Applied DNA and Evvivax Announce Positive Preliminary Results of Phase I Clinical Trial for LinearDNA™ COVID-19 Vaccine Candidate in Felines

- Vaccine Candidate Well Tolerated and Effective in Cohort -

- Strong Neutralizing Antibody Titer Elicited Across Cohort -

Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced positive preliminary Phase I clinical trial results for a LinearDNA™ COVID-19 vaccine candidate (the “vaccine candidate”) in adult domestic felines. Results following administration of a single prime dose of the vaccine candidate on day 1 in late February indicate that the LinearDNA vaccine candidate is well-tolerated by the cohort. A SARS-CoV-2 neutralization assay was conducted by the Cornell University Animal Health Diagnostic Center at the College of Veterinary Medicine 20 days after prime dose delivery to establish the immune response of all cohort members. The results of the neutralization assay yielded high titers of SARS-CoV-2 neutralizing antibodies (NAb) from all cohort members. Follow-on NAb assay results after administration of the vaccine candidate booster are expected to be available in late April 2021. Based on the initial promising NAb titers after a single prime dose of the LinearDNA vaccine candidate, the companies intend to extend the evaluation of neutralizing antibodies in select cohort members through September 2021 to determine the durability of the immune response.

Dr. Diego Diel, D.V.M., M.S., Ph.D., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics, who performed the NAb assay, stated, “The levels of neutralizing antibodies elicited in the vaccinated cats after only a single prime dose are compelling. Based on these preliminary data, it seems like this vaccine candidate has the potential to be effective in cats and perhaps other COVID-19-susceptible animals such as ferrets and minks.”

Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS, veterinary oncologist at Guardian Veterinary Specialists (GVS) in Brewster, N.Y., and Trial Supervising Investigator for the study, said, “Administration of the vaccine candidate via electroporation was well-tolerated with no adverse events in the normal healthy feline volunteers. Preliminary findings with antibody production at this level are very encouraging and support the continued development of the vaccine candidate.”

Dr. James A. Hayward, president and CEO, Applied DNA, said, “We are excited to present these preliminary results of our first proof-of-concept clinical study for a LinearDNA-based vaccine that seeks to prevent cats from acting as a potential reservoir of SAR-CoV-2 that might eventually find its way to humans. We would expect a further three- to four-fold increase in titer levels post-booster vaccination from the already high average titer levels generated by the prime vaccination.

“There is increasing concern globally as new variants, including B.1.1.7, have been found¹ in domestic pets in both the UK and the US. While there is no evidence of transmission from pets to their owners, the rate of testing pets for COVID-19 is too low to estimate infection rates. Hence, the Company believes that preparations for a pet vaccine are wise. The data we have generated to date also lays the foundation for the application of the vaccine candidate to additional mammals, such as commercially farmed mink, where there is a clear commercial need both domestically and abroad that is made more urgent by the rise of coronavirus variants.”

Dr. Luigi Aurisicchio, chief executive officer and chief scientific officer, Evvivax and Takis Biotech, commented, “Cats, mink, and ferrets share a receptor for the virus that is very similar to the human receptor that SARS-CoV-2 uses to infect humans. In 2020, minks were infected following exposure from infected humans where it mutated, and people then transmitted it back into the human population. Known as ‘Cluster 5’, this SARS-CoV-2 mink-associated variant devastated the farmed mink industry, particularly in the EU and is also present in the U.S. More recently, cats have been shown to be susceptible to certain variants that pose greater threats to humans, including B.1.1.7. This clinical trial can help develop a productive path forward to the benefit of cat, mink, and humans.”

Phase I is a single-center clinical trial designed to evaluate domestic feline immune response, safety, and tolerability of the vaccine candidate with a cohort of 11 healthy, client-owned domestic felines and conducted at GVS. The LinearDNA vaccine candidate is administered intramuscularly via gene electrotransfer of primer and booster 28-35 days apart. The vaccine candidate has previously demonstrated antibody and T-cell responses at low doses of LinearDNA in preclinical mouse models. Applied DNA has manufactured a complete supply of the vaccine candidate in a lyophilized (freeze-dried) form that is shelf-stable at room temperature (zero cold chain requirement) with no loss of potency once resolubilized with water.

On the assumption that the Phase I endpoint is met, Applied DNA and Evvivax are expected to initiate Phase II that will involve the placement of seroconverted vaccinated non-client-owned cats among infected cats, with the primary endpoint being the percent of vaccinated cats that resist infection. In addition, the two companies expect to initiate a Phase I/II clinical trial using the LinearDNA vaccine candidate in minks upon the receipt of all necessary regulatory approvals.

Concluded Dr. Hayward, “The study marks the first clinical trial to evaluate our proprietary PCR-produced LinearDNA platform that offers the advantages of speed and ease of manufacture in adapting vaccines to match variants and with room temperature stability. We believe the data from this clinical trial is an important stepping-stone on the path to the eventual application of a LinearDNA platform for human use.”

Footnote:

¹ Grimm, David. “Major Coronavirus Variant Found in Pets for First Time.” Science, March 19, 2021. https://www.sciencemag.org/news/2021/03/major-coronavirus-variant-found-pets-first-time.

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap® Index.

About Evvivax

Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets.

Visit www.evvivax.com for more information.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020 and Form 10-Q filed on February 11, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

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