Nanoviricides, Inc. · AMEX:NNVC
Nanoviricides — LD Micro 500 Virtual Investor Conference 2020
32 slides from Nanoviricides's conference presentation, Sep 3, 2020
Slide 1: NanoViricides' SARS-CoV-2 Treatment Moving Towards Clinical Candidate Selection and IND Filing
“Bind-Encapsulate-Destroy” NNVC (NYSE American) NanoViricides’ SARS-CoronaVirus-2 Treatment Moving Towards Clinical Candidate Selection and IND Filing for COVID-19 Topical Drug Candidate Against Shingles (VZV) Preparing for Regulatory Trials; An Array of Other Indications in Herpecide™ Program Alone
Slide 2: Disclosure Statement
Disclosure Statement NanoViricides, Inc. is a NYSE-American listed publicly traded company (stock symbol: NNVC). 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.nanoviricide
Slide 3: Presentation Layout
Presentation Layout SARS-CoV-2 Therapeutics Development Strategy and Status Lead Drug Candidate Emerging Against SARS-CoV-2 NV-HHV-101 for Shingles Rash Indication - IND prioritized after SARS-CoV-2 Developing Drugs that Virus May Not Escape due to Mutations Industry-Leading Platform Technology Excl
Slide 4: SARS-Cov-2 NanoViricide Drug Development Using Biomimetic Technology
SARS-Cov-2 NanoViricide Drug Development Using Biomimetic Technology SARS-CoV-2 has caused the COVID-19 pandemic which is costing economies several trillions of dollars and several hundreds of thousands of lives NIAID-RML We are Developing a Drug mimicking ACE2, the receptor that SARS-CoV-2 binds to
Slide 5: Milestones Achieved - April 2020
SARS-Cov-2 NanoViricide Drug Development Using Biomimetic Technology - Milestones Achieved - April 2020 By April, 2020, We had already: Found Small Chemical Ligands Using Molecular Modeling that Bind to SARS-CoV- Spike Protein at Its ACE2-Receptor Interface Produced Certain Ligands at 50g to Kg Scal
Slide 6: Milestones Achieved - July 2020
SARS-Cov-2 NanoViricide Drug Development Using Biomimetic Technology - Milestones Achieved - July, 2020 By July, 2020, We had already: Developed a BSL2 Animal Model of ACE2-utilizing h-CoV-NL63 Coronavirus for This Surrogate for BSL3/4 SARS-CoV-2 is now believed to provide people with protection aga
Slide 7: Milestones Achieved - September 2020
SARS-Cov-2 NanoViricide Drug Development Using Biomimetic Technology - Milestones Achieved - September, 2020 By September, 2020, We are already: Close to Declaring a Clinical Candidate, named NV-CoV-1 Awaiting Data Analysis of Cell Cultures Studies in Our Own BSL2 Virology Lab - Data looks exciting,
Slide 8: Novel Platform Technology: A nanoviricide is a Cell Mimic
Novel Platform Technology: A nanoviricide® is a Cell Mimic Viral Resistance to the Nanoviricide Drug is Unlikely because Even as the Virus Mutates, It Still Binds to the Same Cell Surface Receptor(s), in the Same Fashion HIV Particle binding to a Cell via CD4 and a Coreceptor ® CD4 “Key” that binds
Slide 9: SARS-Cov-2 NanoViricide Drug Mechanism is Orthogonal to Most Other Drug Candidates
SARS-Cov-2 NanoViricide Drug Mechanism is Orthogonal to Most Other Drug Candidates Putative Mechanism of Action of a NanoViricides Drug Candidate is by Direct and Targeted Attack on the Virus Particle Blocks Virus Reinfection Cycle Potentially the NanoViricide Drug Can Bind to Infected Cells Because
Slide 10: A NanoViricide Attacking a Virus Particle: Unique, Novel, Nanotech Design
A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design ENCAPSULATE DESTROY BIND © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-mkt: NNVC) Slide 10
Slide 11: Healthy Financial Position
Healthy Financial Position Reported $6.44 Million (M) Cash at end of March 30, 2020 Quarter Subsequent Two Raises (No Warrants Issued), Added about $19.8M Last Raise at $7.30/share Burn Rate is About $1.6 Million per Quarter Have Sufficient Funds to Support Anticipated Clinical Trials of At Least On
Slide 12: Lead Drug Candidate NV-HHV-101 Skin Cream for Shingles Rash: Business Case
Lead Drug Candidate NV-HHV-101 Skin Cream for Treatment of Shingles Rash: Business Case Potentially Billion+ Dollar Market for Topical Shingles Rash Treatment alone, even after the new vaccine Shingrix® has been introduced 500,000 to 1,000,000 Cases Annually in the USA Alone Additionally, NV-HHV-101
Slide 13: VZV (Shingles) Topical Drug Candidate Update: IND Application Writing in Progress
VZV (Shingles) Topical Drug Candidate Update: IND Application Writing in Progress All Required IND-Enabling Studies are Completed cGMP Manufacture for GLP Safety/Toxicology Studies Completed Almost All Reports are In Hand Regulatory Consultants Retained IND Drafts are Being Circulated Clinical Trial
Slide 14: Nanoviricides Dismantling MCMV Virus Particle
Nanoviricides Dismantling MCMV Virus Particle Control Treated A MCMV Virus Particle Containing Multiple Capsids Virus Dismantled; Capsids Spilling Out A: intermediate state; C: total dismantling C © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-mkt: NNVC) © All Rights Res
Slide 15: Unique Drug Developer with Own cGMP-Capable Manufacturing
NanoViricides is a Unique Drug Developer Company with Its Own cGMP-Capable Manufacturing Capability Clinical Product Supply Capability for Mostly All of Our Nanoviricides Significant Time and Cost Savings Potential for Manufacturing Commercial Product - Market Entry & Early Revenues Nanomedicines Ch
Slide 16: Platform Technology Has Enabled Several Drug Programs for a Broad Drug Pipeline
NanoViricides Platform Technology Has Enabled Several Drug Programs for a Broad Drug Pipeline Pre-Clinical Successes Achieved in Several Programs FluCide™ FluCide™ HivCide™ DengueCide™ SARS-CoV-2 a. Injectable b. Oral “Functional Cure?” Avoid ADE For Hospitalized For Out-Patients West Nile Virus, Pa
Slide 17: Leveraging Herpecide Program Developments into Multiple Drugs Franchise
The patient reported a history of right-sided herpes zoster Our Current Focus is on the HerpeCide™ Program Regulatory Development underwent anterior cham ophthalmicus 1 month prior for which she completed a merase chain reaction an 10 day course of famciclovir. Past medical history included chicken
Slide 18: NanoViricides' Regulatory Strategy
NanoViricides’ Regulatory Strategy Dermal Topical Drug as First Candidate -> Quicker Path rather than systemic therapeutics Multiple Indications with Same Drug Candidate or its Derivatives to Maximize Shareholder Value and ROI Distribute Development Costs over Multiple Indications VZV Shingles Herpe
Slide 19: Lead Drug Candidate NV-HHV-101 Status - Getting Ready for IND Filing
Lead Drug Candidate NV-HHV-101 Status - Getting Ready for IND Filing Indication: Shingles Rash Treatment. Form: Topical Skin Cream Anticipate Human Clinical Trials to Begin in CY 2020 Q1/Q2 FDA Response “Generally Adequate” on Pre-IND Filed with FDA Non-Clinical Safety/Toxicology Studies Complete -
Slide 20: Investment Thesis: Platform Technology and Facility
Investment Thesis: NanoViricides Platform Technology and Facility Platform Technology - A “Venus-Fly-Trap” for Viruses - “Bind-Encapsulate-Destroy” - Drugs that Viruses Cannot Escape by Mutations Multiple Drug Programs with Many Candidates having demonstrated Successful Animal Model Effectiveness an
Slide 21: Investment Thesis: NanoViricides Valuation
Investment Thesis: NanoViricides Valuation Company Founded and taken public (reverse shell merger) in 2005 - Platform Technologies Licensed from TheraCour Pharma, Inc. Market Cap Historically Around $100~150M Uplisted to NYSE-American in September 2013 Moved to Integrated cGMP Manufacturing & R&D Fa
Slide 22: Shingles Rash breakouts - HHV-3 aka VZV
Shingles Rash breakouts - HHV-3 aka VZV Unmet Medical Need : Available drugs in use not very effective (vaccines exist) The chickenpox virus surviving in ganglia causes Shingles in adults About 500,000 to 1 Million Cases Per Year in the USA Alone Risk Increases with Age Triggered by Reduced Immune F
Slide 23: Lead Drug Candidate NV-HHV-101 Dermal Topical Skin Cream for Treating Shingles Rash
Lead Drug Candidate NV-HHV-101 Dermal Topical Skin Cream for Treating Shingles Rash Risk is Minimized for Human Clinical Studies, Since Efficacy and Safety Data are Obtained in Human Skin Itself Standard of Care, Valtrex® Oral, is Not Very Effective Because viral TK enzyme activity required for conv
Slide 24: VZV (Shingles) Topical Candidates Highly Effective - Five Times More Effective than Acyclovir
Optimization Studies VZV (Shingles) Topical Candidates Highly Effective - Five Times More Effective against VZV than Acyclovir in Cell Cultures (Pre-Clinical) NanoViricides Drug Candidates Effective Against VZV (Shingles Virus) Infection 125 Virus Production at 6 days in cell culture, by GP1-ELISA,
Slide 25: Match Efficacy of Cidofovir in Human Skin Organ Culture Model of VZV Infection
VZV (Shingles) Topical Drug Candidates Are Highly Effective Match Efficacy of Cidofovir in Human Skin Organ Culture Model of VZV Infection (Pre-Clinical) NV-118 Treated VZV Infected Skin Normal Dermis and Epidermis. No viral infiltration or lesions seen VZV Infected Skin - Basal Layer Breaches seen,
Slide 26: VZV Topical Candidate Moving Rapidly To Clinical Trials: Non-GLP Safety Studies
VZV (Shingles) Topical Candidate Moving Rapidly To Clinical Trials Preliminary Non-GLP Safety/Tolerability Studies in Rats Successful (2018) No clinically observable adverse safety and toxicology effects in topical administration No clinically observable adverse safety and toxicology effects in syst
Slide 27: VZV Topical Drug Candidate: IND-Enabling Safety/Toxicology Package Studies
VZV (Shingles) Topical Drug Candidate : IND-Enabling Safety/Toxicology Package Studies Non-GLP Studies Non-GLP Portion of IND-Enabling Safety/Toxicology Studies Completed by BASi, IN ca. February, 2019 Excellent Safety Profile Observed cGMP Manufacture for GLP Safety/Toxicology Studies Completed GLP
Slide 28: HerpeCide Program Future Expansion
HerpeCide™ Program Future Expansion Drug Candidates in Current HerpeCide Program May Have Applications Against Other HerpesViruses: Epstein-Barr Virus: Mononucleosis Monoclonal Gammopathy other B-cell diseases, etc. Cytomegalovirus: Retinitis, Organ Transplant etc. HHV-6A, HHV-6B, HHV-7 several dise
Slide 29: Strong Executive Team
Strong Executive Team Anil R. Diwan, PhD Randall W. Barton, PhD President & Exec. Chairman CSO and Acting CRO Co-Founder 30+ Years of Pharmaceutical Industry Experience in Drug Led Uplisting to NYSE-American Exchange in 2013 Discovery and Pre-clinical Regulatory Development Raised $65M Former Direct
Slide 30: Board of Directors
Board of Directors Anil R. Diwan, PhD Stanley Glick, CPA ✔ President & Exec. Chairman Chairman, Audit Committee Co-Founder, Led Uplisting to NYSE-Amer. in 2013, Raised Auditing, Accounting, Tax, & Mgmt. Advisory Services $65M+, Co-Inventor of Nanoviricides® & of TheraCour ® Financial Management Over
Slide 31: Recap
Recap “Resistance is Futile” - Antiviral Nanomachines Designed to Destroy Viruses Despite Viral Mutations Broad and Deep Pipeline based on Platform Technology Next Generation NanoViricides (with Encapsulated Additional Action) Already in Development In-house cGMP Manufacture Enabling Early Commercia
Slide 32: The End
The End © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-Amer.: NNVC) Slide 32
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