On November 13, 2026 BeyondSpring Inc. (NASDAQ: BYSI) ("BeyondSpring" or the "Company"), a clinical-stage company developing innovative therapies for the treatment of cancer and other diseases, reported 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.

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"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.

(Press release, BeyondSpring Pharmaceuticals, NOV 13, 2026, View Source [SID1234674747])