logo

Applied DNA Enters Dietary Supplements Market with Multi-year Nutrition21 Contract

hidden spacer image
DNA underlay

Applied DNA Enters Dietary Supplements Market with Multi-year Nutrition21 Contract

Posted on

CertainT® Products and Services Delivered for 2020 Commercial Deployment

STONY BROOK, N.Y., February 19, 2020 Applied DNA Sciences, Inc. (“Applied DNA”, the “Company”, NASDAQ: APDN), and Nutrition21, LLC (“Nutrition21”), announce the successful implementation of Applied DNA’s CertainT authenticity and traceability solution for Nutrition21’s leading sports supplement ingredient, Nitrosigine®. After extensive product development, testing and lab-to-production scaleup, both a multi-year Master Services Agreement and a Trademark Licensing Agreement (the “Agreements”) were signed to cover commercial production of Nitrosigine, as well as potential expansion to other products within the Nutrition21 portfolio. Separately, a Broker Agreement was also signed between the parties to enable Nutrition21 to represent Applied DNA’s CertainT platform throughout its extensive network in the dietary supplement market.

“The functional branded ingredient market follows our work in pharmaceuticals, where we believe transparency and trust are key tenets to drive consumer confidence. The CertainT platform provides Nutrition21 proof positive of their ingredients all the way through to their customers’ finished products and onto retail shelves and online stores. CertainT supports Nutrition21’s investment in brand and intellectual property protection for its ingredients and its customers’ final products,” said Dr. James Hayward, president and CEO, Applied DNA.

In the highly competitive dietary supplement industry, Nutrition21 takes brand and intellectual property protection seriously as an industry role model with a significant focus on consumer education and quality. It currently holds over 100 domestic and international issued and pending patents for products. Many support unique claims associated with glucose metabolism, weight management, brain health, cardiovascular health, and sports nutrition, among others.

A success in the Nutrition21 product portfolio, Nitrosigine is the first product covered under the Agreements. Nitrosigine is a bonded arginine-silicate with FDA New Dietary Ingredient notification status, clinically shown to significantly boost nitric oxide levels. Following its introduction to the market, Nitrosigine has since been integrated into over 250 consumer products and is a leading branded ingredient in the pre-workout sports nutrition space.

The CertainT “Tag-Test-Track” platform enables companies and their supply chains to designate a unique molecular identity tag that has meaning specific to the tagged material: for example, geographic facility location, brand, product line or date of manufacture. This tag can be blended into ingredients, packaging inks and varnishes in the pharmaceutical, functional food, and dietary supplements industries. The tag enables its carrier to be verified for authenticity, proper potency of the mixture and blending detection, either at the customer or in the Applied DNA laboratory, depending on application requirements.

“Nutrition21 employs rigorous preclinical and clinical trials as a key part of its product development strategy to ensure product safety and consumer trust. The scientific evidence provided by Applied DNA’s CertainT platform will support these principles with verification of product compliance through the supply chain,” said Bill Levi, Vice President of Operations at Nutrition21.

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN.

About Nutrition 21
Nutrition21 is a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. With a diverse portfolio of patented health and wellness ingredients, Nutrition21 provides ingredient solutions to some of the most successful dietary supplement brands in the marketplace today.Nutrition 21 currently holds over 100 domestic and international issued and pending patents for products with highly marketable claims including: Nitrosigine®, Velositol®, Chromax®, nooLVL®, and Lepidamax®. Innovative Ingredients. Real Results For more information, please visit: www.Nutrition21.com.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of 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 our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, the possibility of failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, the Company’s history of net losses, limited financial resources, limited market acceptance and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor Contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program Contact: Judy Murrah, Chief Information Officer, 631-240-8819, judy.murrah@adnas.com

Applied DNA To Speed Up Coronavirus Countermeasures

Posted on

By GREGORY ZELLER

Look out, coronavirus – Applied DNA is coming for you.

Adding to its growing portfolio of cutting-edge Polymerase Chain Reaction-based projects, Stony Brook-based Applied DNA Sciences is expanding its Joint Development Agreement with Italian R&D company Takis Biotech, with the headline-making 2019-nCoV in their sights.

coronavirus vaccine collageLinear time: The world won’t see an effective vaccine against 2019-nCoV for months — or maybe sooner, thanks to Applied DNA Sciences.

Already hot on the trail of new cancer vaccines, the partners will now work on a “linear DNA” vaccine against the dreaded Wuhan, China-based illness that’s sweeping the globe.

Applied DNA, Takis Biotech partner on coronavirus vaccine

Posted on

Applied DNA Sciences has extended its partnership with Takis Biotech to include the development of a vaccine for 2019-nCoV coronavirus.

LineaRx, a subsidiary of Applied DNA, will work with Takis Biotech on preclinical development of a linear DNA vaccine based on polymerase chain reaction (PCR).The PCR-produced DNA could accelerate vaccine production, avoid antibiotics and associated resistance genes and provide simple design, as well as deliver strong immunogenicity.

Applied DNA adds that a linear DNA vaccine gene will be sufficient even without integration into the patient’s genome.

Applied DNA Sciences Subsidiary, LineaRx, and Takis Biotech Collaborate for Development of a Linear DNA Vaccine Candidate Against Wuhan Coronavirus 2019-nCoV

Posted on

Expanded Joint Development Agreement Serves as Basis for Preclinical Linear DNA Vaccine; Linear DNA Platform Will be the Production Framework

STONY BROOK N.Y., February 7, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, announced today and in a late-day Investor Call yesterday, that it has expanded its existing Joint Development Agreement (JDA) with Takis Biotech to include the preclinical development of a linear DNA vaccine against 2019-nCoV, the new coronavirus that originated in Wuhan, China, infecting more than 28,000 and killing hundreds in just weeks. The advantages posed by PCR-produced linear DNA for this challenge include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior linear DNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.

The virus expanded its hosts to humans and has been declared a public health emergency by the World Health Organization (WHO) and by the U.S. Department of Health and Human Services (HHS). LineaRx, Inc. (“LineaRx”) is the majority-owned subsidiary of Applied DNA focused on the therapeutic and diagnostic applications of the Company’s large-scale PCR platform that is protected by multiple issued and pending patents.

“We have a patented and proprietary platform for the production of linear DNA that empowers rapid development and large-scale production that we believe will yield a safe and effective vaccine with fewer risks than other DNA production platforms,” said Dr. James Hayward, president and CEO of both Applied DNA and LineaRx. “As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance1.  We believe that one of the many benefits of PCR-produced linear DNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift.”

Dr. Luigi Aurisicchio, CEO/CSO of Takis, stated, “Our collaboration under the JDA on genetic technologies has already shown the ability to induce powerful immune responses in animal models using linear DNA.  To induce antibodies that can neutralize 2019-nCoV, it is essential to use reliable, effective technologies, that can be quickly adapted in the face of shifting pathogens. This global emergency requires a swift response.”

The companies are also developing a cancer vaccine that has shown rapid tumor clearance in test animals as reported this last September. Clinical trials using the linear DNA form of the cancer vaccine in companion animals are being planned. The Company has also participated in collaborative submissions for competitive contracts to develop related genetic countermeasures to protect American warfighters.

The collaborating teams have already begun the design and optimization of a synthetic gene that when delivered to muscles, should enable the temporary production of a designed antigen that could provoke an immune response against the virus. We expect to have linear DNA ready for testing within the next 60 to 90 days. Once the optimized gene is assembled, the Company will produce quantities of the linear DNA prototype vaccine at large scale for tests in mice. Prior evidence indicates that genes made of linear DNA reside only temporarily within the muscle cell nucleus, long enough to provoke an immune response, and is eventually cleared without genomic integration.

No commercial partner to take the coronavirus vaccine to market has been identified, nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.

1Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. R.Lu et alia. The Lancet. Published online: https://doi.org/10.1016/S0140-6736(20)30251-8

About Takis Biotech.
Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include four Cancer Vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in Oncology and Infectious Diseases.

About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list. Common stock listed on NASDAQ under the symbol APDN.

About LineaRx, Inc.
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria. Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture. Go to www.adnas.com for more information on LineaRx and to learn more about how Applied DNA makes life real and safe. LineaRx is a majority-owned Applied DNA Sciences, Inc. (Nasdaq: APDN) company.

Visit www.takisbiotech.it for more information.

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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file 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.

Investor Contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program Contact: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.com

Applied DNA Reports FY’20 Q1 Results

Posted on

Company to Hold Conference Call and Webcast Today, Thursday, February 6, 2020 at 4:30 PM ET

STONY BROOK, N.Y. – February 6, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development and a developer of liquid biopsies today announced consolidated financial results for the fiscal first quarter ended December 31, 2019.

“During our fiscal first quarter, we made meaningful progress on our strategic priorities for fiscal 2020 to position the company for long-term growth while raising capital to support our growth strategy. Our revenue performance reflects a difficult comparison to the year-ago period, which included revenue related to a Department of Defense contract since completed, as well as our historical revenue pattern that troughs in the first quarter and builds over the balance of the year,” stated Dr. James A. Hayward, president and CEO of Applied DNA.

“In our biotherapeutics business that utilizes our proprietary linear DNA production platform for application in adoptive cell therapies; DNA vaccines, such as cancer vaccines; CRISPR and other nucleic acid-based therapies, we continued to build proof points for a new paradigm in linear DNA production with our patented PCR processes ahead of traditional plasmids production. During the quarter, we signed an agreement with Tyme Technologies for our Vita-Assay invasive Circulating Tumor Cell (iCTC) capture assay and services that enable Tyme to monitor disease progression in its pivotal trial for metastatic pancreatic cancer. In our industrials business that utilizes the same platform to illuminate supply chains in large commercial ecosystems for authenticity and traceability, the launch of Colorcon’s on-dose authentication platform powered by our taggant technology demonstrates execution of our pharmaceutical strategy  to partner with Colorcon who will be marketing the platform to its expansive customer base. Strategic progress has continued in this sector into our fiscal second quarter with our entry into the nutraceuticals market with a multi-year CertainT contract with Nutrition 21.”

Concluded Dr. Hayward, “Looking ahead, we are placing greater emphasis on positioning our platform for biotherapeutic and diagnostic applications where there is a growing imperative for our capabilities while also nurturing key industrials applications to commercial-scale deployments. Our recently acquired liquid biopsy technology – the iCTC liquid biopsy platform –  we believe allows us to detect primary cancer tumors often before they are visible to other diagnostic technologies, when preventive care for impending cancer may still be an option. Our iCTC platform is potentially transformative to cancer care, and our relationship with Tyme establishes a partnering model that is applicable to other companies pursuing therapies for such cancers as breast, pancreatic, ovarian, colorectal, among others, that we are actively pursuing.”

Fiscal First Quarter 2020 Financial Results:

  • Revenues decreased 28% for the first quarter of fiscal 2020 to $634 thousand, compared with $884 thousand reported in the same period of the prior fiscal year and decreased 62% from $1.7 million for the fourth quarter of fiscal 2019. This decrease in revenue year over year is due to a decrease of $167 thousand in service revenue and a decrease of $84 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during fiscal 2019.  The decrease in product revenues was primarily related to a decrease of approximately $200 thousand in textiles, related to a cotton customer offset by an increase of $135 thousand in biopharmaceutical revenues.
  • Total operating expenses decreased to $3.0 million for the first fiscal quarter of 2020, compared with $3.9 million in the prior fiscal year’s first quarter. This decrease is primarily attributable to an approximate $352 thousand decrease in payroll and a decrease of $93 thousand in consulting fees, which are both due to a realignment of the sales force and reductions in overall headcount. In addition, there was a decrease of $285 thousand  in stock-based compensation expense and a reduction of $145 thousand in research and development expenses.
  • Net loss for the quarter ended December 31, 2019 was $2.7 million, or $1.12 per share, compared with a net loss of $3.2 million, or $4.25 per share, for the quarter ended December 31, 2018, an improvement of 18%, and a net loss of $1.2 million, or $1.44 per share, for the quarter ended September 30, 2019.
  • Excluding non-cash expenses, Adjusted EBITDA was negative $2.4 million and a negative $2.6 million for the quarters ended December 31, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

  • On February 5, 2020, Applied DNA entered into an amendment to its existing joint development agreement with Takis S.R.L and Evvivax S.R.L.to include pre-clinical development of a potential linear DNA vaccine against 2019-nCoV, the new coronavirus;
  • On January 27, 2020, Applied DNA bolstered its patent portfolio when the U.S. Patent and Trademark Office granted it a U.S. patent that covers methods of tagging man-made cellulosic fibers or materials during production and later authenticating the fiber or materials to confirm provenance and/or authenticity. This newly issued patent  extends the Company’s addressable market within textiles to include cotton, synthetic fibers and materials, and, now, man-made cellulosic fibers and materials;
  • On January 13, 2020, the Company announced a licensing agreement with LifeSensors, Inc. whereby it will incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications. The Company believes that the incorporation of the SUMO-fusion technologies into Applied DNA’s linear amplicons may further optimize protein expression and deliver yet another strength to linear DNA; and
  • On December 23, 2018, Colorcon, Inc. a world leader in the development and supply of film coating systems and excipients for pharmaceuticals, formally launched its On-Dose Authentication capability utilizing the Company’s technology to provide track and trace functionality for supply chain security. Applied DNA’s molecular taggants are integrated into Colorcon’s Opadry® film coating system to significantly reduce the risks associated with the global problem of counterfeit and falsified medications entering the supply chain.

Fiscal First Quarter 2020 Conference Call Information
The Company will hold a conference call and webcast to discuss its fiscal first quarter-end 2020 results on Thursday, February 6, 2020 at 4:30 PM ET. To participate on 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, due to the large number of expected participants, not all questions may be answered.

To Participate:

  • Participant Toll Free:1-844-887-9402
  • Participant Toll: 1-412-317-6798
  • Please ask to be joined to the Applied DNA Sciences call

Live webcast:  https://services.choruscall.com/links/apdn200206.html

Replay (available 1 hour following the conclusion of the live call through February 7, 2020):

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: https://adnasprod.wpengine.com/molecular-based-security/investors/

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 business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business 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 is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol ‘APDN’.

Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of 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 our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, the possibility of failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, the Company’s history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s product candidates will advance further in the preclinical research or clinical trial process, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

APPLIED DNA SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS

December 30, 2019 (unaudited)September 30, 2019
ASSETS
Current assets:
Cash and cash equivalents$8,662,853$558,988
Accounts receivable, net of allowance of $4,500 at December 31,2019 and September 30, 2019, respectively273,969839,951
Inventories82,683142,629
Prepaid expenses and other current assets 618,077604,740
   
Property and equipment, net184,101226,221
   
Other assets:  
Deferred offering costs109,698
Goodwill285,386285,386
   
Intangible assets, net702,412 734,771
Total Assets$10,871,831 $3,564,735
   
LIABILITIES AND EQUITY (DEFICIT)  
Current liabilities:  
Accounts payable and accrued liabilities (including related party of$7,559 at December 31, 2019)$1,053,554$1,616,997
Deferred revenue455,051628,993
Total current liabilities1,508,6052,245,990
   
Long term accrued liabilities659,692621,970
   
Secured convertible notes payable, related party. net of debtissuance costs1,479,2541,442,497
Secured convertible notes payable, recorded at fair value102,777
Total liabilities3,647,5514,413,234
   
Commitments and contingencies  
   
Applied DNA Sciences, Inc. Stockholders’ Equity (Deficit): Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of December 31, 2019 and September 30, 2019, respectively
Series A Preferred stock, par value $0.001 per share; 10,000,000shares authorized; -0- issued and outstanding as of December 31,2019 and September 30, 2019, respectively
Series B Preferred stock, par value $0.001 per share; 10,000,000shares authorized; -0- issued and outstanding as of December 31,2019 and September 30, 2019, respectively
Common stock, par value $0.001 per share; 500,000,000 sharesauthorized; 3,485,399 and 1,200,399 shares issued andoutstanding as of December 31, 2019 and September 30, 2019,respectively3,4851,200
Additional paid in capital266,699,007255,962,930
Accumulated deficit(259,471,142)(256,805,589)
Applied DNA Sciences, Inc. stockholders’ equity (deficit):7,231,350(841,459)
Noncontrolling interest(7,070)(7,040)
Total equity (deficit)7,224,280(848,499)
   

APPLIED DNA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018 (unaudited)

Three months ended December 31, 2019Three months ended December 31, 2018
Revenues
Product$237,870$321,875
Service395,649562,447
Total revenues633,519884,322
   
Cost of revenues232,031153,485
   
Operating expenses:  
Selling, general and administrative2,373,4133,082,380
Research and development564,426709,564
Depreciation and amortization75,067135,052
   
Total operating expenses3,012,906 3,926,996
LOSS FROM OPERATIONS(2,611,418) (3,196,159)
   
Other (expense) income:  
Interest (expense) income, net (including related party of $28,543 and $23,470 for the three month periods ended December 31, 2019 and 2018, respectively)(29,091)(31,611)
Other expense, net(22,232)(6,550)
Loss before provision for income taxes(2,662,741)(3,234,320)
Provision for income taxes
NET LOSS (2,662,741)(3,234,320)
Less: Net loss attributable to noncontrolling interest30
NET LOSS attributable to Applied DNA Sciences, Inc.(2,662,711) (3,234,320)
Deemed dividend related to warrant modifications(2,842)
NET LOSS applicable to common stockholders(2,665,553)(3,234,320)
Net loss per share applicable to common stockholders basic and diluted$(1.12)$(4.25)
Weighted average shares outstanding-basic and diluted 2,380,564761,769

APPLIED DNA SCIENCES, INC. CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA (unaudited)

Three months ended December 31, 2019Three months ended December 31, 2018
Net Loss$(2,662,711)$(3,234,320)
Interest expense (income), net29,09131,611
Depreciation and amortization75,067135,052
Stock based compensation expense205,490490,244
Bad debt expense(8,633 )
Total non-cash items309,648648,274
Consolidated Adjusted EBITDA (loss)$(2,353,063)$(2,586,046)

APDN Schedules FY’20 Q1 Financial Results Conference Call

Posted on

STONY BROOK, N.Y., January 30, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today it plans to release financial results for its fiscal 2020 first quarter ended December 31, 2019 after market close on Thursday, February 6, 2020. In conjunction with the release, the Company has scheduled a conference call at 4:30 p.m. Eastern Time that will also be broadcast live over the Internet.

What: Applied DNA’s Fiscal 2020 First Quarter Financial Results Conference Call

When: Thursday, February 6, 2020, at 4:30 p.m. Eastern Time

Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask to join the Applied DNA call; via webcast.

A telephonic replay of the conference call will be available for one day and may be accessed by calling +1 877-344-7529 or +1 412-317-0088 with the passcode 10138146. The webcast will be archived within the ‘Events and Presentations’ portion of the ‘Investors’ page to the company’s website.

About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list. Common stock listed on NASDAQ under the symbol APDN.

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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, approval of Applied DNA’s taggant technology by the U.S. Food and Drug Administration or equivalent foreign regulatory agencies as a physical-chemical identifier (PCID) for solid oral dosage forms and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and other reports we file 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.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com

Innovation in Textiles | US Patent for CertainT in manmade cellulosic fibres

Posted on

Applied DNA Sciences, a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development and liquid biopsies, today announced that the UU Patent and Trademark Office (USPTO) has granted it United States patent no. 10,519,605 entitled Methods of Marking Cellulosic Products.

Innovation in Textiles | January 2020

The newly issued patent covers methods of tagging man-made cellulosic (MMC) fibres or materials with a nucleic acid (DNA) tag during production and later authenticating the nucleic acid-tagged MMC fibers and/or materials via PCR-based detection techniques to confirm provenance and or authenticity.

CertainT planets

According to the company, global MMC production volume more than doubled from 3 million (in 1990) to 6.7 million metric tons in 2018, and is expected to continue to grow at an annual rate of 9% through 2024. MMCs include viscose, Rayon, acetate, lyocell, Tencel, modal and cupro materials.

“Most MMCs are primarily derived from wood. Heightened awareness related to the sourcing of wood raw materials from endangered or ancient forests, the social and environmental concerns relating to the chemicals used in production, as well as the amount of energy and water used to manufacture MMCs, has led to greater oversight of the MMC industry and requires proof that these materials come from controlled and sustainable sources that can be verified by scientific evidence,” Applied DNA said.

Applied DNA Announces Issuance of U.S. Patent Protecting its CertainT® Platform in Man-Made Cellulosic Fibers and Materials

Posted on

STONY BROOK, N.Y. – January 27, 2020. Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development and liquid biopsies, today announced that the U.S. Patent and Trademark Office (USPTO) has granted it United States patent no. 10,519,605 entitled “Methods of Marking Cellulosic Products.” The newly-issued patent covers methods of tagging man-made cellulosic (MMC) fibers or materials with a nucleic acid (DNA) tag during production and later authenticating the nucleic acid-tagged MMC fibers and/or materials via PCR-based detection techniques to confirm provenance and/or authenticity.

Global MMC production volume more than doubled from 3 million (in 1990) to 6.7 million metric tons in 20181, and is expected to continue to grow at an annual rate of 9% through 20242. MMCs include viscose, Rayon, acetate, lyocell, Tencel®, modal and cupro materials.

Most MMCs are primarily derived from wood. Heightened awareness related to the sourcing of wood raw materials from endangered or ancient forests, the social and environmental concerns relating to the chemicals used in production, as well as the amount of energy and water used to manufacture MMCs, has led to greater oversight of the MMC industry and requires proof that these materials come from controlled and sustainable sources that can be verified by scientific evidence.

“The use of MMC fibers and materials is moving the textile industry towards greater sustainability, but has also yielded social and environmental concerns related to deforestation and biodiversity. In response, brands and retailers, such as H&M Group that has articulated a goal to only use MMC fibers from certified, responsibly-managed sources in its products by 20253, are actively strengthening their sourcing policies to address these concerns. Central to their initiatives is traceability of their MMC supply chains to feedstock levels,” said MeiLin Wan, Vice President of Textile Sales at Applied DNA. “With these new patents, together with our linear DNA-based tagging platform, we can offer MMC fiber producers and manufacturers the unparalleled ability to ensure that their brands are real and safe.”

“Transparency related to the source, origin and authenticity of MMCs is the key to unlock valuable claims related to sustainable and ethical sourcing – and this is important for the supply chain to know that their product and brand is secure from source to shelf,” said Wayne Buchen, Vice President of Strategic Sales at Applied DNA. “The Company continues to collaborate with its global network of MMC fiber producers and manufacturers to assure that their brands are verified and traceable. With increased scrutiny of cellulosic fibers originating from certain geographic locations, we plan to provide solutions to enable our partners to digitally verify their products through our CertainT portal, and also help our brand partners to authenticate their products through additional solutions that we offer for protecting hang tags, thread and packaging. We are very excited to now offer our patented technology to all stakeholders in the cellulosic fiber and materials value chain.”“The Company is at the forefront of large-scale PCR-based DNA manufacture innovation as shown by its over 130 pending patent applications and issued patents,” said Dr. James A. Hayward, chairman, president and CEO of Applied DNA. “With the issuance of this patent, we continue to expand the value of our proprietary CertainT platform in textiles, which will be a key focus for fiscal 2020.”1 Textiles Exchange, Preferred Fiber & Materials, Market Report 20192 MarketWatch, Press Release, 2019-24 Cellulose Fiber Market to Register USD 39 bn revenue 2019-07-223 HMG Group sustainability, Man-made Cellulosic Fibres

About Applied DNA Sciences
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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

Common stock listed on NASDAQ under the symbol APDN.

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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, our ability to successfully enter into commercial contracts for the implementation of our CertainT® platform, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and other reports we file 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.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-37777
Program contact: MeiLin Wan, VP Textile Sales, 631-240-8849, meilin.wan@adnas.com

APDN Subsidiary, LineaRx, Inc., Sign Licensing Agreement with LifeSensors

Posted on

LineaRx will incorporate LifeSensors’ SUMO-fusion technologies to maximize protein expression of PCR-produced Linear DNA

STONY BROOK N.Y., January 13, 2020Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) announced today that LineaRx, Inc. (“LineaRx”), its majority-owned subsidiary focused on next-generation biotherapeutics and cancer diagnostics, has signed a licensing agreement with LifeSensors, Inc. (“LifeSensors”), to incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications (the “Agreement”). LifeSensors’ SUMO-fusion technologies enable the attachment of the C-terminus of SUMO (Small Ubiquitin Like Modifier) to the N-terminus of a protein of interest that can dramatically improve protein solubility, achieve native protein folding, and increase total yield by improving expression and decreasing degradation.

Under the terms of the Agreement, LineaRx will have a worldwide license to the applicable LifeSensors intellectual property to make, have made, use, and sell DNA constructs incorporating the SUMO-fusion technologies for therapeutic and diagnostic applications.

“We have already demonstrated expression levels for our linear DNA that meets or exceed that of plasmid-produced DNA,” stated Dr. James Hayward, president and CEO of Applied DNA. “The incorporation of the SUMO-fusion technologies into our linear amplicons we believe will further optimize protein expression and deliver yet another strength to linear DNA. We are in discussions with therapeutic companies on incorporating the SUMO-fusion technologies into their custom amplicon for the therapy of interest.”

“A roadblock to successful gene therapy today is the ability to effectively express and present the therapeutic product in the target cell. Fusion of gene constructs and chimeric genes with SUMOstar overcomes the hurdles of poor gene expression,” said Brenda Bausher, Manager of LifeSensors, Inc.The companies will work together on initially developing and releasing two high expression amplicons; one for the generic Luciferase protein and one for our licensed anti-CD19 therapy.

Data showing the increased expression levels resulting from incorporation of SUMO-fusion technologies are expected to be available over the next few months.“This Agreement demonstrates the commitment we have to optimize PCR-produced linear DNA for therapeutic applications. We expect the LifeSensors’ proven technology will further strengthen our higher performing alternative to plasmids for nucleic acid-based therapies,” concluded Dr. Hayward.

About LineaRx, Inc.
LineaRx seeks to commercialize the biotherapeutic value of Applied DNA’s deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction (“PCR”). Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.  Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health. In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.In all forms of gene therapy, DNA exerts its influence from within the nucleus. Recombinant events for circular DNA are permanent and alter the genomes of the affected cells and their progeny. The fundamental challenge of all gene and cellular therapies is safety. Recent studies have elaborated “unintended consequences” when plasmid and viral vectors are combined that may pose future risks for treated patients.When linear DNA enters the nucleus, it does not need to be incorporated into the genome in to be temporarily expressed as the intended proteins product. LineaRx posits that for the effectiveness of genetic vaccines or genetic immune therapies, transient expression may be sufficient.

About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list. Common stock listed on NASDAQ under the symbol APDN.

About LifeSensors, Inc.
LifeSensors is a biotechnology company focused on SUMO and ubiquitin proteasome and PROTAC drugs, develops and markets technologies for application in protein expression and drug discovery. LifeSensors technologies are employed by academic, government research institutions, pharmaceutical and biotechnology companies worldwide in efforts to improve the quality of human life.For more information on our new line of products, please refer to the LifeSensors web site at www.lifesensors.com.

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 the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and other reports we file 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.

Investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
Program contacts: Brian Viscount, Applied DNA, 631-240-8877, brian.viscount@adnas.comBrenda Bausher, LifeSensors, (610) 644-8845 x 338