Beyondspring Inc Stock Price, News & Analysis

BeyondSpring Inc. (Nasdaq: BYSI), a clinical-stage biopharmaceutical company, announced the filing of its annual report on Form 20-F for the fiscal year ending December 31, 2022, with the SEC on April 18, 2023. This report includes audited consolidated financial statements accessible via the SEC and BeyondSpring's website. The company emphasizes its commitment to providing free hard copies of its report to shareholders upon request.

BeyondSpring focuses on developing innovative therapies for patients with high unmet medical needs, leveraging its unique drug discovery platform. Its lead asset, Plinabulin, is under study for various cancer indications, with promising Phase 3 results in combination with chemotherapy to prevent neutropenia and improve survival rates in non-small cell lung cancer. The company also has multiple preclinical immuno-oncology assets.

BeyondSpring Inc. (NASDAQ: BYSI) reported significant milestones achieved by its subsidiary, SEED Therapeutics, in collaboration with Eli Lilly, resulting in $7 million in milestone payments. The company has completed enrollment in three investigator-initiated trials (IIT) for Plinabulin targeting various cancers. Research and development expenses have decreased to $25.6 million in 2022 from $36.9 million in 2021, while general and administrative expenses fell to $13.0 million from $30.7 million. Despite a net loss of $33.3 million for 2022, reduced expenses indicate improved operational efficiency. Upcoming milestones include NDA submissions for Plinabulin in China by mid-2023 for CIN and NSCLC indications.

BeyondSpring (NASDAQ: BYSI) announced the enrollment of the first patient in its Phase 2 trial for Plinabulin, combined with Merck's Keytruda and Docetaxel, targeting metastatic non-small cell lung cancer (NSCLC) patients who have experienced disease progression after immunotherapy. This study aims to address the significant unmet medical need among these patients, as anti-PD-1 therapies often lead to resistance. The trial is underway at Peking Union Medical College Hospital, with promising data suggesting that Plinabulin may enhance efficacy against advanced cancer, evidenced by a previously noted 40% response rate in a related study.

BeyondSpring Inc. (BYSI) announced that it has regained compliance with Nasdaq's minimum bid price requirement after its shares closed above $1.00 for ten consecutive business days. This compliance issue, previously disclosed, is now closed. However, the company was notified of a compliance issue regarding timely filing of its Form 6-K for the period ended June 30, 2022, with a deadline to submit a compliance plan by March 2023. Despite this, there is no immediate effect on the trading of its shares. BeyondSpring is focused on developing innovative cancer therapies, with positive Phase 3 data from its lead asset, plinabulin.

BeyondSpring (Nasdaq: BYSI) recently presented data from multiple conferences, showcasing the effectiveness of its lead drug, plinabulin, in preventing docetaxel-induced neutropenia (DIN) in non-small cell lung cancer (NSCLC) and breast cancer patients. Analyses revealed that plinabulin significantly reduced the mean duration of severe neutropenia by more than one day compared to standard treatment. The drug demonstrated a favorable safety profile, maintaining quality of life with minimal side effects. This positions plinabulin as a promising alternative for managing DIN in chemotherapy.

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.