STONY BROOK, NY - Applied DNA Sciences, Inc. (NASDAQ:APDN), a company specializing in PCR-based DNA technologies, today announced plans to expand the use of its Linea™ Mpox Virus 1.0 Assay for detecting mpox Clade I. This follows the World Health Organization's declaration on Sunday of a public health emergency concerning the mpox outbreak.
The assay, which was initially approved for detecting mpox Clade II (formerly known as monkeypox) by the New York State Department of Health (NYSDOH) in September 2022, is currently undergoing validation studies for the detection of mpox Clade I. Applied DNA is preparing to file the necessary documentation with NYSDOH as soon as possible, depending on the availability of required reagents and control materials.
If the expansion is approved, Applied DNA Clinical Labs, LLC (ADCL), a NYSDOH CLEP-permitted and Clinical Laboratory Improvement Amendments (CLIA)-certified clinical laboratory, would be able to offer clinical testing services for both mpox Clade I and Clade II in New York State. Additionally, states that recognize New York's CLEP/CLIA certification could also receive testing services from ADCL.
The Linea™ Mpox Virus 1.0 Assay has not been approved or cleared by the U.S. Food and Drug Administration, but is intended for clinical purposes as a laboratory-developed test. The performance characteristics of the assay were determined by ADCL, which is certified to perform high-complexity testing.
Applied DNA has cautioned that the expansion and approval process involves risks and uncertainties, including the validation of the assay for mpox Clade I detection and receipt of NYSDOH approval. The company has a history of net losses and faces challenges such as limited financial resources and potential disruptions in the supply of raw materials.
The information in this article is based on a press release statement from Applied DNA Sciences, Inc.
In other recent news, Applied DNA Sciences reported a failure to reach a quorum at a special meeting of stockholders, leading to an adjournment and necessitating a subsequent meeting. This follows the company's completion of a public offering of common stock and series A and B common stock purchase warrants. In partnership news, a five-year licensing agreement was announced with Indus Group, integrating the CertainT® traceability platform into Indus's non-home textile products. The firm also reported a public offering expected to generate approximately $12 million in gross proceeds.
Financial developments include a significant reduction in manufacturing costs for a key component in mRNA production, in collaboration with Alphazyme LLC, expected to improve profitability. Analysts from H.C. Wainwright, however, have lowered their price target for Applied DNA Sciences shares to $1.50 from the previous $7.00, maintaining a Buy rating.
The company has also received approval from the New York State Department of Health for its pharmacogenomic testing service, TR8™, expanding its accessibility within New York State. Despite these advancements, Applied DNA Sciences faces potential delisting from The Nasdaq Stock Market LLC due to non-compliance with the exchange's minimum bid price requirement. The company plans to implement a reverse stock split to comply with Nasdaq's listing rules. These are the latest developments in Applied DNA Sciences' ongoing efforts to maintain its market position and expand its services.
InvestingPro Insights
As Applied DNA Sciences, Inc. (NASDAQ:APDN) continues to navigate the complexities of expanding its Linea™ Mpox Virus 1.0 Assay, investors and stakeholders are closely monitoring the company's financial health and market performance. In light of recent developments, here are some key insights from InvestingPro that may offer additional context.
Despite the potential for growth in the diagnostic space given the current public health concerns, Applied DNA Sciences faces significant financial challenges. The company is rapidly depleting its cash reserves, which is a critical factor for investors to consider. According to InvestingPro Tips, the company holds more cash than debt, which can provide some cushion, but it is also quickly burning through its cash. Moreover, analysts expect a sales decline in the current year, suggesting that revenue generation could be a concern.
From a market perspective, the stock exhibits high price volatility, which can be a double-edged sword for traders. In the short term, Applied DNA has seen significant returns, with a notable increase over the last week. However, the stock's performance over the last year has been less favorable, indicating a longer-term downward trend.
Looking at the numbers, Applied DNA Sciences has a market capitalization of $18.45 million, reflecting its size in the biotechnology market. The company has not been profitable over the last twelve months, with a negative P/E ratio of -0.35, and analysts do not anticipate profitability this year. The revenue for the last twelve months as of Q3 2024 stands at $3.4 million, which represents a sharp decline of nearly 79% from the previous period. This contraction in revenue underscores the challenges the company faces in scaling its operations and maintaining financial stability.
For those interested in a deeper dive into the financials and future projections of Applied DNA Sciences, there are an additional 16 InvestingPro Tips available, providing a comprehensive analysis of the company's performance and outlook.
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