Symbio's brincidofovir trial advances amidst revised earnings forecast

Symbio Pharmaceuticals Limited (TSE: 4582) announced the enrollment of the first patient in its global Phase Ib/II clinical trial evaluating injectable brincidofovir (IV BCV) for malignant lymphoma, specifically targeting NK/T-cell lymphoma and peripheral T-cell lymphoma. The multi-center trial, spanning Japan, Hong Kong, and Singapore, aims to enroll 15 patients by the end of 2025. This trial aims for early approval, targeting difficult-to-treat lymphomas where new therapies are needed. This milestone occurs as Symbio adjusts its earnings forecast for the fiscal year ending December 31, 2025, with projected net sales revised downwards to JPY1,400 million, a 24.7% decrease from the previous forecast. This revision is primarily due to the shift towards generic drugs and expanded treatment options impacting TREAKISYM® sales. While sales are expected to decline, Symbio has managed to slightly decrease the operating loss by JPY1 million. It also reaffirms ongoing commitments to other key clinical trials including Phase 3 for adenovirus infections and Phase 2 for CMV infections post-stem cell transplant. Despite the sales headwinds, Symbio continues strategic research partnerships focusing on key therapeutic areas for brincidofovir, including viral infections, blood cancers, and neurodegenerative diseases. The assumed exchange rate has been revised to USD 1 = JPY142.00.