Beyondspring Inc Stock Price, News & Analysis

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.

BeyondSpring Pharmaceuticals has released new data at the ASH Annual Meeting demonstrating that plinabulin rapidly reverses chemotherapy-induced neutropenia (CIN) and leukopenia within 24 hours. This effect is attributed to its mechanism of protecting granulocyte-monocyte-progenitor stem cells, with statistical significance marked at p<0.0001. The findings affirm the positive results from the Phase 3 PROTECTIVE-2 study, supporting plinabulin's role in enhancing CIN prevention strategies and potentially improving patient outcomes during chemotherapy.

BeyondSpring Pharmaceuticals (NASDAQ: BYSI) presented analyses from its PROTECTIVE-2 trial at the San Antonio Breast Cancer Symposium on December 10, 2021. The data indicated that the combination of plinabulin and pegfilgrastim significantly alleviates pegfilgrastim-related bone pain and enhances health-related quality of life (HrQoL) for breast cancer patients. Key findings showed lower incidences of bone pain and improved absolute neutrophil counts in patients receiving the combination therapy. Plinabulin is a promising candidate for preventing chemotherapy-induced neutropenia (CIN) and is being explored for various cancer therapies.

BeyondSpring Pharmaceuticals (NASDAQ: BYSI) announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for plinabulin in combination with G-CSF for preventing chemotherapy-induced neutropenia (CIN). The FDA's review concluded that the results from the Phase 3 trial were insufficient, requiring an additional well-controlled trial for approval. BeyondSpring remains optimistic about the drug's potential and plans further discussions with the FDA to explore the clinical pathway.

BeyondSpring (NASDAQ: BYSI), a global pharmaceutical company, announced management participation in the 4th Annual Evercore ISI HealthCONx Conference from November 30 to December 2, 2021. The Fireside Chat is scheduled for November 30 at 4:20 PM ET, with a webcast accessible via their website. BeyondSpring focuses on innovative cancer therapies, particularly its lead asset, plinabulin, which aims to prevent chemotherapy-induced neutropenia (CIN) and has received breakthrough designation in the U.S. and China. A significant PDUFA date of November 30, 2021, is noted for the U.S. approval process.