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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Applied DNA Sciences Inc | NASDAQ:APDN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.26 | -8.78% | 2.70 | 2.70 | 3.04 | 3.0834 | 2.70 | 2.97 | 80,311 | 23:14:39 |
- Receives Second Warrant Exercise Subsequent to Year-End for Net Proceeds of $1.05 Million –
- Company to Hold Conference Call and Webcast Today, Thursday, December 17, 2020 at 4:30 PM ET -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced consolidated financial results for the full fiscal year and quarter ended September 30, 2020.
“Our activities in fiscal 2020 were principally devoted to the establishment of our diagnostic and surveillance testing programs for COVID-19 and to further positioning our proprietary LinearDNA™ manufacturing platform as what we believe to be a cleaner and higher-performing alternative to traditional vaccine development technologies in an environment moving at pandemic speeds to bring efficacious COVID-19 vaccines to market,” said Dr. James A. Hayward, president and CEO, Applied DNA. “With the shutdown in global supply chains severely affecting the performance of our supply chain security business, we redirected resources to our Biotherapeutics and Diagnostics markets: we initiated our own human and veterinary linear DNA COVID-19 vaccine development programs with partner Takis Biotech/EvviVax. While having clear public health goals, these programs also serve to validate our linear DNA manufacturing platform and its manufacturing advantages over plasmid DNA production that underpins current vaccine manufacturing technology; having acquired virus expertise as a result of our vaccine development work, we launched our Linea™COVID-19 Assay Kit (the “COVID-19 test”) and related testing services as part of a multi-pronged approach to the pandemic to establish new revenue streams.
“The result of these efforts was the development of a highly sensitive, highly specific, EUA-authorized diagnostic test that, when paired with safeCircle™, our pooled surveillance testing platform, is in the marketplace today as a cost-effective, and convenient means to help break the chain of virus transmission. We ended the fiscal year having secured our first customer of size for our kit, established an initial base of recurring revenue for our safeCircle platform, and initiated a clinical path for our lead veterinary vaccine candidate with an end goal of enabling commercial veterinary sales for domestic felines.”
Continued Dr. Hayward, “Our development efforts in fiscal 2020 have laid the groundwork for multiple inflection points in fiscal 2021. The sales pipelines for our COVID-19 test and safeCircle offerings are building. In particular, safeCircle is experiencing resonance in the marketplace that, together with a recently established ‘return-to-work’ partnership, enables us to target market niches we believe we can exploit profitably, such as local governments, private and enterprise clients, schools, and higher education athletics departments. We anticipate both offerings to scale up their contributions to our top-line over the coming quarters.
“Our own human linear DNA COVID-19 vaccine development program has not progressed as anticipated; however, the preclinical work we have conducted to date serves as the basis for a veterinary COVID-19 vaccine candidate that we believe offers a shorter and less costly regulatory path to commercialization. Domestic cats are a known virus reservoir and can easily transmit the virus to other felines. If all trial endpoints are met, we will apply for conditional licensure from the U.S.D.A., which we project to be in the latter half of the fiscal year. With about 58 million1 domestic cats in the U.S. and a likely first-mover advantage, we believe that a veterinary vaccine could be commercially significant to us if approved. We would then seek to expand the addressable market for our veterinary vaccine to include the farmed mink industry globally that has been ravaged by the virus, resulting in substantial commercial losses.
“As human COVID-19 vaccines obtain regulatory approval, we believe they evidence shortcomings in their manufacture and distribution that we believe are solvable by linear DNA forms of their vaccines. We believe our LinearDNA platform can produce PCR-based linear DNA at large scale enzymatically and likely with an improved safety profile, modify vaccines reliant on plasmids to address mutations in weeks, not months or years, and offer stability in distribution that potentially eliminates the need for expensive cold-chain requirements. This value proposition can benefit not only COVID-19 vaccines but also every nucleic acid-based program under development today. Concurrently, we see an uptick in contract research activity for biotherapeutic applications that we take to reflect the increasing value being placed on linear DNA by drug developers. Today, we are proud to count leading biotechnology and pharmaceutical companies working in the field of nucleic acid-based medicine as contract research customers. As manufacturing and distribution increasingly become key issues in advancing nucleic-acid-based therapeutic development pipelines, we expect that our LinearDNA platform will become increasingly relevant to existing and prospective customers.
“Finally, we await the return of increased demand patterns in our supply chain security market. The need for brand assurance and supply chain integrity remains as evidenced by our new supply agreement for our CertainT® platform with Pillar Technologies as it relates to the authenticity of personal protective equipment being consumed by our front-line healthcare workers, and by Nutrition21 who has transitioned its portfolio of IP-protected ingredients to CertainT. We remain cautiously optimistic on the prospects in this business in the new fiscal year,” concluded Dr. Hayward.
Fiscal Fourth Quarter 2020 Financial Results:
Full Fiscal Year 2020 Financial Results:
Select Recent Operational Highlights:
COVID-19
Linea™COVID-19 SARS-CoV-2 Diagnostic Assay Kit (“assay kit”)
Applied DNA Clinical Labs, LLC (ADCL)
Vaccine Candidates
LineaRx
Supply Chain Security
Corporate
Footnote: 1 https://www.avma.org/resources-tools/reports-statistics/us-pet-ownership-statistics
Fiscal Fourth Quarter 2020 Conference Call Information
The Company will hold a conference call and webcast to discuss its fiscal fourth quarter-end 2020 results on Thursday, December 17, 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:
Live webcast: https://services.choruscall.com/links/apdn201210.html
Replay (available 1 hour following the conclusion of the live call through December 24, 2019):
Webcast replay: https://services.choruscall.com/links/apdn201210.html
For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘IR Calendar’ portion of the Company’s Investor Relations web site: https://adnas.com/molecular-based-security/investors/
About the LineaTM COVID-19 Assay Kit
The Linea™ COVID-19 Assay Kit is authorized by FDA EUA for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens, including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider. The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
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.
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’.
Applied DNA is a member of the Russell Microcap® Index.
Forward-Looking Statements
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s 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 (U.S. FDA), the U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA, the USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, FDA and/or CMS relating to COVID-19 surveillance testing, 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 17, 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.
Financial Tables Follow
APPLIED DNA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2020 AND 2019
September 30,
2020
2019
ASSETS
Current assets:
Cash and cash equivalents
$
7,786,743
$
558,988
Accounts receivable, net of allowance of $11,968 and $4,500 at September 30, 2020 and 2019, respectively
194,319
839,951
Inventories
497,367
142,629
Prepaid expenses and other current assets
599,296
604,740
Total current assets
9,077,725
2,146,308
Property and equipment, net
1,277,655
226,221
Other assets:
-
-
Deferred offering costs
-
109,698
Deposits
95,083
62,351
Goodwill
285,386
285,386
Intangible assets, net
605,330
734,771
Total Assets
$
11,341,179
$
3,564,735
LIABILITIES AND EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued liabilities
$
1,926,427
$
1,616,997
Promissory notes payable-current portion
329,299
-
Secured convertible notes payable , net of debt issuance costs
1,499,116
-
Deferred revenue
511,036
628,993
Total current liabilities
4,265,878
2,245,990
Long term accrued liabilities
848,307
621,970
Promissory notes payable-long term portion
517,488
-
Secured convertible notes payable, net of debt issuance costs
-
1,442,497
Secured convertible notes payable, recorded at fair value
-
102,777
Total liabilities
5,631,673
4,413,234
Commitments and contingencies (Note K)
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 September 30, 2020 and 2019, respectively
-
-
Series A Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2020 and 2019, respectively
-
-
Series B Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; -0- issued and outstanding as of September 30, 2020 and 2019, respectively
-
-
Common stock, par value $0.001 per share; 200,000,000 and 500,000,000 shares authorized as of September 30, 2020 and 2019, respectively; 5,142,779 and 1,207,993 shares issued and outstanding as of September 30, 2020 and 2019, respectively
5,144
1,208
Additional paid in capital
275,548,737
255,962,922
Accumulated deficit
(269,835,650
)
(256,805,589
)
Applied DNA Sciences, Inc. stockholders’ equity (deficit):
5,718,231
(841,459
)
Noncontrolling interest
(8,725
)
(7,040
)
Total equity (deficit)
5,709,506
(848,499
)
Total liabilities and equity (deficit)
$
11,341,179
$
3,564,735
APPLIED DNA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2020 AND 2019
2020
2019
Revenues:
Product
$
615,430
$
2,136,055
Service
1,316,067
3,253,034
Total revenues
1,931,497
5,389,089
Cost of revenues
720,900
877,613
Operating expenses:
Selling, general and administrative
10,138,103
10,278,045
Research and development
3,321,763
2,967,278
Depreciation and amortization
285,730
390,424
Total operating expenses
13,745,596
13,635,747
LOSS FROM OPERATIONS
(12,534,999
)
(9,124,271
)
Other (expense) income:
Interest expense (including related party interest of $46,586 for the year ended September 30, 2019)
(115,830
)
(162,432
)
Other expense, net
(378,075
)
(43,299
)
Loss on extinguishment of debt
-
(1,260,399
)
Unrealized gain on change in fair value of secured convertible notes payable
-
1,972,955
Loss before provision for income taxes
(13,028,904
)
(8,617,446
)
Provision for income taxes
-
15,000
NET LOSS
(13,028,904
)
(8,632,446
)
Less: Net loss (income) attributable to noncontrolling interest
1,685
9,323
NET LOSS attributable to Applied DNA Sciences, Inc.
(13,027,219
)
(8,623,123
)
Deemed dividend related to warrant modifications
2,842
(309,607
)
NET LOSS applicable to common stockholders
$
(13,030,061
)
$
(8,932,730
)
Net loss per share applicable to common stockholders-basic and diluted
$
(3.32
)
$
(9.69
)
Weighted average shares outstanding-basic and diluted
3,919,072
921,809
APPLIED DNA SCIENCES, INC.
CALCULATION AND RECONCILIATION OF ADJUSTED EBITDA
(unaudited)
Three Month Period Ended September 30,
Twelve Month Period Ended September 30,
2020
2019
2020
2019
Net Loss
$
(4,125,146
)
$
(1,233,460
)
$
(13,028,904
)
$
(8,632,446
)
Interest expense (income), net
29,019
55,226
115,830
162,432
Depreciation and amortization
82,261
70,385
285,730
390,424
Loss on extinguishment of debt
-
1,260,399
-
1,260,399
Change in fair value of convertible notes payable
-
(1,972,955
)
-
(1,972,955
)
Stock based compensation expense (income)
203,503
217,468
1,001,080
1,129,110
Income tax expense
-
15,000
-
15,000
Bad debt expense
23,400
16,281
45,280
7,648
Total non-cash items
338,183
(338,196
)
1,447,920
992,058
Consolidated Adjusted EBITDA (loss)
$
(3,786,963
)
$
(1,571,656
)
$
(11,580,984
)
$
(7,640,388
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20201217006001/en/
Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, sanjay.hurry@adnas.com Web: www.adnas.com Twitter: @APDN
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