Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Celldex Therapeutics (NASDAQ:CLDX) reported Q2 2025 financial results and pipeline updates. The company's lead drug barzolvolimab demonstrated exceptional results in Phase 2 chronic spontaneous urticaria (CSU) studies, with up to 41% of patients maintaining complete response 7 months after treatment completion.
Financial highlights include $630.3 million in cash reserves (sufficient through 2027), Q2 net loss of $56.6 million ($0.85 per share), and increased R&D expenses of $54.2 million. The company is advancing its global Phase 3 program in CSU with two trials enrolling approximately 915 patients each.
Multiple data readouts are expected in 2H 2025, including results from Phase 2 studies in eosinophilic esophagitis (EoE) and chronic inducible urticaria (CIndU), along with Phase 1 data from CDX-622 in healthy volunteers.
Celldex Therapeutics (NASDAQ:CLDX) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornamenti sul pipeline. Il farmaco principale dell'azienda, barzolvolimab, ha mostrato risultati eccezionali negli studi di Fase 2 sull'orticaria cronica spontanea (CSU), con fino al 41% dei pazienti che ha mantenuto una risposta completa fino a 7 mesi dopo il termine del trattamento.
Tra i dati finanziari si evidenziano 630,3 milioni di dollari in riserve di cassa (sufficienti fino al 2027), una perdita netta nel Q2 di 56,6 milioni di dollari (0,85 dollari per azione) e un aumento delle spese in R&S a 54,2 milioni di dollari. L'azienda sta portando avanti il programma globale di Fase 3 per la CSU con due studi che stanno arruolando circa 915 pazienti ciascuno.
Nel secondo semestre del 2025 sono previsti diversi dati clinici, inclusi i risultati degli studi di Fase 2 su esofagite eosinofila (EoE) e orticaria cronica inducibile (CIndU), oltre ai dati di Fase 1 di CDX-622 su volontari sani.
Celldex Therapeutics (NASDAQ:CLDX) inform贸 los resultados financieros del segundo trimestre de 2025 y actualizaciones de su pipeline. El f谩rmaco principal de la compa帽铆a, barzolvolimab, mostr贸 resultados excepcionales en estudios de Fase 2 para urticaria cr贸nica espont谩nea (CSU), con hasta un 41% de los pacientes manteniendo una respuesta completa 7 meses despu茅s de finalizar el tratamiento.
Los aspectos financieros incluyen 630,3 millones de d贸lares en reservas de efectivo (suficientes hasta 2027), una p茅rdida neta en el Q2 de 56,6 millones de d贸lares (0,85 d贸lares por acci贸n) y un aumento en gastos de I+D de 54,2 millones de d贸lares. La compa帽铆a est谩 avanzando en su programa global de Fase 3 para CSU con dos ensayos que est谩n inscribiendo aproximadamente 915 pacientes cada uno.
Se esperan m煤ltiples resultados de datos en la segunda mitad de 2025, incluyendo resultados de estudios de Fase 2 en esofagitis eosinof铆lica (EoE) y urticaria cr贸nica inducible (CIndU), junto con datos de Fase 1 de CDX-622 en voluntarios sanos.
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鞛 頃橃澊霛检澊韸鸽電� 6鞏� 3,030毵� 雼煬鞚� 順勱笀 氤挫湢鞎�(2027雲勱箤歆� 於╇秳), 2攵勱赴 靾滌啇鞁� 5,660毵� 雼煬(欤茧嫻 0.85雼煬), 鞐瓣惮臧滊皽牍� 歃濌皜 5,420毵� 雼煬臧� 韽暔霅╇媹雼�. 須岇偓電� 鞎� 915氇呾敥 霊� 臧滌潣 鞛勳儊鞁滍棙鞚� 歆勴枆頃橂姅 CSU 旮�搿滊矊 3靸� 頂勲攴鸽灗鞚� 於旍 欷戩瀰雼堧嫟.
2025雲� 頃橂皹旮办棎電� 順胳偘甑� 鞁濍弰鞐�(EoE) 氚� 毵岇劚 鞙犽皽 霊愲摐霟赴(CIndU) 2靸� 鞐瓣惮 瓴瓣臣鞕� 瓯搓皶頃� 歆�鞗愳瀽毳� 雽�靸侅溂搿� 頃� CDX-622 1靸� 雿办澊韯� 霌� 雼れ垬鞚� 雿办澊韯� 氚滍憸臧� 鞓堨爼霅橃柎 鞛堨姷雼堧嫟.
Celldex Therapeutics (NASDAQ:CLDX) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 ainsi que des mises 脿 jour sur son pipeline. Le m茅dicament principal de la soci茅t茅, barzolvolimab, a d茅montr茅 des r茅sultats exceptionnels lors des 茅tudes de phase 2 sur l'urticaire chronique spontan茅e (CSU), avec jusqu'脿 41 % des patients maintenant une r茅ponse compl猫te 7 mois apr猫s la fin du traitement.
Les points financiers cl茅s incluent 630,3 millions de dollars de r茅serves de tr茅sorerie (suffisantes jusqu'en 2027), une perte nette au T2 de 56,6 millions de dollars (0,85 dollar par action) et une augmentation des d茅penses en R&D 脿 54,2 millions de dollars. La soci茅t茅 fait progresser son programme mondial de phase 3 en CSU avec deux essais recrutant environ 915 patients chacun.
Plusieurs r茅sultats de donn茅es sont attendus au second semestre 2025, notamment les r茅sultats des 茅tudes de phase 2 dans l'艙sophagite 脿 茅osinophiles (EoE) et l'urticaire chronique induite (CIndU), ainsi que les donn茅es de phase 1 de CDX-622 chez des volontaires sains.
Celldex Therapeutics (NASDAQ:CLDX) ver枚ffentlichte die Finanzergebnisse f眉r das zweite Quartal 2025 sowie Updates zur Pipeline. Das f眉hrende Medikament des Unternehmens, barzolvolimab, zeigte herausragende Ergebnisse in Phase-2-Studien zur chronischen spontanen Urtikaria (CSU), wobei bis zu 41 % der Patienten sieben Monate nach Behandlungsende eine vollst盲ndige Remission aufrechterhielten.
Zu den finanziellen Highlights z盲hlen 630,3 Millionen US-Dollar an Barreserven (ausreichend bis 2027), ein Nettoverlust im Q2 von 56,6 Millionen US-Dollar (0,85 US-Dollar je Aktie) sowie gestiegene F&E-Ausgaben von 54,2 Millionen US-Dollar. Das Unternehmen treibt sein globales Phase-3-Programm bei CSU mit zwei Studien voran, die jeweils etwa 915 Patienten einschreiben.
F眉r die zweite H盲lfte des Jahres 2025 werden mehrere Datenauswertungen erwartet, darunter Ergebnisse aus Phase-2-Studien zu eosinophiler 脰sophagitis (EoE) und chronischer induzierbarer Urtikaria (CIndU) sowie Phase-1-Daten von CDX-622 an gesunden Freiwilligen.
- Strong Phase 2 CSU results with 41% of patients maintaining complete response 7 months post-treatment
- Robust cash position of $630.3M sufficient through 2027
- Phase 3 CSU program actively enrolling with clear development pathway
- Multiple catalyst readouts expected in H2 2025 across pipeline
- Up to 77% of CSU patients with angioedema became symptom-free at Week 52
- Increased net loss to $56.6M in Q2 2025 vs $35.8M in Q2 2024
- Revenue decreased to $0.7M in Q2 2025 from $2.5M in Q2 2024
- R&D expenses increased 36.5% to $54.2M in Q2 2025
- G&A expenses rose to $10.4M from $9.1M year-over-year
Insights
Celldex reports promising Phase 2 results for barzolvolimab in CSU, with strong durability and Phase 3 trials progressing well.
Celldex's lead asset barzolvolimab is demonstrating exceptional clinical performance in chronic spontaneous urticaria (CSU), with 41% of patients maintaining complete response 7 months after treatment cessation in their Phase 2 trial. This remarkable durability distinguishes it from current biologics which typically require continuous dosing. The correlation between symptom relief and improved quality of life (48% reporting disease no longer impacts QoL) strengthens the clinical value proposition.
The company's execution on their pipeline is impressive, with two Phase 3 CSU trials (EMBARQ-CSU1 and EMBARQ-CSU2) actively enrolling approximately 915 patients each across 40 countries. These trials include patients who failed current biologics, potentially positioning barzolvolimab as both a first-line and rescue therapy. The planned long-term extension study with a retreatment arm is particularly noteworthy as it will provide critical data on the drug's repeated efficacy profile.
Beyond CSU, Celldex is strategically expanding barzolvolimab into multiple mast cell-driven diseases including chronic inducible urticaria (CIndU), eosinophilic esophagitis (EoE), prurigo nodularis (PN), and atopic dermatitis (AD). This represents a potential multi-billion dollar market opportunity across several inflammatory conditions with significant unmet needs.
Their second platform asset, the bispecific antibody CDX-622 targeting both SCF and TSLP, represents an innovative approach to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses. Initial healthy volunteer data expected in H2 2025 will be crucial for validating this mechanism.
With $630.3 million in cash providing runway through 2027, Celldex is well-positioned to advance these programs through critical development milestones without immediate financing pressure.
Celldex's strong financial position and promising clinical data support continued pipeline advancement despite increasing quarterly losses.
Celldex's financial profile reveals the classic biotech model of significant R&D investment preceding commercialization. Their $630.3 million cash position provides approximately 2.5 years of runway at current burn rates, offering substantial breathing room through key inflection points. The quarter-over-quarter decrease of $43 million indicates an annualized burn rate approaching $172 million, accelerating as Phase 3 programs advance.
R&D expenses increased 36.5% year-over-year to $54.2 million for the quarter, primarily driven by the barzolvolimab clinical and manufacturing scale-up. This escalation is entirely expected given the transition to late-stage development with two parallel Phase 3 trials enrolling across 500 sites globally. The infrastructure necessary to support this expansion justifies the 14.3% increase in G&A expenses year-over-year.
Revenue remains minimal at $0.7 million, down from $2.5 million in Q2 2024, highlighting Celldex remains years from product commercialization. The company posted a net loss of $56.6 million ($0.85 per share), compared to $35.8 million ($0.54 per share) in Q2 2024 鈥� a 58% increase in net loss.
Despite widening losses, Celldex's financial strategy appears sound given their promising clinical data. The broader pipeline expansion beyond CSU into multiple indications creates multiple shots on goal, diversifying risk while leveraging their understanding of mast cell biology. The advancement of CDX-622 further enhances their portfolio value.
For a clinical-stage biotech with multiple late-stage assets, Celldex maintains a solid balance sheet that should support them through key clinical milestones and potential partnership discussions without immediate financing pressure.
- Strong execution and continued progress across pipeline
- Unprecedented data delivered from Phase 2 CSU study demonstrating profound, sustained complete response and improved quality of life 7 months after completion of barzolvolimab dosing
- Data anticipated from Phase 2 studies of barzolvolimab in EoE and CIndU and Phase 1 study of CDX-622 in healthy volunteers in 2H 2025
HAMPTON, N.J., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2025 and provided a corporate update.
"In the second quarter of 2025, data from our now completed Phase 2 study in chronic spontaneous urticaria were presented that we believe clearly show that barzolvolimab is best in disease and achieves the goal of treatment for patients and physicians鈥攔apid, profound, durable complete response which is correlated with meaningful improvements in quality of life,鈥� said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. 鈥淭he Celldex team is working diligently to bring this important medicine to patients and we remain focused on executing across our Phase 3 program in CSU, which is on track and expected to be fully enrolled next summer.鈥�
鈥淭he second half of the year will bring additional important data readouts from our barzolvolimab Phase 2 studies in CIndU and EoE and our CDX-622 Phase 1 study in healthy volunteers and we look forward to sharing our continued progress.鈥�
Recent Program Highlights
Barzolvolimab - KIT Inhibitor Program
Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.听
Chronic Urticarias
Phase 3 Development
- A consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) was initiated in July and enrollment is ongoing. The studies are designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and also include patients who remain symptomatic after treatment with biologics. EMBARQ-CSU1 and EMBARQ-CSU2 will enroll approximately 915 patients each across approximately 40 countries and 500 sites. In addition, Celldex plans to initiate a global Phase 3b long term extension (LTE) study for patients who complete the EMBARQ-CSU Phase 3 trials. The study will consist of 2 Groups: Group 1 (Observation Group), containing patients whose disease remains well controlled (UAS7<16) and Group 2 (Barzolvolimab Retreatment Group) containing patients whose disease is currently moderate to severe (UAS7鈮�16). Patients in Group 2 will receive up to an additional year of treatment with barzolvolimab. Patients in the observation group (Group 1) whose CSU flares to a UAS7>/=16 in the first 6 months of the LTE will also be able to receive treatment.
- The Company is currently planning a global Phase 3 program in chronic inducible urticaria (CIndU), which is expected to initiate in 2H 2025.
Phase 2 Development
- Barzolvolimab met all primary and secondary endpoints at 12 weeks across the Company鈥檚 Phase 2 studies in and . Results were highly statistically significant and clinically meaningful.
- , which includes 24-weeks of off-treatment follow-up, from the Phase 2 study in CSU were presented in a late breaking oral presentation in June at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025. Seven months after completion of dosing, patients continued to experience profound clinical benefit, with up to
41% of patients reporting a complete response at 76 weeks and48% of patients reporting that their disease no longer impacted their quality of life. Barzolvolimab demonstrated a well tolerated safety profile throughout the study. - on the impact of barzolvolimab on angioedema symptoms in the Phase 2 CSU study were also presented at EAACI. Up to
77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema free (AAS7=0) at Week 52 and patients treated with barzolvolimab were angioedema free up to72% of the time over the 52 week treatment period. - 20 week treatment data from the Phase 2 CIndU study will be presented later this year. After completing treatment, patients on study are followed for 24 weeks and patients with returning symptoms can enter an open label extension during the follow up period.
- , which includes 24-weeks of off-treatment follow-up, from the Phase 2 study in CSU were presented in a late breaking oral presentation in June at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025. Seven months after completion of dosing, patients continued to experience profound clinical benefit, with up to
Additional Indications
- Enrollment is complete in the Phase 2 study in eosinophilic esophagitis (EoE) and data from this study (12 week analysis) are expected in 2H 2025. This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with active EoE.
- Enrollment continues in the Phase 2 study in prurigo nodularis (PN). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe PN.
- Enrollment is ongoing in the Phase 2 study in atopic dermatitis (AD). This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD.
Bispecific Antibody Platform
CDX-622 鈥� Bispecific SCF & TSLP
CDX-622 targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Combined neutralization of SCF and TSLP with CDX-622 is expected to simultaneously reduce tissue mast cells and inhibit Type 2 inflammatory responses to potentially offer enhanced therapeutic benefit in inflammatory and fibrotic disorders.
- Enrollment is ongoing in the Phase 1 study in healthy volunteers. This two-part randomized, double-blind, placebo-controlled, dose escalation study is designed to assess the safety, pharmacokinetics, and pharmacodynamics of single ascending doses (Part 1) and multiple ascending doses (Part 2) of CDX-622 in up to 56 healthy participants. The pharmacodynamic biomarkers from blood and skin will be highly informative on the ability of CDX-622 to engage and neutralize SCF and TSLP. Data from Part 1 of the study are expected in 2H 2025.
Second Quarter 2025 Financial Highlights and 2025 Guidance
Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2025 were
Revenues: Total revenue was
R&D Expenses: Research and development (R&D) expenses were
G&A Expenses: General and administrative (G&A) expenses were
Net Loss: Net loss was
Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2025 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.听Visit .
Forward-Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
Patrick Till
Meru Advisors
(484) 788-8560
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| Research and development | 听 | 54,196 | 听 | 听 | 听 | 39,687 | 听 | 听 | 听 | 106,810 | 听 | 听 | 听 | 71,348 | 听 |
| General and administrative | 听 | 10,391 | 听 | 听 | 听 | 9,128 | 听 | 听 | 听 | 21,211 | 听 | 听 | 听 | 18,231 | 听 |
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| Total operating expenses | 听 | 64,587 | 听 | 听 | 听 | 48,815 | 听 | 听 | 听 | 128,021 | 听 | 听 | 听 | 89,579 | 听 |
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| Investment and other income, net | 听 | 7,257 | 听 | 听 | 听 | 10,475 | 听 | 听 | 听 | 16,201 | 听 | 听 | 听 | 18,275 | 听 |
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| Net loss | $ | (56,600 | ) | 听 | $ | (35,842 | ) | 听 | $ | (110,396 | ) | 听 | $ | (68,650 | ) |
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| Basic and diluted net loss per common share | $ | (0.85 | ) | 听 | $ | (0.54 | ) | 听 | $ | (1.66 | ) | 听 | $ | (1.10 | ) |
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| Shares used in calculating basic and diluted net loss per share | 听 | 66,392 | 听 | 听 | 听 | 66,019 | 听 | 听 | 听 | 66,388 | 听 | 听 | 听 | 62,445 | 听 |
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| Cash, cash equivalents and marketable securities | $ | 630,337 | 听 | 听 | $ | 725,281 | 听 | 听 | |||||||
| Other current assets | 听 | 18,067 | 听 | 听 | 听 | 21,878 | 听 | 听 | |||||||
| Property and equipment, net | 听 | 4,392 | 听 | 听 | 听 | 4,346 | 听 | 听 | |||||||
| Intangible and other assets, net | 听 | 39,611 | 听 | 听 | 听 | 40,835 | 听 | 听 | |||||||
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| Stockholders' equity | 听 | 655,406 | 听 | 听 | 听 | 747,005 | 听 | 听 | |||||||
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FAQ
What were the key findings from Celldex's Phase 2 CSU trial for barzolvolimab?
What is CLDX's financial position as of Q2 2025?
How many patients will Celldex's Phase 3 CSU trials enroll?
What major clinical trial results is CLDX expecting in second half of 2025?
How did Celldex's R&D expenses change in Q2 2025?
