Full Press Release Details
Applied DNA Reports 2020 Year End and
Fiscal Fourth Quarter Financial Results
- Receives Second Warrant Exercise Subsequent
to Year-End for Net Proceeds of $1.05 Million -
- Company to Hold Conference Call and
Thursday, December 17, 2020 at 4:30 PM ET -
STONY BROOK, N.Y. - December 17,
2020 - Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase
Chain Reaction (PCR)-based DNA manufacturing, today announced consolidated financial results for the full fiscal year and quarter
ended September 30, 2020.
"Our activities in fiscal 2020 were principally
devoted to the establishment of our diagnostic and surveillance testing programs for COVID-19 and to further positioning our proprietary
LinearDNA manufacturing platform as what we believe to be a cleaner and higher-performing alternative to traditional vaccine
development technologies in an environment moving at pandemic speeds to bring efficacious COVID-19 vaccines to market," said
Dr. James A. Hayward, president and CEO, Applied DNA. "With the shutdown in global supply chains severely affecting the performance
of our supply chain security business, we redirected resources to our Biotherapeutics and Diagnostics markets: we initiated our
own human and veterinary linear DNA COVID-19 vaccine development programs with partner Takis Biotech/EvviVax. While having clear
public health goals, these programs also serve to validate our linear DNA manufacturing platform and its manufacturing advantages
over plasmid DNA production that underpins current vaccine manufacturing technology; having acquired virus expertise as a result
of our vaccine development work, we launched our Linea COVID-19 Assay Kit (the "COVID-19 test") and related testing
services as part of a multi-pronged approach to the pandemic to establish new revenue streams.
"The result of these efforts was the development
of a highly sensitive, highly specific, EUA-authorized diagnostic test that, when paired with safeCircle , our pooled surveillance
testing platform, is in the marketplace today as a cost-effective, and convenient means to help break the chain of virus transmission.
We ended the fiscal year having secured our first customer of size for our kit, established an initial base of recurring revenue
for our safeCircle platform, and initiated a clinical path for our lead veterinary vaccine candidate with an end goal of enabling
commercial veterinary sales for domestic felines."
Continued Dr. Hayward, "Our development
efforts in fiscal 2020 have laid the groundwork for multiple inflection points in fiscal 2021. The sales pipelines for our COVID-19
test and safeCircle offerings are building. In particular, safeCircle is experiencing resonance in the marketplace that, together
with a recently established return-to-work' partnership, enables us to target market niches we believe we can exploit
profitably, such as local governments, private and enterprise clients, schools, and higher education athletics departments. We
anticipate both offerings to scale up their contributions to our top-line over the coming quarters.
"Our own human linear DNA COVID-19 vaccine
development program has not progressed as anticipated; however, the preclinical work we have conducted to date serves as the basis
for a veterinary COVID-19 vaccine candidate that we believe offers a shorter and less costly regulatory path to commercialization.
Domestic cats are a known virus reservoir and can easily transmit the virus to other felines. If all trial endpoints are met, we
will apply for conditional licensure from the U.S.D.A., which we project to be in the latter half of the fiscal year. With about
58 million1 domestic cats in the U.S. and a likely first-mover advantage, we believe that a veterinary vaccine could
be commercially significant to us if approved. We would then seek to expand the addressable market for our veterinary vaccine to
include the farmed mink industry globally that has been ravaged by the virus, resulting in substantial commercial losses.
"As human COVID-19 vaccines obtain regulatory
approval, we believe they evidence shortcomings in their manufacture and distribution that we believe are solvable by linear DNA
forms of their vaccines. We believe our LinearDNA platform can produce PCR-based linear DNA at large scale enzymatically and likely
with an improved safety profile, modify vaccines reliant on plasmids to address mutations in weeks, not months or years, and offer
stability in distribution that potentially eliminates the need for expensive cold-chain requirements. This value proposition can
benefit not only COVID-19 vaccines but also every nucleic acid-based program under development today. Concurrently, we see an uptick
in contract research activity for biotherapeutic applications that we take to reflect the increasing value being placed on linear
DNA by drug developers. Today, we are proud to count leading biotechnology and pharmaceutical companies working in the field of
nucleic acid-based medicine as contract research customers. As manufacturing and distribution increasingly become key issues in
advancing nucleic-acid-based therapeutic development pipelines, we expect that our LinearDNA platform will become increasingly
relevant to existing and prospective customers.
"Finally, we await the return of increased
demand patterns in our supply chain security market. The need for brand assurance and supply chain integrity remains as evidenced
by our new supply agreement for our CertainT platform with Pillar Technologies as it relates to the authenticity of personal
protective equipment being consumed by our front-line healthcare workers, and by Nutrition21 who has transitioned its portfolio
of IP-protected ingredients to CertainT. We remain cautiously optimistic on the prospects in this business in the new fiscal year,"
concluded Dr. Hayward.
Fiscal Fourth Quarter
2020 Financial Results:
Fiscal Year 2020 Financial Results:
Select Recent Operational
Linea COVID-19 SARS-CoV-2 Diagnostic Assay Kit ("assay
Applied DNA Clinical Labs, LLC (ADCL)
The trial allows for immunologic data to be gathered
across the clinical trial cohort that may also support the initiation of a near-concurrent challenge trial, which is under development. Achievement
of both trials' primary endpoints we believe would enable the Company and EvviVax to apply for a USDA APHIS conditional license
(9 CFR 102.6) for a LinearDNA COVID-19 vaccine candidate for domestic felines.
The Company believes that an efficacious vaccine for
domestic felines would be similarly efficacious to mink, another known COVID-19 reservoir. SARS-CoV-2 has severely impacted the
farmed mink industry and mink-linked virus mutations now present in humans in at least 7 countries. Applied DNA believes that should
its veterinary COVID-19 vaccine candidate gain conditional licensure for the vaccine candidate, it could have significant utility
in mitigating the spread of the virus in commercial animal populations and from animal populations to humans.
Supply Chain Security
Fiscal Fourth Quarter 2020 Conference Call Information
The Company will hold a conference call and webcast to discuss
its fiscal fourth quarter-end 2020 results on Thursday, December 17, 2020 at 4:30 PM ET. To participate on the conference call,
please follow the instructions below. While every attempt will be made to answer investors' questions on the Q&A portion
of the call, due to the large number of expected participants, not all questions may be answered.
Live webcast: https://services.choruscall.com/links/apdn201210.html
Replay (available 1 hour following the conclusion of the
live call through December 24, 2019):
Webcast replay: https://services.choruscall.com/links/apdn201210.html
For those investors unable to attend the live call, a copy
of management's PowerPoint presentation will be available for review under the IR Calendar' portion of the
Company's Investor Relations web site: https://adnas.com/molecular-based-security/investors/
About the LineaTM COVID-19 Assay Kit
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.
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,