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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 (NASDAQ: BYSI) recently announced positive results from its Phase 3 PROTECTIVE-2 Study, showcasing that the combination of plinabulin and pegfilgrastim significantly reduces the incidence of profound neutropenia by 53% compared to pegfilgrastim alone (21.6% vs. 46.4%, p=0.0001). Additionally, the combination therapy leads to a 41% reduction in the odds of febrile neutropenia. These findings were presented at the 2020 San Antonio Breast Cancer Symposium. The company aims to submit a New Drug Application in Q1 2021, following Breakthrough Therapy Designation by the FDA.
BeyondSpring (NASDAQ: BYSI) announced its participation in two significant upcoming events: the 62nd American Society of Hematology (ASH) Annual Meeting (December 5-8, 2020) and the San Antonio Breast Cancer Symposium (SABCS) (December 8-11, 2020). Notably, the company will present findings from the PROTECTIVE-2 Trial, focusing on the Plinabulin and Pegfilgrastim combination's efficacy in preventing chemotherapy-induced neutropenia in breast cancer patients. Presentations will include a poster at ASH on December 5 and three posters at SABCS starting December 9, 2020, featuring research by Dr. Douglas W. Blayney from Stanford University.
BeyondSpring Inc. (NASDAQ: BYSI), a biopharmaceutical company focused on immuno-oncology therapies, will present a corporate overview at the Evercore ISI HealthCONx Conference on December 2, 2020. Dr. Lan Huang, Co-founder and CEO, will participate in a fireside chat at 9:15 am ET. Investors can access a live webcast and replay on BeyondSpring's website under the Investors section. The company's lead asset, plinabulin, is in a Phase 3 trial for non-small cell lung cancer and has received Breakthrough Therapy designation from the U.S. FDA for preventing chemotherapy-induced neutropenia.
BeyondSpring announced a public offering of 7,500,000 ordinary shares priced at $10.00 each, aiming to raise approximately $75 million. The offering is set to close on November 23, 2020, pending customary conditions. Proceeds will support the commercialization of plinabulin and further clinical development. The underwriters also hold a 30-day option for an additional 1,125,000 shares. The offering is conducted under the existing shelf registration with the SEC, effective from November 12, 2020.
BeyondSpring has launched an underwritten public offering of $75 million of its ordinary shares, with the potential to grant underwriters an additional $11.25 million. The proceeds are designated for the commercialization of Plinabulin, ongoing clinical development, and general corporate purposes. The offering is managed by BofA Securities, Jefferies, and Evercore ISI, with terms subject to market conditions. This offering follows the Company's effective shelf registration statement filed with the SEC on November 3, 2020.
BeyondSpring reported its Q3 2020 financial results and operational updates, highlighting a pivotal Phase 3 study for plinabulin showing superior outcomes in preventing chemotherapy-induced neutropenia compared to pegfilgrastim alone. The company plans to file a New Drug Application for plinabulin in the U.S. by early 2021.
Financially, R&D expenses rose to $8.6 million, while G&A expenses increased to $6.7 million, leading to a net loss of $14.5 million. BeyondSpring has $30.9 million in cash and believes it can sustain ongoing clinical trials and NDA preparations.
BeyondSpring (NASDAQ: BYSI) announced positive topline data from its PROTECTIVE-2 Phase 3 study, demonstrating that plinabulin combined with pegfilgrastim significantly prevents Grade 4 neutropenia in chemotherapy patients (31.5% vs. 13.6%, p=0.0015). The combination also achieved significant secondary endpoints, impacting duration of severe neutropenia and absolute neutrophil count. With Breakthrough Therapy designations from the U.S. FDA and China NMPA, BeyondSpring is preparing for NDA submission in Q1 2021. The study included 221 patients and provides promising insights for addressing chemotherapy-induced neutropenia in up to 440,000 U.S. patients annually.
BeyondSpring, a biopharmaceutical company trading on NASDAQ under the symbol BYSI, will present a corporate overview at the Jefferies London Healthcare Conference on November 17, 2020, at 2:55 pm Eastern Time. The event will highlight the company's innovative immuno-oncology therapies aimed at patients with high unmet medical needs. Plinabulin, their lead immune asset, is undergoing Phase 3 trials for chemotherapy-induced neutropenia and non-small cell lung cancer. The presentation can be accessed via a live webcast and archived on their official website.
Seed Therapeutics, a subsidiary of BeyondSpring, announced a collaboration with Eli Lilly to develop targeted protein degradation (TPD) therapies. The agreement includes a $10 million upfront payment and a $10 million equity investment from Lilly. Seed Therapeutics could receive up to $780 million in milestone payments and royalties from resulting products. The company aims to address previously undruggable proteins linked to diseases like cancer and Alzheimer's, utilizing its proprietary 'molecular glue' technology to create new therapeutic options.
Seed Therapeutics, a subsidiary of BeyondSpring (NASDAQ: BYSI), has appointed Edward Dongheng Liu as its new Chief Financial Officer. Liu, who has been BeyondSpring's CFO since 2018, will leverage his extensive experience in investment banking and corporate development to enhance the financial strategies of Seed Therapeutics. The company focuses on a molecular glue platform for targeted protein degradation, aiming to address diseases previously deemed undruggable. This appointment is expected to bolster Seed's position in the innovative drug discovery landscape.
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