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Applied DNA High-Sensitivity and High-Throughput COVID-19 Diagnostic Kit Enters Validation Process in Partnership with Stony Brook University Hospital

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Applied DNA High-Sensitivity and High-Throughput COVID-19 Diagnostic Kit Enters Validation Process in Partnership with Stony Brook University Hospital

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Paves Path for Application to FDA for Emergency Use Authorization before end of April 2020; Company providing high-throughput RNA-extraction robotics and enhanced-sensitivity RT-qPCR assay with goals to diminish false negatives, quantify viral loads and enhance testing volumes for the region

STONY BROOK, N.Y. April 21, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) today announced the signing of an Agreement with Stony Brook University Hospital (the “Hospital”) to validate and implement the Company’s patent-pending nucleic acid diagnostic (LineaCOVID-19™) to detect and quantify in diagnostic samples the presence of SARS-CoV-2, the virus that causes the disease, COVID-19. Validation is expected to begin immediately with results to be used to support the Company’s application to the U.S. Food and Drug Administration (FDA) before the end of April 2020 for Emergency Use Authorization (EUA).“Built upon our work to develop COVID-19 vaccine candidates, we believe we have developed a high-sensitivity, high-throughput diagnostic that is urgently needed to meet the mass testing requirements of not just New York State, but also across the U.S. and the world. Working together with a local partner that is world-class medical institution, we are now at the final step of our diagnostic kit development program before moving to seek Emergency Use Authorization from the FDA,” stated Dr. James Hayward, president and CEO of Applied DNA. “We are very encouraged by our internal testing results to-date. We aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. This gene is highly conserved, being close to 100% (99.97%) identical across variants; meaning that detection via our diagnostic kit should be consistent even against the capacity for this virus to mutate.”

Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA and a 30-year veteran of the RNA-based molecular diagnostics industry, stated, “We are pleased to be donating state-of -the-art robotics and diagnostic devices and integrating them into the Hospital’s facilities with the objective of yielding throughputs of more than 500 patient samples per 8-hour shift, with expected enhanced sensitivity and fewer false negatives.  Our scientists and the Hospital are collaborating closely to dramatically increase throughput and sensitivity to better protect first responders and patients, and to enable comprehensive testing to the residents of Long Island.”

Yuhua Sun, Director of Applied Genomics at Applied DNA, and one of the developers of the assay, stated, “By teaming with our neighboring world-class hospital, we have mobilized with great speed, not only in development of the diagnostic, but in the continued exploration of viral loads in novel fluids and tissue samples to learn more about the course of this disease and the potential to improve diagnostics and therapeutics.”

The Agreement calls for Applied DNA to permanently contribute equipment to the Hospital who will act as third-party validator of the Company’s LineaCOVID-19 diagnostic, and for the Company to sell diagnostics kits to the Hospital once the EUA has been granted by FDA. Two forms of the diagnostic kit will be available to the market, a “Basic Kit” designed for high-volume labs that can provide some of the bulk ingredients usually found in large reserves at labs routinely processing thousands of patient samples per day, and a “Premium Kit” for labs that need everything at their fingertips. In addition, the Company is working with its vendors to provide a fully integrated monobloc platform that will allow certified testing organizations to install turnkey operations in a single order.

The Company plans to manufacture the positive controls (that confirm the test is operating properly) using its LinearDNA™ platform used recently to deliver quantities of five candidate linear DNA vaccines designed by its development partner in Italy, Takis Biotech.  The LineaCOVID-19 diagnostic leverages the Company’s established knowhow regarding the Spike protein that is abundant on the surface of the virus.  The Company believes the abundance of messenger RNA encoding for Spike is one of the factors that enhance the sensitivity of the assay. A provisional patent application has been filed with the United States Patent and Trademark Office (USPTO) protecting the concepts on which the assay is based.

Applied DNA makes clear that while the Company expects to file an EUA with the U.S. FDA by the end of the month, the U.S. FDA has not yet approved the Company’s diagnostic and there is no guarantee that any EUA will be approved.

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

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

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

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 uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners diagnostic or therapeutic 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 unknown outcome of any applications to 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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

LI Biotech Speeds COVID-19 Vaccine Candidates To Italy

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Cure bet: If vaccine candidates prepared by Applied DNA’s LinearDNA manufacturing system perform as well as plasmid-based candidates prepared by Italian biopharma Takis Biopharma, the cross-Atlantic collaboration may be on to something.

Stony Brook-based Applied DNA Sciences announced Wednesday that it has completed “design qualifications” and shipped five COVID-19 vaccine candidates to Italian biopharma Takis Biotech, a frequent collaborator working closely with Applied DNA to counter the coronavirus.

The vaccine candidates were produced using the Stony Brook biotech’s proprietary, polymerase chain reaction-based LinearDNA manufacturing system, which factored heavily in the two companies’ previous forays into cancer research.

Now, LineaRX – Applied DNA’s linear DNA-focused 2018 spinoff – is knee-deep in the global pandemic, churning out five vaccine candidates scheduled for immediate preclinical animal testing in Italy.

Applied DNA Ships COVID-19 LinearDNA™ Vaccine Candidates to Italian Development Partner to Begin Preclinical Animal Testing

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STONY BROOK, N.Y., and ROME, ITALY. April 15, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it has completed design qualification, production and shipment of five COVID-19 vaccine candidates to Italy-based Takis Biotech (“Takis”), a developer of cancer vaccines and the Company’s COVID-19 vaccine development partner, to support preclinical animal testing that will begin immediately. The vaccine candidates were produced by the Company’s proprietary PCR-based LinearDNA™ manufacturing systems.

“Preliminary animal test results from the plasmid-based vaccine templates, from which Applied DNA’s linear DNA-based vaccine constructs were manufactured at scale, were immunogenic and induced a strong production of antibodies across all five vaccine candidates,” said Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech. “Our next step is to utilize these LinearDNA candidates to inoculate mice whose sera will be tested for the presence of antibodies that bind to purified Spike protein. The Spike protein is the most abundant protein on the surface of SARS-CoV-2, the virus that causes the disease, COVID-19, and is the means of binding to and entering into human host cells. Those positive candidates whose antibodies bind to Spike will be tested for their ability to neutralize SARS-CoV-2 by preventing uptake of the virus in cells in culture and in animal models.”

Dr. James Hayward, president and CEO of Applied DNA, stated, “We are very encouraged by the preliminary results from Takis, given the prior close correlation we observed in efficacy between plasmid templates and linear DNA vaccines, and we anticipate similar results from our LinearDNA candidates with the added advantage of lower risk of antibiotic resistance and genome integration often present when circular DNA that is found in plasmids is used. Linear DNA vaccines also holds a significant advantage over plasmids in their speed of production that will be critical to containing this global pandemic. Having shipped the vaccine candidates, we turn our attention to the execution of our cGMP plan to support human trials scheduled to begin this fall. Our focus on Spike in the vaccination process is a natural correlate of our focus on Spike in our diagnostic assay. The abundance of Spike protein on the surface of the virus is a natural consequence of the abundance of Spike RNA in the cytoplasm of infected human cells, greatly enhancing the sensitivity of our RT-qPCR (Reverse Transcriptase-quantitative PCR) assay, which is advancing quickly in development. Based on the preliminary results we have obtained with our assay, we believe that its sensitivity may help to lower the false negative rates seen in other assays, that confound epidemiology, diagnosis and treatment of COVID-19.  However, our results must be validated in third-party laboratories where our work will be repeated.”

Applied DNA and Takis make clear that no commercial partner has been identified to take the coronavirus vaccine candidates, nor our diagnostic in development, to market nor is there any indication that the Company’s applications to U.S. Food and Drug Administration or equivalent foreign regulatory agencies would be approved for our vaccine or COVID-19 diagnostic.

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

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

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.

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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

Applied DNA to Speak on COVID-19 Panel at Maxim Group’s Infectious Disease Virtual Conference on May 5

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STONY BROOK, N.Y., April 14, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced its participation at Maxim Group’s Infectious Disease Virtual Conference on May 5, 2020. Applied DNA CEO Dr. James Hayward will join a panel of drug developers to share his insights on how gene-based vaccines, such as those being advanced by the Company and its joint development partner, Rome, Italy-based Takis Biotech, are at the forefront of COVID-19 vaccine development programs. The panel, entitled ‘COVID-19 (Vaccine, Treatment, Testing)’, is scheduled for 2:00 p.m. ET to 3:30 p.m. ET. To RSVP for the virtual conference, please click through: Maxim Group’s Infectious Disease Virtual Conference.

Applied DNA’s COVID-19 development program spans both vaccine candidates and a diagnostic assay kit to enable mass testing of the SARS-CoV-2, the virus that causes the disease COVID-19. Together with Takis Biotech, the Company is currently progressing five vaccine candidates that are based on COVID-19’s ‘spike’ protein. Utilizing LinearDNA™, its proprietary and patent-protected platform for large-scale DNA manufacture by PCR, the Company expects to complete production of all candidate vaccines in April 2020 and for preclinical animal testing by Takis Biotech to begin in late April 2020. Concurrently, the Company has begun manufacturing of a high-sensitivity Research Use Only (RUO) diagnostic assay kit for SARS-CoV-2 and plans to seek eventual approval under the U.S. Federal Drug Administration’s Emergency Use Authorizations.

Dr. Hayward will hold one-on-one meetings with institutional investors through Maxim Group. To schedule a one-on-one meeting, please contact sdorce@maximgrp.com.

Applied DNA makes clear that no commercial partner has been identified to take the coronavirus vaccine candidates or diagnostic under development to market nor is there any indication that the Company’s vaccine candidates or diagnostic would be approved by regulators.

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

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

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.

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, the unknown outcome of any applications to U.S. FDA or equivalent 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

Applied DNA and Takis Biotech Expand COVID-19 Vaccine Development Program to Include 5th Candidate

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Linear DNA Production for All Candidates Scheduled to Be Completed and Preclinical Animal Testing Expected to Commence This Month

STONY BROOK, N.Y., and ROME, ITALY,  April 2, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, and Takis Biotech (“Takis”), a company focused on the development of cancer vaccines and founded by scientists from Merck Research Laboratories, today announce an expansion of their COVID-19 vaccine development program to include a fifth vaccine candidate. Production of all vaccine candidates is expected to be completed this month at Applied DNA’s LinearDNA™ production facility in Stony Brook, N.Y. All vaccine candidates have also been approved by Italy’s Ministry of Health for preclinical animal testing that is scheduled to begin in late April 2020.

“The newly added 5th linear DNA vaccine candidate encodes an engineered fusion protein of a COVID-19 Spike domain with an immunomodulator moiety,” indicated Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech,  “This additional candidate expands the breath of our study, further increasing the probability that a successor emerges from our preclinical trials.”

Dr. James Hayward, president and CEO of Applied DNA, stated, “With the addition of a fifth candidate, we have more “arrows in our quiver” to enhance our probability of success. The new potential candidate may facilitate a productive immune response, while minimizing mechanisms known to have potential negative effects on the infection. Concurrent with the Takis animal trials, Applied DNA will prepare for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall.”

Under the terms of the companies’ amended Joint Development Agreement, Takis will use the scaled-up LinearDNA synthetic genes produced by Applied DNA for each of the five 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 proven in a prior LinearDNA vaccine preclinical study, 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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

Applied DNA Ships LinearDNA™ to Another Development Customer

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Subsidiary of Global Biopharmaceutical Company to Evaluate Linear DNA as Replacement for Plasmids for CAR T Applications

STONY BROOK, N.Y., March 26, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, announced today that it has shipped two CAR T amplicons proprietary to the biologics subsidiary of a U.S.-based, global biopharmaceutical company. The customer is one of nearly two dozen development customers in various stages of evaluating the use of linear DNA manufactured by the Company.

“We see a steady flow of interest for our LinearDNA™ manufacturing platform from customers with gene and redirected-cell therapies. Securing development customers is the first step in our LinearDNA commercialization strategy that offers a path to higher and recurring revenues as customers validate linear DNA as a viable alternative to plasmid DNA. We expect some customers will license our intellectual property to enable the optimal performance of their therapeutic,” said Dr. James Hayward, president and CEO of Applied DNA. “I am especially proud of our team during this coronavirus outbreak who continue to prioritize our work on COVID-19-related therapies and diagnostics, as well as deliver linear DNA to customers without interruption. In the coming weeks and months, we expect to continue our work with all therapeutic customers to optimize LinearDNA for their unique therapeutic applications.”

LinearDNA™ is Applied DNA’s branded platform for large-scale DNA manufacture by PCR.

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

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, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies, Applied DNA’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies, 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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

Provisional Patent Application Filed for High Sensitivity COVID-19 Diagnostic Assay

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STONY BROOK, N.Y., – March 24, 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 diagnostics, announced today the filing of a provisional patent application with the United States Patent and Trademark Office (USPTO) for its diagnostic assay under development for SARS-CoV-2, the virus that causes the disease COVID-19. The application follows the Company’s announcement on March 19, 2020 that it had completed the design of its COVID-19 detection assay.

“This provisional patent application is a necessary and important step to protect our intellectual property that underpins our detection assay. With the U.S. Federal Drug Administration having recently issued guidance that allows companies to manufacture and ship COVID-19 tests under the Agency’s Emergency Use Authorizations, we are in the process of manufacturing kits for validation at hospitals both in New York State and Italy,” stated said Dr. James Hayward, president and CEO of Applied DNA. “This application is also reflective of our expanding nucleic acid-based therapeutic and diagnostic patent estate. With the addition of this provisional patent application, Applied DNA has over 15 pending and issued patents aimed at nucleic acid-based therapeutics and diagnostics, including certain U.S. and PCT (international) patent applications pertaining to the use of PCR-produced LinearDNA™ amplicons as DNA vaccines that, if granted, we believe, would encompass our linear DNA-based COVID-19 vaccines candidates currently being co-developed with Takis Biotech.”

Applied DNA makes clear that no commercial partner has been identified to take the developmental diagnostic to market nor is there any indication that the Company’s diagnostics would be approved by the U.S. Federal Drug Administration and other regulators.

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

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, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies, Applied DNA’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; 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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

APDN Secures Top-20 Pharmaceutical Manufacturer as Drug Development Customer

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Agreement Engages Full Scope of Linear DNA Platform; Customer to Evaluate Use of Linear DNA to Potentially Improve Efficacy and Safety of CAR Therapy Pipeline

STONY BROOK N.Y., March 20, 2020Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA”) (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, announced today that it has signed a Research Agreement (the “Agreement”) with a global Top-20 pharmaceutical company (the “customer”) to evaluate the full scope of the Company’s linear DNA platform: linear DNA production as part of the customer’s improvement strategy for the manufacturing process of CAR (Chimeric Antigen Receptor) therapy and in conjunction with their non-viral gene transduction technology, The research project will include;. the Company’s patented technologies that leverage LifeSensors’ SUMO-fusion technologies to maximize protein expression as well as, Applied DNA’s unique linear anti-CD19 CAR T construct (for treatment of acute lymphocytic leukemia).

The Agreement is aligned with the customer’s strategy to deploy technologies to improve the efficacy and safety of its CAR therapies development pipeline with an emphasis on non-plasmid, non-viral technologies. Under the terms of the Agreement, the customer cannot be identified, and the financial terms cannot be disclosed. However, the contract will be entirely prepaid in advance.

”This agreement validates our linear DNA platform strategy and evidences growing interest in our manufacturing platform for the development of nucleic acid-based therapies and diagnostics from the highest tier of pharmaceutical manufacturers for applications that range from CAR-T to RNA vaccines,” stated Dr. James A. Hayward, president and CEO of Applied DNA. “Whereas interest from our development customer base to date reflects their increasing need for an alternative to plasmids as the source of DNA, the inclusion of an evaluation of our non-viral, plasmid-free LinCART19 CAR T therapy in this Agreement opens the door for the potential use of linear DNA in the customer’s CAR T pipeline as well as the a potential for sponsorship for our antiCD19 CAR T. Successful evaluations across the three components of the Agreement should lead to a scaling of orders over time to establish a base of recurring revenue.

“We believe that a faster, cheaper and potentially safer alternative to plasmids underpins in an entirely new approach to nucleic acid therapies. LinearDNA™ avoids the potential problems of plasmid-based therapies, including contamination by bacterial toxins and other bacterial substances, accidental inclusion of off-target DNA from the bacteria and plasmids (including the genes associated with antibiotic resistance), and integration into the patient genome. As the sole manufacturer of PCR-produced linear DNA at scale, we believe our platform can be the industry’s sea change,” concluded Dr. Hayward.

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.

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, 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, the unknown outcome of any applications to U.S. FDA 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 Leverages COVID-19 Vaccine Development and Proprietary Linear DNA Manufacturing Capability to Design a High Sensitivity Diagnostic Kit for Virus Detection

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Assay under development uses PCR-based detection of viral sequences that code for the Spike protein that is also the target of the Company’s vaccine candidate with Takis Biotech
messenger RNA abundance for Spike in host cells should yield high sensitivity

STONY BROOK, N.Y., March 19, 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 diagnostics, announced today the completion of design of a diagnostic kit for SARS-CoV-2 (the virus that causes the disease COVID-19) being developed for production via the Company’s proprietary PCR-based DNA (LinearDNA™) manufacturing process.

The Company’s announcement follows its statement on March 2, 2020, updating their collaborative progress with Takis Biotech, in Rome, Italy, on a series of LinearDNA™ vaccine candidates against the Spike protein of SARS-CoV-2. Yesterday’s announcement highlighted that the preclinical trials for the jointly developed vaccines have been authorized by the Italian Ministry of Health, and are the first trials in Italy to have reached this stage.

The recently designed novel diagnostic kit focuses on the gene that encodes the surface spike (S) protein, an essential glycoprotein for viral entry into human host cells. Said Dr. James Hayward, president and CEO of Applied DNA: “We aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. This gene is highly conserved, being close to 100% (99.97%) identical across variants; meaning that detection via our diagnostic kit under development should be consistent even against the capacity for this virus to mutate. We believe that we are the first company to engage both in detection and prevention of COVID-19.”

“After in-silico analysis, the assay appears highly accurate and specific for SARS-CoV-2”, said Yuha Sun, Director of Applied Genomics at Applied DNA, and one of the developers of the assay. “Applied DNA plans to conduct in-vitro verification of the in-silico analysis in the coming weeks.”

“Because the Spike protein is very abundant on the virus surface, many copies of the messenger RNA are present per host cell, increasing, we believe, the probable sensitivity of the diagnostic,” said Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA.

The Company will undertake the PCR-based manufacture of the positive controls for its proposed kit under its LinearDNA platform and believes that its capacity for such manufacture is unmatched anywhere in the world. “We are approaching partners for the validation of our pending diagnostic with samples from confirmed COVID-19 patients,” continued Dr. Hayward. “We believe our capacity for PCR-based manufacture of linear DNA could be of utility to other diagnostic and vaccine manufacturers.”

Applied DNA makes clear that no commercial partner has been identified to take the developmental diagnostic to market, nor is there any indication that the Company’s diagnostics would be approved by regulators. The assay will use the Applied Biosystems 7500 Fast Dx Real Time PCR instrument, widely deployed in diagnostic labs and hospitals the world over.  Once fully validated and ready for shipment, the Company plans to sell the diagnostic kit as “For Research Use only” while awaiting the potential Emergency Use Authorization by FDA, which would empower sales to diagnostic labs.

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, the unknown outcome of any applications to U.S. FDA 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 contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com