High-Expression Amplicons Facilitate Non-Recombinant Gene Therapies. Hold the Potential to Serve as an Alternative to Plasmids and Viral Vectors.
STONY BROOK N.Y., August 27, 2018 – Applied DNA Sciences Inc., (NASDAQ: APDN, “Applied DNA,”), the leader in large-scale PCR-based DNA manufacturing, will present a poster entitled “Linear DNA High-Expression Amplicons (HEAs) for Gene Therapy” at the 6th Annual Immuno-Oncology Summit in Boston at the Seaport World Trade Center, August 28-30, 2018. The Company will exhibit its patent-pending HEA technology at booth 301, where it will offer its Contract Research and Contract Manufacturing services to Summit attendees. The Summit brings together a unique and international mix of large and medium pharmaceutical and biotech companies, leading universities and clinical research institutions, government and national labs, CROs, emerging companies and tool providers with a dedicated focus on next-generation immunotherapy programs.
The term “linear” in this context refers to the physical form of highly purified DNA as produced by polymerase chain reaction or PCR, the platform upon which Applied DNA is founded. In contrast, the traditional methods of producing DNA in the larger quantities required by biotherapeutics have employed plasmids, the extrachromosomal circular DNA found in bacteria. Plasmids are best known as the DNA form by which the genes for antibiotic resistance are exchanged between bacteria.
A fundamental challenge of gene therapy is the development of safe and effective delivery vectors. Most of the more than 2,600 current clinical trials in gene therapy are virally mediated. However, viral vectors have risks stemming from potential allergic responses and the consequences of permanent alterations to the cellular genome. Recently, our PCR-produced linear DNA in high-expression amplicons, demonstrated successful expression both in cell lines in vitro, and in vivo. When linear DNA enters the nucleus, it does not need to be incorporated into the genome in order to be temporarily expressed as the intended protein product. In order to elicit the biological response intended by genetic vaccines or genetic immune therapies, transient expression may be sufficient. “We believe this shift in the therapeutic mechanism can improve the outcome for many gene therapies,” commented Dr. Stephen Hughes, Director of DNA Programs at Applied DNA.
Linear DNA high-expression amplicons, a product of Applied DNA’s effort in synthetic genomics, have the potential to become a viable alternative to plasmids and to viral vectors for delivery of the required gene therapy constructs because:
Synthetic vehicles have lower risks of unwanted immunogenicity than viral vectors,
Patients should have less pre-existing immunity to a synthetic DNA than would be the case with some viral delivery systems, thus lessening the risk of allergic response,
HEAs allow incorporation of long DNA sequences in multi-gene cassettes,
HEAs are easier to synthesize than viral vectors,
HEAs contain no bacterial plasmid contaminants or sequences of prokaryotic origin such as the genes for antibiotic resistance, and,
HEAs can be used to introduce nucleic acid end-modifications and bioconjugate chemistry (not generally attainable in plasmids or viral vectors) to facilitate their uptake, stability and expression in cells.
Applied DNA will offer access to a unique portfolio of patented and proprietary technologies, such as those that increase the expression of therapeutic or endogenous genes and improve the circulating lifetimes and efficiencies of the protein products of gene therapies. By supplying value-adding technology to existing and new DNA and RNA therapeutics via its HEA technology, Applied DNA can offer improvements to its customers’ therapeutics.
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 DNA mass production for diagnostics, personalized medicine and therapeutics.
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. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.
SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials, and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems.
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 our history of 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 28, 2017and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018, May 3, 2018 and August 13, 2018, which are available at www.sec.gov. APDN 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, LHA Investor Relations, shurry@lhai.com media contact: Cheryl Schneider, Dian Griesel Int’l, 212-825-3210, cschneider@dgicomm.com program contact: Brian Viscount, Director, Product Management, 631-240-8877 web: www.adnas.com twitter: @APDN
Maybe you bought a new mattress and want sheets just as spiffy. Or you’ve got houseguests coming and you want to give them a five-star hotel experience. Perhaps it’s just time for an upgrade to the finer things in life. Whatever your reason for deciding to invest in luxury bedding, finding the perfect sheet set can be an exhausting process – but so satisfying when you get it right. Let us cut through the clutter and present our pick for the best of the best – the Wamsutta® Dream Zone® 1000-Thread-Count PimaCott® Sheet Set.
What Makes a Luxury Sheet Set Different? When you’re searching for the perfect bedding linens, there are lots of different things to consider – but just a few things that really set investment-quality sheets and pillowcases apart. We all know to look for a high thread count, the measure of individual threads woven into each square inch of fabric, but even more important is the type of cotton itself – and the purity of that cotton. A high-quality cotton will stay stronger and softer longer. Make sure you choose an extra long staple variety – like Pima – that you can verify hasn’t been mixed with inferior cottons. With the highest quality cotton and a reputable brand, a higher thread count (up to about 1,000) really will make for a silkier feeling sheet. Finally, true luxury is found in attention to detail, so look for a sheet set that goes above and beyond in features that makes the bedding easier to care for, use, and love.
Why are Wamsutta® Dream Zone® Sheets the Best? Not only does the Wamsutta® Dream Zone® 1000-Thread-Count PimaCott® Sheet Set hit the upper end of the thread count sweet spot, but they’re made with the ultimate in luxury cotton. PimaCott is the only cotton that is scientifically proven to be pure pima, free of any inferior cotton blends or deceptive labeling. The sheets and pillowcases in this luxury bedding set are made of 100% sateen-weave PimaCott cotton for the ultimate in sleeping comfort and long-wearing quality. Proven pure pima cotton is softer, stronger, more breathable, and less likely to pill or fade than other cottons. When it comes to high-quality details, the Wamsutta® Dream Zone® feature a unique Boxer Fit design, with an extra-deep pocket fitted sheet to fit mattress up to 20 inches deep, and the pillowcases have a tailored European envelope design that holds the pillow in place and neatly covers the end of the pillow.
Experience luxury that lasts. Wamsutta linens made with PimaCott are verified pure pima cotton, grown in the San Joaquin Valley, CA. The purity of our extra long and dense fibers makes PimaCott softer, more durable, and more vibrant than regular cotton. Never blended or contaminated, you’re getting the purest pima possible. It’s the Wamsutta quality you expect and the luxuriousness you’ll enjoy for years to come.
Company to Hold Conference Call and Webcast Today, Monday, August 13, 2018 at 4:30 PM EST-
STONY BROOK, N.Y. – August 13, 2018 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”), announced financial results for the fiscal 2018 third quarter ended June 30, 2018.Commenting on Applied DNA’s results for the fiscal third quarter, Dr. James A. Hayward, president and CEO, stated, “Results for the quarter did not fulfill our expectations for recognized revenue due to the shipping of an initial cotton DNA order under extended payment terms. Nonetheless, our performance stands out for the progress we have made in driving commercial adoption of our DNA taggant platform through large commercial-scale feasibility activities:
in pharmaceuticals, together with Colorcon we performed a larger scale production run for solid oral dosage form tagging;
in leather, we are nearing the completion of a commercial-scale tagging and testing trial following the completion of the feasibility program supported by several global brands and supply chain stakeholders,
and in cannabis, we designed, built and publicly unveiled our cannabis tracking system (CTS), a major milestone under our TheraCann agreement which will power seed-to-sale legal cannabis tracking.
In addition to these activities under existing development contracts, we signed new agreements with large marquee companies, UL and Everledger, that we expect will broaden our access to new markets and increase our value proposition to customers. Concurrently, business in our biopharma research and manufacturing offerings has been gaining promising momentum.”
Continued, Dr. Hayward, “As global supply chains move to address growing business imperatives centered on supply chain traceability, transparency and trust, we are expanding our opportunities for revenue by seeding markets with partners that recognize the value proposition of our taggant technology. With momentum growing globally for the legalization of cannabis and supply chain participants seeking regulatory compliance, our launch of the industry’s first seed-to-sale cannabis tagging system with TheraCann is timely. Our partner Everledger, endorses our view that the linkage of digital blockchain-enabled transactions with a forensic physical goods identifier increases the value of the platform to global ecosystems. That identifier is our DNA taggant.
“We also reached new milestones in biotherapeutic contract research and contract manufacturing of linear DNA, with multiple firms throughout Europe and the US. We believe that our ability to deliver large-scale PCR-based DNA production for DNA/RNA vaccines, gene therapies, adoptive cell therapies and diagnostics, may eliminate the risks associated with current plasmid- and virus-based genetic methods. With these milestones, we demonstrate the potential to replace plasmid production methods and viral vectors, potentially opening large, high-value markets that will bring the benefits of our technology to patients.
Concluded Hayward, “Applied DNA sits at the nexus between global supply chains and market forces dictating the need for increased transparency and responsible procurement. With our taggant technology platform proven at scale, a foundation of recurring revenues, new commercial agreements that open previously untapped markets, we are well positioned to leverage tailwinds in the marketplace to deliver sustainable growth to our shareholders.”
Fiscal Third Quarter Financial Results:
Revenues decreased 43% for the third quarter of fiscal 2018 to $1.0 million, compared with $1.8 million reported in the third quarter of fiscal 2017, and remained flat as compared to revenues for the fiscal second quarter ended March 31, 2018. The year-over-year decrease in revenues is primarily attributable to shipments relating to the initial order of $1.2 million in our cotton vertical for the upcoming ginning season being recorded in deferred revenue at June 30, 2018 due to extended payment terms. This decrease was offset by an increase in revenues from feasibility pilots in pharmaceutical and cannabis industries.
Deferred revenue increased to $2.3 million as of June 30, 2018 as compared to $352 thousand at September 30, 2017. The reason for this increase is due to the initial cotton order of $1.2 million noted above as well as fees paid for a variety of contracts that include specific milestones and therefore were not able to be fully recognized as revenue during the quarter ended June 30, 2018.
Total operating expenses were $3.6 million, compared with $4.2 million in the prior year’s quarter, a decrease of approximately 13%. The decrease in year-over-year total operating expenses is primarily attributable to a decrease in stock-based compensation expense of $328 thousand and bad debt expense of $343 thousand.
Net loss for the quarter ended June 30, 2017 was $2.9 million, or $0.10 per share, compared with a net loss of $2.6 million, or $0.10 per share for the same period in the prior fiscal year and a net loss of $2.1 million, or $0.07 per share for the first fiscal quarter ended March 31, 2018.
Excluding non-cash expenses, Adjusted EBITDA for the quarter ended June 30, 2018 was negative $2.5 million, compared to negative Adjusted EBITDA of $1.5 million for the same quarter last fiscal year and negative Adjusted EBITDA of $2.3 million in the prior fiscal quarter. See below for information regarding non-GAAP measures.
Nine-Month Financial Highlights:
Revenues for the first nine months of fiscal 2018 totaled $2.7 million, a decrease of 25% from $3.6 million from the same period in the prior fiscal year. The decrease in revenues was due to the deferral of approximately $1.2 million for product shipped for the marking of cotton with extended payment terms during the quarter ended June 30, 2018.
Operating expenses for the nine months ended June 30, 2018 decreased by $2.8 million or 22% for the same period last fiscal year. The decrease is primarily attributable to a decrease in stock-based compensation, offset by an increase in R&D due to the government contract award.
Net loss for the nine months ended June 30, 2018 was $8.2 million or $0.28 per share, compared with a net loss of $10 million or $0.38 per share for the nine months ended June 30, 2017.
Excluding non-cash expenses and interest, Adjusted EBITDA for the nine months ended June 30, 2018 was a negative $7.6 million as compared to a negative $6.6 million for the same period in the prior fiscal year. See below for information regarding non-GAAP measures.
Recent Operational Highlights:
On August 2, Applied DNA announced that it has reached new milestones in therapeutic contract research and contract manufacturing of Polymerase Chain Reaction (PCR)-produced linear DNA. PCR is a well-proven technique of DNA amplification that holds the potential to replace plasmid production methods and viral vectors in nucleic acid based therapeutics.
On July 31, the Company announced the signing of a MOU with Everledger to build a CertainT Blockchain platform for high-end product markets. The molecular tag, test and track platform provides physical identity and traceability for Everledger’s digital platform with the leather supply chain as the first target market.
On July 24, the Company announced that, in conjunction with TheraCann International, it will launch the cannabis industry’s first DNA based cannabis tagging system (CTS) using Applied DNA’s CertainT® platform of tag, test and track. The deviceis designed to rapidly molecularly tag cannabis plants in commercial harvests of any scale.
On July 17, Applied DNA announced the shipment of a $1.2 million order in its fiscal 2018 third quarter to tag cotton in the upcoming 2018/2019 ginning season. The order for the Company’s SigNature T® platform technology will be used to tag, test and track three US cotton varietals, Pima, Acala and Delta. Revenues were deferred until payment is due.
On July 10, the Company announced a strategic partnership with UL. The commercial agreement aims to expand product authentication and traceability solutions throughout the product supply chain.
On May 8, Applied DNA announced that Louis Dreyfus Company (LDC) has installed Applied DNA Sciences’ SigNature® T cotton traceability system at its Moree gin in Australia to tag, test and track pure HomeGrown™ Australian cotton.
Fiscal Third Quarter 2018 Conference Call Information
The Company will hold a conference call and webcast to discuss its fiscal third quarter-end 2018 results on Monday, August 13, 2018 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
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 DNA mass production for diagnostics, personalized medicine and therapeutics.
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. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.
SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials, and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems.
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 our lack of significant revenues, limited financial resources, limited market acceptance, history of net losses, market competition, risk of not obtaining regulatory approval 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 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018 and May 3, 2018 and August 13, 2018, 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. CONSOLIDATED BALANCE SHEETS
June 30, 2018 (unaudited)
September 30, 2017
ASSETS
Current assets:
Cash and cash equivalents
2,514,816
2,959,781
Accounts receivable, net
1,414,948
2,587,969
Inventories
295,278
326,468
Prepaid expenses and other current assets
602,800
366,954
Total current assets
4,827,842
6,241,172
Property and equipment, net
535,805
523,688
Other assets:
Deposits
62,380
61,626
Goodwill
285,386
285,386
Intangible assets, net
896,562
1,042,076
Total Assets
6,607,975
8,153,948
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable and accrued liabilities
818,642
944,133
Deferred revenue
2,298,152
351,735
Total current liabilities
3,116,794
1,295,868
Long-term accrued liabilities
433,051
–
Total liabilities
3,549,845
1,295,868
Commitments and contingencies
Stockholders’ Equity
Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of June 30, 2018 and September 30, 2017
—
—
Series A Preferred stock, par value $0.001 per share, 10,000,000 shares authorized; -0- issued and outstanding as of June 30, 2018 and September 30, 2017
—
—
Series B Preferred stock, par value $0.001 per share, 10,000,000 shares authorized; -0- issued and outstanding as of June 30, 2018 and September 30, 2017
—
—
Common stock, par value $0.001 per share; 500,000,000 shares authorized; 30,112,057 and 27,377,057 shares issued and outstanding as of June 30, 2018 and September 30, 2017, respectively
30,112
27,377
Additional paid in capital
247,918,818
243,503,858
Accumulated deficit
(244,890,800)
(236,673,155)
Total stockholders’ equity
3,058,130
6,858,080
Total Liabilities and Stockholders’ Equity
6,607,975
8,153,948
APPLIED DNA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
Three Months Ended June 30, 2018
Three Months Ended June 30, 2017
Nine Months Ended June 30, 2018
Nine Months Ended June 30, 2017
Revenues:
Product revenues
393,758
1,493,449
1,230,232
2,887,054
Service revenues
622,597
303,933
1,477,746
718,709
Total revenues
1,016,355
1,797,382
2,707,978
3,605,763
Cost of revenues
252,562
232,348
956,155
804,552
Operating expenses:
Selling, general and administrative
2,882,158
3,402,817
7,471,917
10,534,105
Research and development
625,006
603,095
2,034,886
1,757,616
Depreciation and amortization
122,999
161,441
425,927
486,786
Total operating expenses
3,630,163
4,167,353
9,932,730
12,778,507
LOSS FROM OPERATIONS
(2,866,370)
(2,602,319)
(8,180,907)
(9,977,296)
Other income (expense):
Interest income, net
–
228
–
2,763
Other (expense) income , net
(21,353)
(8,758)
(36,738)
(26,556)
Loss before provision for income taxes
(2,887,723)
(2,610,849)
(8,217,645)
(10,001,089)
Provision for income taxes
—
—
—
—
NET LOSS
(2,887,723)
(2,610,849)
(8,217,645)
(10,001,089)
Net loss per share-basic and diluted
(0.10)
(0.10)
(0.28)
(0.38)
Weighted average shares outstanding-
Basic and diluted
30,112,057
26,374,023
29,290,555
26,049,866
APPLIED DNA SCIENCES, INC. CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA (Unaudited)
Romancing the stones: Stony Brook-based biotech Applied DNA Sciences is at it again, this time partnering with an international blockchain ace on the development of an “integrated physical and digital security” program for supply-chain traceability and certification focused on high-end merchandise.
Applied DNA and London-based Everledger – named a 2018 Technology Pioneer at the recent World Economic Forum – have announced a Memorandum of Understanding that will combine the biotech’s DNA-based tagging and tracing protocols with Everledger’s “leadership in tracking provenance,” which has provided asset protection for various industries, particularly those focused on precious stones.
According to a joint statement, the two companies will “collaboratively integrate their respective technology platforms and pursue various market opportunities, including leather,” a market where Applied DNA already has some experience. Applied DNA President and CEO James Hayward said his company is thrilled to buddy up to “the global leader in blockchain applications.”
Applied DNA Sciences, Inc. has signed an memorandum of understanding (MoU) with Everledger to build CertainT Blockchain platform for high-end products including leather. The molecular tag, test and track platform will provide physical identity and traceability for Everledger digital platform with leather supply chain as first target market.
Everledger’s leadership in tracking provenance on its blockchain-based platform has been proven to offer transparency and asset protection across various industries. The company’s emerging technology solution is scaled for industry standardisation as evidenced by the provenance of over 2.2 million diamonds encrypted on its platform. The company was recently named as a World Economic Forum 2018 Technology Pioneer.
NEW YORK — More than a half dozen New York based businesses have partnered with U.S. Immigration and Customs Enforcement’s (ICE), Homeland Security Investigations (HSI) in New York Thursday by joining the agency’s employment compliance program IMAGE, or “ICE Mutual Agreement between Government and Employers.”
“It is an honor to become a partner of the ICE IMAGE Program. As a company whose technologies are used by Department of Defense (DOD) and non-DOD federal agencies to establish traceability, authenticate products and enable supply chain security, the discipline under the certification criteria is especially meaningful to us and to our customers,” said Janice Meraglia, VP of Government and Military Programs for Applied DNA Sciences, Inc.
Diagnostics Shipments, Vaccines Research, CAR T, and System Development bring in Requests for DNA
STONY BROOK, N.Y., August 6, 2018 – Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today it plans to release financial results for its fiscal 2018 third quarter ended June 30, 2018 after market close on Monday, August 13, 2018. 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.
When: Monday, August 13, 2018, at 4:30 p.m. Eastern Time
Where: Via phone by dialing +1 844-887-9402 or +1 412-317-6798 and ask for 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 10122259. The webcast will be archived in the Investors section of the company’s website.
These projects are following the typical preclinical biotherapeutic path of proving efficacy at small scale prior to securing larger production appropriate for clinical trials and deployment.
Most DNA-based therapeutic products, both approved and in development, rely on legacy science of plasmid and viral vector production methods that are time-consuming, carry the risks of bacterial toxins and triggering complications or unintended consequences. Several recent clinical trials have been halted by FDA due to unintended consequences of plasmid-derived DNA. As an alternative, Polymerase Chain Reaction (PCR), is a well-proven technique of DNA amplification first introduced in the 1980’s as an investigative tool in research and diagnostic laboratories. Applied DNA’s patented large-scale PCR production capability is a breakthrough for therapeutic applications as it has already demonstrated that PCR product can be made available very cleanly and at the scale required for population-scale diagnostics.
The most significant Applied DNA milestones recently achieved in this field come from work with multiple companies worldwide to qualify PCR-based linear DNA expression constructs for therapeutic applications. From these collaborative efforts, we have shown that linear DNA is effective in expression of genes in vivo.
These forms are in direct contradistinction to Applied DNA’s DNA tags for supply chains, which are too small to express proteins, have no means of entering cells or tissues, and contain none of the control elements necessary to do so.
This accomplishment is among the first times a linear DNA expression amplicon produced by PCR has demonstrated expression in vivo.
In all cases, companies in our pipeline have been driven to Applied DNA’s market position as an alternative to the current science of plasmid-produced DNA to gain PCR-based linear DNA vectors inherently superior to plasmid and viral vectors in several important aspects:
Bacteria-free: Absence of bacterial plasmid contaminants or sequences of prokaryotic origin such as genes for antibiotic resistance,
Speed: Shorter lead times (days) from vector design to large scale production,
Custom design turnaround time: custom modifications in sequence during the PCR process to enable experimentation comparisons on therapeutic performance, and,
On-site Production: patented platform for large scale production supports the feasibility of DNA production closer and tailored to the point of care to support the concept of personalized medicine.
“The milestones achieved to-date are a result of a multi-year business plan beginning with the acquisition of Vandalia Research assets three years ago. Now attracting new business at an accelerating rate and showing results that go toe-to-toe with legacy plasmid production is a major milestone for the viability of PCR-produced DNA for use in therapeutics,” said Dr. James Hayward, president and CEO of Applied DNA. “We will continue to work with companies developing therapeutics to expand the processes necessary to grow this business alongside our mainstay tagging business.”
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 DNA mass production for diagnostics, personalized medicine and therapeutics.
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. The proprietary DNA-based “CertainT®” platform can be used to identify, tag, test, and track products, to help assure authenticity, origin, traceability, sustainability and quality of products.
SigNature® DNA describes the core technology ingredient that is at the heart of a family of uncopiable, security and authentication solutions, targeted a wide range of industries, including but not limited to, pharmaceuticals and nutraceuticals, textiles and defense materials, and DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track-and-trace. Our products provide a forensic chain of evidence in large commercial ecosystems.
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 our lack of significant revenues, limited financial resources, limited market acceptance, history of net losses, market competition, risk of not obtaining regulatory approval 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 28, 2017 and our subsequent quarterly reports on Form 10-Q filed on February 8, 2018 and May 3, 2018, 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, among the world’s largest producers of linear DNA, has reached new technical milestones in the growth of its Contract Research (CRO) and Contract Manufacturing (CMO) businesses. In the past 12 months, Applied DNA has shipped over 8,000mg of PCR-produced linear DNA for use in Diagnostic and Therapeutic applications. The Company has completed, or is progressing through, key milestones of a growing number of therapeutics research contracts for companies producing DNA and RNA vaccines and adoptive cell therapies. Key milestones of success for these gene therapies are delivery of DNA effectively into a cell, expressing the gene product from that DNA and eventually demonstrating the desired clinical outcome.
Commissioned by Applied DNA Sciences, survey finds 73% would stop purchasing
Stony Brook, N.Y. – Women and younger adults are particularly avid about valid product claims, according to a new poll.
The Harris Poll, which was conducted last month and commissioned by Applied DNA Sciences, found that the two groups were the most likely to drop products they discovered to be inauthentic. In addition to boycotting such products, they would be the most likely to write negative reviews and contact regulatory authorities.
