Perfluorocarbon oxygen carrier

Tucson, AZ, September 6th, 2024 – NuvOx Pharma LLC, a wholly owned subsidiary of NuvOx Therapeutics Inc. (together, “NuvOx”) announced that it has received a Qualified Person’s Declaration Equivalence to UK / EU GMP for Investigational Medicinal Products Manufactured outside of EU (in Third Countries) . This declaration fulfills a key requirement to initiate the NOVEL clinical trial (“NanO2 in Large VessEL Occlusion Stroke”). The declaration verifies that, based on audits of the manufacturing of NanO2TM that the manufacturing complies with good manufacturing practice (“GMP”) standards that are at least equivalent to European Union GMP requirements. Evan Unger, MD, CEO of NuvOx, said, “The NanO2 in Large VessEL Occlusion Stroke trial is crucial in advancing our product, NanO2, in its next stage of clinical development. This trial is designed as a multi-center, single-blind, randomised, placebo-controlled blinded end-point clinical trial to evaluate the safety, tolerability and preliminary efficacy of perfluorocarbon in acute ischemic stroke due to large vessel occlusion.” “This declaration is an impressive achievement for the NuvOx team”, added Rong Wang, President and COO of NuvOx. “GMP standard in the UK / EU is very stringent, especially since 2023, when the European standard for sterile product was further tightened. We went through a site inspection at end of Q1 2024, and had to plan and implement many upgrades in our operation and quality systems. Such upgrades were completed while we also ramped up our regular production to support our multiple clinical programs. This milestone showcases our passionate spirit.” Calvin Koerner, (ex-FDA Consultant, I.Q. Auditing), said, “I have been advising NuvOx in its GMP compliance and evaluation since 2023. In the nearly 30 years that I have worked in the biopharma industry, obtaining the declaration, under the revised European Annex 1 (2022) in a relative short time, is a huge feat and very impressive. Their accomplishments and achievements are well deserved.” The NOVEL study is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC). About NuvOx NuvOx is a privately held Phase IIb ready company developing a novel oxygen therapeutic where hypoxia plays a role. Hypoxia, or low oxygen, is responsible for resistance to cancer treatment, brain damage in stroke, and the death of COVID-19 patients with acute respiratory distress syndrome (ARDS). The Company’s lead drug candidate- NanO2 represents a disruptive platform technology ad-dressing 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 neuroprotect-ant. It was shown to be the most effective oxygen therapeutic among 74 clinical-stage com-pounds in 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 synergis-tic, rather than competitive with standard of care. The company also has a strong IP portfolio: 11 Patent Families; 11 issued US patents and 32 foreign equivalents. NuvOx is conducting a Phase IIb clinical trial as a radiosensitizer in treatment of primary brain cancer, glioblastoma, and also 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. About the National Institute for Health and Care Research (NIHR) The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by: •Funding high quality, timely research that benefits the NHS, public health and social care; •Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services; •Partnering with patients, service users, carers and communities, improving the rele-vance, quality and impact of our research; •Attracting, training and supporting the best researchers to tackle complex health and social care challenges; •Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system; •Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries. NuvOx Contact: NuvOx Pharma Dr. Evan Unger, CEO Rong Wang, President and COO Investor Contact: Rong Wang rwang@nuvoxpharma.com Forward looking statement Certain statements in this release may constitute “forward-looking statements.” When used in this release, words like “may,” “will,” “can,” “should,” “expect,” “anticipate,” “believe,” “project,” or “intend” and other similar expressions are intended to identify forward-looking statements. Statements regarding future events and developments and future performance, as well as our expectations, beliefs, plans, or projections, are forward-looking statements which reflect only our predictions, assumptions, and estimates regarding future events and circumstances. Actual events or results may differ substantially as a result of risks and uncertainties facing us. The forward-looking statements are based on current expectations as of the date of these statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of future events, new information, or otherwise.

Scientists developed a method to make silk-based materials that refuse to stick to water, or almost anything else containing water. Molded into forms like plastic, or coated onto surfaces as a film, the silk material has nonstick properties that surpass those of commercially available non-stick surfaces. Researchers at Tufts University have developed a method to make silk-based materials that refuse to stick to water, or almost anything else containing water for that matter. In fact, the modified silk, which can be molded into forms like plastic, or coated onto surfaces as a film, has non-stick properties that surpass those of nonstick surfaces typically used on cookware, and it could see applications that extend into a wide range of consumer products, as well as medicine. Silk is a natural fiber spun by moths and has been used for thousands of years to make durable and fine fabrics -- and surgical sutures to close wounds. More recently, scientists have learned to break down the fibers to their basic protein element -- silk fibroin -- and reconstitute it into gels, films, sponges, and other forms to create everything from implantable orthopedic screws to textile inks that change color in response to body chemistry. "What makes silk such a unique material is that not only can it take on a wide range of forms and shapes, but one can easily change its properties by chemically modifying the silk fibroin," said Krishna Kumar, Robinson Professor of Chemistry at Tufts. "If we want to make orthopedic screws that are absorbed by the body at different rates using silk fibroin, we modify the chemistry," he said. "If we want to create a blood sensor that detects oxygen, or glucose, or other blood components, we modify the chemistry. In this study, we modified silk fibroin to repel water, and we can do it in a way that can 'tune' the material to be more or less water repellant." The advance was reported in the journal ChemBioChem. Turning silk into a water repellent material involved covering the surface of the silk fibroin with short chemical chains containing carbon and fluorine, called perfluorocarbons. These chains are very stable and do not react with other chemicals, nor do they interact with proteins and other biological chemicals in the body. While the natural surface of the silk protein acts like a magnet to water, with negatively and positively charged branches on the silk attracting water, a silk protein covered with perfluorocarbons leaves little for the water to grab on to. Perfluorocarbons even resist attraction caused by other forces that typically bring molecules together. Changing the number and length of perfluorocarbon chains on the silk protein can adjust how 'unsticky' it behaves. Luke Davis, Assistant Professor of Chemistry, established the level of fluorine required on the surface of silk to exhibit nonstick behavior. The chemical synthesis is done under mild conditions, so unlike the production of other non-stick substances, the manufacturing process could be safer, both for workers and the environment Safer manufacturing and a renewable biological source of material checks off two boxes for sustainability. The Tufts researchers measured the nonstick property by observing how water beads up on the surface of the material -- like how water rolls off a waxed car. In fact, on nonstick silk molded into bars using the highest level of perfluorocarbons, the water rolled up into drops that are rounded even tighter than they do on Teflon. It's not just water that rolls off the nonstick silk, but any substance that has water as a major component, which could include various foods, blood, cells, and tissues. Although not tested in this study, perfluorinated materials are known to repel oils as well. "Modifying medical devices to prevent detrimental interactions with water and other biologics has the potential to preserve strength and integrity for as long as they are needed," explained Julia Fountain, graduate student in Kumar's lab and co-author of the paper. "Silk is already relatively inert to the immune system, so tuning its ability to repel cells or other substances could make it even more useful." The advantages of highly nonstick surfaces go well beyond medical applications. While there is concern regarding chemicals absorbed in the body from commercially available nonstick coatings, silk-based non-stick surfaces may offer an alternative option which can be explored for its relative safety. One could also imagine automotive windshields where rainwater just rolls off without using wipers, coatings on metals that help prevent rust, or on fabrics to make them easier to clean. "The success we had with modifying silk to repel water extends our successes with chemically modifying silk for other functionalities -- such as the ability to change color, conduct electrical charge, or persist or degrade in a biological environment," said David Kaplan, Stern Family Professor of Engineering at Tufts. "As a protein, silk lends itself well to modular chemistry -- the ability to 'plug in' different functional components on a natural scaffold."