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BYSI

BeyondSpringD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-05-13
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Earnings documents stored for BYSI.

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Investor releaseQuarter not tagged2026-05-13

BeyondSpring shares rise after narrower quarterly loss and pipeline advances (BYSI)

InvestorsHub

Shares of BeyondSpring (NASDAQ:BYSI) climbed more than 6% in premarket trading on Wednesday after the company reported a smaller loss from continuing operations and highlighted progress across its development pipeline. The stock gained 6.47% following the earnings update. BeyondSpring reported a net loss from continuing operations of $2.4 million for the three months ended March 31, 2026, compared with a loss of $2.6 million during the same quarter last year. The company did not record any revenue during the quarter. As of March 31, 2026, BeyondSpring held $7.9 million in cash, cash equivalents and short-term investments. Research and development expenses rose to $1.1 million from $0.9 million a year earlier. The company said the increase was driven by expanded drug manufacturing activities in preparation for potential future clinical studies. General and administrative expenses declined to $1.1 million from $1.7 million in the prior-year period, mainly due to lower personnel-related and legal advisory costs. BeyondSpring pointed to new data presented at the AACR Annual Meeting 2026 showing that Plinabulin significantly improved both efficacy and tolerability in antibody-drug conjugate regimens based on topoisomerase inhibitors. According to the company, preclinical findings demonstrated stronger complete response rates, improved survival outcomes and enhanced immune responses. “Plinabulin continues to demonstrate the ability to enhance both efficacy and tolerability in ADC-based regimens, supporting its positioning as a potential backbone agent across a rapidly evolving treatment landscape,” said Lan Huang, co-founder, chair and chief executive officer of BeyondSpring. At SEED Therapeutics, BeyondSpring advanced ST-01156, described as a novel RBM39 molecular glue degrader, into Phase 1 clinical development. The company said the first dosing cohort has already been completed. Additional data presented at AACR 2026 showed complete tumour eradication in an in vivo neuroblastoma model. BeyondSpring recorded a net loss from discontinued operations of $4.3 million during the quarter. In the same period last year, the company reported net income from discontinued operations of $3.8 million. BeyondSpring stock price

Investor releaseQuarter not tagged2026-05-13

BeyondSpring Reports First-Quarter 2026 Financial Results and Provides Corporate Update

GlobeNewswire

AACR 2026 Data Positions Plinabulin as a Potential Backbone Agent to Combine with Antibody-Drug Conjugate (ADC)-Based Therapies to Improve Anti-Cancer Efficacy and Tolerability SEED Advances First Molecular Glue Degrader into Clinical Development with Biomarker-Driven Strategy FLORHAM PARK, N.J., May 13, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today announced its financial results for the quarter ended March 31, 2026, and provided a corporate update highlighting significant scientific and clinical advancements across its pipeline. “Plinabulin continues to demonstrate the ability to enhance both efficacy and tolerability in ADC-based regimens, supporting its positioning as a potential backbone agent across a rapidly evolving treatment landscape,” said Dr. Lan Huang, Co-Founder, Chair, and Chief Executive Officer of BeyondSpring. “Data presented at AACR 2026 further highlights the expanding value of our pipeline and reinforces our strategy of advancing highly differentiated therapies with the potential to address significant unmet medical needs. We believe Plinabulin has the potential to become a foundational combination agent that unlocks the full clinical and commercial value of ADC therapies.” Dr. Huang continued, “At SEED, the advancement of ST-01156, a novel RBM39 molecular glue degrader, into clinical development in oncology indications, coupled with a biomarker-driven approach, underscores the strength and scalability of our RITE3™ platform. These milestones reflect disciplined execution across our portfolio and position us to unlock meaningful long-term value through multiple clinical and strategic partnership opportunities.” Recent Clinical Highlights Plinabulin: Expanding Role as a Potentially Foundational Combination Therapy AACR 2026 data demonstrated that Plinabulin significantly enhances both efficacy and tolerability of topoisomerase inhibitor–based ADC regimens, with or without immune checkpoint inhibitors Preclinical findings showed: Improved complete response rate and survival outcomes Improved tolerability Enhanced CD8+ T cell / Treg ratio - shifting the tumor immune environment from suppression to attack These preclinical results suggest Plinabulin’s potential to address key limita...

Investor releaseQuarter not tagged2026-03-25

BeyondSpring Reports 2025 Year-End Financial Results

GlobeNewswire

Plinabulin (BeyondSpring's Lead Program): Phase 3 Survival Benefit Confirmed: Plinabulin combined with docetaxel demonstrated statistically significant overall survival benefit vs. standard of care docetaxel in EGFR wild-type NSCLC patients whose tumors progressed after first line therapy — DUBLIN-3 study results published in The Lancet Respiratory Medicine Confirmatory Trial Planned: Based on DUBLIN-3 Phase 3 data and US FDA discussions, BeyondSpring is advancing DUBLIN-4, a confirmatory global Phase 3 study in a biomarker-selected EGFR wild-type NSCLC patient population progressed on immune checkpoint inhibitors (NCT07361484) Overcoming Immunotherapy Resistance: Early clinical data at MD Anderson Cancer Center and Peking Union Hospital suggest Plinabulin may restore sensitivity to checkpoint inhibitors — a significant unmet need affecting most patients on PD-1/PD-L1 therapies – Results published in Cell Press journal Med 2025 and presented at SITC 2025 SEED Therapeutics (Reported as Discontinued Operations): First Patient Dosed for lead oncology program: ST-01156, a novel oral RBM39 degrader, initiated Phase 1a clinical trials in January 2026 following IND clearance in both the U.S. and China Financing Strengthened: Completed $30 million Series A-3 financing; appointed Dr. Bill Desmarais as Chief Financial Officer and Chief Business Officer FLORHAM PARK, N.J., March 25, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today announced its financial results for the year ended December 31, 2025, and highlighted late-stage clinical progress for Plinabulin and strategic developments related to its equity interest in SEED Therapeutics (“SEED”). 2025: Clinical and Operational Progress “2025 was a year of important clinical and operational progress for BeyondSpring and SEED Therapeutics,” said Dr. Lan Huang, Co-Founder, Chairman and Chief Executive Officer of BeyondSpring. “We advanced our Phase 3 Plinabulin program, generated meaningful clinical data, and strengthened our strategic and financial position.” “BeyondSpring made meaningful progress advancing Plinabulin in Phase 3 NSCLC, while SEED Therapeutics reached a critical milestone — initiating its first clinical trial following IND clearance in both the U.S....

Investor releaseQuarter not tagged2025-11-12

BeyondSpring Reports Third‑Quarter 2025 Financial Results and Provides Corporate Update

GlobeNewswire

Two SITC 2025 presentations: First-in-class dendritic cell (DC) maturation agent Plinabulin drives immune re-sensitization in metastatic NSCLC patients who had progressed after PD-1/L1 inhibitors with disease control rate of 85% in combination with docetaxel and Keytruda. Mechanism studies with MD Anderson collaborators showed DC maturation and M1 macrophage polarization via a Plinabulin specific GEF-H1 dependent mechanism in responding patients with Plinabulin, PD-1 inhibitor and radiation. SEED, co-founded by BeyondSpring with 38% equity share, successfully completed its $30 million Series A-3 financing, alongside U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for its lead program targeting RBM39. SEED Named Finalist for 2025 Prix Galien USA “Best Start-Up” Award FLORHAM PARK, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q3 2025 financial results alongside clinical and corporate milestones. “With over 700 patients treated, Plinabulin continues to demonstrate a favorable safety profile and meaningful potential as an immune-modulating therapy with unique mechanism of dendritic cell (DC) maturation and T cell priming,” said Dr. Lan Huang, Co-Founder, Chair and Chief Executive Officer of BeyondSpring. “With DC bridging innate and adaptive immunity, Plinabulin offers new hope for patients with NSCLC and other cancers whose disease progresses after checkpoint inhibitors, presented at recent SITC conference. In addition, results from our global Phase 3 DUBLIN-3 trial, published in The Lancet Respiratory Medicine, showed that Plinabulin in combination with docetaxel achieved durable survival benefits and reduced chemotherapy-induced neutropenia, reinforcing its potential to advance the standard of care and drive long-term value creation.” Dr. Huang added, “At SEED, which we co-founded with Lilly five years ago, we are excited that our RBM39 molecular-glue degrader has received IND clearance from both the US FDA and China NMPA. It is such an honor to be the only target protein degradation company nominated by the Prix Galien Foundation, recognizing our commitment to developing transformative medicine for patients. We are also grateful for the support of our inves...

Investor releaseQuarter not tagged2025-08-13

BeyondSpring Reports Second‑Quarter 2025 Financial Results and Provides Corporate Update: Accelerates Momentum with Promising Clinical Advances and Strategic Leadership Appointment

GlobeNewswire

ASCO 2025 presentation: First-in-class agent Plinabulin drives immune re-sensitization in NSCLC patients progressed to PD-1/L1 therapies Med (Cell Press) Publication with MD Anderson Collaboration highlights Plinabulin’s rapid dendritic cell activation in responding patients across eight cancer types who failed prior immunotherapy SEED Therapeutics’ RBM39 degrader ST-01156 clears FDA IND and advances toward Phase 1 trials New SEED Therapeutics CFO and CBO Dr. Bill Desmarais brings over 20 years of biotech leadership experience to accelerate development FLORHAM PARK, N.J., Aug. 13, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, today reported Q2 2025 financial results alongside clinical and corporate milestones. “At the heart of BeyondSpring’s pipeline is Plinabulin, a first-in-class agent potentially redefining cancer treatment by harnessing the body’s own immune system,” said Dr. Lan Huang, Co-Founder, Chair, and CEO. “Plinabulin’s ability to mature dendritic cells in human studies, bridges innate and adaptive immunity, offering potentially new hope to the 60% of NSCLC patients whose disease progresses after checkpoint inhibitor therapy. In our global Phase 3 trial (Dublin-3, published in LANCET Respiratory Medicine), plinabulin and docetaxel combination compared to standard of care docetaxel alone, delivered durable survival benefits alongside reduced chemotherapy-induced neutropenia — a combination with strong potential to influence standards of care.” Dr. Huang added, “BeyondSpring’s impact extends beyond Plinabulin. As SEED Therapeutics’ (“SEED”) founding shareholder, BeyondSpring, along with cornerstone investors and research collaborators Eli Lilly and Eisai, has supported SEED’s pioneering work in targeted protein degradation. SEED’s oral RBM39 molecular glue degrader, ST-01156, recently received FDA clearance to enter clinical trials, targeting aggressive cancers including Ewing Sarcoma and KRAS-driven tumors, with U.S. leading cancer institutions driving development forward.” Key Milestones: ASCO 2025 Presentation on Plinabulin Effect in Re-sensitizing Tumors Progressed on Prior PD-1/L1 Inhibitors: New data from a phase 2 study evaluating pembrolizumab in combination with Plinabulin and docetaxel in metastatic NSCLC patients who...

Investor releaseQuarter not tagged2025-05-13

BeyondSpring Reports First‑Quarter 2025 Financial Results and Provides Corporate Update

GlobeNewswire

Presentation at IO 360° conference showed early efficacy for Plinabulin combinations in metastatic NSCLC and Hodgkin lymphoma resistant to PD‑1/L1 therapy SEED’s first‑in‑class RBM39 degrader, reported at AACR 2025 for its total tumor regression data in mechanism targeted cancer indication-Ewing Sarcoma, remains on track for IND filing mid‑2025 FLORHAM PARK, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a clinical‑stage global biopharmaceutical company focused on developing cancer therapeutics, today announced its unaudited financial results for the quarter ended March 31, 2025, and provided a corporate update. “Plinabulin has now been administered to more than 700 patients with a favorable safety profile. By promoting dendritic‑cell maturation, it offers a potential option for the approximately 60 percent of cancer patients who progress on PD‑1/L1 inhibitors,” said Dr. Lan Huang, Co‑Founder, Chair, and Chief Executive Officer of BeyondSpring. “Early readouts in metastatic NSCLC and Hodgkin lymphoma who failed PD-1/L1 inhibitors showed durable responses that deserve further evaluation.” Dr. Huang added, “Within SEED, our RBM39 molecular‑glue degrader achieved complete tumor regression in mechanism-targeted Ewing sarcoma models and is on track for an IND submission mid‑year. We are also pursuing additional mechanism-targeted larger indications including liver cancer and KRAS‑mutant tumors with leading centers including Dana‑Farber, Memorial Sloan Kettering, and MD Anderson.” Recent HighlightsPlinabulin Clinical Presentations March 2025 (Oral Presentation at the Immuno-Oncology 360o Summit in Boston): Plinabulin combination regimen showed clinically meaningful responses in patients of multiple cancer types who failed prior immunotherapies, including NSCLC and Hodgkin lymphoma, with prolonged PFS. Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation (MD Anderson Cancer Center) showed promising data in re-sensitizing Hodgkin lymphoma for patients who failed 12 to 16 prior lines of treatments including stem cell transplant, CAR-T, and PD-1 inhibitor with duration of response of over 19 months. SEED Therapeutics Program RBM39 molecular‑glue degrader produced durable tumor regression in Ewing sarcoma animal models; IND‑enabling studies underway. Dual‑PROTAC approach using two E3 ligases overcame the hook e...

Investor releaseQuarter not tagged2025-03-27

BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones

GlobeNewswire

Plinabulin Final Phase 3 Data Published in The Lancet Respiratory Medicine, Demonstrating Overall Survival Benefit in 2L/3L NSCLC EGFR Wild Type vs. Docetaxel Plinabulin Phase 2 Data Highlights Potential to Resensitize Tumors Progressed on PD-1/PD-L1 Inhibitors in Metastatic NSCLC SEED Therapeutics Enters into Targeted Protein Degradation Research Collaboration with Eisai with potential payment to SEED of up to $1.5 Billion and Completes $24 Million First Close of Series A-3 Financing SEED Therapeutics’ Lead Oncology Asset RBM39 Degrader Granted Rare Pediatric Disease and Orphan Drug Designations by the FDA FLORHAM PARK, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, today announced its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments. “2024 was a pivotal year for BeyondSpring, with significant clinical progress for our first-in-class agent Plinabulin and strategic advancements for SEED Therapeutics (SEED), which BeyondSpring co-founded and owns an equity stake in. We believe these developments create value benefiting all stakeholders,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring. “Plinabulin demonstrated a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a setting where no new therapies have been approved in over a decade. This Phase 3 data, now published in The Lancet Respiratory Medicine, strengthens our regulatory strategy as we prepare for submission to the Chinese National Medical Products Administration (NMPA) and potentially regulatory authorities in other jurisdictions.” “BeyondSpring is also advancing Plinabulin’s potential as a next-generation immuno-oncology agent, with its potent effect in dendritic cell maturation. An ongoing Phase 2 study showed that Plinabulin, in combination with a PD-1 inhibitor and docetaxel, produced promising efficacy in patients with metastatic NSCLC who had progressed on prior PD-1/PD-L1 inhibitors with good tolerability. While PD-1 and PD-L1 antibody annual sales have exceeded $50 billion, with most sales coming from lung cancer, 60% of patients across multiple cancer indications de...

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook