Core Insights - BeyondSpring Inc. reported Q2 2025 financial results and highlighted significant clinical and corporate milestones, focusing on its lead asset, Plinabulin, which is positioned to redefine cancer treatment by leveraging the immune system [1][2]. Clinical Developments - Plinabulin is a first-in-class agent that matures dendritic cells, potentially offering new hope to 60% of non-small cell lung cancer (NSCLC) patients whose disease progresses after checkpoint inhibitor therapy [2]. - In the global Phase 3 trial (Dublin-3), the combination of Plinabulin and docetaxel showed durable survival benefits and reduced chemotherapy-induced neutropenia compared to standard docetaxel alone [2]. - New data from a Phase 2 study indicated that the combination of pembrolizumab, Plinabulin, and docetaxel in metastatic NSCLC patients demonstrated a median progression-free survival (PFS) of 6.8 months and an overall survival (OS) of 78% at 15 months [5]. - A collaboration with MD Anderson highlighted Plinabulin's rapid dendritic cell activation across eight cancer types, reporting an objective response rate (ORR) of 23% and a disease control rate (DCR) of 54% [5]. Corporate Milestones - SEED Therapeutics, in which BeyondSpring is a founding shareholder, received FDA clearance for its RBM39 molecular glue degrader, ST-01156, targeting aggressive cancers [2][4]. - Dr. Bill Desmarais joined SEED Therapeutics as CFO and CBO, bringing over 20 years of biotech leadership experience [6]. Financial Performance - For the six months ended June 2025, BeyondSpring reported a net income of $1 million, an improvement from a net loss of $2.6 million in the same period of 2024 [7]. - Research and development (R&D) expenses increased to $1.9 million for the six months ended June 2025, compared to $1.6 million in the prior year, primarily due to higher professional service fees [9]. - General and administrative (G&A) expenses decreased to $2.7 million for the six months ended June 2025, down from $3.1 million in the same period of 2024 [9]. Financial Position - As of June 30, 2025, cash and cash equivalents stood at $9.5 million, a significant increase from $2.9 million as of December 2024 [9]. - Current assets totaled $15.7 million, down from $25.3 million as of December 2024, reflecting the impact of discontinued operations [9].

FLORHAM PARK, N.J., July 07, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) today announced publication of a human clinical study in Med (Cell Press) demonstrating that Plinabulin, when combined with radiation and a checkpoint inhibitor, induces dendritic cell (DC) maturation and elicits tumor responses in patients across multiple cancer types who had failed prior ICI therapy. The study also identified a potential biomarker—baseline GEF-H1 immune signature—that may enable patient pre-selection an ...

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]

Median PFS at 6.8 months, Disease Control Rate of 77.3%, 15 months OS% at 78% in Metastatic NSCLC Patients after Progression on PD-1/L1 Therapies Median Progression-Free Survival (PFS): 6.8 months — nearly double the 3.7 months seen with current standard of care (SOC) docetaxel Confirmed Objective Response Rate (ORR): 18.2% — higher than the 12.8% seen with SOC docetaxel Disease Control Rate (DCR: PR + SD > 4 months): 77.3% — indicating clinical benefit majority of patients who progressed on prior PD-1/L1 i ...

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]

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]

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]