Beyondspring Inc Stock Price, News & Analysis

BeyondSpring (NASDAQ: BYSI) reported post-hoc DUBLIN-3 analyses showing that plinabulin + docetaxel improved outcomes versus docetaxel in non-squamous EGFR wild-type NSCLC patients after progression on anti-PD-(L)1 therapy.

Key metrics in the subset: median OS 15.8 vs 11.7 months (HR=0.55), PFS 5.6 vs 3.8 months (HR=0.67), ORR 18.2% vs 8.0%. Metastasis-free survival improved to 15.34 vs 7.7 months (HR=0.52, p=0.0012) and new brain metastasis incidence fell to 4.32% vs 7.83%. Safety signals included a reduction in grade 4 neutropenia (5.13% vs 33.58%, p<0.0001) and fewer exposure-adjusted grade 3/4 AEs (p=0.0235). BeyondSpring plans a global registrational Phase 3 DUBLIN-4 to confirm these findings.

BeyondSpring (NASDAQ: BYSI) reported Q3 2025 results and clinical/corporate milestones on Nov 12, 2025. Key clinical data: a Phase 2 investigator-initiated NSCLC cohort (n=47) showed DCR 85%, median PFS 7.0 months, ORR 18.2%, DOR 7.2 months, 12‑month OS 79% and 24‑month OS 66% (median OS not reached). Phase 1 data across eight cancer types showed DCR 54% and a GEF‑1 dependent DC maturation/M1 macrophage mechanism. Corporate: co‑founded SEED (BeyondSpring ~38% ownership) closed a $30M Series A‑3 and received FDA and China NMPA IND clearance for SEED’s RBM39 program; SEED was finalist for Prix Galien USA. Q3 finances: continuing ops R&D $1.0M, G&A $0.8M, net loss continuing ops $1.7M, cash $12.5M as of Sept 30, 2025. BeyondSpring currently reports SEED as discontinued operations and expects future SEED sales to reduce ownership to ~14%.

BeyondSpring (NASDAQ: BYSI) reported Q2 2025 financial results and significant clinical advances. The company's lead drug Plinabulin showed promising results in NSCLC patients who progressed after PD-1/L1 therapy, demonstrating 6.8 months median PFS and 18.2% ORR in combination with pembrolizumab and docetaxel.

A Med (Cell Press) publication highlighted Plinabulin's ability to activate dendritic cells across eight cancer types, achieving 23% ORR and 54% DCR in immunotherapy-resistant patients. Additionally, SEED Therapeutics, where BeyondSpring holds a 40% stake, received FDA IND clearance for its RBM39 degrader ST-01156 and appointed Dr. Bill Desmarais as CFO/CBO.

Q2 2025 financials showed a net loss of $1.9M from continuing operations, improved from $2.7M in Q2 2024, with $9.5M cash on hand as of June 30, 2025.

BeyondSpring (NASDAQ: BYSI) has published significant clinical results in Med (Cell Press) demonstrating the effectiveness of Plinabulin in combination with radiation and checkpoint inhibitors for cancer treatment. The study showed an overall response rate (ORR) of 23% and a disease control rate (DCR) of 54% in patients who previously failed immune checkpoint inhibitor (ICI) therapy.

The research revealed that Plinabulin works through GEF-H1-dependent dendritic cell maturation, with particularly strong responses in non-small cell lung cancer, head and neck squamous cell carcinoma, and Hodgkin lymphoma. Notably, Hodgkin lymphoma patients demonstrated durable responses exceeding 19 months despite having undergone 12-16 prior lines of therapy.

BeyondSpring (NASDAQ: BYSI) presented promising Phase 2 data for their 303 Study at the 2025 ASCO Annual Meeting, evaluating the combination of Plinabulin, pembrolizumab, and docetaxel in metastatic NSCLC patients who progressed on first-line PD-1/L1 inhibitors. The study of 47 patients showed impressive results with median PFS of 6.8 months (nearly double the standard of care), Disease Control Rate of 77.3%, and 15-month OS rate of 78%. The treatment demonstrated an 18.2% Objective Response Rate and was well-tolerated, with 51.1% of patients experiencing grade 3 or higher treatment-related adverse effects. Plinabulin, as a first-in-class tubulin binder, shows potential to address acquired resistance to checkpoint inhibitors through its dual innate and adaptive immune mechanism.

BeyondSpring (NASDAQ: BYSI) has announced a poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentation will focus on the 303 Study, an investigator-initiated study supported by Merck and BeyondSpring, examining the combination of Pembrolizumab, Plinabulin, and Docetaxel in second and third-line non-small cell lung cancer (NSCLC) patients who progressed on PD-1/PD-L1 inhibitors.

The presentation, titled "Phase 2 Study of Pembrolizumab plus Plinabulin and Docetaxel for Patients with Metastatic NSCLC," will be delivered on May 31, 2025, from 1:30 PM to 4:30 PM CDT at the McCormick Place Convention Center. The study focuses on efficacy and safety results related to immune re-sensitization in patients who progressed after first-line immune checkpoint inhibitor therapy.

BeyondSpring (NASDAQ: BYSI) reported its Q1 2025 financial results and corporate updates. The company's lead drug Plinabulin has shown promising results in treating patients who failed PD-1/L1 inhibitors, with notable success in NSCLC and Hodgkin lymphoma. A Phase 1 study at MD Anderson showed extended response duration of over 19 months in heavily pretreated Hodgkin lymphoma patients. The company's SEED subsidiary is advancing its RBM39 degrader program, which achieved complete tumor regression in Ewing sarcoma models, with IND filing expected mid-2025. Financially, Q1 2025 saw increased expenses with R&D costs up 21% to $874,000 and G&A expenses up 30% to $1.74M, resulting in a net loss of $2.58M from continuing operations. BeyondSpring currently maintains approximately 40% ownership in SEED following a partial sale of Series A-1 Preferred Shares.

BeyondSpring (NASDAQ: BYSI), a global clinical-stage biopharmaceutical company focused on innovative cancer therapies, has filed its annual report on Form 10-K for the fiscal year ended December 31, 2024. The report was submitted to the SEC on March 27, 2025.

The annual report, containing audited consolidated financial statements, is accessible through the SEC website and BeyondSpring's corporate website under the Investors section. The company offers shareholders the option to request free hard copies of the annual report through their Investor Relations department in Florham Park, NJ.

BeyondSpring (NASDAQ: BYSI) has announced the sale of a portion of its Series A-1 Preferred Shares in SEED Therapeutics for $35.4 million. After the transaction, BeyondSpring will retain approximately 14.4% ownership in SEED. The proceeds will fund late-stage clinical trials of Plinabulin, the company's lead anti-cancer agent.

Plinabulin has shown promising results across multiple studies: The DUBLIN-3 phase 3 study demonstrated significant overall survival benefits in NSCLC patients; the 303 Study showed 89.3% disease control rate and 8.6 months median PFS in NSCLC patients; and the 302 Study began enrollment for first-line ES-SCLC treatment.

SEED Therapeutics, co-founded with Eli Lilly in 2020, focuses on Targeted Protein Degradation technology and recently completed a Series A-3 financing led by Eisai at a $100 million pre-money valuation.