Ascelia Pharma (ACE) HC Andersen Life Science Seminar summary

Company overview and pipeline

• Focuses on developing novel drugs for rare cancer conditions, with two main programs: Orviglance and Oncoral.

• Orviglance is a first-in-class oral diagnostic for patients with cancer and renal disease, targeting an $800 million market.

• Oncoral is a daily tablet version of irinotecan for solid tumors, ready for phase II trials.

Orviglance clinical and regulatory progress

• Orviglance addresses unmet needs in vulnerable cancer patients with renal disease, supported by strong phase III data.

• Manufacturing scaled to commercial levels, with NDA submission planned for mid-2025.

• Phase III trial met all endpoints with high statistical significance, resolving prior reader variability issues.

• Full clinical study report expected early Q4, FDA meeting in Q1 2025, NDA submission by mid-2025.

Commercialization and market strategy

• U.S. market prioritized, representing nearly half of the global opportunity.

• Target market includes 50,000 patients and 100,000 procedures annually in the U.S., concentrated in 400 healthcare providers.

• Pricing benchmark for Orviglance is $3,000–$4,500 per dose, justified by improved safety and diagnostic value.

• Seeking commercial partners, open to both global and regional deals, with a focus on efficient market penetration.