Ascelia Pharma (ACE) Q1 2026 earnings summary

Executive summary

• Orviglance, a liver MRI contrast agent for patients with severe kidney impairment, is advancing toward FDA approval with a PDUFA date set for July 3, 2026, supported by completed clinical development and strong Phase 3 data.

• Operational focus includes regulatory approval, commercialization readiness, and securing a partner, with multiple discussions ongoing.

• Oncoral, an oral irinotecan chemotherapy, is progressing in Phase 2 for gastric cancer, with a clinical collaboration established.

• Management changes include a new CFO and the departure of the Deputy CEO, alongside a SEK 20 million capital raise post-quarter to extend liquidity into 2027.

• Orviglance targets a global addressable market of USD 800 million, with a partner-driven commercialization strategy prioritizing the US.

Financial highlights

• Q1 2026 operating loss was SEK 17.2 million, an improvement from SEK 20.3 million in Q1 2025, mainly due to lower R&D and administrative costs.

• Net loss for Q1 2026 was SEK 16.4 million, with earnings per share at SEK -0.13.

• Liquid assets at quarter-end were SEK 33.9 million, with SEK 20 million raised in April 2026, extending the cash runway into 2027.

• Cash flow from operations was SEK -15.9 million in Q1 2026.

Outlook and guidance

• Orviglance is on track for potential FDA approval in July 2026, with commercial launch planned through partners and optimism about regulatory and partnering milestones.

• Partnership discussions are progressing, with multiple scenarios considered for timing relative to approval.

• Financial runway secured to support ongoing partnership talks and commercialization readiness.