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STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), a biotechnology firm specializing in PCR-based DNA technologies with a market capitalization of $2.3 million and current gross profit margins of 39%, has announced its submission of a validation package to the New York State Department of Health (NYSDOH) for a laboratory-developed test (LDT) aimed at detecting the H5 bird flu virus. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 4.72, indicating robust short-term financial stability. The test, known as Linea™ Avian Influenza H5 Dx assay (AIH5 Dx), is designed to identify and subtype the influenza A (H5) virus, commonly referred to as the highly pathogenic avian influenza or H5N1.
The company initiated the development of AIH5 Dx in January 2025 in response to the escalating spread of the H5 bird flu virus among dairy cows and poultry in the United States, as well as several human infection cases among dairy and poultry workers. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash burn, with negative free cash flow of $13.8 million in the last twelve months. The Centers for Disease Control and Prevention (CDC) issued a health advisory recommending swift subtyping of all influenza A-positive specimens from hospitalized patients, highlighting the need for such a test.
The AIH5 Dx assay is described as a highly sensitive, multi-target diagnostic tool that can discern between pan-influenza A and H5 bird flu. Applied DNA’s clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), is currently permitted for virology and genetics testing and is certified by the Clinical Laboratory Improvement Amendments (CLIA). If the NYSDOH approves the assay, ADCL plans to offer the H5 bird flu testing service to physicians across U.S. states that recognize New York’s CLEP/CLIA certification.
Dr. James A. Hayward, CEO of Applied DNA, stated that the development of AIH5 Dx leverages the company’s proven capability to rapidly develop and gain regulatory approval for LDTs targeting emergent health crises. He emphasized that ADCL is prepared to provide access to testing, contingent on NYSDOH approval.
The press release also referenced recent scientific findings about mutations in the H5 bird flu virus that could potentially increase its capacity to infect humans, as well as a CDC report suggesting that human H5 bird flu infections might be underestimated in the U.S. With revenue declining by 58% in the last twelve months, investors seeking deeper insights into Applied DNA Sciences’ financial health and growth prospects can access comprehensive analysis through InvestingPro, which offers exclusive access to 15+ additional ProTips and detailed financial metrics.
Applied DNA Sciences operates in two main business markets: the enzymatic production of synthetic DNA for nucleic acid-based therapeutics and the detection of DNA and RNA in molecular diagnostics and genetic testing services.
The timeline for the NYSDOH’s review of the company’s validation package is currently unknown, as is the potential approval. The company has made forward-looking statements regarding the prospects of the AIH5 Dx assay, acknowledging the uncertainties involved in research and development and regulatory approval processes.
This news is based on a press release statement from Applied DNA Sciences, Inc. The company’s stock currently trades near its 52-week low, with analysts expecting continued challenges in profitability for the current fiscal year. For comprehensive analysis of Applied DNA Sciences and similar biotech opportunities, investors can access detailed Fair Value assessments and financial health scores through InvestingPro’s extensive research platform.
In other recent news, Applied DNA Sciences reported a significant increase in revenue for the first quarter of fiscal year 2025, with earnings rising to $1.2 million from $891,000 in the previous year. Despite this growth, the company faced an operating loss of $3 million, an improvement from the prior year’s $3.8 million loss. The company has also announced a 1-for-50 reverse stock split to meet Nasdaq’s minimum bid price requirement, which will reduce outstanding shares from approximately 55.2 million to about 1.1 million.
Additionally, Applied DNA Sciences experienced challenges in securing a quorum at its special stockholder meeting, which was necessary for approving the exercisability of private placement warrants from a previous stock offering. The company plans to reconvene the meeting to obtain the required stockholder approval. Furthermore, Applied DNA Sciences initiated a strategic restructuring, including a 20% workforce reduction, to optimize costs and focus on its LinearRx platform, aiming to expand into the CRISPR and gene editing markets.
Analysts from firms like H.C. Wainwright have shown interest in the company’s developments, particularly in its new Linea products for CRISPR therapies. The company’s strategic initiatives and restructuring efforts are focused on improving its financial health and advancing its business objectives amidst ongoing challenges.
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