# EDGAR Filing Document

**Accession Number:** 0000744452
**File Stem:** 0001104659-23-017571
**Filing Date:** 2023-2
**Character Count:** 23677
**Document Hash:** 8fc5d3fb1a1dc4c0ed7052693a7dea24
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-017571.hdr.sgml**: 20230209

**ACCESSION NUMBER**: 0001104659-23-017571

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20230209

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230209

**DATE AS OF CHANGE**: 20230209

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** APPLIED DNA SCIENCES INC
- **CENTRAL INDEX KEY:** 0000744452
- **STANDARD INDUSTRIAL CLASSIFICATION:** SERVICES-MISCELLANEOUS BUSINESS SERVICES [7380]
- **IRS NUMBER:** 592262718
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0930

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36745
- **FILM NUMBER:** 23606203

**BUSINESS ADDRESS:**
- **STREET 1:** 50 HEALTH SCIENCES DRIVE
- **CITY:** STONY BROOK
- **STATE:** NY
- **ZIP:** 11790
- **BUSINESS PHONE:** 631-240-8800

**MAIL ADDRESS:**
- **STREET 1:** 50 HEALTH SCIENCES DRIVE
- **CITY:** STONY BROOK
- **STATE:** NY
- **ZIP:** 11790

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** PROHEALTH MEDICAL TECHNOLOGIES INC
- **DATE OF NAME CHANGE:** 20010504

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** DCC ACQUISITION CORP
- **DATE OF NAME CHANGE:** 19990211

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** DATALINK CAPITAL CORP/TX/
- **DATE OF NAME CHANGE:** 19980306

?xml version="1.0" encoding="utf-8"?

**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): February 9, 2023

**Applied DNA Sciences, Inc.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware**<br> (State or other jurisdiction<br> of incorporation) | **001-36745**<br> (Commission File Number) | **59-2262718**<br> (IRS Employer<br> 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 <br> Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, $0.001 par value | APDN | The Nasdaq Stock Market |

---

**Item 2.02 Results of Operations and Financial Condition.**

On February 9, 2023, Applied DNA Sciences, Inc. ("Applied DNA Sciences" or the "Company") issued a press release announcing its results of operations for the three-month period ended December 31, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

**Item 9.01. Financial Statements and Exhibits.**

(*d) Exhibits*

---

| | |
|:---|:---|
| [99.1](tm236000d1_ex99-1.htm) | [Press Release of Applied DNA Sciences, Inc. dated February 9, 2023 regarding results of operations for the three-month period ended December 31, 2022.](tm236000d1_ex99-1.htm) |
| 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: February 9, 2023 | APPLIED DNA SCIENCES, INC. | APPLIED DNA SCIENCES, INC. |
|  | By: | /s/ James A. Hayward |
|  | Name: | James A. Hayward |
|  | Title: | Chief Executive Officer |

---

**EXHIBIT INDEX**

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm236000d1_ex99-1.htm) | [Press Release issued by Applied DNA Sciences, Inc. dated February 9, 2023 regarding results of operations for the three-month period ended December 31, 2022.](tm236000d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm236000d1_ex99-1img02.jpg)

![](tm236000d1_ex99-1img01.jpg)

Applied DNA Reports First Quarter Fiscal 2023 Financial Results<br> *- Total Revenues of $5.3 Million, Up 48% Over FQ4 2022 and 26% Over FQ1 2022, 72% and 74% Reduction in Operating Loss, Respectively -*

*- Included Orders for R&D Quantities of linearDNA™ from New Biopharma Customers -*

*- Maintains Timeline to cGMP Capacity, Initiates Build-out of Cost-Efficient Facility -*

*- Business Update Conference Call/Webcast Scheduled for Today at 4:30 PM ET -*

**STONY BROOK, N.Y.** – **February 9, 2023** - <u>Applied DNA Sciences, Inc</u>. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced consolidated financial results for the first quarter of fiscal 2023, ended December 31, 2022.

"Applied DNA delivered a solid start to the fiscal year with sequential and year-over-year revenue growth driven by molecular diagnostic testing demand at ADCL, our clinical laboratory subsidiary, several orders for linearDNA™, including a pair of orders from first-time biopharma customers for mRNA research and development use, and from deferred textile DNA tagging revenue," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our top-line performance was paired with a 72% and 74% reduction in operating loss sequentially and year-over-year, respectively, due in part to higher testing volumes coupled with cost management actions previously taken at ADCL.

"We also achieved progress on our strategic priority of establishing linearDNA and our LinearDNA™ platform as the common denominator for the manufacture of the next generation of nucleic acid-based therapies while working to concurrently position ADCL and our supply chain traceability businesses for profitable growth and positive cash flows," continued Dr. Hayward. "Since the launch of our linearDNA IVT template production offering last summer, interest has grown steadily as the industry gains an appreciation for our capacity for high quality, enzymatically produced template to meet therapy developers' need for this critical mRNA manufacturing starting material. Concurrently, the industry's clinical interest in mRNA extends beyond COVID-19 vaccines to new applications for mRNA, such as personalized cancer treatments and other therapeutic uses. Our linearDNA IVT templates can be produced rapidly with chemical modifications and highly homogeneous poly(T) tails that we believe are very well suited to support this next chapter in mRNA therapeutics.

Concluded Dr. Hayward, "At ADCL, we believe we are well positioned to leverage the population health platform we built during the pandemic to propel this subsidiary into the genetic testing marketplace of the future. Approaching enterprise customers with a reference lab model differentiates ADCL from those labs struggling to gain reimbursement from third parties and insurance companies. We have successfully completed our clinical validation and data analysis for our pharmacogenomics (PGx) testing panel and plan to file our validation package with New York State Department of Health in the coming weeks. Prospective PGx customer feedback has been very encouraging and gives us confidence that PGx testing can be a profitable post-pandemic path forward. In our supply chain traceability business, we continued to add CertainT® platform customers for isotopic analysis testing, which is an excellent complement to DNA tagging. We are encouraged by the macro environment for textile material provenance testing following the recent passage of the federal Omnibus Bill that increases funding for compliance with the Uyghur Forced Labor Prevention Act."

**First Quarter Fiscal 2023 Financial Highlights:**

&nbsp;&nbsp;&nbsp;&nbsp;• Total revenues increased 26% to $5.3 million,
which included $4.5 million in clinical laboratory service revenues (COVID-19 testing revenue). This compares with total revenues of $4.2
million in the prior fiscal year period, which included $3.2 million of clinical laboratory service revenues.

The year-over-year increase was offset by a decrease in product revenues of $310 thousand due to a decrease in sales of our molecular diagnostics (MDx) test kits and supplies.

&nbsp;&nbsp;&nbsp;&nbsp;• Gross profit was $2.4 million, or 45%, compared to $1.1 million,
or 27%, in the prior fiscal year period. The improvement in gross margin was primarily the result of an improved gross profit margin for
our MDx testing service. This improvement was the result of higher testing volumes, coupled with cost management efforts for our contracts
where we also provide and staff the test collection centers. To a lesser extent, the improvement in gross profit for the current period
was due to the prior fiscal year period having a high COVID-19 positivity
rate, which resulted in our clinical laboratory having to reduce the test pooling size, which increased the cost of consumables
per sample, therefore having a negative impact on gross profit.

&nbsp;&nbsp;&nbsp;&nbsp;• Total operating expenses were $3.6 million compared to $5.8 million in the
prior fiscal year period, reflecting a decrease in stock-based compensation expense of $1,6 million, primarily relating to officer stock
option grants during the first three months of fiscal 2022, that vested immediately, as well as to the annual non-employee board of director
grant that vests one-year from the date of grant. The remainder of the decrease primarily relates to a decrease in bad debt expense of
$300,000 for the collection of an outstanding receivable that was previously fully reserved for.

&nbsp;&nbsp;&nbsp;&nbsp;• Operating loss was $1.2 million compared to an operating loss of $4.7 million
in the prior fiscal year period.

&nbsp;&nbsp;&nbsp;&nbsp;• Excluding non-cash expenses, Adjusted EBITDA was negative $1.1 million compared
to negative $2.7 million in the prior fiscal year period. See below for information regarding non-GAAP measures.

&nbsp;&nbsp;&nbsp;&nbsp;• Cash and cash equivalents stood at $12.9 million on December 31, 2022,
compared with $15.2 million as of September 30, 2022.

&nbsp;&nbsp;&nbsp;&nbsp;• Our current warrants outstanding on December 31, 2022, stood at 7.3
million. Approximately 2.2 million of these warrants have exercise prices ranging from $2.80 to $2.84 per warrant share, which, if exercised,
could result in exercise proceeds to the Company of approximately $6.3 million; 5.1 million of these warrants have an exercise price of
$4.00 per warrant share, which, if exercised, could result in total exercise proceeds of approximately $20.3 million. Of the 5.1 million
warrants, 2.1 million expire in September 2023, which, if exercised, would total proceeds of $8.4 million.

**First Quarter Fiscal 2023 Conference Call Information**

The Company will hold a conference call and webcast to discuss its first quarter of fiscal year 2023 financial results on Thursday, February 9, 2023, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors' questions on the Q&A portion of the call, not all questions may be answered.

To Participate, please ask to be joined to the 'Applied DNA Sciences' call:

&nbsp;&nbsp;&nbsp;&nbsp;• Domestic callers (toll free): 844-887-9402

&nbsp;&nbsp;&nbsp;&nbsp;• Canadian callers (toll free): 866-605-3852

&nbsp;&nbsp;&nbsp;&nbsp;• International callers: 412-317-6798

Live and replay of webcast: <u>https://event.choruscall.com/mediaframe/webcast.html?webcastid=gZ93PCbr</u>

**Telephonic replay (available 1 hour following the conclusion of the live call through February 16, 2023):**

&nbsp;&nbsp;&nbsp;&nbsp;• Domestic callers (toll free) :
1-877-344-7529

&nbsp;&nbsp;&nbsp;&nbsp;• Canadian callers (toll free): 1-855-669-9658

&nbsp;&nbsp;&nbsp;&nbsp;• Participant Passcode: 2079390

An accompanying slide presentation will be embedded in the webcast (live and replay) and can also be accessed in the 'Company Events' section of the 'News & Events' tab of the Applied DNA investor relations website at <u>https://investors.adnas.com</u>/

**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 manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.

Visit <u>adnas.com</u> for more information. Follow us on <u>Twitter</u> and <u>LinkedIn</u>. Join our <u>mailing list</u>.

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, the unknown amount of revenues and profits that will result from any diagnostic testing contract, limited market acceptance for its supply chain security products and services, whether any of Applied DNA's or its customers therapeutic candidates utilizing the linearDNA platform will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval as therapeutic products from the FDA, the USDA or equivalent foreign regulatory agencies, the unknown duration of the COVID-19 public health emergency, changes in guidance promulgated by the CDC, FDA and/or CMS relating to COVID-19 testing, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology 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 14, 2022, as amended, its 10-Q filed on February 9, 2023, and other reports it files with the SEC, which are available at <u>www.sec.gov</u>. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events, or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

**Investor Relations contact:** Sanjay M. Hurry, 917-733-5573, sanjay.hurry@adnas.com

**Web:** www.adnas.com

**Twitter:** @APDN

**Financial Tables Follow**

**APPLIED DNA SCIENCES, INC.**

**CONDENSED CONSOLIDATED BALANCE SHEETS**

---

| | | |
|:---|:---|:---|
|  | **December 31,** | **September 30,** |
|  | **2022** | **2022** |
| **ASSETS** | (unaudited) |  |
| Current assets: |  |  |
| Cash and cash equivalents | $12877179 | $15215285 |
| Accounts receivable, net of allowance of $40,831 and $330,853 at December 31, 2022 and September 30, 2022, respectively | 4053477 | 3067544 |
| Inventories | 477014 | 602244 |
| Prepaid expenses and other current assets | 924682 | 1058056 |
| Total current assets | 18332352 | 19943129 |
| Property and equipment, net | 1865772 | 2222988 |
| Other assets: |  |  |
| Deposits | 98987 | 98997 |
| Total assets | $20297111 | $22265114 |
| **LIABILITIES AND EQUITY** |  |  |
| Current liabilities: |  |  |
| Accounts payable and accrued liabilities | $3056123 | $3621751 |
| Deferred revenue | 273880 | 563557 |
| Total current liabilities | 3330003 | 4185308 |
| Long term accrued liabilities | 31467 | 31467 |
| Warrants classified as a liability | 7777200 | 5139400 |
| Total liabilities | 11138670 | 9356175 |
| Commitments and contingencies (Note F) |  |  |
| 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, 2022 and September 30, 2022, respectively |  |  |
| Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2022 and September 30, 2022, respectively |  |  |
| Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of December 31, 2022 and September 30, 2022, respectively |  |  |
| Common stock, par value $0.001 per share; 200,000,000 shares authorized as of December 31, 2022 and September 30, 2022, 12,908,520 shares issued and outstanding as of December 31, 2022 and September 30, 2022 | 12909 | 12909 |
| Additional paid in capital | 305492756 | 305399008 |
| Accumulated deficit | (296343460) | (292500088) |
| Applied DNA Sciences, Inc. stockholders' equity: | 9162205 | 12911829 |
| Noncontrolling interest | (3764) | (2890) |
| Total equity | 9158441 | 12908939 |
| Total liabilities and equity | $20297111 | $22265114 |

---

**APPLIED DNA SCIENCES, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS**

**(unaudited)**

---

| | | |
|:---|:---|:---|
|  | **Three Months Ended December 31,** | **Three Months Ended December 31,** |
|  | **2022** | **2021** |
| Revenues |  |  |
| &nbsp;&nbsp;&nbsp;Product revenues | $516396 | $826311 |
| &nbsp;&nbsp;&nbsp;Service revenues | 232061 | 139273 |
| &nbsp;&nbsp;&nbsp;Clinical laboratory service revenues | 4514295 | 3200122 |
| Total revenues | 5262752 | 4165706 |
| Cost of product revenues | 365378 | 434929 |
| Cost of clinical laboratory service revenues | 2519691 | 2621639 |
| Total cost of revenues | 2885069 | 3056568 |
| Gross profit | 2377683 | 1109138 |
| Operating expenses: |  |  |
| Selling, general and administrative | 2625357 | 4735619 |
| Research and development | 971304 | 1080096 |
| Total operating expenses | 3596661 | 5815715 |
| LOSS FROM OPERATIONS | (1218978) | (4706577) |
| Interest income, net | 3686 | 273 |
| Unrealized loss on change in fair value of warrants classified as a liability | (2637800) |  |
| Other income (expense), net | 8846 | (14607) |
| Loss before provision for income taxes | (3844246) | (4720911) |
| Provision for income taxes |  |  |
| NET LOSS | (3844246) | (4720911) |
| Less: Net loss (income) attributable to noncontrolling interest | 874 | (855) |
| NET LOSS attributable to Applied DNA Sciences, Inc. | $(3843372) | $(4721766) |
| Net loss per share attributable to common stockholders-basic and diluted | $(0.30) | $(0.63) |
| Weighted average shares outstanding- basic and diluted | 12908520 | 7486120 |

---

**APPLIED DNA SCIENCES, INC.**

**CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA**

**(unaudited)**

---

| | | |
|:---|:---|:---|
|  | Three Month Period Ended December 31, | Three Month Period Ended December 31, |
|  | 2022 | 2021 |
| Net Loss | $(3844246) | $(4720911) |
| Interest income, net | (3686) | (273) |
| Depreciation and amortization | 338918 | 320751 |
| Provision for bad debt | (290022) | 10000 |
| Unrealized loss on change in fair value of warrants classified as a liability | 2637800 |  |
| Stock based compensation expense | 93748 | 699920 |
| Total non-cash items | 2776758 | 2030398 |
| Consolidated Adjusted EBITDA loss (non-GAAP) | $(1067488) | $(2690513) |

---

###