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

Rhea-AI Summary

BeyondSpring (NASDAQ: BYSI) reported Q2 2025 financial results and significant clinical advances. The company's lead drug Plinabulin showed promising results in NSCLC patients who progressed after PD-1/L1 therapy, demonstrating 6.8 months median PFS and 18.2% ORR in combination with pembrolizumab and docetaxel.

A Med (Cell Press) publication highlighted Plinabulin's ability to activate dendritic cells across eight cancer types, achieving 23% ORR and 54% DCR in immunotherapy-resistant patients. Additionally, SEED Therapeutics, where BeyondSpring holds a 40% stake, received FDA IND clearance for its RBM39 degrader ST-01156 and appointed Dr. Bill Desmarais as CFO/CBO.

Q2 2025 financials showed a net loss of $1.9M from continuing operations, improved from $2.7M in Q2 2024, with $9.5M cash on hand as of June 30, 2025.

Positive

• Plinabulin combination therapy showed strong efficacy with 6.8 months PFS and 18.2% ORR in NSCLC patients
• FDA IND clearance received for SEED's RBM39 degrader ST-01156
• Cash position improved to $9.5M from $2.9M in December 2024
• Net loss decreased to $1.9M in Q2 2025 from $2.7M in Q2 2024
• G&A expenses reduced by $0.9M year-over-year through cost optimization

Negative

• R&D expenses increased by $0.2M quarter-over-year
• Discontinued operations showed increased net loss of $2.8M vs $1.4M year-over-year
• Current assets declined to $15.7M from $25.3M in December 2024
• BeyondSpring's stake in SEED Therapeutics will decrease to 14% after planned sale transactions

Insights

Biotechnology Analyst

BeyondSpring shows promising clinical advances with Plinabulin in NSCLC but faces financial challenges despite pipeline progress.

BeyondSpring's Q2 report reveals compelling clinical data for its lead asset Plinabulin, particularly in non-small cell lung cancer (NSCLC) patients who've progressed on PD-1/L1 inhibitors. The combination therapy with pembrolizumab and docetaxel demonstrated a median PFS of 6.8 months and ORR of 18.2% – metrics that compare favorably to historical outcomes for this difficult-to-treat population where response rates typically fall below 10%.

The Med (Cell Press) publication provides crucial mechanistic validation, confirming Plinabulin's ability to mature dendritic cells – the critical bridge between innate and adaptive immunity. This mechanism explains how Plinabulin potentially re-sensitizes tumors to immunotherapy across multiple cancer types, with the study showing a 23% ORR in patients previously refractory to immunotherapy. The identification of a potential predictive biomarker (GEF-H1 immune signature) is particularly significant, as it could enable targeted patient selection.

While the clinical data is encouraging, BeyondSpring's financial position warrants scrutiny. The company reported cash reserves of $9.5 million as of June 2025, up from $2.9 million in December 2024. However, with quarterly losses of $1.9 million from continuing operations and additional losses from discontinued operations, the company likely has less than 18 months of runway at current burn rates. The divestiture of SEED Therapeutics stakes (reducing ownership from 40% to approximately 14%) suggests strategic repositioning to focus resources on Plinabulin development while managing capital constraints.

The FDA clearance for SEED's RBM39 degrader represents validation of the platform technology, but BeyondSpring's decreased ownership means diminished economic benefit from this advancement. The company appears to be narrowing its focus to Plinabulin's development in NSCLC while managing limited resources – a sensible strategy but one that increases the importance of successful outcomes in its lead program.

Financial Analyst

BeyondSpring shows mixed financial signals: improved cash position but ongoing losses and strategic divestiture of SEED assets.

BeyondSpring's financial performance reveals a nuanced picture with both positive developments and ongoing challenges. The company has strengthened its cash position to $9.5 million as of June 2025, a significant improvement from $2.9 million at the end of 2024. This cash infusion appears connected to the strategic partial divestiture of SEED Therapeutics, reducing BeyondSpring's ownership from approximately 40% to a projected 14% upon completion of planned transactions.

The quarterly net loss decreased to $1.9 million from $2.7 million year-over-year, reflecting the company's cost control efforts. General and administrative expenses showed a substantial reduction of 50% to $0.9 million, primarily through lower professional service costs and reduced headcount. However, R&D expenses increased by $0.2 million to $1.0 million, reflecting greater investment in Plinabulin's development.

The accounting reclassification of SEED Therapeutics as discontinued operations under ASC 205-20 following the January 2025 agreement to sell majority shares is particularly telling. This transaction appears to be a strategic move to strengthen the balance sheet while narrowing focus. The discontinued operations reported a $2.8 million loss in Q2, double the $1.4 million loss from the same period last year, suggesting SEED's operations were consuming significant resources.

With approximately $4.5 million in losses for the first half of 2025 from continuing operations, the current cash position provides a runway of roughly 4-5 quarters at the present burn rate. This timeline creates some urgency for BeyondSpring to either secure additional funding or achieve valuable clinical milestones that could attract partnership opportunities. The company's strategy appears to be concentrating resources on advancing Plinabulin through late-stage development while reducing exposure to the capital-intensive early-stage work at SEED Therapeutics.

• 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 Results¹
Continuing 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 Results¹
Continuing 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 Update
Following 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 BeyondSpring
BeyondSpring (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 Therapeutics
SEED 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 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 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. 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			3,686				3,783
Noncurrent liabilities of discontinued operations			6,197				4,986
Total noncurrent liabilities			37,590				36,858
Total liabilities			48,600				48,588
Commitments and contingencies
Shareholders’ deficit
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 40,316,320 and 40,322,320 shares issued and outstanding as of December 31, 2024 and June 30, 2025, respectively)			4				4
Additional paid-in capital			373,185				373,515
Accumulated deficit			(407,425	)			(404,754	)
Accumulated other comprehensive income			1,336				1,019
Total BeyondSpring Inc.’s shareholders’ deficit			(32,900	)			(30,216	)
Noncontrolling interests			18,615				12,671
Total shareholders’ deficit			(14,285	)			(17,545	)
Total liabilities and shareholders’ deficit			34,315				31,043

BEYONDSPRING INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) (Unaudited)
	Three months ended June 30,								Six months ended June 30,
	2024				2025				2024				2025
	$				$				$				$
Revenue		-				-				-				-
Operating expenses
Research and development		(829	)			(1,002	)			(1,550	)			(1,876	)
General and administrative		(1,812	)			(947	)			(3,146	)			(2,683	)
Loss from operations		(2,641	)			(1,949	)			(4,696	)			(4,559	)
Foreign exchange gain (loss), net		(22	)			47				(83	)			76
Interest income		11				28				40				45
Other income, net		1				18				8				18
Loss before income tax		(2,651	)			(1,856	)			(4,731	)			(4,420	)
Income tax expenses		-				(22	)			-				(42	)
Net loss from continuing operations		(2,651	)			(1,878	)			(4,731	)			(4,462	)
Discontinued operations
Loss from discontinued operations		(1,438	)			(2,771	)			(2,646	)			(6,003	)
Gain on sale of subsidiary interests		-				-				-				6,986
Income tax expenses		-				-				-				-
Net income (loss) from discontinued operations		(1,438	)			(2,771	)			(2,646	)			983
Net loss		(4,089	)			(4,649	)			(7,377	)			(3,479	)
Less: Net loss attributable to noncontrolling interests from continuing operations		(58	)			(72	)			(115	)			(147	)
Less: Net loss attributable to noncontrolling interests from discontinued operations		-				(2,771	)			-				(6,003	)
Net income (loss) attributable to BeyondSpring Inc.		(4,031	)			(1,806	)			(7,262	)			2,671
Earnings (loss) per share, basic and diluted
Continuing operations		(0.07	)			(0.04	)			(0.12	)			(0.11	)
Discontinued operations		(0.03	)			-				(0.07	)			0.18
Basic and diluted earnings (loss) per share		(0.10	)			(0.04	)			(0.19	)			0.07
Weighted-average shares outstanding
Basic and diluted		39,280,607				40,316,320				39,154,885				40,316,320
Other comprehensive loss, net of tax of nil:
Foreign currency translation adjustment gain (loss) from continuing operations		165				(343	)			587				(494	)
Foreign currency translation adjustment loss from discontinued operations		(3	)			(27	)			(11	)			(34	)
Comprehensive loss		(3,927	)			(5,019	)			(6,801	)			(4,007	)
Less: Comprehensive income (loss) attributable to noncontrolling interests from continuing operations		1				(194	)			97				(324	)
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations		-				(2,798	)			-				(6,037	)
Comprehensive income (loss) attributable to BeyondSpring Inc.		(3,928	)			(2,027	)			(6,898	)			2,354

FAQ

What were the key clinical results for BeyondSpring's (BYSI) Plinabulin in NSCLC patients?

In NSCLC patients who progressed on PD-1/L1 inhibitors, Plinabulin combination therapy showed 6.8 months median PFS, 18.2% ORR, 7.2 months DOR, and 77% DCR, with 78% overall survival at 15 months.

How did BeyondSpring (BYSI) perform financially in Q2 2025?

BeyondSpring reported a net loss of $1.9M from continuing operations (improved from $2.7M in Q2 2024), with $9.5M in cash as of June 30, 2025. R&D expenses were $1.0M and G&A expenses were $0.9M.

What is the status of SEED Therapeutics' RBM39 degrader program?

SEED Therapeutics received FDA IND clearance for ST-01156, their brain penetrant oral RBM39 degrader. Preclinical data showed complete tumor regression in Ewing Sarcoma models and promising activity in KRAS G12D-driven tumors.

What were the results of BeyondSpring's (BYSI) Plinabulin study published in Med?

The Med publication showed Plinabulin combination therapy achieved 23% ORR and 54% DCR across eight cancer types in patients who failed prior immunotherapy, demonstrating rapid dendritic cell maturation.

How will BeyondSpring's (BYSI) ownership in SEED Therapeutics change?

BeyondSpring currently owns 40% of SEED Therapeutics and will reduce its stake to approximately 14% following planned sale transactions of Series A-1 Preferred Shares.