CLDX

Key Points

• Anthony Marucci highlighted a strong 2021 with positive clinical data across programs and a follow-on offering securing the balance sheet, providing cash runway through end 2025.
• Tibor Keler discussed Phase 1 subcutaneous formulation study results in healthy volunteers, showing favorable safety profile, profound tryptase suppression, and no injection site reactions.
• Diane Young provided updates on pipeline programs, including plans for Phase 2 studies in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU) starting next quarter, expansion into eosinophilic esophagitis (EoE) with initiation planned in Q4 2022, and amendments to prurigo nodularis trial for efficiency.
• Completion of six-month chronic toxicology study in nonhuman primates supporting Phase 2 readiness for urticaria trials.

Forward-Looking Statements

• Cash runway through end of 2025 supported by $408 million cash at year-end 2021.
• Expected data readout from CSU multi-dose study for late-breaking presentation at EAACI 2022 in July.
• Phase 2 trials in CSU and CIndU to initiate next quarter, with doses of 75mg, 150mg every 4 weeks and 300mg every 8 weeks planned.
• Initiation of Phase 2 study in EoE in Q4 2022.

No detailed financial performance by product segments provided in the transcript.

Risks Identified

• Potential toxicities observed in nonhuman primate studies related to spermatogenesis, though reversibility expected based on literature.
• Uncertainties in clinical trial outcomes, including patient enrollment and response rates in certain urticaria subtypes.
• Regulatory risks associated with obtaining approvals for new indications and formulations.

Q&A Exchanges

• Q: About Phase 1b data for EAACI, including refractory patients and 4.5 mg cohort.

A: Diane Young responded that refractory patients are included and 4.5 mg data is not needed to move forward.

• Q: Heme profile with subcu vs IV dosing.

A: Margo Heath-Chiozzi discussed similar heme profiles with mild decreases in neutrophils and white blood cell counts, within normal ranges.

• Q: Biomarkers for EoE.

A: Diego Alvarado explained mutual regulation of mast cells and eosinophils, with IL-5 playing a role in recruitment, and biopsies to assess tissue mast cells in EoE.

• Q: Cholinergic urticaria inclusion in registrational study.

A: Diane Young stated focusing on common forms (cold and symptomatic dermographism) but potential inclusion in Phase 3.

• Q: Reproductive preclinical studies.

A: Tibor Keler discussed ongoing studies and expectation of reversibility of spermatogenesis effects upon drug clearance.

• Q: Tech transfer for CDMO of CDX-0159.

A: Anthony Marucci said the transfer has started and will complete later in the year.

• Q: Subcutaneous administration for 0159.

A: Anthony Marucci and Diane Young discussed eventual self-administration, starting with professional administration in trials.

• Q: Relationship between mast cells and eosinophils in EoE.

A: Diego Alvarado explained mast cells secrete IL-5, recruiting eosinophils, and preclinical evidence of 0159 reducing eosinophil infiltration.