Celldex Q2 2024 Financial Results and Corporate Update

Celldex Therapeutics, Inc. recently unveiled its financial performance for the second quarter ending June 30, 2024, alongside a comprehensive corporate update. The company has made significant strides in its clinical programs, particularly with barzolvolimab, a promising treatment for various forms of urticaria.

In July 2024, Celldex kicked off a global Phase 3 program for chronic spontaneous urticaria (CSU), involving two major trials, EMBARQ-CSU1 and EMBARQ-CSU2. These trials are geared towards validating the efficacy and safety of barzolvolimab in adult patients who remain symptomatic despite antihistamine treatment, including those unresponsive to biologics. Both trials are actively enrolling participants. Concurrently, the company completed Phase 2 studies of barzolvolimab in CSU and chronic inducible urticaria (CIndU), specifically targeting cold urticaria (ColdU) and symptomatic dermographism (SD). These Phase 2 trials showed that barzolvolimab achieved the primary efficacy endpoint and demonstrated rapid, durable, and clinically meaningful responses with a favorable safety profile.

Additionally, Celldex reported positive topline 12-week results from the Phase 2 CIndU study in July 2024, showing that barzolvolimab effectively managed symptoms in ColdU and SD patients. The complete 12-week data is expected in the second half of 2024.

In February 2024, Celldex shared 12-week treatment results from the Phase 2 CSU study at the AAAAI Annual Meeting. The primary efficacy endpoint was achieved, showing a significant mean change in the weekly urticaria activity score (UAS7) from baseline to Week 12 compared to placebo. Secondary and exploratory endpoints further supported these findings. The 52-week data from this study is projected for release in the latter half of 2024.

Barzolvolimab also showed noteworthy improvements in treating angioedema, with data presented at the EAACI Congress 2024, indicating statistically significant and durable improvements in the weekly angioedema activity score (AAS7) across all doses at Week 12.

Moreover, Celldex has broadened its research with ongoing Phase 2 trials in prurigo nodularis (PN) and eosinophilic esophagitis (EoE), initiated in early 2024 and July 2023, respectively. Enrollment is ongoing for these studies. The company aims to launch a Phase 2 trial for atopic dermatitis (AD) by the end of 2024, highlighting barzolvolimab’s potential to address moderate to severe AD cases where current systemic therapies are insufficient.

Celldex is also advancing its bispecific antibody platform, with CDX-622 set to enter clinical trials by the end of the year. CDX-622 targets chronic inflammation by neutralizing thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell factor (SCF) starvation. Preclinical studies have shown that CDX-622 effectively inhibits TSLP and SCF, and was well tolerated in multi-dose toxicology tests in non-human primates.

Financially, Celldex remains robust with over $800 million in cash, cash equivalents, and marketable securities as of June 30, 2024. This financial position supports the continued advancement of the barzolvolimab program and other pipeline projects.

For the second quarter of 2024, Celldex reported total revenue of $2.5 million, a significant increase from $0.3 million in the same period in 2023, driven primarily by manufacturing and R&D agreements with Rockefeller University. R&D expenses rose to $39.7 million, reflecting increased costs associated with barzolvolimab's clinical trials. General and administrative expenses also increased to $9.1 million, attributed to higher stock-based compensation and commercial planning costs for barzolvolimab. The net loss for the quarter was $35.8 million, compared to $30.5 million in the second quarter of 2023.

Celldex's financial guidance indicates sufficient funds to meet operational needs through 2027, ensuring the company's continued progress in developing transformative therapeutics for severe inflammatory and allergic diseases.