Full Press Release Details
Applied DNA Announces First Quarter Fiscal Year
- Company On Track to
Initiate First-Phase GMP Production Capacity for mRNA Critical Starting Materials During First Half of Calendar 2024, Projects Initial
Facility Capacity to Enable up to $15 Million1 of Linea IVT Revenue2 Annually -
- Conference Call/Webcast
Scheduled for Today at 4:30 PM ET -
STONY BROOK, N.Y. - February
8, 2024 - 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 first fiscal quarter ended December 31, 2023. The
Company's Form 10-Q can be viewed at https://investors.adnas.com/sec-filings/.
"We made substantial progress
in advancing the commercialization of our Linea IVT platform and the availability of GMP capacity for the manufacture of critical
starting material for mRNA therapeutics during the past quarter," stated Dr. James A. Hayward, president and CEO of Applied DNA.
"Our efforts centered on establishing and implementing new quality systems for GMP manufacturing to meet our customer requirements
at a scale sufficient for use through clinical-stage mRNA therapy development. In addition, we initiated a scale-up manufacturing project
for our Linea RNA polymerase (RNAP) with an enzyme manufacturer to optimize the enzyme's production for commercial-scale
use. We also secured our first CDMO partner to validate the commercial scale-up of Linea IVT within a cGMP workflow setting.
"In parallel, we expanded our sales pipeline
and active projects with the addition of new research and development-stage customers for Linea IVT that can serve as the basis for potential
long-term supply agreements as customers' therapies enter toxicology, pharmacokinetics, and early-stage clinical development,"
continued Dr. Hayward. "We generated data readouts that further substantiate the capacity of Linea IVT to create equal or
greater RNA yields with double-stranded RNA contamination at levels 10x-50x lower than those found using conventional mRNA production
methods. Feedback to-date on our Linea IVT and Linea DNA platforms has been positive, having completed multiple successful customer evaluations
within the quarter. Particularly noteworthy, we completed an evaluation with a clinical stage mRNA customer in which our IVT templates
meet or exceeded all customer quality metrics with manufacturing speed that exceeded all other IVT template sources being evaluated by
on company internal modeling utilizing current pricing projections and industry figures
is comprised of Linea DNA IVT templates, Linea RNAP and technology license royalty
Concluded Dr. Hayward, "Supplying
both DNA template and RNA polymerase positions us to capture a greater percentage of the economics of mRNA therapy production that we
believe establishing our GMP production capacity will unlock. After the close of the quarter, we completed an equity offering that supports
the initial phase of our GMP plan and timeline for critical starting materials in the production of mRNA. Slated to come online during
first half of calendar 2024 and based on internal modeling, current pricing projections, and industry figures, we project our GMP facility,
with an initial footprint of less than 1,000 square feet, to enable annual total Linea IVT revenues of up to $15 million. We believe
our manufacturing workflow is highly reproducible, allowing us to scale our production facilities to meet incremental customer demand
quickly. Looking ahead, we will continue to prioritize the commercialization of our Linea IVT and Linea DNA platforms and rationalize
our cost structure in support of our biotherapeutic goals."
Summary First Quarter Fiscal 2024 Financial Results:
| Cash and cash equivalents stood at $3.4 million on December 31, 2023, compared with $7.2 million as of September 30, 2023. | ||
| On February 2, 2024 , the Company closed on a registered direct offering with institutional investors for gross proceeds of $3.44 million. In a concurrent private placement, the Company issued 11,288,122 unregistered warrants with an exercise price of $0.609 per warrant share. If these warrants were to be exercised assuming stockholder approval is obtained, it would result in additional gross proceeds of $6.87 million. The Company also agreed to reduce the exercise price of warrants previously issued to the investors as well as other certain other prior investors with exercise prices ranging from $1.29 to $4.00 per warrant to $0.609 per warrant. The Company further agreed to extend the expiration dates for such warrants to August 2028. The foregoing reductions of the exercise price and extension of expiration dates of such warrants is subject to stockholder approval and if such warrants were to be exercised, it would result in additional gross proceeds of $1.86 million. |
First Quarter Fiscal 2024 Conference Call Information
The Company will hold a conference call and webcast to discuss its
first quarter of fiscal year 2024 financial results on Thursday, February 8, 2024, 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
| Domestic callers (toll free): 844-887-9402 | ||
| International callers: 412-317-6798 | ||
| Canadian callers (toll free): 866-605-3852 |
Live and replay of webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=UXIQvhHk
Telephonic replay (available 1 hour following the conclusion of
the live call through February 15, 2024):
| Domestic callers (toll free): 1-877-344-7529 | ||
| Canadian callers (toll free): 1-855-669-9658 | ||
| Participant Passcode: 3086410 |
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/
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.
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 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.
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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 incremental GMP manufacturing facility, the unknown amount
of revenues and profits that will result from our Linea IVT and or Linea DNA platforms, limited market acceptance for its supply chain