Successful Phase 3 ConfIdeS Trial Outcome
The Phase 3 ConfIdeS trial showed a strong p-value of 0.0001, indicating significant unmet medical need for highly sensitized patients. This supports the forthcoming BLA filing in the U.S.
U.S. Market Opportunity
The U.S. market represents a significant growth opportunity with 15,000 highly sensitized patients on the transplant waitlist and robust clinical data supporting a potential launch in the second half of 2026, subject to FDA approval.
Strong Cash Position
The company reported cash and cash equivalents of SEK 252.1 million, increasing to SEK 888 million including net proceeds from a recent capital raise.
Improved Gross Margin
The company's gross margin for the nine months ended September 30, 2025, was 60%, up from 50% for the same period in 2024.