Presentation at IO 360° conference showed early efficacy for Plinabulin combinations in metastatic NSCLC and Hodgkin lymphoma resistant to PD‑1/L1 therapy
SEED’s first‑in‑class RBM39 degrader, reported at AACR 2025 for its total tumor regression data in mechanism targeted cancer indication-Ewing Sarcoma, remains on track for IND filing mid‑2025
FLORHAM PARK, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical‑stage global biopharmaceutical company focused on developing cancer therapeutics, today announced its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update.
“Plinabulin has now been administered to more than 700 patients with a favorable safety profile. By promoting dendritic‑cell maturation, it offers a potential option for the approximately 60 percent of cancer patients who progress on PD‑1/L1 inhibitors,” said Dr. Lan Huang, Co‑Founder, Chair, and Chief Executive Officer of BeyondSpring. “Early readouts in metastatic NSCLC and Hodgkin lymphoma who failed PD-1/L1 inhibitors showed durable responses that deserve further evaluation.”
Dr. Huang added, “Within SEED, our RBM39 molecular‑glue degrader achieved complete tumor regression in mechanism-targeted Ewing sarcoma models and is on track for an IND submission mid‑year. We are also pursuing additional mechanism-targeted larger indications including liver cancer and KRAS‑mutant tumors with leading centers including Dana‑Farber, Memorial Sloan Kettering, and MD Anderson.”
Recent Highlights
Plinabulin Clinical Presentations
March 2025 (Oral Presentation at the Immuno-Oncology 360o Summit in Boston): Plinabulin combination regimen showed clinically meaningful responses in patients of multiple cancer types who failed prior immunotherapies, including NSCLC and Hodgkin lymphoma, with prolonged PFS.
Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation (MD Anderson Cancer Center) showed promising data in re-sensitizing Hodgkin lymphoma for patients who failed 12 to 16 prior lines of treatments including stem cell transplant, CAR-T, and PD-1 inhibitor with duration of response of over 19 months.
SEED Therapeutics Program
RBM39 molecular‑glue degrader produced durable tumor regression in Ewing sarcoma animal models; IND‑enabling studies underway.
Dual‑PROTAC approach using two E3 ligases overcame the hook effect in KRAS G12D cell lines; manuscript in preparation.
Corporate and Financial
As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED in January 2025, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes. SEED’s financials results are now presented as “discontinued operations” under U.S. GAAP. SEED continues to operate independently. BeyondSpring currently owns approximately 40% of the outstanding equity interest in SEED.
Selected Unaudited Financial Data
Q1 2025 | Q1 2024 | Change (%) | ||||
R&D expense from continuing operations ($ 000s) | 874 | 721 | 21 | % | ||
G&A expense from continuing operations ($ 000s) | 1,736 | 1,334 | 30 | % | ||
Net loss from continuing operations ($ 000s) | 2,584 | 2,080 | 24 | % | ||
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 biotechnology company pioneering targeted protein degradation (TPD) through the discovery of novel molecular glues and bifunctional degraders. Powered by its proprietary RITE3™ platform, SEED is advancing a pipeline of first-in-class degraders to address traditionally undruggable targets across oncology, neurodegeneration, immunology, and virology. SEED’s strategic collaborations with Eli Lilly and Company and Eisai Co., Ltd. support its mission to develop transformational therapies, with its lead RBM39 degrader program expected to enter clinical trials in 2025. 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.
Contacts
Investor Relations: ir@beyondspring.com
Media: pr@beyondspringpharma.com
Financial Tables to Follow
BEYONDSPRING INC. | |||||
As of | |||||
December 31, 2024 | March 31, 2025 | ||||
$ | $ | ||||
(Unaudited) | |||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | 2,922 | 6,527 | |||
Short-term investments | - | 2,000 | |||
Advances to suppliers | 240 | 284 | |||
Prepaid expenses and other current assets | 68 | 90 | |||
Current assets of discontinued operations | 25,347 | 22,625 | |||
Total current assets | 28,577 | 31,526 | |||
Noncurrent assets: | |||||
Property and equipment, net | 239 | 221 | |||
Operating right-of-use assets | 513 | 492 | |||
Other noncurrent assets | 213 | 215 | |||
Noncurrent assets of discontinued operations | 4,773 | 4,650 | |||
Total noncurrent assets | 5,738 | 5,578 | |||
Total assets | 34,315 | 37,104 | |||
Liabilities and equity | |||||
Current liabilities: | |||||
Accounts payable | 295 | 358 | |||
Accrued expenses | 840 | 909 | |||
Current portion of operating lease liabilities | 282 | 301 | |||
Other current liabilities | 780 | 1,364 | |||
Current liabilities of discontinued operations | 8,813 | 9,733 | |||
Total current liabilities | 11,010 | 12,665 | |||
Noncurrent liabilities: | |||||
Operating lease liabilities | 307 | 246 | |||
Deferred revenue | 27,400 | 27,561 | |||
Other noncurrent liabilities | 3,686 | 3,706 | |||
Noncurrent liabilities of discontinued operations | 6,197 | 5,593 | |||
Total noncurrent liabilities | 37,590 | 37,106 | |||
Total liabilities | 48,600 | 49,771 | |||
Commitments and contingencies | |||||
Shareholders’ deficit | |||||
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 40,316,320 shares issued and outstanding as of December 31, 2024 and March 31, 2025) | 4 | 4 | |||
Additional paid-in capital | 373,185 | 373,396 | |||
Accumulated deficit | (407,425 | ) | (402,948 | ) | |
Accumulated other comprehensive income | 1,336 | 1,239 | |||
Total BeyondSpring Inc.’s shareholders’ deficit | (32,900 | ) | (28,309 | ) | |
Noncontrolling interests | 18,615 | 15,642 | |||
Total shareholders’ deficit | (14,285 | ) | (12,667 | ) | |
Total liabilities and shareholders’ deficit | 34,315 | 37,104 | |||
BEYONDSPRING INC. | |||||
Three months ended March 31, | |||||
2024 | 2025 | ||||
$ | $ | ||||
Revenue | - | - | |||
Operating expenses | |||||
Research and development | (721 | ) | (874 | ) | |
General and administrative | (1,334 | ) | (1,736 | ) | |
Loss from operations | (2,055 | ) | (2,610 | ) | |
Foreign exchange gain (loss), net | (61 | ) | 29 | ||
Interest income | 29 | 17 | |||
Other income, net | 7 | - | |||
Loss before income tax | (2,080 | ) | (2,564 | ) | |
Income tax expenses | - | (20 | ) | ||
Net loss from continuing operations | (2,080 | ) | (2,584 | ) | |
Discontinued operations | |||||
Loss from discontinued operations | (1,208 | ) | (3,232 | ) | |
Gain on sale of subsidiary interests | - | 6,986 | |||
Income tax expenses | - | - | |||
Net income (loss) from discontinued operations | (1,208 | ) | 3,754 | ||
Net income (loss) | (3,288 | ) | 1,170 | ||
Less: Net loss attributable to noncontrolling interests from continuing operations | (57 | ) | (75 | ) | |
Less: Net loss attributable to noncontrolling interests from discontinued operations | - | (3,232 | ) | ||
Net income (loss) attributable to BeyondSpring Inc. | (3,231 | ) | 4,477 | ||
Earnings (loss) per share, basic and diluted | |||||
Continuing operations | (0.05 | ) | (0.06 | ) | |
Discontinued operations | (0.03 | ) | 0.17 | ||
Basic and diluted earnings (loss) per share | (0.08 | ) | 0.11 | ||
Weighted-average shares outstanding | |||||
Basic and diluted | 39,029,163 | 40,316,320 | |||
Other comprehensive loss, net of tax of nil: | |||||
Foreign currency translation adjustment gain (loss) from continuing operations | 422 | (151 | ) | ||
Foreign currency translation adjustment loss from discontinued operations | (8 | ) | (7 | ) | |
Comprehensive income (loss) | (2,874 | ) | 1,012 | ||
Less: Comprehensive income (loss) attributable to noncontrolling interests from continuing operations | 96 | (130 | ) | ||
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations | - | (3,238 | ) | ||
Comprehensive income (loss) attributable to BeyondSpring Inc. | (2,970 | ) | 4,380 | ||