Welcome to our dedicated page for Applied DNA Sciences news (Ticker: APDN), a resource for investors and traders seeking the latest updates and insights on Applied DNA Sciences stock.
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) announced that the Czech Republic's State Institute for Drug Control approved a Phase I clinical trial for UHKT-CAR123-01, a CD123-specific autologous CAR T-cell therapy using Applied DNA's Linea DNA technology. The trial, conducted by the Institute of Hematology and Blood Transfusion (ÚHKT) in Prague, targets relapsed and/or refractory acute myeloid leukemia (AML).
The therapy aims to address high costs and long manufacturing times associated with traditional viral vector-based CAR T-cell therapies. Preclinical data demonstrated that ÚHKT's non-viral workflow using Linea DNA achieved rapid production of CAR T-cells with high potency while reducing manufacturing costs and timelines.
Applied DNA Sciences (NASDAQ:APDN) announced strategic restructuring to focus on manufacturing critical starting materials for genetic medicines. The company plans to divest its CertainT® platform and targets 15% operating expense reduction by Q2 FY2025. The company's GMP manufacturing facility is expected to be completed by January 9, 2025, with projected annual revenue capacity between $4-16 million.
Q4 FY2024 financial results showed revenues of $813,000 (up from $780,000 in Q4 FY2023), with an operating loss of $3.3 million (improved from $4.2 million). FY2024 total revenues were $3.4 million, down from $13.4 million in FY2023. Cash position was $6.4 million as of September 30, 2024, with additional $5.8 million raised through an October offering.
Applied DNA Sciences (NASDAQ:APDN) announced it will release its fourth quarter and fiscal year 2024 financial results after market close on December 17, 2024. The company will host a conference call and webcast for investors on January 9, 2025, at 4:30 p.m. ET, which will include an update on its GMP manufacturing facility build-out. The presentation will be accessible via webcast and conference call, with replay options available for 7 days following the event. An accompanying slide presentation will be available on the company's investor relations website.
Applied DNA Sciences (NASDAQ:APDN) has announced the pricing of a $6.5 million registered direct offering and concurrent private placement. The offering includes 20,312,500 shares at $0.32 per share, along with Series C and Series D Warrants. The Series C Warrants expire in 5 years and Series D Warrants in 18 months after stockholder approval, both with an exercise price of $0.32. The company plans to use proceeds for developing Therapeutic DNA Production Services and general corporate purposes. The offering is expected to close around October 31, 2024, with Craig-Hallum acting as exclusive placement agent.
Applied DNA Sciences, Inc. (NASDAQ:APDN) has announced its participation in the 2024 Maxim Healthcare Virtual Summit. The company's president and CEO, Dr. James A. Hayward, will engage in a fireside chat on Wednesday, October 16, 2024, at 12:50 p.m. EDT. This virtual event, hosted by Maxim Group , runs from October 15th to 17th.
The interview will be conducted by Jason McCarthy, Ph.D., Maxim's senior managing director and head of Biotechnology Research. Registered conference attendees will have access to view Applied DNA's fireside chat. Applied DNA, known for its leadership in PCR-based DNA technologies, will use this platform to share insights with the healthcare investment community.
Applied DNA Sciences, Inc. (NASDAQ:APDN) has regained compliance with Nasdaq's minimum bid price requirement. The company received a notification letter on September 17, 2024, confirming that its common stock maintained a closing bid price of $1.00 or higher for 20 consecutive business days from August 19 to September 16, 2024. This development resolves the previous non-compliance issue reported on July 12, 2024, when APDN's stock failed to maintain the required minimum bid price. Nasdaq now considers this matter closed, ensuring Applied DNA's continued listing on the exchange.
Applied DNA Sciences (NASDAQ:APDN) announced its participation in the 3rd Annual mRNA Process Development & Manufacturing Summit in Boston from September 17-19, 2024. The company will showcase its Linea™ IVT platform, a solution for faster and better mRNA production with reduced double-stranded RNA contamination.
LineaRx, a majority-owned Applied DNA company, will present the platform, which combines an enzymatically produced DNA template with a next-generation RNA polymerase. Additionally, LineaRx and mRNA CDMO partner Kudo Biotechnology will co-host a seminar luncheon on September 19 to present data demonstrating Linea IVT's capability for rapid manufacturing of dsRNA-mitigated mRNA.
Applied DNA Sciences (NASDAQ:APDN) has received a follow-on order valued at over $500,000 for Linea™ DNA from a global manufacturer of in vitro diagnostics (IVDs). This order, placed under a long-standing supply agreement, is for non-therapeutic DNA used in a cancer diagnostic test. The company plans to deliver the order over four quarterly shipments in calendar 2025.
The accelerated receipt of this annually recurring order, coming less than a year after the previous one, suggests a strong customer commitment to Linea DNA. Applied DNA has been servicing this customer with multiple gram-scale orders for nearly a decade, positioning itself well to meet the growing DNA needs of the diagnostic industry and potentially expand its IVD customer base for increased recurring order-flow.
Applied DNA Sciences (NASDAQ:APDN) has announced the expansion of its clinical testing services for Mpox (formerly monkeypox) to include both Clade I and Clade II detection. This launch follows interactions with regulatory bodies, including the New York State Department of Health (NYSDOH) and the FDA. The company's subsidiary, Applied DNA Clinical Labs (ADCL), will provide the testing service from its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, N.Y.
The Linea™ Mpox Virus 1.0 Assay was previously approved for Clade II detection by NYSDOH in September 2022. In August 2024, ADCL validated the assay's ability to detect Clade I, which is the subject of the WHO's recent public health emergency declaration. This expanded testing service aims to support New York and other states in responding to the growing mpox threat by improving testing accessibility.
Applied DNA Sciences (NASDAQ:APDN) has been awarded a subcontract by LRQA for a pilot isotopic testing program in Pakistan. The project, part of the Global Trace Protocol initiative, aims to reduce child and forced labor in global supply chains through traceability. Applied DNA will use its CertainT platform, which employs isotope testing, DNA tagging, and genomic testing for cotton textile traceability.
The project is funded by the U.S. Department of Labor with a total of $4 million in federal funds. Applied DNA will work with Isotech to conduct isotopic analysis of raw materials and products at key points in the cotton textile value chain. This initiative aligns with new import regulations requiring verification of cotton origin to ensure it doesn't come from high-risk sources.
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