Celldex Therapeutics (CLDX) investor relations material

Program and pipeline overview

• Lead asset Barzolvolimab (CDX-0159) is in Phase III for chronic spontaneous urticaria (CSU) and advancing in other urticaria subtypes, prurigo nodularis (PN), and atopic dermatitis (AD).

• Phase III CSU studies are global, enrolling 1,830 patients across 480 sites in over 40 countries.

• Upcoming data readouts include 20-week urticaria data in Q4 2024 and 44-week data in early 2026; Phase III studies in cold urticaria and symptomatic dermographism are planned to start late 2024 or early 2026.

• CDX-622, a bispecific antibody targeting TSLP and stem cell factor, is in healthy volunteer studies with initial data expected by year-end and further studies in 2026.

• Cash runway of $630 million is expected to fund operations through 2027 and into 2028, covering multiple key clinical milestones.

Clinical insights and differentiation

• Barzolvolimab demonstrated sustained complete response in 41% of CSU patients seven months post-treatment, a result considered unprecedented compared to existing therapies.

• Safety profile includes reversible KIT-related adverse events such as neutrophil drops and mild, reversible hair/skin color changes, which have not deterred patients or most clinicians.

• Rapid onset and durable effect distinguish Barzolvolimab from other treatments, with potential for long periods off therapy while maintaining response.

• Phase III CSU studies are designed to closely mirror successful Phase II trials, with the addition of a loading dose to enhance rapidity and depth of response.

• 93% of patients in prior studies experienced clinically meaningful change, supporting broad applicability across patient subtypes.

Market positioning and strategy

• Barzolvolimab is positioned to treat the full spectrum of CSU patients, including those refractory to antihistamines and Xolair-experienced individuals.

• Market opportunity for urticaria subtypes is significant, with overlapping patient populations managed by the same specialists.

• Anticipated to be used after Xolair, with flexibility to move earlier in the treatment paradigm depending on specialist preference and future data.

• Competing primarily with standard of care and leading therapies from Novartis and Sanofi, with other KIT programs considered less immediate competition.

• Pricing strategy will be informed by Phase III data, aiming for premium pricing if efficacy and safety are confirmed.