Ascelia Pharma (ACE) Q4 2024 earnings summary

Executive summary

• Orviglance completed pivotal Phase III (SPARKLE) with strong efficacy and safety, meeting primary and secondary endpoints with high statistical significance (p<0.001), advancing to NDA submission targeting mid-2025 and commercialization partnerships.

• Orviglance addresses an $800M global market for liver imaging in cancer patients with severe kidney impairment, with orphan drug designation from the FDA and high unmet need recognized by healthcare professionals.

• Oncoral, an oral irinotecan, is ready for phase II in gastric cancer, targeting a $3B market, with enrollment paused to prioritize Orviglance.

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

• Board strengthened with the addition of Marianne Koch, bringing global pharma expertise, and board changes proposed.

Financial highlights

• Q4 2024 operating loss was SEK 21.9 million, up from Q3 due to NDA preparation costs; full-year EBIT improved to -67.8 MSEK from -110.9 MSEK in 2023.

• Net loss for Q4 2024 was -28.3 MSEK; full-year net loss was -80.0 MSEK.

• Cash and cash equivalents at year-end were SEK 75–75.3 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 2025.

• No revenue recognized as products are not yet launched; other income mainly from currency gains.

Outlook and guidance

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

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

• Oncoral phase II study in gastric cancer to commence, with potential expansion to other solid tumors.

• Additional funding possible from warrants and partnerships, with TO1 warrants potentially adding up to 70 MSEK.

• Focus remains on regulatory approval and commercial launch preparations for Orviglance.