An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer

Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC. Besides, KEYNOTE-604 study revealed that adding pembrolizumab to standard first-line EP significantly improves PFS in patients with ES-SCLC and is associated with durable responses in a subset of patients. 12-m PFS rate were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. The statistical threshold for declaring significant prolongation of OS was narrowly missed. Considering sicker pts was enrolled and the interim analysis was quite often, even though the investigators narrowly missed the OS endpoint, longer numerical OS data was observed. The latest version of NCCN SCLC guidelines still recommended pembrolizumab as an option for ES-SCLC patients.
Plinabulin received breakthrough designation from both US and China FDA for CIN (Chemotherapy Induced Neutropenia) prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients. In a poster released at 2021 ASCO conference, a phase I trial of Plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer: Big Ten Center Research Consortium (BTCRC-LUN17-127) study. Plinabulin in combination with nivolumab and ipilimumab was safe and well tolerated with promising efficacy signal of 46% ORR.
From above, Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC should be a promising combination therapy, as the investigators expect increased efficacy and reduced toxicity with the addition of Plinabulin. In this proof of concept phase II study, the investigators will investigate that the efficacy and safety of Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC.

Start Date07 Mar 2024

Sponsor / Collaborator

Wuhan Xiehe Hospital Tower

NCT05130827

/ Active, not recruitingPhase 2IIT

Pilot Trial of Plinabulin and Pegfilgrastim to Reduce the Duration of Absolute Neutropenia After Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

Start Date21 Dec 2021

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

[+1]

NCT04902040

/ TerminatedPhase 1/2IIT

An Open-label, Single-Center, Phase 1b/2 Study to Evaluate the Safety of Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Malignancies After Progression on PD-1 or PD-L1 Targeted Antibodies

This phase Ib/II trial studies the side effects and best dose of plinabulin in combination with radiation therapy and immunotherapy in patients with select cancers that have spread to other places in the body (advanced) after progression on PD-1 or PD-L1 targeted antibodies. Plinabulin blocks tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving plinabulin in combination with radiation therapy and immunotherapy may work better in treating advanced cancers.

Start Date14 Apr 2021

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

100 Clinical Results associated with Plinabulin

100 Translational Medicine associated with Plinabulin

100 Patents (Medical) associated with Plinabulin

100

Literatures (Medical) associated with Plinabulin

01 Oct 2025·Med

Plinabulin following radiation enhances dendritic cell maturation and checkpoint inhibitor retreatment of relapsed/refractory cancers

Article

Author: Huang, Lan ; Braun, Chen ; Cohen, Evan N ; Lu, Yingjuan June ; Lloyd, G Kenneth ; Peng, Jing ; Tonra, James R ; Jayachandran, Gitanjali ; Rodon, Jordi ; Lin, Steven H ; Hong, David ; Ye, Rui ; Karp, Daniel ; Sharma, Amrish ; Fu, Siqing ; Yu, Hao ; Son, Ye Lin ; Lyu, Yue ; Reuben, James M ; Fang, Penny ; Neri, Shinya ; Subbiah, Vivek ; Li, Ziyi ; Gao, Hui ; Li, Nan

BACKGROUND:

Plinabulin exerts immunomodulatory activity through guanine nucleotide exchange factor (GEF)-H1 release from depolymerizing tubulin in the cytoskeleton, leading to dendritic cell (DC) activation. Preclinical studies demonstrated that irradiation potentiates plinabulin-induced DC maturation and, when combined with immune checkpoint inhibitors (ICIs), triggers an abscopal antitumor response via increased tumor-infiltrating DCs and T cells.

METHODS:

A phase 1 translational study (NCT04902040) of plinabulin plus ICIs after radiation therapy (RT) initiation was conducted in ICI-relapsed/refractory cancers with primary (safety, tolerability, and objective tumor response rate) and secondary (disease control rate [DCR]) endpoints.

FINDINGS:

This triple regimen was safe and achieved a DCR of 54% (3/13 partial response [PR] and 4/13 stable disease [SD]) in mostly heavily pretreated patients. Responding tumors included non-small cell lung cancer (2/2 PR + SD), head-and-neck squamous cell carcinoma (2/3 PR + SD), and Hodgkin's lymphoma (2/2 PR in patients after 12 or 16 prior lines of therapy). PR + SD patients had significantly higher GEF-H1 immune-activation scores in peripheral blood and intratumorally at pretreatment/baseline and DC activation/T cell clonal expansion post-treatment compared with progressive disease patients.

CONCLUSIONS:

These preliminary results provide a rationale for testing RT/plinabulin/ICI combination in future post-ICI-failure confirmatory trials.

FUNDING:

This study was funded by BeyondSpring Pharmaceuticals, Inc.

01 Oct 2025·Molecular diversity

Design, synthesis, and structure–activity relationship study of novel plinabulin derivatives as anti-tumor agents based on the co-crystal structure

Article

Author: Li, Feifei ; Ding, Zhongpeng ; Li, Wenbao ; Wang, Shixiao ; Tang, Yu ; Zhong, Changjiang

Plinabulin, a 2, 5-diketopiperazine-type tubulin inhibitor derived from marine natural products, is currently undergoing Phase III clinical trials for the treatment of non-small cell lung cancer (NSCLC) and chemotherapy-induced neutropenia (CIN). To obtain novel 2, 5-diketopiperazine derivatives with higher biological activity, we designed and synthesized two series of 37 plinabulin derivatives at the C-ring, based on the co-crystal structure of compound 1 and tubulin. Their structures were characterized using NMR and HRMS. All compounds were screened in vitro using the lung cancer cell line NCI-H460 using the MTT method, and the compounds with better activity were further screened in BxPC-3 and HT-29 cells. The compounds 16c (IC₅₀ = 2.0, NCI-H460; IC₅₀ = 1.2 nM, BxPC-3; IC₅₀ = 1.97 nM, HT-29) and 26r (IC₅₀ = 0.96, NCI-H460; IC₅₀ = 0.66 nM, BxPC-3; IC₅₀ = 0.61 nM, HT-29) had the best activity. The cytotoxic activity of compound 26r against various tumor cell lines occurred at less than 1 nM.

01 Sep 2025·BIOPHYSICAL JOURNAL

Dynamic microtubules as sensors in animal cells

Review

Author: Mitchison, Timothy J

Microtubules physically organize eukaryotic cells by serving as structural elements and polarized transport tracks. This article advances the hypothesis that dynamic microtubules also serve as sensors of cell shape and cytoplasmic state, building on ideas proposed for higher plant cells. Microtubule polymerization dynamics and lattice structure are sensitive to mechanical, chemical, and signaling inputs that alter the balance between microtubules and soluble tubulin and regulate MAP binding affinity. These changes are detected by transducers, which include the GTP exchange factor GEF-H1 (ARHGEF2) and MARK family kinases. The resulting signals regulate cytoplasmic behavior, gene expression, and tissue physiology. The microtubule-destabilizing drugs colchicine and plinabulin may mimic sensing of pathophysiological cues by microtubules, leading to activation of gene expression programs that promote cell survival, growth, and repair, which account for the therapeutic actions of the drugs. In tissue cells with stable morphologies, the sensory functions of microtubules may be as or more important than their architectural functions. This reframing of microtubule biology suggests new directions for mechanistic inquiry and drug discovery.

News (Medical) associated with Plinabulin

12 Dec 2025

·www.globenewswire.com

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

Consistent OS benefit in an Asian subset with a strong HR of 0.69 for non-squamous patients, and meaningful safety advantage position Plinabulin as a late-stage candidate showing survival improvement in 2L/3L EGFR WT NSCLC. FLORHAM PARK, N.J., Dec. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced results from the Asian subset (n=488) of its global Phase 3 DUBLIN-3 trial evaluating Plinabulin plus docetaxel compared to docetaxel alone in second- or third-line EGFR wild-type non-small cell lung cancer (NSCLC). Dublin-3’s global intent-to-treat (ITT) patient data was published in Lancet Respiratory Medicine in 2024. These new findings were presented by Dr. Baohui Han of Shanghai Chest Hospital at the European Society for Medical Oncology (ESMO) Asia Congress 2025. In this large Asian intent-to-treat cohort, Plinabulin + docetaxel (DP, n=243) achieved a statistically significant improvement in overall survival compared to docetaxel (D, n=245): DP 10.8 months vs. D 8.8 months, HR 0.81, p=0.0426. In the mechanism-based non-squamous subgroup, the hazard ratio was 0.69 with a median OS benefit of 3 months (p=0.0064), highlighting enhanced benefit in patients whose disease biology aligns with Plinabulin’s immune-modulating and tumor vasculature-targeting mechanisms.The combination also doubled 2-year and 3-year survival rates, reflecting durable benefit consistent with Plinabulin’s first-in-class dendritic-cell maturation mechanism. Plinabulin demonstrated a marked reduction in docetaxel-induced grade 4 neutropenia (DP: 3.9% vs. D 26.5%, p<0.0001), while maintaining a favorable tolerability profile. This safety improvement supports better treatment exposure, an important driver of chemotherapy benefit. “These data from nearly 500 Asian patients further strengthen the robust global evidence supporting Plinabulin’s potential to become a new standard of care for EGFR wild-type NSCLC,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring. “The consistent survival benefit, particularly in the mechanism-aligned non-squamous population, together with the marked reduction in severe neutropenia, reflects Plinabulin’s first-in-class immune-modulating mechanism and its ability to improve chemotherapy tolerability. These results reinforce our confidence as we advance Plinabulin into a global Phase 3 confirmatory study.” About PlinabulinPlinabulin is a first-in-class, brain-penetrating, dendritic-cell maturation small molecule. It has been used in over 700 cancer patients, with good tolerability and showed durable anti-cancer benefit across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy-induced neutropenia and could thereby increase docetaxel tolerability. About DUBLIN-3 Study (103 Study)DUBLIN-3 (n=559, NCT02504489) was a multicenter, single-blinded (patient) and randomized, phase 3 trial in 58 medical centers (US, China, and Australia). Only patients with EGFR wild-type NSCLC who had progressed after first-line platinum-based therapy were enrolled. Patients were randomized (1:1) to receive docetaxel (75 mg/m2) on Day 1 and either plinabulin (30 mg/m2) or placebo on Days 1 and 8 in 21-day cycles until progression, unacceptable toxicity, withdrawal, or death. Treated patients were included in the safety analysis and ITT population in the primary efficacy analyses. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. The study was published in Lancet Resp Med 12:775, 2024. About BeyondSpringBeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin’s novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at https://beyondspringpharma.com. Investor Contact: IR@beyondspringpharma.com Media Contact: PR@beyondspringpharma.com

Clinical ResultPhase 3Immunotherapy

11 Dec 2025

·www.globenewswire.com

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

In DUBLIN-3 non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1, Plinabulin + docetaxel showed consistent and clinically meaningful improvements in OS, PFS, and ORR, reinforcing Plinabulin as a late-stage therapy with consistent survival benefit in anti-PD-(L)1-progressed NSCLC patients. Supported by anti-cancer efficacy and safety in significant reduction exposure-adjusted grade 3/4 adverse events in DUBLIN-3, BeyondSpring will conduct DUBLIN-4, a global, double-blind Phase 3 registrational trial. This study will evaluate Plinabulin + docetaxel vs. docetaxel in non-squamous EGFR wild-type NSCLC after progression on anti-PD-(L)1 and chemotherapy, and is intended to serve as the global confirmatory study. FLORHAM PARK, N.J., Dec. 11, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage biopharmaceutical company developing first-in-class immune-modulating cancer therapies, today announced new post-hoc analyses from its global Phase 3 DUBLIN-3 Study (Lancet Resp Med 12:775, 2024), showing that Plinabulin plus docetaxel provides clinically meaningful benefit for patients with EGFR wild-type (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC) who progressed after anti-PD-(L)1 immunotherapy. The findings were presented by Dr. Trevor Feinstein of Piedmont Cancer Center and acting chair of the Lung Disease Group for the OneOncology network at the 2025 IASLC/ASCO North America Conference on Lung Cancer (NACLC). More than 60% of NSCLC patients eventually develop resistance to anti-PD-(L)1 therapy, yet no new treatments have been approved in a decade. Nine late-stage trials, including ADC and anti-PD-(L)1combination regimens, have failed to show overall survival improvement over docetaxel. Plinabulin is a late-stage therapeutic candidate that has demonstrated consistent survival benefit in this rapidly growing population with major unmet medical need. In a mechanism-driven, post-hoc subset analysis of DUBLIN-3, non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1 therapy with at least 3 months of prior clinical benefit, Plinabulin + docetaxel (DP) combination showed clinically meaningful improvement compared to docetaxel alone (D). Median overall survival (OS): DP 15.8 months vs. D 11.7 months (HR=0.55), Median progression-free survival (PFS): DP 5.6 vs. D 3.8 months (HR=0.67),Objective response rate (ORR): 18.2% vs. 8.0%. These benefits reflect Plinabulin’s first-in-class dendritic-cell maturation mechanism, which helps to restore antigen presentation and T-cell function after acquired resistance to checkpoint inhibitors. BeyondSpring plans to initiate a global Phase 3 DUBLIN-4 trial following its End-of-Phase 2 meeting with the U.S. FDA. DUBLIN-4, together with DUBLIN-3, is expected to support a future NDA submission in non-squamous EGFR wild-type NSCLC following progression on anti-PD-(L)1 therapy. Post-hoc analysis of DUBLIN-3 intent-to-treat (ITT, N=559) EGFR WT NSCLC population showed additional clinically meaningful benefits for the Plinabulin + docetaxel combination compared to docetaxel. Meaningful improvement in metastasis-free survival: Metastasis-free survival improved to 15.34 months (DP) versus 7.7 months (D, HR=0.52, p=0.0012), consistent with Plinabulin’s DC maturation and durable anti-cancer benefit.Reduction in new brain metastasis: The incidence of new brain metastasis was reduced to 4.32% (DP) vs. 7.83% (D), consistent with Plinabulin’s brain-penetrant properties which demonstrated survival benefit in glioblastoma anal model as a monotherapy.Improved safety: Plinabulin significantly reduced docetaxel-induced grade 4 neutropenia (5.13% vs. 33.58%, p<0.0001). Plinabulin combination had significantly decreased exposure-adjusted grade 3/4 adverse events vs. docetaxel (p=0.0235), supporting prolonged treatment exposure and contributing to improved clinical outcomes. “Patients who relapse after anti-PD-(L)1 therapy represent one of the most significant unmet needs in NSCLC, with docetaxel as the only treatment option while multiple late-stage clinical trials have failed to improve upon it,” said Dr. Trevor Feinstein. Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring, said, “These new analyses suggest Plinabulin’s unique ability to potentially reinvigorate anti-tumor immune function and improve outcomes in patients who have developed resistance to checkpoint inhibitors. The post-hoc analysis data from DUBLIN-3 are consistent with our findings from the prospective 303 study in similar patients, as presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting. The observed reductions in brain metastasis and the substantial improvement in metastasis-free survival further highlight Plinabulin’s differentiated clinical profile. These findings provide strong momentum as we move forward with our global confirmatory Phase 3 DUBLIN-4 trial.” About PlinabulinPlinabulin is a first-in-class, brain-penetrating, dendritic -cell maturation small molecule. It has been used in over 700 cancer patients, with good tolerability and showed durable anti-cancer benefit across multiple clinical studies. As a reversible binder at a distinct tubulin pocket, plinabulin does not change tubulin dynamics or antagonize tubulin stabilizing agents, such as docetaxel, which contributes to its differentiated activity and tolerability compared to other tubulin binders. In addition, plinabulin significantly reduces chemotherapy-induced neutropenia and could thereby increase docetaxel tolerability. About DUBLIN-3 Study (103 Study)DUBLIN-3 (n=559, NCT02504489) was a multicenter, single-blinded (patient) and randomized, phase 3 trial in 58 medical centers (US, China, and Australia). Only patients with EGFR wild-type NSCLC who had progressed after first-line platinum-based therapy were enrolled. Patients were randomized (1:1) to receive docetaxel (75 mg/m2) on Day 1 and either plinabulin (30 mg/m2) or placebo on Days 1 and 8 in 21-day cycles until progression, unacceptable toxicity, withdrawal, or death. Treated patients were included in the safety analysis and ITT population in the primary efficacy analyses. The primary endpoint for the study was OS, and secondary endpoints were PFS, ORR, Duration of Response (DoR), Grade 4 neutropenia and Quality of Life. The study was published in Lancet Resp Med 12:775, 2024. About BeyondSpringBeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin’s novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at https://beyondspringpharma.com. Investor Contact: IR@beyondspringpharma.com Media Contact: PR@beyondspringpharma.com

Clinical ResultPhase 3ImmunotherapyASCOPhase 2

12 Nov 2025

·www.globenewswire.com

BeyondSpring Reports Third‑Quarter 2025 Financial Results and Provides Corporate Update

Two SITC 2025 presentations: First-in-class dendritic cell (DC) maturation agent Plinabulin drives immune re-sensitization in metastatic NSCLC patients who had progressed after PD-1/L1 inhibitors with disease control rate of 85% in combination with docetaxel and Keytruda. Mechanism studies with MD Anderson collaborators showed DC maturation and M1 macrophage polarization via a Plinabulin specific GEF-H1 dependent mechanism in responding patients with Plinabulin, PD-1 inhibitor and radiation. SEED, co-founded by BeyondSpring with 38% equity share, successfully completed its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39.SEED Named Finalist for 2025 Prix Galien USA “Best Start-Up” Award FLORHAM PARK, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q3 2025 financial results alongside clinical and corporate milestones. “With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming,” said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. “With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation.” Dr. Huang added, “At SEED, which we co-founded with Lilly five years ago, we are excited that our RBM39 molecular-glue degrader has received IND clearance from both the US FDA and China NMPA. It is such an honor to be the only target protein degradation company nominated by the Prix Galien Foundation, recognizing our commitment to developing transformative medicine for patients. We are also grateful for the support of our investors and collaborators, including Lilly and Eisai, and clinicians from leading US institutions, as we work together to advance molecular glue development to address undruggable targets for patients with unmet medical needs.” Key Milestones: Two SITC 2025 Presentations on Plinabulin Anti-cancer Clinical Benefit: Resensitize NSCLC Patients Who Progressed on Prior PD-1/L1 Inhibitors with Disease Control Rate of 85% in Phase 2 Clinical Study: New data from a phase 2 investigator-initiated study (NCT05599789, Peking Union Hospital China) evaluating Plinabulin, docetaxel, and pembrolizumab in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors (n=47), showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 7.0 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 85%, and 12-month overall survival (OS) rate at 79%, and 24-month OS rate at 66% (median OS not reached).Resensitize Patients with Eight Cancer Types Who Failed Prior PD-1/L1 Inhibitors with Disease Control Rate of 54% through DC Maturation and M1 Macrophage Polarization via GEF-H1-dependent Mechanism in Phase 1 Clinical Study: This phase 1 investigator-initiated study (NCT04902040, MD Anderdon Cancer Center) shows that in addition to potent DC maturation for a systemic immune response, plinabulin combined with radiation and PD-1 inhibitor promotes proinflammatory monocytes and M1 macrophage polarization via a Plinabulin specific GEF-H1-dependent mechanism with the potential of overcoming acquired resistance to immune checkpoint inhibitors from pro-tumor macrophages. SEED, Co-founded by BeyondSpring with 38% Equity Share, Secured Financial Position and Achieved IND Clearance: SEED completed its $30 million Series A-3 financing and received U.S. FDA and China NMPA clearance of its Investigational New Drug (IND) application for its lead RBM39 degrader program. SEED was also named a finalist for the 2025 Prix Galien USA “Best Start-Up” Award and co-hosted a targeted protein degradation symposium at NYU Grossman School of Medicine honoring Co-Founder and Nobel Laureate Prof. Avram Hershko, with leading thought leaders in the TPD field as presenters. Third Quarter Financial Results1Continuing operations: Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2025 compared to $0.6 million for the quarter ended September 30, 2024. The $0.4 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.General and administrative (G&A) expenses were $0.8 million for the quarter ending September 30, 2025 compared to $1.7 million for the quarter ended September 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development and partnership initiatives, and lower salary expenses driven by decrease in administrative headcount.Net loss: $1.7 million for the quarter ended September 2025, compared to $2.2 million for the quarter ended September 2024Cash and cash equivalents: $12.5 million as of September 30, 2025, compared to $2.9 million as of December 2024 Discontinued operations: Net loss: $3.2 million for the quarter ended September 2025, compared to $2.4 million for the quarter ended September 2024Current assets: $11.4 million as of September 2025, compared to $25.3 million as of December 2024 Year to Date Financial Results1Continuing Operations: Research and development (R&D) expenses were $2.9 million for the nine months ended September 30, 2025 compared to $2.2 million for the nine months ended September 30, 2024. The $0.7 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs, and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.General and administrative (G&A) expenses were $3.4 million for the nine months ended September 30, 2025, compared to $4.9 million for the nine months ended September 30, 2024. The $1.5 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, lower professional services in consulting for business development and partnership initiatives, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.Net loss: $6.2 million for the nine months ended September 2025, compared to $6.9 million for the nine months ended September 2024 Discontinued operations: Net loss: $2.2 million for the nine months ended September 2025, compared to $5.0 million for the nine months ended September 2024 Note 1: Accounting UpdateFollowing definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 38% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares. About BeyondSpringBeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies addressing high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and other indications. Plinabulin’s novel mechanism as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors resistant to checkpoint inhibitors. Learn more at beyondspringpharma.com. About SEED TherapeuticsSEED Therapeutics is a clinical-stage biotechnology company pioneering rationally designed molecular glue degraders to treat diseases driven by undruggable proteins. Its proprietary RITE3™ platform enables targeted protein degradation with small-molecule precision. SEED’s lead candidate, ST-01156, is a brain-penetrant RBM39 degrader entering clinical development for Ewing sarcoma and other RBM39-dependent cancers. SEED’s investors and collaborators include Eli Lilly and Eisai, both of whom have been instrumental in supporting SEED’s mission to unlock undruggable disease targets. The company’s pipeline includes nine programs across oncology, neurodegeneration, immunology, and virology. Learn more at seedtherapeutics.com. Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 10-K on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. ContactsInvestor Relations: ir@beyondspring.comMedia: pr@beyondspringpharma.com BEYONDSPRING INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) As of December 31, 2024 September 30, 2025 $ $ (Unaudited) Assets Current assets: Cash and cash equivalents 2,922 12,483 Short term investments - 141 Advances to suppliers 240 250 Prepaid expenses and other current assets 68 131 Current assets of discontinued operations 25,347 11,406 Total current assets 28,577 24,411 Noncurrent assets: Property and equipment, net 239 184 Operating right-of-use assets 513 368 Other noncurrent assets 213 219 Noncurrent assets of discontinued operations 4,773 4,302 Total noncurrent assets 5,738 5,073 Total assets 34,315 29,484 Liabilities and equity Current liabilities: Accounts payable 295 304 Accrued expenses 840 990 Current portion of operating lease liabilities 282 313 Other current liabilities 780 676 Current liabilities of discontinued operations 8,813 10,608 Total current liabilities 11,010 12,891 Noncurrent liabilities: Operating lease liabilities 307 93 Deferred revenue 27,400 28,094 Other noncurrent liabilities 3,686 3,840 Noncurrent liabilities of discontinued operations 6,197 4,376 Total noncurrent liabilities 37,590 36,403 Total liabilities 48,600 49,294 Commitments and contingencies Shareholders’ deficit Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 40,316,320 and 40,322,320 shares issued and outstanding as of December 31, 2024 and September 30, 2025, respectively) 4 4 Additional paid-in capital 373,185 373,602 Accumulated deficit (407,425) (406,294)Accumulated other comprehensive income 1,336 913 Total BeyondSpring Inc.’s shareholders’ deficit (32,900) (31,775)Noncontrolling interests 18,615 11,965 Total shareholders’ deficit (14,285) (19,810) Total liabilities and shareholders’ deficit 34,315 29,484 BEYONDSPRING INC.CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)(Unaudited) Three months ended September 30, Nine months ended September 30, 2024 2025 2024 2025 $ $ $ $ Revenue - - - - Operating expenses Research and development (622) (1,039) (2,172) (2,915)General and administrative (1,736) (751) (4,882) (3,434) Loss from operations (2,358) (1,790) (7,054) (6,349)Foreign exchange gain, net 128 24 45 100 Interest income 15 19 55 64 Other income, net - 30 8 48 Loss before income tax (2,215) (1,717) (6,946) (6,137)Income tax expenses - (26) - (68) Net loss from continuing operations (2,215) (1,743) (6,946) (6,205) Discontinued operations Loss from discontinued operations (2,358) (3,201) (5,004) (9,204)Gain on sale of subsidiary interests - - - 6,986 Income tax expenses - - - - Net loss from discontinued operations (2,358) (3,201) (5,004) (2,218) Net loss (4,573) (4,944) (11,950) (8,423)Less: Net income (loss) attributable to noncontrolling interests from continuing operations (83) 41 (198) (106)Less: Net loss attributable to noncontrolling interests from discontinued operations (2,358) (3,445) (2,358) (9,448)Net income (loss) attributable to BeyondSpring Inc. (2,132) (1,540) (9,394) 1,131 Earnings (loss) per share, basic and diluted Continuing operations (0.05) (0.04) (0.17) (0.15)Discontinued operations - - (0.07) 0.18 Basic and diluted earnings (loss) per share (0.05) (0.04) (0.24) 0.03 Weighted-average shares outstanding Basic and diluted 40,300,350 40,317,266 39,539,494 40,316,639 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustment loss from continuing operations (905) (166) (318) (660)Foreign currency translation adjustment gain (loss) from discontinued operations 4 (17) (7) (51)Comprehensive loss (5,474) (5,127) (12,275) (9,134)Less: Comprehensive loss attributable to noncontrolling interests from continuing operations (408) (19) (311) (343)Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations (2,354) (3,462) (2,354) (9,499)Comprehensive income (loss) attributable to BeyondSpring Inc. (2,712) (1,646) (9,610) 708

Phase 1Phase 2Clinical ResultFinancial StatementIND

100 Deals associated with Plinabulin

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D09655	Plinabulin	-	DB05992

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	NDA/BLA	China	BeyondSpring Pharmaceuticals, Inc.	17 Aug 2021
Neutropenia	NDA/BLA	China	Dalian Wanchun Biotechnology Co. Ltd.	17 Aug 2021
Neutropenia	NDA/BLA	China	Pharmaceutics International, Inc.	17 Aug 2021
Early Stage Breast Carcinoma	Phase 3	China	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
Early Stage Breast Carcinoma	Phase 3	Ukraine	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
HER2-negative breast cancer	Phase 3	China	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
HER2-negative breast cancer	Phase 3	Ukraine	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
Truncus Arteriosus, Persistent	Phase 3	China	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
Truncus Arteriosus, Persistent	Phase 3	Ukraine	BeyondSpring Pharmaceuticals, Inc.	23 Oct 2019
Breast Cancer	Phase 3	United States	Pharmaceutics International, Inc.	15 Oct 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02504489 (DUBLIN-3, GlobeNewswire) Manual	Phase 3	Non-squamous non-small cell lung cancer Second line EGFR Gene Mutation Negative	559	Plinabulin + Docetaxel	xbuinmerpm(jpearxtbjg) = gekxzwpyld yisyvyognp (wuwpkxxmyn ) View more	Positive	11 Dec 2025
				Docetaxel	xbuinmerpm(jpearxtbjg) = juitlrjcuf yisyvyognp (wuwpkxxmyn ) View more
NCT04902040 (SITC2025)	Phase 1	Neoplasms GEF-H1	12	Plinabulin + Plinabulinckpoint blockade (Radiation therapy)	ptmxolzldt(mkuaxspetr) = spbjlvdutd avxuwhvtbx (bzvuobbwoy ) View more	Positive	05 Nov 2025
NCT03575793 (BTCRC-LUN17-127, CTgov)	Phase 1/2	Recurrent Lung Small Cell Carcinoma	39	Ipilimumab+Nivolumab+Plinabulin	zafxcdyafq = voumbmkcfd gmeukeewhw (kmknqqktfk, qmrkyirlfr - aldxbrucao)	-	12 Nov 2024
NCT02504489 (DUBLIN-3, ESMO2024 \| Pubmed) Manual	Phase 3	Non-Small Cell Lung Cancer Second line \| Third line EGFR wild-type	559	Plinabulin+Docetaxel	dhegtzeswb(oomufirmqy) = vjjddsghde vliqtbzkqz (edvgefpjyx, 9.34 - 11.87) View more	Positive	14 Sep 2024
				Placebo+Docetaxel	dhegtzeswb(oomufirmqy) = qvumwxmzbb vliqtbzkqz (edvgefpjyx, 8.38 - 10.68) View more
NCT03102606 (PROTECTIVE-1 \| Study 105 \| BPI-2358-105, CTgov)	Phase 3	Solid tumor \| Neutropenia \| Metastatic breast cancer ... View more	105	D5W Placebo+Pegfilgrastim (Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin)	qxdhgnqumn(vonjpcyvxb) = vmbccnsosb tvpkjpttow (phksmgrddn, acjisehogo - mwqbomdjdq) View more	-	29 Aug 2024
				Saline Placebo+Plinabulin (Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim)	qxdhgnqumn(vonjpcyvxb) = mssptvodue tvpkjpttow (phksmgrddn, jhanbsiajw - cibcrtdree) View more
NCT04345900 (CTgov)	Phase 2	Solid tumor \| Neutropenia \| metastatic non-small cell lung cancer	55	Pegfilgrastim+Docetaxel (Arm 1)	tbfsscimqq(amsqedbyba) = hvsyhuhmvm sanreorxyf (jfgorawqvq, 0.376) View more	-	16 May 2024
				Plinabulin+Docetaxel (Arm 2)	tbfsscimqq(amsqedbyba) = zyywxlnkme sanreorxyf (jfgorawqvq, 0.929) View more
IMS2023	Not Applicable	Multiple Myeloma	15	Plinabulin + pegfilgrastim	vehphkhcyc(zfpgkrrbpi) = vjyuuhgvsh hrcgorqzlc (puyejwmgzg ) View more	-	26 Sep 2023
NCT02504489 (ASCO2023) Manual	Phase 2/3	Non-Small Cell Lung Cancer	-	Plinabulin+Docetaxel	xmhuhifaft(fkvfgmiumn) = With Plin, AE frequency of diarrhea was slightly higher (5.2% vs 1%; 1 Gr4 case with Plin), but was manageable, and so was hypertension (11.2% vs 1.7%; all Gr3 cases) vs Plac. Hypertension occurred around the time of infusion and was short-lasting (~2-4 hours) and typically self-limiting. Plin had less AEs of neutropenia (16.4% vs 50.3%) and leukopenia (15.5% vs 38.5%) vs Plac. wdusuqmbbq (obukdfjbmd )	Positive	31 May 2023
				Placebo+Docetaxel
NCT03102606 (PROTECTIVE-1, SABCS2023)	Phase 3	Solid tumor \| Neutropenia \| Metastatic breast cancer ... NCCN high FN risk factor View more	27	Plinabulin	mcgvbjqaze(onpxxdouim) = Plin was superior vs No-Treatment for Doc-induced neutropenia and HC, while maintaining QoL and with minimal AE and bone pain burden unmmmrydxw (ilqcohvbdn ) View more	Positive	01 Mar 2023
NCT03102606 (PROTECTIVE-1, ESMO_ASIA2022)	Phase 2/3	Non-Small Cell Lung Cancer	30	Plinabulin	xlloszvcwn(ugzfqybngl) = vrbkqgradd kjpqvkaqzb (tbnoxqjwir )	Positive	03 Dec 2022

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