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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 submitted a validation package to the New York State Department of Health (NYSDOH) to expand its Linea™ Mpox Virus 1.0 Assay to include both mpox clade I and clade II. The company's validation studies confirmed that the assay's primers and probe have 100% homology to mpox clade I and clade Ib, the latter being the subject of the WHO's recent public health emergency declaration.
The assay was previously approved for detecting mpox clade II in September 2022. If approved for clade I, Applied DNA could provide clinical testing services for both clades in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification.
Applied DNA Sciences (NASDAQ:APDN) has announced plans to expand the intended use of its Linea™ Mpox Virus 1.0 Assay to include detection of mpox Clade I, following the WHO's recent declaration of a public health emergency. The company's internal data suggests the assay can detect mpox Clade I's genetic sequence, and validation studies are underway to support a filing with the New York State Department of Health (NYSDOH).
If approved, Applied DNA could offer clinical testing services for both mpox Clade I and Clade II in its Stony Brook, N.Y. laboratory for samples from New York State and states recognizing New York's CLEP/CLIA certification. The assay is currently approved as a laboratory-developed test for mpox Clade II detection. The company emphasizes that the timing and approval of the NYSDOH filing are uncertain.
Applied DNA Sciences (NASDAQ:APDN) announced its Q3 FY2024 financial results, revealing a revenue decline to $798,000 from $2.9 million in Q3 FY2023. The decrease was primarily due to the conclusion of a COVID-19 testing contract. Gross profit fell to $245,000 with a 31% margin, down from $1.3 million and 44% margin in the prior year. Operating expenses decreased to $3.6 million, while the operating loss increased to $3.3 million. The company ended the quarter with $10.4 million in cash, bolstered by a recent $10.5 million public offering.
Despite financial challenges, Applied DNA reported progress in its business segments. The company is on track to launch a GMP facility for Linea™ IVT templates, secured new customers for its Linea™ IVT platform, and established a potential $25 million annual revenue opportunity for its TR8™ PGx testing service. The company also entered a multi-year commercialization agreement with Indus Group for its CertainT® platform.
Applied DNA Sciences, Inc. (NASDAQ:APDN) has announced the release of its third quarter fiscal 2024 financial results on Thursday, August 8, 2024, after market close. The company will host a conference call for analysts and investors at 4:30 p.m. ET on the same day to discuss the financial results and recent accomplishments. Domestic callers can dial toll-free at 844-887-9402, while international callers can use 412-317-6798. A live webcast will be available, and a slide presentation will be embedded in the webcast. A telephonic replay of the conference call will be accessible until August 15, with replay access codes provided for different regions.
Applied DNA Sciences (NASDAQ: APDN) will showcase its Linea™ IVT platform at the 4th Annual mRNA-based Therapeutics Summit from July 29-31, 2024, in Boston. The Linea IVT platform integrates an enzymatically produced DNA template with a next-gen RNA polymerase, aiming to enhance mRNA production by reducing double-stranded RNA (dsRNA) contamination.
The poster titled Reduction of dsRNA Contamination in High-Yield mRNA Production, authored by Yuhua Sun, Huan Dong, Qiang Zhao, Finly Philip, Clay Shorrock, Aaron Chung, and James A. Hayward, will be presented on July 30, 2024, from 3:45 - 4:30 p.m. (local time). According to Clay Shorrock, executive director at LineaRx, reducing dsRNA is important for efficient mRNA expression and regulatory compliance. The platform promises simplified workflows, lower purification costs, and faster production times, supporting the development of mRNA therapeutics, vaccines, and personalized therapies.
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.
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