Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): January 13, 2025

Applied DNA Sciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction

of incorporation)

001-36745

(Commission File Number)

59-2262718

(IRS Employer

Identification No.)

50 Health Sciences Drive

Stony Brook, New York 11790

(Address of principal executive offices; zip code)

Registrant’s telephone number, including area code:

631-240-8800

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		APDN		The Nasdaq Stock Market

Item 7.01.

Regulation FD Disclosure.

On January 13, 2025, Applied DNA Sciences, Inc. (the “Company”) utilized a company presentation which may be used in presentations to investors from time to time. A copy of the presentation is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The information furnished in this Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 of this Current Report on Form 8-K is not incorporated by reference into any filings of the Company made under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in the filing unless specifically stated so therein.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Company Presentation, dated January 13, 2025
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 13, 2025	APPLIED DNA SCIENCES, INC.

	By:	/s/ James A. Hayward
	Name:	James A. Hayward
	Title:	Chief Executive Officer

Exhibit 99.1

©2025 Applied DNA Sciences, Inc. 2 The statements made by Applied DNA in this presentation may be “forward - looking” in nature within the meaning of Section 27 A of the Securities Act of 1933 , Section 21 E 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, the unknown amount of revenues and profits that will result from its Linea IVT and or LineaDNA 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 TR 8 PGx testing service, the limited market acceptance for its supply chain security products and services, 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 . Safe Harbor Statement

©2025 Applied DNA Sciences, Inc. Applied DNA at a Glance Located in Stony Brook , NY (SBU Campus) 30k sqft facility R&D, PD, and QC capabilities GMP manufacturing suite and Dx labs Industry Leader in Large - Scale PCR Pioneered PCR - based DNA production at very large scale 15 years of experience Multi - gram production Diverse Client Portfolio Strong existing and potential customer base Pharma, biotechs, IVD and CDMOs Robust and diverse sales opportunities Multiple Potential Revenue Streams Broad relevance to most genetic medicines, as well as IVD manufacturing and Dx testing Attractive margin profile With our proven track record of commercializing PCR - based technologies, we have developed a novel and disruptive 100% cell - free DNA production platform to displace the use of plasmid DNA as the cornerstone of modern genetic medicines manufacture 3

©2025 Applied DNA Sciences, Inc. Sales pipeline Sufficient cash balance for near - term goals * GMP buildout complete Multiple high - margin revenue streams Restructuring • Manufacture of DNA for therapies ( GMP , GLP, RUO ) • DNA for IVD manufacturing • Dx testing • Empowers long - term GMP supply agreements • Capacity is rapidly scalable with customer demand • Strong GMP and non - GMP DNA sales funnel • Converting early adopters to commercial contracts • Sharpened focus on LineaRx platforms for growth and margin expansion • Sufficient cash balance after completion of GMP buildout to accomplish near - term goals Investment Case Positioned for scalable growth *Based on internal Company modeling using current cash balance, forecasted OPEX and forecasted future revenue 4

©2025 Applied DNA Sciences, Inc. A Year of Company Milestones Validation of Linea IVT Platform Linea RNAP manufacturing scaleup completed Validation of reduced dsRNA at commercial scale Cost equivalence to legacy platforms demonstrated Initial GMP Site Completed Purpose built for LineaDNA Platform Production of IVT templates Estimated 10g/year initial capacity LineaDNA Enters the Clinic Used as critical component of CAR - T therapy First in human use of LineaDNA Reduced regulatory hurdles for customer as compared to pDNA Customer Success Over 25 customer projects in FY24 Multiple customers entering the clinic in FY25 GMP orders for IVT templates expected in 1HFY25 PGx Approval NYSDOH approval of 120 SNP targets relevant to a wide range of therapeutic indications Cardiac, pain management, oncology, and others Restructuring Targeting reduction in CAPEX of 15% v. FY2024 Sharpened focus on LRx Exploring divestiture of low margin tagging segment 5

©2025 Applied DNA Sciences, Inc. DNA is Critical to Modern Medicine Multiple high - margin market opportunities 7 1 IVT Templates Market size of $58B by 2033 Launched in late 2022 GMP Ready, with near - term manufacturing opportunities 2 Personalized Cancer Vaccines (PCV) Market size of $30B by 2033 Pursuing strategic partnerships Published data supporting production of PCVs 3 DNA Drug Substance DNA for manufacture of CAR - T, vaccines and gene therapies LineaDNA entered the clinic in December 2024 4 Gene Editing Market size of $40B by 2033 Recurring supply to a large multinational life sciences company for homology directed repair (HDR) 5 Linea IVT Platform Linea RNAP - Strong IP position Increases LineaRx TAM by ≈3x - 5x 6 Diagnostic (IVD) Applications DNA IVD Market size of $ 17 B by 2034 Current multi - year multi - gram contract Large growth opportunity Sources: ( i ) https://www.biospace.com/mrna - therapeutics - market - size - set - to - soar - usd - 58 - 90 - bn - by - 2033; (ii) https://www.biospace.com/genome - editing - market - size - to - reach - usd - 40 - 48 - billion - by - 2033 ;(iii) https://www.globenewswire.com/news - release/2024/08/23/2934961/0/en/Cancer - Vaccines - Market - Size - Expected - to - Reach - USD - 30 - 16 - Bn - by - 2033.html;(iv) https://www.biospace.com/press - releases/dna - diagnostics - market - size - to - worth - around - usd - 17 - billion - by - 2034 Significant dsRNA reduction at equal cost to legacy IVT platforms

©2025 Applied DNA Sciences, Inc. 8 • Large capital expenditure • Regulatory scrutiny • Long lead times • Based on 40 - year - old technology • Poor batch - to - batch consistency and batch failures • Unwanted DNA sequences including antibody resistance gene • Complex sequences are unstable • Increased complexities into mRNA manufacturing Legacy DNA Manufacturing Plasmid DNA Complexity

©2025 Applied DNA Sciences, Inc. 9 DNA Made Simple STEP 01 Obtain DNA Target Sequence and Design PCR Primers STEP 05 Provide Line a DNA to Customer STEP 04 Step 2 Perform High - Fidelity Large - Scale PCR STEP 03 Purify PCR Amplicons Platform Perform Analytical Characterization of PCR Amplicons High purity v. plasmid DNA Only 5 production steps Rapid large - scale production Uses enzymes and is 100% cell free Large yield in small footprint Only target DNA produced Simple process is well suited to cGMP Platform

©2025 Applied DNA Sciences, Inc. Comparison to pDNA IVT Template Data generated in collaboration with Kudo Biotechnology, Inc. Fragment Analyzer chromatograms shown mRNA COVID - 19 vaccine candidate shown mRNA from IVT Templates 10

©2025 Applied DNA Sciences, Inc. 11 • Various quality grades available • ISO13485 - based quality system • Robust analytical testing development capabilities • All LineaDNA IVT templates produced in new Stony Brook, NY GMP facility • Separate manufacturing spaces for RUO and IVD DNA GMP IVT Templates

©2025 Applied DNA Sciences, Inc. Current* LRx IVT Template Potential Sales Funnel 15 Selling Phase Estimated Timing of Potential GMP Run Application Product Customer Multiple evaluations complete. GMP quote issued. Negotiation of MSA. FY25Q2 sa - mRNA linDNA IVT templates A Multiple evaluations complete. GMP quote Issued FY25Q3 Prophylactic mRNA vaccine linDNA IVT templates B Second round of evaluation underway FY25Q3 sa - mRNA linDNA IVT templates C Multiple evaluations complete. GMP quote issued. FY25Q4 mRNA - based CAR - T cell linDNA IVT templates D Second round of evaluation underway FY25Q4 sa - mRNA linDNA IVT templates E Initial evaluation FY25Q4 Prophylactic mRNA vaccine Linea IVT platform F Initial evaluation FY25Q4 mRNA vaccine Linea IVT platform G Initial evaluation FY25Q4 Therapeutic mRNA vaccine Linea IVT platform H ©2024 Applied DNA Sciences, Inc. *As of 1/10/25

©2025 Applied DNA Sciences, Inc. Potential LineaRx IVT Template GMP Revenue Small size, big opportunity 16 $0 $10,000,000 $20,000,000 $30,000,000 $40,000,000 $50,000,000 3 6 9 12 18 Annual mass (g) of GMP DNA Sold Potential LRx GMP Revenue Opportunity* GMP IVT Templates Only GMP IVT Templates +50% Linea RNAP GMP IVT Templates +100% LineaRNAP *Based on Company internal modeling using current unit pricing and market analysis. All figures are for illustrative purposes on ly and do not constitute financial guidance and may be subject to further change without notice. Internal modeling is based on assumptions the Company believes are reasonable but could be mistaken. Potentia l r evenue opportunity may not be realized and is not indicative of profit. Projected FY2025 GMP Manufacturing Capacity Additional manufacturing capacity required • Initial ≈ 10g/year projected GMP capacity out of less than 1,000 sqft clean room • Potential expansion of current site or additional site needed to expand capacity • Sale of Linea RNAP significantly increases revenue and margin versus IVT templates alone

©2025 Applied DNA Sciences, Inc. LineaDNA Success Across Genetic Medicine Modalities Oncology DNA Vaccines Gene Therapy CAR - T Manufacture Neoantigen DNA Vaccine LNP/DNA IM Administration Protective Prophylactic DNA Vaccine AAV ITR - Transgene Production 17 1 - Kaštánková I, et al . Enzymatically produced piggyBac transposon vectors for efficient non - viral manufacturing of CD19 - specific CAR T cells. Mol Ther Methods Clin Dev. 2021 Aug 26;23:119 - 127. doi : 10.1016/j.omtm.2021.08.006. PMID : 34631931 2 - Conforti, A., Salvatori , E., Lione , L. et al. Linear DNA amplicons as a novel cancer vaccine strategy. J Exp Clin Cancer Res 41, 195 (2022). https://doi.org/10.1186/s13046 - 022 - 02402 - 5 3 - Mathias, M., Diel, D., Hayward, J. et al. A Linear SARS - CoV - 2 DNA Vaccine Candidate Reduces Virus Shedding in Ferrets. bioRxiv 2002.09.29.510112. https://doi.org/10.1101/2022.09.29.510112 4 – Internal company data

©2025 Applied DNA Sciences, Inc. Optionality on Dx Revenue • NYSDOH CLEP/CLIA Certified Permitted in virology and genetic testing (molecular) Approved LDTs for COVID - 19, mpox, and 120 target PGx Access to out of state patients in most states via NYSDOH licensure • TR8 TM PGx Testing 120 SNP targets relevant to a wide range of medications covering diverse disease indications Push towards personalized medicine is driving adoption of PGx as standard of care Ability to “break up” genetic targets to create numerous smaller PGx panels for specific indications • Minimal OPEX FY24 OPEX less than 10% of company consolidated OPEX Small team of 5 fulltime employees • Large Potential Upside PGx testing via self - pay provides strong margin profile Ability to run over 150 tests/week with existing equipment and staff Demonstrated ability to rapidly develop and gain approval for LDTs targeting emergent health crisis • Deep Scientific Bench Unique ability to leverage scientific expertise of LRx for complex assay development Access to assets of LRx such as NGS and LineaDNA manufacturing for LDT production 20

©2025 Applied DNA Sciences, Inc. The Path to Breakeven 21 $19 - 21m Annual Revenue Target to Breakeven* *Based on Company internal modeling using currently projected OPEX, product margins and current unit pricing. All figures are fo r illustrative purposes only and do not constitute financial guidance and may be subject to further change without notice. Internal modeling is based on assumptions the Company believes are reasonable but could be mistaken. Revenue Growth • Multiple and diverse high margin opportunities available now - GMP IVT Templates - Linea RNAP - DNA for IVD applications - PGx Testing • Cleanroom design is highly expandable - Less than $600k/cleanroom. Rapidly deployable - Grow capacity in lockstep with customer demand • Development of new DNA polymerase • Large tranche of existing warrants near or in the money Target New DNA Markets • Substantial near - term opportunity in personalized cancer vaccines (PCVs) - Exploring strategic partnerships • Gene editing/homology directed repair (HDR) • Closed ended DNA expression vectors Optimize Cost Structure • Restructuring underway - Targeting 15% reduction in OPEX as compared to FY2024 - Planned completion in current quarter • Potential for additional cost optimization to further reduce OPEX Expansion of GMP Capacity

©2025 Applied DNA Sciences, Inc. $3.4mm LTM Revenue (as of 9/30) $10.1mm Cash and Equivalents $ 0 Debt 55,188,523 Common Shares Outstanding 133,539,159 Options and Warrants 188,727,682 Fully Diluted Shares Outstanding***** Sept. 30 Fiscal Year - End Financial Snapshot Represents financial results as of September 30, 2024, except cash and equivalents on November 3, 2024; warrant and share counts as of January 8, 2025 22 Summary Warrant Schedule Warrants Exercised, Proceeds to Date Potential Remaining Gross Proceeds Warrants Remaining Outstanding Exercise Price Term Warrants 3.6m, $729K $17.6M 88.2M $0.20****** 5 yrs from 9/30/24 Series A 2.3M, $0 $0 2.3M or 6.8M*/** $1.99 or $0*/** 1 yr from 9/30/24 Series B n/a $6.5M 20.3M $0.32 5 yrs from shareholder approval*** Series C n/a $0 20.3M (1 - for 1 cashless)**** $0.32**** 18 months from shareholder approval*** Series D * Pursuant to alternative cashless option exercise (3 - for - 1) ** Subject to reset in the event of a reverse stock split; *** Unregistered; subject to shareholder approval at 23 Jan. Special Meeting; 1.02M placement warrants at identical exercise price also subject to shareholder approval **** Subject to reset in the event of a reverse stock split; floor of $0.0634 ***** Excludes potential resets or remaining Series B 3 - for - 1 cashless option exercises ******Majority of Series A are at $.20, with small tranche at $0.19

Cover	Jan. 13, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 13, 2025
Entity File Number	001-36745
Entity Registrant Name	Applied DNA Sciences, Inc.
Entity Central Index Key	0000744452
Entity Tax Identification Number	59-2262718
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	50 Health Sciences Drive
Entity Address, City or Town	Stony Brook
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	11790
City Area Code	631
Local Phone Number	240-8800
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value
Trading Symbol	APDN
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false