Tucson, AZ – September 26, 2025 – NuvOx Therapeutics, Inc. (“NuvOx”) and FYR Bio (“FYR”) today announced a collaboration pairing NuvOx’s Phase IIb glioblastoma trial of NanO₂ with FYR’s EV-based liquid-biopsy expertise to provide additional biomarker insights that support clinical development, through an NCI (a division of NIH) grant “Liquid Biopsy in Glioblastoma Treated with Chemoradiation and an Oxygen Therapeutic”.
Dr. Evan Unger, co-founder and Executive Chairman of NuvOx said, “Biomarkers are a powerful tool to gain insights about a drug candidate’s effect and the tumor microenvironment. Our technology aims at reversing tumor hypoxia. This grant will enable us to study these factors, leveraging our Phase IIb Glioblastoma trial. We also hope that this study promotes the differentiation of pseudo progression vs. true progression, a well know challenge for treating Glioblastoma patients.”
Dr. Jenny Johnson, Chief Scientific Officer and co-founder of NuvOx said: “We are extremely grateful for being awarded this grant. Non-dilutive funding is a significant catalyst in our clinical development. This grant is extremely synergistic with our current Phase IIb Glioblastoma trial. We will be working with our clinical sites as well as collaborators with deep expertise in liquid biopsy.”
“This is an exciting collaboration,” said Dr. Katie Havranek, Director of R&D of FYR Bio, “By applying FYR’s cutting-edge EV-Omics platform to longitudinal samples from NuvOx’s Phase IIb glioblastoma study, we have the opportunity to follow tumor hypoxia biology as patients undergo treatment. This approach highlights the power of EVs and demonstrates how blood-based biomarkers can provide a deeper, non-invasive window into treatment response. We are excited to bring our expertise in neuro-oncology, liquid biopsies, and EV technologies to this important effort.”
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 Innovative Oxygen Therapeutics | NuvOx Pharma | Arizona.
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.
NIH Disclaimer:
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.
Investor Relations
Hanover International, Inc.
E: ka@hanoverintlinc.com
Forward-looking statement
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “antici-pates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding our first-in-class product being able to help ARDS patients; the potential of NanO2 to restore blood oxygen levels, decrease lung inflammation, and improve survival; the EXTEND Trial paving the way for NanO2 as treatment for ARDS; and NanO2 representing a potentially disruptive platform technology addressing multiple unmet needs, NanO2 being synergistic with standard of care and plans to start a Phase IIb clinical trial for NanO2 in treatment of acute ischemic stroke and a Phase Ib clinical trial for NanO2 in treatment of respiratory distress. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees. These risks should not be construed as exhaustive. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.