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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, 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.
Applied DNA Sciences (NASDAQ: APDN) has received full approval from the New York State Department of Health for its Monkeypox Virus Diagnostic test. This allows its laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), to provide monkeypox testing services to hospitals and clinical labs in New York and other states recognizing New York's certification. The test, designed to detect the Clade II variant of the monkeypox virus, aims to enhance testing capacity amidst over 20,000 reported cases in the U.S., with New York being severely affected.
Applied DNA Sciences (NASDAQ: APDN) announced that its clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package for its monkeypox virus test to the New York State Department of Health (NYSDOH). The test, named Linea™ Monkeypox Virus 1.0 Assay, is designed to identify the Clade II variant, currently prevalent in the U.S. If approved, it will complement ADCL's COVID-19 testing services, enhancing their high-throughput infectious disease testing offerings. The test aims to provide quick turnaround times for results to aid public health efforts.
Applied DNA Sciences reported a 153% year-over-year revenue growth for Q3 fiscal 2022, totaling $4.3 million. This increase was attributed primarily to clinical testing services related to COVID-19. The company's cash balance stands at $16.8 million, bolstered by an equity offering. However, the gross profit margin decreased to 24% due to higher costs in testing contracts. A net loss of $1.1 million was reported, an improvement from a loss of $3.4 million in the prior-year quarter. Ongoing developments and contracts position the company for potential future growth.
Applied DNA Sciences (NASDAQ: APDN) announced its subsidiary, LineaRx, successfully administered a linearDNA-LNP construct in mice via intramuscular injection without electroporation, enhancing the feasibility of LinearDNA-based therapies. This approach could potentially revolutionize applications in therapeutics, building on LineaRx's past successes, such as anti-lymphoma vaccines. The company is also formulating a canine lymphoma vaccine for similar administration. This achievement aligns with the rising significance of lipid nanoparticle (LNP) technology in vaccine delivery.
Applied DNA Sciences (NASDAQ: APDN) has secured a 12-month extension of its health services contract with The City University of New York (CUNY) for COVID-19 testing and vaccine policy management, running through July 2023. This contract, operational since August 2021, utilizes the safeCircle™ platform to manage health services for over 300,000 individuals across CUNY's 25 campuses, amidst rising COVID-19 variant positivity rates. The partnership is expected to mitigate risks as the academic year progresses, highlighting ADCL's effective testing and management services.
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