On March 27, 2025 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, reported its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments (Press release, BeyondSpring Pharmaceuticals, MAR 27, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-2024-year-end-financial-results-and-highlights-key-clinical-strategic-milestones [SID1234651519]).

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"2024 was a pivotal year for BeyondSpring, with significant clinical progress for our first-in-class agent Plinabulin and strategic advancements for SEED Therapeutics (SEED), which BeyondSpring co-founded and owns an equity stake in. We believe these developments create value benefiting all stakeholders," said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring.

"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. This Phase 3 data, now published in The Lancet Respiratory Medicine, strengthens our regulatory strategy as we prepare for submission to the Chinese National Medical Products Administration (NMPA) and potentially regulatory authorities in other jurisdictions."

"BeyondSpring is also advancing Plinabulin’s potential as a next-generation immuno-oncology agent, with its potent effect in dendritic cell maturation. An ongoing Phase 2 study showed that Plinabulin, in combination with a PD-1 inhibitor and docetaxel, produced promising efficacy in patients with metastatic NSCLC who had progressed on prior PD-1/PD-L1 inhibitors with good tolerability. While PD-1 and PD-L1 antibody annual sales have exceeded $50 billion, with most sales coming from lung cancer, 60% of patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors, which we believe represents a significant opportunity for Plinabulin to impact the treatment landscape and create substantial value."

"SEED also made significant progress in 2024, securing a strategic research collaboration with Eisai Co., Ltd. ("Eisai"), a second global pharma partnership in addition to the Eli Lilly and Company ("Lilly") partnership. Under this collaboration, SEED will be eligible to receive upfront payments and potential preclinical, clinical, regulatory and sales milestone payments of up to $1.5 billion, plus tiered royalties on net sales. In parallel, SEED is advancing its internal lead oncology asset, RBM39 degrader, toward clinical development. SEED’s recognition in two Nature review papers as a leader in targeted protein degradation (TPD), along with recent granting of Rare Pediatric Disease and Orphan Drug Designations by the FDA for its RBM39 degrader ST-01156, further underscore its unique platform and reinforce its leadership in this emerging field."

"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.

Recent Clinical and Business Updates
Plinabulin Clinical Updates
Plinabulin Phase 3 Data Published in The Lancet Respiratory Medicine and Presented at the IASLC 2024 conference
Demonstrated a statistically significant overall survival, PFS and ORR benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard-of-care docetaxel.
Supports planned regulatory submissions to NMPA and potentially regulatory authorities in other jurisdictions.
Plinabulin Combination Therapy in multiple cancers which failed PD-1/PD-L1 therapies at MD Anderson Cancer Center
Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation showed encouraging data in re-sensitizing NSCLC, Head and Neck cancer, and Hodgkin’s Lymphoma.
Responding patients showed dendritic cell maturation.
Plinabulin Combination Therapy in NSCLC
Ongoing Phase 2 investigator-initiated study (Study 303) of Plinabulin + PD-1 inhibitor + Docetaxel showed encouraging efficacy and safety outcomes in metastatic NSCLC patients who had progressed on prior PD-1/PD-L1 inhibitors.
Supports Plinabulin’s potential to resensitize tumors to checkpoint inhibitors.
Other Ongoing Clinical Trial
Enrolled first patient in a Phase 2 investigator-initiated study (Study 302) of Plinabulin + PD-1 inhibitor + Etoposide/Platinum (EP) for first-line extensive-stage small-cell lung cancer (ES-SCLC).d
BeyondSpring Business Update
Entered into definitive agreements to sell a portion of BeyondSpring’s 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 completed in February 2025.
SEED Updates
Strategic Collaborations & Financing
Research collaboration with Eisai to develop molecular glue degraders for oncology and neurodegenerative diseases with potential payments to SEED of up to $1.5 billion.
$24 million Series A-3 financing first close, led by Eisai.
Achieved third milestone with Lilly R&D collaboration.
Industry Recognition & FDA Designations
SEED was recognized in two Nature review articles as a leading company in TPD.
Received Rare Pediatric Disease and Orphan Drug Designations from the FDA for RBM39 degrader ST-01156, reinforcing its potential as a breakthrough therapy for hard-to-treat cancers.
Full-Year 2024 Financial Results1
Continuing operations:

R&D expenses: $2.6 million (vs. $7.3 million in 2023), reflecting completion ofPlinabulin Dublin-3 and Protective Studies.
G&A expenses: $6.1 million (vs. $7.8 million in 2023), driven by cost optimization measures.
Net loss: $8.9 million (vs. $14.0 million in 2023).
Cash, cash equivalents, and short-term investments: $2.9 million as of December 31, 2024.

Discontinued operations:

Net loss: $7.8 million (vs. $7.9 million in 2023).
Current assets: $25.3 million as of December 31, 2024.

Expected 2025 Milestones
Plinabulin
1H 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors.
2H 2025: Preliminary data from Phase 2 of Study 302 in 1L ES-SCLC.
SEED
Mid-2025: Expected IND filing of RBM39 degrader.
2H 2025: RBM39 degraderexpected to begin patient enrollment.
2H 2025: Tau degraderexpected to achieve in vivo efficacy.
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.