BeyondSpring(BYSI) - 2025 Q2 - Quarterly Results

Corporate and Clinical Highlights BeyondSpring reported significant clinical progress for Plinabulin in NSCLC and SEED Therapeutics achieved FDA IND clearance for ST-01156 CEO's Statement CEO Dr. Lan Huang emphasized Plinabulin's immune-modulating potential and SEED Therapeutics' ST-01156 FDA IND clearance - Plinabulin is positioned as a first-in-class agent that harnesses the body's immune system by maturing dendritic cells, bridging innate and adaptive immunity[3] - The combination of plinabulin and docetaxel has shown durable survival benefits and reduced chemotherapy-induced neutropenia in a global Phase 3 trial[3] - SEED Therapeutics' oral RBM39 molecular glue degrader, ST-01156, received FDA clearance to enter clinical trials for aggressive cancers like Ewing Sarcoma and KRAS-driven tumors[3] Key Milestones Key milestones include Plinabulin's ASCO 2025 presentation, 'Med' publication, SEED Therapeutics' ST-01156 FDA IND clearance, and new leadership - ASCO 2025 presentation highlighted Plinabulin's ability to drive immune re-sensitization in NSCLC patients who have progressed on PD-1/L1 therapies[5] - A publication in 'Med' (Cell Press) detailed Plinabulin's rapid activation of dendritic cells in patients across eight cancer types who had failed prior immunotherapy[5] - SEED Therapeutics' lead asset, RBM39 degrader ST-01156, received FDA IND clearance and is advancing toward Phase 1 trials[5] - Dr. Bill Desmarais was appointed as the new CFO and CBO of SEED Therapeutics to accelerate development[5] Plinabulin Clinical Updates Plinabulin's Phase 2 NSCLC study showed encouraging efficacy, and a publication with MD Anderson confirmed its dendritic cell maturation mechanism Plinabulin Phase 2 NSCLC Study Efficacy Data (ASCO 2025) | Metric | Result | | :--- | :--- | | Median Progression-Free Survival (PFS) | 6.8 months | | Confirmed Objective Response Rate (ORR) | 18.2% | | Duration of Response (DOR) | 7.2 months | | Disease Control Rate (DCR) | 77% | | Overall Survival (OS) at 15 months | 78% | - A study with MD Anderson showed Plinabulin, combined with radiation and a checkpoint inhibitor, rapidly induces dendritic cell maturation in patients who failed prior immunotherapy[6] - In the MD Anderson study across eight cancer types, the combination therapy achieved an Objective Response Rate (ORR) of 23% and a Disease Control Rate (DCR) of 54%[6] SEED Therapeutics Updates SEED Therapeutics achieved FDA IND clearance for ST-01156, showing complete tumor regression in preclinical models, and appointed new leadership - The FDA cleared the IND application for ST-01156, a brain-penetrant, novel orally administered molecular glue degrader targeting RBM39[6][7] - Preclinical data presented at AACR 2025 showed ST-01156 demonstrated complete tumor regression in Ewing Sarcoma models[9] - Dr. Bill Desmarais, Ph.D., MBA, joined SEED Therapeutics as CFO and Chief Business Officer, bringing over two decades of biopharma leadership experience[9] Financial Performance BeyondSpring reported a reduced Q2 2025 net loss from continuing operations, improved cash, and reclassified SEED Therapeutics as discontinued operations Q2 2025 Financial Results Summary Q2 2025 saw increased R&D, reduced G&A, a lower net loss, and a strengthened cash position for continuing operations Q2 Financial Highlights (Continuing Operations) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $1.0 million | $0.8 million | | G&A Expenses | $0.9 million | $1.8 million | | Net Loss | $1.9 million | $2.7 million | Cash Position | Metric | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $9.5 million | $2.9 million | Year-to-Date 2025 Financial Results Summary Year-to-date 2025 showed a slightly improved net loss from continuing operations and a total net income including discontinued operations Six-Month Financial Highlights (Continuing Operations) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | R&D Expenses | $1.9 million | $1.6 million | | G&A Expenses | $2.7 million | $3.1 million | | Net Loss | $4.5 million | $4.7 million | - Net income from discontinued operations was $1.0 million for the first six months of 2025, compared to a net loss of $2.6 million for the same period in 2024[8] Accounting for SEED Therapeutics BeyondSpring reclassified SEED Therapeutics' financial results as discontinued operations after agreements to reduce its ownership stake - SEED Therapeutics' financial results are now reported as discontinued operations under ASC 205-20[9] - BeyondSpring's ownership in SEED is set to be reduced from approximately 40% to 14% upon completion of future sale transactions[10] Condensed Consolidated Balance Sheets As of June 30, 2025, BeyondSpring's balance sheet showed increased cash, stable assets and liabilities, and a widened shareholders' deficit Selected Balance Sheet Data (in thousands) | Balance Sheet Item | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,544 | $2,922 | | Total assets | $31,043 | $34,315 | | Total liabilities | $48,588 | $48,600 | | Total shareholders' deficit | ($17,545) | ($14,285) | Condensed Consolidated Statements of Comprehensive Income (Loss) Q2 2025 showed no revenue and a net loss from continuing operations, with year-to-date results including net income from discontinued operations Income Statement Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $0 | $0 | $0 | | Loss from operations | ($1,949) | ($2,641) | ($4,559) | ($4,696) | | Net loss from continuing ops | ($1,878) | ($2,651) | ($4,462) | ($4,731) | | Net income (loss) from discontinued ops | ($2,771) | ($1,438) | $983 | ($2,646) | | EPS (Continuing ops) | ($0.04) | ($0.07) | ($0.11) | ($0.12) | Company Overview BeyondSpring is a clinical-stage biopharmaceutical company developing first-in-class therapies, featuring Plinabulin and affiliate SEED Therapeutics About BeyondSpring BeyondSpring is a clinical-stage biopharmaceutical company focused on developing Plinabulin, a late-stage anti-cancer agent for NSCLC - The company's lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC[11] - Plinabulin's novel mechanism as a dendritic cell maturation agent offers a unique approach to resensitizing tumors resistant to checkpoint inhibitors[11] About SEED Therapeutics SEED Therapeutics specializes in targeted protein degradation via its RITE3™ platform, developing a pipeline with strategic partners - SEED Therapeutics pioneers targeted protein degradation through its proprietary RITE3™ platform[12] - The company has strategic collaborations with major pharmaceutical companies Eli Lilly and Eisai[12] - SEED's lead RBM39 degrader program has received US FDA IND clearance[12] Cautionary Note Regarding Forward-Looking Statements This section warns that forward-looking statements are subject to significant risks and uncertainties, which could cause actual results to differ - The press release contains forward-looking statements that are not historical facts and are based on current knowledge, beliefs, and expectations[13] - Actual results could differ materially due to risks such as difficulties in raising capital, unexpected clinical trial results, regulatory delays, and market competition[13]