Key Highlights

● BeyondSpring agreed to sell its majority equity interest in Chinese unit Bulin to Biolin Investment Limited on September 28.

● Biolin pays no cash at closing and must complete the China portion of DUBLIN-4, about 221 of roughly 442 patients.

● Citizens JMP Securities may sell up to 9,200,000 shares under an at-the-market program, with commission up to 3.0 percent.

● The FDA granted Fast Track designation to plinabulin plus docetaxel in advanced or metastatic non-squamous non-small cell lung cancer.

BeyondSpring Inc. (NASDAQ:BYSI) announced three related developments in a Form 8-K filed September 29, 2026. It agreed on September 28 to sell its majority equity interest in its Chinese unit Dalian Wanchunbulin Pharmaceuticals Ltd., known as Bulin, to Biolin Investment Limited, which will fund the China portion of the Phase 3 DUBLIN-4 trial of plinabulin plus docetaxel. It set up an at-the-market program for up to 9,200,000 ordinary shares with Citizens JMP Securities. And it announced that the FDA granted Fast Track designation to plinabulin plus docetaxel in non-squamous non-small cell lung cancer.

The Bulin Sale

The filing describes a Share Purchase and Collaboration Agreement dated September 28, 2026 among BeyondSpring, Bulin and Biolin, a Hong Kong entity. The company will transfer the entire issued share capital of BeyondSpring Ltd., a British Virgin Islands company that holds the majority equity in Bulin. The filing states that "No cash consideration will be paid or payable by the Investor to the Company at the closing of the Sale." Instead, the consideration is Biolin's obligation to conduct and complete the China portion of DUBLIN-4, which the press release puts at about 221 of roughly 442 patients.

The agreement includes performance protections. Bulin must use commercially reasonable efforts to enroll a certain number of patients during a three-year post-closing enrollment period. The filing quotes a clawback provision: "if the enrollment shortfall is equal to ninety percent (90%) or greater, the Investor must return one hundred percent (100%) of the Equity Interests." BeyondSpring receives an exclusive, perpetual, sublicensable license to the trial data, and the filing states that no regulatory approval is required to effect the closing. The press release says BeyondSpring retains global rights to plinabulin outside Greater China and expects the arrangement to substantially reduce its cash needs for DUBLIN-4.

The At-The-Market Program

Under an Open Market Sale Agreement signed September 29, 2026, Citizens JMP Securities may sell up to 9,200,000 ordinary shares, par value $0.0001, on BeyondSpring's behalf, with a commission of up to 3.0 percent of gross proceeds. Sales would be made under shelf registration statement 333-280153 and a prospectus supplement dated September 29. The agent must use commercially reasonable efforts to sell shares as directed. The program permits sales but does not require the company to sell any.

Fast Track and the Trial

The FDA granted Fast Track designation to plinabulin plus docetaxel for advanced or metastatic non-squamous NSCLC without actionable genomic alterations, in patients whose disease progressed after anti-PD-(L)1 therapy and platinum-based chemotherapy. Fast Track is a program that facilitates development and can allow rolling review of an application; it does not mean approval.

DUBLIN-4 plans to randomize 442 patients 1:1, with overall survival as the primary endpoint and progression-free survival and objective response rate as secondary endpoints. A prespecified interim analysis is planned at 221 progression-free survival events. The release cites earlier data: in the Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine in 2024, plinabulin plus docetaxel showed an overall survival hazard ratio of 0.72 in non-squamous patients.

Chief Executive Officer Min Qiu is quoted as saying that the designation, "an FDA-aligned global Phase 3 strategy, and funding to support China-generated clinical data would meaningfully strengthen our ability to advance Plinabulin and DUBLIN-4 toward the trial's next major clinical milestone."

Bulin Sale Closing and DUBLIN-4 Enrollment Ahead

The release lists risks that include satisfaction of closing conditions, counterparty performance, enrollment challenges, regulatory and data-transfer complications, the possibility that China data cannot support registrations outside Greater China, financing difficulties, and the company's ability to meet Nasdaq's continued listing requirements. The filing includes a legal opinion from Maples and Calder (Hong Kong) LLP as Exhibit 5.1, and the redacted agreement as Exhibit 10.1. Key items to follow are the closing of the Bulin sale, patient enrollment in China against the three-year period, any sales under the at-the-market program as they appear in later filings, and the interim analysis at 221 events.