BeyondSpring Reports Third-Quarter 2026 Financial Results and Provides Corporate Update

Rhea-AI Summary

BeyondSpring (NASDAQ: BYSI) reported third-quarter 2026 net income of $50.492 million, reflecting a gain on the sale of subsidiary interests. The $53.674 million gain accompanied a continuing-operations loss of $2.064 million, versus $1.622 million a year earlier. Cash and short-term investments fell to $580,000 from $3.967 million at year-end 2025.

On September 30, BeyondSpring completed the sale of its subsidiary BeyondSpring to Biolin. Non-cash consideration includes funding support for China trial activities expected to enroll approximately 221 of DUBLIN-4’s planned 442 patients, with BeyondSpring receiving access to the data. The company is targeting an interim analysis at 221 progression-free survival events. The FDA granted Fast Track designation to Plinabulin plus docetaxel for previously treated, advanced or metastatic non-squamous lung cancer without actionable genomic alterations. BeyondSpring continues pursuing financing and strategic opportunities.

19 points · 1 major

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1 major · 6 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointThird-quarter net income reached $50.492 million, versus a $4.944 million loss a year earlier, including the subsidiary-sale gain.
• Moderate pointPlinabulin plus docetaxel received FDA Fast Track designation for the previously treated lung cancer population targeted by DUBLIN-4.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Completed Biolin transaction provides non-cash funding support for China activities expected to enroll approximately 221 DUBLIN-4 patients.
• Moderate pointShareholders’ equity reached $15.245 million, versus a $23.990 million deficit at year-end 2025.
• Minor pointBeyondSpring retains access to clinical data generated by the China portion of DUBLIN-4.

14 minor points

• Minor pointNine-month net income reached $38.118 million, versus an $8.423 million loss a year earlier.
• Minor pointThird-quarter earnings per share reached $1.24, versus a $0.04 loss a year earlier.
• Minor pointNine-month earnings per share rose to $1.16, versus $0.03 a year earlier.
• Minor pointNine-month continuing-operations loss narrowed to $5.736 million from $5.786 million a year earlier.
• Minor pointNine-month administrative expenses fell to $2.674 million from $3.188 million a year earlier.
• Minor pointDUBLIN-3 non-squamous subgroup showed improved overall survival versus docetaxel alone: hazard ratio 0.72; p=0.0078.
• Minor pointDUBLIN-3 combination treatment doubled two- and three-year survival rates versus docetaxel alone.
• Minor pointDUBLIN-3 combination treatment improved progression-free survival and tumor response rates versus docetaxel alone.
• Minor pointDUBLIN-3 combination treatment reduced severe grade 4 neutropenia versus docetaxel alone: p<0.0001.
• Minor pointDUBLIN-3 post-immunotherapy subgroup’s exploratory analysis showed median survival of 15.8 months versus 11.7 months; hazard ratio 0.55.
• Minor pointDUBLIN-3 post-immunotherapy subgroup’s exploratory analysis showed tumor response rates of 18.2% versus 8.0%.
• Minor pointPhase 2 Study 303 reported median progression-free survival of 7.0 months with the three-drug combination.
• Minor pointStudy 303 reported 79.5% disease control and an 18.2% confirmed tumor response rate.
• Minor pointStudy 303 reported 58% two-year survival, nearly double the historical docetaxel rate in a similar population.

Negative

• Major pointCash and short-term investments fell to $580,000 from $3.967 million at December 31, 2025.
• Moderate pointThird-quarter continuing-operations loss widened to $2.064 million from $1.622 million a year earlier.
• Moderate pointBeyondSpring continues pursuing financing and strategic opportunities to support global DUBLIN-4 execution.
• Minor pointThird-quarter research expenses rose to $1.107 million from $968,000 a year earlier.
• Minor pointThird-quarter administrative expenses rose to $956,000 from $672,000 a year earlier.
• Minor pointNine-month research expenses rose to $3.071 million from $2.667 million a year earlier.

News Explained

The balance sheet reports ordinary shares issued and outstanding of 41,122,320 on December 31, 2025 and 41,409,059 on September 30, 2026; the higher issued share count reduces an existing holder’s ownership percentage absent offsetting changes.

Key Figures

Quarterly R&D expenses: $1.1 million Quarterly G&A expenses: $1.0 million Quarterly net loss: $2.1 million +4 more

Quarterly R&D expenses

$1.1 million

Quarter ended September 30, 2026; compared with $1.0 million in 2025

Quarterly G&A expenses

$1.0 million

Quarter ended September 30, 2026; compared with $0.7 million in 2025

Quarterly net loss

$2.1 million

Quarter ended September 30, 2026; compared with $1.6 million in 2025

Cash, cash equivalents and short-term investments

$0.6 million

As of September 30, 2026; compared with $4.0 million at December 31, 2025

Planned global DUBLIN-4 enrollment

442 patients

Global Phase 3 trial

Expected China enrollment

Approximately 221 patients

Approximately half of planned DUBLIN-4 enrollment; supported by Biolin funding

Interim analysis trigger

221 progression-free survival events

Prespecified DUBLIN-4 interim analysis

Previous Earnings Reports

1 past event · Latest: Aug 14

Same Type 1 event

1. Aug 14

   Q2 earnings

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   -15.2%

   Q2 results included $6.5 million in cash and investments at June 30 and updated Phase 2 data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fast track designation, progression-free survival, overall survival, antibody-drug conjugates

4 terms

fast track designation regulatory

"FDA granted Fast Track designation to Plinabulin plus docetaxel"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

progression-free survival medical

"prespecified interim analysis at 221 progression-free survival events"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"demonstrated a statistically significant improvement in OS"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

antibody-drug conjugates medical

"chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors"

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

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FDA Fast Track Designation for Plinabulin plus docetaxel marks key regulatory milestone in DUBLIN-4 study population of Post-ICI Non-Squamous NSCLC with no actionable genomic alteration (AGA)

Strategic transaction with Biolin provides data from approximately half of DUBLIN-4’s 442 patients and supports the planned interim analysis at 221 PFS events

FLORHAM PARK, N.J., Nov. 13, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, today announced its financial results for the quarter ended September 30, 2026, and provided a corporate update highlighting regulatory and strategic progress for Plinabulin and its global Phase 3 DUBLIN-4 trial.

“The third quarter marked an important regulatory and strategic step forward for Plinabulin,” said Min Qiu, Chief Executive Officer of BeyondSpring. “The FDA’s Fast Track designation underscores the significant unmet need for new treatment options for NSCLC patients without AGA and progressing after immune checkpoint inhibitor therapy, where docetaxel is still the standard of care.  Plinabulin has been shown to improve the tolerability and dose intensity of docetaxel and demonstrated a long-term survival benefit in the previous successful DUBLIN-3 study in second- and third-line EGFR wild-type NSCLC, published in The Lancet Respiratory Medicine in 2024.”

Mr. Qiu continued, “With an FDA-aligned Phase 3 design and a strategic transaction with Biolin to support approximately half of DUBLIN-4’s planned 442-patient enrollment, generating quality data from China, we remain focused on advancing the study toward its prespecified interim analysis at 221 progression-free survival events. We believe positive interim results could represent a significant value inflection point for BeyondSpring, as we continue to pursue financing and strategic opportunities to support global execution.”

Recent Regulatory, Clinical and Corporate Highlights

FDA Fast Track designation for Plinabulin plus docetaxel in post-ICI non-squamous NSCLC

• The Company announced that the U.S. Food and Drug Administration granted Fast Track designation to Plinabulin plus docetaxel for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA), following prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
• The designated population corresponds to the second- or third-line patient population targeted in the global DUBLIN-4 trial. Fast Track designation may facilitate more frequent FDA interactions and, if applicable criteria are met, rolling review of a future application.

Strategic transaction to fund half of DUBLIN-4’s planned patient enrollment

• The Company completed the sale of BeyondSpring Ltd., its wholly owned subsidiary that indirectly held the majority equity interest in Dalian Wanchunbulin Pharmaceuticals Ltd. (“Bulin”), to Biolin Investment Limited (“Biolin”) on September 30, 2026, pursuant to a definitive agreement among the parties.
• As non-cash consideration, Biolin will support the funding of DUBLIN-4 clinical development activities conducted by Bulin at participating sites in China, which are expected to include enrollment of approximately 221 patients, or approximately half of the planned 442-patient global enrollment. BeyondSpring will receive access to clinical data generated from the China portion of the trial.

Third Quarter Financial Results

Continuing operations:

• Research and development (R&D) expenses were $1.1 million for the quarter ended September 30, 2026, compared to $1.0 million for the quarter ended September 30, 2025. The increase of $0.1 million was primarily due to a $0.3 million increase in preclinical expenses related to Plinabulin treatment combination research in support of strategic business development and partnership initiatives, partially offset by lower patent-related legal services and drug manufacturing costs.
• General and administrative (G&A) expenses were $1.0 million for the quarter ended September 30, 2026, compared to $0.7 million for the quarter ended September 30, 2025. The increase of $0.3 million was primarily due to an increase in legal fees related to financing activities and higher consulting expenses related to accounting advisory and audit services, partially offset by lower personnel-related and travel expenses.
• Net loss was $2.1 million for the quarter ended September 30, 2026, compared to $1.6 million for the quarter ended September 30, 2025.
• Cash, cash equivalents, and short-term investments were $0.6 million as of September 30, 2026, compared to $4.0 million as of December 31, 2025.

Year-to-Date Financial Results

Continuing operations:

• Research and development (R&D) expenses were $3.1 million for the nine months ended September 30, 2026, compared to $2.7 million for the nine months ended September 30, 2025. The increase of $0.4 million was primarily due to expanded drug manufacturing activities and increased preclinical Plinabulin treatment combination research, partially offset by lower patent-related legal services and personnel-related expenses.
• General and administrative (G&A) expenses were $2.7 million for the nine months ended September 30, 2026, compared to $3.2 million for the nine months ended September 30, 2025. The decrease of $0.5 million was primarily due to lower personnel-related expenses, mainly from lower incentive compensation and share-based compensation, as well as lower professional service expenses in legal advisory and lower travel and entertainment expenses.
• Net loss was $5.7 million for the nine months ended September 30, 2026, compared to $5.8 million for the nine months ended September 30, 2025.

About BeyondSpring
BeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for cancers with high unmet needs. Its lead asset, Plinabulin, has been studied in more than 700 cancer patients and is in late-stage development across multiple cancer indications. Plinabulin’s novel mechanism as a GEF-H1 agonist with dendritic cell maturation benefit supports both anticancer activity and immune modulation, offering a unique approach to resensitizing tumors that have progressed on checkpoint inhibitors. In addition, it has the potential to synergize with chemotherapy, antibody-drug conjugates (ADCs), radiation, and checkpoint inhibitors. BeyondSpring is also an early incubator of and maintains an equity interest in SEED Therapeutics, a clinical-stage targeted protein degradation molecular glue company with investments from Eli Lilly and Eisai. Learn more at beyondspringpharma.com.

About Plinabulin and the Clinical Rationale for the DUBLIN-4 Trial
Plinabulin is a late-stage, first-in-class investigational GEF-H1 agonist with a differentiated mechanism of action that includes dendritic cell maturation, anti-angiogenic activity and mitigation of chemotherapy-induced neutropenia. To date, more than 700 cancer patients have been treated with Plinabulin across multiple clinical programs in various cancer types, demonstrating an extensive clinical safety database.

The post-ICI setting remains difficult to treat: 12 Phase 3 trials evaluating different treatment approaches against docetaxel, including four involving ADCs, have failed to demonstrate an overall survival benefit over docetaxel.

In the Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine in 2024, Plinabulin combined with docetaxel demonstrated a statistically significant improvement in OS in second- and third-line EGFR wild-type NSCLC vs. docetaxel alone (n=559), showing superior OS benefit in non-squamous patients (n=332, OS HR 0.72, p=0.0078). The combination also demonstrated statistically significant improvements compared to docetaxel alone, including doubling the 2-year and 3-year survival rates and improvements in PFS and ORR, while also significantly reducing grade 4 neutropenia (p<0.0001).

Importantly, a post hoc analysis of the DUBLIN-3 post-ICI subgroup showed a median OS of 15.8 months with Plinabulin plus docetaxel versus 11.7 months with docetaxel alone (HR 0.55), with ORR of 18.2% versus 8.0%, respectively. These findings support the clinical rationale for Plinabulin’s differentiated dendritic cell maturation mechanism and its further evaluation in DUBLIN-4.

This rationale was further supported by prospective data from the Phase 2 Study 303 (n=47), presented at ASCO 2026. In patients with NSCLC whose disease had progressed following PD-1 inhibitor treatment, the combination of Plinabulin, docetaxel and a PD-1 inhibitor demonstrated encouraging anticancer activity. With a median follow-up of 28.8 months, the Plinabulin combination showed a median PFS of 7.0 months, a disease control rate of 79.5%, and a confirmed ORR of 18.2%, with a 2-year OS rate of 58%, nearly double the historical rate reported with docetaxel in a similar patient population.

Investor Contact: IR@beyondspringpharma.com
Media Contact: PR@beyondspringpharma.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, 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 a number of factors, including, but not limited to, the inability of Biolin and Bulin to perform their respective funding, clinical development, data generation and other obligations; delays or challenges in enrollment or execution of the China portion of DUBLIN-4; regulatory, data-transfer or human-genetic-resources requirements that may affect the transfer or use of China-generated clinical data; the inability of such data to support regulatory submissions outside Greater China; the possibility that the transaction may not achieve the anticipated benefits; the possibility that Fast Track designation may not result in a faster development or regulatory review process, and the fact that such designation does not increase the likelihood of regulatory approval; difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all; unexpected results from preclinical studies or clinical trials; the risk that preclinical results may not be predictive of clinical results; delays in, or failure to obtain, regulatory approvals; results that do not meet the Company’s expectations regarding the safety, efficacy, clinical utility, or regulatory pathway 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 and subsequent filings 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.

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, 2025				September 30, 2026
		$				$
					(Unaudited)
Assets
Current assets:
Cash and cash equivalents		2,967				580
Short term investments		1,000				-
Advances to suppliers		105				112
Prepaid expenses and other current assets		68				592
Current assets of discontinued operations		16,742				-
Total current assets		20,882				1,284
Noncurrent assets:
Property and equipment, net		155				117
Operating right-of-use assets		278				88
Long-term equity investment		-				18,373
Other noncurrent assets		98				-
Noncurrent assets of discontinued operations		4,520				-
Total noncurrent assets		5,051				18,578
Total assets		25,933				19,862
Liabilities and equity
Current liabilities:
Accounts payable		256				743
Accrued expenses		865				2,381
Current portion of operating lease liabilities		307				79
Other current liabilities		770				1,414
Current liabilities of discontinued operations		11,378				-
Total current liabilities		13,576				4,617
Noncurrent liabilities:
Other noncurrent liabilities		90				-
Noncurrent liabilities of discontinued operations		36,257				-
Total noncurrent liabilities		36,347				-
Total liabilities		49,923				4,617
Shareholders’ equity (deficit)
Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 41,122,320 and 41,409,059 shares issued and outstanding as of December 31, 2025 and September 30, 2026, respectively)		4				4
Additional paid-in capital		375,664				375,924
Accumulated deficit		(408,431	)			(360,647	)
Accumulated other comprehensive income (loss)		602				(36	)
Total BeyondSpring Inc.’s shareholders’ (deficit) equity		(32,161	)			15,245
Noncontrolling interests		8,171				-
Total shareholders’ (deficit) equity		(23,990	)			15,245
Total liabilities and shareholders’ (deficit) equity		25,933				19,862

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 September 30,								Nine months ended September 30,
	2025				2026				2025				2026
		$				$				$				$
Revenue		-				-				-				-
Operating expenses
Research and development		(968	)			(1,107	)			(2,667	)			(3,071	)
General and administrative		(672	)			(956	)			(3,188	)			(2,674	)
Loss from operations		(1,640	)			(2,063	)			(5,855	)			(5,745	)
Foreign exchange gain (loss), net		1				(1	)			8				(2	)
Interest income		19				-				63				11
Loss before income tax		(1,620	)			(2,064	)			(5,784	)			(5,736	)
Income tax expenses		(2	)			-				(2	)			-
Net loss from continuing operations		(1,622	)			(2,064	)			(5,786	)			(5,736	)
Discontinued operations
Loss from discontinued operations		(3,298	)			(1,015	)			(9,557	)			(9,425	)
Gain on sale of subsidiary interests		-				53,674				6,986				53,674
Income tax expenses		(24	)			(103	)			(66	)			(395	)
Net income (loss) from discontinued operations		(3,322	)			52,556				(2,637	)			43,854
Net income (loss)		(4,944	)			50,492				(8,423	)			38,118
Less: Net loss attributable to noncontrolling interests from discontinued operations		(3,404	)			(300	)			(9,554	)			(9,666	)
Net income (loss) attributable to BeyondSpring Inc.		(1,540	)			50,792				1,131				47,784
Earnings (loss) per share, basic and diluted
Continuing operations		(0.04	)			(0.05	)			(0.14	)			(0.14	)
Discontinued operations		0.00				1.29				0.17				1.30
Basic and diluted earnings (loss) per share		(0.04	)			1.24				0.03				1.16
Weighted-average shares outstanding
Basic and diluted		40,317,266				41,119,820				40,316,639				41,119,820
Other comprehensive loss, net of tax of nil:
Foreign currency translation adjustment loss from continuing operations		-				-				-				-
Foreign currency translation adjustment loss from discontinued operations		(183	)			(281	)			(711	)			(1,248	)
Comprehensive income (loss)		(5,127	)			50,211				(9,134	)			36,870
Less: Comprehensive loss attributable to noncontrolling interests from continuing operations		-				-				-				-
Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations		(3,481	)			(490	)			(9,842	)			(10,276	)
Comprehensive income (loss) attributable to BeyondSpring Inc.		(1,646	)			50,701				708				47,146

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were BeyondSpring’s third-quarter 2026 earnings?

BeyondSpring reported $50.492 million in net income and $1.24 in basic and diluted earnings per share. Results included a $53.674 million gain on the sale of subsidiary interests. Continuing operations recorded a $2.064 million loss, compared with a $1.622 million loss a year earlier.

How does BeyondSpring’s Biolin transaction support DUBLIN-4?

Biolin will support funding for China clinical development activities expected to enroll approximately 221 patients, approximately half of DUBLIN-4’s planned 442-patient enrollment. This is non-cash consideration for the subsidiary sale completed September 30, 2026. BeyondSpring receives access to the China trial data and plans an interim analysis at 221 progression-free survival events.

What could Fast Track designation mean for BeyondSpring’s Plinabulin combination?

Fast Track designation may facilitate more frequent FDA interactions and rolling review of a future application if applicable criteria are met. The designated population has advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations, following prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

What treatment and patient group did BeyondSpring’s Phase 2 Study 303 evaluate?

Study 303 evaluated Plinabulin, docetaxel and a PD-1 inhibitor in 47 patients with non-small cell lung cancer that had progressed following PD-1 inhibitor treatment. Results were presented at ASCO 2026, with median follow-up of 28.8 months.