STONY BROOK, NY, May 18, 2020 — Stony Brook University now has access to a new highly sensitive clinical test for COVID-19. The new testing protocol, developed in collaboration with scientists at Applied DNA Sciences, received FDA Emergency Use Authorization (EUA) for a unique assay, which detects RNA of SARS Cov-2, the novel coronavirus that causes COVID-19.
The EUA was based on clinical studies performed in the Molecular Pathology Laboratory of Stony Brook University Hospital (SBUH), directed by Dr. Silvia Spitzer and supported by Pathology resident, Dr. Karen Bai, Medical Scientist Training Program (MSTP) student, John Yuen as well as several other graduate and MSTP student volunteers.
According to Dr. Kenneth Shroyer, Chair of the Department of Pathology, the efforts put forth by the team provided the FDA with the necessary evidence demonstrating the new RNA assay is highly sensitive and specific and thus, could provide another tool that could be deployed to perform COVID-19 testing for patients at Stony Brook University Hospital.
The U.S. Food and Drug Administration (FDA) granted emergency use authorization to several developers of molecular tests, including Hologic’s high-throughput Aptima SARS-CoV-2 assay, according to the FDA’s website.
Separately, the FDA also granted EUA to GeneMatrix for its NeoPlex COVID 19 Detection Kit and Applied DNA Sciences for its Linea COVID-19 Assay Kit. Both test kits are designed to run on real-time PCR instruments.
Applied DNA Sciences Inc. (Stony Brook, NY, USA) has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the clinical use of the company’s patent-pending Linea COVID-19 RT-PCR test.
The Linea COVID-19 assay kit is an rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed to detect specific highly conserved target sequences of the SARS-CoV-2 Spike (S) gene.
Company to Hold Conference Call and Webcast Today, Thursday, May 14, 2020, at 4:30 p.m. EDT
STONY BROOK, N.Y. May 14, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced consolidated financial results for the fiscal second quarter and the six months ended March 31, 2020.
“Continued execution on our strategic priorities in our second fiscal quarter resulted in an expansion of our linear DNA story to include COVID-19 vaccine candidate and diagnostic kit programs and the addition of new development customers. These new development customers, several of which are leaders in the field of gene and redirected-cell therapies, demonstrate broadening interest and adoption of our proprietary linear DNA approach to preclinical biotherapeutics and diagnostics development and further validate linear DNA as a viable alternative for plasmid DNA,” stated Dr. James A. Hayward, president and CEO of Applied DNA.
“Most of our activities during the quarter were devoted to our COVID-19 development programs that serve to also elevate the profile of our PCR-based LinearDNA™ platform to the biopharma industry as a powerful, large-scale tool for the rapid manufacture of DNA-based therapeutics,” continued Dr. Hayward. “The global focus on the pandemic and the speed with which vaccine candidates are being developed are laying bare the limitations of modern vaccine development that are almost-exclusively reliant on plasmid-based technologies that are often slow and require much more downstream processing. Because our linear DNA approach does not require bacterial fermentation and has the added advantage of essentially no risk of contamination by genes for antibiotic resistance and other genetic contaminants, we believe our platform is well suited for such DNA-based therapeutics as engineered T cells, gene therapies, RNAi, and vaccines, such as for COVID-19 or future emerging infectious diseases. One new development customer, a global Top-20 pharmaceutical manufacturer, is evaluating the full scope of our platform to potentially serve as a foundational tool for their future genetic therapy pipeline. As the industry comes to terms with the limitations of plasmid-based technologies in terms of production speed and risk, we believe this will set the stage for a paradigm shift towards the rapid manufacturing of linear DNA vaccines with our LinearDNA platform as the accelerator.”
Concluded Dr. Hayward, “Looking ahead, we remain focused on driving interest and building demand for our linear DNA approach across certain highly-regulated markets, such as drug development, that we believe offer a path to higher and more recurring revenue. Takis Biotech (“Takis”) has initiated preclinical animal trials of our LinearDNA version of their vaccine candidates that we believe will demonstrate similar, robust immune responses to their plasmid-based constructs, but with the added advantage of speed and scalability to manufacture for global use. Concurrently, we are preparing for the possibility for Takis to progress to human trials this fall by readying our facility for compliance with the FDA’s cGMP regulations that govern the quality of biologics for human use. We have also developed our Linea™ COVID-19 high-throughput and high-sensitivity SARS-CoV-2 detection kit to enable mass-testing that can be a crucial tool in the toolbox of health systems and governments in the fight to further ‘flatten the curve.’ Having received Emergency Use Authorization from the FDA today, we are now focused on the commercialization of our kit to assist frontline workers leading the charge against the pandemic. Pharmaceutical molecular tagging is another target market and one where the FDA has granted us entry into its Emerging Technology Program that gives us a path to drive the industry’s adoption of our authentication technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain. We will continue to build our business development pipeline and execute on our strategy to advance and prove the capabilities of linear DNA to drug developers and the broader pharmaceutical industry.”
Fiscal Second Quarter 2020 Financial Results:
Revenues decreased 29% for the second quarter of fiscal 2020 to $552 thousand, compared with $778 thousand reported in the same period of the prior fiscal year and decreased 13% from $634 for the first quarter of fiscal 2020. This decrease in revenues year over year is due to a decrease of $305 thousand in service revenues, offset by an increase of $79 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019 and a decline in precommercial feasibility projects in both textiles and cannabis. The increase in product revenues was primarily related to an increase in biopharmaceutical revenues during the quarter ended March 31, 2020.
Total operating expenses decreased to $3.1 million for the second fiscal quarter of 2020, compared with $3.3 million in the prior fiscal year’s second quarter. This decrease is attributable to a decrease in professional fees of approximately $183 thousand due to reduced legal fees. To a lesser extent, the decrease relates to a reduction of approximately $64 thousand in travel fees as result of travel restrictions associated with COVID-19. This decrease was offset by an increase in research and development expenses of $52 thousand.
Net loss for the quarter ended March 31, 2020 was $3.0 million, or $0.79 per share, compared with a net loss of $2.7 million, or $3.22 per share, for the quarter ended March 31, 2019, an increase of 10%, and a net loss of $2.7 million, or $1.12 per share, for the quarter ended December 31, 2019.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.6 million and a negative $2.3 million for the quarters ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.
Cash was $8.7 million at March 31, 2020 that includes the exercise of warrants associated with the November 15, 2019 underwritten public offering (“the offering”) totaling approximately $2.8 million in net proceeds. Subsequent to March 31, 2020 the Company received a further $2.9 million of net proceeds through the exercise of warrants associated with the offering. There is a total of approximately 1.5 million warrants outstanding from the offering at May 14, 2020.
Six Months Ended March 31, 2020 Financial Results:
Revenues decreased 29% for the first half of fiscal 2020 to $1.2 million, compared with $1.7 million reported in the same period of the prior fiscal year. This decrease in revenue year over year is due to a decrease of $472 thousand in service revenues and a decrease of $5 thousand in product revenues. The decrease in service revenues is primarily attributable to a decrease from a government contract award that ended during the second half of fiscal 2019.
Total operating expenses decreased to $6.1 million for the six months ended March 31, 2020, compared with $7.2 million in the prior fiscal year’s first six months. This decrease is primarily attributable to decreases in payroll of approximately $272 thousand, attributable to headcount reductions, a decrease in stock-based compensation expense of approximately $262 thousand as well as decreases in legal and professional fees of $139 thousand, consulting fees of $121 thousand, reduced travel expenses of $110 thousand and research and development of $93 thousand.
Net loss for the six-month period ended March 31, 2020 was $5.6 million, or $1.76 per share, compared with a net loss of $5.9 million, or $6.51 per share, for the six months ended March 31, 2019, an improvement of 5%.
Excluding non-cash expenses, Adjusted EBITDA was negative $5.0 million and a negative $4.9 million for the six months ended March 31, 2020 and 2019, respectively. See below for information regarding non-GAAP measures.
Select Quarterly Operational Highlights: Applied DNA progressed its COVID-19 development program that spans both vaccine development and clinical diagnostic kit development:
On May 14, 2020, Applied DNA announced that it had received Emergency Use Authorization for its COVID-19 diagnostic Assay kit from the U.S. FDA. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments can immediately begin ordering and using the LineaTM COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19;
On May 5, 2020, the Company announced that it had applied to the U.S. Food and Drug Administration for Emergency Use Authorization for its COVID-19 diagnostic kit, Linea™ COVID-19, a RT-PCR-based, high-sensitivity and high-throughput COVID-19 diagnostic test;
On May 4, 2020, Applied DNA and its COVID-19 development partner, Takis, announced that the first injections of their DNA vaccine candidates against the Spike protein (‘S’ gene) of the SARS-CoV-2 virus that causes the COVID-19 disease, have produced neutralizing antibodies in test animals. The studies were completed at the renowned Lazzaro Spallanzani (“Spallanzani”) National Institute for Infectious Diseases in Rome. These initial results were obtained using plasmids (the templates for LinearDNA™) to baseline results; Applied DNA’s linear DNA dose-response trials begin in the week of May 4, 2020;
On April 21, 2020, the Company signed an agreement with Stony Brook University Hospital to validate and implement the Company’s COVID-19 diagnostic test; Linea™ COVID-19. The diagnostic test targets the SARS-CoV-2 Spike (S) gene, which is also the subject of the Company’s COVID-19 vaccine development program.;
On April 15, 2020, Applied DNA announced that it had shipped five linear DNA versions of COVID-19 vaccine candidates to its drug development partner, Takis, to support the immediate start of preclinical animal testing. Shipment of the vaccine candidates follows Takis’ receipt of approval from Italy’s Ministry of Health to begin preclinical testing. Concurrent with Takis’ animal trials, Applied DNA is preparing for cGMP production of selected vaccine candidate(s) to support human trials scheduled to begin this fall; and
On March 24, the Company announced that it had filed a provisional patent application with the U.S. Patent and Trademark Office for a diagnostic assay for COVID-19.
The Company’s LinearDNA™ platform for preclinical biotherapeutic (gene and redirected-cell therapies) and diagnostic applications development continued to shift towards broader adoption:
On March 26, the Company announced that it had shipped CAR T amplicons proprietary to a new development customer, the biologics subsidiary of a U.S.-based, global biopharmaceutical company, for use in evaluating the use of linear DNA; and
On March 20, Applied DNA announced the signing of a research agreement with a new development customer, a global Top-20 pharmaceutical manufacturer, to evaluate the full scope of the Company’s linear DNA platform to potentially improve the efficacy and safety of the customer’s CAR T therapy pipeline. The research agreement includes the Company’s patented technologies to maximize protein expression and unique linear DNA anti-CD19 CAR T construct for the treatment of acute lymphocytic leukemia.
The Company’s DNA tagging business for supply chain security continued to build awareness and adoption:
On February 24, the Company announced the receipt of international patents on its Beacon® secure optical molecular market technologies in China, Canada, and the U.S., each a key market for brand protection and assurance for Applied DNA;
On February 20, Applied DNA received Pareve kosher certification for products within its SigNature® and CertainT® brands from Orthodox Union, the world’s largest and most widely recognized international kosher certification agency. Certification supports the Company’s business development efforts in the food, pharmaceutical, and dietary supplements markets to maximize adoption of its molecular-based tagging platform;
On February 19, the Company entered the dietary supplements market with a multi-year contract with Nutrition21, a trusted developer and supplier of novel and clinically substantiated branded ingredients for the nutritional supplement industry. Under the terms of the contract, the application of Applied DNA’s CertainT platform to Nutrition21’s leading sports supplement, Nitrosigine®, offers Nutrition21 the certainty of its ingredients all the way through to their customers’ finished products and onto retail shelves and online stores. Separately, the two companies signed an additional agreement to enable Nutrition21 to represent the CertainT platform throughout Nutrition21’s extensive network in the dietary supplement market.
Fiscal Second Quarter 2020 Conference Call Information The Company will hold a conference call and webcast to discuss its fiscal second quarter-end 2020 results on Thursday, May 14, 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
For those 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.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statements The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to 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 therapeutic or diagnostic 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, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, the unknown outcome of any applications or requests to U.S. FDA or equivalent foreign regulatory agencies, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, disruptions in the supply of raw materials and supplies, 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 reports on Form 10-Q filed on February 6, 2020 and May 14, 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.
APPLIED DNA SCIENCES, INC. CONSOLIDATED BALANCE SHEETS MARCH 31, 2020 AND September 30, 2019
ASSETS
March 31, 2020 (unaudited)
September 30, 2019
Current assets:
8,662,889
558,988
Cash and cash equivalents
Accounts receivable, net allowance of $4500 at March 31, 2020 and September 30, 2019, respectively
549,123
839,951
Inventories
88,941
142,629
Prepaid expenses and other current assets
678,120
604,740
Total current assets
9,979,073
2,146,308
Property and equipment, net
265,400
226,221
Other assets:
Deferred offering costs
–
109,698
Deposits
76,085
62,351
Goodwill
285,386
285,386
Intangible assets, net
720,953
734,771
Total Assets
11,326,897
3,564,735
LIABILITIES AND EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued liabilities (including related party of $40,000 at March 31, 2020)
1,178,358
1,616,997
Deferred revenue
671,526
628,993
Total current liabilities:
1,849,884
2,245,990
Long term accrued liabilities
722,564
621,970
Secured convertible notes payable, related party, net of debt issuance costs
1,485,673
1,442,497
Secured convertible notes payable, recorded at fair value
–
102,777
Total liabilities
4,058,121
4,413,234
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 March 31, 2020 and September 30, 2019, respectively
–
–
Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of March 31, 2020 and September 30, 2019, respectively
–
–
Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- shares issued and outstanding as of March 31, 2020 and September 30, 2019, respectively
–
–
Common stock, par value $0.001 per share, 500,000,000 shares authorized; 4,059,943 and 1,207,993 shares issued and outstanding as of March 31, 2020 and September 30, 2019, respectively
4,060
1,208
Additional paid in capital
269,693,833
255,962,922
Accumulated deficit
(262,423,267)
(256,805,589)
Applied DNA Sciences, Inc. stockholders’ equity (deficit)
7,274,626
(841,459)
Noncontrolling interest
(5,850)
(7,040)
Total equity (deficit)
7,268,776
(848,499)
Total liabilities and equity (deficit)
11,326,897
3,564,735
APPLIED DNA SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS THREE AND SIX MONTHS ENDED MARCH 31, 2020 AND 2019 (unaudited)
2020
2019
2020
2019
Revenues
Product
197,801
119,036
435,671
440,747
Service
354,672
659,432
750,321
1,222,044
Total revenues
552,473
778,468
1,185,992
1,662,791
Cost of revenues
179,582
133,141
411,613
286,626
Operating expenses:
Selling, general and administrative
2,285,544
2,528,914
4,68,957
5,611,295
Research and development
703,018
651,377
1,267,444
1,360,941
Depreciation an amortization
66,537
97,673
141,604
232,724
Total operating expenses
3,055,099
3,277,964
6,068,005
7,204,960
LOSS FROM OPERATIONS
(2,682,208)
(2,632,637)
(5,293,626)
(5,828,795)
Other (expense) income:
Interest expense (including related parties interest of $25,840 and $49, 310 for the three and six months ended March 31, 2019, respectively)
(29,096)
(37,417)
(58,187)
(69,028)
Other expense, net
(239,601)
(16,703)
(261,833)
(23,254)
Loss before provision for income taxes
(2,950,905)
(2,686,757)
(5,613,646)
(5,921,077)
Provision for income taxes
–
–
–
–
NET LOSS
Less: Net (income) loss attributable to noncontrolling interest
(2,950,905)
(2,686,757)
(5,613,646)
(5,921,077)
NET LOSS attributable to Applied DNA Sciences, Inc.
(1,220)
–
(1,190)
–
Deemed dividend related to warrant modifications
–
–
2,842
–
NET LOSS attributable to common stockholders
(2,952,125)
(2,686,757)
(5,617,678)
(5,921,077)
Net loss per share applicable to common stockholders – basic and diluted
(0.79)
(3.22)
(1.76)
(6.51)
Weighted average shares outstanding – basic and diluted
3,758,512
834,990
3,196,616
909,623
APPLIED DNA SCIENCES, INC. CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA (unaudited)
Three Month Period Ended March 31, 2020
Three Month Period Ended March 31, 2019
%Δ
Net loss
$(2,950,905)
$(286,757)
Interest expense (income), net
29,096
37,417
Depreciation and amortization
66,537
97,673
Stock based compensation expense (income)
227,268
267,094
Bad debt expense
–
–
Total non-cash items
332,901
402,184
Consolidated Adjusted EBIDTA (loss)
$(2,628,004)
$(2,284,573)
15%
.
Six Month Period Ended March 31, 2020
Six Month Period Ended March 31, 2019
%D
Net loss
$(5,613,646)
(5,921,077)
Interest expense (income), net
58,187
69,028
Depreciation and amortization
141,604
232,724
Stock based compensation expense (income)
432,758
757,338
Bad debt expense
–
–
Total non-cash items
632,549
1,050,457
Consolidated Adjusted EBIDTA (loss)
$(4,981,097)
$(4,870,620)
2%
INVESTOR CONTACT: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, shurry@lhai.com
By LabPulse.com staff writers — Applied DNA Sciences has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for a real-time reverse transcription polymerase chain reaction (RT-PCR) test for the novel coronavirus.
Advanced Single Well Assay Designed for High-Throughput Testing
STONY BROOK, N.Y. – May 14, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company,” “our”) announced today that the U.S. Food and Drug Administration (FDA) has provided Emergency Use Authorization (EUA) for the clinical use of the Company’s patent-pending Linea™ COVID-19 RT-PCR test for COVID-19. Clinical laboratories in the United States certified under Clinical Laboratory Improvement Amendments (CLIA) can immediately begin ordering and using the Linea™ COVID-19 assay kit to detect SARS-CoV-2, the virus that causes COVID-19.
The Linea™ COVID-19 assay kit is a high-sensitivity, high-fidelity rRT-PCR (reverse transcription, Real Time Polymerase Chain Reaction)-based assay designed to detect specific highly conserved target sequences of the SARS-CoV-2 Spike (S) gene. The Linea™ COVID-19 assay is an advanced single-well multiplex test that allows for simple set up and higher-throughput as compared to tests that require multiple wells per test. The Linea™ COVID-19 assay is approved to run on the FDA-approved Applied Biosystems QuantStudio™ Dx real-time PCR instrument, which allows for testing results for up to 94 samples within one hour, or more than 2,000 tests in 24 hours per device.
“I am very proud of our development team, who, despite the challenges presented by the current global pandemic, developed our Linea™ COVID-19 assay kit, filed patent applications, established supply chain relationships, developed our initial customer prospects and secured FDA EUA approval all within record time,” said Dr. James A. Hayward, president and CEO of Applied DNA. “This extraordinary achievement highlights the Company’s commitment to combating the COVID-19 pandemic both locally and nationwide. We also thank our neighbor and collaborator Stony Brook University Hospital for its invaluable assistance.”
Dr. Mohan Chellani, Director of Diagnostic Regulatory Affairs at Applied DNA and a 30-year veteran of the RNA-based molecular diagnostics industry, stated, “We believe we have developed an assay with numerous commercial advantages over other EUA approved COVID-19 detections assays. We developed the LineaTM COVID-19 assay kit for high-throughput operations where accurate and rapid high-volume testing is requisite. In addition, we have worked closely with our supply chain partners to evolve safeguards to ensure a steady supply of inputs necessary for the construction of our kit.”
For more information on the Linea™ COVID-19 assay kit, please visit www.adnas.com/dxcovid.
The Company notes that while the Linea™ COVID-19 assay kit has been approved by FDA under an EUA for clinical use in CLIA certified labs for the detection of SARS-CoV-2 RNA, the Linea™ COVID-19 assay kit has not been FDA cleared or approved. However, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating or preventing a disease or condition, as in the case of the novel coronavirus when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31, 2020. The Linea™ COVID-19 assay kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statements The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to 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 diagnostic or therapeutic 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, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies, the unknown duration of this or any EUA approval, disruptions in the supply of raw material and supplies, 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.
STONY BROOK, N.Y., May 7, 2020 – Applied DNA Sciences, Inc. (NASDAQ: APDN), announced today it plans to release financial results for its fiscal 2020 second quarter ended March 31, 2020 after market close on Thursday, May 14, 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.
When: Thursday, May 14, 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 week beginning one hour after the end of the live conference call. Replay can be accessed by calling 1-877-344-7529 or +1-412-317-0088 with the passcode 10141899. 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.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statements The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to 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 fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, 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
STONY BROOK, N.Y. May 6, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, has received approximately $5.3 million in net proceeds calendar year to date as a result of the exercise of equity warrants.
Applied DNA issued approximately 2.6 million warrants in connection with an underwritten public offering that closed on November 15, 2019. Each warrant entitles its owner to purchase one share of common stock in the Company at a per share price of $5.25 until November 15, 2024. Approximately 1.5 million warrants associated with the November 15, 2019 offering remain outstanding.
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.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly-traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statement 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 fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, 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
Kit offers same-day results to physician; Sensitivity to 1.25 copies of viral genome equates to less likely false negatives
Spike protein and the corresponding gene links the diagnostic assay to the Company’s LinearDNA™ Vaccine Strategy
STONY BROOK, N.Y. – May 5, 2020 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company,” “our”) today announced that it applied prior to the end of April for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Linea™ COVID-19 diagnostic kit candidate to detect SARS-CoV-2, the novel coronavirus that causes the disease COVID-19. Validation for the EUA was completed in collaboration with Stony Brook University Hospital; the company’s neighbor and collaborator on campus.
We believe that Applied DNA is one of the only companies engaged both in the detection of the virus and in its prevention. The diagnostic assay, which uses a method known as “real-time, Reverse Transcription PCR (rRT-PCR, or Polymerase Chain Reaction),” detects minute quantities of the viral S gene (as few as 1.25 copies), lowering the probability of “false negatives.” To design the assay, the Company aligned 74 variants of the S-gene sequence currently available in the NCBI (National Center for Biotechnology Information) database. Results showed this gene to be highly conserved, being close to 100% (99.97%) identical across variants. Detection via our diagnostic kit should be consistent across these variants, and perhaps new variants which have yet to arise.
The assay is designed to be run in high-throughput workflows that enable same-day results to be transmitted to the ordering physician. In a spirit of continuous innovation and improvement of the end-to-end process of patient diagnosis, the Company is investigating methods to enhance the assay to increase the ease of patient sampling by using saliva instead of invasive nasopharyngeal swabbing methods.
Both aspects of the Company’s COVID-19 platform (detection and prevention) target the protein (and its viral gene) that enables the virus to gain entry into human cells. Called “Spike” because of its novel appearance on the surface of the virus, in cross-section, it appears like crown, giving the virus its “corona” name. Spike binds to receptors found in the upper and lower airways using that path to gain access to the inside of cells, where it commandeers the cellular machinery to replicate itself. The protein is encoded in the S gene of the virus.
As a complement to the diagnostic kit, the Company’s candidate vaccines use engineered (by partner Takis Biotech in Rome) synthetic portions of the S gene to present the antigens of the protein to the patient’s immune system, hopefully eliciting the generation of antibodies that recognize and help clear the virus from the patient, and neutralize the ability of SARS-CoV-2 to infect human cells. Early results announced yesterday, suggest that the vaccine candidates do so in test animals. The pre-clinical and clinical trial plan calls for utilizing Applied DNA’s novel DNA platform of linear DNA.
Applied DNA makes clear that while the Company has filed an EUA with the U.S. FDA, the U.S. FDA has not yet approved the Company’s diagnostic and there is no guarantee that any EUA will be approved. In addition, numerous other SARS-CoV-2 diagnostic kits are under development by other third parties or have been granted EUA approval by U.S. FDA, any of which may be more successful than the Company’s assay, and even if the Company’s assay gains EUA approval, the assay may generate only limited revenue and profits for the Company.
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.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
Forward-Looking Statements The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to there being no assurance that our vaccine (or diagnostic) candidate will be successfully shown to provide immunity (or detect) SARS-CoV-2, that the vaccine (or diagnostic) candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the vaccine candidate can be manufactured in large quantities or that third parties with an established presence in vaccine distribution, compliance and marketing will enter into an agreement with the Company or Takis, that positive results in animals may not be predictive of human outcomes after DNA vaccination, that numerous other SARS-CoV-2 vaccines (and diagnostics) are under development by other third parties, any of which may be more successful than the Company’s and Takis’ vaccine candidate (or the Company’s diagnostic candidate) and even if the Company’s and Takis’ vaccine candidate (or the Company’s diagnostic candidate) is successful, it may generate only limited revenue and profits for the Company, 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 therapeutic 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, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including 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.
