NuvOx Announces Dosing of 87th Patients in Its RESTORE trial: A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM

Tucson, AZ – September 26, 2025 - NuvOx Therapeutics, Inc. (“NuvOx”) announced that it has dosed 87 patients in its RESTORE trial: A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM. This reached the number of patients required to perform statistic analysis.

Scott Gellert, VP of Clinical Operation, said, “We are very grateful for the strong support from our sites to achieve this important milestone. The enthusiasm and tireless work of the RESTORE Investigators and their clinical teams was the key to our success.”

Evan Unger, M.D., Co-founder and Executive Chair of NuvOx, said, “Glioblastoma is a fatal disease without good solution. Our technology, tested as radiosensitizer, strives to reverse tumor hypoxia, a well-known impediment for standard chemoradiation treatment. We are thrilled to be able to treat these patients, and look forward to the trial readout. We still have additional patients who have consented and will receive treatment.” 

“Glioblastoma is an orphan disease and one of our leading indications,” added Rong Wang, President and CEO of NuvOx, “It is a giant step towards our major inflection point in the overall clinical development map. This turns a new page in our journey to not only battle Glioblastoma, but many more cancer types.”

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.

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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," "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.