Ascelia Pharma (ACE) Q3 2026 earnings summary

Executive summary

• FDA’s July CRL requires additional clinical evidence for Orviglance; after the September Type A meeting, prospective reanalysis of SPARKLE images with a new endpoint was identified as a potential alternative to a new-patient study.

• Priorities include FDA endpoint alignment, European regulatory feedback, Orviglance partnering, and cost-conscious Oncoral development and partnering.

• Q3 operating loss was SEK 10.4m; liquid assets were SEK 27.8m at 30 September, with runway into Q2 2027.

Financial highlights

• Q3 net sales were SEK 0; operating loss was SEK 10.4m versus SEK 15.3m, net loss SEK 10.3m versus SEK 15.7m, and EPS SEK -0.08 versus SEK -0.13.

• Q3 R&D costs were SEK 7.8m and SG&A SEK 2.6m; lower costs reflected NDA finalization and cost-saving initiatives.

• 9M operating loss was SEK 39.0m versus SEK 58.6m; net loss was SEK 38.7m versus SEK 60.4m.

• 9M R&D costs fell to SEK 30.1m from SEK 45.2m, and administrative costs to SEK 9.3m from SEK 13.2m, mainly following NDA completion and lower personnel costs.

• Liquid assets were SEK 27.8m at 30 September 2026 versus SEK 72.3m a year earlier; equity was SEK 79.7m versus SEK 114.4m.

Outlook and guidance

• FDA endpoint selection and acceptance are prerequisites for rereading SPARKLE images; a Type C interaction was planned to seek alignment, with further timing detail expected early next year.

• European regulatory dialogue will assess whether the current Orviglance data package supports approval; FDA has not confirmed whether a proposed U.S. path will be acceptable.

• Existing cash resources are assessed to fund operations into Q2 2027; full financing for the coming 12 months is not secured.

• Oncoral’s Phase 2 metastatic gastric cancer study is planned for ~100 patients, with a 2–2.5-year study period; start is pending.

• Orviglance partnering and Oncoral development preparations and partnering outreach will continue.