Ascelia Pharma (ACE) Q3 2024 earnings summary

Executive summary

• Orviglance completed pivotal Phase III (SPARKLE) with strong results, meeting primary and secondary endpoints for improved liver lesion visualization in patients with severe kidney impairment, and is advancing to NDA submission preparation for a $800M global market opportunity.

• Oncoral, an oral irinotecan, is ready for phase II in gastric cancer, with IND approved in the US and a clinical collaboration with Taiho Oncology, targeting a $3B market, though enrollment is paused to prioritize Orviglance.

• Rights issue fully subscribed, raising SEK 105M, extending cash runway to late 2025, well beyond NDA submission.

• Orviglance data accepted for presentation at major scientific conferences, reinforcing clinical and market potential.

• Marianne Kock elected to board, bringing extensive pharma experience.

Financial highlights

• Q3 2024 operating loss was SEK 17.8M, slightly higher than Q2 due to NDA preparation costs.

• Liquid assets at end of September 2024 were SEK 96M, including rights issue proceeds.

• SEK 7.5M of convertible loan repaid; potential for SEK 70M additional funding via warrants in 2025.

• Net loss for Q3 2024 was SEK -21.7M; 9M 2024 net loss was SEK -51.7M.

• No revenue expected before product launch; net sales for Q3 and 9M 2024 were SEK 0.

Outlook and guidance

• NDA submission for Orviglance planned for mid-2025, with FDA pre-submission meeting outcome expected in Q1 2025.

• Standard FDA review period anticipated at 10 months post-submission.

• Commercialization strategy focuses on partnering, with ongoing dialogues and launch readiness activities.

• Cash runway extends to late 2025, excluding potential partner payments and warrant proceeds.

• Ongoing preparations for Orviglance market launch and continued development of Oncoral, with Phase 2 study ready to start.