VIVALDI BIOSCIENCES RECEIVES GRANT TO STUDY ITS UNIVERSAL FLU VACCINE’S ABILITY TO BLOCK VIRUS TRANSMISSION

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 www.vivaldibiosciences.com. 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.

 

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