BeyondSpring(BYSI) - 2025 Q3 - Quarterly Report

Clinical Development - Plinabulin has been administered to over 700 cancer patients, demonstrating generally good tolerability and is being developed for various cancer indications, particularly in NSCLC with EGFR wild type [154]. - The DUBLIN-3 Phase 3 study enrolled 559 patients and showed a statistically significant overall survival benefit with a hazard ratio of 0.76, alongside an 80% reduction in grade 4 neutropenia from over 33% to 5% (p<0.0001) [156]. - Plinabulin is being studied in multiple combination therapies, including with Keytruda® and docetaxel for NSCLC patients who have progressed on PD-1/PD-L1 therapies [156]. - The company plans to file a New Drug Application (NDA) with the NMPA for Plinabulin as soon as possible following positive study results [156]. Financial Performance - Consolidated net loss for the three months ended September 30, 2025, was $4.9 million, with an accumulated deficit of $406.3 million as of the same date [163]. - For the three months ended September 30, 2025, the company reported no revenue from product sales, with discontinued operations generating $0.5 million in revenue [172]. - The net loss from continuing operations for the three months ended September 30, 2025, was $1.7 million, a 21% improvement from a loss of $2.2 million in 2024 [181]. - The company incurred a net loss of $8.4 million for the nine months ended September 30, 2025, representing a 30% reduction from a loss of $11.9 million in 2024 [192]. - The company reported a net loss of $8.4 million for the nine months ended September 30, 2025, compared to a net loss of $12.0 million in 2024 [196]. Cash Flow and Capital Resources - The company has raised approximately $299.0 million in equity financings and held $12.5 million in cash and cash equivalents as of September 30, 2025 [162]. - Cash and cash equivalents as of September 30, 2025, were $12.5 million, with the company needing additional capital resources to meet operational expenses [193]. - The company reported a net cash used in operating activities of $14.3 million for the nine months ended September 30, 2025, compared to $17.4 million in 2024 [194]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $14.3 million, a decrease of $3.1 million from $17.4 million in 2024 [196]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $15.9 million, primarily from $15.9 million cash proceeds from maturity of time deposits [198]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $3.0 million, a significant decrease from $24.9 million in 2024 [199]. - The company anticipates that its current financial resources will allow it to meet operational expenses and capital expenditures in the next 12 months [193]. - The company anticipates needing additional funding for future operations due to ongoing development and regulatory approval processes [200]. - Future capital requirements will depend on various factors, including the success of product candidates in clinical development and regulatory reviews [203]. Operational Changes - SEED Technology Limited, a majority-owned subsidiary, has been classified as discontinued operations, with the company owning approximately 38.03% of SEED's outstanding equity interest as of September 30, 2025 [169]. - The company is exploring strategic options including licensing, partnerships, or a sale to support its business plan and maximize shareholder value [164]. - The company has lease commitments for office space in New Jersey with a monthly rent of $26,344, set to increase in August 2026 [205]. - The company is entitled to receive a rent subsidy of approximately $31,000 from the local government in Dalian, China [206]. - The company has entered into a government grant agreement committing to specific operational conditions until 2033 [208]. Expenses - Research and development expenses increased by 67% to $1.0 million for the three months ended September 30, 2025, compared to $0.6 million in the same period of 2024 [182]. - General and administrative expenses decreased by 57% to $0.8 million for the three months ended September 30, 2025, down from $1.7 million in 2024 [184]. - For the nine months ended September 30, 2025, research and development expenses totaled $2.9 million, a 34% increase from $2.2 million in the same period of 2024 [187]. - The total other income, net, for the three months ended September 30, 2025, was $73, a decrease of 49% from $143 in 2024 [181]. - Cash inflows from discontinued operations were used to support their own operations, indicating no negative impact on the liquidity of continuing operations [195].