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])

On November 12, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, and Kyoto University, a research institution known for its groundbreaking advancements in medicine and science reported a research collaboration to develop advanced biological signatures to enhance targeted treatment strategies for patients with esophageal squamous cell carcinoma (ESCC).

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This research will leverage BostonGene’s AI-powered, multi-scale, omnimodal platform to analyze tumor molecular profiles and assess their correlation with response to a novel immune checkpoint inhibitor (ICI) and chemoradiotherapy (CRT) combination therapy. The study builds on the NOBEL trial, an investigator-initiated clinical study led by Dr. Manabu Muto of Kyoto University, by integrating genomic and transcriptomic profiling from ESCC patients to identify immune-related biomarkers that drive drug development, optimize clinical trial design and enable more accurate patient stratification.

As part of the collaboration, Kyoto University will provide clinical samples and patient data and BostonGene will apply its AI-powered molecular analytics to uncover key biological pathways and associated biomarkers influencing treatment response.

"This collaboration will generate actionable insights into the tumor microenvironment and immune landscape of esophageal cancer," said Yukimasa Shiotsu, PhD, President of BostonGene Japan. "Combining Kyoto University’s clinical expertise and BostonGene’s AI-powered analytics, we will refine and advance precision treatment strategies for ESCC patients."

"Understanding the molecular and immune characteristics of ESCC is essential for developing more effective treatment strategies," said Dr. Manabu Muto, Professor at Kyoto University and Principal Investigator of the NOBEL trial. "Through this collaboration, we will apply cutting-edge AI-powered analytics to clinical data, enabling us to identify biomarkers that can directly inform treatment decisions and improve patient outcomes."

About NOBEL trial

NOBEL trial is a Phase II study evaluating the efficacy and safety of a combination treatment of chemoradiotherapy and an immune checkpoint inhibitor for advanced esophageal cancer.

The NOBEL trial is being conducted as an investigator-initiated trial with financial support from Ono Pharmaceutical Co., Ltd.

(Press release, BostonGene, NOV 12, 2025, View Source [SID1234659864])

On November 12, 2025 Nucleai, a leader in AI-powered spatial biology for precision medicine, and the University of Glasgow, a global leader in spatial proteomics and transcriptomics research, reported a collaboration to identify and validate predictive biomarkers for colorectal cancer (CRC) and advanced polyp incidence. The project leverages artificial intelligence and multimodal spatial biology data, combining tissue, molecular, and clinical data to improve patient risk stratification and early detection.

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The collaboration will analyze data from the Integrated Technologies for Improved Polyp Surveillance (INCISE) study – one of the world’s most comprehensive and unique colon precancerous polyp cohorts – to uncover how tissue architecture, cell-to-cell interactions, and molecular signaling influence cancer progression. These insights will lay the foundation to develop clinically validated precision diagnostic products, designed to predict disease risk and personalize surveillance strategies.

Harnessing AI and Multimodal Data to Predict and Prevent Colorectal Cancer

Colorectal cancer remains one of the most preventable yet deadly cancers, with outcomes heavily dependent on early detection and accurate risk assessment. Current surveillance programs often suffer from overuse and limited precision, leading to unnecessary procedures and missed opportunities for cancer detection and prevention.

The collaboration combines the University of Glasgow’s clinical and pathology excellence with Nucleai’s scalable multimodal spatial pipeline, the most advanced in the world for spatial proteomics and tissue-level AI analysis. This pipeline integrates multiplex immunofluorescence (mIF), IHC, H&E, and clinical data in an automated, AI-driven workflow, enabling biomarker discovery and validation at unprecedented scale and accuracy.

"This collaboration is a significant step toward realizing the promise of multimodal spatial precision medicine," said Avi Veidman, CEO of Nucleai. "By combining Glasgow’s leadership in spatial biology with our AI-powered platform, we’re moving from discovery to deployable diagnostics – translating complex biological data into actionable clinical insights."

Nigel Jamieson, Professor of Hepatobiliary and Pancreatic surgery, University of Glasgow, added: "Deep phenotyping of pathology specimens using spatial omics technologies has the potential to revolutionize our understanding of disease mechanisms and progression, and to drive the discovery of novel spatial biomarkers. Through SPARC (Spatial Pathology Analytic for Research and Clinical Integration), we have established substantial spatial-omics capability at the University of Glasgow, empowering us to better characterize a wide range of immune conditions and cancers, including colorectal and pancreatic cancer. SPARC and the University of Glasgow are at the forefront of this spatial biology revolution, but a key challenge remains — the integration of multimodal data encompassing clinical information, tissue imaging, and computational pathology. Our partnership with Nucleai will help us address this challenge and accelerate the translation of spatial biology insights into clinical practice, ultimately improving patient care."

Joanne Edwards, Professor of Translational Cancer Pathology, University of Glasgow, added: "The INCISE study represents a transformative opportunity to understand colorectal cancer at a systems level. By integrating spatial biology with clinical data, we’re uncovering the hidden architecture of disease progression. This partnership with Nucleai allows us to translate these insights into predictive tools that can truly personalize surveillance and prevention strategies — bringing precision medicine into routine care."

A New Approach for Deployable Diagnostics

Nucleai’s approach uniquely integrates high dimensionality multimodal data for biomarker discovery and applies complexity reduction techniques to translate those discoveries into scalable diagnostic tests. This strategy bridges the gap between advanced discovery science and real-world clinical deployment – enabling broad accessibility without compromising biological depth. Unlike approaches based solely on low-complexity or H&E data, Nucleai’s platform captures a greater biological context of disease, yielding more predictive and clinically actionable tests.

Building the Future of Precision Medicine

This project marks the first step in Nucleai’s broader initiative to build a global precision medicine network – connecting academia, life science tools, and clinical institutions. By extending its platform beyond drug development into diagnostics, Nucleai is positioning itself as the operating system for next-generation precision medicine, capable of translating biological complexity into clinical action.

"And this is just the beginning," Veidman added. "We’re preparing additional announcements that will expand our multimodal collaborations and further solidify our role in shaping the future of precision medicine."

(Press release, University of Glasgow, NOV 12, 2025, View Source [SID1234659863])

On November 12, 2025 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States with its National Medical Center ranked among the nation’s top cancer centers by U.S. News & World Report, reported it will present leading-edge findings at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition happening Dec. 6-9 in Orlando and online.

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Across 105 sessions, City of Hope experts will highlight advances in blood cancer research, cellular therapies and precision medicine.

The ASH (Free ASH Whitepaper) meeting is the world’s largest hematology gathering, attracting more than 30,000 hematology professionals globally.

"ASH is where the future of hematology takes shape," said Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive and president of City of Hope National Medical Center. "Our teams are proud to share discoveries that deepen scientific understanding and accelerate progress toward more effective, safer treatments for patients worldwide."

From innovative immunotherapies to strategies that improve transplant outcomes, City of Hope is leading progress in areas that matter most to patients.

ORAL ABSTRACT SESSIONS

Leukemia

Plenary 6: Results from paradigm – a phase 2 randomized multi-center study comparing azacitidine and venetoclax to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia
Time: Sunday, Dec. 7, 3:45 p.m. EST
Senior Author: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

443: CD19-CAR T cell therapy as a definitive consolidation in older adults with b-ALL in CR1 is safe and induces durable MRD-remission
Time: Sunday, Dec. 7, 10:30 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Lymphoma

151: 3-year follow-up of the S1826 study confirms improved progression-free survival with nivolumab-AVD compared to brentuximab vedotin-AVD in advanced stage classic Hodgkin lymphoma
Time: Saturday, Dec. 6, noon EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

268: BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease
Time: Saturday, Dec. 6, 2:45 p.m. EST
Presenter: Elizabeth Budde, M.D., Ph.D., City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

883: Interim analysis of the phase II study of glofitamab, lenalidomide and venetoclax (GLOVe) in untreated patients w/ high-risk mantle cell lymphoma. Response and safety outcomes after the completion of stage 1 of 2 enrollment.
Time: Monday, Dec. 8 at 2:45 p.m. EST
Presenter: Tycel Phillips, M.D., associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

1013: CAR T cell therapy outcomes in adolescent and young adult patients with non-Hodgkin lymphoma
Time: Monday, Dec. 8, 5:30 p.m. EST
Presenter: Lindsey Murphy, M.D., M.S., City of Hope assistant professor, Department of Pediatrics

Myeloma

405: Safety and efficacy of out-of-specification ciltacabtagene autoleucel (cilta-cel) in relapsed/refractory multiple myeloma (RRMM)
Time: Saturday, Dec. 6, 4:30 p.m. EST
Presenter: Azra Borogovac, M.D., M.S., City of Hope assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

Transplantation

376: Total marrow and lymphoid irradiation (TMLI) with fludarabine-melphalan (FM) conditioning for matched donor hematopoietic cell transplant (HCT) in older patients with relapsed/refractory (R/R) disease
Time: Saturday, Dec. 6, 4:45 p.m. EST
Presenter: Monzr M. Al Malki, M.D., City of Hope professor, Department of Hematology & Hematopoietic Cell Transplantation

276: First-in-human trial of allogeneic CD6-CAR tregs in patients with chronic graft-versus-host disease after allogeneic hematopoietic cell transplantation
Time: Saturday, Dec. 6, 3:15 p.m. EST
Presenter: Amandeep Salhotra, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

160: A TLR4-HSP70 efferocytic program in thymic macrophages sustains thymic homeostasis and T cell output
Time: Saturday, Dec. 6, 12:45 p.m. EST
Presenter: Andri Lemarquis, M.D., Ph.D., City of Hope staff scientist

CITY OF HOPE-LED EDUCATIONAL SESSIONS

14th Annual BMT & Cell Therapy Winter Workshop, co-chaired by Dr. Marcel van den Brink
Time: Friday, Dec. 5, 1:30 – 8 p.m. EST
Register for virtual attendance here.

Satellite Symposia fss25-93: Moving Forward in B-ALL: Insights on Modern and Emerging Standards With Off-the-Shelf Bispecific Antibodies
Time: Friday, Dec. 5, 7 a.m. EST
Presenter: Ibrahim Aldoss, M.D., City of Hope associate professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop on State of the Art (ws25-58): Integrating Functional and Genomic Precision Medicine for Hematologic Malignancies
Time: Friday, Dec. 5, 3 p.m. EST
Chair: Pamela Becker, M.D., Ph.D., professor, Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation

Scientific Workshop: Microbiome and Diet and Cancer Immunotherapy
Time: Friday, Dec. 5, 3:06 p.m. EST
Presenter: Marcel van den Brink, M.D., Ph.D., City of Hope chief physician executive

How I Treat: How I Incorporate Novel Therapies into Hodgkin Lymphoma Treatment: Frontline vs. Relapse
Time: Sunday, Dec. 7 at 8 a.m. EST
Presenter: Alex Herrera, M.D., City of Hope professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation

Educational Spotlight: Measures to Minimize Infection Risk in Immunocompromised Patients after Cellular Therapies — How, for Whom, for How Long?
Time: Monday, Dec. 8, 4:30 p.m. EST
Presenter: Randy Taplitz, M.D., City of Hope professor, Department of Medicine

(Press release, City of Hope, NOV 12, 2025, View Source [SID1234659862])

On November 12, 2025 Leukogene Therapeutics Inc., a biopharmaceutical company developing next-generation therapies for hematologic and other immunologically "cold" malignancies, reported that it has received funding from the South Carolina Research Authority (SCRA) and its investment affiliate, SC Launch Inc.

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"We are honored to receive this strategic funding from SCRA and SC Launch Inc. It will allow us to advance our programs toward the clinic, strengthen our position as a leader in developing next-generation cancer therapeutics and continue building a world-class biotech company right here in South Carolina," said Dr. Sandeep Gupta, Chief Executive Officer of Leukogene. Nathan Dolloff, PhD, Founder and Chief Scientific Officer added, "This investment represents a strong validation of our vision and science and enables us to accelerate our mission of bringing transformative therapies to patients with hard-to-treat cancers."

"Leukogene Therapeutics exemplifies the kind of innovative, high-growth company that SCRA and SC Launch Inc. were designed to support," said Matt Bell, Executive Director of SC Launch. "Their groundbreaking immunotherapy platform and strong leadership team are well-positioned to make a lasting impact in oncology and the broader biotech sector. We are proud to partner with them as they advance toward clinical development."

(Press release, Leukogene Therapeutics, NOV 12, 2025, View Source [SID1234659861])