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LineaRx Receives Multiple Orders for Linear DNA for Use in Therapeutic Development

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LineaRx Receives Multiple Orders for Linear DNA for Use in Therapeutic Development

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Orders Reflect Growing Interest across the Biotech Industry for Bacteria-Free, Plasmid-Free Therapies

STONY BROOK, NY. July 1, 2019 – LineaRx, Inc., a wholly-owned subsidiary of Applied DNA Sciences, Inc. (“Applied DNA or the Company,” NASDAQ: APDN), announced today that it has received multiple purchase orders, from several major developers of gene and cell therapies, for its proprietary and patented large-scale, polymerase-chain-reaction (PCR)-produced linear DNA. LineaRx believes this momentum reflects increasing interest across the biotech industry to pursue a cleaner, higher-performing alternative to plasmid DNAs that are produced by fermentation in bacteria.

Under these Phase 1 CRO (Contract Research Organization) agreements, the performance of linear DNA will be benchmarked by criteria such as gene expression, and cell viability, against existing data from DNA produced using plasmids. LineaRx will also optimize, produce, and purify the products as required for testing both in vitro and in vivo by our customers. Upon successful benchmarking, LineaRx expects these customers will proceed to Phase 2 studies that leverage additional LineaRx intellectual property to enhance expression levels or expression lifetimes to drive greater therapeutic performance, while optimizing costs.

“In a number of completed studies, our linear DNA has met or exceeded the performance of plasmid DNA, as measured by gene expression, cell viability, and immunogenicity,” stated Dr. James Hayward, president and CEO of LineaRx. “These new Phase 1 CRO studies will seek to establish the performance of our linear DNA with several significant biotech companies focused on gene and cell therapies, including those focused on adoptive cellular therapies as well as RNA-based therapeutics. This increasing interest that encompasses a broad spectrum of industry players is an early, yet important, endorsement of our view that our proprietary PCR technology offers the potential for improved outcomes relative to current plasmid and viral-vector production technologies.”

To produce the quantities of DNA required for therapeutics, plasmid DNA is grown in bacteria and requires a costly purification process in an attempt to remove bacterial and non-target plasmid DNA, as well as bacterial toxins, before the purified DNA is used. It is commonly known that residual unintended DNA may still be present worrisome concentrations in the final product. LineaRx intends to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in current therapies via its expertise in the design, manufacture and chemical modification of DNA by large scale PCR.

“We attribute the increase in CRO orders, from marquis companies, to the growing desire to eliminate the risk associated with the presence of bacterial or unintended plasmid DNA in their therapies,” added Hayward. “We expect these CRO projects will evolve to CMO (Contract Manufacturing Organization) orders as some of these customers, once through their pre-clinical work, will bring linear DNA-based therapies to clinical trial within the next 18 months.”

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA Sciences’ deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, ability to maintain its NASDAQ listing and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

LineaRx to Support Therapy Development for Neurodegenerative Diseases

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Interest in large-scale Linear DNA for nucleic acid-based therapies continues to rise

STONY BROOK, NY. June 26, 2019 – LineaRx, Inc. a wholly-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it has shipped multiple customized linear DNA amplicons to Evotec SE, a well-known therapeutic development company, to support their research efforts related to neurodegenerative diseases such as Huntington’s, Parkinson’s or Alzheimer’s disease. DNA amplicons are segments of DNA that can serve as templates to generate the RNA or more DNA necessary for nucleic acid-based therapies.

“LineaRx collaborated closely with the customer on the design, production and post processing of their unique amplicon specifications,” stated Dr. James Hayward, president and CEO of LineaRx. “Evotec SE, like a growing number of other cutting-edge biotech companies, sees value in evaluating linear DNA as a foundation for their research and recognizes the strengths of LineaRx in the design and large-scale production of linear DNA using LineaRx’s proprietary platform for DNA production by polymerase chain reaction (“PCR”). The amplicons will be evaluated by Evotec SE over the next few months.”

Our shipment to Evotec SE, in support of neurodegenerative disease therapy research, is representative of a growing number of therapy developers coming to LineaRx and placing research quantity orders to evaluate the benefits of linear DNA in their therapeutic development pipeline. Many of the disease targets would have been considered unapproachable by gene therapies only a short time ago.

“Our expertise in PCR, as well as our pathway to cGMP large scale production, makes LineaRx a valuable partner to those companies pursuing a plasmid-free path,” indicated Brian Viscount, Director of LineaRx. “We continue to see growing demand for linear DNA, in both double-stranded and single-stranded formats, across a wide variety of nucleic acid-based therapies. We have the research bandwidth and production capacity to respond to the increasing demand we are seeing.”

About LineaRx
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA Sciences’ deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance , the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the uncertainly relating to its ability to maintain its NASDAQ listing and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact: Brian Viscount, 631-240-8877, brian.viscount@adnas.com

Pot Startup Uses the Blockchain to Smoke Out Weed Strains

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In what amounts to interesting – and very cannafuturoid – word salad, a Panamanian company called TheraCann has begun to add “DNA tag-based forensic traceability and authenticity with TruTrace’s Industry Blockchain Hub.” In other words they’re sequencing your weed’s DNA and sticking it onto the blockchain.“

The biotrace system provides seed-to-sale traceability for cannabis and hemp and uses Applied DNA’s unique, safe and persistent molecular tag for the identification of any biomass, extraction, isolate, derivative or cannabis packaging,” said CEO Jason Warnock in a release. “Collaborating with TruTrace connects the dots with an information platform linking the provenance of material, testing information and patient data that is so vital to the safety and efficacy of the global market.”

TheraCann Adds Blockchain Functionality to ETCH biotrace Platform Powered by Applied DNA

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ETCH biotrace to Combine Applied DNA’s DNA tag-based Forensic Traceability and Authenticity with TruTrace’s Industry Blockchain Hub to Deliver Unparalleled Tag-Test-Track Capabilities to Global Cannabis and Hemp Industry

STONY BROOK, N.Y., June 24, 2019 Applied DNA Sciences, Inc. (“Applied DNA”, NASDAQ: APDN), announced today that its cannabis and hemp industry partner, TheraCann International Benchmark Corporation (“TheraCann”), a leading full service international cannabis consultancy and technology firm, has signed a letter of intent (LOI) with TruTrace Technologies (CSE: TTT) (OTC: BKKSF) (“TruTrace”), creator of the a fully-integrated blockchain platform that registers and tracks intellectual property for the cannabis industry.

The CertainT physical molecular taggant, backed up by Applied DNA’s in-field and laboratory authentication products and services, can provide unique traceability information for the product itself not available elsewhere. The collaboration includes connecting TruTrace’s StrainSecure™ system and blockchain with TheraCann’s non-appendable Electronic Product Code Information Services (EPCIS) blockchain to provide forensic levels of traceability of cannabis and cannabis derivatives at any point in the supply chain to guarantee product quality.

“The ETCH biotrace system provides seed-to-sale traceability for cannabis and hemp and uses Applied DNA’s unique, safe and persistent molecular tag for the identification of any biomass, extraction, isolate, derivative or cannabis packaging. The molecular tag does not genetically modify the organism (non-GMO) and can be added into derivative products within the supply chain,” said Jason Warnock, Chief Executive Officer of TheraCann. “Collaborating with TruTrace connects the dots with an information platform linking the provenance of material, testing information and patient data that is so vital to the safety and efficacy of the global market.”

About CertainT
Applied DNA’s CertainT® “Tag-Test-Track” platform, enables companies and their supply chains to designate a unique molecular identity Tag that has meaning specific to the tagged material: for example, geographic facility location, brand, product line or even date of manufacture. This Tag can be blended into excipients, active ingredients and packaging inks and varnishes in the pharmaceutical, nutraceutical, and dietary supplements industry. The Tags are then Tested either in the field or in the lab, depending on application requirements.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, ability to maintain its NASDAQ listing and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contacts: Judy Murrah, Chief Information Officer, judy.murrah@adnas.com

With Synthetic Opioids Lurking, DNA Detector Scores

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Real deal: Applied DNA’s field-tested, molecular-taggant supply chain authenticator is earning serious scientific cred in pharmaceutical circles.

With synthetic opioids increasingly implicated in the alarming number of drug-overdose deaths plaguing the nation, a stalwart Long Island biotech’s DNA-based tracking technology has received a major endorsement.

The peer-reviewed scientific journal PLOS ONE has published a paper by Stony Brook-based Applied DNA Sciences on the molecular tagging of pharmaceuticals – a next-gen supply-chain authenticator that Applied DNA considers unforgeable, inescapable and particularly useful in a world where counterfeit drugs are routinely killing unsuspecting users.

Molecular Tagging of Pharma Drugs Published in Peer-Reviewed Journal

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PLOS ONE Publication Details Proprietary Method to Distinguish Legitimate Pharmaceutical Drugs from Counterfeit Products Including Counterfeit Opioids

STONY BROOK, N.Y., June 14, 2019 Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that its scientific paper entitled, Rapid authentication of pharmaceuticals via DNA tagging and field detection, has been published in the June 2019 edition of PLOS ONE, detailing a novel Physical-Chemical Identifier (PCID) to authenticate and track legitimate pharmaceutical products through the pharmaceutical supply chain.

The paper summarizes a study in which a pharmaceutical manufacturer tagged acetaminophen capsules with pharmaceutical-grade ink containing a unique DNA tag produced by Applied DNA and its subsequent authentication. Study results indicate that authentication can be performed reliably in a laboratory or in the field utilizing easy to use portable devices, and proves that Applied DNA’s SigNature® Molecular Tag can be safely introduced onto the surface of a capsule in ordinary pharmaceutical ink. The patent-pending, user-friendly method and system showed the molecular tag can be read at any time after simple, non-destructive swabbing.

“We believe DNA tagging of inks, coatings, and other ingredients can be used in the pharmaceutical supply chain, securing authenticity of an individual dose from the manufacturer, to the distributor, and finally the pharmacy. Authentication is possible, even when the product is separated from packaging, making it a solid complement to serialization and a platform to be considered as a weapon against today’s most difficult challenges, such as the opioid crisis,” said Dr. James Hayward, president and CEO, Applied DNA.

Drug overdose deaths in the United States are at unprecedented levels, with synthetic opioids increasingly implicated in overdoses, and the World Health Organization (WHO) estimates that 1-in-10 medical products  circulating in low- and middle-income countries is either substandard or falsified.

“Counterfeit drugs represent a large and growing problem for the global pharmaceutical industry, and can lead to serious illness or death. Publication of our methods and systems for molecular tagging of pharmaceuticals is a seminal development in our industrial deployment, and acceptance of our methods by scientific peers is a welcome endorsement,” said Dr. Michael Hogan, vice president, Life Sciences, Applied DNA.

About PLOS ONE
The world’s first multidisciplinary Open Access journal, PLOS ONE accepts scientifically rigorous research, regardless of novelty. PLOS ONE’s broad scope provides a platform to publish primary research including interdisciplinary and replication studies as well as negative results. The journal’s publication criteria are based on high ethical standards and the rigor of the methodology and conclusions reported.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, uncertainties relating to its ability to maintain its NASDAQ listing, uncertainties relating to receiving regulatory clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly reports on Form 10-Q filed on February 7, 2019 and May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contacts: Dr. Michael Hogan, Vice President, Life Sciences, 631-240-8820, mike.hogan@adnas.com

Ink, coating technologies create experiences for consumers

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Ink advancements aid in product integrity

The AMC historical spy drama “Turn” highlighted many of the creative practices that the revolutionaries utilized to confuse and evade the British soldiers. Among the common practices that prominently were featured was the use of invisible inks to avoid exposure should the message get into the wrong hands. Technology today has elevated the capabilities of inks not just for communications, but also for branding aspects within the consumer packaged goods market.

Beverage-makers today are turning to inks and coatings to create a deeper purpose and connection with consumers and the products they purchase, experts note.

In addition to branding aspects, suppliers note that beverage-makers also want inks that clearly communicate food safety and efficacy aspects.

“Quality inks deliver excellent printer and code performance,” says Sherry Washburn, business unit manager for supplies at Wood Dale, Ill.-based Videojet. “Inks formulated for coding and marking allow beverage manufacturers to identify dates, lot and batch numbers, and other manufacturing information directly on bottles, cans, pouches, boxes, cases and pallets. Unique codes fight product diversion to unauthorized channels and counterfeiting. Clean, clearly printed information like ‘best-by’ dates can enhance a consumer’s perception of the brand.”

Applied DNA Sciences helps companies on sustainability

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Applied DNA Sciences is helping companies which have declared sustainability goals to be achieved by 2020, in traceability. Applied DNA’s CertainT platform provides the evidence that recycled product is used. CertainT-verifiable products are now available through supply chain partners and brands, including Amazon and other e-commerce and retail stores.

The CertainT platform and forensic services were conceived to empower companies with the most advanced commercially-scalable and affordable technologies to help prove their compliance with stated sustainability goals.

TheraCann International Secures Agreement with House of Hemp

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Includes Implementation of TheraCann’s ETCH biotrace™ platform Utilizing Technology from Applied DNA

STONY BROOK, N.Y., June 10, 2019Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), a leader in PCR-based DNA manufacturing for product authenticity and traceability solutions, announced that its strategic partner to the global cannabis industry, TheraCann International Benchmark Corporation (“TheraCann”), has secured a collaboration agreement with House of Hemp (HoH), a licensed pioneer in South African fiber, seed, oil and Cannabidiol (CBD) medicinal production. The collaboration includes the implementation of TheraCann’s molecular-tagging ETCH biotrace technology that uses a physical molecular tag exclusively supplied by Applied DNA. TheraCann was selected by HoH to be their technical expert and project management team to achieve medical GMP standard for international cannabis export and to provide the necessary technologies to track every gram, every penny, and to ensure crop quality and reliability.

Link to original TheraCann press release: https://www.prnewswire.com/news-releases/theracann-and-house-of-hemp-enter-collaboration-agreement-to-build-a-sustainable-cannabis-industry-in-south-africa-300864076.html

John Shearman, VP for APDN’s Cannabis business, stated: “The agreement with HOH demonstrates the pipeline of leads and opportunities are converting into business agreements across an array of various use case for the ETCH platform.”

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 18, 2018 and our subsequent quarterly report on Form 10-Q filed on May 9, 2019, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
program contact: John Sherman, 631-240-8838, john.shearman@adnas.com