Ascelia Pharma (ACE) Q2 2024 earnings summary

Executive summary

• Orviglance completed pivotal Phase 3 SPARKLE study, meeting primary endpoint with strong statistical significance (P<0.001) for improved liver lesion visualization in patients with severe kidney impairment, with no serious adverse reactions and mild-to-moderate nausea as the most common side effect.

• Orviglance targets an $800 million annual global market, with half in the US, and is advancing toward FDA approval as an orphan drug.

• NDA submission for Orviglance is planned for mid-2025, with commercialization and partnering discussions ongoing.

• Rights issue of up to SEK 105 million, with SEK 70 million guaranteed, launched to fund NDA submission, commercialization, and partial loan repayment.

• Oncoral, an oral irinotecan chemotherapy, is Phase 2-ready for gastric cancer, with study start contingent on additional financing.

Financial highlights

• Q2 2024 operating loss was SEK 11.3 million, a decrease from Q1 2024 and a significant improvement from SEK 41.8 million in Q2 2023, reflecting cost-cutting.

• H1 2024 operating result was SEK -28.0 million, compared to SEK -78.5 million in H1 2023.

• Net loss for Q2 2024 was SEK -13.3 million; H1 2024 net loss was SEK -30.0 million.

• Liquid assets at end of June 2024 were SEK 29.8–30 million, including fully drawn loan and convertible financing.

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

Outlook and guidance

• NDA submission for Orviglance expected by mid-2025, with full clinical study report in early Q4 2024 and FDA pre-submission meeting conclusions by Q1 2025.

• Rights issue proceeds to fund NDA activities, commercialization readiness, and partial loan repayment.

• Commercial launch readiness and partnership agreements are top priorities, with a focused launch planned for the defined patient population.

• Oncoral Phase 2 study initiation is contingent on securing additional financing.