Ascelia Pharma reported a narrowed second-quarter loss of SEK 12 million as cost-cutting measures offset the impact of a U.S. Food and Drug Administration setback on its lead diagnostic candidate, Orviglance.
The Swedish biotech, listed on Nasdaq Stockholm’s main market, held SEK 38 million in cash at the end of June, following a SEK 20 million directed share issue in April. The company’s cash runway is projected to extend into Q2 2025 under a minimal-resubmission scenario. Shares traded at $0.58 on Friday, down 1.69% and well below its 52-week range of $0.455 to $5.13.
The FDA issued a Complete Response Letter (CRL) for Orviglance in early July, a liver MRI contrast agent targeting patients with severely impaired kidney function. The regulator’s concerns centered on clinical imaging interpretation and product quality specifications, rather than trial conduct or safety data, according to CEO Magnus Corfitzen.
Corfitzen described the CRL as unexpected, citing prior FDA communications, audits, and meetings that had suggested approval was likely. The agency’s inspections during the review process were completed without critical findings. Management emphasized that the core issue involves the justification of medical image re-reads and potential bias in reader training, not the integrity of the Phase III trial or data collection.
Orviglance, which holds U.S. Orphan Drug Designation providing seven years of market exclusivity, has commercial-scale manufacturing in place. The global addressable market for the product is estimated at $800 million, with roughly half in the U.S. Ascelia plans to address the FDA’s concerns in a Type A meeting scheduled for September 9, 2024, with meeting minutes expected within 30 days.
The company also noted a new patent application filed in late June covering Orviglance’s packaging and manufacturing processes. The biotech’s second program, Oncoral, a tablet-based irinotecan product for oncology, was not discussed in detail during the earnings call.
