NuvOx Announces Positive Completion of 2nd Cohort in its EXTEND-1b Trial and Presentation at RIS
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Tucson, Arizona — April 30, 2026 — NuvOx Therapeutics (“NuvOx”), a clinical-stage biotechnology company developing oxygen therapeutics for life-threatening hypoxemic conditions, today announced positive preliminary results from the second cohort of its ongoing EXTEND Phase Ib clinical trial of NanO₂™ (dodecafluoropentane emulsion) in patients with mild respiratory distress. The results demonstrated stronger oxygenation signals with dose escalation while maintaining an excellent safety profile. These findings will be presented both orally and in a poster form at the 2026 Respiratory Innovation Summit (RIS) as part of the ATS 2026 International Conference.
The EXTEND-1b study is a dose-escalation trial evaluating the safety, tolerability, and oxygenation effects of intravenous NanO₂ in hospitalized patients requiring supplemental oxygen by nasal cannula. The study includes three escalating dose cohorts designed to identify the recommended Phase II dose for patients with more severe respiratory distress.
Six patients were enrolled in the first cohort and six patients were enrolled in the second cohort. No drug-related serious adverse events were observed. Preliminary analysis from the second cohort demonstrated statistically significant improvement in arterial oxygenation measured by arterial blood gas, along with improved pulse oximetry readings, supporting a clear dose-response relationship and stronger efficacy signals at the higher dose.
“Each year, thousands of patients develop severe respiratory distress requiring intubation and mechanical ventilation, and despite advances in supportive care, treatment options remain limited,” said Dr. Senaratne, a site Principal Investigator of the trial and Intensivist at Grey Nuns Community Hospital in Edmonton, Alberta. “We urgently need therapies that can improve oxygen delivery without adding ventilator-associated risks. NanO₂ may offer a promising new approach for the very sickest patients because of its unique ability to enhance oxygen transport at low doses.”
“The observed improvement in PaO₂ by arterial blood gas, together with improved pulse oximetry, is important because these are direct and objective measures of oxygen transfer into the bloodstream,” said Dr. Evan Unger, Co-Founder and Executive Chairman. “Respiratory distress is fundamentally a disorder of inadequate oxygenation, and a therapy that can produce measurable improvement in oxygen delivery may represent a differentiated approach from conventional treatments that primarily provide ventilatory support, reduce inflammation, or treat the underlying cause. These results provide a strong physiologic rationale for advancing the program toward an NDA pathway, including dose selection and the design of a pivotal trial using objective oxygenation endpoints supported by clinically meaningful secondary outcomes.”
“Currently, there are no approved therapeutic solutions specifically addressing acute respiratory distress syndrome,” said Rong Wang, President and CEO of NuvOx. “This is an important application for our oxygen therapeutics platform, and we believe NanO₂ has the potential to become a breakthrough treatment for patients with significant unmet medical needs.”
The third cohort will evaluate a higher infusion dose to determine the maximum tolerated dose and recommended Phase II dose. A subsequent Phase II study, already allowed by Health Canada, will enroll patients with moderate-to-severe respiratory distress and will assess NanO₂’s ability to improve oxygenation and reduce progression to invasive mechanical ventilation.
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.
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 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 the EXTEND Trial:
This project has been supported in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00034.
About Covenant Health:
Covenant Health is one of Canada’s largest Catholic healthcare organizations with more than 15,000 physicians, employees and volunteers serving in 13 communities across Alberta. A major provider in Alberta's integrated health system, Covenant Health works with community partners to positively influence the health of Albertans through a broad range of programs and services. CovenantHealth.ca
About RIS:
The Respiratory Innovation Summit, hosted by the American Thoracic Society, is a
premier global forum for advancing novel therapies in respiratory care. RIS unites the innovators, investors, clinicians and advocacy groups who are leading the charge to create powerful new treatments for deadly and crippling diseases of the lungs and airways. This meeting historically attracts 400+ global leaders representing all facets of the respiratory industry, including representatives from start-ups, business development, venture capital, government, academia and clinical medicine. RIS 2026 event will take place May 15-16, 2026, in Orlando, Florida, USA.
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 presenting the data results the 2026 Respiratory Innovation Summit, the study identifying the recommended Phase II dose for patients with more severe respiratory distress, NanO₂ offering a promising new because of its unique ability to enhance oxygen transport at low doses, a therapy that can produce measurable improvement in oxygen delivery representing a differentiated approach from conventional treatments, advancing the program toward an NDA pathway, including dose selection and the design of a pivotal trial using objective oxygenation endpoints supported by clinically meaningful secondary outcome, NanO₂ becoming a breakthrough solution for great unmet medical needs, evaluating in the third cohort higher infusion doses to determine the maximum tolerated dose and recommended Phase II dose, enrolling patients in a subsequent Phase II trial with moderate-to-severe respiratory distress to assess NanO₂’s ability to improve oxygenation and reduce progression to invasive mechanical ventilation 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.
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