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BeyondSpring(BYSI) - 2025 Q1 - Quarterly Report
2025-05-12 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38024 BeyondSpring Inc. (Exact name of registrant as specified in its charter) Cayman Islands Not Applicable (State or other ju ...
BeyondSpring(BYSI) - 2025 Q1 - Quarterly Results
2025-05-12 20:30
EXHIBIT 99.1 BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update FLORHAM PARK, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical‑stage global biopharmaceutical company focused on developing cancer therapeutics, today announced its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update. "Plinabulin has now been administered to more than 700 patients with a favorable safety profile. By promoting de ...
BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire· 2025-05-12 20:30
Presentation at IO 360° conference showed early efficacy for Plinabulin combinations in metastatic NSCLC and Hodgkin lymphoma resistant to PD‑1/L1 therapySEED’s first‑in‑class RBM39 degrader, reported at AACR 2025 for its total tumor regression data in mechanism targeted cancer indication-Ewing Sarcoma, remains on track for IND filing mid‑2025 FLORHAM PARK, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical‑stage global biopharmaceutical company focused on developing cancer ...
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
Core Insights - BeyondSpring Inc. has filed its annual report on Form 10-K for the fiscal year ended December 31, 2024, with the SEC on March 27, 2025, which includes the company's audited consolidated financial statements [1] - The company is focused on developing innovative cancer therapies, with its lead asset, Plinabulin, in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Financial Reporting - The annual report can be accessed on the SEC's website and the company's website under the "Financials & Filings" section [1] - BeyondSpring offers a hard copy of its annual report containing audited consolidated financial statements free of charge to shareholders upon request [2] Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company that aims to address high unmet medical needs through first-in-class therapies [3] - Plinabulin operates as a dendritic cell maturation agent, providing both anti-cancer activity and immune modulation, which may help resensitize tumors to checkpoint inhibitors [3]
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
Core Insights - SEED Therapeutics Inc. has received Rare Pediatric Disease and Orphan Drug designations from the FDA for its molecular glue ST-01156, which targets RBM39, an RNA splicing factor involved in solid tumors [1][5] - The company is preparing to file an Investigational New Drug (IND) application for ST-01156 in the first half of 2025, which may lead to a priority review voucher upon approval [2] - BeyondSpring Inc., SEED's largest shareholder, is selling a portion of its Series A-1 Preferred Shares, retaining approximately 14.4% of SEED's outstanding shares post-transaction [3] Company Progress - SEED is transitioning into a clinical-stage company with the planned IND filing for ST-01156, marking a significant milestone in its journey to develop innovative therapies [4] - The FDA designations for ST-01156 are expected to expedite the development and commercialization process, addressing significant unmet needs in rare oncology [5] - The recent transactions are aimed at diversifying SEED's shareholder base, aligning its capital structure with institutional investor expectations, and enhancing its ability to advance its clinical pipeline [5] Company Overview - SEED Therapeutics focuses on discovering and developing targeted protein degradation therapeutics, leveraging its RITE3™ platform to address diseases with limited treatment options [6] - The company collaborates with Eli Lilly and Company and Eisai Co., Ltd., and has a robust pipeline of novel drug candidates nearing clinical development [6]