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LineaRx Achieves Higher Expression and Survival Rates in Human T Cells

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LineaRx Achieves Higher Expression and Survival Rates in Human T Cells

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STONY BROOK, NY. April 29, 2019 – LineaRx, Inc. (the “Company”) a wholly owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today that it has improved expression levels and survival rates of linear DNA constructs delivered without viruses or plasmids to human T cells. In collaboration with Avectas, a cell engineering technology business enabling the manufacture of cell therapies, LineaRx has achieved a greater than four-fold increase in cell survival, and a more than 50% increase in linear gene expression of a model amplicon. Results were presented by Avectas last week at the Cell & Gene Meeting on the Mediterranean, attended by more than 50 companies.

“We expect to achieve expression levels of LinCART19™ that will permit our analysis of tumor kill rates in vitro and in animal models, allowing us to complete our preclinical evaluation of this promising therapy,” said Dr. James Hayward, president and CEO of Applied DNA. “We can now see that therapeutic doses are well within our planned range of numbers of redirected T cells. In addition to the pursuit of our own therapies, we are being increasingly approached by companies who see the value of linear DNA in gene and redirected cell therapies.”

Dr. Michael Maguire, CEO of Avectas said, “This is an exciting example of how Solupore® non-viral cell engineering is being used in a next-generation therapeutic product candidate. Through a simpler cell engineering process, Solupore® technology will improve the efficacy and accessibility of such potentially curative products.”

In October 2018, LineaRx announced an exclusive North American licensing and research services agreement with iCell Gene Therapeutics (“iCell”) for an anti-CD19 CAR T therapy. Leveraging Applied DNA’s expertise in large-scale PCR-based production and chemical modification of DNA, LineaRx will utilize its non-viral, plasmid-free (NVPF) platform to develop and produce expression vectors for CAR T therapies, including its own anti-CD19 CAR T therapy candidate, LinCART19.

As presented at the LineaRx Analyst Day on December 6, 2018, the CAR-T gene construct upon which LinCART19 is based, led to 3 of 3 complete remissions in patients with acute lymphocytic leukemia (ALL) up to 9 months at a very-low-dose in a clinical trial conducted by iCell in China under local regulations. While these promising clinical results provide evidence in the value of the genetic code utilized, the CAR T cells were transfected via a viral vector. LinCART19 will utilize linear DNA transfected by non-viral delivery into T Cells.

The Company recently announced the first anti-CD19 expression in human T cells from a gene construct utilizing linear DNA produced via a scalable PCR manufacturing process. Without the use of viral vectors or plasmids, LineaRx’s NVPF manufacturing platform holds numerous potential advantages over existing viral/plasmid-based CAR T approaches offering the possibility of more efficient, affordable and safer gene therapies for patients.

About Avectas
Avectas is a cell engineering technology business, enabling the manufacture of cell therapies. Avectas’ technology, Solupore®, delivers advanced molecules such as mRNA, proteins and gene editing tools to a range of primary cell types including T cells for immuno-oncology and gene editing applications. Solupore® utilizes a membrane disruptive approach to rapidly deliver advanced molecules to cells. It is a simple, rapid and gentle process that yields superior engineered cells. Solupore® results in improved cell processing times and cell health relative to viral vectors and electroporation, leading to a more cost-effective manufacturing process. Avectas is currently partnering with immuno-oncology and gene editing businesses to deliver their proprietary molecules. Avectas is also seeking therapeutic molecules to in-license as the core of a therapeutic program.

About LineaRx
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.

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, and warrants are listed under the symbol APDNW.

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 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, 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, 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 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 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 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, 631-240-8877, brian.viscount@adnas.com 
web: www.adnas.com, www.linearxdna.com
twitter: @APDN, @LineaRxDNA

As Counterfeits Flood the Marketplace, Consumers Demand Accountability

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By Stephen Birkhold

When it comes to fashion, image is everything. Consumers proudly display labels of the hottest designers, the newest styles, and as of late, the causes they care about. In fact, socially conscious consumers are a growing category, and they care as much about the sustainability and ethical practices of the brands they wear as they do about their fashionable relevance.

APDN and GHCL launch the Rekoop bedding collection on Amazon

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Dedicated page includes videos that explain sustainability and traceability products

Stony Brook, NY – Earth Day was Amazon debut day for Rekoop ecologically conscious bedding.

GHCL’s Rekoop bedding is made by blending 60% cotton with 49 polyester fiber obtained from recycling post-consumer PET bottles. There are 36 PET bottles used for the production of every 250 thread count sheet set. The collection is designed to help reduce landfill space, crude oil consumption and carbon emissions in the atmosphere.

APDN, GHCL Launch REKOOP On Amazon.com On Earth Day

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STONY BROOK, N.Y. — April 22, 2019 — Applied DNA Sciences Inc., a supplier of PCR-based DNA manufacturing for product authenticity and traceability solutions, and GHCL announced today the launch of REKOOP on Amazon.com. The REKOOP range of bedding products is meant for the ecologically conscious consumer who is making purchase decisions to support the environment and is supportive of initiatives that help reduce the carbon footprint.

Consumers are assured of REKOOP’s ecologically conscious practices through the molecular tagging of the recycled fiber that comprise its product line through Applied DNA’s, CertainT platform that secures provenance and complete traceability across the supply chain.

GHCL launches PET bedding range on Amazon

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GHCL Limited, one of India’s leading chemical and textiles company, has launched Rekoop CertainT verified recycled PET bedding products on Amazon.com. Rekoop bedding is made by blending cotton with polyester fibre which is obtained from recycling post-consumer PET bottles. The launch coincided with the celebrations of the World Earth Day.

The platform is designed to tag, test and track synthetic fibres to provide transparency, traceability and trust throughout the textile supply chain. Reliance Industries Ltd. (RIL), India’s largest private company, is GHCL’s fibre-manufacturing partner and supplies the truly eco-friendly recycled polyester fiber – Recon Green Gold, which is used in Rekoop bedding.

APDN Receives Initial $1 Million Payment from TheraCann International

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STONY BROOK, N.Y., (April 24, 2019)Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), a leader in PCR-based DNA manufacturing for product authenticity and traceability solutions, announced today that it has received the first $1 million of a $5 million licensing fee as per the terms of its exclusive agreement entered into with TheraCann International Corporation (“TheraCann”) on March 29, 2019. The balance of $4 million in payments to Applied DNA is expected by mid-August in accordance with the terms of the Agreement.

“The agreement with TheraCann represents further validation of the commercialization of our CertainT® technology platform across industries where compliance, control and tracking are essential to marketplace safety and security,” noted Dr. James A. Hayward, president and CEO of Applied DNA. “Powered by our CertainT platform, TheraCann’s ETCH biotrace system can provide the global legal cannabis and hemp industries the unparalleled ability to ensure true authentication and origin verification for products through the supply chain.

Concurrently, the Company announced that it received $793 thousand through the cash exercise of 1,773,100 common stock warrants. Warrants were exercised to purchase 1,558,100 and 215,000 shares of common stock at the price of $0.44 and $0.50 per share, respectively. The warrants were originally issued as part of financings completed in December 2017 and December 2018.  No inducements or incentives were offered to the parties exercising the warrants, and no commissions or placement fees have been paid related to the funds received from these exercised Warrants.

Additional information with respect to the TheraCann Agreement was filed via Form 8-K with the Securities and Exchange Commission on April 3, 2019.  Additional details on the warrants may be found in Applied DNA’s quarterly filings with the Securities and Exchange Commission.

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, and warrants are listed under the symbol APDNW.

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 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, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, 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 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay M. Hurry, 212-838-3777, shurry@lhai.com
program/media contact: John Shearman, 631-240-8838, john.shearman@adnas.com

Applied DNA and GHCL Launch “REKOOP” Verified by the CertainT Platform on Amazon.com on Earth Day

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CertainT Verified Recycled PET Bedding Drives Sustainability for Global E-commerce

STONY BROOK, N.Y. (April 22, 2019)Applied DNA Sciences Inc. (NASDAQ: APDN) , a leader in PCR-based DNA manufacturing for product authenticity and traceability solutions, and GHCL announced today the launch of “REKOOP” on Amazon.com. The “REKOOP” range of bedding products is meant for the ecologically conscious consumer who is making purchase decisions to support the environment and is supportive of initiatives that help reduce the carbon footprint.

Consumers are assured of REKOOP’s ecologically conscious practices through the molecular tagging of the recycled fiber that comprise its product line through Applied DNA’s CertainT platform that secures provenance and complete traceability across the supply chain.

Reliance Industries Ltd. (RIL), India’s largest private sector company, is GHCL’s fiber-manufacturing partner and supplies the truly ecofriendly recycled polyester fiber – Recon® Green Gold, which is used in REKOOP bedding.

REKOOP bedding is made by blending cotton with polyester fiber obtained from recycling post-consumer PET bottles. The concept is sustainable, durable and free of any hazardous chemicals. There are 36 PET bottles used for the production of every 250 TC (thread count) REKOOP sheet set (60% cotton 40% recycled PET). This helps in the reduction of landfill space, crude oil consumption and carbon emissions in the atmosphere.

“Powered by our CertainT platform, REKOOP brings to the mass consumer market the ability for individuals to express their commitment to sustainable textile practices via one of the world’s leading retailers. As sustainability in manufacturing becomes increasingly relevant to today’s consumer, our CertainT platform can be a hallmark for sustainable production practices for consumers and manufacturers alike,” stated MeiLin Wan, vice president, textiles, Applied DNA Sciences.

For more information on REKOOP, please visit www.rekoop.pet.

About GHCL
GHCL is a well-diversified organization with an ascertained footprint in Chemicals, Textiles and Consumer Products segment. In Chemicals, the company mainly manufactures Soda Ash (Anhydrous Sodium Carbonate) that is a major raw material for Detergents & Glass industries and Sodium Bicarbonate (baking soda). One of India’s leading manufacturers of Home Textiles, GHCL has an integrated set up which commences right from spinning of fiber (yarn), weaving, dyeing, printing till the finished products, like sheets & duvets, take shape which are primarily exported worldwide. The in-house spinning unit has the capability to manufacture multiple varieties of 100% cotton and blended yarns at various facilities. A perennial innovator in bed linen category some of the recent innovations in the category of sheets include ‘Cirkularity’ – a collection of 8 ranges that support the Circular Economy and focus on ‘reuse, reduce and recycle’, ‘Meditasi’,  a health and wellness collection with 9 ranges that include radiation control, temperature regulation, moisture management and athletic recovery, ‘Nile Harvest’, a foolproof traceable Egyptian cotton solution and ‘Fabfit’, a unique fit solution where three sheets fit the six sizes of mattresses. Consumer Products operation is another business for GHCL where it is a leader in manufacturing and selling Edible salt, Industrial grade salt and Honey in the country under the brand name of I-Flo.

At GHCL Ltd, Sustainability is a core element of our business strategy as defined under the aegis of ‘GHCL Way’ which has four pillars i.e. Responsible Stewardship, Social Inclusiveness, Promoting Relationship and Adding Value.

About Reliance Industries
Reliance Industries (RIL) is India’s largest private sector company, with a consolidated turnover of INR 330,180 crore ($ 50.9 billion), cash profit of INR 42,800 crore ($ 6.6 billion), and net profit of INR 29,901 crore ($ 4.6 billion) for the year ended March 31, 2017. RIL is the first private sector company from India to feature in Fortune’s Global 500 list of ‘World’s Largest Corporations’ – currently ranking 203rd in terms of revenues, and 110th in terms of profits. The company stands 106th in the ‘Forbes Global 2000’ rankings for 2017 – the top-most among Indian companies. It ranks 10th in LinkedIn’s ‘Top Companies Where India Wants to Work Now’ (2017). RIL’s activities span hydrocarbon exploration and production, petroleum refining and marketing, petrochemicals, retail and 4G digital services.

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.

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 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, limited market acceptance, shifting enforcement priorities of US federal laws relating to cannabis, 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 18, 2018 and our subsequent quarterly report on Form 10-Q filed on February 7, 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 to reflect the occurrence of unanticipated events, unless otherwise required by law.

investor contact: Sanjay Hurry, 212-838-3777, shurry@lhai.com
media contact: Meryl Rader, 781-639-4924, meryl@cgprpublicrelations.com
program contacts: MeiLin Wan, 631-240-8849, meilin.wan@adnas.com

Trustees of the Earth

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By Namrata Rana

Business responsibility is not a new phrase. Everything that needed to be said about it has possibly already been said in many forums, several times over. Still, there is a gap between intent and action. CEOs say the right things all the time, yet companies continue to bypass every single responsibility paradigm. Why? What stops them from doing the right thing?

Responsibility is an abstract term. So are sustainability, ethics, CSR and values. Embracing responsibility means bringing change in the organisation. And change is never easy. It brings pain. It brings resistance. Change is also not a single event. It is a series of events, involving several things and the biggest of them involves emotions and the inherent human resistance to change. What will bridge this gap between intent and action?

Do corporate incentives need to change? Do processes need to change? Do we need more transparency?

Given the scenario that we face, we need new ways of looking at things. One such lens is the concept of trusteeship proposed by Mahatma Gandhi. It specifies that everything we do must be economically viable as well as ethical—at the same time making sure we build sustainable livelihoods for all. When applied to the world of today, it defines the core values of a business which run through how the business needs to conduct itself. Perhaps we need to look back so that we can move forward. Some extensions of it’s core beliefs can be:

Leadership for the fourth industrial revolution has to be about mindfulness. It has to be about people. A new kind of leadership is needed that builds trust, is driven by values and is open to change. The leader has to be a trustee to all the stakeholders, rising above the stereotypes to decide what she will and will not do. As a trustee to the organisation, there is no exit strategy. The leader is responsible for the impact of her decisions. This could be food for thought for venture funded companies that are currently destroying business models without taking responsibility for the damages caused. Their current philosophy is: if we don’t do it someone else will. Perhaps it could it change to, ‘If it can be done, let’s do it right and take people along.’

There are no outsiders anymore. New ways of thinking and acting are required from all stakeholders, including individuals, business executives, social influencers and policy-makers. Deep, meaningful conversations and not just excel sheets hold the key to responsibility. This means thinking not just about what new perspectives might be needed, but finding entirely new ways to create and update our thinking over time in collaboration with other people in the industry, policy makers and customers themselves. The corporate brand needs to move from product attributes, smart logos and great TV advertisements into being more human, responsive and above all trustworthy.

Pro-active responsibility for an accelerating world. Current models of responsibility are mostly reactive. They seek to rectify damage to the environment and social systems. In a data-driven world, there is the potential to cause massive damage with far-reaching consequences. In the next few years existing systems and value chains will need a reboot not just in terms of finding newer markets and growth avenues, they will come under increasing regulatory and public pressure for transparency, trustworthiness and public good. We can’t any longer say, ‘Hey this is a new innovative product that will be loved by millions but there will be a few downstream issues. But, we needn’t look at them now, let’s cross that bridge when we get to it.’ Companies, reputations and lives will get destroyed with such short-term thinking. Trusteeship is about taking the higher ground, about getting the design right in the first place. Proactive is the default norm.

Business responsibility therefore needs a modern context. It needs to bring in the many connections and technology interchanges that really define the twenty-first century, as well as build frameworks that reflect the changing realities. If done right, responsibility for the modern world can define the boundaries of the corporation—and its very soul!

Namrata Rana is the author of BALANCE – Responsible business for the digital age. She is Director-Strategy and Brand, at Futurescape and India Ambassador of University of Cambridge Institute for Sustainability Leadership. Her work focuses on creating responsible brands through customer journey mapping and leadership workshops. She has worked in the areas of retail, healthcare, mobility, food, hospitality and infrastructure. She is also visiting faculty at IIM Udaipur, and her annual study on India’s top companies for Sustainability and CSR is a pioneering work which is very well regarded by industry and practitioners.