Confirms Assay Kits’ Value in Tracking New SARS-CoV-2 Variants in Surveillance and Diagnostic Testing
Vast Majority of PCR and Antigen Testing Unable to Detect Currently Known Variants
Multiple-Targets Assay Design Provides for Positive Results for Infected Individuals, while S-Gene “Dropout” Signals the Presence of a Variant

STONY BROOK, N.Y. January 19, 2021. Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its Linea™  COVID-19 Assay Kit (the “Assay Kit”) identified COVID-19 positive samples that are variants distinct from the wild-type virus that has dominated the U.S. in the pandemic until now. The variants were identified as part of the Company’s safeCircle™ pooled surveillance testing service, which is powered by the Company’s Assay Kits. The Assay Kits are also available for diagnostic use in third-party laboratories certified for complex molecular diagnostics.

Beginning in December 2020, the Assay Kit identified multiple instances of COVID-19 positive individuals whose samples evidenced a specific S-gene mutation known as 69-70 deletion (69-70del). Detection of samples carrying 69-70del with the Assay Kit is accomplished via S-gene dropout observed in one of the two Assay Kit’s SARS-CoV-2 genetic targets. Gene sequencing methods confirmed the variants identified by the Assay Kit. The 69-70del mutation is found in several variants, including B.1.1.7, also known as the U.K. variant, that is characterized by increased transmissibility.

Dr. James Hayward, president and CEO of Applied DNA, stated: “We believe that a testing strategy that is grounded in its use of our Assay Kit should be considered by any community, company, government or organization that wants to surveil their cohorts for the presence of new variants, detect them early, and take steps to contain them. Our Assay Kit is available immediately for any certified diagnostic lab or surveillance program.”

As announced on January 8, 2021, the U.S. Food and Drug Administration announced that the Company’s Assay Kit was one of a select few molecular diagnostics that could potentially identify SARS-CoV-2 variants that contain a specific S-gene (that encodes for Spike protein) mutation known as 69-70del. Due to the Assay Kit’s multi-target design, the overall sensitivity of the Assay Kit is not impacted, and a positive result is still obtained for variant-infected samples.

The virus that causes COVID-19, SARS-CoV-2, is prone to mutate over time, especially within patients who remain chronically infected over months, resulting in genetic variations in the population of circulating viral strains. Concern has been building among scientists that new variants will dominate in American infections by Spring, a challenge exacerbated by the inability of the vast majority of PCR and antigen tests to specifically detect these variants. The recent detection of multiple variants via S-gene dropout with the Assay Kit highlights the importance of utilizing a molecular diagnostic assay that can easily and cost-effectively identify potential variants. The Company believes that the identification of variants, especially the more transmissible U.K. (B.1.1.7) and new variants from other phylogenetic paths, is essential to containing the spread of COVID-19.

About the Linea™ COVID-19 Assay Kit and Pooled Surveillance Testing
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.

To learn more about the Linea™ COVID-19 Assay Kit: https://adnasprod.wpengine.com/dxcovid/

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.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’.Applied DNA is a member of the Russell Microcap® Index.

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 its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 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.

Average Daily Testing in January 2021 to Date Up 158% Over December 2020, Driven Primarily by Scale Up in Testing Contracts
Company Increases Production of Assay Kits (Tests) and Sample Collection Kits to Meet Further Demand
Applied DNA Clinical Laboratories On Track to Request Re-Inspection for CLEP-CLIA Certification

STONY BROOK, N.Y. January 15, 2021. Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that its safeCircle^™ pooled surveillance testing service has seen a 158% increase in the daily average number of tests performed to date in January 2021 compared to December 2020. The increase is chiefly the result of the scale-up of certain testing contracts and from the acquisition of new clients. Launched in the fourth quarter of fiscal 2020 (ended September 30, 2020), safeCircle now counts 33 primary/secondary/higher education institutions, private client, local government, and businesses as clients.

Concurrently, the Company stated that it is increasing production of its Linea™ COVID-19 Assay Kit (the “Assay Kit”) and sample collection kits to meet expected demand from existing customers, from its safeCircle service that is powered by the Assay Kit, and due to heightened interest in the Assay Kit following a recent U.S. Food & Drug Administration’s Food & Drug Administration (FDA) alert that identified the assay as an EUA-approved molecular diagnostic test that can potentially identify certain SARS-CoV-2 mutations (the “FDA Alert”). The Company also said that Applied DNA Clinical Laboratories, LLC (ADCL), its wholly-owned subsidiary, is on track to submit a request for CLEP-CLIA re-inspection during the current quarter ending March 31, 2021. If granted, CLEP-CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing.

“Positive business trends for safeCircle have carried over into January and are further enhanced by the growing awareness of our platform regionally and through our partnership with CLEARED4. The profile of prospective clients is changing with more and larger opportunities in our sales pipeline,” said Dr. James A. Hayward, president and CEO.

“The FDA’s recent Alert has the potential to be a catalyst to revenue,” concluded Dr. Hayward. “We believe our assay is one of the few cost-effective and rapid ways a laboratory can detect S-gene target dropout that serves as a potential indication of a SARS-CoV-2 variant, including the U.K.’s B.1.1.7 that is characterized by increased transmissibility. We believe the ability to identify new potential COVID-19 variants with an EUA-approved molecular diagnostic test that is in-market today is essential in the continuing fight against COVID-19. Diagnostic labs using molecular diagnostic tests that do not have the ability to discriminate potential COVID-19 variants from wildtype are unable to quickly and easily identify patients that are potentially infected with a more infectious variant, which we believe may lead to further infection spread.”

safeCircle™ Pooled Surveillance Testing Service
In recent weeks safeCircle has added new clients. They include:

• The U.S. division of a Germany-based international jewelry company for the testing of its New York-based staff;
• A private higher education institution based on Long Island, N.Y., for the testing of its residential and student-athlete populations;
• A previously announced award with a local county (N.Y.) government.

Ramp Up in Production of Kits utilized in COVID-19 Sample Collection
The Company is also increasing the production of sample collection kits utilized in surveillance testing by a factor of four to meet the testing scale-up of the Assay Kit’s largest customer and for use by new safeCircle clients.

CLEARED4 Partnership Generating New Clients
Applied DNA’s recently announced partnership with CLEARED4, a provider of return-to-work health safety solutions, has begun to bear fruit. In addition to being utilized as a mobile-friendly, value-added option for the management of aggregate results testing and reporting to a key safeCircle client, Applied DNA is now providing CLEARED4 services to a second safeCircle client, the aforementioned jewelry company. Applied DNA expects to onboard a third new client this week, the aforementioned private higher education institution. The Company believes that the combination of its safeCircle offering with the CLEARED4 platform is a compelling service in a marketplace that is in search of an accurate, easy-to-employ, faster-turnaround testing service that incents participation.

Linea™ COVID-19 Assay Kit (Test) Production
The Company’s largest customer for its Assay Kit expects to increase its use of the Assay and sample collection kits for its in-house surveillance testing program beginning in early February 2021 to coincide with its campus reopening for the Spring semester. The customer’s in-house program oversees the weekly surveillance testing of thousands of faculty and staff for the presence of COVID-19. Applied DNA receives recurring replenishment orders from the customer for both Assay and sample collection kits to meet its in-house surveillance testing needs.In response to the FDA Alert, the Company is relaunching its sales and marketing strategy to center on the Assay Kit’s potential ability to signal for the presence of a SARS-CoV-2 variant due to S-gene target dropout. Refreshed Frequently Asked Questions are available for reference for prospective diagnostic laboratory customers nationally at https://adnasprod.wpengine.com/sars-cov-2-69-70del-mutation-covid-assay-kit/.

Update on Applied DNA Clinical Laboratories (ADCL) CLEP-CLIA Certification
The Company is in the process of completing remediation of deficiencies in ADCL’s clinical standard of practice and expects to submit a request for re-inspection during the current quarter ending March 31, 2021. CLEP-CLIA certification will enable ADCL to capture diagnostic COVID-19 revenues currently being conducted by third party clinical labs. CLEP-CLIA certification would also potentially allow ADCL to develop an additional revenue stream through the development and commercialization of a broad-array of diagnostic tests, as laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL.

About the Linea^™ COVID-19 Assay Kit and Pooled Surveillance Testing
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.

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.

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’.

Applied DNA is a member of the Russell Microcap® Index.

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 its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 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, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com

Background

• Mutations are the norm for viruses, especially RNA viruses like SARS-CoV-2. SARS-CoV-2 has been mutating throughout the pandemic. Recently a deletion mutation in the S-gene of SARS-CoV-2 has emerged. The mutation is a 6-nucleotide deletion (21765-21770) within the S-gene that results in the deletion of two amino acids at sites 69 and 70 in the spike protein. The new deletion mutation is commonly referred to as 69-70del. The 69-70del has been observed in multiple variant lineages of SARS-CoV-2, including the so called “U.K. variant” technically known as the B.1.1.7 variant or UK VOC-202012/01. The B.1.1.7 variant, which has been detected in the United States, has at least 17 mutations, including 69-70del, and has been linked to an increase in transmissibility.[1]

How Does 69-70del Impact the Linea COVID-19 Assay Kit?

• The Assay Kit is a multi-target assay with two targets (S1 and S2) within the SARS-CoV-2 S-gene. In silico and clinical sample analysis results show that the S1 target of the Assay Kit experiences “drop out” in the presence of 69-70del. The Assay Kit’s S2 target is not impacted by 69-70del. The overall sensitivity of the Assay Kit is not impacted.

How Does 69-70del Impact the Linea COVID-19 Assay Kit Results?

• The Linea COVID-19 Assay Kit was designed as a multi-target assay in anticipation of the naturally occurring viral mutations common in RNA viruses such as SARS-CoV-2. The advantage of a multi-target assay is built in redundancy with two different S-gene targets.
• S1 target dropout in the presence of 69-70del does not mean a result is negative. The Assay Kit, when used as per our Instructions for Use (IFU), provides for a positive result to be called if one of the two assay targets are detected. Since there is no 69-70del related impact on the Assay Kit’s S2 target, a sample with S1 target dropout can still be called positive.
• To date, neither 69-70del, nor any other mutation has been found to impact test results obtained from the Assay Kit. S1 target dropout in the presence of 69-70del does not cause a decrease in the overall sensitivity of the Assay Kit.

Can the Linea COVID-19 Assay Kit Be Used for SARS-CoV-2 Variants That Contain 69-70del, Including the B.1.1.7 Variant?

• While the Assay Kit is not currently authorized to detect 69-70del, the U.S. FDA has stated that S1 target dropout in a positive sample tested with the Assay Kit may be indicative that the sample contains a SARS-CoV-2 variant with 69-70del, which includes, but is not limited to the B.1.1.7 variant.[2] Thus, S1 target dropout in a positive sample tested with the Assay Kit provides for a low-cost and rapid indication of new potential SARS-CoV-2 variants for further investigation, especially if genetic sequencing capacity is limited.
• If S1 target dropout in a positive sample tested with the Assay Kit is observed, the FDA recommends that the sample should be considered for further characterization via genetic sequencing. The Assay Kit has been used to identified SARS-CoV-2 variants via S1 target dropout that were confirmed to contained the 69-70del via genetic sequencing.[3]

What Are the Recommendations for Current Users of the Linea COVID-19 Assay Kit?

• Since there are two targets used in the Assay Kit and a positive result is called when only one of the two targets are detected (per our IFU), no adaptation to the Assay Kit or change in use are necessary at this time.

What is Applied DNA Sciences Doing to Monitor S-gene Mutations Impacting the Linea COVID-19 Assay Kit?

• We regularly monitor public database updates to assess the impact of new S-gene mutations on the Assay Kit. To date, there have been no reports of Assay Kit test results being impacted due to the 69-70del.

[1] https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html[2] https://www.fda.gov/medical-devices/letters-health-care-providers/genetic-variants-sars-cov-2-may-lead-false-negative-results-molecular-tests-detection-sars-cov-2[3] https://www.fda.gov/medical-devices/letters-health-care-providers/genetic-variants-sars-cov-2-may-lead-false-negative-results-molecular-tests-detection-sars-cov-2

STONY BROOK, N.Y. January 13, 2021. Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today the closing of its previously announced registered direct offering with a group of institutional investors of 1,810,000 shares of common stock at a price of $8.30 per share, priced at-the-market under Nasdaq rules, resulting in total gross proceeds of approximately $15 million, before deducting the placement agent’s fees and other estimated offering expenses.

The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, for research and development, and to advance the adoption of its LinearDNA™ manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the “SEC”) on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at rothecm@roth.com.This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

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.

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’.

Applied DNA is a member of the Russell Microcap® Index.

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 in this press release are subject to a number of risks and uncertainties, including, but not limited to market and other conditions and the intended use of net proceeds from the offering. 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 possibility that its assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s 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 (U.S. FDA) 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 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.

The US Food and Drug Administration (FDA) has published a safety communication that identifies Applied DNA Sciences’ Linea COVID-19 Assay Kit as one of only two tests marketed under its emergency use authorisation (EUA) to detect certain SARS-CoV-2 mutations.

The mutations include the one found in the UK variant of SARS-CoV-2 called B.1.1.7. It can potentially increase the transmission risk of the virus that causes Covid-19.The detection of specific mutations can help in identifying samples that should be further characterised through genetic sequencing and can help to detect the new variants in patients early

By GREGORY ZELLER // JANUARY 11, 2021

Only two COVID-19 test kits earning U.S. Food and Drug Administration Emergency Use Authorization can detect the mutant “UK strain” – and one of them is produced on Long Island.

Applied DNA Science’s Linea COVID-19 Assay Kit has been identified by the FDA as “potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the UK,” the company said this week.

That’s a direct reference to B.1.1.7, the faster-spreading mutation first identified in the United Kingdom and now confirmed to have crossed the pond, including multiple New York State cases.

According to an FDA “safety communication” issued Jan. 8, the administration monitors the potential effects of viral mutations on EUA-approved test kits – including Applied DNA’s assay, which is actually designed to detect multiple genetic targets associated with SARS-CoV-2, the virus that causes COVID-19.

STONY BROOK, N.Y. – January 11, 2021 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that it has entered into a securities purchase agreement with certain institutional investors, providing for the purchase and sale of 1,810,000 shares of common stock  at a price of $8.30 per share, priced at-the-market under Nasdaq rules, in a registered direct offering, resulting in total gross proceeds of approximately $15 million, before deducting the placement agent’s fees and other estimated offering expenses.The offering is expected to close on or about January 13, 2021, subject to the satisfaction of customary closing conditions.The Company currently intends to use the net proceeds from the offering for general corporate purposes, including working capital, for research and development, and to advance the adoption of its LinearDNA™ manufacturing platform.

Roth Capital Partners served as sole placement agent for the transaction.

The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-238557) (including a prospectus) previously filed with the Securities and Exchange Commission (the “SEC”) on May 21, 2020, and declared effective by the SEC on June 1, 2020. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at rothecm@roth.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

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.

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’.

Applied DNA is a member of the Russell Microcap® Index.

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 in this press release are subject to a number of risks and uncertainties, including, but not limited to market and other conditions, the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering. 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 possibility that its assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s 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 (U.S. FDA) 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 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, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com 

Early and Cost-Effective Identification of Samples Potentially Containing the B.1.1.7 or Other Variants May Help Reduce Further Spread of Infection

STONY BROOK, N.Y. January 8, 2021. Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced today that the U.S. Food and Drug Administration (FDA) published a safety communication (the “Communication”) that identifies the Company’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) as one of only two tests marketed under the FDA’s Emergency Use Authorization (EUA) that are potentially able to identify certain SARS-CoV-2 mutations, including a mutation found in the U.K. variant of SARS-CoV-2 (B.1.1.7). According to recent publications, the B.1.1.7 variant has been identified within the United States and may be associated with an increased risk of transmission of the virus that causes COVID-19. The identification of certain mutations can help identify samples that should be further characterized via genetic sequencing and can potentially assist with the early detection of new variants in patients, which may reduce further spread of infection.

The full text of the Communication is accessible on the official FDA website.

According to the Communication, the FDA monitors the potential effects of genetic variation on molecular tests that have received EUA, including the Company’s Assay Kit. The Communication notes that molecular tests designed to detect multiple SARS-CoV-2 genetic targets, such as the Assay Kit, are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target. Based on analysis conducted by the Company and FDA, one of the two S-gene targets (S1 and S2) of the Assay Kit has significantly reduced sensitivity in the presence of certain S-gene mutations, including a mutation found in the B.1.1.7 variant. The Communication notes that the reduced sensitivity, also known as an S-gene dropout, may be indicative of certain SARS-CoV-2 mutations, including the B.1.1.7 variant. Due to the Assay Kit’s multi-target design, the Communication states the Assay Kit’s overall sensitivity should not be impacted.

“Our ability to potentially identify certain variants of SARS-CoV-2 is grounded in the multi-target design of our assay that mitigates the impact of a mutation to the S-gene on test sensitivity. We believe our Assay Kit can give public health officials and diagnostic laboratories a fast and cost-efficient tool – whether through diagnostic or pooled surveillance testing – with which to potentially identify and track B.1.1.7 spread that is made all the more challenging by the variant’s apparent transmission advantage,” said Dr. James A. Hayward, president and CEO, Applied DNA. “Using our Assay Kit, we have already identified variants of SARS-CoV-2 via S-gene dropout, sequenced the identified variants with partners and identified common genetic progenitors that are shared by B.1.1.7 and other emerging SARS-CoV-2 variants. Utilizing this knowledge, we have begun to develop new assays to detect specific mutations in SARS-CoV-2 and to adapt our assay to address the evolving SARS-CoV-2 threat.”

About the Linea™ COVID-19 Assay Kit and Pooled Surveillance Testing
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.

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.

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’.

Applied DNA is a member of the Russell Microcap® Index.

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 its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) 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 or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, 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 17, 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, Applied DNA Sciences,917-733-5573, sanjay.hurry@adnas.com
Program contact: Mike Munzer, Applied DNA Sciences, 631-240-8814, mike.munzer@adnas.com

January 7, 2021, 6:21 PM EST Corrected January 8, 2021, 4:32 PM EST

President-elect Joe Biden says he’ll distribute more of the available doses of coronavirus vaccines, as the U.S. surpassed 4,000 daily fatalities for the first time. New York City has 270,000 unused vaccine doses that it’s seeking to administer to residents over age 75, Mayor Bill de Blasio said. Maine broke records for infections and deaths.

London’s mayor declared an emergency as the U.K. reported record fatalities. Germany also reported the most daily deaths since the start of the pandemic.

Key Developments:

Tests Largely Accurate on Virus Variants, FDA Says (2:15 p.m. NY)

The performance of three Covid-19 tests authorized for U.S. use could be affected by the emergence of coronavirus variants, though not significantly, and the overall risk of variants — including one that appears to be more transmissible — affecting testing accuracy is low, the Food and Drug Administration said on Friday.

The tests in question are Mesa Biotech Inc.’s Accula test, Thermo Fisher Scientific Inc.’s TaqPath Covid-19 Combo Kit and Applied DNA Sciences’ Linea Covid-19 Assay Kit, according to the FDA, though the agency noted that the latter two tests are designed to detect multiple genetic targets and so their overall sensitivity should not be affected. Those two tests could even help identify new variants early based on their detection patterns, the regulator said.

Applied DNA Sciences Chief Executive Officer James Hayward said in an interview the FDA communication actually suggests his company’s test is “one of the few ways, out of the hundred alternatives, to actually detect the variant.” The test, which is being used in diagnostic laboratories and surveillance efforts, has detected two instances of a coronavirus variant over the last two weeks, he said.