Ascelia Pharma (ACE) Q4 2024 earnings summary

Executive summary

• Orviglance completed pivotal Phase III (SPARKLE) with strong efficacy and safety, confirming statistically significant improvement in liver lesion visualization for patients with impaired kidney function, and is advancing to NDA submission targeting mid-2025.

• Orviglance addresses an $800M global market for liver imaging in cancer patients with severe kidney impairment and holds orphan drug designation from the FDA.

• Commercialization strategy for Orviglance focuses on partnering, with active discussions and launch readiness underway.

• Oncoral, an oral irinotecan, is ready for phase II in gastric cancer, with potential expansion to other solid tumors, but enrollment is paused to prioritize Orviglance.

• Board strengthened with the addition of Marianne Koch, bringing global pharma expertise.

Financial highlights

• Q4 2024 operating loss was SEK 21.9 million, higher than Q3 due to NDA preparation costs.

• Full year 2024 operating loss was SEK 67.8 million, improved from SEK 110.9 million in 2023, due to cost-cutting and completion of clinical activities.

• Net loss for 2024 was SEK 80.0 million, with earnings per share at SEK -1.48, improved from SEK -3.24 in 2023.

• Cash position at year-end was SEK 75.3 million, with a cash runway to late 2025, supported by a SEK 105 million rights issue in Q3.

• Additional potential SEK 70 million from TO1 series warrants in April.

Outlook and guidance

• NDA submission for Orviglance is on track for mid-2025, with pre-NDA FDA meeting conclusions expected in Q1.

• Commercial launch preparations and partnering for Orviglance are progressing, aiming for readiness upon approval.

• Cash runway extends to late 2025, with potential for further extension through warrants and partnering.