BeyondSpring(BYSI)

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BeyondSpring(BYSI) - 2024 Q4 - Annual Report
2025-03-27 11:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to To Commission File No. 001-38024 BeyondSpring Inc. (Exact name of registrant as specified in its charter) Cayman Islands Not Applicable (State or other jurisdiction of in ...
BeyondSpring Files 2024 Annual Report on Form 10-K
GlobeNewswire· 2025-03-27 11:05
FLORHAM PARK, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, today announced that it has filed its annual report on Form 10-K for the fiscal year ended December 31, 2024 with the U.S. Securities and Exchange Commission (“SEC”) on March 27, 2025. The annual report on Form 10-K, which contains the Company’s audited consolidated financial statements, can be acc ...
BeyondSpring(BYSI) - 2024 Q4 - Annual Results
2025-03-27 11:00
Financial Performance - BeyondSpring reported a net loss of $16.7 million for the year ended December 31, 2024, compared to a net loss of $21.9 million in 2023, reflecting a 24% improvement [21]. - The net loss attributable to BeyondSpring Inc. was $11.1 million for 2024, compared to $21.0 million in 2023, indicating a significant reduction in losses [21]. - Comprehensive loss for the period was $21,223 million, up from $15,966 million year-over-year [23]. - Comprehensive loss attributable to BeyondSpring Inc. was $20,568 million, compared to $10,681 million in the previous period, indicating a significant increase in losses [23]. Expenses - Research and development expenses decreased to $2.6 million in 2024 from $7.3 million in 2023, a reduction of approximately 64% [10]. - General and administrative expenses were reduced to $6.1 million in 2024, down from $7.8 million in 2023, representing a 22% decrease [10]. Assets and Cash Position - The company had cash, cash equivalents, and short-term investments of $2.9 million as of December 31, 2024, compared to $5.4 million in 2023 [10]. - The company reported total current assets of $28.6 million as of December 31, 2024, an increase from $18.4 million in 2023 [19]. Clinical Development and Collaborations - Plinabulin demonstrated a statistically significant overall survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC), with data published in The Lancet Respiratory Medicine [4]. - BeyondSpring completed the first closing of approximately $7.35 million from the sale of Series A-1 Preferred Shares of SEED to advance Plinabulin's clinical development [6]. - SEED Therapeutics secured a research collaboration with Eisai Co., Ltd., with potential payments of up to $1.5 billion, including upfront and milestone payments [10]. - The company plans to file an Investigational New Drug (IND) application for the RBM39 degrader in mid-2025, with patient enrollment expected to begin in the second half of 2025 [18]. Foreign Currency Adjustments - Foreign currency translation adjustment gain from continuing operations was $760 million, while the loss from discontinued operations was $(35) million [23].
BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones
GlobeNewswire· 2025-03-27 11:00
"SEED also made significant progress in 2024, securing a strategic research collaboration with Eisai Co., Ltd. ("Eisai"), a second global pharma partnership in addition to the Eli Lilly and Company ("Lilly") partnership. Under this collaboration, SEED will be eligible to receive upfront payments and potential preclinical, clinical, regulatory and sales milestone payments of up to $1.5 billion, plus tiered royalties on net sales. In parallel, SEED is advancing its internal lead oncology asset, RBM39 degrader ...
BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones
Newsfilter· 2025-03-27 11:00
Core Insights - BeyondSpring Inc. reported significant clinical advancements in 2024, particularly for its lead drug Plinabulin, which showed a statistically significant survival benefit in patients with non-small cell lung cancer (NSCLC) [2][3] - The company also highlighted strategic progress for SEED Therapeutics, including a collaboration with Eisai Co., Ltd. that could yield up to $1.5 billion in potential payments [2][10] Clinical Developments - Plinabulin demonstrated a statistically significant overall survival benefit in a Phase 3 trial for second- and third-line NSCLC (EGFR wild-type), with results published in The Lancet Respiratory Medicine [3][5] - Ongoing Phase 2 studies indicated Plinabulin's potential to resensitize tumors that have progressed on PD-1/PD-L1 inhibitors, showing promising efficacy and tolerability [3][9] - SEED Therapeutics made strides in targeted protein degradation, securing a strategic collaboration with Eisai and advancing its lead oncology asset, RBM39 degrader, toward clinical development [3][10] Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $16.7 million, a decrease from a net loss of $21.9 million in 2023 [17][18] - Research and development expenses were $2.6 million, down from $7.3 million in 2023, reflecting the completion of certain studies [10] - As of December 31, 2024, the company had cash and cash equivalents of $2.9 million, with total current assets amounting to $28.6 million [15][16] Strategic Collaborations - SEED Therapeutics entered into a research collaboration with Eisai, which includes potential milestone payments and tiered royalties on net sales [10] - The collaboration with Eli Lilly and the recognition of SEED as a leader in targeted protein degradation further solidify its position in the biotech industry [10][12] Future Milestones - Key upcoming milestones include updated data from ongoing Phase 2 studies in metastatic NSCLC and extensive-stage small-cell lung cancer (ES-SCLC) expected in 2025 [10][18] - The expected IND filing for the RBM39 degrader is anticipated in mid-2025, with patient enrollment expected to begin in the second half of 2025 [10][18]
BeyondSpring Announces $35.4 Million Sale of a Portion of Equity Interest in SEED Therapeutics to Advance Lead Asset Plinabulin to Anti-Cancer Registrational Studies
Newsfilter· 2025-01-28 12:00
Core Viewpoint - BeyondSpring Inc. has entered into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED Therapeutics Inc. for gross proceeds of approximately $35.4 million, while retaining about 14.4% of SEED's outstanding shares, which will help fund its late-stage clinical trials of Plinabulin [1][3]. Group 1: Company Overview - BeyondSpring is a global clinical-stage biopharmaceutical company focused on developing innovative cancer therapies, particularly its lead asset, Plinabulin, which is advancing into late-stage clinical development [12]. - SEED Therapeutics, co-founded by BeyondSpring and Eli Lilly in 2020, specializes in Targeted Protein Degradation (TPD) technology and has established itself as a leader in this innovative drug discovery approach [2][15]. Group 2: Financial and Strategic Moves - The recent Series A-3 financing led by Eisai valued SEED at a pre-money valuation of $100 million, highlighting its market potential and innovation [3]. - The proceeds from the sale of SEED shares will be utilized to advance BeyondSpring's late-stage clinical trials of Plinabulin, ensuring critical resources without diluting shareholder equity [3]. Group 3: Product Development and Clinical Trials - Plinabulin is a first-in-class anti-cancer agent that has been administered to over 700 cancer patients, demonstrating good tolerability and durable anti-cancer benefits across multiple clinical studies [4][8]. - The DUBLIN-3 Study showed that Plinabulin combined with docetaxel achieved significant overall survival benefits in patients with non-small-cell lung cancer (NSCLC) [6][9]. - Ongoing studies (303 and 302) are targeting severe unmet medical needs, with Plinabulin's mechanism of action expected to address these challenges [5][10][11].
SEED Receives FDA Rare Pediatric Disease and Orphan Drug Designations for Lead Oncology Asset RBM39 Degrader and Enters Strategic Transactions with New Investors
Newsfilter· 2025-01-28 12:00
KING OF PRUSSIA, Pa., Jan. 28, 2025 (GLOBE NEWSWIRE) -- SEED Therapeutics Inc. ("SEED"), a biotechnology company pioneering the discovery of molecular glues for targeted protein degradation (TPD) using its proprietary RITE3™ platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Orphan Drug designations to SEED's ST-01156 molecular glue. This novel agent degrades RBM39, an RNA splicing factor implicated in multiple mechanism-targeted solid tumor ind ...
BeyondSpring Presents Updated Efficacy Results from a Phase 2 IIT Study of Triple IO Combo of Pembrolizumab plus Plinabulin/Docetaxel in Metastatic NSCLC after Progressing on Prior Immune Checkpoint Inhibitors at the 39th SITC Annual Meeting
GlobeNewswire News Room· 2024-11-11 13:00
Core Insights - BeyondSpring Inc. presented phase 2 IIT data on plinabulin for non-small cell lung cancer (NSCLC) at the SITC Annual Meeting, indicating promising efficacy and safety results [1][7]. Study Overview - The 303 Study is an ongoing phase 2 trial evaluating a combination of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after PD-1/PD-L1 inhibitors [3][9]. - The study aims to enroll a total of 47 patients, with 30 patients already treated and reported on [4][9]. Patient Demographics - The median age of treated patients was 68 years, with 73.3% male and 60% being current or former smokers [4]. - Histological breakdown showed 57% with non-squamous cell carcinoma and 43% with squamous cell carcinoma [4]. Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was 21.1% [5]. - The median progression-free survival (PFS) was reported at 8.6 months, which is significantly higher than historical controls [5][6]. - The disease control rate was 89.3%, indicating a strong clinical benefit [5][6]. Safety Profile - The combination therapy was generally well tolerated, with 46.7% of patients experiencing grade 3 or higher treatment-related adverse effects [5]. - The most common adverse effects included myelosuppression and gastrointestinal issues, each at 13.3% [5]. Mechanism of Action - Plinabulin acts as a potent inducer of dendritic cell maturation, enhancing T cell activation and potentially overcoming resistance to immune checkpoint inhibitors [6][8]. - This unique mechanism contributes to its differentiated activity and tolerability compared to other treatments [8]. Company Background - BeyondSpring is focused on developing innovative therapies for high unmet medical needs, with plinabulin as its lead asset in late-stage clinical development for NSCLC [10].
BYSI Sees Quick 5.39% Surge Amid Low Trading Volume
Gurufocus· 2024-10-02 20:11
Company Overview - BeyondSpring Inc. (BYSI) experienced a stock price increase of 5.39%, reaching $2.54 per share [1] - The company reported a revenue of $1,000,000 and a net loss of $7.26 million, resulting in an earnings per share (EPS) of -$0.19 and a price-to-earnings (P/E) ratio of -6.29 [1] - BeyondSpring is engaged in clinical-stage biopharmaceutical activities, focusing on cancer treatments and immuno-oncology drugs [2] Trading Activity - The trading volume for BeyondSpring was 20,920 shares, with a turnover rate of 0.05% and a volatility of 10.37% [1] - No institutional ratings or recommendations (buy, hold, sell) are currently available for BYSI [1] Industry Context - Within the biotechnology sector, the average decline was 1.17% [1] - Specific stocks in the biotechnology industry showed significant variations, with notable gains in Tc Biopharm (Holdings) Plc, Coeptis Therapeutics Holdings Inc., and Bioatla, Inc. [1] - Stocks with substantial volatility included Pasithea Therapeutics Corp, Tevogen Bio Holdings Inc., and Apollomics Inc., with volatility rates of 145.55%, 70.19%, and 60.44%, respectively [2]
BeyondSpring Presents Efficacy/Safety Results from a Phase 2 Study of Pembrolizumab plus Plinabulin/Docetaxel in Metastatic NSCLC after Progressing on First-Line Immune Checkpoint Inhibitors at ESMO Congress 2024
GlobeNewswire News Room· 2024-09-16 11:00
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck & Co., Inc’s (NYSE: MRK, known as MSD outside of the United States and Canad ...