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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) and Northwell Health have established a pro bono Material Transfer Agreement for a real-time surveillance program to identify SARS-CoV-2 mutations. This program involves screening over 2,000 COVID-positive specimens using Applied DNA's Linea™ COVID-19 Assay Kit and Selective Genomic Surveillance™ Mutation Panel. Initial results show that approximately 80% of samples tested contain mutations. The data may aid in vaccine design and support clinical care improvements. The combination of these tools aims to optimize the use of limited next-generation sequencing resources.
Applied DNA Sciences (NASDAQ: APDN) announced the reappointment of Clay Shorrock as Chief Legal Officer and Executive Director, Business Development. Shorrock, who has over a decade of experience in intellectual property and biotechnology, will lead legal, regulatory, and business development functions. CEO Dr. James A. Hayward emphasized Shorrock's expertise and prior contributions, such as securing Emergency Use Authorization for the COVID-19 assay kit. This new leadership role is aimed at advancing the company's proprietary LinearDNA platform across multiple sectors, enhancing growth and innovation.
Applied DNA Sciences (NASDAQ: APDN) announced a purchase order for its Linea™ COVID-19 Assay Kit to conduct 10,000 tests under a Master Services Agreement. The delivery is expected primarily in the fiscal quarter ending March 31, 2021. The Assay Kit is authorized under the FDA's Emergency Use Authorization and can detect certain SARS-CoV-2 mutations. The company views this order as validation of the kit's effectiveness amid rising vaccination rates and the spread of COVID-19 variants, specifically the U.K. variant.
Applied DNA Sciences (NASDAQ: APDN) has launched its Linea™ COVID-19 Selective Genomic Surveillance™ Mutation Panel to enhance tracking of SARS-CoV-2 Variants of Concern in the U.S. This panel utilizes proprietary qPCR assays to optimize Next Generation Sequencing resources and is marketed towards government labs, hospitals, and academic institutions. The SGS Panel, currently for research use only, aims to identify significant samples for NGS analysis, thereby assisting in the management of variant spread amidst vaccine rollout. The company also aims to sequence 100 SARS-CoV-2 genomes daily, potentially doubling capacity.
Applied DNA Sciences (NASDAQ: APDN) will participate in several upcoming virtual investor conferences. Key events include a company presentation by Dr. James A. Hayward at the H.C. Wainwright Global Life Sciences Virtual Conference on March 9-10, and a panel discussion at Roth Capital Markets’ 33rd Annual Conference on March 15. Additionally, Dr. Hayward will present at the Inaugural Emerging Growth Virtual Conference on March 17-19. These presentations will be accessible via the company’s website.
Applied DNA Sciences (NASDAQ: APDN) has initiated Phase I of its clinical trial for a LinearDNA™ COVID-19 vaccine aimed at felines. The trial evaluates the vaccine's safety and immunogenicity, targeting the prevention of SARS-CoV-2 transmission from cats to humans. Following successful Phase I results, Applied DNA and Evvivax plan to progress to Phase II, with the potential to apply for a USDA APHIS conditional license for commercial sales. The trial emphasizes the significance of the vaccine in preventing zoonotic transmission, with approximately 58.4 million cats in the U.S.
Applied DNA Sciences (NASDAQ: APDN) announced the issuance of United States Patent No. 10,920,274 for methods of authenticating objects using nucleic acid-coated submicron particles. The patent enhances the company's strong intellectual property portfolio, which now includes 92 issued patents and 40 pending applications. Dr. James Hayward, President and CEO, emphasized the patent's importance for their CertainT® platform in combating counterfeit pharmaceuticals and nutraceuticals. Applied DNA continues to focus on their LinearDNA™ platform across various markets, including diagnostics and anti-counterfeiting.
Applied DNA Sciences (NASDAQ: APDN) will provide weekly COVID-19 surveillance testing for LIM College students, faculty, and staff as they resume in-person classes starting February 22, 2021. The testing will use the safeCircle™ program and the FDA-authorized Linea™ COVID-19 Assay Kit, which can detect certain SARS-CoV-2 variants. The Company emphasizes that this program offers an efficient solution for maintaining health and safety in educational environments.
Applied DNA Sciences reported a 155% revenue increase to $1.6 million for Q1 2021, driven by demand for its COVID-19 testing services, particularly safeCircle™ and the Assay Kit. The company anticipates continued growth due to new client acquisitions and ongoing orders. However, operating expenses rose to $4.3 million, primarily due to increased payroll and stock-based compensation. The net loss applicable to common stockholders was $4.8 million, or $0.88 per share. As of January 31, 2021, cash and equivalents were approximately $16.5 million following a registered direct offering.
Applied DNA Sciences (NASDAQ: APDN) and Cytocheck Laboratory reported the first identification of the SARS-CoV-2 UK variant (B.1.1.7) in Kansas on February 3, 2021. The identification utilized Applied DNA's Linea™ COVID-19 Assay Kit, which screens for specific mutations associated with increased transmissibility. This advancement highlights a growing need for genomic surveillance in the U.S. to monitor variant spread effectively. The assay kit enhances the testing workflow of Cytocheck, which services multiple states, signaling its potential impact on public health responses.
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