Applied DNA Sciences

Applied DNA Sciences, Inc. engages in developing and marketing technologies to produce and detect deoxyribonucleic acid. It operates through the following segments: Therapeutic DNA Production, MDx Testing Services, and DNA Tagging and Security Products and Services. The Therapeutic DNA Production segment consists of the manufacture of DNA for use in nucleic acid-based therapeutics. The MDx Testing Services segment is involved in performing and developing clinical molecular diagnostic tests and clinical laboratory testing services. The DNA Tagging and Security Products and Services segment includes manufacture and detection of DNA for industrial supply chain security services. The company was founded in 1983 and is headquartered in Stony Brook, NY.

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Applied DNA Sciences reports strong Q1 results and eyes revenue diversification

Applied DNA Sciences demonstrated robust revenue growth and operational improvements in Q1 2023, driven by key revenue streams and cost management.
While facing financial challenges and dependency on key projects for guidance, the company is strategically positioned for growth and innovation.
Opportunities in nucleic acid therapies, strategic partnerships, and revenue diversification present a promising outlook for Applied DNA Sciences.

Applied DNA Sciences adapts focus to genomics amid revenue challenges

Applied DNA Sciences faced revenue challenges in Q2 2023 but showcased resilience through strategic focus on pharma genomics testing and DNA tagging solutions.
The company's emphasis on efficiency in mRNA manufacturing and pursuit of acquisitions signal a proactive approach to enhancing market competitiveness and technological capabilities.
While financial challenges persist, opportunities in genetic testing and compliance solutions position Applied DNA Sciences for future growth and market leadership.

Applied DNA Sciences reports revenue decline and operational challenges

Applied DNA Sciences faced challenges in revenue decline and increased operating expenses in Q3 2023, leading to an operating loss and concerns about its financial sustainability.
Despite these challenges, the company demonstrated strengths in enhancing mRNA initiatives through the Spindle Biotech acquisition and Linea IVT platform, as well as continued growth in supply chain traceability.
Opportunities lie in expanding partnerships with evaluation customers, leveraging the Linea IVT platform's capabilities, and exploring new revenue streams in DNA tagging applications.

Applied DNA Sciences reports Q4 revenue decline, focuses on growth

Applied DNA Sciences faced a challenging quarter with declining revenues and operating losses, but maintained a focus on innovation and growth.
The company's strategic strengths lie in biotherapeutic manufacturing, successful acquisitions, and plans for revenue expansion through the Linea IVT platform.
However, challenges such as Nasdaq compliance issues and financial pressures require careful management and strategic decision-making.
Opportunities for revenue growth and market expansion exist through customer relationships, product development, and addressing regulatory requirements.

Applied DNA Sciences tackles financial challenges while eyeing revenue growth

Applied DNA Sciences faces challenges with declining revenues and profitability, necessitating a focus on cost management and revenue generation to improve financial health.
Despite financial pressures, the company's strategic strengths lie in innovative product development, quality control measures, and efforts to enhance operational efficiency.
Opportunities for revenue growth exist through the commercialization of Linea IVT platform, international expansion, and partnerships, signaling potential for market expansion and increased customer adoption.

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Applied DNA Sciences, Inc. is a biotechnology company, which engages in the development and commercialization of technologies to produce and detect deoxyribonucleic acid and ribonucleic acid. It operates through the following segments: Therapeutic DNA Production Services, MDx Testing Services, and DNA Tagging and Security Products and Services. The Therapeutic DNA Production Services segment consists of the enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and, the development and sale of a proprietary RNAP for use in the production of mRNA therapeutics. The MDx Testing Services segment develops clinical molecular diagnostic and genetic tests and clinical laboratory testing services. The DNA Tagging and Security Products and Services segment is involved in the detection of DNA for industrial supply chains and security services. The company was founded in 1983 and is headquartered in Stony Brook, NY.

- Regulatory Approval Showcases Clinical Advancement of Linea DNA™ as a Rapid and Effective Means of Producing CAR-T cell Therapies - STONY BROOK, NY / ACCESSWIRE / December 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, announced that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial of an investigational CD123-specific autologous CAR T-cell therapy by the Institute of Hematology and Blood Transfusion (ÚHKT/Eng: IHBT) in Prague for the treatment of relapsed and/or refractory acute myeloid leukemia (AML). UHKT-CAR123-01 utilizes Applied DNA's synthetic DNA, Linea™ DNA, as a critical component in its manufacture.

Applied DNA Customer ÚHKT Initiates Phase I Clinical Trial for Rapidly Manufacturable CAR T-Cell Therapy Produced from Linea DNA

Applied DNA Sciences (APDN) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $5.20 per share a year ago.

Applied DNA Sciences (APDN) Reports Q4 Loss, Tops Revenue Estimates

- Pursuing Divestiture of CertainT® Platform, Implements Changes to Corporate Leadership - - Build-out of GMP Manufacturing Facility to be Completed by January 9, 2025 - - Webcast and Conference Call Scheduled for Thursday, January 9, 2025, at 4:30 PM ET - STONY BROOK, NY / ACCESSWIRE / December 17, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024. An update on the buildout of the Company's GMP manufacturing facility is available for viewing via slideshow on the Presentations page of the Investor Relations portion of the Company's website.

Applied DNA Announces Fourth Quarter and Fiscal Year 2024 Financial Results, Announces Strategic Restructuring to Prioritize the Manufacture of Critical Starting Materials for Genetic Medicines

STONY BROOK, NY / ACCESSWIRE / December 16, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in polymerase chain reaction (PCR)-based technologies, today announced that it will release its fourth quarter and fiscal year 2024 financial results after the market close on Tuesday, December 17, 2024. The Company will host a conference call for the investment community to coincide with an update on its GMP manufacturing facility build-out on Thursday, January 9, 2025, at 4:30 p.m.

Applied DNA to Report Fourth Quarter and Fiscal Year 2024 Financial Results After Market Close on December 17, 2024; Sets Webcast and Conference Call for January 9, 2025, to Coincide with Update on GMP Manufacturing Facility Build-out

STONY BROOK, NY / ACCESSWIRE / October 30, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the pricing of a registered direct offering and concurrent private placement with gross proceeds to the Company expected to be approximately $6.5 million before deducting placement agent fees and other estimated expenses payable by the Company. The offering is comprised of 20,312,500 shares (the "Shares") of the Company's common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.32 per share of common stock (or pre-funded warrants in lieu thereof, which shall have the same purchase price, less the exercise price of $0.0001) in a registered direct offering priced at-the-market under Nasdaq rules.

Applied DNA Announces Pricing of $6.5 Million Registered Direct Offering and Concurrent Private Placement

STONY BROOK, NY / ACCESSWIRE / October 15, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA"), a leader in PCR-based DNA technologies, today announced that Dr. James A. Hayward, president and chief executive officer, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit.

Applied DNA to Participate in the 2024 Maxim Healthcare Virtual Summit on Wednesday, October 16

STONY BROOK, NY / ACCESSWIRE / September 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that on September 17, 2024, it received a notification letter (the "Notification Letter") from the Listing Qualifications Department of the Nasdaq Stock Market ("Nasdaq"), informing the Company that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Requirement"). As previously reported, the Company was notified on July 12, 2024, that its common stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Minimum Bid Price Requirement.

Applied DNA Regains Compliance with Nasdaq Minimum Bid Price Requirement

- Co-Hosts Seminar with mRNA CDMO Kudo Bio to Demonstrate Linea IVT Capability for Rapid mRNA Manufacturing - STONY BROOK, NY / ACCESSWIRE / September 17, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced its participation at upcoming mRNA events in Boston this week: 3rd Annual mRNA Process Development & Manufacturing Summit - members of Applied DNA's Biotherapeutics Sales and Business Development teams (collectively 'LineaRx,' a majority-owned Applied DNA company) will attend the 3rd Annual mRNA Process Development & Manufacturing Summit taking place September 17-19, 2024. LineaRx will present its Linea™ IVT platform - a combination of an enzymatically produced DNA template (Linea™ DNA IVT template) coupled with a next-generation RNA polymerase (Linea™ RNAP) - as a solution to enable mRNA producers to manufacture better mRNA faster via simplified workflows and reduced double-stranded RNA (dsRNA) contamination.

Applied DNA to Showcase Linea IVT as a High-yield, dsRNA-Mitigated Platform for the GMP Manufacture of RNA at the 3rd Annual mRNA Process Development & Manufacturing Summit

- Recurring and Accelerated Receipt of Order Reflects Customer Commitment to Linea DNA - STONY BROOK, NY / ACCESSWIRE / September 17, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced it has received a follow-on order valued at more than $500,000 for a quantity of Linea™ DNA from a global manufacturer of in vitro diagnostics (IVDs). The follow-on order was placed under a long-standing supply agreement for the bulk manufacture of Linea DNA (non-therapeutic) used in the manufacture of a cancer diagnostic test.

Applied DNA Receives Linea DNA Follow-on Order from Global Manufacturer of IVDs for Cancer Diagnostic Application

STONY BROOK, NY / ACCESSWIRE / September 11, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has launched an expansion of its clinical testing services for the detection of Mpox (formerly monkeypox) to include testing for both mpox Clade I and Clade II. The launch of the expanded mpox testing service comes after ADCL's interaction with relevant regulatory bodies, including the New York State Department of Health (NYSDOH) and the U.S. Food and Drug Administration (FDA).

Applied DNA Launches Mpox Clade I and Clade II Testing Service

- Pilot Project To Demonstrate Effectiveness of CertainT® for Cotton Textile Traceability - STONY BROOK, NY / ACCESSWIRE / September 4, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced the receipt of a subcontract award from LRQA following a competitive tender for a pilot isotopic testing program. Under the terms of the subcontract, Applied DNA, together with its traceability partner, Isotech (a Stratum Reservoir company), will employ CertainT® to conduct isotopic testing and analysis to support cotton traceability in Pakistan.

Applied DNA Selected by LRQA for Isotopic Testing Pilot Project in Pakistan

Applied DNA Sciences, Inc. APDN stock traded higher on Friday on a strong session volume of 114.23 million, compared to the average volume of 6.78 million, according to data from Benzinga Pro.

Why Is Diagnostic Tests Provider Applied DNA Sciences Stock Trading Higher On Friday?

-Validation Studies Confirmed the Assay Can Detect Mpox Clade I and Clade Ib in addition to Clade II- STONY BROOK, NY / ACCESSWIRE / August 23, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (the "Company"), a leader in PCR-based DNA technologies, today announced that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of an expansion of the permitted use of its Linea™ Mpox Virus 1.0 Assay (the "Assay") to include both mpox clade I and clade II. The Company's validation studies concluded that the Assay's primers and probe have 100% homology to mpox clade I and clade Ib, the latter of which was the subject of the World Health Organization's (WHO) recently declared public health emergency of international concern.

Applied DNA Submits Validation Package to New York State Department of Health to Expand Linea Mpox Virus 1.0 Assay to Mpox Clade I

STONY BROOK, NY / ACCESSWIRE / August 19, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced its intention to seek an expansion of the approved intended use of its Linea™ Mpox Virus 1.0 Assay (the "Assay") to include the detection of mpox Clade I that is the subject of the World Health Organization's (WHO) 14 August 2024 declaration of a public health emergency of international concern (PHEIC). The Company's internally generated data show that the Assay can detect the genetic sequence of mpox Clade I and is now undertaking validation studies to enable the filing of necessary documentation with the New York State Department of Health (NYSDOH).

Applied DNA To Submit Application to New York State Department of Health to Expand Intended Use of Linea Mpox Virus 1.0 Assay to Mpox Clade I

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Applied DNA Sciences, Inc. (NASDAQ:APDN ) Q3 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Corporate Participants Sanjay Hurry - Head of IR Beth Jantzen - Chief Financial Officer Jim Hayward - Chairman, President and Chief Executive Officer Clay Shorrock - Chief Legal Officer and Head of Business Development Conference Call Participants Operator Good day, and welcome to the Applied DNA Fiscal Third Quarter 2024 Investor Conference Call. All participants will be listen-only mode.

Applied DNA Sciences, Inc. (APDN) Q3 2024 Earnings Call Transcript

Applied DNA Sciences (APDN) came out with quarterly earnings of $0.47 per share, beating the Zacks Consensus Estimate of a loss of $0.64 per share. This compares to loss of $4.80 per share a year ago.

Applied DNA Sciences (APDN) Tops Q3 Earnings Estimates

- Conference Call/Webcast Scheduled for Today at 4:30 PM ET - STONY BROOK, NY / ACCESSWIRE / August 8, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced consolidated financial results for its third fiscal quarter ended June 30, 2024. The Company's Form 10-Q can be viewed at https://investors.adnas.com/sec-filings/.

Applied DNA Announces Third Quarter Fiscal Year 2024 Financial Results

STONY BROOK, NY / ACCESSWIRE / August 7, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in polymerase chain reaction (PCR)-based technologies, today announced that it will release its third quarter fiscal 2024 financial results after market close on Thursday, August 8, 2024. In conjunction with this announcement, Applied DNA management will host a conference call for analysts and members of the investment community starting at 4:30 p.m.

Applied DNA to Report Third Quarter Fiscal 2024 Financial Results on Thursday, August 8, 2024

- This Version Removes the Use of 'Presentation' from the Prior-issued Headline - - Linea™ IVT Platform Delivers All The Benefits of Conventional IVT Without dsRNA Contamination - STONY BROOK, NY / ACCESSWIRE / July 29, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, will present a poster at the 4th Annual mRNA-based Therapeutics Summit taking place July 29 - 31, 2024, in Boston. The poster presents the Company's Linea™ IVT platform - a combination of an enzymatically produced DNA template (Linea™ DNA IVT template) coupled with a next-generation RNA polymerase - as a solution to enable mRNA producers to manufacture better mRNA faster via simplified workflows and reduced double-stranded RNA (dsRNA) contamination.

CORRECTING AND REPLACING: Applied DNA to Showcase Linea IVT as a High-yield, dsRNA-Mitigated Platform for the GMP Manufacture of RNA at the 4th Annual mRNA-based Therapeutics Summit

- Linea™ IVT Platform Delivers All The Benefits of Conventional IVT Without dsRNA Contamination - STONY BROOK, NY / ACCESSWIRE / July 29, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, will present a poster at the 4th Annual mRNA-based Therapeutics Summit taking place July 29 - 31, 2024, in Boston. The poster presents the Company's Linea™ IVT platform - a combination of an enzymatically produced DNA template (Linea™ DNA IVT template) coupled with a next-generation RNA polymerase - as a solution to enable mRNA producers to manufacture better mRNA faster via simplified workflows and reduced double-stranded RNA (dsRNA) contamination.

Applied DNA to Showcase Linea IVT as a High-yield, dsRNA-Mitigated Platform for the GMP Manufacture of RNA at the 4th Presentation Annual mRNA-based Therapeutics Summit

- Indus Group Consumes Approximately 450 Million Pounds of Cotton Annually for the Manufacture of Apparel, Footwear, and Accessories for Global Brands and Retailers - STONY BROOK, NY / ACCESSWIRE / July 25, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the signing of a five-year license and commercialization agreement for its CertainT ® traceability platform (the "Agreement") with Indus Group ("Indus") a multinational apparel/textile manufacturing and sourcing company with a reputation for cutting-edge fabric technology and product innovation. Indus consumes approximately 450 million pounds of cotton annually.

Applied DNA Enters into Multi-Year Commercialization Agreement with Indus Group for Large-Scale Implementation of CertainT Cotton Traceability

STONY BROOK, NY / ACCESSWIRE / July 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that the U.S. Defense Logistics Agency (DLA) exercised the first one-year option period of a three-year base contract with two one-year option periods entered into in May 2021. The contract supports DLA's counterfeit mitigation initiatives and product verification and testing programs specific to FSC 5962 microcircuits.

U.S. Defense Logistics Agency Exercises 1-Year Option Period in Applied DNA Counterfeit Mitigation Contract

Applied DNA Sciences (APDN) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Applied DNA Sciences (APDN) Upgraded to Buy: What Does It Mean for the Stock?

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