Plinabulin (
- Phase 3 Survival Benefit Confirmed: Plinabulin combined with docetaxel demonstrated statistically significant overall survival benefit vs. standard of care docetaxel in EGFR wild-type NSCLC patients whose tumors progressed after first line therapy —
DUBLIN -3 study results published in The Lancet Respiratory Medicine - Confirmatory Trial Planned: Based on
DUBLIN -3 Phase 3 data andUS FDA discussions,BeyondSpring is advancingDUBLIN -4, a confirmatory global Phase 3 study in a biomarker-selected EGFR wild-type NSCLC patient population progressed on immune checkpoint inhibitors (NCT07361484) - Overcoming Immunotherapy Resistance: Early clinical data at
MD Anderson Cancer Center andPeking Union Hospital suggest Plinabulin may restore sensitivity to checkpoint inhibitors — a significant unmet need affecting most patients on PD-1/PD-L1 therapies – Results published inCell Press journal Med 2025 and presented at SITC 2025
SEED Therapeutics (Reported as Discontinued Operations):
- First Patient Dosed for lead oncology program: ST-01156, a novel oral RBM39 degrader, initiated Phase 1a clinical trials in
January 2026 following IND clearance in both theU.S. andChina - Financing Strengthened: Completed
$30 million Series A-3 financing; appointed Dr.Bill Desmarais as Chief Financial Officer and Chief Business Officer
2025: Clinical and Operational Progress
“2025 was a year of important clinical and operational progress for
“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
Positioned for 2026 and Beyond
“With a solid scientific and clinical foundation and clear regulatory pathways, we believe
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.
At
- 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
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 2025 and SITC 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 inChina 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 inFebruary 2025 .
SEED Therapeutics (Reported as Discontinued Operations)
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. andChina - Dosed first patient in a Phase 1a study in
January 2026
- Received
- ST-01156 Phase 1a enrolling at leading
U.S. cancer centers: Dana-Farber,Massachusetts General Hospital , MemorialSloan Kettering ,MD Anderson Cancer Center , Hoag, andCity of Hope - Presentation at AACR 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 Results¹
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 ofDecember 31, 2025
Discontinued operations:
- Net loss:
$5.5 million (vs.$7.8 million in 2024) - Current assets:
$8.0 million as ofDecember 31, 2025
Note 1. As a result of
About
About SEED Therapeutics
SEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision. SEED’s lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for
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 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 ability to complete the sale of BeyondSpring’s equity interest in SEED Therapeutics on terms acceptable to
Investor Contact: IR@beyondspringpharma.com
Media Contact: PR@beyondspringpharma.com
Financial Tables to Follow
CONSOLIDATED BALANCE SHEETS (Amounts in thousands of | ||||
| As of December 31, | ||||
| 2024 | 2025 | |||
| $ | $ | |||
| Assets | ||||
| Current assets: | ||||
| Cash and cash equivalents | 2,922 | 7,786 | ||
| Short-term investments | - | 4,775 | ||
| Advances to suppliers | 240 | 227 | ||
| Prepaid expenses and other current assets | 68 | 71 | ||
| Current assets of discontinued operations | 25,347 | 8,023 | ||
| Total current assets | 28,577 | 20,882 | ||
| Noncurrent assets: | ||||
| Property and equipment, net | 239 | 166 | ||
| Operating right-of-use assets | 513 | 305 | ||
| Other noncurrent assets | 213 | 224 | ||
| Noncurrent assets of discontinued operations | 4,773 | 4,356 | ||
| Total noncurrent assets | 5,738 | 5,051 | ||
| Total assets | 34,315 | 25,933 | ||
| Liabilities and equity | ||||
| Current liabilities: | ||||
| Accounts payable | 295 | 363 | ||
| Accrued expenses | 840 | 938 | ||
| Current portion of operating lease liabilities | 282 | 320 | ||
| Other current liabilities | 780 | 822 | ||
| Current liabilities of discontinued operations | 8,813 | 11,133 | ||
| Total current liabilities | 11,010 | 13,576 | ||
| Noncurrent liabilities: | ||||
| Operating lease liabilities | 307 | - | ||
| Deferred revenue | 27,400 | 28,600 | ||
| Other noncurrent liabilities | 3,686 | 3,981 | ||
| Noncurrent liabilities of discontinued operations | 6,197 | 3,766 | ||
| Total noncurrent liabilities | 37,590 | 36,347 | ||
| Total liabilities | 48,600 | 49,923 | ||
| Shareholders’ deficit | ||||
| Ordinary shares ( | 4 | 4 | ||
| Additional paid-in capital | 373,185 | 375,664 | ||
| Accumulated deficit | (407,425 | ) | (408,431 | ) |
| Accumulated other comprehensive income | 1,336 | 602 | ||
| Total BeyondSpring Inc.’s shareholders’ deficit | (32,900 | ) | (32,161 | ) |
| Noncontrolling interests | 18,615 | 8,171 | ||
| Total shareholders’ deficit | (14,285 | ) | (23,990 | ) |
| Total liabilities and shareholders’ deficit | 34,315 | 25,933 | ||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Amounts in thousands of | |||||||
| Year ended | |||||||
| 2024 | 2025 | ||||||
| $ | $ | ||||||
| Revenue | - | - | |||||
| Operating expenses | |||||||
| Research and development | (2,644 | ) | (4,388 | ) | |||
| General and administrative | (6,110 | ) | (4,557 | ) | |||
| Loss from operations | (8,754 | ) | (8,945 | ) | |||
| Foreign exchange gain (loss), net | (96 | ) | 165 | ||||
| Interest income | 59 | 78 | |||||
| Other income, net | 22 | 77 | |||||
| Loss before income tax | (8,769 | ) | (8,625 | ) | |||
| Income tax expenses | (96 | ) | (90 | ) | |||
| Net loss from continuing operations | (8,865 | ) | (8,715 | ) | |||
| Discontinued operations | |||||||
| Loss from discontinued operations | (7,828 | ) | (12,488 | ) | |||
| Gain on disposal of discontinued operations | - | 6,986 | |||||
| Income tax expenses | - | - | |||||
| Net loss from discontinued operations | (7,828 | ) | (5,502 | ) | |||
| Net loss | (16,693 | ) | (14,217 | ) | |||
| Less: Net loss attributable to noncontrolling interests from continuing operations | (388 | ) | (242 | ) | |||
| Less: Net loss attributable to noncontrolling interests from discontinued operations | (5,182 | ) | (12,969 | ) | |||
| Net loss attributable to | (11,123 | ) | (1,006 | ) | |||
| Net earnings (loss) per share, basic and diluted | |||||||
| Continuing operations | (0.21 | ) | (0.21 | ) | |||
| Discontinued operations | (0.07 | ) | 0.19 | ||||
| Basic and diluted loss per share | (0.28 | ) | (0.02 | ) | |||
| Weighted-average shares outstanding | |||||||
| Basic and diluted | 39,733,191 | 40,406,347 | |||||
| Other comprehensive loss, net of tax of nil: | |||||||
| Foreign currency translation adjustment gain (loss) from continuing operations | 710 | (1,147 | ) | ||||
| Foreign currency translation adjustment gain (loss) from discontinued operations | 17 | (107 | ) | ||||
| Comprehensive loss | (15,966 | ) | (15,471 | ) | |||
| Less: Comprehensive loss attributable to noncontrolling interests from continuing operations | (131 | ) | (655 | ) | |||
| Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations | (5,154 | ) | (13,076 | ) | |||
| Comprehensive loss attributable to | (10,681 | ) | (1,740 | ) | |||
Source: 