BeyondSpring(BYSI)
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BeyondSpring Announces Plinabulin and ADC Combination Poster Presentation at AACR Annual Meeting 2026
Globenewswire· 2026-03-30 11:30
Core Viewpoint - BeyondSpring Inc. is set to present its research on Plinabulin at the 2026 Annual Meeting of the American Association for Cancer Research, highlighting its innovative approach to cancer treatment [1]. Group 1: Company Overview - BeyondSpring Inc. is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for significant unmet medical needs [3]. - The company's lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent for non-small cell lung cancer (NSCLC) and other indications [3]. - Plinabulin operates through a novel mechanism as a dendritic cell maturation agent, which supports both anti-cancer activity and immune modulation, aiming to enhance tumor sensitivity to checkpoint inhibitors [3]. Group 2: Presentation Details - The poster presentation will take place on April 21, 2026, from 2 PM to 5 PM PT at the San Diego Convention Center [4]. - The session will focus on immunology, specifically under the category of T Cell Engagers 2 / Antibody-Drug Conjugates 1 [4]. - The poster will be numbered 5597 and located at Poster Board Number 16 [4].
BeyondSpring(BYSI) - 2025 Q4 - Annual Report
2026-03-25 20:36
Financial Performance - As of December 31, 2025, total assets decreased to $25,933,000 from $34,315,000 in 2024, representing a decline of approximately 24%[753] - The net loss attributable to BeyondSpring Inc. decreased to $1,006,000 in 2025 from $11,123,000 in 2024, reflecting a reduction of about 91%[755] - The total shareholders' deficit increased to $23,990,000 in 2025 from $14,285,000 in 2024, an increase of approximately 68%[753] - The company reported a loss from discontinued operations of $12,488,000 in 2025, compared to $7,828,000 in 2024, which is an increase of about 60%[755] - Basic and diluted loss per share improved to $0.02 in 2025 from $0.28 in 2024, showing a significant reduction in loss per share[755] - BeyondSpring Inc. reported a net loss of $16.693 million for the year ended December 31, 2024, and a net loss of $14.217 million for 2025, indicating a decrease in losses of approximately 8.8% year-over-year[762] - The company incurred $2.255 million in share-based compensation in 2024, which decreased to $722,000 in 2025, a reduction of 68.0%[762] - For the year ended December 31, 2025, the consolidated net loss was $14,217,000, a decrease from $16,693,000 in 2024[920] Cash and Liquidity - Cash and cash equivalents increased to $7,786,000 in 2025 from $2,922,000 in 2024, marking a growth of about 167%[753] - The total cash and cash equivalents from continuing operations at the end of 2025 were $7.786 million, up from $2.922 million at the end of 2024, representing a 167.5% increase[762] - Cash used in operating activities increased to $19.769 million in 2025 from $16.443 million in 2024, reflecting a 20.5% rise in cash outflows[762] - The company’s cash and cash equivalents as of December 31, 2025, were $4,352 million, down from $13,125 million in 2024[841] Liabilities and Shareholder Equity - Total current liabilities increased to $13,576,000 in 2025 from $11,010,000 in 2024, representing a rise of approximately 23%[753] - The total liabilities for the company were $14,899 million as of December 31, 2025, slightly down from $15,010 million in 2024[841] - Total current liabilities increased from $8,813 million in 2024 to $11,133 million in 2025, reflecting a rise of approximately 26.3%[841] Research and Development - Research and development expenses rose to $4,388,000 in 2025, up from $2,644,000 in 2024, indicating an increase of approximately 66%[755] - The company’s research and development expenses increased from $7,503 million in 2024 to $10,853 million in 2025, marking a rise of approximately 44.5%[844] - Clinical and pre-clinical expenses increased from $462,000 in 2024 to $1,630,000 in 2025[920] Revenue and Recognition - The company had no revenue reported for both 2024 and 2025, maintaining a consistent revenue position[755] - The Company recognizes revenue under ASC 606 when control of promised goods or services is obtained by the customer[804] - Collaboration arrangements are assessed under ASC 808 to determine the appropriate revenue recognition method[807] - The Company recognizes revenue from non-refundable upfront fees for licenses at the point in time when the license is transferred to the licensee[810] - The Lilly Collaboration Agreement resulted in recognized collaboration revenue of $2,001 million for both years ended December 31, 2024 and 2025[853] Asset Management - The company reported a decrease in depreciation expenses from $285,000 in 2024 to $87,000 in 2025, a decline of 69.5%[762] - The total long-lived assets of continuing operations decreased from $239,000 in 2024 to $166,000 in 2025[920] - Property and equipment, net, decreased from $239 million in 2024 to $166 million in 2025, a decline of approximately 30.5%[854] Shareholder Information - BeyondSpring Inc. has a total of 41,122,320 ordinary shares outstanding as of December 31, 2025, reflecting an increase from 40,316,320 shares at the end of 2024[765] - The total fair value of share options vested during 2024 was $1,412 million and decreased to $246 million in 2025[876] - As of December 31, 2025, the company had 2,731,806 share options outstanding with a weighted average exercise price of $5.01[875] - The intrinsic value of share options as of December 31, 2025 was $514 million[875] Strategic Initiatives - The Company operates in two reportable segments: Plinabulin pipeline and Targeted Protein Degradation (TPD) platform, with a focus on innovative cancer therapies[801] - On December 13, 2024, the Company approved a divestiture plan to sell 90% to 100% of its interests in SEED, qualifying the TPD platform for discontinued operations reporting[802] - The Company plans to divest approximately 90% to 100% of its interests in SEED, reflecting a strategic shift to optimize resources towards higher potential pipelines[836] - The divestiture of SEED will result in all assets and liabilities being classified as held-for-sale in the consolidated balance sheet as of December 31, 2024, and 2025[836] Taxation - The Company evaluates uncertain tax positions based on ASC 740, recognizing tax benefits that are "more likely than not" to be sustained[817] - The Company uses the liability method for accounting income taxes, with deferred tax assets and liabilities classified as non-current on the balance sheets[816] - The total deferred tax assets increased from $58,995 million in 2024 to $61,321 million in 2025[863] - The company recorded a valuation allowance against deferred tax assets of $57,812 million in both 2024 and 2025, indicating no change[863] Miscellaneous - The Company has not experienced any losses on cash and cash equivalents or short-term investments to date, indicating effective risk management[823] - The Series A-2 Preferred Shares redemption rights were removed on July 26, 2024, reclassifying them from mezzanine equity to permanent equity[909] - The Series A-3 Preferred Shares were classified as permanent equity due to the absence of non-controllable redemption features[911] - Wanchunbulin, a subsidiary, has committed to specific local authorities in PRC until 2033 under a government grant agreement[913]
BeyondSpring Files 2025 Annual Report on Form 10-K
Globenewswire· 2026-03-25 20:30
Core Viewpoint - BeyondSpring Inc. has filed its annual report on Form 10-K for the fiscal year ended December 31, 2025, with the SEC, which includes the company's audited consolidated financial statements [1]. Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for high unmet medical needs [3]. - The company's lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent for non-small cell lung cancer (NSCLC) and other indications [3]. - Plinabulin operates through a novel mechanism as a dendritic cell maturation agent, which supports anti-cancer activity and immune modulation, providing a unique approach to enhancing tumor sensitivity to checkpoint inhibitors [3]. Financial Reporting - The annual report on Form 10-K can be accessed on the SEC's website and the company's website under the "Latest Results" section in the Investors area [1]. - The company offers a hard copy of its annual report containing audited consolidated financial statements free of charge to shareholders upon request [2].
BeyondSpring(BYSI) - 2025 Q4 - Annual Results
2026-03-25 12:30
Financial Performance - BeyondSpring reported a net loss of $14.2 million for the year ended December 31, 2025, compared to a net loss of $16.7 million in 2024, reflecting a decrease of 15%[26] - Net loss attributable to BeyondSpring Inc. was $11.123 million, compared to a loss of $1.006 million in the previous period[27] - Basic and diluted loss per share was $0.28, up from $0.02 in the prior year[27] - Comprehensive loss attributable to BeyondSpring Inc. was $10.681 million, compared to $1.740 million in the previous period[27] - Continuing operations reported a comprehensive loss of $15.966 million, slightly higher than $15.471 million from the previous year[27] - Weighted-average shares outstanding decreased to 39,733,191 from 40,406,347[27] Research and Development - Research and development expenses increased to $4.4 million in 2025 from $2.6 million in 2024, driven by higher costs associated with drug manufacturing and clinical trials[20] - Plinabulin demonstrated a median overall survival improvement of 2.5 months compared to docetaxel in the DUBLIN-3 study, with a hazard ratio of 0.72 (p=0.0078)[13] - The DUBLIN-4 confirmatory trial for Plinabulin is planned to focus on EGFR wild-type NSCLC patients who have progressed on immune checkpoint inhibitors[10] - The overall response rate (ORR) for Plinabulin combined with pembrolizumab and docetaxel in a Phase 2 study was reported at 18.2%[14] - The company reported a favorable safety profile for Plinabulin, reducing grade 4 neutropenia from over 30% to 5% in clinical studies[13] - SEED Therapeutics initiated its first clinical trial following IND clearance in both the U.S. and China, marking a critical milestone for the company[4] Financial Position - The company completed a $30 million Series A-3 financing to strengthen its financial position and support ongoing clinical programs[20] - As of December 31, 2025, cash, cash equivalents, and short-term investments totaled $12.6 million, a significant increase from $2.9 million in 2024[20] - Current assets decreased to $20.9 million in 2025 from $28.6 million in 2024, primarily due to the reclassification of SEED's operations as discontinued[23] Foreign Currency Adjustments - Foreign currency translation adjustment from continuing operations showed a gain of $710, contrasting with a loss of $1,147 in the prior year[27] - Foreign currency translation adjustment from discontinued operations reported a gain of $17, compared to a loss of $107 previously[27] Noncontrolling Interests - Net loss attributable to noncontrolling interests from discontinued operations was $5.182 million, down from $12.969 million[27] - Net loss attributable to noncontrolling interests from continuing operations was $0.388 million, compared to $0.242 million in the previous period[27] - The company experienced a significant increase in comprehensive loss attributable to noncontrolling interests from discontinued operations, which was $5.154 million compared to $13.076 million last year[27]
BeyondSpring Reports 2025 Year-End Financial Results
Globenewswire· 2026-03-25 12:30
Core Insights - BeyondSpring Inc. reported significant clinical and operational progress in 2025, particularly with its lead program Plinabulin, and highlighted strategic developments related to its equity interest in SEED Therapeutics [2][3] Clinical and Operational Progress - The company advanced its Phase 3 Plinabulin program for non-small cell lung cancer (NSCLC) and generated meaningful clinical data [3] - SEED Therapeutics initiated its first clinical trial following IND clearance in both the U.S. and China, marking a critical milestone [3] - Plinabulin demonstrated a statistically significant overall survival benefit in the DUBLIN-3 study compared to docetaxel alone, with a median overall survival improvement of 2.5 months [6][11] - The DUBLIN-4 confirmatory trial is planned to further evaluate Plinabulin in a biomarker-selected patient population [8][9] Financial Developments - BeyondSpring completed a $30 million Series A-3 financing and appointed Dr. Bill Desmarais as Chief Financial Officer and Chief Business Officer [19] - The company reported a net loss of $8.7 million for 2025, slightly improved from a net loss of $8.9 million in 2024 [19][24] - Cash, cash equivalents, and short-term investments totaled $12.6 million as of December 31, 2025 [19] Future Outlook - BeyondSpring is focused on advancing the DUBLIN-4 trial for Plinabulin and supporting SEED's Phase 1a clinical program for ST-01156 in solid tumors [4] - The company aims to create long-term value for shareholders through its strategic initiatives and clinical advancements [4]
BeyondSpring to Participate at the 12th Annual Immuno-Oncology 360° Conference
Globenewswire· 2026-02-09 12:15
Core Viewpoint - BeyondSpring Inc. is participating in the Immuno-Oncology 360° Conference 2026 to present its innovative cancer therapy, Plinabulin, which aims to enhance PD-1/PD-L1 blockade and address resistance in cancer treatment [1][2]. Company Overview - BeyondSpring Inc. is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for high unmet medical needs, with its lead asset, Plinabulin, in late-stage clinical development for non-small cell lung cancer (NSCLC) and other indications [4]. Presentation Details - Dr. Lan Huang, Co-Founder, Chairman, and CEO, will present on the topic "Overcoming PD-1/L1 Resistance: Translational Insights with Plinabulin" on February 11, 2026, from 4:55 PM to 5:10 PM ET at the Sheraton Boston Hotel [3]. - The presentation will be part of the Translational Science & Biomarkers track, focusing on expanding therapeutic horizons [3]. - Following the presentation, slides will be available on the company's website [3]. Mechanism of Action - Plinabulin operates as a dendritic cell maturation agent, which supports both anti-cancer activity and immune modulation, providing a unique approach to resensitizing tumors that are resistant to checkpoint inhibitors [4].
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
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]
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].