BeyondSpring (NASDAQ:BYSI), a clinical-stage biopharmaceutical company focused on transformative cancer therapies, today announced its financial results for the fiscal year ended December 31, 2025.
The year was defined by critical regulatory and clinical milestones for its lead asset, plinabulin, and the successful transition of its subsidiary, SEED Therapeutics, into a clinical-stage entity.
A major highlight of the year was the confirmed Phase 3 success of the DUBLIN-3 study, which evaluated plinabulin in combination with docetaxel for second- and third-line non-small cell lung cancer (NSCLC) in patients with EGFR wild-type tumors.
The trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) with a hazard ratio of 0.72 (p=0.0078) and a median OS increase of 2.5 months compared to docetaxel alone.
Notably, the combination also reduced the incidence of Grade 4 neutropenia to 5%.
Based on these results and subsequent FDA discussions, BeyondSpring is advancing DUBLIN-4 (NCT07361484), a confirmatory global Phase 3 study.
Strategic progress also accelerated at SEED Therapeutics, in which BeyondSpring maintains a significant equity interest.
SEED recently initiated a Phase 1a clinical trial in January 2026 for its lead oncology program, ST-01156.
A first-in-class oral RBM39 "molecular glue" degrader, ST-01156 is being investigated for aggressive cancers, including Ewing Sarcoma.
To support its clinical expansion, SEED completed a $30 million Series A-3 financing and strengthened its leadership team with the appointment of Dr. Bill Desmarais as CFO and CBO.
Financially, BeyondSpring reported a cash and cash equivalents balance of $12.6 million as of December 31, 2025.
Following a strategic agreement in early 2025 to sell a portion of its Series A-1 preferred shares in SEED, BeyondSpring now reports SEED’s financial results as discontinued operations.
This move, which provided nearly $35.4 million in gross proceeds, has allowed the company to refocus its capital on the late-stage development and regulatory pathway for plinabulin.