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Overview
Applied DNA Sciences is a biotechnology company specializing in the enzymatic production and detection of synthetic deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) using advanced polymerase chain reaction (PCR) technologies. The company caters to multiple industries with a focus on nucleic acid-based therapeutics, molecular diagnostics, and forensic authentication to secure supply chains and protect intellectual property.
Core Business Segments
- Therapeutic DNA Production Services: Leveraging its proprietary Linea DNA platform, the company produces highly pure, scalable synthetic DNA that serves as a critical component in the manufacture of nucleic acid-based therapies, including mRNA therapeutics and DNA vaccines.
- MDx Testing Services: Through its molecular diagnostics (MDx) capabilities, Applied DNA Sciences performs advanced genetic and clinical laboratory testing. These services are directed at ensuring accurate diagnostic results and personalized treatment strategies, contributing to better patient outcomes.
- DNA Tagging and Security Products & Services: With innovative solutions like the CertainT platform, the company provides botanical-DNA based security and authentication technology. This system verifies the authenticity of materials in supply chains, thereby protecting brands, assets, and intellectual property from fraud, counterfeiting, and diversion.
Key Technologies and Platforms
Applied DNA Sciences stands out due to its integration of state-of-the-art biochemical processes and robust forensic methodologies. Its proprietary platforms include:
- Linea DNA: A cell-free, enzymatic production platform that generates high-fidelity synthetic DNA constructs with versatile applications in therapeutics and diagnostics.
- Linea IVT: This innovative platform pairs DNA IVT templates with a next-generation RNA polymerase, streamlining mRNA production while reducing double-stranded RNA contamination, a critical factor in ensuring product purity and regulatory compliance.
- CertainT: A comprehensive traceability solution that integrates isotopic testing, DNA tagging, and genomic analyses. This platform delivers multiple key proof points to verify the origin and authenticity of raw materials and finished products, particularly within the textile industry.
Market Position and Strategic Significance
By combining advanced manufacturing protocols with forensic traceability techniques, Applied DNA Sciences provides robust solutions that address critical challenges across various sectors. The company's technologies not only enhance the efficiency of nucleic acid-based therapeutics production but also fortify supply chains against counterfeiting and fraud. Its unique approach of integrating multiple layers of verification underlines its commitment to quality, security, and innovation.
Operational Excellence and Industry Impact
The firm's reliance on enzymatic PCR-based processes sets it apart as an expert in producing synthetic DNA with high scalability and fidelity. This technical proficiency supports a diverse customer base, including pharmaceutical developers, diagnostic laboratories, governmental agencies, and global manufacturers who demand reliable, secure, and innovative solutions. Furthermore, by continuously refining its production and testing methodologies, the company demonstrates a strong dedication to research and development, ensuring its processes remain at the forefront of biotechnology innovation.
Conclusion
Overall, Applied DNA Sciences delivers comprehensive solutions that span from the production of synthetic DNA for advanced therapeutics to the forensic authentication of products in global supply chains. Its balanced focus on clinical, industrial, and security applications positions the company as a multifaceted player in the biotechnology sector, dedicated to enhancing product integrity and operational efficiency through innovative, proof-based technologies.
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.
Applied DNA Sciences, Inc. (NASDAQ: APDN) will announce its fiscal 2021 first quarter financial results on February 11, 2021, after the market closes. A conference call and webcast led by CEO Dr. James A. Hayward, CFO Beth Jantzen, and COO Judith Murrah will follow at 4:30 p.m. ET. The webcast and PowerPoint presentation will be accessible on the company’s website and archived for future viewing. The company specializes in molecular technologies for supply chain security, anti-counterfeiting, and product genotyping.
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