Investment Conference - 22nd Annual Global 15 September 2020 - Applied DNA Sciences
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
22nd Annual Global
Investment Conference
15 September 2020
APDN
NASDAQ Listed
Safe Harbor
The statements made by Applied DNA in this presentation 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
limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, the unknown ability to manufacture the vaccine candidates in large
quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to
generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology
approved for therapeutic use, 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 other reports filed by the Company with the Securities
and Exchange Commission, which are available at www.sec.gov. Forward-looking statements include all statements which are not historical facts, and can
generally be identified by terms such as anticipates, believes, could, estimates, intends, may, plans, projects, should, will, would, or the negative of those
terms and similar expressions. 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.
2
Investment Highlights
Disruptive Nucleic Acid Manufacturing Platform
Nascent Biopharma Opportunity
LinearDNA™
a scaled linear DNA Broad Applicability: RNA/DNA, CAR-T, vaccine, and gene therapies
manufacturing platform
Inherent Advantages Amplified by Pandemic vs.
Plasmid-based DNA Production
COVID-19 programs – detect and protect against coronavirus
3
Corporate Structure
Applied DNA – Linear DNA Manufacturing Platform
Industrial DNA LineaRx Applied DNA
for supply chain nucleic acid-based Clinical Labs
integrity, brand Rx & Dx utilizing molecular testing
protection linear DNA laboratory
Active CMO/CRO business Commercial development of
supplying bulk GLP DNA diagnostic tests in virology,
products; opportunity for oncology; COVID-19 TaaS
cGMP validation
4LinearDNA™ Manufacturing Platform
Large-scale PCR-based DNA Production for Rx and Dx Therapeutic Applications of Linear DNA:
• Proprietary process enables large, gram-scale production of DNA
through PCR (polymerase chain reaction)
• Does not require recombination, hence, no need for virus
• No need for plasmids, reducing risks and unwanted DNA or
contaminants that need to be removed
As a Substitute
for DNA
Production:
5LineaRx
• Cancer Vaccine, in
partnership with
Takis/Evvivax SRL
• Multiple revenue- generating • Anti-CD19b CAR T
Development Customers Adoptive Cell Therapy
• COVID-19 Vaccine
Candidates 6Development Pipeline (inclusive of COVID-19)
Preclincal Clinical
Discovery IND-enabling Phase 1 Phase 2 Phase 3 Comments
Canine Anti-Cancer Vaccine
Yielded strong antibody and T cell
(with Takis Biotech) responses even at low doses of linear
Vaccine and Therapeutics
DNA in mice
• All five LineaDNA vaccine candidates
Linear DNA COVID-19
Vaccine Candidates
provoked seroconversion in all mice
(with Takis Biotech) to produce IgG against SARS-CoV-2
Spike protein by Day 14 and
significantly enhanced responses by
Anti-CD19b Day 38.
CAR T adoptive cell
therapy
Application of one LinearDNA vaccine
candidate to domestic cats
Feline Vaccine against Coronavirus utilizing • Safety and tolerability study for 30
human Linear DNA COVID-19 Vaccine enrollees dosed at 1mg/month for 3
Candidates
consecutive months
• Primary endpoint in month 4 is
evidence of antibody and t-cell
responseCOVID-19 - Diagnostic Assay
Linea™ COVID-19 Diagnostic Assay Kit – enabling accurate and rapid high-volume testing
Launched rRT-PCR Molecular Diagnostic Assay
• PCR-based tests remain the gold standard
• Validated at a NYS University Hospital, EUA approved
• 95% sensitivity, 100% specificity, LoD less than 1 copy/µL
Purpose-designed for High Throughput Clinical Laboratories
• Advanced single well multiplex assay, useful for all PCR labs via ”Lab Developed Tests”
• Allows for simple set up and higher-throughput on 96-well systems common to PCR laboratories
• Validated on Applied BioSystems’ QuantStudio Dx and QuantStudio 5 Real-Time PCR Systems
Fast turnaround times with majority of results available within 3 hours
Manufacturing Assay Kits for Distribution
• In-house kit production: 100, 500, or 1,000 reactions (tests) per kit; current production capacity of 10s of thousands per day with ability to ramp
• Specimen collection via NP and ANS; Saliva being used in Surveillance Testing, self collected
Upcoming Catalysts
• Closing in on first commercial contract with regional medical center
• Partnerships with COVID-19 therapy developers for use as a companion diagnostic
• Further amendments to EUA to expand addressable markets
8COVID-19 – Applied DNA Clinical Lab
Testing-as-a-Service
Capturing More of the Economies of Testing
Surveillance Testing
• Regional/ schools and businesses
• Strategic collaborations driving testing opportunities
Fast Turnaround Time
• Robotic automation supports increased testing speed and throughput
Expanding Testing Capacity
• Current at several thousand tests per day with capacity to expand as needed
Upcoming Catalysts
• Pursuing ‘Return to Work’ partnership to drive testing demand
• Progressing CAPCLIA certification from New York State Dept. of Health
Linea™
Collection Sampling Clinical Lab Results in 24
COVID-19
(NP, OP, ANS, and soon Saliva) Test Hours
Assay
9Capital Markets
Shares Outstanding¹: 5,142,779
Warrants2 (APPDW; $5.25 ~1,000,000
APDN
exercise):
Cash Balance3: $10,924,968
Debt Balance3: $1,492,292
NASDAQ Listed
Year-end: September 30
Index: Russell
Microcap
1 At July 31, 2020 2 At August 6, 2020 3 At June 30, 2020
10Thank you!
You can also read
