Nanoviricides, Inc. · AMEX:NNVC
Nanoviricides — Investor Presentation (September 2024)
43 slides from Nanoviricides's investor presentation, Sep 18, 2024
Slide 1: NanoViricides Revolutionary Platform Technology For Treatment of Antiviral Infections
“Bind-Engulf-Destroy” Stock Symbol: NNVC (NYSE American) NanoViricides Revolutionary Platform Technology For Treatment of Antiviral Infections: One Lead Drug Alone Addresses a $2.5 to $4.3 Billion Market Presented on: 2024-09-18 Presented by: Anil R. Diwan, PhD President & Exec. Chairman Mobile: +1
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 Outline
Presentation Outline NV-387, A Revolutionary Broad-Spectrum Antiviral Drug Candidate NV-387 Clinical Indications in Development and Markets: RSV, Influenza, COVID, MPOX/Smallpox, Severe Acute Respiratory Infections (SARI-Viral) Virus-Family-Specific Drugs in Pipeline NV-HHV-1 -> HerpesVirus Family N
Slide 4: Attacking Very Large Market Sizes - Lead Drug 1 NV-387
NanoViricides, Inc. Attacking Very Large Market Sizes - Lead Drug 1 NV-387 is A Revolutionary Broad-Spectrum Antiviral Proven in Animal Efficacy Studies Against RSV, Influenza, COVID, Smallpox/MPox RSV: NV-387 Cured RSV Lethal Lung Infection in Mice Influenza: NV-387 Substantially Superior to Tamifl
Slide 5: NV-387 is Available With Many Routes of Administration
NanoViricides, Inc. Attacking Very Large Market Sizes - Lead Drug 1 NV-387 is Available With Many Routes of Administration NV-387 is Orally Available Oral Syrup -> Enables Titration by Body Weight for Pediatric Cases Oral Gummies (“soft solid”, dissolving slowly in mouth) -> No Swallowing Issues NV-
Slide 6: NV-387 is Phase II Ready
NanoViricides, Inc. Attacking Very Large Market Sizes - Lead Drug 1 NV-387 is Phase II Ready; Clinical Trials for Multiple Indications NV-387 Has Completed Phase I Human Clinical Trial No Reported Adverse Events Safety and Tolerability in Humans Established NV-387 is Eligible for Phase II for Treatm
Slide 7: NV-387 for Treatment of Influenza Infection - Large Market
NV-387 for Treatment of Influenza Infection - Large Market Influenza Viruses Develop Drug Resistance Resistance Not Likely Against NV-387, because of its Host-Mimetic, Direct-Acting Antiviral Mechanism ~$4.6Bn in 2024 growing to ~$5.9 Bn in 2027, 8.35+% CAGR, estimated for USA Market Exceeding $10 B
Slide 8: NV-387 for Treatment of RSV Infection - Another Large Market
NV-387 for Treatment of RSV Infection - Another Large Market RSV - An Important Disease Especially for Newborns and Young Children Also for Adults over 65 and Patients with Immune Compromise Status USA Market Size Estimated at ~$2.6Bn in 2024 growing to ~$4.3 Bn in 2027, 18+% CAGR Current MCMs are 2
Slide 9: RSV Treatment Market Value - A Case Study
RSV Treatment Market Value - A Case Study Pfizer Acquired ReViral for ~$525 Million in 2022 Pfizer Estimated Revenues Exceeding $1.5 Bn Per Year for this RSV Drug Company had only one Phase II drug, that was indicated only for RSV Infection (fusion inhibitor), Sisunatovir Pfizer Purchased Company Im
Slide 10: NV-387 for Treatment of COVID, Long COVID - Large Market
NV-387 for Treatment of COVID, Long COVID - Large Market COVID Waves 2-3 Times Annually; plus other seasonal coronaviruses USA Market Size is Still in Billions, Post-Pandemic “Long COVID” Cases - A Majority Have Residual Virus Current MCMs are Not Very Effective Remdesivir Requires Infusions; Toxic,
Slide 11: NV-387 Other Markets: Biodefense Smallpox/Mpox
NV-387 Other Markets: Biodefense Smallpox/Mpox US BARDA Has a Requirement for an Alternative Drug for Smallpox Also, TPOXX® (tecovirimat) Failed in Clinical Trial for Treatment of MPOX Infection; Raises Doubts About Its Clinical Value Against Smallpox as well NV-387 is Eligible for Phase II for Trea
Slide 12: Lead Drug 2 NV-HHV-1 Phase I Ready
NanoViricides, Inc. Attacking Very Large Market Sizes - Lead Drug 2 NV-HHV-1 Phase I Ready NV-HHV-1 => A Drug Designed to Treat All HerpesViruses NV-HHV-1 as Skin Cream for Treatment of Shingles, HSV-1 “Cold Sores”, and HSV-2 “Genital Ulcers” is Phase I Ready Has Completed Required Non-clinical Safe
Slide 13: Lead Drug 3 NV-HIV-1 Towards Phase I
NanoViricides, Inc. Attacking Very Large Market Sizes - Lead Drug 3 NV-HIV-1 Towards Phase I NV-HIV-1 => A Drug Designed to Treat All HIV Viruses Injectable Drug Has Excellent Animal Trial Results Oral Drug Also in Development Next Step is to Advance it Into Regulatory IND-Enabling Studies —————————
Slide 14: Current Drug Assets Summary
NanoViricides Current Drug Assets Summary Indication(s) Asset Name Type (Animal Model Stage Remarks Efficacy) Broad-Spectrum No AEs, No Drop-outs in Ph I Antiviral: Phase I Completed Nanoviricide Drug Healthy Subjects. 1 NV-387 Candidate COVID, RSV, Oral Syrup and Oral Efficacy Superior to Existing In
Slide 15: NanoViricides is Revolutionizing Treatment of Viral Diseases
NanoViricides is Revolutionizing Treatment of Viral Diseases, Just as Antibiotics Revolutionized Treatment of Bacterial Diseases! Ultra-Broad-Spectrum Antiviral NV-387 Completed Phase I Clinical Trial Collaboration in India NV-387 is Highly Active Against Coronaviruses, RSV, Influenza, Smallpox/MPox
Slide 16: Technology is Not Limited to Antivirals or Anti-Infectives
NanoViricides Technology is Not Limited to Antivirals or Anti-Infectives: Applications Across Many Therapeutics Areas Biomimetic, Biocompatible, and Biodegradable Drug Delivery Platform Site-Directed Drug Delivery is Feasible Oncology - Replace Antibody-Based Receptor Recognition Multi-modal Drugs w
Slide 17: Strong Executive Team
Strong Executive Team Anil R. Diwan, PhD Krishna Menon, VMD, MRCS, PhD President & Exec. Chairman Consulting Pre-Clinical Studies Co-Founder 30+ Years of Pharmaceutical Industry Experience in Drug Led Uplisting to NYSE-American Exchange in 2013 Discovery and Pre-clinical Regulatory Development Raise
Slide 18: Board of Directors
Board of Directors Anil R. Diwan, PhD Mak Jawadekar, PhD ✔ President & Exec. Chairman 35+ Years of Pharmaceutical Industry Experience, Pharma Strategic Consultant. Previously at Pfizer, Inc., as Director, Portfolio Management & Analytics, and as Vice President, Asia Co-Founder, Led Uplisting to NYSE
Slide 19: NanoViricides is Revolutionizing Treatment of Viral Diseases
NanoViricides is Revolutionizing Treatment of Viral Diseases, Just as Antibiotics Revolutionized Treatment of Bacterial Diseases! © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-Amer.: NNVC) Slide 19
Slide 20: Thank you for your attention
“Nanotechnology-Enabled Targeted Viricides” A Publicly Traded Company, “NNVC” www.nanoviricides.com Thank you for your attention. Please address additional inquiries/ To Destroy Viruses correspondence to: Anil R. Diwan, Ph.D. President & Executive Chairman NanoViricides, Inc. Office: 1 Controls Driv
Slide 21: APPENDIX
APPENDIX © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-Amer.: NNVC) Slide 21
Slide 22: Schematic Structure of a Nanoviricide
Schematic Structure of a Nanoviricide™: Customizable, Tailorable Platform Technology 1. An Antiviral Ligand is designed based on how the virus binds to a cell. 2. This ligand is chemically attached to a Nanoviricide Base Polymeric Micelle to Create a Nanoviricide. 3. Optionally, Other APIs with Comp
Slide 23: Technology Platforms Summary
NanoViricides Technology Platforms Summary Technology Purpose Stage Remarks Platform Asset Tested in Animal Models for Protect Guest Drug & For Encapsulation of NanoViricides Remdesivir itself, a Improve PK/PD. Difficult Drugs, 1 Encapsulation Enabling Oral and Other Remdesivir-prodrug, a Enable Oral
Slide 24: Responding to Novel Viral Pandemics - The Pain Points
Responding to Novel Viral Pandemics - The Pain Points MCM Technology Vaccines Antibodies Small Chemicals Nanoviricides Attribute Yes. Not Yes. Yes. Highly Unlikely Escape Variants Amenable to Necessitating New Requiring New (Drug Remains Arise? Rapid New Development Development Active) development S
Slide 25: Technology Differentiation
NanoViricides Technology Differentiation Nanoviricide Drug Antibodies Other Drugs Vaccines Re-Infection Replication Antibodies Mechanism Neutralization Inhibition Inhibition Generation Therapeutic Yes Yes Yes No Post-Infection? Viral Resistance Unlikely Rapidly Eventually Rapidly Cure Possible for N
Slide 26: Complex Virus LifeCycle Enables Many Strategies for Attack
Complex Virus LifeCycle Enables Many Strategies for Attack After Primary Infection from External Sources; BUT for the Infection to Take Hold in the Host: Viruses Have Evolved Diverse All Viruses Must Infect Cells Strategies for Each of the BIND to ATTACHMENT RECEPTOR(s) LifeCycle Events Making it Ve
Slide 27: The Achilles Heel(s) of the Virus
The “Achilles Heel(s)” of the Virus THE ENTRY MECHANISMS OF VIRUSES CAN YIELD SAFE AND EFFECTIVE, BROAD-SPECTRUM AS WELL AS SPECIFIC, DRUG STRATEGIES RESULTING IN DRUGS THAT THE VIRUS CANNOT ESCAPE Even As a Virus Mutates, including in its Receptor Interaction Regions; the Site on the Receptor to wh
Slide 28: The Achilles Heel(s) of the Virus: Attachment Receptor(s) and Cognate Receptor(s)
The “Achilles Heel(s)” of the Virus: Attachment Receptor(s) and Cognate Receptor(s) Cognate Receptors are Virus-Type/Subtype Specific (e.g. SARS-CoV-2 uses ACE2, HIV uses CD4; HSVs use HVEM). Activity Spectrum of Drugs Mimicking Cognate Receptor Sites would be that of the Virus Type including all mu
Slide 29: Technology Platform Defines A Novel Paradigm
NanoViricides Technology Platform Defines A Novel Paradigm : Cell-Mimicking Nanomachines that Seek to Bind, Encapsulate and Destroy a Virus Particle Without Immune System Assistance A Virus Uses Specific Cellular Receptor(s). Small Chemical Ligands : . Viral Coat Protein Mutates Readily; that Mimick
Slide 30: Enabling Potential Cures of Non-Latency Viruses
Enabling Potential Cures of Non-Latency Viruses: UNIQUE DUAL MODE ATTACK Enabled by Encapsulation Capability Example: NV-387-g-485 is Designed to Completely Block Many Viruses (Encapsulates a Nucleotide Analog NV-485 within NV-387 Polymeric Micelles) Normal Virus LifeCycle Dual Blockade of Virus Lif
Slide 31: NV-387 is a Host-side Sulfated-ProteoGlycan-Mimetic Nanoviricide
NV-387 NV-387 is a Host-side Sulfated-ProteoGlycan-Mimetic Nanoviricide Its Activity Spectrum Includes: Influenza Viruses* including H5N1 Bird Flu**, Coronaviruses (incl. COVID, Long COVID-virus associated), RSV, as well as Poxviruses Potentially Activity Anticipated Against: Dengue Viruses, Hendra-
Slide 32: NV-387 Safety Studies
NV-387 Safety Studies NV-387 Safety is Established in Non-Clinical Studies: Non-Immunogenic; Non-Allergenic Non-Mutagenic Non-Genotoxic (In-Vitro MNT) NOAEL 1,200 mg/Kg and MTD 1,500 mg/Kg for IV in Rats No Adverse Effects in Micro-Histology GLP Cardiotoxicity Study in Cyanomolgus Monkeys (NHP): No
Slide 33: NV-387 Pharmacokinetics
NV-387 Pharmacokinetics Both I.V. and Oral Dosing Result in Sustained, Plateau Plasma Profiles Non-GLP PK/TK in Cyanomolgus Monkey (NHP) upon Slow Infusion Dosing: A Nearly Flat Plateau from 0.5-6h with ~70% Retained at 24h at Doses of 25, 50 and 100mg/Kg. Non-GLP PK/TK in of Oral Gummies Formulatio
Slide 34: cGMP-Compliant Manufacture at Clinical Scales
cGMP-Compliant Manufacture at Clinical Scales NV-387 Scale-Up in Stirred-Tank Reactors to ~5-6Kg Drug Substance Scale Completed NV-387 Clinical Drug Products - Oral Syrup and Oral Gummies (500mg, 1g Strengths) Multi-Kg Scale Formulated, Filled, Packaged, Labeled and Shipped for Phase I Clinical Tria
Slide 35: NV-387 Phase I Clinical Trial Completed Successfully
NV-387 Phase I Clinical Trial of NV-387 Oral Syrup and Oral Gummies Completed Successfully Clinical Trial for COVID Indication Conducted In India, by the Drug Sponsor and Our Collaborator, Karveer Meditech Pvt. Ltd. In-Hospital Stage Completed ca. end of December, 2023 No Drop-Outs Clinical Observat
Slide 36: NV-387 Phase I Clinical Trial - Design
NV-387 Phase I Clinical Trial of NV-387 - Design Two Formulations (Oral Syrup and Oral Gummies); 3 Dose Levels Each 10 mg/Kg, 20 mg/Kg and 40 mg/Kg Oral Syrup 500 mg, 1,000 mg and 2,000 mg Oral Gummies Total 6 Cohorts at SAD and MAD; 6 Healthy Subjects per Cohort All Subjects Sequestered in Hospital
Slide 37: Effective Against a Diverse Family of Viruses
NV-387, A Single Drug that is Effective Against a Diverse Family of Viruses: In Lethal Animal Infection Models NV-387 is Superior to Existing Drugs Virus Animal % Improvement in Survival, Virus Survival, Days Family Model Compared to Reference Drug NV-387, PO = Full Survival NV-387, PO, Led to Balb-
Slide 38: NV-HHV-1 Further Developments
NV-HHV-1 Further Developments (HerpeCide™ Program) IND - NV-HHV-1 Skin Cream for the Treatment of Shingles Rash Non-Clinical Development of Systemic NV-HHV-1 and NV-HHV-2 Phase I/II - NV-HHV-1 Skin Cream for the Treatment of Shingles Rash Phase I/II - NV-HHV-1 or NV-HHV-2 for the Systemic Treatment
Slide 39: NV-HIV-2 Further Developments
NV-HIV-2 Further Developments Non-Clinical Development of Systemic NV-HIV-2 Phase I/II - NV-HIV-2 for the Systemic Treatment of HIV-1, HIV-2 Infections Goal - First-Line Treatment to Bring Viral Load to Undetectable Levels, Study Length of Treatment Discontinuation Before Retreatment Required © All
Slide 40: NanoViricides Drug Pipeline
NanoViricides Drug Pipeline Virus Drug Candidate & Brief Description of Virus Notes Indications Stage Family Formulations Drug 1. Complete Survival of Lethally Infected Preparing for Mice from RSV Infection, Compared to 1. RSV Infection leading to Phase II Clinical Ribavirin that extended lifespan P
Slide 41: NanoViricides Encapsulation Platform
NanoViricides Encapsulation Platform: NV-387, Already Phase I Completed (DMF Possible) Drug Rescue: Rescue Active APIs with Poor Pharmacokinetics/ Metabolism NV-387 Encapsulation of Drugs or Pro-drugs Provides Many Benefits Sustained Pharmacokinetic Profile Enable Twice Daily or Less Frequent Dosing
Slide 42: Encapsulation Platform with Site-Directing Ligands Attached
NanoViricides Encapsulation Platform: NV-387 with Site-Directing Ligands Attached for Receptor-based Drug Delivery NV-387 can be Covalently Modified with Small Chemical Ligands Delivery of Guest API to Specific Sites of Action is Made Possible by Receptor-Mediated Drug Delivery Using such Conjugates
Slide 43: NanoViricides is a Unique Drug Developer Company with Its Own cGMP-Capable Manufacturing
NanoViricides is a Unique Drug Developer Company with Its Own cGMP-Capable Manufacturing Capability Nanomedicines Characterization Facility Virology BSL-2 Certified Lab Protect Proprietary Technology & Intellectual Property Rapid Transfer from Lab Bench to cGMP Manufacture Highly Customizable and Fl
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