Clinical Development - Plinabulin has been administered to over 700 cancer patients, demonstrating generally good tolerability and is being developed for various cancer indications, particularly in NSCLC with EGFR wild type [154]. - The DUBLIN-3 Phase 3 study enrolled 559 patients and showed a statistically significant overall survival benefit with a hazard ratio of 0.76, alongside an 80% reduction in grade 4 neutropenia from over 33% to 5% (p<0.0001) [156]. - Plinabulin is being studied in multiple combination therapies, including with Keytruda® and docetaxel for NSCLC patients who have progressed on PD-1/PD-L1 therapies [156]. - The company plans to file a New Drug Application (NDA) with the NMPA for Plinabulin as soon as possible following positive study results [156]. Financial Performance - Consolidated net loss for the three months ended September 30, 2025, was $4.9 million, with an accumulated deficit of $406.3 million as of the same date [163]. - For the three months ended September 30, 2025, the company reported no revenue from product sales, with discontinued operations generating $0.5 million in revenue [172]. - The net loss from continuing operations for the three months ended September 30, 2025, was $1.7 million, a 21% improvement from a loss of $2.2 million in 2024 [181]. - The company incurred a net loss of $8.4 million for the nine months ended September 30, 2025, representing a 30% reduction from a loss of $11.9 million in 2024 [192]. - The company reported a net loss of $8.4 million for the nine months ended September 30, 2025, compared to a net loss of $12.0 million in 2024 [196]. Cash Flow and Capital Resources - The company has raised approximately $299.0 million in equity financings and held $12.5 million in cash and cash equivalents as of September 30, 2025 [162]. - Cash and cash equivalents as of September 30, 2025, were $12.5 million, with the company needing additional capital resources to meet operational expenses [193]. - The company reported a net cash used in operating activities of $14.3 million for the nine months ended September 30, 2025, compared to $17.4 million in 2024 [194]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $14.3 million, a decrease of $3.1 million from $17.4 million in 2024 [196]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $15.9 million, primarily from $15.9 million cash proceeds from maturity of time deposits [198]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $3.0 million, a significant decrease from $24.9 million in 2024 [199]. - The company anticipates that its current financial resources will allow it to meet operational expenses and capital expenditures in the next 12 months [193]. - The company anticipates needing additional funding for future operations due to ongoing development and regulatory approval processes [200]. - Future capital requirements will depend on various factors, including the success of product candidates in clinical development and regulatory reviews [203]. Operational Changes - SEED Technology Limited, a majority-owned subsidiary, has been classified as discontinued operations, with the company owning approximately 38.03% of SEED's outstanding equity interest as of September 30, 2025 [169]. - The company is exploring strategic options including licensing, partnerships, or a sale to support its business plan and maximize shareholder value [164]. - The company has lease commitments for office space in New Jersey with a monthly rent of $26,344, set to increase in August 2026 [205]. - The company is entitled to receive a rent subsidy of approximately $31,000 from the local government in Dalian, China [206]. - The company has entered into a government grant agreement committing to specific operational conditions until 2033 [208]. Expenses - Research and development expenses increased by 67% to $1.0 million for the three months ended September 30, 2025, compared to $0.6 million in the same period of 2024 [182]. - General and administrative expenses decreased by 57% to $0.8 million for the three months ended September 30, 2025, down from $1.7 million in 2024 [184]. - For the nine months ended September 30, 2025, research and development expenses totaled $2.9 million, a 34% increase from $2.2 million in the same period of 2024 [187]. - The total other income, net, for the three months ended September 30, 2025, was $73, a decrease of 49% from $143 in 2024 [181]. - Cash inflows from discontinued operations were used to support their own operations, indicating no negative impact on the liquidity of continuing operations [195].

Financial Performance - BeyondSpring reported a net loss of $1.7 million for Q3 2025, an improvement from a net loss of $2.2 million in Q3 2024[10] - The company reported a net loss of $6.2 million for the nine months ended September 30, 2025, compared to $6.9 million for the same period in 2024[10] - For the three months ended September 30, 2024, the net loss attributable to BeyondSpring Inc. was $2,132,000, compared to a net loss of $1,540,000 for the same period in 2025[18] - The comprehensive loss attributable to operations for the three months ended September 30, 2024, was $2,712,000, compared to a loss of $1,646,000 in 2025[19] - The net loss from discontinued operations for the three months ended September 30, 2024, was $2,358,000, compared to a loss of $3,201,000 in 2025, showing an improvement[18] - The net loss before income tax for the nine months ended September 30, 2024, was $6,946,000, compared to $6,137,000 in 2025, indicating a worsening financial position[18] Research and Development - Research and development (R&D) expenses increased to $1.0 million in Q3 2025, up from $0.6 million in Q3 2024, primarily due to higher drug manufacturing and regulatory affairs costs[10] - Research and development expenses for the nine months ended September 30, 2024, were $2,172,000, compared to $2,915,000 in 2025, indicating a decrease of approximately 25.5%[18] - BeyondSpring's lead asset, Plinabulin, is in late-stage clinical development targeting NSCLC and other indications, focusing on immune modulation and tumor resensitization[11] Cash and Assets - Cash and cash equivalents rose significantly to $12.5 million as of September 30, 2025, compared to $2.9 million as of December 31, 2024[10] - Current assets decreased to $11.4 million as of September 30, 2025, down from $25.3 million as of December 31, 2024[10] Operational Efficiency - General and administrative (G&A) expenses decreased to $0.8 million in Q3 2025 from $1.7 million in Q3 2024, reflecting lower consulting and salary expenses[10] - General and administrative expenses decreased to $1,736,000 for the three months ended September 30, 2024, from $751,000 in 2025, reflecting a significant increase in operational efficiency[18] Clinical Outcomes - The disease control rate for Plinabulin in combination with docetaxel and Keytruda was reported at 85% for metastatic NSCLC patients who progressed after PD-1/L1 inhibitors[5] - The median progression-free survival (PFS) for Plinabulin in a Phase 2 study was 7.0 months, with a 12-month overall survival (OS) rate of 79%[6] Equity and Financing - BeyondSpring's equity share in SEED Therapeutics is approximately 38%, with SEED completing a $30 million Series A-3 financing[7]

Core Insights - BeyondSpring Inc. reported Q3 2025 financial results and highlighted significant clinical and corporate milestones, particularly focusing on its lead asset, Plinabulin, which is in late-stage development for cancer treatment [1][2]. Clinical Developments - Plinabulin has shown a favorable safety profile and potential as an immune-modulating therapy, with over 700 patients treated. It demonstrated an 85% disease control rate in combination with docetaxel and Keytruda for metastatic non-small cell lung cancer (NSCLC) patients who progressed after PD-1/L1 inhibitors [2][4]. - The global Phase 3 DUBLIN-3 trial results published in The Lancet Respiratory Medicine indicated that Plinabulin combined with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia [2][4]. - A Phase 2 study showed a median progression-free survival (PFS) of 7.0 months and a 12-month overall survival (OS) rate of 79% for patients treated with Plinabulin, docetaxel, and pembrolizumab [5]. Financial Performance - For the nine months ended September 2025, the net loss was $6.2 million, a decrease from $6.9 million for the same period in 2024. The net loss for Q3 2025 was $1.7 million, compared to $2.2 million in Q3 2024 [7][10]. - Research and development (R&D) expenses increased to $2.9 million for the nine months ended September 2025, up from $2.2 million in the same period in 2024, primarily due to higher drug manufacturing and regulatory affairs expenses [10][17]. - General and administrative (G&A) expenses decreased to $3.4 million for the nine months ended September 2025, down from $4.9 million in 2024, attributed to lower salary expenses and professional service costs [10][17]. Corporate Milestones - SEED Therapeutics, co-founded by BeyondSpring, completed a $30 million Series A-3 financing and received IND clearance from both the US FDA and China NMPA for its lead program targeting RBM39 [4][5]. - SEED was named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award, highlighting its innovative approach in the field of targeted protein degradation [4][5].

Core Insights - Chinese concept stocks experienced significant gains, with the top five performers showing substantial percentage increases in their stock prices [1] Group 1: Stock Performance - Meiyantang (MCTA) surged by 75%, closing at 7.000 with a trading volume of 27.48 million [1] - Kuke Music (KUKE) rose by 39.18%, reaching a price of 1.3900 and a trading volume of 1.99 million [1] - Wanchun Pharmaceutical (BYSI) increased by 26.44%, closing at 2.200 with a trading volume of 548,600 [1] - Juhua Mall (JWEL) saw a rise of 23.98%, ending at 2.120 with a trading volume of 25.46 million [1] - Smart Logistics (SLGB) gained 19.01%, closing at 3.130 with a trading volume of 598,280 [1]

Group 1 - The 2025 Annual Meeting of Shareholders for BeyondSpring Inc. was officially called to order by the Chair of the Board and CEO, Lan Huang [2] - A notice of the meeting was sent to all shareholders of record as of August 6, 2025, and a quorum was confirmed with more than a majority of outstanding shares present [3] - The only item on the agenda was the ratification of CBIZ as the independent registered public accounting firm for the fiscal year ending December 31, 2025, with a recommendation from the Board for shareholders to vote in favor [4]

Core Viewpoint - Nestlé is facing significant leadership turmoil following the abrupt firing of CEO Laurent Freixe due to a romantic relationship with a subordinate, marking the second CEO ouster in just over a year, which has led to increased pressure on Chair Paul Bulcke to resign [1][4][5]. Leadership Changes - Laurent Freixe was dismissed without severance pay after an internal investigation confirmed his affair, which was reportedly an "open secret" within the company [1][7]. - This dismissal follows the ousting of former CEO Mark Schneider in August 2024, leading to concerns about governance and stability within Nestlé [4][11]. - Philipp Navratil, previously head of Nespresso, has been appointed as the new CEO, but investors are skeptical about his ability to lead the entire conglomerate [5][15]. Investor Sentiment - Major shareholders are expressing dissatisfaction with Bulcke's leadership, with calls for his resignation due to the perceived governance failures and the impact on the company's credibility [5][10][16]. - Nearly 10% of shareholders voted against Bulcke's re-election as chair at the annual meeting, with an additional 5.4% abstaining [9]. Governance Concerns - The repeated leadership changes have raised alarms about the governance structure at Nestlé, with critics arguing that Bulcke's dual influence over management and the board has shielded him from accountability [9][10][12]. - Investors are concerned about the effectiveness of the board, with some suggesting that an external leader is needed to address the ongoing issues [12][16]. Financial Impact - Nestlé's shares have fallen 40% since 2022, resulting in billions in lost market value amid stagnating sales and governance scandals [9][17]. - The leadership crisis is seen as a core issue affecting investor trust, with shareholders indicating that Bulcke's continued presence could exacerbate the situation [16].

Group 1 - The core viewpoint of the article highlights the financial performance and market position of BeyondSpring Inc. (BYSI), a biopharmaceutical company focused on innovative cancer therapies [1] - As of August 25, BYSI's stock opened at $1.87 per share, reflecting a 6.25% increase, with a total market capitalization of $75.42 million [1] - Financial data shows that for the period ending June 30, 2024, BYSI reported total revenue of $1.00 million, representing a year-over-year growth of 14.29%, while the net profit attributable to shareholders was -$7.26 million, indicating a 42.91% increase in losses compared to the previous year [1] Group 2 - BeyondSpring is a clinical-stage biopharmaceutical company established in 2013, headquartered in the United States, focusing on the development of novel cancer therapies, including advanced tumor immunotherapy [1] - The company's primary project, Plinabulin, is derived from natural compounds and has therapeutic potential for various cancers due to its biochemical activities [1] - BeyondSpring employs a novel, 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] - The target research areas include non-small cell lung cancer, prevention of neutropenia, and Plinabulin combined with PD-1 monoclonal antibodies [1]

Core Insights - BeyondSpring Pharmaceuticals (BYSI) experienced a stock price increase of 2.9%, reaching $1.77 per share, with a total market capitalization of $71.38 million as of August 22 [1] - For the fiscal year ending June 30, 2024, the company reported total revenue of $1.00 million, reflecting a year-over-year growth of 14.29%, while the net profit attributable to shareholders was -$7.26 million, showing a year-over-year increase of 42.91% [1] Company Overview - BeyondSpring Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, including advanced tumor immunotherapy [2] - The company was founded in 2013 and is headquartered in the United States, with a mission to transform cancer treatment through its academic and business capabilities [2] - The primary project, Plinabulin, is derived from natural compounds and has therapeutic potential for various cancers, with a unique and scalable business model that integrates resources from the U.S. and China for efficient and low-cost drug approval and development [2] - Target research areas include non-small cell lung cancer, prevention of neutropenia, and Plinabulin combined with PD-1 monoclonal antibodies [2]

Core Insights - BeyondSpring Pharmaceuticals (BYSI) experienced a stock price increase of 5.19%, reaching $1.841 per share with a total market capitalization of $74.24 million as of August 20 [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] Company Overview - BeyondSpring is a clinical-stage biopharmaceutical company focused on developing novel cancer therapies, including advanced tumor immunotherapy [1] - The company was founded in 2013 and is headquartered in the United States, aiming to transform cancer treatment through its academic and business capabilities [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 - BeyondSpring employs a novel, 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] - The target research areas include non-small cell lung cancer, prevention of neutropenia, and the combination of Plinabulin with PD-1 monoclonal antibodies [1]

[Forward-Looking Statements](index=4&type=section&id=FORWARD-LOOKING%20STATEMENTS) [Forward-Looking Statements](index=4&type=section&id=FORWARD-LOOKING%20STATEMENTS) This section cautions investors that forward-looking statements involve risks and uncertainties, and actual results may differ - The report identifies numerous forward-looking statements concerning the company's operations, including clinical trial progress, regulatory filings, commercialization potential, financial projections, and intellectual property strategy[12](index=12&type=chunk)[16](index=16&type=chunk) - Investors are directed to "Part II, Item 1A. Risk Factors" for a detailed discussion of risks that could cause actual results to differ from those projected in the forward-looking statements[11](index=11&type=chunk)[13](index=13&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q2 2025 financial statements report a net loss of $4.6 million, reclassifying SEED Therapeutics as a discontinued operation [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets decreased to **$31.0 million**, while cash from continuing operations increased to **$9.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands of U.S. Dollars) | Account | Dec 31, 2024 | June 30, 2025 (Unaudited) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $2,922 | $9,544 | | Current assets of discontinued operations | $25,347 | $15,712 | | Total assets | $34,315 | $31,043 | | **Liabilities & Equity** | | | | Total current liabilities | $11,010 | $11,730 | | Total liabilities | $48,600 | $48,588 | | Total shareholders' deficit | ($14,285) | ($17,545) | [Condensed Consolidated Statements of Comprehensive Income (Loss)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income%20(Loss)) For H1 2025, net loss from continuing operations was **$4.5 million**, but a **$7.0 million** gain from subsidiary sale resulted in a total net income of **$2.7 million** Six Months Ended June 30, (in thousands of U.S. Dollars) | Metric | 2024 | 2025 | | :--- | :--- | :--- | | Revenue | $0 | $0 | | Research and development | ($1,550) | ($1,876) | | General and administrative | ($3,146) | ($2,683) | | Net loss from continuing operations | ($4,731) | ($4,462) | | Net income (loss) from discontinued operations | ($2,646) | $983 | | Net income (loss) attributable to BeyondSpring Inc. | ($7,262) | $2,671 | | Basic and diluted EPS | ($0.19) | $0.07 | [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For H1 2025, net cash used in operating activities was **$10.1 million**, offset by **$17.2 million** from investing activities, resulting in a net cash increase of **$7.1 million** Cash Flow Summary for Six Months Ended June 30, (in thousands of U.S. Dollars) | Cash Flow Activity | 2024 | 2025 | | :--- | :--- | :--- | | Net cash used in operating activities | ($12,254) | ($10,072) | | Net cash provided by investing activities | $0 | $17,154 | | Net cash provided by financing activities | $3,000 | $0 | | Net increase (decrease) in cash | ($9,354) | $7,080 | [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the divestiture of SEED Therapeutics as a discontinued operation, collaboration agreements, and the company's deferred tax asset valuation allowance - The company approved a plan to sell 90-100% of its interest in SEED Therapeutics. The first closing occurred in February 2025 for **$7.35 million**, resulting in a recognized gain of **$7.0 million**. The company's ownership in SEED decreased to **40.12%** but it retained control[62](index=62&type=chunk)[68](index=68&type=chunk)[70](index=70&type=chunk) - The collaboration with Hengrui for Plinabulin in Greater China involves an upfront fee of **$31.0 million** (RMB 200 million) and potential milestones. No revenue has been recognized from this agreement as of June 30, 2025, and the upfront fee is recorded as deferred revenue[71](index=71&type=chunk)[72](index=72&type=chunk)[74](index=74&type=chunk) - The collaboration with Eli Lilly via subsidiary SEED involves an upfront fee of **$10 million** and potential milestones up to **$780 million**. Revenue from this agreement is recognized over time and is reported within discontinued operations[76](index=76&type=chunk)[77](index=77&type=chunk)[81](index=81&type=chunk) - As of June 30, 2025, the company maintained a full valuation allowance against its net deferred tax assets, believing it is more likely than not that they will not be realized[87](index=87&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Plinabulin development, SEED Therapeutics divestiture, and H1 2025 financial results, noting decreased G&A and increased R&D expenses - The company's lead asset, Plinabulin, is being developed as an anti-cancer agent, with a focus on non-small cell lung cancer (NSCLC) patients who have progressed on checkpoint inhibitors. The company plans to file a New Drug Application (NDA) with China's NMPA[122](index=122&type=chunk)[124](index=124&type=chunk) - The company entered into agreements to sell a portion of its SEED preferred shares for **$35.4 million** in three tranches. The first closing in February 2025 yielded **$7.35 million**. Future closings are expected by December 2025 and December 2026[134](index=134&type=chunk) - As of June 30, 2025, continuing operations held **$9.5 million** in cash and cash equivalents. Management anticipates that current financial resources will be sufficient to meet operational expenses for the next 12 months[130](index=130&type=chunk)[161](index=161&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) For H1 2025, R&D expenses increased by **21%** to **$1.9 million**, while G&A expenses decreased by **15%** to **$2.7 million**, improving net loss from continuing operations Comparison of Operating Results for the Six Months Ended June 30, (in thousands of U.S. Dollars) | Item | 2024 | 2025 | Change % | | :--- | :--- | :--- | :--- | | Research and development | ($1,550) | ($1,876) | 21% | | General and administrative | ($3,146) | ($2,683) | -15% | | Loss from operations | ($4,696) | ($4,559) | -3% | | Net loss from continuing operations | ($4,731) | ($4,462) | -6% | - The **$0.3 million** increase in R&D expenses for H1 2025 was primarily due to higher professional service fees for regulatory and CMC activities and increased research on Plinabulin combination therapies[155](index=155&type=chunk) - The **$0.4 million** decrease in G&A expenses for H1 2025 was mainly due to lower salary expenses from reduced administrative headcount and lower investor relations and D&O insurance costs[157](index=157&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity improved in H1 2025, with cash from continuing operations reaching **$9.5 million** due to the SEED equity sale, and current resources are sufficient for the next 12 months - The company financed operations through a combination of equity offerings, loans, sale of subsidiary interests, and collaboration arrangements. In February 2025, it received **$7.4 million** from the first closing of the SEED sale[160](index=160&type=chunk) - Net cash used in operating activities decreased to **$10.1 million** in H1 2025 from **$12.3 million** in H1 2024[160](index=160&type=chunk)[162](index=162&type=chunk) - Management is evaluating various financing alternatives for medium to long-term funding, including equity/debt financing, licensing, partnerships, or other strategic transactions[161](index=161&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, BeyondSpring Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is exempt from providing quantitative and qualitative disclosures about market risk because it qualifies as a smaller reporting company under Exchange Act Rule 12b-2[181](index=181&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Based on an evaluation as of June 30, 2025, the Principal Executive and Financial Officer concluded that the company's disclosure controls and procedures were effective[182](index=182&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, these controls[184](index=184&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would materially adversely affect its business or financial condition - As of the filing date, the company is not involved in any material legal proceedings[186](index=186&type=chunk) [Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) There are no material changes to the risk factors previously disclosed in the company's 2024 Annual Report on Form 10-K - The company states there are no material changes from the risk factors disclosed in its 2024 Annual Report on Form 10-K[187](index=187&type=chunk) [Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, primarily including officer certifications and Inline XBRL data files - Exhibits filed include CEO/CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[192](index=192&type=chunk)