NuvOx Announces First Patient Dosed for its EXTEND trials: novEl oXygen ThErapeutic NanO2 for mild respiratory distress in Phase Ib and ARDS in Phase II Trials

Tucson, AZ – June 12, 2025 - NuvOx Therapeutics, Inc. (“NuvOx”) announced that the first patient has been dosed for its EXTEND trials: novEl oXygen ThErapeutic NanO2 for mild respiratory distress in Phase Ib and ARDS in Phase II Trials.

Evan Unger, M.D., Co-founder and Executive Chair of NuvOx, said, “Acute Respiratory Distress Syndrome (ARDS) has been an important part of our overall development strategy and it remains a grave unmet medical need. We believe our first-in-class product will be able to help ARDS patients. We are thrilled to dose the first patient as part of the Phase Ib dose escalation.” 

“Dosing the first patient is a major milestone,” added Jennifer Johnson, Ph.D., Co-founder and CSO of NuvOx, “as it takes rigorous and longtime preparation. We are extremely grateful to our collaborating investigators in this trial, as well as the entire care team. We are also very grateful to U.S. Department of Health & Human Services, Biomedical Advanced Research and Development Authority (BARDA), with whom we entered into a partnership last year. We look forward to treating more patients with rapid enrollment.”

Jarrod Mosier, M.D., Professor of Emergency Medicine & Medicine, Vice Chair for Research in Emergency Medicine, the University of Arizona, lead author on the article, "The impact of intravenous dodecafluoropentane on a murine model of acute lung injury," Intensive Care Medicine Experimental 11.1 (2023): 33., and Chair of the Data Safety Monitoring Committee for the EXTEND Trial, said, “I am very excited for this news. NanO2 has shown efficacy in animal models of respiratory distress, demonstrating the potential to restore blood oxygen levels, decrease lung inflammation, and improve survival. ARDS carries a high mortality in patients, and this disease desperately needs effective therapy. The EXTEND Trials are expected to pave the way for NanO2 as treatment for this deadly disease.”

Approximately 10 to 15% of patients admitted to the intensive care units and up to 23% of mechanically ventilated patients meet the criteria for ARDS (1). Despite advances in critical care, ARDS still has high morbidity and mortality (2).  Hypoxia from the inciting illness contributes to various cognitive changes that may persist for months after discharge. Although NanO2’s safety and efficacy are still under investigation via various clinical trials and it has not been granted market authorization by Health Canada, its use in the EXTEND Trial aims at addressing this unmet medical need. 

This project has been partially funded with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00034.

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, and also plans to start a Phase IIb clinical trial for NanO2 in the treatment of acute ischemic stroke.

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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.

(1) Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A., LUNG SAFE Investigators. ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. [PubMed] 

(2) Acute Respiratory Distress Syndrome - StatPearls - NCBI Bookshelf (nih.gov)