Full Press Release Details
Applied DNA Reports 2020 Fiscal Second
Quarter Financial Results
Company to Hold Conference Call and Webcast
Thursday, May 14, 2020, at 4:30 p.m. EDT
STONY BROOK, N.Y. - May 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 in vitro diagnostics, pre-clinical nucleic
acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced
consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020.
"Continued execution on our strategic
priorities in our second fiscal quarter resulted in an expansion of our linear DNA story to include COVID-19 vaccine candidate
and diagnostic kit programs and the addition of new development customers. These new development customers, several of which are
leaders in the field of gene and redirected-cell therapies, demonstrate broadening interest and adoption of our proprietary linear
DNA approach to preclinical biotherapeutics and diagnostics development and further validate linear DNA as a viable alternative
for plasmid DNA," stated Dr. James A. Hayward, president and CEO of Applied DNA.
"Most of our activities during the quarter
were devoted to our COVID-19 development programs that serve to also elevate the profile of our PCR-based LinearDNA platform
to the biopharma industry as a powerful, large-scale tool for the rapid manufacture of DNA-based therapeutics," continued
Dr. Hayward. "The global focus on the pandemic and the speed with which vaccine candidates are being developed are laying
bare the limitations of modern vaccine development that are almost-exclusively reliant on plasmid-based technologies that are often
slow and require much more downstream processing. Because our linear DNA approach does not require bacterial fermentation and has
the added advantage of essentially no risk of contamination by genes for antibiotic resistance and other genetic contaminants,
we believe our platform is well suited for such DNA-based therapeutics as engineered T cells, gene therapies, RNAi, and vaccines,
such as for COVID-19 or future emerging infectious diseases. One new development customer, a global Top-20 pharmaceutical manufacturer,
is evaluating the full scope of our platform to potentially serve as a foundational tool for their future genetic therapy pipeline.
As the industry comes to terms with the limitations of plasmid-based technologies in terms of production speed and risk, we believe
this will set the stage for a paradigm shift towards the rapid manufacturing of linear DNA vaccines with our LinearDNA platform
as the accelerator."
Concluded Dr. Hayward, "Looking ahead,
we remain focused on driving interest and building demand for our linear DNA approach across certain highly-regulated markets,
such as drug development, that we believe offer a path to higher and more recurring revenue. Takis Biotech ("Takis")
has initiated preclinical animal trials of our LinearDNA version of their vaccine candidates that we believe will demonstrate similar,
robust immune responses to their plasmid-based constructs, but with the added advantage of speed and scalability to manufacture
for global use. Concurrently, we are preparing for the possibility for Takis to progress to human trials this fall by readying
our facility for compliance with the FDA's cGMP regulations that govern the quality of biologics for human use. We have also
developed our Linea COVID-19 high-throughput and high-sensitivity SARS-CoV-2 detection kit to enable mass-testing that can
be a crucial tool in the toolbox of health systems and governments in the fight to further flatten the curve'. Having
received Emergency Use Authorization from the FDA today, we are now focused on the commercialization of our kit to assist frontline
workers leading the charge against the pandemic. Pharmaceutical molecular tagging is another target market and one where the FDA
has granted us entry into its Emerging Technology Program that gives us a path to drive the industry's adoption of our authentication
technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain. We
will continue to build our business development pipeline and execute on our strategy to advance and prove the capabilities of linear
DNA to drug developers and the broader pharmaceutical industry."
Fiscal Second Quarter
2020 Financial Results:
March 31, 2020 Financial Results:
Operational Highlights:
Applied DNA progressed
its COVID-19 development program that spans both vaccine development and clinical diagnostic kit development:
LinearDNA platform for preclinical biotherapeutic (gene and redirected-cell therapies) and diagnostic applications development
continued to shift towards broader adoption:
DNA tagging business for supply chain security continued to build awareness and adoption:
Fiscal Second Quarter 2020 Conference Call Information
The Company will hold a conference call and webcast to discuss
its fiscal second quarter-end 2020 results on Thursday, May 14, 2020 at 4:30 PM EDT. 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.
Replay (available 1 hour following
the conclusion of the live call through May 21, 2020):
For those unable to attend
the live call, a copy of management's PowerPoint presentation will be available for review under the Events and Presentations'
section of the company's Investor Relations web site: https://adnas.com/molecular-based-security/investors/
Information about Non-GAAP Financial
As used herein, "GAAP" refers to accounting principles
generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and
presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined
in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a
numerical measure of a company's historical or future performance, financial position, or cash flows that either excludes
or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented
in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation
or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial
measure for internal financial and operational decision making purposes and as a means to evaluate period-to-period comparisons
of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures
provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not
be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow
for greater transparency with respect to key metrics used by management in its financial and operational decision making.
"EBITDA"- is defined as earnings (loss) before interest
expense, income tax expense and depreciation and amortization expense.
"Adjusted EBITDA"- is defined as EBITDA adjusted
to exclude (i) stock-based compensation and (ii) other non-cash expenses.
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
Visit adnas.com for more
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'.
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 therapeutic or diagnostic 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 fact that there has never been a
commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the unknown outcome of any