On April 21, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, reported a preliminary estimated revenue range for the fiscal second quarter ended March 31, 2021 and a business update (Press release, Applied DNA Sciences, APR 21, 2021, View Source [SID1234578286]). The Company expects revenues for its fiscal second quarter to be in the range of $2.5 million to $2.7 million. This compares to revenues of $1.6 million in the fiscal first quarter of 2021 and $552 thousand in the fiscal second quarter of 2020. The sequential growth in quarterly revenues was driven principally by demand for safeCircle, the Company’s pooled COVID-19 surveillance testing program, and from sales of its Linea COVID-19 Assay Kit (the "Assay Kit").
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Concurrently, the Company announced that it had received notification during the fiscal quarter that a loan of approximately $847 thousand received in May 2020 under the Paycheck Protection Program of the Coronavirus Aid, Relief, and Economic Security Act was fully forgiven. As a result of the full forgiveness of the loan, the Company is debt-free.
These preliminary unaudited results are based on management’s initial analysis of operations for the second fiscal quarter of 2021 ended March 31, 2021 and are subject to review and revision. The Company expects to issue full financial results for the second fiscal quarter of 2021 in mid-May 2021.
Dr. James A. Hayward, president and CEO, stated, "We are pleased to preliminarily report a second consecutive quarter of revenue growth that was driven primarily by the continued adoption of safeCircle as the surveillance testing component of clients’ COVID-19 ‘normalization’ strategies. The high sensitivity of our Assay Kit that powers safeCircle and its resultant ability to detect asymptomatic infections, coupled with the favorable economics of pooled testing, offers compelling value to communities that continue to see significant transmission alongside expanding vaccine eligibility. As such, under-vaccinated populations and organizations implementing reopening compliance strategies are target market segments for us and we are evolving our sales strategy to match.
"Our diagnostics business model has been made more resilient through product diversification and service improvements to develop adjacent revenue streams. In particular, the launch of our Selective Genomic Surveillance (SGS) Mutation Panel (SGS Panel) is coincident with the rising need for tools to supplement and strengthen the nation’s genomic sequencing capacity. Our SGS Panel can quickly and cost-effectively identify COVID-19 mutations and potentially influence vaccine/booster or therapeutics design. We also continued to demonstrate the potential for our LinearDNA platform as an alternative to plasmids to produce nucleic acid-based therapies, notably reporting compelling positive preliminary Phase I results for our LinearDNA COVID-19 vaccine candidate in felines," concluded Dr. Hayward.
Business Update
Applied DNA Clinical Labs, LLC (ADCL)
Resubmitted for and completed a re-inspection of its facility by the New York State Department of Health (DoH) Clinical Laboratory Evaluation Program (CLEP) as a requisite for Clinical Laboratory Improvement Amendments (CLIA) certification. If granted, CLIA certification would enable ADCL to serve as a diagnostic laboratory that would allow for it to conduct diagnostic COVID-19 testing utilizing its Assay Kit. The Company offers no timeline to a CLIA determination by the DoH. 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, including laboratory-developed tests (LDTs), that once approved by the applicable regulatory authority, could be offered by ADCL;
Secured an LSL (Limited Service Laboratory) registration from DoH to conduct COVID-19 diagnostic testing using third-party EUA-authorized, CLIA-waived COVID-19 testing platforms. The LSL enables ADCL to offer faster turnaround times on confirmatory diagnostic tests to safeCircle clients and capture testing revenues for diagnostic tests currently being conducted by third-party clinical labs.
Nearing completion of an upgrade of space and equipment within the Company’s Stony Brook, NY facility intended for diagnostic testing and cGMP (current Good Manufacturing Practice standards and procedures) capacity for LinearDNA production and processing.
LineaRx
Continued execution on a phased approach towards higher standards of cGMP, including upgrades in space and equipment noted above to support human therapeutic trials, veterinary therapeutics, and the subsidiary’s biotherapeutic CRO customers seeking to move into human clinical trials using LinearDNA.
About safeCircle
ADCL’s pooled surveillance testing program, known as safeCircle, utilizes frequent, high-sensitivity pooled testing to help prevent virus spread by quickly identifying infections within a community, school, or workplace. safeCircle provides 24-hour results using real-time PCR (RT-PCR) testing.
Click through to learn more about how safeCircle can help your community, school, and workplace: safeCircle
About the LineaCOVID-19 Assay Kit and Pooled Surveillance Testing
The LineaCOVID-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 LineaCOVID-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 LineaCOVID-19 Assay Kit. The Selective Genomic Surveillance (SGS) Mutation Panel (the "SGS Panel") is for Research Use Only (RUO) and shall not be used for clinical diagnostic purposes. The SGS Panel has not been approved or authorized to diagnose, ameliorate and/or detect any disease by any U.S. or international regulatory authority.