BeyondSpring Reports Second‑Quarter 2025 Financial Results and Provides Corporate Update: Accelerates Momentum with Promising Clinical Advances and Strategic Leadership Appointment

ASCO 2025 presentation: First-in-class agent Plinabulin drives immune re-sensitization in NSCLC patients progressed to PD-1/L1 therapies

Med (Cell Press) Publication with MD Anderson Collaboration highlights Plinabulin's rapid dendritic cell activation in responding patients across eight cancer types who failed prior immunotherapy

SEED Therapeutics' RBM39 degrader ST-01156 clears FDA IND and advances toward Phase 1 trials

New SEED Therapeutics CFO and CBO Dr. Bill Desmarais brings over 20 years of biotech leadership experience to accelerate development

FLORHAM PARK, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ:BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q2 2025 financial results alongside clinical and corporate milestones.

"At the heart of BeyondSpring's pipeline is Plinabulin, a first-in-class agent potentially redefining cancer treatment by harnessing the body's own immune system," said Dr. Lan Huang, Co-Founder, Chair, and CEO. "Plinabulin's ability to mature dendritic cells in human studies, bridges innate and adaptive immunity, offering potentially new hope to the 60% of NSCLC patients whose disease progresses after checkpoint inhibitor therapy. In our global Phase 3 trial (Dublin-3, published in LANCET Respiratory Medicine), plinabulin and docetaxel combination compared to standard of care docetaxel alone, delivered durable survival benefits alongside reduced chemotherapy-induced neutropenia, a combination with strong potential to influence standards of care."

Dr. Huang added, "BeyondSpring's impact extends beyond Plinabulin. As SEED Therapeutics' ("SEED") founding shareholder, BeyondSpring, along with cornerstone investors and research collaborators Eli Lilly and Eisai, has supported SEED's pioneering work in targeted protein degradation. SEED's oral RBM39 molecular glue degrader, ST-01156, recently received FDA clearance to enter clinical trials, targeting aggressive cancers including Ewing Sarcoma and KRAS-driven tumors, with U.S. leading cancer institutions driving development forward."

Key Milestones:

ASCO 2025 Presentation on Plinabulin Effect in Re-sensitizing Tumors Progressed on Prior PD-1/L1 Inhibitors: New data from a phase 2 study evaluating pembrolizumab in combination with Plinabulin and docetaxel in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors, showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 6.8 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 77%, and overall survival (OS) of 78% at 15 months.

Med (Cell Press) Publication on Plinabulin Mechanism in Dendritic Cell Maturation in Human Studies with MD Anderson Collaboration: Plinabulin, when used in combination with radiation and a checkpoint inhibitor, rapidly induces dendritic cell (DC) maturation in multiple cancer types in patients who failed prior immunotherapy. The combination was associated with tumor responses across eight types of cancer in patients previously refractory to immune checkpoint inhibitor (ICI) therapy, including NSCLC, head and neck cancer, and Hodgkin lymphoma. The study reported an ORR of 23% and a DCR of 54%. Importantly, the research identified a potential predictive biomarker, baseline GEF-H1 immune signature, which may support patient selection and clinical response prediction.

SEED's IND Clearance from US FDA for Lead Oncology Asset RBM39 Degrader ST-01156: The U.S. Food and Drug Administration (FDA) cleared SEED's Investigational New Drug (IND) application for ST-01156, a brain penetrant, novel orally administered molecular glue degrader targeting RBM39.

AACR 2025 Presentation on SEED's Two Key Preclinical Advancements: 1) ST-01156 demonstrated complete tumor regression in Ewing Sarcoma models, and its corresponding mechanism, and 2) a dual-degrader approach showed promising activity in KRAS G12D target degradation and KRAS G12D-driven tumors.

SEED Strengthened Leadership: Dr. Bill Desmarais, Ph.D., MBA, joins SEED Therapeutics as CFO and Chief Business Officer, bringing two decades of leadership in finance, business development, and strategic expertise in biopharma and biotech.

Second Quarter Financial Results1Continuing operations:

Research and development (R&D) expenses were $1.0 million for the quarter ended June 30, 2025 compared to $0.8 million for the quarter ended June 30, 2024. The $0.2 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.

General and administrative (G&A) expenses were $0.9 million for the quarter ended June 30, 2025, compared to $1.8 million for the quarter ended June 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development initiatives, and lower salary expenses driven by decrease in administrative headcount. 

Net loss: $1.9 million for the quarter ended June 2025, compared to $2.7 million for the quarter ended June 2024

Cash and cash equivalents: $9.5 million as of June 30, 2025, compared to $2.9 million as of December 2024

Discontinued operations:

Net loss: $2.8 million for the quarter ended June 2025, compared to $1.4 million for the quarter ended June 2024

Current assets: $15.7 million as of June 2025, compared to $25.3 million as of December 2024

Year to Date Financial Results1Continuing Operations:

Research and development (R&D) expenses were $1.9 million for the six months ended June 30, 2025 compared to $1.6 million for the six months ended June 30, 2024. The $0.3 million increase was primarily due to higher professional service fees in regulatory and CMC activities as well as increased costs for Plinabulin research.

General and administrative (G&A) expenses were $2.7 million for the six months ended June 30, 2025, compared to $3.1 million for the six months ended June 30, 2024. The $0.4 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs. 

Net loss: $4.5 million for the six months ended June 2025, compared to $4.7 million for the six months ended June 2024

Discontinued operations:

Net income (loss): $1 million for the six months ended June 2025, compared to ($2.6 million) for the six months ended June 2024

Note 1: Accounting UpdateFollowing definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED's financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 40% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED's outstanding shares.

About BeyondSpringBeyondSpring (NASDAQ:BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin's novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at beyondspringpharma.com.

About SEED TherapeuticsSEED Therapeutics pioneers targeted protein degradation through novel molecular glues and bifunctional degraders powered by its proprietary RITE3™ platform. SEED is advancing a pipeline targeting traditionally undruggable proteins across oncology, neurodegeneration, immunology, and virology. Strategic collaborations with Eli Lilly and Eisai support SEED's mission to develop transformational therapies. SEED's lead RBM39 degrader program has cleared US FDA IND. Learn more at seedtherapeutics.com.

Cautionary Note Regarding Forward-Looking StatementsThis 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 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

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Financial Tables to Follow

BEYONDSPRING INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Amounts in thousands of U.S. Dollars ("$"), except for number of shares and per share data)

 

 

 

As of

 

 

 

December 31, 2024

 

 

June 30, 2025

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

 

2,922

 

 

 

9,544

 

Advances to suppliers

 

 

240

 

 

 

255

 

Prepaid expenses and other current assets

 

 

68

 

 

 

200

 

Current assets of discontinued operations

 

 

25,347

 

 

 

15,712

 

Total current assets

 

 

28,577

 

 

 

25,711

 

 

 

 

 

 

 

 

 

 

Noncurrent assets:

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

239

 

 

 

202

 

Operating right-of-use assets

 

 

513

 

 

 

431

 

Other noncurrent assets

 

 

213

 

 

 

216

 

Noncurrent assets of discontinued operations

 

 

4,773

 

 

 

4,483

 

Total noncurrent assets

 

 

5,738

 

 

 

5,332

 

 

 

 

 

 

 

 

 

 

Total assets

 

 

34,315

 

 

 

31,043

 

 

 

 

 

 

 

 

 

 

Liabilities and equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

 

295

 

 

 

266

 

Accrued expenses

 

 

840

 

 

 

926

 

Current portion of operating lease liabilities

 

 

282

 

 

 

307

 

Other current liabilities

 

 

780

 

 

 

612

 

Current liabilities of discontinued operations

 

 

8,813

 

 

 

9,619

 

Total current liabilities

 

 

11,010

 

 

 

11,730

 

 

 

 

 

 

 

 

 

 

Noncurrent liabilities:

 

 

 

 

 

 

 

 

Operating lease liabilities

 

 

307

 

 

 

170

 

Deferred revenue

 

 

27,400

 

 

 

27,919

 

Other noncurrent liabilities