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Applied DNA COVID-19 Collaboration Partner Takis Biotech Receives Italy Ministry of Health Approval to Begin Testing of a Vaccine Candidate on Pre-Clinical Models

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Applied DNA COVID-19 Collaboration Partner Takis Biotech Receives Italy Ministry of Health Approval to Begin Testing of a Vaccine Candidate on Pre-Clinical Models

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STONY BROOK, N.Y., March 18, 2020Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA”) today announced that its COVID-19 collaboration partner, Takis Biotech, a Rome, Italy-based a company focused on the development of cancer vaccines founded by scientists from Merck Research Laboratories, has received approval from the Italy’s Ministry of Health to begin a pre-clinical trial of a COVID-19 vaccine candidate. As announced by Applied DNA on March 2, 2020, the vaccine is one of four PCR-produced (polymerase chain reaction vaccine) linear DNA vaccine candidates under joint development by Takis Biotech and Applied DNA. Applied DNA entered large-scale production of the candidates in March 2020. Takis Biotech anticipates first results of its pre-clinical trial will be available in April 2020.

Click here to read Takis Biotech’s announcement (in English and Italian): http://www.takisbiotech.it/index.php/en/news/209-rome-17-march-2020-takis-a-biotech-company-in-castel-romano-rome-announces-that-it-is-ready-to-test-its-covid-19-vaccine-on-pre-clinical-models

Click here to learn more about Applied DNA’s proprietary linear DNA production capabilities for DNA vaccines: https://www.wshu.org/post/covid-19-brings-dna-vaccines-forefront

About Takis Biotech
Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

Visit www.takisbiotech.it for more information.

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, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.

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.

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

Stony Brook firm working on coronavirus vaccine

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A Stony Brook anti-counterfeiting company is seeking to adapt its DNA expertise to create a coronavirus vaccine with an Italian biotechnology partner.

Applied DNA Sciences Inc. on Monday announced that it is expanding its alliance with Rome-based Takis Biotech on four potential vaccines to test on animals.

In February, the companies announced a joint development agreement between Applied DNA subsidiary LineaRx Inc. and Takis for preclinical development of a vaccine.

James Hayward, chairman and chief executive of Applied DNA, said that about half of the company’s 55-person workforce is working on the coronavirus project.

APDN, Takis Biotech design four Covid-19 vaccine candidates

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The PCR-produced linear DNA is expected to accelerate vaccine production.

Applied DNA Sciences and Takis Biotech have designed four Covid-19 vaccine candidates to help protect against the novel coronavirus.

The companies plan to manufacture the DNA vaccine candidates using PCR-based DNA (LinearDNA) manufacturing systems for preclinical testing in animals.

Last month, Applied DNA Sciences subsidiary LineaRx expanded its collaboration with Takis Biotech for the preclinical development of a LinearDNA Covid-19 vaccine.

The vaccine candidates were created using the structure of the Spike protein that allows the coronavirus to bind and infect the host cells.

Applied DNA Speeds Coronavirus Vaccines Toward Tests

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By GREGORY ZELLER //

Just weeks after announcing an expanded international collaboration targeting the menacing novel coronavirus, Applied DNA Sciences is preparing to mass-produce four potential vaccines.

Leveraging the Stony Brook-based biotech’s unique DNA-manufacturing abilities, Rome, Italy-based Takis Biotech will test potential vaccines against the coronavirus (now going by COVID-19) in laboratory mice, on a large scale.

Applied DNA expects delivery of four DNA-based “preclinical vaccine candidates” from Takis this month, and “within weeks” will use its proprietary, polymerase chain reaction-based DNA-sequencing technology to reproduce each for immediate animal testing.

Applied DNA Sciences (NASDAQ: APDN) Updates on COVID-19 Collaboration with Takis Biotech, 4 Preclinical LinearDNA™ Vaccine Candidates Designed

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Applied DNA Expected to Enter Large-Scale Production of Candidates in March; Preclinical Testing in Animals by Takis Biotech Anticipated to Begin in Calendar Q2 2020
Candidates Inspired by the Sequence of Viral Spike Protein
Designed to Prevent Entry of Coronavirus into Human Host’s Cells

STONY BROOK, N.Y., and ROME, ITALY – March 2, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, and Takis Biotech (“Takis”), a company focused on the development of cancer vaccines, and founded by scientists from Merck Research Laboratories, announced today that the design of 4 DNA vaccine candidates will be produced for preclinical animal testing via the Company’s proprietary PCR-based DNA (“LinearDNA”) manufacturing systems.

The companies’ announcement follows their statement on February 7, 2020 announcing an expanded Joint Development Agreement (JDA) between the Company’s majority-owned subsidiary, LineaRx, Inc. and Takis Biotech to include the preclinical development of a PCR-produced LinearDNA vaccine against COVID-19.

“Since expanding our JDA to include the pursuit of a COVID-19 vaccine, the virus has appeared on almost every continent. We expect delivery of the 4 preclinical vaccine candidates from Takis in this month. Within weeks of arrival we expect to immediately scale up PCR-based production of each vaccine candidate and ship them back to Takis who will determine each vaccine’s relative abilities to provoke an immune response in vaccinated mice,” stated Dr. James A. Hayward, president and CEO of Applied DNA and LineaRx.

The two firms have designed 4 preclinical vaccines on the basis of the “Spike” protein structure (the proteins responsible for the “crown” on the virus surface, and from whence its name derives). It is the Spike protein that enables uptake of the coronavirus, by binding to specific receptors on the host cells. One of the 4 candidate vaccines is the entire spike gene; the remaining 3 are variants based upon epitope mapping (identifying the likely antigenic portions of the protein) and assembling the corresponding parts of the ‘S’ gene into a new synthetic LinearDNA gene, and codon optimization (to ensure the new LinearDNA vaccine genes are efficiently expressed as proteins, once the genes have been delivered to a small percentage of the nuclei of the patient’s muscle cells.) Additionally, Applied DNA has proprietary means, which are the subject of pending patent applications, for genetic ensembles that increase the expression, folding efficiency and compartmentalization of proteins that can be built into the putative vaccine constructs if the results obtained in animal studies warrant this consideration.

Continued Dr. Hayward, “Our patented and proprietary platform for the production of LinearDNA not only empowers rapid development and large-scale production, but we believe it has the potential to yield an effective vaccine with fewer risks than other currently utilized DNA production platforms. As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance. We believe that one of the many benefits of PCR-produced LinearDNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift.”

Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech, stated: “Our original collaboration under the JDA on a pan cancer vaccine that will soon enter trials for the treatment of companion animals has already proven the ability of PCR-produced LinearDNA to induce powerful immune responses in animal models. For the induction of antibodies that can neutralize COVID-19, it is essential to use reliable, effective technologies that can be quickly adapted in the face of shifting pathogens, and we believe that is the advantage that Applied DNA’s platform affords us over traditional vaccine development and other modern DNA-based vaccines. This global emergency requires a swift response.”

Under the terms of the amended JDA, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the four putative vaccines to inoculate mice, whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models.

The potential advantages posed by PCR-produced LinearDNA vaccines, as opposed to the circular DNA obtained from more traditional plasmid sources, include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior LinearDNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.

Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine to market nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.

About Takis Biotech
Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

Visit www.takisbiotech.it for more information.

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

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.

LinearDNA™ is a trademark of Applied DNA Sciences, Inc.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform 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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners 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, 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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 or 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: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

Applied DNA Announces Receipt of International Patents on its Beacon® Secure Optical Molecular Marker Technologies

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New Patents in Key International Markets Allow 1st-Level Verification in Seconds

STONY BROOK, N.Y. February 24, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that brings integrity to global supply chains, and innovation to diagnostics and nucleic-based therapeutics, today announced the issuance of a Chinese patent and the receipt of a Notice of Allowability for a Canadian patent application, both for the invention “Encrypted Optical Markers for Security Applications” relating to its Beacon encrypted optical molecular marker technologies. The Company was previously granted United States Patent No. 10,047,282 on its Beacon technologies and has additional United States and international patent applications pending.

“China, Canada and the United States are key markets for our Beacon technology which provides formidable brand protection and assurance,” said Wayne Buchen, VP Strategic Sales. “The Company and its partners utilizing the Beacon technology, such as global sewing thread producer A&E, LLC and security label producer Schreiner MediPharm, are seeing strong customer interest in areas such as textiles, luxury goods and pharmaceutical packaging.”

The Beacon encrypted optical marker technology provides rapid, secure, real-time in-field authentication of a DNA-tagged substrate through the use of an encrypted fluorescing signal that can only be identified in the presence of a specially formulated decryptant. Without the paired decryptant, both Beacon and SigNature® DNA are invisible to normal and UV light. Based on its novel technology, we believe that Beacon is more secure than other non-encrypted chemical tracers that can be purchased on the open market and readily copied.

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.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform 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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, 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 12, 2019  and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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 or to reflect the occurrence of unanticipated events, unless otherwise required by law.

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

CertainT®: Be Definite About Your Dietary Supplement Ingredients

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By Heather Jacques, February 21, 2020

The supplement industry started the year out with a huge mess after a contract manufacturer was indicted following years of FDA violations. Regardless of what is parroted in the mainstream media, the supplement industry is heavily regulated, and the ABH situation is a prime example of this.

The ABH news story really got supplement companies, manufacturers, ingredient suppliers, and consumers talking about how they can ensure their dietary supplements are meeting label claims. There are multiple parties involved in producing a supplement, so it’s important that every step of the process has several checks and balances to ensure the end product is what it was intended to be.

Industry leaders such as Nutrition21 are pioneering innovative ways to verify and ensure that dietary supplement ingredients are not altered, adulterated, or underdosed throughout the product creation process. They are implementing fascinating new technology named CertainT® which can help protect the dietary supplement industry and its consumers from fraud.

APDN Receives Kosher Certification from OU for Qualifying Products

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Products within the SigNature® and CertainT® Brand Certified in Strict Compliance with OU Standards as Ingredients for Dietary Supplements, Pharmaceuticals and Food Products

STONY BROOK, N.Y. Applied DNA Sciences, Inc. (“Applied DNA”, the “Company”, NASDAQ: APDN), announced receipt of certification from the Orthodox Union (OU®) for products within the SigNature and CertainT line following a thorough evaluation of the Company’s products and manufacturing processes. The Pareve kosher designation will first be used for the Nutrition21 Nitrosigine® sports supplement product recently announced. The Company’s products and services, used by its customers to manage traceability and authenticity in the name of brand assurance, are also suitable for related markets such as food and pharmaceuticals.

Applied DNA Receives Kosher Certification from Orthodox Union for Qualifying Products

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Products within the SigNature® and CertainT® Brand Certified in Strict Compliance with OU Standards as Ingredients for Dietary Supplements, Pharmaceuticals and Food Products

STONY BROOK, N.Y., February 20, 2020 – Applied DNA Sciences, Inc. (“Applied DNA”, the “Company”, NASDAQ: APDN), announced receipt of certification from the Orthodox Union (OU®) for products within the SigNature and CertainT line following a thorough evaluation of the Company’s products and manufacturing processes. The Pareve kosher designation will first be used for the Nutrition21 Nitrosigine® sports supplement product recently announced. The Company’s products and services, used by its customers to manage traceability and authenticity in the name of brand assurance, are also suitable for related markets such as food and pharmaceuticals.

The OU (Orthodox Union) Kosher is the world’s largest and most widely recognized international kosher certification agency, certifying over 800,000 products produced in more than 9,011 plants located in 104 countries around the world. Over $150 billion of kosher certified products are consumed annually, with the OU kosher symbol appearing on close to 70% of America’s kosher certified foods.

“As we grow our presence in food, pharmaceutical and dietary supplements markets, we are pleased to be supportive of the business imperatives critical to meet market requirements that maximize adoption. We are proud to have the OU certification on our qualifying products. OU maintains strict guidelines for certification and ongoing manufacturing, marketing and distribution of products, making Applied DNA’s mission for enabling our customers a platform for proof of authenticity and traceability nicely complementary for OU-certified products,” said Dr. James Hayward, president and CEO, Applied DNA.

The Company’s qualifying CertainT and SigNature molecular tags enable companies and their supply chains to designate a unique molecular identity to products with meaning specific to the tagged material: for example, geographic facility location, brand, product line or date of manufacture. This tag can be blended into ingredients and packaging inks and varnishes in the pharmaceutical, nutraceutical, and dietary supplements industry. The tag enables its carrier to be verified for authenticity and blending detection, either at the customer or in the Applied DNA laboratory, depending on application requirements.

“Applied DNA Sciences is leading the way in supply chain authentication,” commented Rabbi Menachem Genack, CEO, OU Kosher, “and we are excited to partner with them as they expand into the market of dietary supplements, food ingredients and nutraceuticals. In turn,” he observed, “their molecular tag offers our supervision program an additional instrument for validating the integrity of our certified products.”

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.

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 Reform 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 our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, the possibility of failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, the Company’s history of net losses, limited financial resources, limited market acceptance 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 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, 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: Judy Murrah, Chief Information Officer, 631-2240-8819, judy.murrah@adnas.com