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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) has secured a new firm fixed-price indefinite delivery contract valued at up to $1.04 million with the Defense Logistics Agency’s Product Test Center in Columbus, Ohio. This contract aims to support the DLA's counterfeit mitigation efforts by providing unique DNA marking services and quality control testing. This collaboration builds on their long-standing partnership since 2014, ensuring the integrity of products in critical sectors.
Applied DNA Sciences (NASDAQ: APDN) announced an amendment to its Master Services Agreement, doubling its maximum value for COVID-19 Assay Kits. The agreement ensures continued access for a customer’s surveillance testing program, with a purchase order for 16,000 tests supporting in-person graduation ceremonies in May 2021. CEO Dr. James A. Hayward emphasized the importance of proactive monitoring amid increasing vaccination rates and new virus variants. The Linea™ COVID-19 Assay Kit is FDA EUA authorized for specific respiratory specimens, aiding in the detection of SARS-CoV-2.
Applied DNA Sciences (NASDAQ: APDN) reported preliminary fiscal Q2 2021 revenues between $2.5 million and $2.7 million, a significant increase from $1.6 million in Q1 2021 and $552,000 in Q2 2020, driven by demand for its safeCircle™ COVID-19 testing program and Linea™ Assay Kit. The company also announced the full forgiveness of an $847,000 PPP loan, leaving it debt-free. The results are preliminary and await full financial disclosure in mid-May 2021.
Applied DNA Sciences (NASDAQ: APDN) announced positive preliminary results from a Phase I clinical trial of its LinearDNA™ COVID-19 vaccine candidate for domestic felines. Conducted in February, the trial showed that the vaccine was well-tolerated, producing high levels of SARS-CoV-2 neutralizing antibodies in all 11 participating cats. The company intends to extend the study until September 2021 to assess the durability of the immune response. Following these results, plans for Phase II trials are anticipated, focusing on vaccinated cats’ resistance to infection.
Applied DNA Sciences, Inc. (NASDAQ: APDN) announced an interview with CEO Dr. James A. Hayward on BBC’s Business Daily, focusing on traceability in cotton. The Company’s CertainT® platform authenticates materials in complex supply chains, having secured approximately 300 million pounds of North American cotton. CertainT ensures product integrity by marking cotton fibers with a unique identifier to combat illicit blending, including forced labor. The Company also commercializes its LinearDNA™ platform for diagnostics and drug development, alongside applications in supply chain security.
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.
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