Workflow
Plinabulin
icon
Search documents
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 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 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].
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 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].
BeyondSpring Reports Second‑Quarter 2025 Financial Results and Provides Corporate Update: Accelerates Momentum with Promising Clinical Advances and Strategic Leadership Appointment
Globenewswire· 2025-08-13 12:00
Core Insights - BeyondSpring Inc. reported Q2 2025 financial results and highlighted significant clinical and corporate milestones, focusing on its lead asset, Plinabulin, which is positioned to redefine cancer treatment by leveraging the immune system [1][2]. Clinical Developments - Plinabulin is a first-in-class agent that matures dendritic cells, potentially offering new hope to 60% of non-small cell lung cancer (NSCLC) patients whose disease progresses after checkpoint inhibitor therapy [2]. - In the global Phase 3 trial (Dublin-3), the combination of Plinabulin and docetaxel showed durable survival benefits and reduced chemotherapy-induced neutropenia compared to standard docetaxel alone [2]. - New data from a Phase 2 study indicated that the combination of pembrolizumab, Plinabulin, and docetaxel in metastatic NSCLC patients demonstrated a median progression-free survival (PFS) of 6.8 months and an overall survival (OS) of 78% at 15 months [5]. - A collaboration with MD Anderson highlighted Plinabulin's rapid dendritic cell activation across eight cancer types, reporting an objective response rate (ORR) of 23% and a disease control rate (DCR) of 54% [5]. Corporate Milestones - SEED Therapeutics, in which BeyondSpring is a founding shareholder, received FDA clearance for its RBM39 molecular glue degrader, ST-01156, targeting aggressive cancers [2][4]. - Dr. Bill Desmarais joined SEED Therapeutics as CFO and CBO, bringing over 20 years of biotech leadership experience [6]. Financial Performance - For the six months ended June 2025, BeyondSpring reported a net income of $1 million, an improvement from a net loss of $2.6 million in the same period of 2024 [7]. - Research and development (R&D) expenses increased to $1.9 million for the six months ended June 2025, compared to $1.6 million in the prior year, primarily due to higher professional service fees [9]. - General and administrative (G&A) expenses decreased to $2.7 million for the six months ended June 2025, down from $3.1 million in the same period of 2024 [9]. Financial Position - As of June 30, 2025, cash and cash equivalents stood at $9.5 million, a significant increase from $2.9 million as of December 2024 [9]. - Current assets totaled $15.7 million, down from $25.3 million as of December 2024, reflecting the impact of discontinued operations [9].
BeyondSpring Publishes Human Clinical Study in Med (Cell Press) Showing Plinabulin-Driven Dendritic Cell Maturation and Tumor Response After Prior Checkpoint Inhibitor Failure
Globenewswire· 2025-07-07 11:00
Core Insights - BeyondSpring Inc. announced a human clinical study demonstrating that Plinabulin, in combination with radiation and a checkpoint inhibitor, induces dendritic cell maturation and elicits tumor responses in patients with multiple cancer types who had previously failed ICI therapy [1][2] - The study identified a potential biomarker, baseline GEF-H1 immune signature, which may enable patient pre-selection and clinical response prediction [1][8] Clinical Study Overview - The Phase 1 translational trial evaluated a triple immunotherapy approach combining Plinabulin, radiation, and anti-PD-1 checkpoint inhibitors in patients with eight cancer types who are refractory or relapsed on prior ICI therapy [3] - Nineteen patients received the combination regimen, with an objective response rate (ORR) of 23% and a disease control rate (DCR) of 54% in non-irradiated lesions [4][8] Mechanism of Action - Plinabulin triggered dendritic cell maturation post-radiation via GEF-H1 signaling, leading to increased expression of DC maturation markers [5][11] - The mechanism of Plinabulin is distinct from traditional tubulin agents, promoting dendritic cell maturation and anti-tumor T-cell immunity without interfering with tubulin stabilizers [11] Biomarker Insights - Single-cell RNA sequencing differentiated responders from non-responders, identifying baseline GEF-H1 immune gene expression as a potential predictive biomarker for Plinabulin response [6][8] Company Background - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for high unmet medical needs, with Plinabulin as its lead asset in late-stage clinical development for various cancer indications [14]
BeyondSpring (BYSI) Earnings Call Presentation
2025-07-04 09:03
Plinabulin's Mechanism and Preclinical Evidence - Plinabulin is a unique tubulin binder with a distinct binding site compared to other tubulin-binding agents[16, 21] - Preclinical studies show that Plinabulin, combined with radiation and anti-PD-1, activates dendritic cells (DCs), stimulates T-cell proliferation, and achieves abscopal effects[17, 24] - Plinabulin induces DC maturation, especially when administered after irradiation (IR), and Plinabulin-treated DCs stimulate T cell proliferation, enhanced by combining with IR[25] Clinical Efficacy and Immune Activation - In a Phase 1 study, the Plinabulin triple combination (with radiation and PD-1/PD-L1 inhibitors) led to an 80% disease control rate (DCR) in 10 IO-refractory patients[18, 32] - Durable responses were observed in 2 Hodgkin lymphoma patients who progressed after 12 or 16 prior lines of therapy[33] - Responding patients exhibited early immune activation with DC maturation and proinflammatory monocytes in the peripheral blood across six different cancer types[19, 35] Summary and Future Directions - Plinabulin demonstrates induction of DC maturation and re-sensitization to anti-PD(L)1 in IO-refractory tumors[37] - The impressive overall results, showing a high 80% disease control rate in ICI-refractory and heavily pre-treated patients, warrant further clinical studies of Plinabulin/IO combinations in IO-refractory settings[37, 38]