction in baseline UAS7 of 82% at Week 12 for the 4.5 mg/kg dose group[86]. - In a Phase 2 study, barzolvolimab achieved a statistically significant mean change from baseline to Week 12 in UAS7 compared to placebo across all dose levels, with a mean change of -23.87 for the 300 mg Q8W group[92]. - 71% of patients treated with barzolvolimab 150 mg Q4W and 52% of patients treated with 300 mg Q8W had a complete response (UAS7=0) at Week 52[96]. - Approximately 72% of patients on study had angioedema at baseline, with barzolvolimab demonstrating significant improvements in AAS7 across all doses at Week 12[95]. - At Week 12, 37.5% of patients in the 300 mg Q8W group achieved complete control (UAS7=0), compared to 6.4% in the placebo group[92]. - Barzolvolimab's mechanism of action demonstrated strong improvement in UAS7 independent of prior omalizumab treatment status, benefiting even omalizumab-refractory patients[93]. - At Week 52, barzolvolimab demonstrated an 86% mean reduction in angioedema symptoms for the 150 mg Q4W arm and an 82% reduction for the 300 mg Q8W arm[97]. - 77% of patients treated with barzolvolimab were angioedema free (AAS7=0) at Week 52, with patients being angioedema free up to 72% of the time during the treatment period[97]. - In the Phase 2 CSU study, at Week 76, the UAS7 mean change from baseline was -20.42 for the 150 mg Q4W group and -21.10 for the 300 mg Q8W group[100]. - 41% of patients on 150 mg Q4W and 35% on 300 mg Q8W achieved a complete response (UAS7=0) at Week 76[100]. - A complete response was achieved in 95% of patients with ColdU and SD treated with a single dose of 3 mg/kg, with a median duration of complete response of 77+ days[105]. - At Week 12, 53.1% of patients treated with 300 mg barzolvolimab achieved a negative provocation test for Cold Urticaria, compared to 12.5% in the placebo group, with a p-value of 0.0011[111]. - In the same study, 75% of patients receiving 300 mg barzolvolimab had a complete or partial response per provocation test, versus 31.3% in the placebo group, with a p-value of 0.0006[111]. - By Week 20, 66% of Cold Urticaria patients and 49% of Symptomatic Dermographism patients achieved a complete response with barzolvolimab, compared to 16% and 10% in the placebo groups, respectively[118]. Research and Development Expenses - Total research and development expenses for the nine months ended September 30, 2025, were $169.7 million, compared to $116.6 million for the same period in 2024, reflecting a 45.5% increase[80]. - The Barzolvolimab/Anti-KIT Program incurred $134.0 million in R&D expenses for the nine months ended September 30, 2025, up from $88.6 million in the same period of 2024[80]. - The company incurred an aggregate of $459.7 million in research and development expenses over the past five years through December 31, 2024[79]. - Research and development expenses increased by 39% to $62.93 million for the three months ended September 30, 2025, compared to $45.26 million in 2024, driven by barzolvolimab-related costs[139]. - Research and development expenses for the nine months ended September 30, 2025, rose by 46% to $169.74 million, up from $116.61 million in 2024, reflecting increased investment in barzolvolimab[149]. - Research and development expenses increased by $43.3 million (67%) to $108.1 million for the nine months ended September 30, 2025, primarily due to higher clinical trial and contract manufacturing expenses for barzolvolimab[155]. Financial Performance - Total revenues for the three months ended September 30, 2025, were $3.19 million, a decrease of 100% compared to the same period in 2024, primarily due to a $3.19 million drop in contracts and grants revenue[139]. - The net loss for the three months ended September 30, 2025, was $67.04 million, a 59% increase from the net loss of $42.12 million in the same period in 2024[140]. - For the nine months ended September 30, 2025, total revenues were $1.42 million, a decrease of 76% compared to $5.85 million in 2024, with a significant drop in contracts and grants revenue[149]. - The company incurred a loss of $177.4 million for the nine months ended September 30, 2025[160]. Clinical Development Initiatives - The company initiated a Phase 2 study in Prurigo Nodularis (PN) in April 2024, with positive data reported from a Phase 1b study in November 2023[73]. - The company is developing CDX-622, a bispecific antibody targeting TSLP and SCF, with a Phase 1a dose-escalation study initiated in November 2024[73]. - The company plans to initiate a global Phase 3 study in Cold Urticaria and Symptomatic Dermographism in December 2025, based on positive results from earlier studies[114]. - A Phase 2 study for Atopic Dermatitis has been initiated, evaluating the efficacy of barzolvolimab in approximately 120 patients, with initial data expected in the second half of 2026[124][127]. - The company has expanded clinical development of barzolvolimab into Prurigo Nodularis, targeting a significant unmet need with an estimated 154,000 patients in the U.S. having undergone treatment in the last year[115]. - Enrollment is ongoing for the Phase 2 subcutaneous study in Prurigo Nodularis, which will include approximately 120 patients and is designed to evaluate the clinical effect of barzolvolimab on itch response[123]. - The company discontinued the development of barzolvolimab for eosinophilic esophagitis (EoE) based on Phase 2 study results, which showed no improvement in EoE symptoms despite meeting the primary endpoint of mast cell depletion[128]. Safety and Tolerability - Barzolvolimab was well tolerated, with most adverse events being mild to moderate; common events included hair color changes (9%) and neutropenia (8%) without a clear association with infections[94]. - The Phase 1b study included 45 patients with moderate to severe CSU, assessing safety and pharmacokinetics of barzolvolimab[84]. - Barzolvolimab was well tolerated with a favorable safety profile, and no new safety signals were identified during the follow-up period[100]. - Barzolvolimab demonstrated a favorable safety profile, with 18% of patients experiencing hair color changes and 12% experiencing neutropenia, both primarily grade 1 adverse events[112][118]. Cash Flow and Financial Position - Cash, cash equivalents, and marketable securities totaled $583.2 million as of September 30, 2025, sufficient to meet estimated working capital requirements through 2027[160]. - Net cash used in operating activities was $147.0 million for the nine months ended September 30, 2025, compared to $125.3 million for the same period in 2024, reflecting increased research and development and general administrative expenses[162]. - Net cash provided by investing activities was $153.6 million for the nine months ended September 30, 2025, compared to net cash used of $314.2 million for the same period in 2024, primarily due to net sales and maturities of marketable securities[165]. - Net cash provided by financing activities decreased to $1.0 million for the nine months ended September 30, 2025, down from $441.1 million in the same period in 2024, due to reduced net proceeds from stock issuances[166]. - Investment and other income decreased by $3.43 million for the three months ended September 30, 2025, primarily due to lower cash and investment balances[148]. - Investment and other income, net decreased by $5.5 million for the nine months ended September 30, 2025, primarily due to lower cash and investment balances[157].

Financial Performance - Total revenue for the third quarter of 2025 was $0.0 million, and $1.4 million for the nine months ended September 30, 2025, compared to $3.2 million and $5.8 million for the same periods in 2024, reflecting a decrease primarily due to reduced services under manufacturing and research agreements[13] - Net loss for the third quarter of 2025 was $67.0 million, or ($1.01) per share, compared to a net loss of $42.1 million, or ($0.64) per share, for the third quarter of 2024[16] - The net loss for the three months ended September 30, 2025, was $67.044 million, compared to a net loss of $42.121 million for the same period in 2024, indicating a 59% increase in losses[23] - Basic and diluted net loss per share for the three months ended September 30, 2025, was $1.01, compared to $0.64 for the same period in 2024[24] Cash and Assets - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $583.2 million, down from $630.3 million as of June 30, 2025, primarily due to $48.6 million used in operating activities during the third quarter[12] - Cash, cash equivalents, and marketable securities as of September 30, 2025, totaled $583.223 million, down from $725.281 million as of December 31, 2024[25] - Total assets decreased to $648.439 million as of September 30, 2025, from $792.340 million as of December 31, 2024[25] - Current liabilities increased to $46.465 million as of September 30, 2025, compared to $39.501 million as of December 31, 2024[25] - Stockholders' equity decreased to $598.363 million as of September 30, 2025, from $747.005 million as of December 31, 2024[25] Expenses - Research and development (R&D) expenses were $62.9 million in the third quarter of 2025, up from $45.3 million in the same quarter of 2024, driven by increased costs associated with barzolvolimab clinical trials[14] - General and administrative (G&A) expenses were $10.7 million in the third quarter of 2025, compared to $10.1 million in the same quarter of 2024, attributed to higher stock-based compensation and increased employee headcount[15] - Operating expenses for the three months ended September 30, 2025, were $73.617 million, up from $55.317 million in the same period in 2024, reflecting a 33% increase[23] - Research and development expenses for the three months ended September 30, 2025, were $62.931 million, compared to $45.263 million for the same period in 2024, marking a 39% increase[23] - Investment and other income for the three months ended September 30, 2025, was $6.573 million, down from $10.005 million in the same period in 2024, representing a 34% decrease[23] Clinical Trials and Future Plans - Barzolvolimab demonstrated a complete response in 71% of patients at 52 weeks in the Phase 2 study for Chronic Spontaneous Urticaria (CSU), with over 40% of patients maintaining a complete response at 76 weeks post-treatment[10] - In the Phase 2 study for Cold Urticaria (ColdU) and Symptomatic Dermographism (SD), 66% of patients achieved a complete response at 20 weeks, compared to 16% in the placebo group[10] - Celldex plans to initiate a global Phase 3 study in ColdU and SD in December 2025, following the positive results from earlier studies[7] - The company expects multiple data readouts throughout 2026, indicating ongoing progress across its pipeline[3] Cash Position - Celldex believes its cash position is sufficient to meet working capital requirements and fund planned operations through 2027[17]

Core Insights - Celldex reported financial results for Q3 2025, highlighting advancements in its pipeline, particularly with barzolvolimab, which has shown clinical benefits in treating cold urticaria and symptomatic dermographism [1][2] Financial Performance - Cash Position: As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $583.2 million, down from $630.3 million as of June 30, 2025, primarily due to $48.6 million used in operating activities during Q3 [13] - Revenues: Total revenue was $0.0 million for Q3 2025 and $1.4 million for the nine months ended September 30, 2025, compared to $3.2 million and $5.8 million for the same periods in 2024, reflecting a decrease due to reduced services under manufacturing and R&D agreements [14] - R&D Expenses: R&D expenses were $62.9 million for Q3 2025 and $169.7 million for the nine months ended September 30, 2025, up from $45.3 million and $116.6 million in 2024, attributed to increased clinical trial costs for barzolvolimab [15] - G&A Expenses: G&A expenses were $10.7 million for Q3 2025 and $31.9 million for the nine months ended September 30, 2025, compared to $10.1 million and $28.3 million in 2024, mainly due to higher stock-based compensation and employee headcount [16] - Net Loss: The net loss was $67.0 million, or ($1.01) per share, for Q3 2025, and $177.4 million, or ($2.67) per share, for the nine months ended September 30, 2025, compared to a net loss of $42.1 million, or ($0.64) per share, for Q3 2024 [17] Pipeline Developments - Barzolvolimab: This humanized monoclonal antibody has shown significant efficacy in treating chronic spontaneous urticaria (CSU) and cold urticaria, with 71% of patients achieving a complete response at 52 weeks in the Phase 2 CSU study [5][6] - Upcoming Studies: A global Phase 3 study for cold urticaria and symptomatic dermographism is set to begin in December 2025, following positive Phase 2 results [7] - CDX-622: The first stem cell factor neutralizing bispecific antibody studied in humans, showing promising Phase 1 data with a favorable safety profile [10][12] Corporate Updates - Leadership: Teri Lawver has joined Celldex as Senior Vice President, Chief Commercial Officer, bringing extensive experience in launching immunology drugs, which is expected to aid in the commercialization of barzolvolimab [2]

Core Insights - Celldex has appointed Teri Lawver as Senior Vice President and Chief Commercial Officer, succeeding Richard Wright who is retiring after over a decade of service [1][2] - Teri Lawver brings 30 years of experience in global healthcare, particularly in biopharmaceuticals and medical technology, with a strong background in immunology and inflammation [2][3] - Lawver's previous roles include Chief Commercial Officer at Dexcom, where she managed $4 billion in annual revenue, and significant positions at Johnson & Johnson, including Worldwide Vice President for Janssen Immunology [2] Company Overview - Celldex is focused on advancing immunology to develop novel antibody-based therapies aimed at improving outcomes for patients with allergic, inflammatory, and autoimmune disorders [3] - The company is preparing for the potential launch of barzolvolimab and is advancing its broader pipeline of therapies [2][3]

Group 1 - Celldex will participate in upcoming investor conferences, including the Guggenheim 2nd Annual Healthcare Innovation Conference on November 11, TD Cowen Immunology & Inflammation Summit on November 13, and the 8th Annual Evercore Healthcare Conference on December 2 [1][3] - Live webcasts of the presentations will be available on the "Events & Presentations" page of the Celldex website, with replays accessible for 90 days following each event [1] Group 2 - Celldex is focused on pioneering new therapies in immunology, particularly through novel antibody-based treatments aimed at improving the lives of patients with allergic, inflammatory, and autoimmune disorders [2]