Applied DNA Announces Joint Development Agreement To Integrate Linea IVT Platform Into CDMO Kudo Biotechnology's mRNA Manufacturing Workflow

Agreement Seeks to Leverage Linea IVT Platform to Enable Kudo Bio to Offer a Differentiated mRNA Manufacturing Capability with Mitigated dsRNA and Reduced Turnaround Times

Applied DNA Sciences, Inc. (Applied DNA), a leader in PCR-based DNA technologies, and Kudo Biotechnology (Kudo Bio), a leading global mRNA CDMO offering end-to-end cGMP mRNA manufacturing solutions, today announced their entry into a joint development agreement (the "JDA") to integrate Applied DNA's Linea IVT platform (the "Platform") into Kudo Bio's commercial mRNA manufacturing workflows.

Under the terms of the JDA, the Companies will seek to optimize mRNA quality, yields, and mitigation of contamination by double-stranded RNA ("dsRNA") in an integrated workflow at manufacturing scale and establish a global co-marketing relationship. Upon successful completion of the JDA, the Companies plan to negotiate agreements to enable the commercial launch of the joint workflow in the second half of calendar 2024.

The Linea IVT Platform combines Applied DNA's enzymatically produced Linea DNA IVT templates and its proprietary Linea RNA polymerase ("RNAP"), obtained through the recent acquisition of Spindle Biotech, to provide what Applied DNA believes to be numerous advantages over conventional mRNA manufacturing methods, including the prevention or reduction of dsRNA contamination and reduced mRNA manufacturing turn-around-times.

Dr. James A. Hayward, president and CEO of Applied DNA, stated, "The JDA is an important first step in the enablement of the commercial availability of a differentiated mRNA workflow empowered by our powerful platform. We believe that upon completion of the work under the JDA, Kudo Bio will possess critical advantages in turnaround time, scalability, and dsRNA reductions as compared to other mRNA CDMOs."

Added Molly S. McGlaughlin, CEO of Kudo Bio, "We are excited to work with Applied DNA, a clear technology leader, to access cutting-edge technologies to significantly improve our customers' cost of goods, speed to clinic, and overall safety to their patients!"

About the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely cell-free DNA production platform founded on Applied DNA's long-standing expertise in the large-scale enzymatic production of DNA. Capable of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.

The Linea IVT platform combines DNA IVT templates manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and saRNA manufacturers to produce what Applied DNA believes to be better mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material; 2) the prevention or reduction of dsRNA contamination; and 3) simplified mRNA production workflows.