FLORHAM PARK, N.J., Feb. 09, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced that the Company will participate in the Immuno-Oncology 360° (IO360°) Conference 2026, held February 10-12, 2026 in Boston, MA. Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring, will present on Plinabulin as a differentiated immuno-oncology asset designed to enhance PD-1/PD-LD blockade and ...

Group 1 - ZIM Integrated Shipping Services Ltd shares increased by 7.6% to $21.38 in pre-market trading following an update on a strategic review [1] - The company received multiple competitive proposals from strategic parties to acquire all outstanding shares, which the board is currently evaluating to enhance shareholder value [1]

Core Insights - BeyondSpring Inc. announced significant findings from the Asian subset of its Phase 3 DUBLIN-3 trial, demonstrating that Plinabulin combined with docetaxel improves overall survival in patients with EGFR wild-type non-small cell lung cancer (NSCLC) [1][4] Group 1: Clinical Trial Results - In the Asian intent-to-treat cohort, the combination of Plinabulin and docetaxel (DP) achieved a median overall survival of 10.8 months compared to 8.8 months for docetaxel alone (D), with a hazard ratio of 0.81 and a p-value of 0.0426 [2] - The mechanism-based non-squamous subgroup showed a hazard ratio of 0.69 with a median overall survival benefit of 3 months (p=0.0064), indicating enhanced efficacy in patients aligned with Plinabulin's immune-modulating mechanisms [8] Group 2: Safety and Tolerability - Plinabulin significantly reduced the incidence of docetaxel-induced grade 4 neutropenia (3.9% for DP vs. 26.5% for D, p<0.0001), while maintaining a favorable tolerability profile, which is crucial for chemotherapy benefit [3] - The safety improvements support better treatment exposure, which is an important factor in the effectiveness of chemotherapy [3] Group 3: Company Overview and Future Directions - BeyondSpring is focused on developing first-in-class therapies for high unmet medical needs, with Plinabulin as its lead asset in late-stage clinical development for NSCLC and other indications [7] - The company plans to advance Plinabulin into a global Phase 3 confirmatory study, bolstered by the robust evidence from the DUBLIN-3 trial [5]

Core Insights - BeyondSpring Inc. announced new post-hoc analyses from its Phase 3 DUBLIN-3 Study, indicating that Plinabulin combined with docetaxel offers significant clinical benefits for patients with EGFR wild-type non-squamous non-small cell lung cancer who have progressed after anti-PD-(L)1 therapy [1][6] Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to address high unmet medical needs, with its lead asset, Plinabulin, in late-stage clinical development for non-small cell lung cancer and other indications [12] Study Findings - The DUBLIN-3 Study involved 559 patients with EGFR wild-type NSCLC who progressed after first-line platinum-based therapy, showing that the combination of Plinabulin and docetaxel resulted in improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) compared to docetaxel alone [11][7] - Median OS for the Plinabulin + docetaxel group was 15.8 months compared to 11.7 months for docetaxel alone, with a hazard ratio (HR) of 0.55 [7] - Median PFS was 5.6 months for the combination therapy versus 3.8 months for docetaxel alone, with an HR of 0.67 [7] - The ORR was 18.2% for the combination compared to 8.0% for docetaxel alone [7] Mechanism of Action - Plinabulin operates through a unique dendritic-cell maturation mechanism, which aids in restoring antigen presentation and T-cell function after resistance to checkpoint inhibitors [4][10] Future Plans - BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial to further evaluate the Plinabulin + docetaxel combination in patients with non-squamous EGFR wild-type NSCLC after progression on anti-PD-(L)1 therapy [4][6] Safety Profile - The combination therapy significantly reduced the incidence of grade 4 neutropenia (5.13% vs. 33.58%, p<0.0001) and showed a decrease in exposure-adjusted grade 3/4 adverse events compared to docetaxel alone, supporting prolonged treatment exposure and improved clinical outcomes [8][6]

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].

Financial Performance - BeyondSpring reported a net loss of $1.7 million for Q3 2025, an improvement from a net loss of $2.2 million in Q3 2024[10] - The company reported a net loss of $6.2 million for the nine months ended September 30, 2025, compared to $6.9 million for the same period in 2024[10] - For the three months ended September 30, 2024, the net loss attributable to BeyondSpring Inc. was $2,132,000, compared to a net loss of $1,540,000 for the same period in 2025[18] - The comprehensive loss attributable to operations for the three months ended September 30, 2024, was $2,712,000, compared to a loss of $1,646,000 in 2025[19] - The net loss from discontinued operations for the three months ended September 30, 2024, was $2,358,000, compared to a loss of $3,201,000 in 2025, showing an improvement[18] - The net loss before income tax for the nine months ended September 30, 2024, was $6,946,000, compared to $6,137,000 in 2025, indicating a worsening financial position[18] Research and Development - Research and development (R&D) expenses increased to $1.0 million in Q3 2025, up from $0.6 million in Q3 2024, primarily due to higher drug manufacturing and regulatory affairs costs[10] - Research and development expenses for the nine months ended September 30, 2024, were $2,172,000, compared to $2,915,000 in 2025, indicating a decrease of approximately 25.5%[18] - BeyondSpring's lead asset, Plinabulin, is in late-stage clinical development targeting NSCLC and other indications, focusing on immune modulation and tumor resensitization[11] Cash and Assets - Cash and cash equivalents rose significantly to $12.5 million as of September 30, 2025, compared to $2.9 million as of December 31, 2024[10] - Current assets decreased to $11.4 million as of September 30, 2025, down from $25.3 million as of December 31, 2024[10] Operational Efficiency - General and administrative (G&A) expenses decreased to $0.8 million in Q3 2025 from $1.7 million in Q3 2024, reflecting lower consulting and salary expenses[10] - General and administrative expenses decreased to $1,736,000 for the three months ended September 30, 2024, from $751,000 in 2025, reflecting a significant increase in operational efficiency[18] Clinical Outcomes - The disease control rate for Plinabulin in combination with docetaxel and Keytruda was reported at 85% for metastatic NSCLC patients who progressed after PD-1/L1 inhibitors[5] - The median progression-free survival (PFS) for Plinabulin in a Phase 2 study was 7.0 months, with a 12-month overall survival (OS) rate of 79%[6] Equity and Financing - BeyondSpring's equity share in SEED Therapeutics is approximately 38%, with SEED completing a $30 million Series A-3 financing[7]

Core Insights - BeyondSpring Inc. reported Q3 2025 financial results and highlighted significant clinical and corporate milestones, particularly focusing on its lead asset, Plinabulin, which is in late-stage development for cancer treatment [1][2]. Clinical Developments - Plinabulin has shown a favorable safety profile and potential as an immune-modulating therapy, with over 700 patients treated. It demonstrated an 85% disease control rate in combination with docetaxel and Keytruda for metastatic non-small cell lung cancer (NSCLC) patients who progressed after PD-1/L1 inhibitors [2][4]. - The global Phase 3 DUBLIN-3 trial results published in The Lancet Respiratory Medicine indicated that Plinabulin combined with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia [2][4]. - A Phase 2 study showed a median progression-free survival (PFS) of 7.0 months and a 12-month overall survival (OS) rate of 79% for patients treated with Plinabulin, docetaxel, and pembrolizumab [5]. Financial Performance - For the nine months ended September 2025, the net loss was $6.2 million, a decrease from $6.9 million for the same period in 2024. The net loss for Q3 2025 was $1.7 million, compared to $2.2 million in Q3 2024 [7][10]. - Research and development (R&D) expenses increased to $2.9 million for the nine months ended September 2025, up from $2.2 million in the same period in 2024, primarily due to higher drug manufacturing and regulatory affairs expenses [10][17]. - General and administrative (G&A) expenses decreased to $3.4 million for the nine months ended September 2025, down from $4.9 million in 2024, attributed to lower salary expenses and professional service costs [10][17]. Corporate Milestones - SEED Therapeutics, co-founded by BeyondSpring, completed a $30 million Series A-3 financing and received IND clearance from both the US FDA and China NMPA for its lead program targeting RBM39 [4][5]. - SEED was named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award, highlighting its innovative approach in the field of targeted protein degradation [4][5].

Core Insights - Chinese concept stocks experienced significant gains, with the top five performers showing substantial percentage increases in their stock prices [1] Group 1: Stock Performance - Meiyantang (MCTA) surged by 75%, closing at 7.000 with a trading volume of 27.48 million [1] - Kuke Music (KUKE) rose by 39.18%, reaching a price of 1.3900 and a trading volume of 1.99 million [1] - Wanchun Pharmaceutical (BYSI) increased by 26.44%, closing at 2.200 with a trading volume of 548,600 [1] - Juhua Mall (JWEL) saw a rise of 23.98%, ending at 2.120 with a trading volume of 25.46 million [1] - Smart Logistics (SLGB) gained 19.01%, closing at 3.130 with a trading volume of 598,280 [1]

Group 1 - The 2025 Annual Meeting of Shareholders for BeyondSpring Inc. was officially called to order by the Chair of the Board and CEO, Lan Huang [2] - A notice of the meeting was sent to all shareholders of record as of August 6, 2025, and a quorum was confirmed with more than a majority of outstanding shares present [3] - The only item on the agenda was the ratification of CBIZ as the independent registered public accounting firm for the fiscal year ending December 31, 2025, with a recommendation from the Board for shareholders to vote in favor [4]

Core Viewpoint - Nestlé is facing significant leadership turmoil following the abrupt firing of CEO Laurent Freixe due to a romantic relationship with a subordinate, marking the second CEO ouster in just over a year, which has led to increased pressure on Chair Paul Bulcke to resign [1][4][5]. Leadership Changes - Laurent Freixe was dismissed without severance pay after an internal investigation confirmed his affair, which was reportedly an "open secret" within the company [1][7]. - This dismissal follows the ousting of former CEO Mark Schneider in August 2024, leading to concerns about governance and stability within Nestlé [4][11]. - Philipp Navratil, previously head of Nespresso, has been appointed as the new CEO, but investors are skeptical about his ability to lead the entire conglomerate [5][15]. Investor Sentiment - Major shareholders are expressing dissatisfaction with Bulcke's leadership, with calls for his resignation due to the perceived governance failures and the impact on the company's credibility [5][10][16]. - Nearly 10% of shareholders voted against Bulcke's re-election as chair at the annual meeting, with an additional 5.4% abstaining [9]. Governance Concerns - The repeated leadership changes have raised alarms about the governance structure at Nestlé, with critics arguing that Bulcke's dual influence over management and the board has shielded him from accountability [9][10][12]. - Investors are concerned about the effectiveness of the board, with some suggesting that an external leader is needed to address the ongoing issues [12][16]. Financial Impact - Nestlé's shares have fallen 40% since 2022, resulting in billions in lost market value amid stagnating sales and governance scandals [9][17]. - The leadership crisis is seen as a core issue affecting investor trust, with shareholders indicating that Bulcke's continued presence could exacerbate the situation [16].