Core Insights - BeyondSpring Pharmaceuticals (BYSI) experienced a stock price increase of 2.22%, reaching $2.075 per share, with a total market capitalization of $83.6564 million as of August 1 [1] - For the fiscal year ending June 30, 2024, the company reported total revenue of $1 million, reflecting a year-over-year growth of 14.29%, while the net profit attributable to shareholders was -$7.262 million, showing a 42.91% increase in losses compared to the previous year [1] - The company is set to release its fiscal year 2024 annual report on May 5, with the actual disclosure date subject to company announcements [1] Company Overview - BeyondSpring Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, including advanced tumor immunotherapy [1] - Established in 2013 and headquartered in the United States, the company aims to leverage its academic and business expertise in cancer treatment to transform the current landscape of cancer therapy [1] - The primary project, Plinabulin, is derived from natural compounds and has therapeutic potential for various cancers due to its biochemical activities [1] Business Model and Research Focus - The company employs an innovative and highly scalable business model that integrates resources from both the U.S. and China to efficiently and cost-effectively achieve drug approval and development [1] - Key research areas include non-small cell lung cancer, prevention of neutropenia, and the combination of Plinabulin with PD-1 monoclonal antibodies [1]

Core Insights - BeyondSpring Inc. announced a human clinical study demonstrating that Plinabulin, in combination with radiation and a checkpoint inhibitor, induces dendritic cell maturation and elicits tumor responses in patients with multiple cancer types who had previously failed ICI therapy [1][2] - The study identified a potential biomarker, baseline GEF-H1 immune signature, which may enable patient pre-selection and clinical response prediction [1][8] Clinical Study Overview - The Phase 1 translational trial evaluated a triple immunotherapy approach combining Plinabulin, radiation, and anti-PD-1 checkpoint inhibitors in patients with eight cancer types who are refractory or relapsed on prior ICI therapy [3] - Nineteen patients received the combination regimen, with an objective response rate (ORR) of 23% and a disease control rate (DCR) of 54% in non-irradiated lesions [4][8] Mechanism of Action - Plinabulin triggered dendritic cell maturation post-radiation via GEF-H1 signaling, leading to increased expression of DC maturation markers [5][11] - The mechanism of Plinabulin is distinct from traditional tubulin agents, promoting dendritic cell maturation and anti-tumor T-cell immunity without interfering with tubulin stabilizers [11] Biomarker Insights - Single-cell RNA sequencing differentiated responders from non-responders, identifying baseline GEF-H1 immune gene expression as a potential predictive biomarker for Plinabulin response [6][8] Company Background - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for high unmet medical needs, with Plinabulin as its lead asset in late-stage clinical development for various cancer indications [14]

Plinabulin's Mechanism and Preclinical Evidence - Plinabulin is a unique tubulin binder with a distinct binding site compared to other tubulin-binding agents[16, 21] - Preclinical studies show that Plinabulin, combined with radiation and anti-PD-1, activates dendritic cells (DCs), stimulates T-cell proliferation, and achieves abscopal effects[17, 24] - Plinabulin induces DC maturation, especially when administered after irradiation (IR), and Plinabulin-treated DCs stimulate T cell proliferation, enhanced by combining with IR[25] Clinical Efficacy and Immune Activation - In a Phase 1 study, the Plinabulin triple combination (with radiation and PD-1/PD-L1 inhibitors) led to an 80% disease control rate (DCR) in 10 IO-refractory patients[18, 32] - Durable responses were observed in 2 Hodgkin lymphoma patients who progressed after 12 or 16 prior lines of therapy[33] - Responding patients exhibited early immune activation with DC maturation and proinflammatory monocytes in the peripheral blood across six different cancer types[19, 35] Summary and Future Directions - Plinabulin demonstrates induction of DC maturation and re-sensitization to anti-PD(L)1 in IO-refractory tumors[37] - The impressive overall results, showing a high 80% disease control rate in ICI-refractory and heavily pre-treated patients, warrant further clinical studies of Plinabulin/IO combinations in IO-refractory settings[37, 38]

Core Insights - BeyondSpring Inc. presented interim Phase 2 data for its 303 Study on Plinabulin in combination with pembrolizumab and docetaxel for metastatic non-small cell lung cancer (NSCLC) patients who progressed on PD-1/L1 therapies, showing promising results in terms of progression-free survival and overall survival [1][2][3] Study Overview - The 303 Study enrolled 47 patients, with a median age of 67, and included a majority of male patients (80.9%) and current or former smokers (72.3%) [2] - The study evaluated the efficacy and safety of the triple combination therapy, with a median follow-up of 12.7 months [2][10] Key Results - Median Progression-Free Survival (PFS) was reported at 6.8 months, nearly double the 3.7 months seen with standard of care docetaxel [6] - Disease Control Rate (DCR) was 77.3%, indicating a clinical benefit for the majority of patients who had previously progressed on PD-1/L1 inhibitors [6] - The 15-month Overall Survival (OS) rate was 78%, which is longer than the median OS of 11.8 months for standard of care docetaxel [6] Mechanism of Action - Plinabulin is a first-in-class, late-stage differentiated tubulin binder that activates GEF-H1, leading to dendritic cell maturation and T cell activation, which may reverse acquired resistance to immune checkpoint inhibitors [5][9] Clinical Implications - The results suggest that Plinabulin could address the significant unmet medical need for effective treatments in NSCLC patients who have developed resistance to PD-1/L1 therapies [4][7] - The combination therapy demonstrated good tolerability, with 51.1% of patients experiencing grade 3 or higher treatment-related adverse effects, but no treatment-related deaths were reported [6]

Company Overview - BeyondSpring Inc. is a clinical-stage global biopharmaceutical company focused on developing cancer therapies, particularly its lead asset Plinabulin, which is in late-stage clinical development for non-small cell lung cancer (NSCLC) and other cancer indications [3] Study Announcement - BeyondSpring announced a poster presentation on the 303 Study, an investigator-initiated study supported by Merck, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3 in Chicago, IL [1] 303 Study Details - The 303 Study is an open-label, single-arm Phase 2 study evaluating the efficacy and safety of Plinabulin in combination with docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC who have progressed after anti-PD-(L)1 inhibitor therapy [4] - The study involves 47 enrolled patients and is conducted at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang as the principal investigator [4] - The primary endpoint is the investigator-based overall response rate (ORR), while secondary endpoints include progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety [4] Presentation Details - The presentation will take place on May 31, 2025, from 1:30 PM to 4:30 PM CDT at McCormick Place Convention Center, focusing on initial efficacy and safety results related to immune re-sensitization [5]

Financial Performance - BeyondSpring Inc. reported a consolidated net loss of $3.3 million for the three months ended March 31, 2024, and a consolidated net income of $1.2 million for the three months ended March 31, 2025, which included a gain of $7.0 million from the sale of preferred shares of SEED[148]. - For the three months ended March 31, 2025, discontinued operations generated $0.5 million in revenue through SEED's collaboration with Eli Lilly, while continuing operations did not generate any revenue[155]. - The net loss from continuing operations was $2.6 million for the three months ended March 31, 2025, a 24% increase from a net loss of $2.1 million in 2024[165]. - The company reported a net income of $1.2 million for the three months ended March 31, 2025, primarily due to a gain on the sale of subsidiary interests amounting to $7.0 million[171]. - The company incurred a loss from discontinued operations of $3.2 million for the three months ended March 31, 2025, compared to a loss of $1.2 million in 2024[165]. - The company had an accumulated deficit of $402.9 million as of March 31, 2025, down from $407.4 million at the end of 2024[171]. Cash and Financing - The company has raised approximately $299.0 million in equity financings and held $6.5 million in cash and cash equivalents as of March 31, 2025[147]. - Cash used in operating activities decreased to $4.2 million for the three months ended March 31, 2025, from $5.3 million in 2024, reflecting a reduction in operating cash expenditures[174]. - Net cash provided by investing activities was $6.3 million for the three months ended March 31, 2025, primarily from the sale of equity interests in SEED[176]. - The company anticipates needing additional capital resources to fund operations and expects general and administrative expenses to increase due to SEC reporting requirements[178]. - The company plans to finance future operations through a combination of equity and debt financing, licensing arrangements, and potential sales of subsidiary interests[180]. Research and Development - Plinabulin has been administered to over 700 cancer patients, demonstrating a statistically significant reduction in grade 4 neutropenia by over 80% in the DUBLIN-3 Phase 3 study[140]. - The DUBLIN-3 study enrolled 559 patients globally, showing significant overall survival benefits for the Plinabulin and docetaxel combination compared to docetaxel alone[140]. - The company plans to file a New Drug Application (NDA) with the NMPA for Plinabulin as soon as possible following positive study results[140]. - Research and development expenses increased by 21% to $0.9 million for the three months ended March 31, 2025, compared to $0.7 million for the same period in 2024[166]. Operational Expenses - General and administrative expenses rose by 30% to $1.7 million for the three months ended March 31, 2025, compared to $1.3 million in 2024[168]. - BeyondSpring Inc. expects to incur significant expenses and operating losses as it advances its product candidates through clinical development and seeks regulatory approval[149]. Partnerships and Collaborations - The company has partnered with Hengrui to commercialize Plinabulin in Greater China, pending drug approval and successful pricing negotiations[145]. - The upfront payment of RMB 200 million (approximately $31 million) received from Hengrui is recorded as deferred revenue, to be recognized over time after product approval[155]. Discontinued Operations - SEED's operations have been reclassified as discontinued operations, with the company owning approximately 40.12% of SEED's outstanding equity interest as of March 31, 2025[150]. Lease Commitments - The company has lease commitments for office space in New Jersey, totaling 9,727 square feet, with a monthly rent of $25,939, expiring in February 2027[184]. - The annual rent for the New Jersey office will increase by $0.50 per square foot starting in August 2025[184]. - The company leases office space in Dalian, China, with a total area of 210.65 square meters and a monthly rent of $1,404, expiring on December 31, 2027[185]. - The company is entitled to a rent subsidy of approximately $30,000 from the local government in Dalian related to its prior office lease[185]. - Wanchunbulin, a subsidiary, has a government grant agreement requiring it to maintain operations within designated districts until 2033[187]. Accounting and Reporting - There have been no material changes to the company's critical accounting estimates for the three months ended March 31, 2025, compared to the previous year[189]. - The company evaluates its financial estimates based on historical experience, known trends, and contractual milestones[188]. - The company is classified as a smaller reporting company and is not required to provide extensive market risk disclosures[192].

Financial Performance - BeyondSpring reported a net loss from continuing operations of $2,584,000 for Q1 2025, a 24% increase compared to a net loss of $2,080,000 in Q1 2024[5] - The company reported a comprehensive income attributable to BeyondSpring Inc. of $4,380,000 for Q1 2025, compared to a comprehensive loss of $2,970,000 in Q1 2024[13] - The company reported a basic and diluted earnings per share of $0.11 for Q1 2025, compared to a loss of $0.08 in Q1 2024[13] Expenses - Research and development expenses increased by 21% to $874,000 in Q1 2025 from $721,000 in Q1 2024[5] - General and administrative expenses rose by 30% to $1,736,000 in Q1 2025 compared to $1,334,000 in Q1 2024[5] Assets and Cash Position - Cash and cash equivalents increased to $6,527,000 as of March 31, 2025, from $2,922,000 as of December 31, 2024[11] - Total current assets rose to $31,526,000 as of March 31, 2025, compared to $28,577,000 as of December 31, 2024[11] Product Development - Plinabulin has been administered to over 700 patients, showing a favorable safety profile and potential efficacy in cancer patients who have progressed on PD-1/L1 inhibitors[2] - The RBM39 molecular-glue degrader achieved complete tumor regression in Ewing sarcoma models and is on track for an IND submission in mid-2025[2] Discontinued Operations - The company currently owns approximately 40% of the outstanding equity interest in SEED, which is now classified as discontinued operations[4]

Core Viewpoint - BeyondSpring Inc. reported its unaudited financial results for Q1 2025, highlighting advancements in its cancer therapeutics, particularly Plinabulin, and the SEED Therapeutics program, while also noting financial performance metrics. Financial Performance - R&D expenses from continuing operations increased by 21% to $874,000 in Q1 2025 from $721,000 in Q1 2024 [5] - G&A expenses from continuing operations rose by 30% to $1,736,000 in Q1 2025 compared to $1,334,000 in Q1 2024 [5] - Net loss from continuing operations was $2,584,000 in Q1 2025, a 24% increase from $2,080,000 in Q1 2024 [5] Clinical Developments - Plinabulin has been administered to over 700 patients, demonstrating a favorable safety profile and potential efficacy in patients who have progressed on PD-1/L1 inhibitors [2] - Early readouts in metastatic non-small cell lung cancer (NSCLC) and Hodgkin lymphoma showed durable responses warranting further evaluation [2] - The RBM39 molecular-glue degrader achieved complete tumor regression in Ewing sarcoma models and is on track for an IND submission mid-2025 [2][7] Corporate Updates - BeyondSpring owns approximately 40% of SEED Therapeutics, which operates independently and has been classified as discontinued operations for financial reporting [4] - The company reported a total asset increase from $34,315,000 as of December 31, 2024, to $37,104,000 as of March 31, 2025 [12][13] - The total liabilities increased from $48,600,000 to $49,771,000 during the same period [13] Shareholder Information - The net loss attributable to BeyondSpring Inc. was $4,477,000 for Q1 2025, compared to a net loss of $3,231,000 in Q1 2024 [15] - Basic and diluted earnings per share improved to $0.11 in Q1 2025 from a loss of $0.08 in Q1 2024 [15]

Financial Performance - The net loss attributable to BeyondSpring Inc. decreased from $21,026,000 in 2023 to $11,123,000 in 2024, a reduction of approximately 47.1%[769] - Basic and diluted loss per share improved from $0.54 in 2023 to $0.28 in 2024, indicating a 48.1% reduction in loss per share[769] - For the year ended December 31, 2023, BeyondSpring Inc. reported a net loss of $21,948,000, which is an increase from the net loss of $16,693,000 projected for 2024[775] - Loss before income tax decreased from $13,923,000 in 2023 to $8,769,000 in 2024, representing a reduction of approximately 37.5%[877] - For the year ended December 31, 2024, the consolidated net loss was $16,693, a decrease from $21,948 in 2023, indicating a reduction of approximately 24%[932] Assets and Liabilities - Total assets increased from $24,808,000 in 2023 to $34,315,000 in 2024, representing a growth of approximately 38.3%[767] - Current assets rose significantly from $18,419,000 in 2023 to $28,577,000 in 2024, an increase of about 55.2%[767] - The total liabilities remained relatively stable, increasing slightly from $48,269,000 in 2023 to $48,600,000 in 2024[767] - The accumulated deficit increased from $396,302,000 in 2023 to $407,425,000 in 2024, reflecting a rise of approximately 2.8%[767] - The total cash, cash equivalents, and restricted cash from continuing operations decreased from $15,337,000 at the end of 2023 to $2,922,000 at the end of 2024[775] Cash Flow and Investments - Cash used in operating activities remained relatively stable, with a net cash used of $16,474,000 in 2023 compared to $16,443,000 in 2024[775] - Cash flows from investing activities showed a substantial increase in the purchase of short-term investments, from $1,300,000 in 2023 to $12,788,000 in 2024[775] - Financing activities provided a net cash inflow of $26,785,000 in 2024, primarily due to proceeds from the issuance of ordinary shares and loans[775] - Cash and cash equivalents decreased from $5,396,000 in 2023 to $2,922,000 in 2024, a decline of about 46.1%[767] Research and Development - Research and development expenses decreased from $7,272,000 in 2023 to $2,644,000 in 2024, a decline of about 63.6%[769] - The company reported no revenue for both 2023 and 2024, indicating a continued focus on research and development rather than sales[769] - BeyondSpring Inc. is focused on developing innovative cancer therapies and is currently in the clinical stage of its biopharmaceutical activities[778] Shareholder Equity - Total shareholders' deficit improved from $(35,335,000) in 2023 to $(14,285,000) in 2024, a positive change of approximately 59.6%[767] - The company experienced a significant increase in share-based compensation, rising from $770,000 in 2023 to $2,255,000 in 2024[775] - The total fair value of share options vested increased significantly from $367,000 in 2023 to $1,412,000 in 2024, marking a rise of about 284.5%[889] Tax and Deferred Tax - The expected income tax benefit based on the U.S. Federal corporate income tax rate was $2,903,000 (21.0%) for 2023 and $1,841,000 (21.0%) for 2024[877] - The company reported a net operating loss carryforward of approximately $234,539,000 in 2023, which decreased to $133,383,000 in 2024[881] - Total deferred tax assets increased from $57,096,000 in 2023 to $58,995,000 in 2024, indicating a growth of about 3.3%[880] Discontinued Operations - The TPD platform segment qualified for discontinued operations reporting as of December 31, 2024, due to the divestiture plan approved by the Board[929] - Revenue from discontinued operations for the year ended December 31, 2024, was $2,001, up from $1,751 in 2023, representing a growth of 14.3%[857] - The net loss from discontinued operations for 2024 was $7,828, compared to a loss of $7,933 in 2023, indicating a slight improvement[857] Collaborations and Agreements - Under the Hengrui Collaboration Agreement, Wanchunbulin received an upfront fee of $31,039 and is eligible for up to $108,638 in regulatory milestone payments[859] - The Lilly Collaboration Agreement generated revenue of $1,751 in 2023 and $2,001 in 2024, reflecting a year-over-year increase of 14.3%[868] Segment Reporting - The Company has realigned its operations into two reportable segments: Plinabulin pipeline and Targeted Protein Degradation (TPD) platform[813] - The segment net loss for the Plinabulin pipeline and TPD platform was $8,865 in 2024, down from $14,015 in 2023, reflecting a 37% improvement[932] Risk Management - The Company relies on third parties for clinical development and manufacturing, which poses a risk if these parties fail to meet contractual obligations[839] - The Company has not experienced any losses on cash, cash equivalents, and restricted cash to date, indicating effective risk management[836]

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]