NuvOx Therapeutics Highlights Progress of RESTORE Phase II Trial of NanO₂™ in Newly Diagnosed Glioblastoma at the Society for Neuro-Oncology (SNO) 2025 Annual Meeting

Tucson, Arizona — November 12, 2025 — NuvOx Therapeutics, Inc. (“NuvOx”), a clinical-stage biotechnology company developing oxygen therapeutics to enhance the efficacy of cancer treatment, today announced the progress from the ongoing RESTORE Phase IIb clinical trial of NanO₂™ in patients with newly diagnosed glioblastoma (GBM) will be presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting in Honolulu, HI. The presentation will be in a poster session by the Center for Neurosciences in Tucson, Arizona, one of the trial sites for the RESTORE trial in United States.

The RESTORE trial is a Phase II, double-blind, randomized, prospective, placebo-controlled study evaluating NanO₂™ in combination with standard-of-care chemoradiation in patients with newly diagnosed GBM. Patients are randomized 2:1 to receive either NanO₂ or placebo, infused intravenously immediately before each radiation fraction, while breathing supplement oxygen. Following completion of chemoradiation, patients receive standard maintenance temozolomide per Stupp protocol. The primary endpoint of the trial is progression-free survival, with secondary endpoints including overall survival and objective response rate, assessed by modified RANO (mRANO) and RANO 2.0 criteria. 93 patients have been enrolled across multiple sites in United States.

“This ongoing randomized trial is designed to determine whether enhancing oxygen delivery to hypoxic tumor regions can improve outcomes in glioblastoma,” said Evan Unger, MD, Co-founder and Executive Chairman of NuvOx. “The study remains blinded, but safety signals and feasibility have been encouraging. We look forward to evaluating NanO₂’s potential to enhance radiation and chemotherapy efficacy. This is the first prospective, placebo-controlled trial of a fluorocarbon in cancer treatment and the first ever such study of a nanobubble in cancer treatment.”

“Glioblastoma is characterized by extensive intratumoral hypoxia, a key cause of radiation and chemotherapy resistance. We see tremendous need for therapies that target the fundamental hypoxia driving glioblastoma resistance,” said Michael A. Badruddoja, MD, Principal Investigator of the RESTORE trial at Center for Neurosciences. “By increasing oxygen delivery directly to tumor tissue, NanO₂ has the potential to enhance the effect of radiation and chemotherapy, offering new hope for patients facing this devastating disease.”

Scott Gellert, Vice President of Clinical Operations of NuvOx, added, “This is the second year that RESTORE trial progress is presented at SNO. The fast enrollment and enthusiasm from multiple trial sites enabled this exciting development of the trial. We are extremely grateful to our clinical collaborators nationwide. We will also leverage this trial to conduct further study regarding biomarkers.”

About RESTORE Trial:

This project has been supported in part with federal funds from the NIH/NCI, under the grant number 2R44CA144817-03.

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.

About Center for Neurosciences at Tucson, Arizona

The Center for Neurosciences is home to Southern Arizona’s largest and longest standing group practice dedicated to the treatment of neurological disorders. 

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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 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.