BeyondSpring(BYSI)
Search documents
Why ZIM Integrated Shipping Services Shares Are Trading Higher By Around 8%; Here Are 20 Stocks Moving Premarket - ReAlpha Tech (NASDAQ:AIRE), BeyondSpring (NASDAQ:BYSI)

Benzinga· 2025-12-23 10:16
Shares of ZIM Integrated Shipping Services Ltd (NYSE:ZIM) rose sharply in pre-market trading after the company provided an update on an ongoing strategic review.ZIM Integrated Shipping said it received multiple competitive proposals from strategic parties to acquire all outstanding shares of the company. ZIM's board is currently evaluating the proposals to provide significant value to shareholders.ZIM shares jumped 7.6% to $21.38 in the pre-market trading session.Here are some other stocks moving in pre-mar ...
BeyondSpring Announces ESMO Asia Presentation on Plinabulin + Docetaxel Improving Survival in Large Phase 3 DUBLIN-3 Asian Subset for EGFR WT NSCLC Compared to Docetaxel, Strengthening the Case for a Global Registration Path
Globenewswire· 2025-12-12 12:00
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]
BeyondSpring Announces New Analyses of DUBLIN-3 Phase 3 Study Showing Survival Benefit of Plinabulin + Docetaxel in Post Anti-PD-(L)1 for Non-squamous EGFR WT NSCLC and a Reduction in Brain Metastasis Compared to Docetaxel at NACLC 2025
Globenewswire· 2025-12-11 12:00
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]
BeyondSpring(BYSI) - 2025 Q3 - Quarterly Report
2025-11-12 21:31
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].
BeyondSpring(BYSI) - 2025 Q3 - Quarterly Results
2025-11-12 12:00
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]
BeyondSpring Reports Third‑Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-12 12:00
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].
美股异动丨美妍堂涨75%,为涨幅最大的中概股
Ge Long Hui· 2025-10-22 00:16
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]
BeyondSpring Inc. (BYSI) 2025 Annual Shareholders Meeting (Transcript)
Seeking Alpha· 2025-09-15 14:24
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]
Nestlé chair Paul Bulcke under fire after ouster of CEO Lauren Freixe over romantic relationship with subordinate
New York Post· 2025-09-15 14:21
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].
万春医药上涨6.25%,报1.87美元/股,总市值7542.14万美元
Jin Rong Jie· 2025-08-25 13:48
Group 1 - The core viewpoint of the article highlights the financial performance and market position of BeyondSpring Inc. (BYSI), a biopharmaceutical company focused on innovative cancer therapies [1] - As of August 25, BYSI's stock opened at $1.87 per share, reflecting a 6.25% increase, with a total market capitalization of $75.42 million [1] - Financial data shows that for the period ending June 30, 2024, BYSI reported total revenue of $1.00 million, representing a year-over-year growth of 14.29%, while the net profit attributable to shareholders was -$7.26 million, indicating a 42.91% increase in losses compared to the previous year [1] Group 2 - BeyondSpring is a clinical-stage biopharmaceutical company established in 2013, headquartered in the United States, focusing on the development of novel cancer therapies, including advanced tumor immunotherapy [1] - The company's primary project, Plinabulin, is derived from natural compounds and has therapeutic potential for various cancers due to its biochemical activities [1] - BeyondSpring employs a novel, highly scalable business model that integrates resources from both the U.S. and China to efficiently and cost-effectively achieve drug approval and development [1] - The target research areas include non-small cell lung cancer, prevention of neutropenia, and Plinabulin combined with PD-1 monoclonal antibodies [1]