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.

Maravai LifeSciences Holdings

- Project Results in over 70% Reduction in Linea RNAP Manufacturing Cost to Yield a Material Improvement in Linea IVT Platform Profitability - - Applied DNA Secures Commercial Linea RNAP Quantity Sufficient to Support Anticipated Near-Term Demand - STONY BROOK, NY AND JUPITER, FL / ACCESSWIRE / June 20, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, and Alphazyme LLC (Alphazyme), a Maravai LifeSciences company (NASDAQ:MRVI) and global provider of specialty enzymes used in the life sciences sector, announced the successful conclusion of the companies' previously announced Linea™ RNAP manufacturing scale-up agreement. The joint process development project resulted in an over 70% reduction in Linea RNAP manufacturing costs and the manufacture of a quantity of Linea RNAP sufficient to support Applied DNA's anticipated near-term demand for critical starting material for mRNA production.

Applied DNA and Alphazyme Conclude Linea(TM) RNAP Manufacturing Scale-up Project, Deliver Substantial Improvement in Linea(TM) IVT Platform Economics

Partnership Will Aid Physicians in Precision Prescribing Decisions Based on Applied DNA's TR8™ Pharmacogenomic (PGx) Test STONY BROOK, NY / ACCESSWIRE / June 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a global leader in PCR-based DNA technologies, today announced that its molecular diagnostics subsidiary, Applied DNA Clinical Labs, LLC (ADCL), will utilize the GenXys Health Care Systems (GenXys) suite of clinical decision support software for interpretation and reporting of ADCL's New York State Department of Health-approved TR8™ pharmacogenomic (TR8 PGx) test. The partnership is designed to improve patient outcomes and reduce healthcare costs through a data-driven approach that relates an individual's genetic factors to potential responses to prescription drugs.

Applied DNA Partners with GenXys Health Care Systems to Deploy Clinical Decision Support System for Pharmacogenetic (PGx) Testing

STONY BROOK, NY / ACCESSWIRE / June 13, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced that the New York State Department of Health ("NYSDOH") approved the Company's TR8™ PGx ("TR8") pharmacogenomic (PGx) testing service. The Company is currently in discussions to provide large-scale testing to enterprise customers, healthcare networks, and concierge physicians seeking to add PGx testing to their test menu.

Applied DNA Receives Approval for TR8(TM) Pharmacogenomic (PGx) Testing Service from New York State Department of Health

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Patent covers the Composition of the Company's Proprietary Linea™ RNAP, a Core Technology Empowering the Linea™ IVT Platform Patent Application Also Currently Pending in Key International Markets STONY BROOK, NY / ACCESSWIRE / June 5, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the "Company"), a leader in PCR-based DNA technologies, announced today that it received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application 18/302,247, entitled "Compositions and Methods for RNA Synthesis." The resulting patent will cover the composition of the Company's chemically modified RNA polymerase enzyme branded Linea™ RNAP, with expected patent protection into 2041.

Applied DNA Announces Notice of Allowance for U.S. Patent Covering Fundamental Aspect of its Linea(TM) IVT Platform

STONY BROOK, NY / ACCESSWIRE / May 13, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, and the Institute of Hematology and Blood Transfusion (ÚHKT/IHBT) today announced that an abstract relating to the development of a fully enzymatic, non-viral manufacturing workflow to enable the rapid and cost-effective production of clinical-grade (GMP) CAR T-cell therapies has been accepted for presentation at the prestigious European Hematology Association 2024 Hybrid Congress to be held in Madrid, Spain from June 13 - 16, 2024. Accepted abstracts will be available on the Congress' website starting on May 14, 2024.

Institute of Hematology and Blood Transfusion (Prague) to Present on Successful Use of Applied DNA's Linea DNATM for the Non-Viral Manufacture of CAR T-Cell Therapy for Refractory AML

Applied DNA Sciences (APDN) came out with a quarterly loss of $5.31 per share versus the Zacks Consensus Estimate of a loss of $4.60. This compares to loss of $4 per share a year ago.

Applied DNA Sciences (APDN) Reports Q2 Loss, Tops Revenue Estimates

STONY BROOK, NY / ACCESSWIRE / May 10, 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 second fiscal quarter ended March 31, 2024. The Company's Form 10-Q can be viewed at https://investors.adnas.com/sec-filings/.

Applied DNA Announces Second Quarter Fiscal Year 2024 Financial Results

Award Seeks to Demonstrate Feasibility of Manufacturing mRNA Vaccines in Only 7 Days  STONY BROOK, NY / ACCESSWIRE / April 25, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced the award of a contract from HDT Bio for the purpose of rapid, next-generation vaccine development under a ‘Project NextGen: Enabler' award to HDT Bio (the "Project"). The Project seeks to facilitate the rapid production of vaccines during outbreaks/pandemics, focusing on decentralized vaccine manufacturing, with vaccines deemed critical medical countermeasures to infectious disease threats.

Applied DNA Awarded Contract by HDT Bio For Rapid Vaccine Development Program

STONY BROOK, NY / ACCESSWIRE / April 22, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the Company), a leader in PCR-based DNA technologies, today announced that it will effect a 1-for-20 stock split of its common stock, to be effective as of 12:01 a.m. Eastern Time on Thursday, April 25, 2024.

Applied DNA Announces 1-For-20 Reverse Stock Split

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- Project To Increase RNAP Manufacturing Capacity and Reduce Unit Costs of Goods - - Project Slated for Completion Coincident with Company's Planned Initiation of GMP Manufacturing for Linea ™ DNA IVT Templates - STONY BROOK, NY and JUPITER, FL / ACCESSWIRE / March 18, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA or the Company), a leader in PCR-based DNA technologies, and Alphazyme LLC (Alphazyme), a Maravai LifeSciences company (MRVI) and global provider of specialty enzymes used in the life sciences sector, have entered into an agreement under which Alphazyme will scale-up manufacturing of Applied DNA's proprietary Linea™ RNA polymerase ("RNAP"). Under the terms of the agreement, Alphazyme will perform manufacturing process development, enabling the scaling of Linea RNAP manufacturing from its current research scale to the commercial scale necessary to empower the Company's growing demand for the Company's Linea™ IVT platform.

Applied DNA Enters into Agreement with Alphazyme for Scale-Up Manufacturing of its Proprietary Linea(TM) RNAP, Progresses Towards GMP Linea(TM) IVT Production Start

STONY BROOK, NY / ACCESSWIRE / March 14, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, will showcase its Linea™ IVT and Linea™ DNA platforms at the 24th Annual World Vaccine Congress, which will be held April 1 - 4, 2024. Applied DNA sales team members will be available during the Congress for one-on-one meetings.

Applied DNA to Showcase Linea(TM) DNA and Linea(TM) IVT Platforms at 24th Annual World Vaccine Congress

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Applied DNA Sciences, Inc. (APDN) Q1 2024 Earnings Call Transcript

Applied DNA Sciences (APDN) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.14 per share a year ago.

Applied DNA Sciences (APDN) Reports Q1 Loss, Tops Revenue Estimates

- Company On Track to Initiate First-Phase GMP Production Capacity for mRNA Critical Starting Materials During First Half of Calendar 2024, Projects Initial Facility Capacity to Enable up to $15 Million1 of Linea IVT Revenue2 Annually - - Conference Call/Webcast Scheduled for Today at 4:30 PM ET - STONY BROOK, NY / ACCESSWIRE / February 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 first fiscal quarter ended December 31, 2023. The Company's Form 10-Q can be viewed at https://investors.adnas.com/sec-filings/.

Applied DNA Announces First Quarter Fiscal Year 2024 Financial Results

STONY BROOK, NY / ACCESSWIRE / February 5, 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 first quarter fiscal 2024 financial results after market close on Thursday, February 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 First Quarter Fiscal 2024 Financial Results on Thursday, February 8, 2024

STONY BROOK, NY / ACCESSWIRE / February 2, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that it has closed its previously announced registered direct offering of its common stock priced at-the-market under Nasdaq rules with certain existing institutional investors (collectively the "Holders") for the sale of an aggregate of 5,644,061 of its shares of common stock (or prefunded warrants in lieu thereof) at a purchase price of $0.609 per share. In a concurrent private placement, the Company further agreed to issue to the Holders unregistered warrants to purchase up to an aggregate of 11,288,122 shares of its common stock.

Applied DNA Announces Closing of $3.44 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

STONY BROOK, NY / ACCESSWIRE / January 31, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, today announced that it has entered into securities purchase agreements (SPAs) with certain existing institutional investors (collectively the "Holders") for the issuance and sale of an aggregate of 5,644,061 of its shares of common stock (or prefunded warrants in lieu thereof) at a purchase price of $0.609 per share in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 11,288,122 shares of its common stock.

Applied DNA Announces $3.44 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

- Agreement Seeks to Leverage Linea IVT Platform to Enable Kudo Bio to Offer a Differentiated mRNA Manufacturing Capability with Mitigated dsRNA and Reduced Turnaround Times - STONY BROOK, NY and NEEDHAM, MA / ACCESSWIRE / December 14, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) (Applied DNA), a leader in PCR-based DNA technologies, and Kudo Biotechnology (Kudo Bio), a leading global mRNA CDMO offering end-to-end cGMP mRNA manufacturing solutions, today announced their entry into a joint development agreement (the "JDA") to integrate Applied DNA's Linea™ IVT platform (the "Platform") into Kudo Bio's commercial mRNA manufacturing workflows. Under the terms of the JDA, the Companies will seek to optimize mRNA quality, yields, and mitigation of contamination by double-stranded RNA ("dsRNA") in an integrated workflow at manufacturing scale and establish a global co-marketing relationship.

Applied DNA Announces Joint Development Agreement to Integrate Linea(TM) IVT Platform into CDMO Kudo Biotechnology's mRNA Manufacturing Workflow

Applied DNA Sciences, Inc. (NASDAQ:APDN ) Q4 2023 Earnings Conference Call December 7, 2023 4:30 PM ET Company Participants Sanjay Hurry - Head of IR Beth Jantzen - CFO James Hayward - Chairman, President and CEO Clay Shorrock - Chief Legal Officer and Head of Business Development Conference Call Participants Jason McCarthy - Maxim Group Yi Chen - H.C. Wainwright Operator Good Day and welcome to the Applied DNA Sciences Fiscal Fourth Quarter 2023 Financial Results Conference Call.

Applied DNA Sciences, Inc. (APDN) Q4 2023 Earnings Call Transcript

- Conference Call/Webcast Scheduled for Today at 4:30 PM ET - STONY BROOK, NY / ACCESSWIRE / December 7, 2023 / 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 fourth quarter ended September 30, 2023. "Our fiscal fourth quarter concludes a productive year during which we took a number of critical steps that place us firmly in the execution phase of our pivot to a biotherapeutic manufacturing-first growth strategy," stated Dr. James A.

Applied DNA Announces Fourth Quarter Fiscal Year 2023 Financial Results

STONY BROOK, NY / ACCESSWIRE / December 5, 2023 / 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 full year financial results 2023 ended September 30, 2023, on Thursday, December 7, 2023, after the market close. The Company will host a conference call for the investment community to discuss the results and answer questions at 4:30 p.m.

Applied DNA to Report Fiscal 2023 Fourth Quarter and Year End Financial Results on December 7, 2023

STONY BROOK, NY / ACCESSWIRE / November 28, 2023 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the receipt of a follow-on order for Linea™ DNA valued above the mid-six figures. The order was placed under a long-standing supply agreement for the bulk manufacture of Linea DNA (non-therapeutic) for a global manufacturer of in vitro diagnostics (IVD).

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