NS1

Alveo Technologies developed this groundbreaking product in partnership with x-Ovo, Royal GD and Pharmsure; first shipments of Flockscreen to EMEA expected Q3 2024 ALAMEDA, Calif., June 27, 2024 /PRNewswire/ -- Alveo Technologies, Inc. (Alveo), a leader in molecular sensing and diagnostics with its proprietary technology platform, today announced that rigorous development and testing has demonstrated that the Flockscreen LAMP Avian Influenza Molecular Test can accurately detect the presence of virus in both cloacal and oropharyngeal samples from poultry with comparable limit of detection, sensitivity and specificity. Alveo and their development partners performed more than 20,000 reactions on over 4000 assay cartridges during their evaluation of over 100 candidate primer sets and assay conditions, using both contrived and clinical samples. Relevant regulatory bodies have been engaged and appropriate validation and verification activities will be completed prior to shipment. The product is available today for pre-sale in Europe and the Middle East. The company expects to begin shipping in volume in the third quarter of 2024. The current HPAI panzootic has recently spread to cattle and at least 47 other mammalian species. Due to current disease control legislation, this has led to the destruction of more than half a billion poultry worldwide. Rapid, accurate tests are vital for early detection and containment, protection of the poultry industry, the prevention of zoonotic transmission and spillover events from one species to another, food security, the maintenance of agricultural trade, and ongoing monitoring and surveillance. Current agricultural tests for highly pathogenic avian influenza (HPAI) all suffer from one of several significant drawbacks that make them unsuited to these use cases. Polymerase chain reaction (PCR) requires lab processing, which means it can take days to receive a result, and vaccination causes serology tests to turn positive even if the bird is not infected1. Lateral flow (also known as antigen or instant tests) lacks sensitivity and produces a significant percentage of false negative results. Alveo's portable and rugged molecular diagnostic platform has been designed to provide accurate, rapid test results at the point of need. It functions as a core component of a notifiable disease electronic management ecosystem that the company and its strategic partners have developed to support producers, as well as governmental bodies who are looking to expand the surveillance of important zoonotic pathogens. Two multiplexed panels enable the on-site broad detection of Avian Influenza Type A virus (targeting matrix gene) in poultry with differentiation of H5, H7, and H9 subtypes using oropharyngeal or cloacal samples. Both panels contain 7 assays, 6 of which are identical between cartridges. This configuration ensures the greatest coverage of the most clinically relevant global AI strains from the past 5-10 years, through to the current strains. The platform's rugged design enables it to function in the field under extreme conditions, including very hot and near freezing temperatures, following a drop of one meter, and when subjected to movement and vibration, which are common challenges encountered in field settings. Alveo has developed assays for Flockscreen LAMP AI on its proprietary molecular platform with several partners —including x-OvO, Royal GD, and Pharmsure International Ltd. — and it will provide healthcare and government authorities with a rapid, decentralized, molecular test that eliminates the need to ship hazardous samples to a lab. Additionally, the platform has the capability to wirelessly upload time-stamped geotagged results to a common portal, providing organizations with near real-time information on the spread of the virus. The platform will provide veterinarians with intuitive, rapid, point-of-need testing. For producers, Flockscreen will empower rapid responses to reduce the disease's spread and mitigate the impact on their business. "The creation of a decentralized testing ecosystem that respects and expands process control by disease management authorities, combined with molecular biology levels of accuracy, could lead a paradigm shift in the way notifiable disease challenges are controlled," said Dr. Richard Currie, President, x-OvO. "Alveo's molecular diagnostic platform is a groundbreaking technology that raises the bar for speed and accuracy in point-of-need diagnostic testing," said Wim Kieftenbeld, Director Business Development at Royal GD. "Combined with our expertise in veterinary diseases and diagnostics, we've worked together to develop an assay that accurately and rapidly delivers results at point of need for both cloacal and oropharyngeal samples, a first for agricultural diagnostics for HPAI." "Our platform makes it simple to test for HPAI in poultry, and we will be the first diagnostic of its kind that can test both cloacal and oropharyngeal samples," said Shaun Holt, CEO at Alveo. "Our rugged design enables healthcare providers, veterinarians, growers, and public health officials to obtain rapid results at point of need so they can take immediate action." Alveo expects first customer shipments of Flockscreen LAMP AI in EMEA to begin by Q3 2024. For more information visit: alveotechnologies.com/flockscreen About Alveo Alveo is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo's rugged and portable, multiplex-capable diagnostic platform employs a patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: . 1 Tumpey TM, Alvarez R, Swayne DE, Suarez DL. Diagnostic approach for differentiating infected from vaccinated poultry on the basis of antibodies to NS1, the nonstructural protein of influenza A virus. J Clin Microbiol. 2005 Feb;43(2):676-83. doi: 10.1128/JCM.43.2.676-683.2005. PMID: 15695663; PMCID: PMC548100. Media contact Jeff Miller [email protected] 541-207-6413 SOURCE Alveo Technologies

FORT COLLINS, Colorado and VIENNA, Austria – December 18, 2023 – Vivaldi Biosciences today announced it has received a grant from Flu Lab to evaluate the potential of its DeltaFLU universal influenza vaccine, administered by nasal spray, to block influenza virus transmission and spread of infection and disease. Vivaldi Biosciences is a clinical-stage biotechnology company developing vaccines for viral respiratory diseases. Flu Lab, based in Palo Alto, CA, is a philanthropic organization founded to fuel bold approaches to defeat influenza. A vaccine that both protects against all influenza strains and blocks or reduces transmission would be a significant advance in preventing influenza and reducing the disease burden. The transmission study builds on successful clinical trials of DeltaFLU vaccine strains, and preclinical studies showing the potential for DeltaFLU to provide protection against all influenza virus strains causing disease in humans. Vivaldi Biosciences plans to begin the transmission study in early 2024. The study will include evaluations of immune response and protection of DeltaFLU-immunized ferrets against infection by broadly divergent wild-type influenza type A and B strains transmitted by experimentally infected ferrets. The ferret is the most well-characterized and relevant animal model of human influenza infection and immune response. Influenza is a contagious respiratory disease and a serious public health problem. Influenza viruses are transmitted between individuals by tiny droplets that enter the nose, mouth or lungs, where they replicate and cause disease. Each year, influenza infects as many as 30% of children and 10% of adults worldwide, and results in as many as 500,000 deaths. Vaccination is the best way to prevent influenza, but conventional vaccines provide only modest protection. Available vaccines are designed to protect against just three or four selected influenza virus strains and do not prevent transmission of influenza viruses from person to person. Vivaldi Biosciences’ DeltaFLU provides important advantages of needle-free administration and rapid protection in the nasal passages, where it generates a first line of defense at the point of entry of circulating flu viruses. DeltaFLU also activates T cells and antibody-producing B cells for a broadly protective systemic immune response. Vivaldi has secured funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the European Union to conduct clinical trials to demonstrate universal protection with DeltaFLU in adult volunteers. About Vivaldi Biosciences Vivaldi Biosciences develops genetically engineered nasal spray vaccines for epidemic and pandemic viral respiratory diseases. The company’s patented technology centers on eliminating the influenza NS1 gene to generate self-adjuvanting vaccines. Vivaldi Biosciences’ Vero cell-based vaccine manufacturing system uses patented advances in production and purification for high yields and reduced costs. Data from completed Phase 1 and 2 clinical trials of DeltaFLU vaccine strains demonstrate safety and broadly cross-neutralizing antibodies in the serum and nasal mucosa. Studies in animal models provide proof of concept for protection against all influenza virus strain types causing disease in humans, including emerging strains with pandemic potential. Vivaldi Biosciences has received grants for further clinical studies of DeltaFLU universal influenza vaccine from the National Institute of Allergy and Infectious Diseases’ (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVICs) and the European Union’s Horizon Europe research and innovation program under grant agreement No. 101080692. Vivaldi Biosciences is a venture-backed company with operations at the Research Innovation Center at Colorado State University, Fort Collins, Colorado, and in Vienna, Austria. NGN Capital LLC is the company’s lead investor. Learn more at Connect with Vivaldi Biosciences on Linkedin. Contact Bill Wick, CEO, Vivaldi Biosciences Tel: +1 650-400-8915 bill.wick@vivaldibiosciences.com Forward-Looking Statements This release contains forward-looking statements relating to Vivaldi Biosciences, which are not historical facts and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included in this communication concerning activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and involve known and unknown risks, uncertainties and other factors, including, but not limited to, the following: the uncertainty of clinical success and of obtaining regulatory approvals, the difficulty of predicting FDA approvals, acceptance and demand for new vaccines and other pharmaceutical products, product efficacy or safety concerns resulting in product recalls or regulatory action, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the ability to obtain future funding and to obtain such funding on commercially reasonable terms, the regulatory environment and other risks the Company may identify from time to time in the future. These factors are not necessarily all of the important factors that could cause our actual results, performance or achievements to differ materially from those expressed in or implied by any of our forward-looking statements. These forward-looking statements speak only as of the date of this communication and we undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. This press release should not constitute an offer to sell or a solicitation of an offer to buy securities.

A simple-to-apply, needle-free vaccine patch is being developed to protect people from the potentially deadly mosquito-borne Zika virus. A simple-to-apply, needle-free vaccine patch is being developed to protect people from the potentially deadly mosquito-borne Zika virus. A prototype using The University of Queensland-developed and Vaxxas-commercialised high-density microarray patch (HD-MAP) has delivered a University of Adelaide-developed vaccine and elicited an effective immune response to Zika virus in mice. UQ alum and Vaxxas researcher Dr Danushka Wijesundara said Zika virus was a risk to people across the Pacific, Southeast Asia, India, Africa and South and Central America. "We can change the way we combat Zika virus with the HD-MAP patch because it is an effective, pain-free, simple to apply, and easy to store vaccination method," Dr Wijesundara said. "HD-MAP delivers the vaccine to immune cells beneath the skin's surface with thousands of tiny microprojections. "In our pre-clinical trial, the vaccine provided rapid protection against live Zika virus, targeting a specific protein called NS1 which is crucial to the virus's survival. "The vaccine patch evoked T-cell responses that were about 270 per cent higher than from a needle or syringe vaccine delivery." Zika virus generally causes a mild illness but infection in pregnancy can lead to miscarriage and stillbirths or infants born with congenital malformations. In February 2016, the World Health Organization declared a Public Health Emergency of International Concern when Zika virus spread across 40 countries in Latin America, causing more than 1.5 million confirmed or suspected cases in a 6-month period. The University of Adelaide's Associate Professor Branka Grubor-Bauk said limited global surveillance shows Zika virus is active in at least 89 countries and territories but there is no currently licensed vaccine. "This vaccine is unique because it targets a protein inside, rather than outside of the virus meaning it won't enhance the symptoms of closely related viruses such as dengue fever, in people who've been vaccinated," Dr Grubor-Bauk said. Dr David Muller from UQ's School of Chemistry and Molecular Biosciences said the microarray patch and the vaccine could have benefits beyond the ability to protect from Zika virus. "Because the protein we're targeting plays a central role in replication in a virus family known as flaviviruses, there's the potential to apply our approach to target other flaviviruses such as dengue or Japanese encephalitis," Dr Muller said. "It could also deliver a vaccine mixture to target the whole family of viruses, providing greater protection. "A major benefit of the HD-MAP delivery platform is vaccine stability at elevated temperatures -- we found the patch retained vaccine potency when stored at 40 degrees Celsius for up to four weeks. "This increases the reach of vaccines in low- and middle-income countries where refrigeration is challenging." The research team would like to acknowledge the National Health and Medical Research Centre (NHMRC) for funding awarded to Dr Muller and The Hospital Research Foundation Group Fellowship awarded to Dr Branka Grubor-Bauk, who supported the project.