Nanoviricides, Inc. · AMEX:NNVC
Nanoviricides — Marcum conference, New York City, May 2014
28 slides from Nanoviricides's conference presentation, Jun 2, 2014
Slide 1: Eradicating Viral Diseases
Eradicating Viral Diseases May 2014 Marcum conference, New York City Eugene Seymour, MD, MPH Chief Executive Officer “ nanoviricide ” is a registered trademark of NanoViricides, Inc. © All rights reserved - NanoViricides, Inc.
Slide 2: Forward-looking statements and company description
NanoViricides, Inc. is a publicly traded company (stock symbol: NNVC, NYSE MKT .) This is not an offering memorandum and should not be construed as such. It is provided as a non - confidential document for informational purposes only. NanoViricides, Inc. ( www.nanoviricides.com ) is a development st
Slide 3: Overview
Company designs and builds nanoviricides™ nanoviricides are designed to destroy viruses These nanoviricides work on the principle of “ biomimicry ” Rapid nanoviricide creation against new viruses Potential cures for a wide range of viral diseases NanoViricides Inc. addresses a >$50B market A novel d
Slide 4: MERS Corona Virus
MERS Corona Virus
Slide 5: Nanoviricide effect on a Cytomegalovirus (CMV)
nanoviricide effect on a CytomegaloVirus (CMV) 5 Control Treated Intact cytomegalic virus containing multiple capsids and a surrounding envelope with attachment proteins on its surface Envelope of Virus Capsids Attachment Proteins This is a cytomegalic virus being destroyed by a nanoviricide. The en
Slide 6: Nanoviricide mimicking target cell of virus
NANOVIRICIDE TARGET CELL RECEPTOR PROTEINS Alveolus ATTACHMENT PROTEINS ON VIRUS SURFACE 6 nanoviricide mimicking target cell of virus
Slide 7: A nanoviricide in action at-a-glance
A single nanoviricide may be capable of completely engulfing a virus particle Nanomicelles self - assemble during production A single chain micelle shown for convenience (illustration not to scale) A nanoviricide binds to a virus particle. Bound nanoviricide continuing encapsulation of virus particl
Slide 8: FluCide Preclinical Results – Survival
Hours of survival after lethal influenza injection 8 FluCide™ Preclinical Results – Survival
Slide 9: FluCide Preclinical Results – Viral Load
>1,000 - fold Lung Viral Load Reduction in IV FluCide™ Treated Animals <2 - fold reduction with Oseltamivir in this study 4.5 Days (108h) Post - Infection 9 FluCide™ Preclinical Results – Viral Load
Slide 10: FluCide Dosage Forms
10 2 FluCide™ Dosage Forms Oral unit - dose twist - top aseptic package oral FluCide oral FluCide oral FluCide >300,000 hospitalized patients with influenza in the US alone every year 30 - 60M Influenza cases per year in the US annually Billions of cases world - wide in a pandemic
Slide 11: Historical Precedents
Revolutionary advances in prevention and treatment of infectious diseases over the past 200 years Edward Jenner and smallpox vaccination 18 th Century Joseph Lister and the concept of antisepsis 19 th Century Alexander Fleming et al, discovery of penicillin 20 th Century NanoViricides ’ invention of
Slide 12: Global First-in-Class Intellectual Property
More than eighty patents issued to date in 28 countries, including the U.S., Australia, Japan, China, the Philippines, and all of Africa >100 countries expected to approve patent applications by the end of 2014/15 NanoViricides has exclusive worldwide licenses to the platform technology All Patents
Slide 13: Regulatory Recognition
The U.S. FDA and the European Medicines Agency recently granted “ orphan drug ” designation to DengueCide™, the NanoViricides drug for Dengue Fever and Dengue Hemorrhagic Fever NanoViricides was granted an early pre - IND meeting by the US FDA, held in March 2012, for FluCide™, our drug candidate fo
Slide 14: Past and present Partners and Collaborators
UC Berkeley, School of Public Health LSU School of Veterinary Medicine US Centers for Disease Control and Prevention US Army Med Research Institute for Infectious Diseases Walter Reed Army Institute of Medical Research Public Health England 14 Past and present Partners and Collaborators Biologics Co
Slide 15: Manufacturing Capability
Upon completion of construction, we will have a fully operational 18,000 square feet R&D laboratory with cGMP manufacturing capabilities Facility will be ready for move - in with its certificate of occupancy next month We expect that the cGMP plant will be capable of manufacturing any of the NanoVir
Slide 16: Manufacturing Capability
16 Manufacturing Capability
Slide 17: Manufacturing Capability
17 Manufacturing Capability
Slide 18: Manufacturing Capability
18 Manufacturing Capability
Slide 19: Financial Overview
Quarterly operating expenses: $1.75 million (from recent 10Q) ~$36 million in cash and equivalents Avg. trading volume: >425,000 shares per day YTD Market capitalization: ~$190 million Shares outstanding: ~54 million NYSE mkt 1 9 Financial Overview
Slide 20: Product Pipeline
20 Product Pipeline Disease & Indication Drug Candidate In Vitro Development Efficacy - Animals IND - Enabling Studies Human Clinical Trials Primary Programs Hospitalized Patients; All Influenzas Injectable FluCide™ Pandemic, Epidemic, Seasonal, Bird Flu Out - Patients; All Influenzas Oral FluCide™
Slide 21: >$50 Billion Global Market
21 > $50 Billion Global Market Disease / Virus $Billions, estimate HIV/AIDS $ 25 B Influenzas $ 25 B Eye Drops Antiviral $ 1 - 5 B Herpes “ Cold Sores ” Skin Cream & Gel $ 10 B Hepatitis C $ 25 B Dengue, Rabies, other NTD ’ s (combined) $ 1 - 5 B Ebola/Marburg/VHF (combined) $ 1 B
Slide 22: Programs to support accelerated drug approvals or unlicensed use
22 Programs to support accelerated drug approvals or unlicensed use Both the US and EU have initiated programs to support rapid approval or unlicensed use of drugs for seriously ill individuals. Information about these programs are found on the next two slides
Slide 23: Breakthrough Drug Approval in the US
23 Breakthrough Drug Approval in the US To support a breakthrough drug approval, the preliminary clinical evidence (Phase I, IIa) must show that the drug may demonstrate substantial improvement over available therapy on one or more significant endpoints Phase I= 25 health individuals given increasin
Slide 24: Use of unapproved medications in the EU – the specials program
24 Use of unapproved medications in the EU the “ specials ” program “ Compassionate use ” or “ expanded use ” programs allow medicinal products that are not authorized, but are in the development process, to be made available to patients in the EU with a severe disease who have no other satisfactory
Slide 25: Risk Factors - Technology
25 Risk Factors - Technology Is it Safe? Yes. Whenever we engage into first animal efficacy study, we test safety of that drug candidate. Safety is built into the composition and design of the nanomicelle itself. Besides, we design the antiviral ligands, as well as nanoviricide construction chemistr
Slide 26: Risk Factors - Corporate
26 Risk Factors - Corporate Capital Risk • NanoViricides has $36M in cash and equivalents (Mar 31), and spends about $7M cash per year. • We believe we have sufficient cash reserves to take FluCide and possibly DengueCide through initial human clinical trials. • Our drug development costs have been
Slide 27: Goals and Milestones
2013 Milestones Completed non - GLP toxicology studies for FluCide™, with excellent safety demonstration Production Scale - up and characterization studies for FluCide™ progressing satisfactorily Signed NDA with Lovelace Respiratory Research Institute in preparation for formal contracts. Sig
Slide 28: In Summary
Leveraging patented technology to rapidly create powerful new drugs that have the ability to destroy most all viruses in and on the body. Preclinical stage products addressing very large markets (>$40B) Influenza (seasonal, H1N1, H7N9, etc.) - Injectable drug Influenza (seasonal, H1N1, H7N9, etc.) -
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