STONY BROOK, N.Y. March 12, 2025 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in PCR-based DNA technologies, today announced that it will effect a 1-for-50 reverse stock split of its issued and outstanding common stock. The Reverse Stock Split will become effective at 12:01 a.m. Eastern Time on Friday, March 14, 2025, and Applied DNA common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market as of the commencement of market open that same day.
Applied DNA common stock will continue to trade on The Nasdaq Capital Market under the symbol “APDN” following the reverse stock split, with a new CUSIP number of 03815U 508. The CUSIP number for the Company’s book entry warrants will not change.
After the effectiveness of the reverse stock split, the number of outstanding shares of common stock will be reduced from approximately 55.2 million to approximately 1.1 million. The total authorized number of shares will not be reduced. Proportional adjustments will be made to the number of shares of common stock issuable upon exercise or vesting of the Company’s outstanding stock options, restricted stock units, and warrants, as well as the applicable exercise or conversion prices, and to the number of shares issuable under the Company’s equity incentive plans and other existing agreements. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. There will be no change in the par value of $0.001 per share of the common stock as a result of the reverse stock split.
As previously disclosed, at an annual meeting of stockholders held on September 30, 2024, the Company’s stockholders voted to approve a proposal granting the Company’s Board of Directors the discretion to amend the Company’s certificate of incorporation to effect a reverse stock split of the Company’s common stock at a ratio of not less than 1-for-5 and not more than 1-for-50. The Company’s Board of Directors approved a 1-for-50 reverse stock split on March 3, 2025. The reverse stock split is intended to bring the Company into compliance with Nasdaq’s $1.00 per share minimum bid price requirement for continued listing on the Nasdaq Capital Market.
Applied DNA’s transfer agent, Equiniti Trust Company, will provide information to stockholders regarding their stock ownership following the reverse stock split. Stockholders holding their shares in book-entry form or through a bank, broker, or other nominee do not need to take any action in connection with the reverse stock split. Their accounts will be automatically adjusted to reflect the number of shares owned. Beneficial holders are encouraged to contact their bank, broker, or other nominee with any procedural questions.
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. The Company operates in two 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.
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. 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 the effective date of the reverse stock split and the trading of the common stock on a split-adjusted basis, the Company’s belief that the reverse stock split will allow the Company to regain compliance with Nasdaq listing standards, the Company’s 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, and regarding 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 the Company’s 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 a 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, its Quarterly Report on Form 10-Q filed on February 13, 2025, 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.
Applied DNA Sciences Contact: Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com Web:adnas.com
Announces Exit of DNA Tagging and Security Products and Services Business Segment Workforce Reduction of 20% of Headcount Implemented in January GMP Site 1 Facility Complete and Certified for Commercial Operation in January Webcast and Conference Call Scheduled for today at 4:30 PM ET
STONY 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 Updates:
Corporate:
In December 2024, the Company announced a strategic restructuring of its business operations, including the potential divestiture of its DNA Tagging and Security Products and Services (“DNA Tagging”) business segment.
Today, the Company announced its exit from its DNA Tagging business segment and completion of a workforce reduction of approximately 20% of its total headcount related primarily to employees within its DNA Tagging segment. The workforce reduction will result in an approximate 13% reduction in annual payroll costs, offset by one-time separation costs totaling approximately $300,000, which are expected to be recorded in the quarter ending March 31, 2025. The Company will continue to service certain of its existing DNA Tagging customer contracts.
LineaRx (Therapeutic DNA Production and Services subsidiary)
The buildout of the Company’s initial GMP facility located in Stony Brook, New York (“Site 1”), was completed on January 31, 2025, and certified for commercial operation with ISO 7-compliant with ISO 5-compliant workspaces. As currently configured, Site 1 enables the enzymatic manufacture of Linea DNA™ IVT templates used in the production of mRNA clinical trial materials:
The initial projected manufacturing capacity of Site 1 is approximately ten grams per annum, which supports potential annual revenues in the range of $10 million to $30 million, depending on product mix[1].
Site 1 gives the Company the new ability to service clients across all customer product stages with relevant grades of DNA: RUO for research and development; GLP for discovery and early pre-clinical studies; GMP for late pre-clinical studies and clinical phases.
The Company is in the late stage of process development with a U.S.-based therapeutics developer. If development is completed successfully, the Company anticipates its receipt of a first GMP order for IVT templates in the quarter ending June 30, 2025.
The Company’s Linea DNA platform secured its first-in-human clinical validation with Linea DNA used as a critical component in the manufacture of a CAR-T therapy under a Czech Republic State Institute for Drug Control-approved Phase I clinical trial sponsored by the Institute of Hematology and Blood Transfusion (UHKT). The trial represents the first instance of regulatory consent of Linea DNA’s use in a clinical setting and demonstrates Linea DNA’s ability to empower faster manufacturing timelines than conventional plasmid DNA-based therapy development.
Applied DNA Clinical Labs (MDx Testing Services subsidiary)
Completed certifications necessary to expand the TR8™ PGx testing service to all S. States that recognize New York’s CLEP/CLIA certification for genetic testing. Samples collected from outside of New York State will be tested at Applied DNA’s diagnostic laboratory in Stony Brook.
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 operational goals.”
“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.”
First Quarter Fiscal 2025 Financial Highlights
Total revenues: $1.2 million, an increase of 34% compared to $891 thousand for the first quarter of fiscal 2024.
Operating loss: $3.0 million, compared to an operating loss of $3.8 million for the first quarter of fiscal 2024.
Net loss: $2.7 million, compared to a net loss of $1.1 million for the first quarter of fiscal 2024.
Adjusted EBITDA: improved to negative $2.9 million, compared to negative $3.2 million for the first quarter of fiscal 2024.
Cash and cash equivalents as of December 31, 2024: $9.3 million, which includes $5.7 million of net proceeds (after deducting placement agent fees and other offering expenses) from the registered direct offering that closed on October 31, 2024.
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 Sciences’ call:
Telephonic replay (available 1 hour following the conclusion of the live call through February 20, 2025):
Domestic callers (toll free): 1-877-344-7529
Canadian callers (toll free): 1-855-669-9658
Participant Passcode: 7896562
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 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. 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 a 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.
APPLIED DNA SCIENCES, INC. CONSOLIDATED BALANCE SHEETS
December 31, 2024 (unaudited)
September 30, 2024
ASSETS
Current assets:
Cash and cash equivalents
9,294,365
6,431,095
Accounts receivable, net of allowance for credit losses of $82,723 and $75,000 at December 31, 2024, and September 30, 2024, respectively
911,502
362,013
Inventories
468,580
438,592
Prepaid expenses and other current assets
601,508
815,970
Total current assets
11,275,955
8,047,670
Property and equipment, net
638,483
553,233
Other assets:
Restricted cash
750,000
750,000
Intangible assets
2,698,975
2,698,975
Operating right of use asset
607,288
739,162
Total assets
15,970,701
12,789,040
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable and accrued liabilities
1,610,972
1,793,427
Operating lease liability, current
558,426
545,912
Deferred revenue
217,215
58,785
Total current liabilities
2,386,613
2,398,124
Long term accrued liabilities
31,467
31,467
Deferred revenue, long term
194,000
194,000
Operating lease liability, long term
48,861
193,249
Deferred tax liability, net
684,115
684,115
Warrants classified as a liability
76,000
320,000
Total liabilities
3,421,056
3,820,955
Commitments and contingencies (Note G)
Applied DNA Sciences, Inc. stockholders’ equity:
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of December 31, 2024, and September 30, 2024
—
—
Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2024, and September 30, 2024
—
—
Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2024, and September 30, 2024
—
—
Common stock, par value $0.001 per share; 200,000,000 shares authorized as of December 31, 2024 and September 30, 2024, 54,111,523 and 10,311,885 shares issued and outstanding as of December 31, 2024 and September 30, 2024, respectively
54,114
10,314
Additional paid in capital
339,918,754
318,805,058
Accumulated deficit
(327,219,390)
(309,672,755)
Applied DNA Sciences, Inc. stockholders’ equity
12,753,478
9,142,617
Noncontrolling interest
(203,833)
(174,532)
Total equity
12,549,645
8,968,085
Total liabilities and equity
15,970,701
12,789,040
APPLIED DNA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
Three Months Ended December 31, 2024
Three Months Ended December 31, 2023
Revenues
Product revenues
495,847
307,317
Service revenues
374,444
247,147
Clinical laboratory service revenues
326,326
336,700
Total revenues
1,196,617
891,164
Cost of product revenues
264,052
282,545
Cost of clinical laboratory service revenues
248,458
377,522
Total cost of revenues
512,510
660,067
Gross profit
684,107
231,097
Operating expenses:
Selling, general and administrative
2,633,098
3,084,348
Research and development
1,015,010
935,815
Total operating expenses
3,648,108
4,020,163
LOSS FROM OPERATIONS
(2,964,001)
(3,789,066)
Interest income
71,440
33,323
Unrealized gain on change in fair value of warrants classified as a liability
244,000
2,639,000
Other expense, net
(20,152)
(13,538)
Loss before provision for income taxes
(2,668,713)
(1,130,281)
Provision for income taxes
—
—
NET LOSS
(2,668,713)
(1,130,281)
Less: Net loss attributable to noncontrolling interest
29,301
25,181
NET LOSS attributable to Applied DNA Sciences, Inc.
(2,639,412)
(1,105,100)
Deemed dividend related to warrant modifications
(14,907,223)
(77,757)
NET LOSS attributable to common stockholders
(17,456,635)
(1,182,857)
Net loss per share attributable to common stockholders-basic and diluted
(0.56)
(1.73)
Weighted average shares outstanding- basic and diluted
31,518,861
683,672
APPLIED DNA SCIENCES, INC. CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA (unaudited)
Three Month Period Ended December 31, 2024
Three Month Period Ended December 31,2023
Net loss
$ (2,688,713)
$ (1,130,281)
Interest income
(71,440)
(33,323,)
Depreciation and amortization
58,580
298,951
Provision for bad debt
7,723
–
Stock based compensation expense
28,973
340,705
Unrealized gain on change in fair value of warrants classified as a liability
Investor Call and Webcast Scheduled for 4:30 PM ET
STONY BROOK, N.Y. February 12, 2025 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in polymerase chain reaction (PCR)-based technologies, today announced that it will release its first quarter fiscal 2025 financial results after the market close on Thursday, February 13, 2025.
The Company will host a conference call for shareholders and the investment community at 4:30 p.m. ET on that same day.
Webcast and Conference Call Date & Time: Thursday, February 13 @ 4:30 p.m. ET
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 currently operate in three 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; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
STONY BROOK, N.Y. – February 11, 2025 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today issued a reminder to its shareholders to vote ahead of a reconvening of a Special Meeting of Stockholders (the “Special Meeting”) to be held on Friday, February 14, 2025 at 11:00 a.m.
The Company’s Board of Directors encourages any shareholder as of the record date of November 25, 2024, who has not yet voted their shares on the Warrant Exercise Proposal (as defined below), to contact Kingsdale Advisors to vote their shares: 1-855-682-9644 or by e-mail at contactus@kingsdaleadvisors.com.
The Special Meeting was originally held on January 23, 2025, but, due to a lack of quorum, was adjourned to allow additional time for the Company’s stockholders to vote on Proposal One (the “Warrant Exercise Proposal”) set forth in the Company’s definitive proxy statement (the “Proxy Statement”) filed with the U.S. Securities and Exchange Commission on December 10, 2024: to approve, in accordance with Nasdaq Listing Rule 5635(d), the exercisability of certain common stock purchase warrants, and the issuance of the common stock underlying such warrants, which warrants were issued in connection with an offering of securities of the Company that occurred on October 30, 2024.
YOUR VOTE IS IMPORTANT! Your vote is important, and we ask that you please vote “FOR” the Warrant Exercise Proposal. For specific instructions on how to vote your shares, please refer to the instructions on the Notice of Internet Availability of Proxy Materials you received in the mail, the section entitled “About the Special Meeting” beginning on page 1 of the Proxy Statement or, if you request to receive printed proxy materials, your enclosed proxy card. Please note that shares held beneficially in street name may be voted by you in person at the Special Meeting only if you obtain a legal proxy from the broker, bank, trustee, or other nominee that holds your shares giving you the right to vote the shares. If you have any questions or require any assistance with voting your shares, please call the Company’s proxy solicitor, Kingsdale Advisors, at: 1- 855-682-9644 (toll free) or 1-646-491-9095 (call or text outside North America) or by email at contactus@kingsdaleadvisors.com.
Additional Information In connection with the Company’s Special Meeting, the Company has filed with the U.S. Securities and Exchange Commission (“SEC”) and mailed to the shareholders of record entitled to vote at the Special Meeting a definitive proxy statement and other documents, including a proxy card. SHAREHOLDERS ARE ENCOURAGED TO READ THE DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY THE COMPANY AND ALL OTHER RELEVANT DOCUMENTS WHEN FILED WITH THE SEC AND WHEN THEY BECOME AVAILABLE BECAUSE THOSE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. A copy of our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, including financial statements and any financial statement schedules required to be filed in accordance with SEC rules, will be sent without charge to any stockholder of the Company requesting it in writing from: Applied DNA Sciences, Inc., 50 Health Sciences Drive, Stony Brook, New York 11790, Attention: Beth Jantzen. We also make available, free of charge on our website, all of our filings that are publicly filed on the SEC’s EDGAR website, including Forms 10-K, 10-Q and 8-K, at www.adnas.com.
Signals Start of New Commercialization Phase for LineaRx Subsidiary Company Negotiating GMP Supply Agreement Company Reaffirms Strategic Restructuring Timeline
STONY BROOK, N.Y., January 10, 2025 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today announced the completion of the buildout of its new Good Manufacturing Practices (GMP) manufacturing facility (the “facility”) within its Stony Brook, New York, headquarters and readiness to accept orders for the manufacture of LineaDNA™ IVT templates that clients can utilize for the production of mRNA clinical trial materials. The facility is undergoing final testing and is expected to be fully operational by the end of the current month. The Company also announced that it is actively negotiating a supply agreement for GMP IVT template with a mRNA therapeutic developer.
Separately, the Company reaffirmed its intention to complete the implementation of its previously announced strategic restructuring plan by the end of the current quarter. The restructuring is intended to drive sustainable growth from LineaRx, Inc., its biotherapeutic subsidiary, optimize Applied DNA’s cost structure, and extend the parent company’s cash runway.
GMP Facility Overview:
Based on updated modeling, an initial projected annual IVT template manufacturing capacity of approximately ten (10) grams with 100% cell-free workflow;
10mg to gram-scale production in 6-14 weeks with multiple purification options;
Dedicated warehouse, process development, analytical testing, and quality control areas;
The capacity to deliver chemically modified LineaDNA IVT templates paired with the Company’s proprietary RNA polymerase to mitigate double-stranded DNA (dsRNA) contaminants in commercial-scale mRNA production; and,
A projected revenue capacity ranging from $10 million to $30 million, depending on product mix (sales of IVT template or the paired-IVT template and Linea™ RNA polymerase for mRNA production[1].)
“Once operational, our GMP facility stands ready to support the development of next-generation genetic medicines with a cell-free, enzymatic approach to IVT template production that confers the advantages of simplicity, purity, speed, flexibility, and scalability in a fractional footprint relative to conventional plasmid-DNA (fermentation)-based IVT template manufacturing processes. We believe we are in an unmatched position to help bring the advantages of synthetic DNA to our clients to develop innovative therapies,” stated Dr. James A. Hayward, chairman and CEO of Applied DNA.
Added Clay Shorrock, president of LineaRx, Inc., “We believe the upcoming operational launch of our GMP facility is a pivotal junction for the Company, representing the final piece of a multi-year business strategy to commercialize our LineaDNA and Linea IVT platforms and return us to a growth trajectory. With a strong GMP sales funnel for IVT templates and in active negotiations on our first supply agreement, we look forward to engaging with our therapeutic developer and CDMO customers to support their cell-free DNA needs.”
About the LineaDNA™ and Linea™ IVT Platforms The LineaDNA 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 LineaDNA platform can produce high-fidelity DNA constructs ranging from 100bp to 20kb in size. The DNA produced via the LineaDNA 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 LineaDNA 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, we currently operate in three 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; (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.
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, the unknown future demand for its biotherapeutics products and services, the unknown amount of revenues and profits that will result from its 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, 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 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.
Contacts: Investor Relations contact: Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com Program contact: Clay Shorrock, 631-912-6454, clay.shorrock@adnas.com Web: www.adnas.com X: @APDN
STONY BROOK, N.Y. January 8, 2025 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in polymerase chain reaction (PCR)-based technologies, today announced that it has rescheduled its Investor Update call to Thursday, February 13, 2025, to coincide with the release of its first quarter fiscal 2025 financial results.
The Company originally scheduled an Investor Update call for January 9, 2025, to update shareholders on its strategic restructuring announced in December 2024 and GMP initiative. The change reflects the observance of the National Day of Mourning in recognition of the passing of former President Jimmy Carter.
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 currently operate in three 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; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
Regulatory Approval Showcases Clinical Advancement of Linea DNA™ as a Rapid and Effective Means of Producing CAR-T cell Therapies
STONY BROOK, N.Y., – December 18, 2024 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, announced that the State Institute for Drug Control of the Czech Republic (SÚKL) approved an application for a Phase I clinical trial of an investigational CD123-specific autologous CAR T-cell therapy by the Institute of Hematology and Blood Transfusion (ÚHKT/Eng: IHBT) in Prague for the treatment of relapsed and/or refractory acute myeloid leukemia (AML). UHKT-CAR123-01 utilizes Applied DNA’s synthetic DNA, Linea™ DNA, as a critical component in its manufacture.
AML is a hematologic malignancy with a high rate of treatment failure for which current treatment options are often restricted to palliative approaches. Novel emerging methods leveraging advancements in genetic medicines, such as CAR T-cell therapies, can potentially improve outcomes of patients after relapse but have been difficult to establish for clinical use due to high costs and long manufacturing times predominantly attributable to the use of viral vectors.
UHKT-CAR123 seeks to address these issues by generating CD123-specific CAR T-cells in a non-viral workflow utilizing Linea DNA to reduce manufacturing costs and timelines. Preclinical data showed that ÚHKT’s Linea DNA-empowered non-viral workflow resulted in the rapid production of substantial and cost-efficient CAR T-cell yields with high potency[1].
“The use of Linea DNA illustrates our innovative approach to finding new and best-in-class treatments for patients with relapsed or refractory AML,” stated Dr. Jan Vydra, principal investigator of the UHKT-CAR123 clinical trial.
Added Pavel Otáhal, Ph.D., scientific project leader at ÚHKT, “The Linea DNA platform enables the very rapid abiotic production of expression vectors usable for highly effective electroporation-based CAR-T manufacturing compared to plasmid-based vectors. The decreases in complexities and costs of developing autologous CAR-T technologies offer an innovative approach for the rapid clinical testing of novel types of CAR-T products. This is an incredible milestone for ÚHKT and one that we could not have achieved without the commitment of the Applied DNA team.”
Applied DNA CEO Dr. James A. Hayward, said, “We congratulate ÚHKT on their progress into the clinic. Their accomplishment is also a significant milestone for Linea DNA as we look to support additional customers expected to initiate clinical trials in calendar 2025.”
About Linea™ DNA Linea™ DNA is an enzymatically produced, linear DNA manufactured by the Company’s proprietary, large-scale polymerase chain reaction (“PCR”) based manufacturing platform, the Linea™ DNA platform. As an alternative to plasmid-based DNA, Linea DNA can be used to manufacture of a wide range of nucleic acid-based therapies and in vitro diagnostics, including mRNA therapies, DNA vaccines, cell and gene therapies, and molecular and genetic diagnostic tests.
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 currently operate in three 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; (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.
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, the unknown future demand for its biotherapeutics and/or diagnostic products and services, the unknown amount of revenues and profits that will result from its Linea IVT and or Linea DNA platforms, the unknown outcome of the IHBT clinical trial, unforeseeable adverse events that could be encountered in the IHBT clinical trial, the fact that there has never been a commercial drug product utilizing the Linea DNA 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 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.
[1]LINEAR DNA PLATFORM FOR THE NON-VIRAL POINT-OF-CARE PRODUCTION OF. . . by Pavel Otáhal. Copyright (C) 2024 MULTILEARNING Group Inc. https://library.ehaweb.org/eha/2024/eha2024-congress/419809/pavel.othal.linear.dna.platform.for.the.non-viral.point-of-care.production.of.html
Pursuing Divestiture of CertainT® Platform, Implements Changes to Corporate Leadership Build-out of GMP Manufacturing Facility to be Completed by January 9, 2025 Webcast and Conference Call Scheduled for Thursday, January 9, 2025, at 4:30 PM ET
STONY BROOK, N.Y. – December 17, 2024 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA technologies, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024. An update on the buildout of the Company’s GMP manufacturing facility is available for viewing via slideshow on the Presentations page of the Investor Relations portion of the Company’s website. The Company’s Form 10-K can be viewed on the SEC Filings page.
Concurrently, the Company announced a strategic restructuring of its business operations to focus its resources on manufacturing critical starting materials for genetic medicines enabled by its Linea™ DNA and Linea™ IVT platforms. Ongoing and future actions supporting Applied DNA’s restructuring strategy include:
The pursuit of a divestiture of the CertainT® platform for supply chain traceability and authentication[1];
The targeting of operating expense reductions of 15% compared to fiscal 2024, inclusive of costs associated with the potential divestiture of the CertainT platform. Cost reductions are expected to be completed in the second quarter of fiscal 2025 (ending March 31, 2025);
The retention of Applied DNA Clinical Labs, the Company’s clinical laboratory subsidiary, which will pursue profitable growth via its TR8™ pharmacogenomic (PGx) testing services.
The immediate promotion of Chief Operating Officer Judith Murrah to President. Chief Legal Officer and Executive Director of Business Development Clay Shorrock assumes the additional role of President of LineaRx, Inc., the Company’s majority-owned enzymatic DNA manufacturing subsidiary. Dr. James A. Hayward remains Chairman of the Board of Directors and Chief Executive Officer; and
The retention of its non-GMP DNA manufacturing business for in vitro diagnostics (IVD) and other specialty applications.
Management Commentary
“Following a thorough review of our businesses to enhance value for shareholders, we believe that our expertise and experience in enzymatic DNA production, the wealth of data generated over years that validate Linea DNA as a compelling alternative to plasmid DNA, and our proximity to GMP manufacturing are not fully recognized in our current structure. Our actions today will sharpen our focus on commercialization initiatives for our Linea DNA and Linea IVT platforms to return the Company to revenue growth and expand shareholder value,” stated Dr. Hayward. “With several of our existing customers expected to initiate clinical trials in the next twelve months, we believe the completion of our GMP manufacturing facility will allow us to win several long-term, high-margin GMP supply agreements for IVT templates, resulting in the significant utilization of our GMP manufacturing capacity in FY2025.”
Recent Operational Highlights
Therapeutic DNA Production Services (LineaRx)
GMP roadmap execution:
The buildout of the Company’s GMP manufacturing facility is expected to be completed by January 9, 2025, with an annual revenue capacity ranging between $4 million and $16 million depending on product mix (sales of Linea DNA or the paired-Linea DNA IVT template-and-Linea RNA polymerase for mRNA production)[2].
Linea DNA/Linea IVT template commercialization:
GMP production runs are expected to begin in the first half of CY2025 to supply Linea DNA IVT templates to existing customers for the manufacture of mRNA clinical trial materials.
Initiated a development program with a well-known enzyme engineering company for a next-generation high fidelity, long-range DNA polymerase (DNAP) and buffer system to amplify long and complex DNA sequences via PCR. The resultant DNAP/buffer system combination will be exclusive to LineaRx and will allow for greater efficiencies and sequence fidelity in the manufacture of Linea DNA of >6kb in length.
The Linea IVT platform (paired IVT template and RNA polymerase) is being evaluated by a multinational pharmaceuticals manufacturer in Japan.
Linea DNA commercialization for IVT diagnostics:
Received a $500,000 follow-on order from a global manufacturer of IVDs for a cancer diagnostic application.
MDx Testing Services (Applied DNA Clinical Labs)
TR8 PGx testing service commercialization:
Applied DNA Clinical Labs (ADCL), the Company’s clinical molecular diagnostics and genetic testing services subsidiary, is presently exploring reference lab opportunities for volume-based testing. ADCL continues to refine its go-to-market strategy for its precision medicine approach to personalized prescribing.
Financial Highlights Total revenues for the fourth quarter of fiscal 2024 were $813 thousand compared with $780 thousand for the same period of fiscal 2023. The year-over-year increase was a result of higher Service revenues primarily related to an increase in isotopic testing services revenues that offset lower clinical laboratory services revenues due to a decrease in demand for COVID-19 testing.
Operating loss for the fourth quarter of fiscal 2024 was $3.3 million compared with $4.2 million in the prior year period. The improvement is primarily attributable to lower selling, general and administrative costs year-over-year attributable to lower stock-based compensation, offset by an increase in professional fees.
Net loss for the fourth quarter of fiscal 2024 was $3.3 million, or $0.32 per share, compared with $3.6 million, or $5.29 per share, in the prior year period and on a higher number of shares outstanding. Adjusted EBITDA for the fourth quarter of fiscal 2024 was a negative $3.2 million compared with a negative $3.5 million in the prior year period.
Total revenues for fiscal 2024 were $3.4 million compared with $13.4 million in fiscal 2023. The decrease was driven by lower clinical laboratory services revenues due to a decrease in demand for COVID-19 testing services, as the prior fiscal year included testing revenues under our contract with CUNY, which terminated in June 2023.
Operating loss for fiscal 2024 was $14.0 million compared with $11.0 million in the prior year period. The increase was driven primarily by lower clinical laboratory services revenues, offset by a decrease in total operating expenses.
Net loss for fiscal 2024 was $7.1 million, or $1.82 per share, compared with $10.0 million, or $15.21 per share in the prior year period and on a higher number of shares outstanding.
Cash and cash equivalents on September 30, 2024, totaled $6.4 million. On October 31, 2024, the Company completed a registered direct offering and received net proceeds of approximately $5.8 million after deducting placement agent fees and other estimated offering costs payable by the Company. As a result of this offering, cash and cash equivalents as of November 3, 2024, were approximately $10.1 million.
January 9 Investor Update Conference Call Information The Company will hold a conference call and webcast to update investors on its restructuring and GMP roadmap on January 9, 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 Sciences’ call:
Telephonic replay (available 1 hour following the conclusion of the live call through January 16, 2025):
Domestic callers (toll free): 1-877-344-7529
Canadian callers (toll free): 1-855-669-9658
Participant Passcode: 7896562
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 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 currently operate in three 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; (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.
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. 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 a commercial drug product utilizing PCR-produced DNA technology and/or the Linea IVT platform approved for therapeutic use, the unknown amount of revenues and profits that will result from its TR8 PGx testing service, the unknown outcome of the potential divestiture of the Company’s CertainT Platform, and if successfully divested, the unknown consideration that will be received by the Company, the limited market acceptance for its CertainT Platform, 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 7, 2023, its Quarterly Reports on Form 10-Q filed on February 8, 2024, May 10, 2024, August 8, 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.
[1] While the Company is currently in negotiations for the potential divestiture of the CertainT platform, no assurance can be given that a potential divestiture will be completed.
[2] Based on internal company assumptions and modeling using a 1/100 DNA-to-RNA amplification ratio and an mRNA vaccine dose of 30μg. Manufacture of the final mRNA drug substance will be conducted by therapy developers or their CDMO.
APPLIED DNA SCIENCES, INC. CONSOLIDATED BALANCE SHEETS
September 30, 2024
September 30, 2023
ASSETS
Current assets:
Cash and cash equivalents
$ 6,431,095
$ 7,151,800
Accounts receivable, net of allowance for credit losses of $75,000 at September 30, 2024 and 2023
362,013
255,502
Inventories
438,592
330,027
Prepaid expenses and other current assets
815,970
389,241
Total current assets
8,047,670
8,126,570
Property and equipment, net
553,233
838,270
Other assets:
Restricted cash
750,000
750,000
Intangible assets
2,698,975
2,698,975
Operating right of use asset
739,162
1,237,762
Total assets
$12,789,040
$13,651,577
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable and accrued liabilities
$1,793,427
$2,270,388
Operating lease liability, current
545,912
498,598
Deferred revenue
58,785
76,435
Total current liabilities
2,398,124
2,845,421
Long term accrued liabilities
31,467
31,467
Deferred revenue, long term
194,000
194,000
Operating lease liability, long term
193,249
739,162
Deferred tax liability, net
684,115
684,115
Warrants classified as a liability
320,000
4,285,000
Total liabilities
3,820,955
8,779,165
Commitments and contingencies
Applied DNA Sciences, Inc. stockholders’ equity:
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of September 30, 2024 and 2023
—
—
Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2024 and 2023
—
—
Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2024 and 2023
—
—
Common stock, par value $0.001 per share; 200,000,000 shares authorized as of September 30, 2024 and 2023, 10,311,885 and 682,926 shares issued and outstanding as of September 30, 2024 and 2023, respectively
10,314
683
Additional paid in capital
318,805,058
307,397,623
Accumulated deficit
(309,672,755)
(302,447,147)
Applied DNA Sciences, Inc. stockholders’ equity
9,142,617
4,951,159
Noncontrolling interest
(174,532)
(78,747)
Total equity
8,968,085
4,872,412
Total liabilities and equity
$ 12,789,040
$13,651,577
APPLIED DNA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS
Twelve Month Period Ended September 30, 2024 (unaudited)
Twelve Month Period Ended September 30, 2023 (unaudited)
Twelve Month Period Ended September 30, 2024
Twelve Month Period Ended September 30, 2023
Revenues
Product revenues
$ 127,727
$ 87,385
$ 1,074,813
$ 1,218,185
Service revenues
359,899
170,053
1,038,677
996,866
Clinical laboratory service revenues
325,480
522,298
1,317,930
11,152,392
Total revenues
813,106
779,736
3,431,420
13,367,443
Cost of product revenues
285,616
204,777
1,138,650
1,308,620
Cost of clinical laboratory service revenues
282,591
495,963
1,275,891
6,525,391
Total cost of revenues
568,207
700,740
2,414,541
7,834,011
Operating expenses:
Selling, general and administrative
2,684,444
3,310,910
11,447,894
12,751,644
Research and development
831,711
938,907
3,593,750
3,735,078
Total operating expenses
3,516,155
4,249,817
15,041,644
16,486,722
LOSS FROM OPERATIONS
(3,271,256)
(4,170,821)
(14,024,765)
(10,953,290)
Interest income
91,329
41,224
176,301
75,332
Unrealized (loss) gain on change in fair value of warrants
(134,000)
519,700
9,430,000
854,400
Unrealized (loss) on change in fair value of warrants – warrant modifications
–
–
(394,000)
–
Transaction costs related to warrant liabilities
–
–
(633,198)
–
Loss on issuance of warrants
–
(1,633,767)
–
Other income (expense), net
183
(5,754)
(8,877)
642
NET LOSS
$(3,313,744)
$(3,615,651)
$(7,088,306)
$(10,022,916)
Less: Net loss attributable to noncontrolling interest
$17,000
$23,387
$95,785
$75,857
Deemed dividend warrant repricing
$-
$-
$(233,087)
$–
Net loss applicable to common stockholders
$(3,296,744)
$(3,592,264)
$(7,225,608)
$(9,947,059)
Net loss per share-basic and diluted
$ (0.32)
$ (5.29)
$ (1.82)
$ (15.21)
Weighted average shares outstanding- basic and diluted
10,301,831
678,442
3,966,026
653,771
APPLIED DNA SCIENCES, INC. CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA (unaudited)
Three Month Period Ended September 30, 2024
Three Month Period Ended September 30, 2023
Net loss
$ (3,313,744)
$(3,615,651)
Interest income
(91,329)
(41,224)
Depreciation and amortization
76,985
329,681
Provision for bad debt
(6,089)
16,810
Stock based compensation expense
30,248
341,495
Unrealized loss (gain) on change in fair value of warrants classified as a liability
STONY BROOK, N.Y. – December 16, 2024 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in polymerase chain reaction (PCR)-based technologies, today announced that it will release its fourth quarter and fiscal year 2024 financial results after the market close on Tuesday, December 17, 2024.
The Company will host a conference call for the investment community to coincide with an update on its GMP manufacturing facility build-out on Thursday, January 9, 2025, at 4:30 p.m. ET.
Webcast and Conference Call Date & Time: Thursday, January 9 @ 4:30 p.m. ET
Replay for international callers: 412-317-0088, replay access code 7896562
Replay for Canadian callers (toll free): 855-669-9658, replace access code 7896562
An accompanying slide presentation will be embedded in the webcast (live and replay) and can be accessed under the ‘Company Events’ section of the Applied DNA investor relations website at https://investors.adnas.com/news-events/company-events/. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.
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 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; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
