Plinabulin Final Phase 3 Data Published inThe Lancet Respiratory Medicine,Demonstrating Overall Survival Benefit in 2L/3L NSCLC EGFR Wild Type vs. Docetaxel
Plinabulin Phase 2 Data Highlights Potential to Resensitize Tumors Progressed on PD-1/PD-L1 Inhibitors in Metastatic NSCLC
SEED Therapeutics Enters into Targeted Protein Degradation Research Collaboration with Eisai with potential payment to SEED of up to $1.5 Billion and Completes $24 Million First Close of Series A-3 Financing
SEED Therapeutics’ Lead Oncology Asset RBM39 Degrader Granted Rare Pediatric Disease and Orphan Drug Designations by the FDA
FLORHAM PARK, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, today announced its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments.
“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,”saidDr. 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 inThe 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.
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).
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 collaborationwithEisaito developmolecular 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.
R&D expenses: $2.6 million (vs. $7.3 million in 2023), reflecting completion of Plinabulin Dublin-3 and Protective Studies.
G&A expenses: $6.1 million (vs. $7.8 million in 2023), driven bycost optimization measures.
Net loss: $8.9 million (vs. $14.0 million in 2023).
Cash, cash equivalents, and short-term investments: $2.9 million as ofDecember 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 fromPhase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors.
2H 2025: Preliminary data fromPhase 2 of Study 302 in 1L ES-SCLC.
SEED
Mid-2025: Expected IND filing of RBM39 degrader.
2H 2025: RBM39 degraderexpected to beginpatient enrollment.
2H 2025: Tau degraderexpected to achievein 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.
About BeyondSpring BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and a range of cancer indications. Plinabulin’s novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors to checkpoint inhibitors. Learn more at beyondspringpharma.com.
About SEED Therapeutics SEED Therapeutics is a biotech company pioneering targeted protein degradation (TPD). Its proprietary RITE3™ platform is advancing novel molecular glue degraders across oncology, neurodegeneration, immunology, and virology. SEED collaborates with Eli Lilly and Company and Eisai Co., Ltd. and is advancing its RBM39 degrader into clinical development. Learn more at seedtherapeutics.com.
Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 10-K on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,029,163 and 40,316,320 shares issued and outstanding as of December 31, 2023 and 2024, respectively)
4
4
Additional paid-in capital
368,599
373,185
Accumulated deficit
(396,302
)
(407,425
)
Accumulated other comprehensive income
894
1,336
Total BeyondSpring Inc.’s shareholders’ deficit
(26,805
)
(32,900
)
Noncontrolling interests
(8,530
)
18,615
Total shareholders’ deficit
(35,335
)
(14,285
)
Total liabilities, mezzanine equity and shareholders’ deficit
24,808
34,315
BEYONDSPRING INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
Year ended December 31,
2023
2024
$
$
Revenue
-
-
Operating expenses
Research and development
(7,272
)
(2,644
)
General and administrative
(7,809
)
(6,110
)
Loss from operations
(15,081
)
(8,754
)
Foreign exchange loss, net
(128
)
(96
)
Interest income
322
59
Other income, net
964
22
Loss before income tax
(13,923
)
(8,769
)
Income tax expenses
(92
)
(96
)
Net loss from continuing operations
(14,015
)
(8,865
)
Discontinued operations
Loss from discontinued operations
(7,919
)
(7,828
)
Income tax expenses
(14
)
-
Net loss from discontinued operations
(7,933
)
(7,828
)
Net loss
(21,948
)
(16,693
)
Less: Net loss attributable to noncontrolling interests from continuing operations
(922
)
(388
)
Less: Net loss attributable to noncontrolling interests from discontinued operations
-
(5,182
)
Net loss attributable to BeyondSpring Inc.
(21,026
)
(11,123
)
Net loss per share, basic and diluted
Continuing operations
(0.34
)
(0.21
)
Discontinued operations
(0.20
)
(0.07
)
Basic and diluted loss per share
(0.54
)
(0.28
)
Weighted-average shares outstanding
Basic and diluted
38,996,463
39,733,191
Other comprehensive loss, net of tax of nil:
Foreign currency translation adjustment gain from continuing operations
760
710
Foreign currency translation adjustment (loss) gain from discontinued operations
(35
)
17
Comprehensive loss
(21,223
)
(15,966
)
Less: Comprehensive loss attributable to noncontrolling interests from continuing operations
(655
)
(131
)
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations
-
(5,154
)
Comprehensive loss attributable to BeyondSpring Inc.
