NuvOx Announces First Patient Treated Under Single-Patient Expanded Access for Newly Diagnosed Glioblastoma

Tucson, AZ – March 10, 2026 – Today NuvOx Therapeutics, Inc. (“NuvOx” or the “Company”) announced that the first patient has been treated under a U.S. Food and Drug Administration (FDA)-authorized single-patient Expanded Access protocol for newly diagnosed glioblastoma at the Center for Neurosciences. The treatment was administered by Dr. Michael Badruddoja and Dr. Matthew McFarlane, marking a significant milestone in NuvOx’s mission to address unmet needs in patients with aggressive brain cancers.

“This Expanded Access treatment provides an important opportunity to offer a patient access to an investigational therapy while continuing standard chemoradiation,” said Dr. Badruddoja. “Glioblastoma remains a devastating diagnosis, and we are committed to exploring innovative approaches that may improve outcomes.”

The treatment involves NuvOx’s investigational oxygen therapeutic, NanO₂™ (dodecafluoropentane emulsion), designed to enhance oxygen delivery to hypoxic tumor regions when administered alongside standard chemoradiation. By improving tumor oxygenation, NanO₂™ aims to increase the effectiveness of radiation and chemotherapy in patients with glioblastoma, one of the most treatment-resistant forms of cancer.

Dr. Evan Unger, NuvOx’s Co-founder and Executive Chairman, stated: “We are encouraged to reach this milestone and to support physicians and patients seeking additional therapeutic options in newly diagnosed glioblastoma. Expanded Access reflects our commitment to addressing urgent medical needs while continuing to advance our clinical development program.”

Dr. Claire Huang, Director of Clinical Affairs at NuvOx, added, “We are grateful to Dr. Badruddoja and the Center for Neurosciences for their partnership and dedication to advancing care for patients with glioblastoma. This collaboration reflects the shared commitment of investigators and industry to bring forward innovative treatment strategies for this challenging disease.”

Expanded Access, sometimes called compassionate use, permits the use of investigational therapies outside of clinical trials for patients with serious or life-threatening conditions who lack satisfactory approved treatment alternatives. This treatment was conducted in accordance with FDA regulations and institutional review board oversight.

For more, visit Innovative Oxygen Therapeutics | NuvOx Pharma | Arizona.

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).

NuvOx’s product candidate, NanO₂™, is designed to be a 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 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.

NanO₂™ can refer to safety data in ~2,000 subjects, and 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 has completed enrollment in a randomized, placebo-controlled Phase IIb clinical trial as a radiosensitizer in treatment of primary glioblastoma. In this study, the drug was well tolerated. A Phase IIb clinical trial for NanO₂™ in treatment of acute ischemic stroke has also started, funded by the UK government. In addition, NuvOx is conducting a Phase Ib clinical trial for NanO₂™ in treatment of respiratory distress in Canada, partially funded by BARDA.

About Center for Neurosciences:

The Center for Neurosciences is Southern Arizona's largest and longest-standing neuroscience medical practice, with a dedicated Clinical Research Program and extensive experience conducting Phase II through Phase IV clinical trials.

Investor Relations

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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,” “anticipates,” “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 the Company’s mission to address unmet needs in patients with aggressive brain cancers, exploring innovative approaches that may improve outcomes, NanO₂™ enhancing oxygen delivery to hypoxic tumor regions when administered alongside standard chemoradiation, increasing the effectiveness of radiation and chemotherapy in patients with glioblastoma, addressing urgent medical needs while continuing to advance the Company’s clinical development program, bringing forward innovative treatment strategies for glioblastoma and NanO₂™ being a disruptive platform technology addressing multiple unmet needs. 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.