BeyondSpring Inc. (NASDAQ: BYSI), a global clinical-stage biopharmaceutical company, has reported significant clinical progress for its first-in-class agent Plinabulin and strategic advancements for its subsidiary SEED Therapeutics in its 2024 year-end financial results.
Plinabulin Shows Survival Benefit in Lung Cancer
Plinabulin has demonstrated a statistically significant survival benefit in patients with second and third-line non-small cell lung cancer (NSCLC) with EGFR wild-type, according to Phase 3 data published in The Lancet Respiratory Medicine. This represents a significant advancement in a therapeutic area where no new treatments have been approved in over a decade.
"Plinabulin demonstrated a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a setting where no new therapies have been approved in over a decade," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.
The company is preparing for regulatory submission to the Chinese National Medical Products Administration (NMPA) and potentially other regulatory authorities based on these positive results.
Promising Results in Immunotherapy-Resistant Cancers
Beyond its direct anti-cancer effects, Plinabulin is showing promise as a next-generation immuno-oncology agent through its potent effect on dendritic cell maturation. An ongoing Phase 2 study (Study 303) demonstrated that Plinabulin, when combined with a PD-1 inhibitor and docetaxel, produced encouraging efficacy in metastatic NSCLC patients who had progressed on prior PD-1/PD-L1 inhibitors.
This finding is particularly significant as approximately 60% of patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors, representing a substantial unmet medical need in a market where PD-1 and PD-L1 antibody annual sales exceed $50 billion.
A separate Phase 1 investigator-initiated study at MD Anderson Cancer Center showed that Plinabulin in combination with PD-1/PD-L1 inhibitors and radiation therapy demonstrated encouraging data in re-sensitizing NSCLC, Head and Neck cancer, and Hodgkin's Lymphoma. Responding patients showed evidence of dendritic cell maturation, supporting the drug's mechanism of action.
SEED Therapeutics Advances in Targeted Protein Degradation
SEED Therapeutics, co-founded by BeyondSpring, made significant progress in 2024 with strategic partnerships and clinical advancements:
- Secured a research collaboration with Eisai Co., Ltd. to develop molecular glue degraders for oncology and neurodegenerative diseases, with potential payments to SEED of up to $1.5 billion
- Completed a $24 million first close of Series A-3 financing led by Eisai
- Achieved a third milestone in its ongoing R&D collaboration with Eli Lilly and Company
- Received recognition in two Nature review articles as a leading company in targeted protein degradation (TPD)
- Obtained Rare Pediatric Disease and Orphan Drug Designations from the FDA for its RBM39 degrader ST-01156
Financial Results and Future Outlook
For the full year 2024, BeyondSpring reported:
- R&D expenses of $2.6 million (down from $7.3 million in 2023)
- G&A expenses of $6.1 million (down from $7.8 million in 2023)
- Net loss of $8.9 million (improved from $14.0 million in 2023)
- Cash, cash equivalents, and short-term investments of $2.9 million as of December 31, 2024
To support further development of Plinabulin, 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, with a first closing of approximately $7.35 million completed in February 2025.
Key Milestones Expected in 2025
BeyondSpring has outlined several important milestones for 2025:
Plinabulin:
- First half of 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors
- Second half of 2025: Preliminary data from Phase 2 of Study 302 in first-line extensive-stage small-cell lung cancer (ES-SCLC)
SEED Therapeutics:
- Mid-2025: Expected Investigational New Drug (IND) filing of RBM39 degrader
- Second half of 2025: RBM39 degrader expected to begin patient enrollment
- Second half of 2025: Tau degrader expected to achieve in vivo efficacy
"With strongly anchored pipelines, key global partnerships and deliberate plans to navigate regulatory pathways, we believe BeyondSpring and SEED are well-positioned to drive transformative advancements in oncology and TPD in 2025," Dr. Lan Huang concluded.
About BeyondSpring and SEED Therapeutics
BeyondSpring is developing first-in-class therapies for high unmet medical needs, with its lead asset Plinabulin in late-stage clinical development as an anti-cancer agent in NSCLC and other cancer indications. Plinabulin's novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation.
SEED Therapeutics is pioneering targeted protein degradation with its proprietary RITE3™ platform, advancing novel molecular glue degraders across oncology, neurodegeneration, immunology, and virology. The company collaborates with Eli Lilly and Company and Eisai Co., Ltd. and is advancing its RBM39 degrader into clinical development.
