Beyondspring Inc Stock Price, News & Analysis

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.

BeyondSpring (NASDAQ: BYSI) presented updated Phase 2 trial results for a triple combination therapy in non-small cell lung cancer (NSCLC) patients who progressed after PD-1/PD-L1 inhibitor treatment. The study of 30 patients, with a median follow-up of 11.5 months, showed promising results with a disease control rate of 89.3% and median progression-free survival of 8.6 months. The treatment combination of pembrolizumab plus plinabulin/docetaxel achieved a confirmed overall response rate of 21.1% and median duration of response of 11.4 months. The therapy was generally well-tolerated, with 46.7% of patients experiencing grade 3 or higher treatment-related adverse effects.

BeyondSpring (NASDAQ: BYSI) presented final data on the DUBLIN-3 Phase 3 study at ESMO Congress 2024, showing significant improvements in overall survival, progression-free survival, and objective response rate for the plinabulin/docetaxel combination in 2L/3L EGFR wild-type NSCLC patients. The combination demonstrated a favorable benefit/risk ratio over docetaxel alone, including:

1. >80% relative reduction in Grade 4 neutropenia
2. Reduced use of G-CSF
3. Improved quality of life
4. Significant reduction in cycle-adjusted serious adverse events

The study suggests this combination could be a new option for second or third-line NSCLC patients without driver mutation, addressing an unmet medical need.

BeyondSpring (NASDAQ: BYSI) presented interim phase 2 data on the 303 Study at ESMO Congress 2024, evaluating a triple combination regimen of pembrolizumab plus plinabulin/docetaxel in 2L/3L NSCLC patients after progression on 1L PD-1/L1 inhibitors. The study showed promising results:

- Median PFS of 8.63 months (compared to historical 3-4 months)
- Disease Control Rate of 89.5%
- Confirmed ORR of 21.1%
- 6-month PFS rate: 67.1%; 12-month PFS rate: 49.2%
- Median Duration of Response: 11.40 months

The combination was well-tolerated, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects. No treatment-related deaths were reported. The study is ongoing at Peking Union Medical College Hospital, aiming to enroll 47 patients total.