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Applied Dna Sciences Inc (APDN) SEC Filing 10-K Annual Report for the fiscal year ending Thursday, September 30, 2021

Applied Dna Sciences Inc

CIK: 744452 Ticker: APDN

Exhibit 99.1

 

 

 

 

 

Applied DNA Announces Third Quarter Fiscal 2021

 

Revenues Increased 294% Year-Over-Year to $1.7 Million

 

– Year-To-Date Revenues Increase 270% From Last Fiscal Year to $6.0 Million –

 

- Company to Hold Conference Call and Webcast Today, Thursday, August 12, 2021, at 4:30 PM ET -

 

STONY BROOK, N.Y. – August 12, 2021 - Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing and nucleic acid-based technologies, today announced consolidated financial results for the three and nine months ended June 30, 2021.

 

“We delivered excellent year-over-year revenue growth in the fiscal third quarter while laying the groundwork to secure a recently awarded COVID-19 testing services contract that has potential to be the largest contract in the Company’s history,” said Dr. James A. Hayward, president and CEO of Applied DNA. “Demand for safeCircle™, our pooled COVID-19 testing program, experienced a seasonal decline from the fiscal second quarter, reflecting the start of the summer recess months for our academic clients and progressively higher vaccination rates and lower positivity rates in our operating area. Our recent award from the City University of New York for large-scale turnkey COVID-19 testing services should continue to drive strong year-over-year revenue growth over the period of the contract.”

 

Continued Dr. Hayward, “Our operating activities during the quarter were distinguished by an expansion of our COVID-19 offerings to drive incremental revenue and to drive adoption of LinearDNA™ as an alternative to plasmids for nucleic acid-based therapies. Following constructive interactions with the U.S. Food and Drug Administration (FDA) as part of a preliminary Emergency Use Authorization application process and the evolving nature of the pandemic, we revised our LineaTM SARS-CoV-2 Mutation (the “Linea Mutation Panel”) (formerly SGS™ Mutation Panel) to target three SARS-CoV-2 mutations (E48K, L452R, N501Y) that have been designated substitutions (mutations) of therapeutic concern by the Centers for Disease Control and Prevention.

 

“Should the FDA grant an EUA for the Linea Mutation Panel, we believe that it will offer clinical utility to healthcare systems by enabling precision COVID-19 treatment and commercial utility to monoclonal antibody manufacturers by better characterizing patients before treatments. In recent months, several monoclonal antibody treatments have had their EUA revoked or have demonstrated a reduction in efficacy on a standalone or in combination with other treatments due to mutational impact. Use of the Linea Mutation Panel is tied to our Linea™ COVID-19 Assay Kit to determine positivity in clinical samples that would drive additional Assay demand if the EUA is granted for our Mutation Panel. We believe that an EUA-authorized Linea Mutation Panel will also provide additional value to our existing COVID-19 testing customers and, when combined with our Whole Genome Sequencing assets, provide data of interest to epidemiologists.

 

“Concurrently, the launch of our veterinary LinearDNA™ COVID-19 vaccine trial and the subsequently reported strong immune response that the vaccine candidate elicited, further reinforce the value proposition of LinearDNA, and, longer-term, generates invaluable preclinical data supporting the eventual application of LinearDNA to nucleic acid-based therapies in humans.”

 

Concluded Dr. Hayward, “Looking ahead, the confluence of increasing positivity rates due to the Delta variant, the commingling of vaccinated, partially vaccinated, and unvaccinated individuals, and new mandatory testing requirements for local and state-level employees in our operating area affirm the need for ongoing and consistent COVID-19 screening available through safeCircle. Subject to FDA's evolving EUA request review priorities, we expect to file shortly our formal request for EUA for our Linea Mutation Panel. In addition, in the coming weeks we intend to launch our COVID-19 veterinary vaccine candidate challenge trial in furtherance of a commercial animal health opportunity.

 


The following information was filed by Applied Dna Sciences Inc (APDN) on Thursday, August 12, 2021 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Applied Dna Sciences Inc's 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parentheticals)
Consolidated Statement Of Cash Flows
Consolidated Statements Of (Deficit) Equity
Consolidated Statements Of Operations
Accounts Payable And Accrued Liabilities
Accounts Payable And Accrued Liabilities (Details)
Accounts Payable And Accrued Liabilities (Tables)
Basis Of Presentation And Summary Of Accounting Policies
Basis Of Presentation And Summary Of Accounting Policies (Policies)
Basis Of Presentation And Summary Of Accounting Policies (Tables)
Basis Of Presentation And Summary Of Accounting Policies - Additional Information (Details)
Basis Of Presentation And Summary Of Accounting Policies - Property And Equipment (Details)
Basis Of Presentation And Summary Of Accounting Policies - Summary Of Opening And Closing Balances Of The Company's Contract Balances (Details)
Basis Of Presentation And Summary Of Accounting Policies - Summary Of Potential Stock Issuances Under Various Options, And Warrants (Details)
Basis Of Presentation And Summary Of Accounting Policies - Summary Of Revenues Disaggregated By Our Business Operations And Timing Of Revenue Recognition (Details)
Capital Stock
Capital Stock (Details)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Employment Agreement (Details)
Commitments And Contingencies - Future Minimum Rental Payments (Details)
Commitments And Contingencies - Operating Leases (Details)
Geographic Area Information
Geographic Area Information (Details)
Geographic Area Information (Tables)
Going Concern And Management's Plan
Going Concern And Management's Plan (Details)
Income Taxes
Income Taxes (Details)
Income Taxes (Tables)
Income Taxes - Additional Information (Details)
Income Taxes - Components Of Deferred Tax Assets (Details)
Income Taxes - Provision (Benefit) (Details)
Income Taxes - Provision For Income Taxes Differ From Amount Of Income Tax Determined (Details)
Intangible Assets
Intangible Assets (Tables)
Intangible Assets - Additional Information (Details)
Intangible Assets - Summary Of Intangible Assets (Details)
Intangible Assets - Summary Of Intangible Assets - Useful Life (Details)
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Nature Of The Business
Notes Payable
Notes Payable (Details)
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Related Party Transactions (Details)
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Stock Options And Warrants (Details)
Stock Options And Warrants (Tables)
Stock Options And Warrants - Stock Options (Details)
Stock Options And Warrants - Summary Of Value Of Options Granted Using Black Scholes Option Pricing Model With Weighted Average Assumptions (Details)
Stock Options And Warrants - Transactions Involving Stock Options Issued To Employees (Details)
Ticker: APDN
CIK: 744452
Form Type: 10-K Annual Report
Accession Number: 0001410578-21-000497
Submitted to the SEC: Thu Dec 09 2021 4:13:26 PM EST
Accepted by the SEC: Thu Dec 09 2021
Period: Thursday, September 30, 2021
Industry: Miscellaneous Business Services

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