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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) will present its Linea™ IVT platform at the 4th Annual mRNA-based Therapeutics Summit in Boston, July 29-31, 2024. The platform combines an enzymatically produced DNA template with a next-generation RNA polymerase to manufacture mRNA with reduced double-stranded RNA (dsRNA) contamination. This addresses a key industry challenge without sacrificing yields.
The poster, titled 'Reduction of dsRNA Contamination in High-Yield mRNA Production,' will be presented on July 30. Clay Shorrock, executive director of business development at LineaRx, highlighted that dsRNA reduction is a top priority for therapy developers and CDMOs to ensure efficient mRNA expression, reduce immunogenicity risks, and meet regulatory compliance. The Linea IVT platform offers a fully enzymatic solution that could support the development of transformative mRNA-based medicines, including therapeutics, vaccines, and personalized therapies.
Applied DNA Sciences (NASDAQ:APDN) has signed a five-year license and commercialization agreement with Indus Group for its CertainT traceability platform. The agreement covers non-home, cotton-based products from Indus facilities in Pakistan, Egypt, and Jordan. Indus, which consumes about 450 million pounds of cotton annually, will have exclusive use of the platform in these countries and non-exclusive use elsewhere.
The CertainT platform uses forensic, multiple-proof-point evidence for source and authenticity verification of materials throughout global supply chains. This marks CertainT's first large-scale deployment catalyzed by the Uyghur Forced Labor Prevention Act (UFLPA). The agreement is expected to reduce revenue lumpiness in Applied DNA's segment by enabling year-round cotton tagging at Indus's spinners.
Applied DNA Sciences, Inc. (NASDAQ:APDN) announced that the U.S. Defense Logistics Agency (DLA) has exercised the first one-year option period of a three-year base contract with two one-year option periods. This contract, initially entered in May 2021, supports DLA's counterfeit mitigation initiatives and product verification programs for FSC 5962 microcircuits. The contract has a maximal value of $1.04 million over a potential five-year term.
This extension continues Applied DNA's support of DLA's counterfeit mitigation program, which has been ongoing since 2014. The company's forensic DNA mark serves as a secure, high-resolution taggant to track provenance and ensure authenticity in defense-related microcircuits.
Applied DNA Sciences and Alphazyme successfully concluded their Linea(TM) RNAP manufacturing scale-up project, achieving a 70% reduction in production costs. This initiative is expected to significantly enhance the profitability of Applied DNA's Linea IVT platform. The project secured a quantity of Linea RNAP sufficient to meet near-term demand for mRNA production. The company anticipates leveraging these improved economics and new IP protections to secure GMP-grade supply agreements by Q4 2024. This development aligns with Applied DNA's strategy to drive growth through its LineaRx segment.
Applied DNA Sciences (NASDAQ:APDN) has partnered with GenXys Health Care Systems to deploy a clinical decision support system for its TR8™ pharmacogenomic (PGx) test. This collaboration aims to enhance precision prescribing by providing healthcare providers with actionable insights from PGx testing, which examines 120 genetic variants across 30 genes. The TR8 PGx test, approved by the New York State Department of Health, seeks to improve patient outcomes and reduce healthcare costs by guiding drug-gene interactions. The test will be processed in ADCL's CLEP/CLIA-certified lab.
Applied DNA Sciences (NASDAQ:APDN) announced that its TR8(TM) pharmacogenomic (PGx) testing service has received approval from the New York State Department of Health (NYSDOH). The service, offered through Applied DNA Clinical Labs, aims to help healthcare providers tailor medication treatments for cardiovascular, oncology, psychiatric, infectious disease, and pain management based on a patient's genetic profile. TR8(TM) analyzes 120 genetic targets across more than 30 genes using a cheek swab to inform healthcare providers about a patient's response to medications. The company sees this approval as a significant milestone and is actively seeking partnerships to expand its market share in New York State.
Applied DNA Sciences (NASDAQ: APDN) announced it received a Notice of Allowance from the USPTO for patent application 18/302,247, covering its Linea™ RNAP enzyme. This patent protects the composition of the enzyme, a core part of the company's Linea™ IVT platform, until 2041. The technology aims to streamline mRNA production, reducing contamination. Acquired from Spindle Bio in July 2023, Linea RNAP supports the manufacture of mRNA therapies, which are currently in high demand. Applied DNA is also set to start its GMP capabilities soon, reinforcing its commitment to providing critical materials for mRNA manufacturing.
Applied DNA Sciences (NASDAQ: APDN) announced the pricing of a public offering expected to generate approximately $12 million in gross proceeds. The offering includes 9,230,769 units, each consisting of a common share or pre-funded warrant, a Series A Warrant, and a Series B Warrant. Series A Warrants are exercisable at $1.99 per share and expire on the fifth anniversary of stockholder approval, while Series B Warrants also have an exercise price of $1.99 but expire one year after stockholder approval. The offering price per unit with a common share is $1.30. Net proceeds will support development of DNA production and MDx testing services, along with general corporate purposes. The offering is expected to close on May 29, 2024, subject to customary conditions. Craig-Hallum and Laidlaw & Company (UK) are acting as placement agents.
Applied DNA Sciences, Inc. and the Institute of Hematology and Blood Transfusion are collaborating on a non-viral manufacturing workflow for CAR T-cell therapy. The study aims to reduce costs and improve production efficiency using Linea DNA technology. The abstract will be presented at the European Hematology Association 2024 Congress.
Applied DNA announced its second-quarter fiscal year 2024 financial results, reporting a decline in total revenues to $930 thousand due to the conclusion of a testing contract. Gross profit decreased to $296 thousand, with a decline in the gross profit percentage. Operating expenses decreased to $3.9 million. The loss from operations was $3.6 million, and Adjusted EBITDA was a negative $3.3 million. Cash and cash equivalents stood at $3.1 million. The company underwent a one-for-twenty reverse stock split and regained compliance with the Nasdaq minimum bid price requirement.