NuvOx Announces Receipt of IND for Study of NanO2 as Cardioprotectant in Acute Myocardial Infarction

NuvOx Announces Receipt of IND for Study of NanO2 as Cardioprotectant in Acute Myocardial Infarction

Tucson, AZ – March 4, 2025 - NuvOx Therapeutics, Inc. (“NuvOx”) announced that an investigational new drug application (“IND”) has been allowed by the FDA, for a phase 2 trial in myocardial infarction (“MI”), titled, “Nanodroplet oxyGen delivery (NanO2) for ST-elevation myocardial InfarCtion: GNOSTIC”. The proposed trial is an investigator-initiated trial (“IIT”).

“We are thrilled that the FDA has allowed the GNOSTIC Trial,” said Dr. Evan Unger, NuvOx’s Co-Founder and Executive Chairman, “heart disease is the #1 killer of Americans. NanO2 has a powerful mechanism of action to reach hypoxic tissue via a simple, elegant way, when the blood itself is not enough to deliver oxygen. As we can imagine, proper oxygen level is crucial for every part of body, therefore our technology is a true platform and addresses the root cause of death, injury, and resistance to standard of care in many fatal diseases. We are grateful to have the opportunity to address myocardial infarction.”

Myocardial infarction, commonly known as heart attack, affects about 1 million Americans each year and results in more 300,000 deaths. Heart attack is generally caused by blockage of a blood vessel, depriving the heart muscle of oxygen. The heart muscle may die due to the lack of oxygen. In caring for patients, restoration of blood flow to the heart is essential and every minute counts to prevent long term injury and death.

Dr. Linda Peterson, Professor of Medicine and of Radiology at Washington University School of Medicine in St Louis, is Principal Investigator of the GNOSTIC Trial. The trial will evaluate whether NuvOx’s product candidate, NanO2TM can effectively deliver oxygen to heart tissue during ischemia and keep the tissue alive, while the patients undergo a procedure to have the blood vessel blockage eliminated.

“Without an adequate supply of oxygen to the heart, the heart muscle can lose the ability to pump blood throughout the body, which can lead to heart failure or death,” Dr. Peterson said. “We’ll be evaluating whether the NuvOx’s technology can protect the heart from damage during a heart attack and improve patient outcomes.”

The GNOSTIC Trial will be the first time that NanO2 will be studied clinically as a cardioprotectant. Successful completion of the GNOSTIC Trial may lead to a new paradigm in cardioprotection in acute heart attack to improve outcomes in this deadly disease.

Rong Wang, NuvOx’s President and CEO, added, “We have a strong portfolio and pipeline of 7+ indications in various clinical and preclinical stages. Myocardial infarction represents a large market and an important indication in our strategic direction. IIT is an effective and efficient way to advance the technology into the clinical phase. We greatly appreciate this collaboration with Washington University School of Medicine, and plan to leverage further non-dilutive funding for the proposed trial.”

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, and 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 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 using NanO2 as adjunct treatment to deliver oxygen to tissue during ischemia and keep the tissue alive while the patients wait to have ischemia eliminated, NanO2 having the potential to fill the gap of current standard of care extending the time window to allow for blood flow to be restored, successful completion of the GNOSTIC Trial leading to a new paradigm in cardioprotection in acute heart attack to improve outcomes in this disease, the technology being a true platform that addresses the root cause of death, injury, and resistance to standard of care in many fatal diseases, plans to leverage further non-dilutive funding for the proposed GNOSTIC trial, NanO2 representing a 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.