On March 25, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported its financial results for the year ended December 31, 2025, and highlighted late-stage clinical progress for Plinabulin and strategic developments related to its equity interest in SEED Therapeutics ("SEED").
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2025: Clinical and Operational Progress
"2025 was a year of important clinical and operational progress for BeyondSpring and SEED Therapeutics," said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. "We advanced our Phase 3 Plinabulin program, generated meaningful clinical data, and strengthened our strategic and financial position."
"BeyondSpring made meaningful progress advancing Plinabulin in Phase 3 NSCLC, while SEED Therapeutics reached a critical milestone — initiating its first clinical trial following IND clearance in both the U.S. and China — and strengthened its leadership team and capital resources."
Positioned for 2026 and Beyond
"With a solid scientific and clinical foundation and clear regulatory pathways, we believe BeyondSpring and SEED are well positioned for the next stage of development," Dr. Huang concluded. "As we enter 2026, we remain focused on advancing the DUBLIN-4 confirmatory trial for Plinabulin in non-squamous EGFR wild-type NSCLC post immune checkpoint inhibitors, supporting SEED’s Phase 1a clinical program for ST-01156 in solid tumors, and creating long-term value for our shareholders."
Recent Clinical and Business Updates
Plinabulin Demonstrates Overall Survival Benefit in Phase 3 NSCLC Study; Confirmatory Trial Planned
There is a significant unmet need in EGFR wild-type NSCLC following immune checkpoint inhibitor (ICI) therapy, where numerous Phase 3 studies have failed to improve overall survival over standard of care docetaxel.
BeyondSpring reported positive Phase 3 results from the DUBLIN-3 study evaluating plinabulin in combination with docetaxel in second- and third-line (2/3L) EGFR wild-type non-small cell lung cancer (NSCLC). The study demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to docetaxel alone (ITT, n=559), with results published in The Lancet Respiratory Medicine.
At IASLC North America and ESMO (Free ESMO Whitepaper) Asia in December 2025, BeyondSpring presented updated data from the mechanism-targeted non-squamous NSCLC population (n=332; 24-month after database lock), in which the combination achieved:
OS hazard ratio (HR) of 0.72 (p=0.0078)
Median OS improvement of 2.5 months vs. docetaxel
Doubling of 2-year and 3-year survival rates
Favorable safety profile, reducing grade 4 neutropenia from >30% to 5% (p<0.0001)
To date, over 700 patients have been treated with plinabulin across clinical studies, supporting the characterization of its safety and tolerability profile.
Based on these findings and discussions with the U.S. FDA, BeyondSpring plans to initiate the global Phase 3 DUBLIN-4 confirmatory study, focusing on a mechanism-enriched patient population of EGFR wild-type non-squamous NSCLC progressed on prior PD-1/L1 inhibitors with overall survival as the primary endpoint (NCT07361484).
Plinabulin Shows Potential to Overcome PD-1/PD-L1 Resistance
Emerging clinical data suggests plinabulin may help address acquired resistance to PD-1/PD-L1 therapies — a major challenge affecting approximately 60% of patients, with limited therapies for these progressed patients. With PD-1/PD-L1 therapies representing a multi-billion-dollar market, addressing resistance remains one of the most significant opportunities in oncology.
Presentations at ASCO (Free ASCO Whitepaper) 2025 and SITC (Free SITC Whitepaper) 2025 on multiple early-stage and investigator-initiated studies of Plinabulin combinations:
Plinabulin + pembrolizumab + docetaxel (303 study, NCT05599789): A Phase 2 study conducted at Peking Union Hospital in China in metastatic NSCLC patients progressing on PD-1/PD-L1 inhibitors (n=47) demonstrated:
Median progression-free survival (PFS) of 7.0 months
Disease control rate (DCR) of 85% and overall response rate (ORR) of 18.2%
Median OS not reached with 24-month overall survival rate of 66%
Whole blood analysis indicated higher proportions of activated CD4+/CD8+ T-cells post treatment
Plinabulin + PD-1 inhibitor + radiation (NCT04902040): A Phase 1 study conducted at MD Anderson Cancer Center across eight tumor types resistant to checkpoint inhibitors showed:
DCR of 54% and ORR of 23%
Mechanistic evidence of dendritic cell maturation and immune activation
Identification of a potential predictive biomarker (GEF-H1 immune signature)
These findings, published in Med 2025 (Cell Press), support plinabulin’s proposed immune-priming mechanism and its potential role in combination strategies to restore tumor sensitivity to immunotherapy
BeyondSpring Business Update
In January 2025, BeyondSpring entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million was completed in February 2025.
SEED Therapeutics (Reported as Discontinued Operations) Advances First Clinical Program and Strengthens Organization
SEED Therapeutics continued to make progress in 2025 and early 2026, advancing its targeted protein degradation platform and pipeline.
Key highlights include:
ST-01156, a novel oral RBM39 degrader:
Received U.S. FDA Orphan Drug and Rare Pediatric Disease Designations
Achieved IND clearance in both the U.S. and China
Dosed first patient in a Phase 1a study in January 2026
ST-01156 Phase 1a enrolling at leading U.S. cancer centers: Dana-Farber, Massachusetts General Hospital, Memorial Sloan Kettering, MD Anderson Cancer Center, Hoag, and City of Hope
Presentation at AACR (Free AACR Whitepaper) 2025 on ST-01156 mechanism and preclinical studies including complete tumor regression in Ewing sarcoma and other cancer models; new degrader approaches in KRAS G12D degradation
SEED Business Update
Completed a $30 million Series A-3 financing
Appointed Dr. Bill Desmarais as Chief Financial Officer and Chief Business Officer
Named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award
Full-Year 2025 Financial Resultsˆ
Continuing operations:
R&D expenses: $4.4 million (vs. $2.6 million in 2024), driven by increased drug manufacturing, NSCLC data management, Plinabulin combination research, regulatory consulting, and personnel costs
G&A expenses: $4.6 million (vs. $6.1 million in 2024), driven by lower personnel costs, reduced consulting expenses, and lower corporate overhead
Net loss: $8.7 million (vs. $8.9 million in 2024)
Cash, cash equivalents, and short-term investments: $12.6 million as of December 31, 2025
Discontinued operations:
Net loss: $5.5 million (vs. $7.8 million in 2024)
Current assets: $8.0 million as of December 31, 2025
Note 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes.
(Press release, BeyondSpring Pharmaceuticals, MAR 25, 2026, View Source [SID1234663898])