Full Press Release Details
Applied DNA Announces
Fourth Quarter Fiscal Year 2023
Conference Call/Webcast Scheduled for Today at 4:30 PM ET -
N.Y. - December 7, 2023 - Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"),
a leader in PCR-based DNA technologies, today announced consolidated financial results for its fourth quarter ended September 30, 2023.
fiscal fourth quarter concludes a productive year during which we took a number of critical steps that place us firmly in the execution
phase of our pivot to a biotherapeutic manufacturing-first growth strategy," stated Dr. James A. Hayward, president and CEO of
Applied DNA. "We closed on the strategic acquisition of Spindle Biotech that empowered the launch of our Linea IVT platform,
initiated the build-out of an initial GMP manufacturing footprint to produce critical mRNA starting materials, acquired what we believe
to be an enviable base of early-phase customers for both our Linea DNA and Linea IVT platforms, and affirmed our capacity for
the rapid production of multi-gram quantities of Linea DNA. Cumulatively, these steps expand our relevance into the growing and diverse
value chain of genetic medicine manufacturing with a near-term focus on enabling our customers to produce better mRNA faster.
"At our ADCL clinical lab
and supply chain traceability segments, progress has been slower than hoped for due to the ongoing review of our pharmacogenomics assay
and testing service by New York State Department of Health's and as we pursue initiatives to migrate our seasonal cotton tagging
business into a year-around revenue stream, respectively."
Continued Dr. Hayward, "Looking
ahead to fiscal 2024, we believe that continued biotherapeutics segment momentum and anticipated continued expansion in genetic medicine
manufacturing demand, particularly for mRNA, can drive segment growth in the coming fiscal year. Our optimism is founded in our proprietary
Linea IVT platform that enables the cell-free, enzymatic production of critical mRNA starting materials with unprecedented flexibility,
speed, scale, and costs. We believe that this platform offers the industry the ability to outperform conventional mRNA production processes
at the exact time the industry is seeking differentiation and is embracing next-generation, fully enzymatic workflows."
"Furthermore, our planned
GMP capacity for critical mRNA starting materials is expected to now come online in the first half of calendar 2024, subject to the availability
of financing, that will, for the first time, enable us to support current and new customers' migration to the clinic with mRNA
drug candidates. We believe this capacity will be a catalyst for our procurement of larger-scale supply agreements for our platforms.
Additionally, we will continue to invest for the future with a focus on platform optimization and data generation to enhance Linea DNA's
standing as an alternative source of DNA for all genetic medicines. While we expect fiscal 2024 to be a milestones-driven year for us
given the biotherapeutics industry's ongoing investment in mRNA, longer term, we believe the future of our Linea DNA platform is
not constrained to critical starting materials for mRNA production and have already secured research use only orders and are starting
to build a backlog for in vitro diagnostics, gene editing/therapy and adoptive cell therapy applications."
Summary Fourth Quarter Fiscal 2023 Financial Results:
Fourth Quarter Fiscal 2023 Conference Call Information
The Company will hold a conference call and webcast
to discuss its fourth quarter of fiscal year 2023 financial results on Thursday, December 7, 2023, at 4:30 PM ET. To participate in 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, not all questions may be answered.
To Participate, please ask to be joined to the
Applied DNA Sciences' call:
Live and replay of webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=LKq7RVht
Telephonic replay (available 1 hour following
the conclusion of the live call through August 14, 2023):
An accompanying slide presentation will be embedded
in the webcast can be accessed under 'News & Events' tab and Company Events' section of the Applied DNA investor relations
website at https://investors.adnas.com/
Information about Non-GAAP Financial Measures
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 businesses.
Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance
of our businesses 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 the Linea DNA and Linea IVT Platforms
The Linea DNA platform is a completely cell-free
DNA production platform founded on the Company's long-standing expertise in the large-scale enzymatic production of DNA. Capable
of producing DNA in quantities ranging from milligrams to grams, the Linea DNA platform can produce high-fidelity DNA constructs ranging
from 100bp to 20kb in size. The DNA produced via the Linea DNA platform is free of the adventitious DNA sequences found in other sources
of DNA, is rapidly scalable, and provides for simple chemical modification of DNA constructs.
The Linea IVT platform combines DNA IVT templates
manufacturing via the Linea DNA platform with a proprietary Linea RNAP to enable mRNA and saRNA manufacturers to produce better
mRNA faster, with advantages over conventional mRNA production, including: 1) the elimination of plasmid DNA as a starting material;
2) the prevention or reduction of dsRNA contamination; and 3) simplified mRNA production workflows.
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company
developing technologies to produce and detect deoxyribonucleic acid ("DNA"). Using the polymerase chain reaction ("PCR")
to enable both the production and detection of DNA, we operate in three primary business markets: (i) the enzymatic manufacture of synthetic
DNA for use in the production of nucleic acid-based therapeutics and, through our recent acquisition of Spindle Biotech, Inc. ("Spindle"),
the development and sale of a proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; (ii) the
detection of DNA and RNA in molecular diagnostics and genetic testing services; and (iii) the manufacture and detection of DNA for industrial
supply chain security services.
Visit adnas.com for more information.
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.'
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, unknown future demand for its biotherapeutics products and services, our
unknown ability to procure additional financing to build our GMP manufacturing facility, the unknown amount of revenues and profits that
will result from the Linea IVT platform, limited market acceptance for its supply chain security products and services, the declining
demand for Applied DNA's COVID-19 testing services, the fact that there has never been a commercial drug product utilizing PCR-produced
DNA technology and/or the Linea IVT platform approved for therapeutic use, and various other factors detailed from time to time in Applied
DNA's SEC reports and filings, including its Annual Report on Form 10-K filed on December 7, 2023 and other reports it files
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 Relations contact: Sanjay M. Hurry, 917-733-5573,