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].

Core Insights - BeyondSpring Inc. reported significant clinical progress and strategic advancements in 2024, particularly for its lead asset Plinabulin and its partnership with SEED Therapeutics [2][3] Clinical Developments - Plinabulin showed a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a market lacking new therapies for over a decade [3][5] - Ongoing Phase 2 studies indicate Plinabulin's potential to resensitize tumors that have progressed on PD-1/PD-L1 inhibitors, demonstrating promising efficacy and good tolerability [3][9] - SEED Therapeutics secured a strategic collaboration with Eisai Co., Ltd., which could yield up to $1.5 billion in potential payments, enhancing its oncology pipeline [3][10] Financial Performance - For the year ended December 31, 2024, the company reported a net loss of $16.7 million, a decrease from $21.9 million in 2023, indicating improved financial performance [19] - Research and development expenses were $2.6 million in 2024, down from $7.3 million in 2023, reflecting cost optimization measures [10] - As of December 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $2.9 million, with current assets amounting to $25.3 million [10][16] Strategic Collaborations - SEED Therapeutics is advancing its lead oncology asset, RBM39 degrader, which received Rare Pediatric Disease and Orphan Drug Designations from the FDA, reinforcing its potential in targeted protein degradation [3][10] - The collaboration with Eisai and the existing partnership with Eli Lilly are expected to drive significant advancements in oncology and targeted protein degradation [3][10] 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][19] - The expected IND filing for the RBM39 degrader is anticipated in mid-2025, with patient enrollment beginning in the second half of 2025 [10]

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]

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]

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].

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].

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]

Core Insights - BeyondSpring Inc. presented interim phase 2 data on the 303 Study for 2L/3L non-small cell lung cancer (NSCLC) at the ESMO Congress 2024, highlighting the efficacy of a triple combination therapy involving pembrolizumab, plinabulin, and docetaxel [1][3][6] Company Overview - BeyondSpring is a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, with its lead asset, Plinabulin, in late-stage clinical development for NSCLC and other cancer indications [10] Study Details - The 303 Study is a single-arm, open-label phase 2 trial evaluating the efficacy and safety of a combination regimen of pembrolizumab, plinabulin, and docetaxel in patients with metastatic NSCLC who have progressed after prior treatment with immune checkpoint inhibitors [3][9] - The study aims to enroll a total of 47 patients, with a formal interim analysis conducted on 19 evaluable patients [3][9] Efficacy Results - The confirmed overall response rate (ORR) for the combination therapy was reported at 21.1%, with a median progression-free survival (PFS) of 8.63 months [5] - The disease control rate (DCR) was notably high at 89.5%, indicating a significant clinical benefit for patients with severe unmet medical needs [5][6] - The median duration of response (DoR) was reported at 11.40 months, with a 6-month PFS rate of 67.1% and a 12-month PFS rate of 49.2% [5][6] Safety Profile - The combination therapy was well tolerated, with 52.6% of patients experiencing grade 3 or higher treatment-related adverse effects, and no treatment-related deaths reported [5][6] 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]

Financial Performance - For the six months ended June 30, 2024, BeyondSpring Inc. reported revenue of $1,000,000, an increase from $875,000 in the same period of 2023, representing a growth of approximately 14.3%[7] - The net loss for the six months ended June 30, 2024, was $7,377,000, a significant reduction from the net loss of $13,261,000 in the prior year, indicating an improvement of about 44.1%[7] - The basic and diluted net loss per share improved to $(0.19) for the six months ended June 30, 2024, compared to $(0.33) for the same period in 2023[7] - The company reported a comprehensive loss of $6,801,000 for the six months ended June 30, 2024, down from $12,017,000 in the prior year, reflecting a decrease of approximately 43.5%[7] Research and Development - Research and development expenses decreased to $4,149,000 for the six months ended June 30, 2024, down from $9,214,000 in the same period of 2023, reflecting a reduction of approximately 55.0%[7] Assets and Liabilities - Total current assets decreased to $14,919,000 as of June 30, 2024, compared to $18,419,000 as of December 31, 2023, a decline of about 19.0%[5] - Total assets decreased to $20,897,000 as of June 30, 2024, down from $24,808,000 as of December 31, 2023, representing a decrease of approximately 15.9%[5] - Total liabilities decreased to $47,172,000 as of June 30, 2024, compared to $48,269,000 as of December 31, 2023, indicating a reduction of about 2.3%[5] Cash and Revenue - Cash and cash equivalents increased to $8,397,000 as of June 30, 2024, from $7,809,000 as of December 31, 2023, an increase of about 7.5%[5] - Deferred revenue decreased slightly to $34,344,000 as of June 30, 2024, from $35,993,000 as of December 31, 2023, a decline of approximately 4.6%[5]

Core Insights - SEED Therapeutics has entered a strategic research collaboration with Eisai to develop novel molecular glue degraders targeting neurodegeneration and oncology [1][2] - The collaboration includes financial terms that allow SEED to receive up to $1.5 billion in payments and tiered royalties [2] - SEED has initiated Series A-3 financing, raising $24 million in the first close, with a second close planned for Q4 2024 [3] Collaboration Details - SEED will lead preclinical discovery activities, while Eisai will have exclusive rights to develop and commercialize the resulting compounds [2] - This collaboration follows an ongoing partnership between SEED and Eli Lilly for the development of molecular glue degraders [2] Series A-3 Financing - The Series A-3 financing aims to accelerate SEED's clinical development in cancer and neurodegeneration, expanding its TPD platform and pipeline [3] - SEED plans to advance its oral RBM39 Degrader into Phase 1 testing in 2025 and its Tau degrader program for Alzheimer's into in vivo efficacy testing in 2025, with an IND submission in 2026 [3] Company Background - SEED Therapeutics focuses on developing molecular glues and targeted protein degradation therapies for previously undruggable targets [6] - The company has a growing pipeline of drug candidates in neurodegeneration and oncology, supported by collaborations with Eli Lilly and Eisai [6][5] Eisai's Role - Eisai is recognized for its commitment to human health care and aims to address unmet medical needs in neurology and oncology [7] - The collaboration with SEED is seen as a unique opportunity to leverage molecular glue technology in both oncology and neurology [4]