Full Press Release Details
DNA Reports First Quarter Fiscal 2025
Results and Highlights Operational Progress
- Announces Exit of DNA Tagging and Security Products
and Services Business Segment -
- Workforce Reduction of 20% of Headcount Implemented
- GMP Site 1 Facility Complete and Certified
for Commercial Operation in January -
Webcast and Conference Call Scheduled for today at 4:30 PM ET -
BROOK, N.Y. - February 13, 2025 - Applied DNA
Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a
leader in PCR-based DNA technologies, today reported financial results for its first quarter of fiscal 2025 ended December 31,
2024. The Company's Form 10-Q, once filed, can be viewed on the SEC Filings page of
its Investor Relations website.
Recent Corporate and Operational
LineaRx (Therapeutic DNA
Production and Services subsidiary)
Applied DNA Clinical Labs
(MDx Testing Services subsidiary)
Management Commentary
"Our first quarter performance
reflects the implementation of a strategic restructuring to support our growth through our synthetic DNA manufacturing strategy,"
stated Dr. James A. Hayward, Chairman and CEO of Applied. DNA. "We are taking difficult but necessary steps to optimize our
corporate structure to lower our cash burn rate and stabilize our financial position to ensure our ability to execute against near-term
"As we move through fiscal
2025, we are focused on commercializing the DNA production capacity of our recently certified GMP Site 1 facility," concluded Dr. Hayward.
"We are preparing for initial orders of clinical grade materials, the acquisition of which we believe will validate the economics
of our proprietary low-CAPEX approach to enzymatic DNA production in front of an industry that is actively seeking cell-free, synthetic
alternatives to traditional pDNA production processes. We believe our capacity for the GMP production of DNA in an economical, fast, and
scalable manner to advance the rapid development of genetic medicines is a unique competitive advantage in the marketplace and is the
lynchpin to our future success."
1 Based on internal Company data and modeling.
First Quarter Fiscal 2025 Financial Highlights
February 13 Investor Update Conference Call Information
The Company will hold a conference
call and webcast to update investors on its restructuring and GMP roadmap on February 13, 2025, 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
Telephonic replay (available 1 hour following the conclusion of
the live call through February 20, 2025):
An accompanying slide presentation that 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 an entirely cell-free DNA production platform
founded on Applied DNA'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 sa-mRNA manufacturers to produce what Applied DNA believes
to be 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 double-stranded DNA (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, as of February 13, 2025, we operate in two primary business markets: (i) the
enzymatic manufacture of synthetic DNA for use in the production of nucleic acid-based therapeutics and the development and sale of a
proprietary RNA polymerase ("RNAP") for use in the production of mRNA therapeutics; and (ii) the detection of DNA and
RNA in molecular diagnostics and genetic testing services.
Forward-Looking Statements
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. These forward-looking statements are based largely on the Company's expectations and projections about future events
and future trends affecting our business and are subject to risks and uncertainties that could cause actual results to differ
materially from those anticipated in the forward-looking statements, including statements regarding its belief that restructuring
will position the company for future growth potential, its goal to position the company for long term-growth and value creation and
the potential to achieve that goal, the future success of its Linea DNA and Linea IVT platforms and future reductions in operating
expenses. 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, the unknown amount
of revenues and profits that will result from our Linea IVT and or Linea DNA platforms, the fact that there has never been, clinical
trial material and/or commercial drug product produced utilizing the LineaDNA and/or Linea IVT platforms, the unknown amount of
revenues and profits that will result from its TR8 PGx testing service, as well as 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 17, 2024,
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.
Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com
- Financial Tables Follow -
APPLIED DNA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS