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Applied DNA Sciences, Inc. (NASDAQ: APDN) is a biotechnology company pioneering advanced DNA-based technologies to safeguard assets and enhance industrial and healthcare applications. Headquartered in Stony Brook, NY, Applied DNA leverages Polymerase Chain Reaction (PCR) to produce and detect DNA and RNA, operating in three key segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services.
In the Therapeutic DNA Production Services segment, Applied DNA produces synthetic DNA for nucleic acid-based therapeutics. With the acquisition of Spindle Biotech, the company has expanded its portfolio to include a proprietary RNA polymerase (RNAP) for mRNA therapeutics manufacturing. The recent contract with HDT Bio under the 'Project NextGen: Enabler' award aims to expedite mRNA vaccine production, highlighting the company's commitment to rapid-response medical solutions.
The MDx Testing Services segment, which includes clinical molecular diagnostic and genetic testing services, significantly contributes to the company's revenue. Applied DNA's innovative Linea™ IVT platform, designed to produce high-fidelity mRNA with reduced contamination, is a game-changer in molecular diagnostics.
Through the DNA Tagging and Security Products and Services segment, the company offers solutions under the brands Applied DNA Sciences, SigNature®, SigNature® T, fiberTyping, and SigNify®, providing robust anti-counterfeiting and product authentication services. These services are essential for supply chain security across various industries, including textiles and pharmaceuticals.
Recent achievements include closing a $12 million public offering to fund the development of DNA production services and the successful reverse stock split to comply with Nasdaq's minimum bid price requirements. Additionally, Applied DNA received a Notice of Allowance from the USPTO for a patent on its Linea™ RNAP, solidifying its intellectual property portfolio and extending patent protection into 2041.
Applied DNA remains dedicated to advancing DNA technology to meet the world’s evolving needs in healthcare, supply chain security, and beyond. For more information, visit their website at www.adnas.com and follow them on social media for the latest updates.
Applied DNA Sciences (NASDAQ: APDN) reported Q1 fiscal 2023 revenues of $5.3 million, marking a 48% increase from FQ4 2022 and 26% growth from FQ1 2022. The company achieved a 72% reduction in operating loss sequentially and a 74% reduction year-over-year. This growth was primarily driven by demand for molecular diagnostic testing and new orders for linearDNA™ from biopharma clients. The firm is progressing towards establishing a cGMP manufacturing facility by year-end. Additionally, the company aims to leverage its population health platform in genetic testing while expanding its CertainT® platform for textile materials testing.
Applied DNA Sciences (NASDAQ: APDN) will release its financial results for the quarter ending December 31, 2022, after market close on February 9, 2023. A conference call is scheduled for 4:30 p.m. ET to discuss the results and answer questions from investors. Interested parties can participate via domestic and international dial-in numbers or by accessing a live webcast at this link. A replay will be available for one week following the call. Applied DNA focuses on DNA technologies for therapeutics, diagnostics, and supply chain security.
Applied DNA Sciences (NASDAQ: APDN) announced the publication of a peer-reviewed study in Molecular Therapy – Methods & Clinical Development, demonstrating the immunogenicity of its linearDNA vaccine candidate against SARS-CoV-2 in cats. This advancement supports the linearDNA™ platform for vaccine production. The company is also optimizing lipid nanoparticle (LNP) delivery systems to enhance vaccine administration. Concurrent studies with Cornell University aim to test LNP-encapsulated linearDNA in animal models, potentially paving the way for veterinary vaccines.
Applied DNA Sciences (NASDAQ: APDN) reported a 17% revenue growth quarter-over-quarter and 101% year-over-year for fiscal year ended September 30, 2022, achieving record revenues of $18.2 million. The company's cash position stands at $15.2 million. Despite operational challenges, including a decline in gross profit margins to 12%, management remains optimistic, focusing on the commercialization of pharmacogenomics testing and enhancing their linearDNA platform. The company plans a conference call on December 14, 2022, to discuss these results.
Applied DNA Sciences (NASDAQ: APDN) announced it will release its fiscal 2022 fourth quarter and year-end financial results on December 14, 2022, after market close. A conference call will follow at 4:30 PM ET, featuring management discussions led by CFO Beth Jantzen and CEO Dr. James A. Hayward.
Investors can participate by dialing US: 1-844-887-9402 or International: +1-412-317-6798. The results will be accessible on the Applied DNA investor relations website.
Applied DNA Sciences, Inc. (NASDAQ: APDN) has announced plans to double its current DNA production capacity by establishing a new manufacturing facility in Suffolk County, New York. This expansion will enhance the production of cGMP LinearDNA™, catering to the growing demand from pharmaceutical and biotech companies. The new facility is expected to commence operations in the second half of 2023, targeting a monthly production capacity of approximately 50g, supporting drug discovery to late-phase clinical trials. Funding discussions are underway with various entities.
Applied DNA Sciences (NASDAQ: APDN) has received its largest single purchase order for LinearDNA™, valued above mid-six figures, under a long-standing supply agreement with a global in vitro diagnostics manufacturer. The current quarter will see the delivery of LinearDNA, with fulfillment expected over the next three quarters. The enzymatic production platform enhances efficiency and safety, reducing contamination risks associated with traditional plasmid DNA. CEO Dr. James A. Hayward highlighted the potential of DNA-based probes in diagnostics and therapeutic applications.
Applied DNA Sciences (NASDAQ: APDN) announced promising results from a study demonstrating that its LinearDNA vaccine candidate reduced infectious virus shedding and provided protection against SARS-CoV-2 in ferrets. The vaccine showed induction of neutralizing antibodies and T cell responses across multiple animal models, including mice and cats. The study's findings support further development of LinearDNA as a versatile vaccine platform. The manuscript detailing the research is available in a preprint and highlights the vaccine's capability to enhance immunity without side effects.
Applied DNA Sciences (NASDAQ: APDN) has announced a research agreement with Cornell University College of Veterinary Medicine to advance LinearDNA-based vaccine research for animal diseases. This agreement combines LinearDNA with Cornell's viral vector design expertise, aiming to innovate in animal vaccine development. Following positive results from recent intramuscular studies, the company is progressing with LNP-LinearDNA vaccine designs for preclinical trials, including a canine cancer vaccine expected to enter initial clinical trials in 1H 2023.
Applied DNA Sciences (NASDAQ: APDN) will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 2:00 PM ET. The hybrid conference runs from September 12 to 14, 2022. CEO Dr. James A. Hayward will give an overview of the company's business during his presentation. The event will be held at the Lotte New York Palace Hotel, New York, NY. Interested parties can register to view the livestream of the presentation.
Applied DNA specializes in PCR-based DNA technologies for therapeutics, diagnostics, and supply chain security.
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