BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update

Rhea-AI Summary

BeyondSpring (NASDAQ: BYSI) reported its Q1 2025 financial results and corporate updates. The company's lead drug Plinabulin has shown promising results in treating patients who failed PD-1/L1 inhibitors, with notable success in NSCLC and Hodgkin lymphoma. A Phase 1 study at MD Anderson showed extended response duration of over 19 months in heavily pretreated Hodgkin lymphoma patients. The company's SEED subsidiary is advancing its RBM39 degrader program, which achieved complete tumor regression in Ewing sarcoma models, with IND filing expected mid-2025. Financially, Q1 2025 saw increased expenses with R&D costs up 21% to $874,000 and G&A expenses up 30% to $1.74M, resulting in a net loss of $2.58M from continuing operations. BeyondSpring currently maintains approximately 40% ownership in SEED following a partial sale of Series A-1 Preferred Shares.

Positive

• Plinabulin demonstrated durable responses in NSCLC and Hodgkin lymphoma patients who failed prior immunotherapies
• Phase 1 study showed 19+ months duration of response in heavily pretreated Hodgkin lymphoma patients
• SEED's RBM39 degrader achieved complete tumor regression in Ewing sarcoma models
• Plinabulin shows favorable safety profile across 700+ patients

Negative

• Net loss from continuing operations increased 24% to $2.58M in Q1 2025
• R&D expenses increased 21% to $874,000
• G&A expenses rose 30% to $1.74M

Insights

Biotechnology Research Analyst

BeyondSpring's pipeline shows early promise in treatment-resistant cancers, but widening losses and early-stage data temper enthusiasm.

BeyondSpring's Q1 results present a mixed clinical and financial picture. The company's lead asset Plinabulin is generating early efficacy signals in metastatic NSCLC and Hodgkin lymphoma patients who have failed PD-1/PD-L1 inhibitors—addressing a significant unmet need for the estimated 60% of cancer patients who progress on these therapies. Particularly notable is the 19+ month duration of response observed in heavily pretreated Hodgkin lymphoma patients who had failed multiple prior lines including stem cell transplant, CAR-T, and PD-1 inhibitors.

The company's partially-owned SEED Therapeutics platform is advancing a first-in-class RBM39 degrader toward an IND filing by mid-2025, with compelling preclinical data showing complete tumor regression in Ewing sarcoma models. Their dual-PROTAC approach targeting KRAS G12D mutations—a historically undruggable target—represents another potentially valuable asset in development.

Financially, expenses are trending upward with R&D costs increasing 21% to $874,000 and G&A expenses rising 30% to $1,736,000 year-over-year. This resulted in a 24% wider net loss of $2.58 million compared to Q1 2024. The recent sale of a portion of SEED preferred shares (retaining ~40% ownership) has complicated financial reporting, with SEED now treated as discontinued operations.

While the clinical data shows promise, investors should note these are still early-stage results. The Plinabulin safety database of 700+ patients provides some risk mitigation, but the path to commercialization remains long and uncertain. The company's focus on immunotherapy-resistant cancers and collaboration with prestigious cancer centers (Dana-Farber, MSK, MD Anderson) represents a scientifically sound strategy in high-value oncology indications.

• 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 360^o 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. 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			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. 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 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

FAQ

What were BeyondSpring's (BYSI) key financial results for Q1 2025?

BeyondSpring reported a net loss of $2.58M from continuing operations, with R&D expenses of $874,000 (up 21%) and G&A expenses of $1.74M (up 30%) compared to Q1 2024.

What are the latest clinical results for BYSI's Plinabulin drug?

Plinabulin showed promising results in NSCLC and Hodgkin lymphoma patients who failed PD-1/L1 inhibitors, with Phase 1 study showing over 19 months duration of response in heavily pretreated Hodgkin lymphoma patients.

What is the status of BeyondSpring's SEED RBM39 degrader program?

SEED's RBM39 degrader achieved complete tumor regression in Ewing sarcoma models and is on track for IND filing in mid-2025.

How many patients have been treated with Plinabulin and what is its safety profile?

Plinabulin has been administered to more than 700 patients with a favorable safety profile.

What is BeyondSpring's current ownership stake in SEED?

BeyondSpring currently owns approximately 40% of the outstanding equity interest in SEED following a partial sale of Series A-1 Preferred Shares in January 2025.