NuvOx Therapeutics Announces Positive Results from First Cohort of EXTEND-1b Trial of NanO₂™ in Patients with Respiratory Distress

Tucson, Arizona — November 6, 2025 — NuvOx Therapeutics (“NuvOx”), a clinical-stage biotechnology company developing oxygen therapeutics to treat life-threatening hypoxemic conditions, announced encouraging initial safety and oxygenation data from the first cohort of the ongoing EXTEND-1b Phase Ib clinical trial of NanO₂™ (dodecafluoropentane emulsion) in patients with mild respiratory distress. Such results will be presented as a scientific poster at the Critical Care Canada Forum in December of 2025.

The EXTEND-1b study is a dose-escalation trial designed to evaluate the safety, tolerability, and pharmacodynamic effects of intravenous NanO₂ in hospitalized patients requiring ≤ 6 L/min of oxygen by nasal cannula. Following an initial loading dose, participants receive a 21-hour continuous infusion of NanO₂ at one of 3 escalating doses (0.025 → 0.032 → 0.050 mL/kg every 90 minutes for a total of 15 doses). The trial, allowed by Health Canada, will enroll 18 subjects across the three cohorts. The study’s primary objective is safety and to identify a recommended dose for the Phase II study that is planned to follow.

Six patients were enrolled in the first cohort (0.025 mL/kg per administration x 15 administrations). NanO₂ was well tolerated in all participants, with no drug-related serious adverse events.

Arterial blood gas (ABG) analyses demonstrated a trend toward increased oxygenation in four of six patients. In these responders, PaO₂ rose by approximately 10 mmHg without material changes in pH, rises in PaCO₂ (which normally occurs in pulmonary distress), or alterations in oxygenated hemoglobin percentage, supporting NanO₂’s ability to facilitate beneficial oxygen and carbon dioxide transportat very low doses.

“These early findings are an important milestone for our oxygen-delivery platform,” said Evan Unger, MD, Co-founder and Executive Chairman of NuvOx. “NanO₂ represents the first low-boiling-point perfluorocarbon emulsion capable of carrying a clinically meaningful oxygen payload at a fraction of the dose previously required. It also appears to prevent increase and accumulation of carbon dioxide in the lung tissue. The positive safety profile and evidence of increased beneficial blood gas exchange validate our approach and provide a strong foundation for continued dose escalation.”

The EXTEND-1b Cohort 1 results will be presented as a scientific poster at the Critical Care Canada Forum in December of 2025 by Dr. Janek Senaratne, MD, MSc, FRCPC, LMCC, FESC, FACC, Principal Investigator of the trial and Intensivist at Grey Nuns Community Hospital in Edmonton, Alberta, Canada. In the Canadian context, acute respiratory distress syndrome (ARDS) occurs on the order of ~5,000–9,000 cases annually (13–23 per 100,000), and reported hospital mortality rises with severity—approximately 26.5% (mild), 31.8% (moderate), and 60.0% (severe)—underscoring the need for a therapeutic solution in this grave unmet area.

“Each year in Canada, thousands of patients develop ARDS, and despite advances in supportive care, treatment options and outcomes remain poor for the most severe cases,” said Dr. Senaratne. “We urgently need new therapies that can improve oxygen delivery without adding ventilator-associated risks. NanO₂ is a potentially promising approach because of its unique ability to carry substantial oxygen at low doses.”

The second and third cohorts will evaluate higher infusion doses (0.032 mL/kg and 0.050 mL/kg per administration) to determine the maximum tolerated dose (MTD) and recommended Phase II dose. A subsequent Phase II trial, which has also been allowed by Health Canada, will enroll patients with moderate-to-severe respiratory distress (> 6 L O₂/min), assessing NanO₂’s ability to improve oxygenation and reduce progression to invasive mechanical ventilation.

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 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 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   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," "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.