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BeyondSpring Inc. (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company dedicated to developing innovative cancer therapies. The company focuses primarily on its lead asset, Plinabulin, a novel cancer therapeutic. Plinabulin is currently in a global Phase 3 trial for non-small-cell lung cancer (NSCLC) and is also being tested in a pivotal global Phase 3 trial for the prevention of docetaxel-induced neutropenia. This compound operates as a tubulin depolymerizing agent and functions through multiple mechanisms of action, including immune system enhancement, tumor cell apoptosis, and vascular disruption.
BeyondSpring is also expanding clinical trials to address additional cancer indications. These include immuno-oncology applications with immune checkpoint inhibitors in NSCLC, central nervous system malignancies such as glioblastoma (GBM), and KRAS-positive mutant cancers.
Recent developments highlight the promising potential of Plinabulin:
- Brain Cancer Research: New preclinical data from the University of Toledo College of Medicine demonstrate Plinabulin's anti-proliferative properties in glioblastoma multiforme (GBM) at therapeutic concentrations. The data confirm Plinabulin's ability to block GBM patient-derived sphere invasion and significantly decrease GBM cell survival and microtubule extension.
- Immunotherapy Advancements: BeyondSpring and MD Anderson presented at the Society for Immunotherapy of Cancer's (SITC) Annual Meeting, showcasing Plinabulin's immunomodulating activity. The Phase 1 clinical study revealed a high disease control rate in patients with various cancers who had progressed on PD-1, PD-L1, and/or CTLA-4 antibodies.
In addition to its focus on cancer therapies, BeyondSpring has a majority-owned subsidiary, SEED Therapeutics, which is advancing Targeted Protein Degradation (TPD) molecular glue technology for innovative drug discovery. SEED has made significant progress, including a collaboration with Eli Lilly for developing oncology assets.
The company continues to advance its programs strategically, with a notable reduction in R&D and G&A expenses in 2023. As of December 31, 2023, BeyondSpring reported $17.9 million in cash and short-term investments, positioning itself well for upcoming milestones in 2024.
BeyondSpring remains committed to improving clinical outcomes for patients with high unmet medical needs through groundbreaking technology and strategic partnerships.
BeyondSpring Inc. (Nasdaq: BYSI) received notification from Nasdaq on November 18, 2022, indicating non-compliance with the minimum closing bid price of $1.00 per share, effective after 30 consecutive days below this threshold. The notification does not immediately affect the trading of its shares, which will continue on Nasdaq. BeyondSpring has until May 17, 2023, to restore compliance. The company continues to operate normally and is exploring options to meet the listing requirements.
BeyondSpring announced significant data on plinabulin from the ESMO Congress 2022. This data demonstrates plinabulin's ability to rapidly (within 24 hours) mitigate chemotherapy-induced myelosuppression by protecting granulocyte-monocyte progenitor (GMP) stem cells. In the Phase 2/3 PROTECTIVE-1 and PROTECTIVE-2 trials, plinabulin showed a statistically significant increase in absolute neutrophil counts compared to control (p<0.0001). This positions plinabulin as a novel asset in preventing chemotherapy-induced neutropenia, enhancing treatment safety for cancer patients.
BeyondSpring (NASDAQ: BYSI) announced new data from a study presented at the 19th International Myeloma Society Annual Meeting. The study evaluated the combination of plinabulin and pegfilgrastim in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation. Results showed that only 10% of patients experienced non-engagement-related febrile neutropenia, significantly lower than the historical rate of 60%. The study continues, aiming to evaluate neutropenia burden and overall patient outcomes.
BeyondSpring (NASDAQ: BYSI) announced three significant poster presentations at the ASCO Annual Meeting, highlighting crucial data on chemotherapy-induced neutropenia (CIN) and non-small cell lung cancer (NSCLC) treatments. The real-world analysis indicated that current G-CSF therapy for CIN leaves patients vulnerable in the first week post-chemotherapy. Furthermore, the DUBLIN-3 trial revealed that the combination of plinabulin/docetaxel extends median overall survival by 2.6 months compared to docetaxel alone in a specific NSCLC subgroup. This data emphasizes the potential of plinabulin in addressing critical cancer patient needs.
On April 28, 2022, BeyondSpring announced three poster presentations for its lead asset, plinabulin, at the upcoming ASCO Annual Meeting in June. Highlights include a study on granulocyte colony-stimulating factor use in breast cancer chemotherapy and new data from the DUBLIN-3 Phase 3 trial for non-small cell lung cancer (NSCLC). This includes quality of life analysis and subgroup results comparing plinabulin with docetaxel. Plinabulin is part of a broader strategy to enhance cancer treatment outcomes.
BeyondSpring Inc. (Nasdaq: BYSI) has filed its annual report on Form 20-F for the fiscal year ended December 31, 2021, with the SEC. The report includes audited consolidated financial statements, which investors can access on the SEC's website or BeyondSpring’s site under the Investors section. The company is focused on developing innovative cancer therapies, including its lead asset, Plinabulin, which has shown promising Phase 3 results in extending overall survival for certain lung cancer patients. A hard copy of the annual report is available for shareholders upon request.
BeyondSpring (BYSI) reported its fourth-quarter and full-year 2021 financial results. The Company experienced a net loss of $9.5 million for Q4 2021, a reduction from $17.6 million in Q4 2020. For the full year, the net loss was $64.2 million, slightly up from $61.0 million in 2020. R&D expenses decreased to $5.8 million in Q4 2021 and $36.9 million for the year. The Company has $72.4 million in cash and equivalents, ensuring operational stability for the upcoming year. BeyondSpring is progressing with NDA filings for its drug Plinabulin in China and the U.S. for various cancer indications.
BeyondSpring (NASDAQ: BYSI) will release its financial results for the quarter and year ending December 31, 2021, on April 14, 2022. The company will hold a conference call at 8:00 am ET to discuss these results and provide a corporate update. BeyondSpring focuses on innovative cancer therapies, particularly its lead asset, plinabulin, which has shown positive Phase 3 data for preventing chemotherapy-induced neutropenia (CIN) and improving overall survival in NSCLC patients. The company is also developing several pre-clinical immuno-oncology assets.
BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced a reorganization plan, reducing its U.S. workforce by 35% to ensure long-term sustainability and extend its cash runway. This decision follows a Complete Response Letter from the FDA regarding its New Drug Application for plinabulin to prevent chemotherapy-induced neutropenia. The company aims to prioritize its highest value activities, including advancing regulatory processes for plinabulin in both the U.S. and China, as well as continuing clinical trials in immune-oncology.
BeyondSpring reported positive Phase 3 results for plinabulin in non-small cell lung cancer (NSCLC), showing improved overall survival and reduced severe neutropenia compared to docetaxel alone. The company established a partnership with Hengrui for plinabulin in Greater China, including an upfront payment of approximately $30 million and potential milestone payments of up to $170 million. BeyondSpring also plans to submit a new drug application (NDA) for plinabulin in NSCLC in the second half of 2022, while R&D expenses decreased slightly year-over-year.
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