FYR Bio and NuvOx Therapeutics Awarded NCI Direct-to-Phase II SBIR Grant to Advance Liquid-Biopsy Collaboration in Phase IIb Glioblastoma Trial

Funding builds on FYR's neuro-oncology expertise and applies EV-based biomarkers to de-risk NuvOx's clinical development

MISSOULA, Mont., Nov. 19, 2025 /PRNewswire/ -- FYR Bio ("FYR"), a leader in liquid-biopsy precision medicine for neuro-oncology, today announced a collaboration with NuvOx Therapeutics, Inc. ("NuvOx") supported by a two-year $1,976,897 Direct-to-Phase II Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI). The grant, titled "Liquid Biopsy in Glioblastoma Treated with Chemoradiation and an Oxygen Therapeutic," will enable FYR to integrate its EV-based liquid-biopsy technology into NuvOx's Phase IIb glioblastoma (GBM) trial.

Under the award, FYR will apply its EV-Omics^™ (EVO) platform and SPARCs^™ enrichment technology to longitudinal blood samples collected in NuvOx's RESTORE trial of NanO₂^™, a radiosensitizer designed to reverse tumor hypoxia. The collaboration will explore extracellular-vesicle (EV) biomarkers that reflect hypoxia biology, correlate with treatment exposure, and help clinicians differentiate pseudoprogression from true progression—a persistent challenge in GBM management.

Built on FYR's neuro-oncology track record
FYR brings deep expertise in identifying EV-based biomarkers in neuro-oncology. By integrating its EVO Platform into the RESTORE trial, FYR aims to generate multiomic insights that inform patient management and de-risk NuvOx's program and future trial design.

"Our goal is to help drug development companies de-risk their programs and increase the likelihood of clinical trial success, clarifying who benefits, when, and why," said Katie Havranek, Ph.D., Director of Research & Development at FYR. "Building on FYR's neuro-oncology experience and prior insights in GBM, this collaboration explores EV biomarkers that may strengthen endpoints, refine patient selection, and guide the next phase of NuvOx's clinical strategy."

Why this matters for patients and clinical trials

• Distinguishing pseudoprogression from true progression: Pseudoprogression after chemoradiation is common in GBM, and can resemble true progression (tumor growth) on MRI. Better differentiation can reduce unnecessary treatment changes and improve patient care.
• Addressing tumor hypoxia: Hypoxia drives radioresistance in GBM. NanO₂ is being tested to counteract this biology, while EV-based multiomic readouts may reveal who benefits most and how responses evolve through therapy.

About the collaboration scope
FYR will perform EV-based proteomic and transcriptomic analyses from plasma collected at prespecified timepoints to discover and evaluate hypoxia-related biomarkers and progression-state classifiers. These insights are intended to support NuvOx's therapeutic development and inform potential future trial design and strategy.

NIH Acknowledgment
Research reported in this press release is supported by the National Cancer Institute of the National Institutes of Health under Award Number 1R44CA298498-01A1. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About FYR Bio
FYR Bio (FYR Diagnostics Inc) is revolutionizing the ability to dynamically observe disease and treatment response to produce better biomarkers, trials, drugs and outcomes. FYR's EV-Omics (EVO) platform leverages its proprietary technology, SPARCs^™, to enrich for extracellular vesicles from diseased cells and enable assessment of cellular proteins and nucleic acids with just a peripheral blood sample. Utilizing AI-enabled multiomic insights, EVO unravels the complexity of disease mechanisms, thereby informing potential diagnostic and treatment options. The unparalleled view provided by FYR's multiomic approach can transform personalized patient care, from screening through therapy selection and monitoring. For more, visit FYR Bio.

About NuvOx
NuvOx is a privately held clinical-stage biopharmaceutical company developing a novel platform of oxygen therapeutics for the treatment of diseases where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of patients with acute respiratory distress syndrome (ARDS).

The company's drug candidate - NanO₂ represents a potentially disruptive platform technology addressing multiple unmet needs, with positive results demonstrated in two completed Phase Ib/II studies: one in glioblastoma as a radiosensitizer and the other in stroke as a neuroprotectant. It was shown to be the most promising oxygen therapeutic among 74 clinical-stage compounds in a literature review.
It has safety and efficacy data in 7+ indications in various preclinical and clinical stages, including Orphan Drug Designation for both glioblastoma and sickle cell anemia.

The product can refer to safety data in ~2,000 subjects. The product is designed to be synergistic, rather than competitive with standard of care. The company also has a strong IP portfolio: 11 patent families, 11 issued US patents and 31 foreign equivalents.
NuvOx is conducting a Phase IIb clinical trial as a radiosensitizer in treatment of glioblastoma, has started a Phase IIb clinical trial for NanO₂ in the treatment of acute ischemic stroke, funded by the UK government, and is conducting a Phase Ib clinical trial for NanO₂ in the treatment of respiratory distress. For more, visit NuvOx Pharma.

Media Contact (FYR): [email protected]

Media Contact (NuvOx): [email protected]

SOURCE FYR Bio