On November 12, 2025 BeyondSpring Inc. (NASDAQ: BYSI), a clinical-stage company developing transformative therapies for the treatment of cancer and other diseases, reported Q3 2025 financial results alongside clinical and corporate milestones.
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"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 (Free SITC Whitepaper) 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 investors and collaborators, including Lilly and Eisai, and clinicians from leading US institutions, as we work together to advance molecular glue development to address undruggable targets for patients with unmet medical needs."
Key Milestones:
Two SITC (Free SITC Whitepaper) 2025 Presentations on Plinabulin Anti-cancer Clinical Benefit:
Resensitize NSCLC Patients Who Progressed on Prior PD-1/L1 Inhibitors with Disease Control Rate of 85% in Phase 2 Clinical Study: New data from a phase 2 investigator-initiated study (NCT05599789, Peking Union Hospital China) evaluating Plinabulin, docetaxel, and pembrolizumab in metastatic NSCLC patients who progressed on prior PD-1/L1 inhibitors (n=47), showed encouraging efficacy and safety data. The combination demonstrated median progression-free survival (PFS) of 7.0 months, confirmed objective response rate (ORR) of 18.2%, duration of response (DOR) of 7.2 months, disease control rate (DCR) of 85%, and 12-month overall survival (OS) rate at 79%, and 24-month OS rate at 66% (median OS not reached).
Resensitize Patients with Eight Cancer Types Who Failed Prior PD-1/L1 Inhibitors with Disease Control Rate of 54% through DC Maturation and M1 Macrophage Polarization via GEF-H1-dependent Mechanism in Phase 1 Clinical Study: This phase 1 investigator-initiated study (NCT04902040, MD Anderdon Cancer Center) shows that in addition to potent DC maturation for a systemic immune response, plinabulin combined with radiation and PD-1 inhibitor promotes proinflammatory monocytes and M1 macrophage polarization via a Plinabulin specific GEF-H1-dependent mechanism with the potential of overcoming acquired resistance to immune checkpoint inhibitors from pro-tumor macrophages.
SEED, Co-founded by BeyondSpring with 38% Equity Share, Secured Financial Position and Achieved IND Clearance: SEED completed its $30 million Series A-3 financing and received U.S. FDA and China NMPA clearance of its Investigational New Drug (IND) application for its lead RBM39 degrader program. SEED was also named a finalist for the 2025 Prix Galien USA "Best Start-Up" Award and co-hosted a targeted protein degradation symposium at NYU Grossman School of Medicine honoring Co-Founder and Nobel Laureate Prof. Avram Hershko, with leading thought leaders in the TPD field as presenters.
Third Quarter Financial Results1
Continuing operations:
Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2025 compared to $0.6 million for the quarter ended September 30, 2024. The $0.4 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
General and administrative (G&A) expenses were $0.8 million for the quarter ending September 30, 2025 compared to $1.7 million for the quarter ended September 30, 2024. The $0.9 million decrease was primarily due to lower professional service costs in consulting for business development and partnership initiatives, and lower salary expenses driven by decrease in administrative headcount.
Net loss: $1.7 million for the quarter ended September 2025, compared to $2.2 million for the quarter ended September 2024
Cash and cash equivalents: $12.5 million as of September 30, 2025, compared to $2.9 million as of December 2024
Discontinued operations:
Net loss: $3.2 million for the quarter ended September 2025, compared to $2.4 million for the quarter ended September 2024
Current assets: $11.4 million as of September 2025, compared to $3 million as of December 2024
Year to Date Financial Results1
Continuing Operations:
Research and development (R&D) expenses were $2.9 million for the nine months ended September 30, 2025 compared to $2.2 million for the nine months ended September 30, 2024. The $0.7 million increase was primarily due to higher drug manufacturing expenses, higher professional service expenses in regulatory affairs, and higher volume of Plinabulin combination therapy research to support strategic business development and partnership initiatives.
General and administrative (G&A) expenses were $3.4 million for the nine months ended September 30, 2025, compared to $4.9 million for the nine months ended September 30, 2024. The $1.5 million decrease was primarily due to lower salary expenses resulting from decrease in administrative headcount, lower professional services in consulting for business development and partnership initiatives, and lower company overhead expenses mainly due to decrease in investor relations services and D&O insurance related costs.
Net loss: $6.2 million for the nine months ended September 2025, compared to $6.9 million for the nine months ended September 2024
Discontinued operations:
Net loss: $2.2 million for the nine months ended September 2025, compared to $5.0 million for the nine months ended September 2024
Note 1: Accounting Update
Following definitive agreements in January 2025 to sell the majority of its Series A-1 Preferred Shares in SEED Therapeutics, BeyondSpring now reports SEED’s financial results as discontinued operations under ASC 205-20. BeyondSpring currently owns approximately 38% of SEED and upon completion of the future sale transactions BeyondSpring would own approximately 14% of SEED’s outstanding shares.
(Press release, BeyondSpring Pharmaceuticals, NOV 12, 2025, View Source;utm_medium=rss&utm_campaign=beyondspring-reports-third%25e2%2580%2591quarter-2025-financial-results-and-provides-corporate-update [SID1234660862])