Beyondspring Inc Stock Price, News & Analysis

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.

BeyondSpring Inc. (NASDAQ: BYSI) presented final Phase 3 data of its lead anti-cancer asset Plinabulin at ISLAC 2024 World Conference on Lung Cancer. The DUBLIN-3 study showed statistically significant and clinically meaningful efficacy data for Plinabulin plus Docetaxel vs. Docetaxel alone in EGFR wild-type NSCLC patients after progression on platinum-based therapy. Key findings include:

• Improved overall survival (OS) with HR=0.82
• Better progression-free survival (PFS) with HR=0.79
• Nearly doubled objective response rate (ORR)
• Doubled 24-month and 36-month OS rates
• 82% reduction in Grade 4 neutropenia

The combination showed a favorable benefit/risk ratio and could be considered as a new treatment option for this population with high unmet medical needs.

BeyondSpring Inc. (NASDAQ: BYSI) announces upcoming presentations showcasing its lead anti-cancer asset, Plinabulin, at two major oncology conferences. At the 2024 World Conference on Lung Cancer on September 9, an oral presentation will reveal final efficacy data of Plinabulin and docetaxel combination vs. docetaxel from the Dublin-3 phase 3 study in EGFR wild-type 2L/3L non-small cell lung cancer (NSCLC).

Additionally, at the ESMO Congress 2024 on September 14, two poster presentations will cover the Dublin-3 study safety outcome and the 303 Study, an investigator-initiated study supported by Merck in 2L/3L NSCLC patients who failed PD-1/PD-L1 inhibitors. These presentations highlight BeyondSpring's ongoing efforts in developing innovative cancer therapies, particularly for lung cancer patients.

SEED Therapeutics has announced a strategic research collaboration with Eisai Co., to discover and develop novel molecular glue degraders for neurodegeneration and oncology targets. SEED is entitled to receive up to $1.5 billion in upfront and milestone payments, plus tiered royalties. Concurrently, SEED has launched a Series A-3 financing with a first close of $24 million led by Eisai, with a second close targeted for Q4 2024.

The collaboration leverages Eisai's expertise in neurodegeneration and cancer. SEED will lead preclinical discovery activities, while Eisai will have exclusive rights to develop and commercialize resulting compounds. The financing will advance SEED's clinical development of internal programs, including an oral RBM39 Degrader for cancer and a Tau degrader for Alzheimer's disease, as well as expand its TPD platform and pipeline.

BeyondSpring hosted an R&D Day on May 15, 2024, spotlighting their lead asset Plinabulin, which shows promise in treating cancer patients who have failed prior PD-1/PD-L1 inhibitors. Plinabulin has demonstrated significant efficacy in extending overall survival (OS) in phase 3 NSCLC studies and shows potential in combination therapies with chemotherapy or radiation.

SEED Therapeutics, BeyondSpring's subsidiary, focuses on developing molecular glues for undruggable targets using their proprietary TPD platform. SEED plans to file an IND for an oral RBM39 degrader in early 2025 and has a robust pipeline with collaborations, including a partnership with Eli Lilly, which has led to multiple milestone payments.