Raised $30M Convertible Note Extending Runway
Entered a USD 30 million convertible note purchase agreement (fixed 3% interest, semiannual cash payments from Sep 15, 2026, maturity Mar 2031) on Mar 19, 2026, strengthening the balance sheet ahead of potential U.S. approval and launch.
Cash Position and Debt Reduction
Cash and cash equivalents totaled SEK 677 million at quarter end; paid down NovaQuest debt by ~SEK 15 million in January and have no additional payment due until mid-2027.
Regulatory and Clinical Milestones Progressing
BLA review with FDA initiated and described as progressing 'as expected' with no unusual questions; PAES database lock expected next month; ConfIdeS Phase III data accepted for oral presentation at ATC in June; plan to file for full EMA approval in Q4 and PDUFA in December.
Promising Next-Generation Program (5487) and GBS Development
First-in-human study of HNSA-5487 completed: >95% reduction in circulating IgG within hours, clear dose–response for duration, lower anti-drug antibody response vs imlifidase, safe and well tolerated; briefing submitted to FDA for GBS program with clinical phase planned to start by year-end pending FDA feedback expected in May.
Commercial Preparations for U.S. Launch
Full commercial build planned in Q4; focused U.S. site strategy on top 100 centers (approx. 80% transplant volume) with 25 ConfIdeS centers representing ~25% of volume; market-access planning ongoing (NTAP and Outlier payment strategies) and distribution/supply-chain arrangements in progress.
European Market Access Wins and Operational Improvements
Secured regional reimbursement in Catalonia effective Apr 1 (first sale post-Q1); German KOL consensus recommendations rolled out and submitted for publication (expected mid-2026); implemented new commercial systems (CRM, dashboards) and pan-European physician education to improve transparency and performance.
Cost Control in R&D
R&D expense in Q1 2026 totaled ~SEK 57 million, reported as 11% (SEK 7 million) favorable versus Q1 2024 (attributed to wind-down of certain clinical activities and 2025 restructuring).