The quantity was produced by the Company's LinearDNA platform under a large recurring purchase order with a global manufacturer of in vitro diagnostics that was announced in the first quarter of fiscal 2023 and is the largest single shipment of linearDNA to date. The Company expects to ship a final multi-gram quantity in the third fiscal quarter of 2023 to fulfill the purchase order earlier than contractually stipulated.
'We believe that this production milestone underscores our LinearDNA platform's capacity for the rapid, enzymatic production of DNA at very large scale that stands in stark contrast to the scalability bottlenecks and challenges associated with conventional plasmid DNA to support both high value biotherapeutic and lower price-point diagnostic applications,' stated Dr.
The Company's LinearDNA platform is focused on empowering the next generation of nucleic acid-based therapies. The platform uses a cell-free, enzymatic approach that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid DNA (fermentation)-based manufacturing processes. The resultant DNA, known as linearDNA, is currently produced at GLP-grade in volumes from micrograms to grams to support customers' needs. The Company is pursuing a timeline for cGMP linearDNA production that will enable it to support customers from research and development and drug discovery through large-scale manufacturing for clinical trials and commercial use.
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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, unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from any customer order for linearDNA or any linearDNA-based therapeutic, whether any of Applied DNA's or its customers therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the
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