2016-01-23 NanoViricides Inc Fact Sheet.pages

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Summary NanoViricides, Inc. is a developmentstage therapeu9cs company crea9ng specialpurpose nanomaterials for an9viral drugs based on a novel, firstinclass mechanism. The Company's novel nanoviricide® class of drug candidates are designed to specifically aBack enveloped virus par9cles, on the same sites that they use to bind to cells, and dismantle them. Our approach promises that a virus cannot escape our nanoviricide drugs due to muta9ons. NanoViricides is unique in the field also in that we now have our own mul9kgscale cGMPcapable clinical drug manufacturing capability. This facility is an9cipated to enable rapid transla9on to the clinic (as opposed to using an external manufacturer) of our drug candidates. Further, it should allow produc9on of ini9al marke9ng quan99es and thus early revenues from our first drug when licensed, which could be as high as $50MM to $500MM per year, depending upon the drug and pricing. Our broadspectrum an9 influenza drug, injectable FluCide™, for hospitalized pa9ents is our lead candidate. Our an9herpesvirus drugs program is expected to develop into four drugs against different indica9ons, namely, oral herpes, genital herpes, herpes kera99s (eye), and shingles. NanoViricides, Inc. is possibly the first in the world to have developed an orally effec9ve nanomedicine, our oral FluCide™ for outpa9ents. We are also developing drugs against Dengue viruses, and HIV. In addi9on, we have R&D programs against Ebola/Marburg, Rabies, MERS, and other viruses. All of our drugs are in preclinical development, with Influenza drugs in INDenabling studies, and an9Herpes drugs to enter INDenabling studies soon. The Company’s DengueCide™ broadspectrum treatment for Dengue and DHF has been awarded an “orphan drug” designa9on by the US FDA as well as the EMA. In addi9on, the Company’s an9HIV drug candidate, HIVCide™, has shown strong efficacy in animals, sugges9ng it could possibly lead to a “func9onal cure” for HIV/AIDS. State of the Art cGMPcapable Manufacturing Facility for Clinical Drug Produc=on is Ready for Opera=ons The new NanoViricides facility in Shelton, CT, facility contains customizable mul9product cGMP manufacturing capability, as well as advanced nanomedicines characteriza9on and R&D laboratory, to support clinical drug manufacture of any of our drug candidates. Manufacturing Scale to Support Ini=al Marke=ng Needs This facility has the capacity for market entrylevel produc9on of our FluCide™ Injectable drug candidate for hospitalized pa9ents, or our eye an9viral drug for herpes kera99s, among others, when approved. Further, the facility has the capability to manufacture all of the drug needed for trea9ng a small epidemic outbreak, such as the recent Ebola crisis. cGMP Manufacturing capability is a major risk for new pharma companies, especially in nanomedicines. We are happy to report that we are tackling this risk head on, by building our own. INVESTMENT HIGHLIGHTS Company Fact Sheet NYSE-MKT: NNVC Large Class 10,000 Fume Hood Area for Synthetic Chemistry Large Class 100 Cleanroom Area for Injectables Manufacture BIND ENCAPSULATE DESTROY UNIQUE, NOVEL MECHANISM ENABLES FIRST IN CLASS PRODUCTS

Transcript of 2016-01-23 NanoViricides Inc Fact Sheet.pages

Page 1: 2016-01-23 NanoViricides Inc Fact Sheet.pages

Summary  NanoViricides,  Inc.  is  a  development-­‐stage  therapeu9cs  company  crea9ng  special-­‐purpose  nanomaterials  for  an9-­‐viral  drugs  based  on  a  novel,  first-­‐in-­‐class  mechanism.  The  Company's  novel  nanoviricide®  class  of  drug  candidates  are  designed  to  specifically  aBack  enveloped  virus  par9cles,  on  the  same  sites  that  they  use  to  bind  to  cells,  and  dismantle  them.  Our  approach  promises  that  a  virus  cannot  escape  our  nanoviricide  drugs  due  to  muta9ons.    

NanoViricides  is  unique  in  the  field  also  in  that  we  now  have  our  own  mul9-­‐kg-­‐scale  c-­‐GMP-­‐capable  clinical  drug  manufacturing  capability.  This  facility  is  an9cipated  to  enable  rapid  transla9on  to  the  clinic  (as  opposed  to  using  an  external  manufacturer)  of  our  drug  candidates.  Further,  it  should  allow  produc9on  of  ini9al  marke9ng  quan99es  and  thus  early  revenues  from  our  first  drug  when  licensed,  which  could  be  as  high  as  $50MM  to  $500MM  per  year,  depending  upon  the  drug  and  pricing.    

Our  broad-­‐spectrum  an9-­‐influenza  drug,  injectable  FluCide™,  for  hospitalized  pa9ents  is  our  lead  candidate.  Our  an9-­‐herpesvirus  drugs  program  is  expected  to  develop  into  four  drugs  against  different  indica9ons,  namely,  oral  herpes,  genital  herpes,  herpes  kera99s  (eye),  and  shingles.  NanoViricides,  Inc.  is  possibly  the  first  in  the  world  to  have  developed  an  orally  effec9ve  nanomedicine,  our  oral  FluCide™  for  out-­‐pa9ents.  We  are  also  developing  drugs  against  Dengue  viruses,  and  HIV.  In  addi9on,  we  have  R&D  programs  against  Ebola/Marburg,  Rabies,  MERS,  and  other  viruses.  All  of  our  drugs  are  in  pre-­‐clinical  development,  with  Influenza  drugs  in  IND-­‐enabling  studies,  and  an9-­‐Herpes  drugs  to  enter  IND-­‐enabling  studies  soon.  The  Company’s  DengueCide™  broad-­‐spectrum  treatment  for  Dengue  and  DHF  has  been  awarded  an  “orphan  drug”  designa9on  by  the  US  FDA  as  well  as  the  EMA.  In  addi9on,  the  Company’s  an9-­‐HIV  drug  candidate,  HIVCide™,  has  shown  strong  efficacy  in  animals,  sugges9ng  it  could  possibly  lead  to  a  “func9onal  cure”  for  HIV/AIDS.  

State  of  the  Art  cGMP-­‐capable  Manufacturing  Facility  for  Clinical  Drug  Produc=on  is  Ready  for  Opera=ons    The  new  NanoViricides  facility  in  Shelton,  CT,  facility  contains  customizable  mul9-­‐product  cGMP  manufacturing  capability,  as  well  as  advanced  nanomedicines  characteriza9on  and  R&D  laboratory,  to  support  clinical  drug  manufacture  of  any  of  our  drug  candidates.    

Manufacturing  Scale  to  Support  Ini=al  Marke=ng  Needs    This  facility  has  the  capacity  for  market  entry-­‐level  produc9on  of  our  FluCide™  Injectable  drug  candidate  for  hospitalized  pa9ents,  or  our  eye  an9viral  drug  for  herpes  kera99s,  among  others,  when  approved.  Further,  the  facility  has  the  capability  to  manufacture  all  of  the  drug  needed  for  trea9ng  a  small  epidemic  outbreak,  such  as  the  recent  Ebola  crisis.  

cGMP  Manufacturing  capability  is  a  major  risk  for  new  pharma  companies,  especially  in  nanomedicines.  We  are  happy  to  report  that  we  are  tackling  this  risk  head  on,  by  building  our  own.  

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INVESTMENT  HIGHLIGHTS

Company Fact Sheet

NYSE-MKT:NNVC

Large Class 10,000 Fume Hood Area for Synthetic Chemistry

Large Class 100 Cleanroom Area for

Injectables Manufacture

BIND                                                                                  ENCAPSULATE                                                                      DESTROY

UNIQUE,  NOVEL  MECHANISM  ENABLES  FIRST  IN  CLASS  PRODUCTS

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Preclinical  Products  Address  Large  Markets,  $40-­‐70  Billion  es=mated:   HerpesVirus  Mul=ple  Drugs  Franchise  as  well  as  FluCide  Mul=ple  Drugs  Franchise  Could  Result  in  Treatment-­‐Transforma=ons  and  Market  Size  Explosions  Using  the  nanoviricides®  plagorm  technology,  the  Company  has  developed  drug  candidates  targe9ng  some  of  the  world’s  most  pervasive  viruses  (see  the  table  at  top  right  and  product  pipeline  on  next  page).  The  combined  commercial  market  for  our  drug  candidates  has  been  es9mated  well  in  excess  of  $40  to  $70  Billion.    

Whenever  an  effec9ve  drug  is  developed  addressing  an  unmet  need,  very  large  new  markets  appear  (ex.:  Lipitor,  Sovaldi).  We  an9cipate  such  market  explosion  due  to  transforma9ve  treatment  could  happen  for  some  drugs  in  our  FluCide  franchise,  in  our  an9-­‐Herpes  drugs  franchise,  and  possibly  many  other  drugs  in  our  pipeline.  

Key  Issue  of  Drug  Resistance  from  Viral  Muta=ons  is  Unlikely  with  Nanoviricides  Drugs  due  to  Unique  Biomime=c  Technology  The  nanoviricide®  technology  plagorm  mimics  the  host  cell.  We  design  and  develop  a  virus-­‐binding  ligand  that  mimics  the  site  on  the  host  cell  receptor  to  which  the  virus  binds.  This  ligand  is  then  chemically  aBached  to  a  special  polymer  to  make  a  nanoviricide®.  The  virus  is  expected  to  be    fooled  into  binding  to  the  nanoviricide,  like  a  venus-­‐fly-­‐trap.  The  nanoviricide  is  then  expected  to  engulf  the  virus  and  possibly  destroy  it.  To  the  extent  that  the  ligand  accurately  maps  to  the  receptor  binding,  the  virus  would  not  be  able  to  escape  the  nanoviricide  no  maBer  how  much  it  mutates,  because  such  mutants  would  not  be  able  to  bind  efficiently  to  the  natural  receptor,  unable  to  cause  much  disease.    

Beyond  An=bodies  and  Vaccines:   A  Nanoviricide  is  A  Nanomachine  that  Completes  the  Task  of  Destroying  Virus  without  Help  from  the  Pa=ent’s  Immune  System  An9bodies  have  been  developed  as  drugs  against  viruses.  However,  an  an9body  only  binds  by  two  points  to  the  virus.  Moreover,  the  pa9ent’s  immune  system  needs  to  be  healthy  for  the  clearance  of  the  complex  by  the  bodily  systems  of  complement  fixa9on  and  immune  response.  This  is  hardly  the  case  when  a  viral  infec9on  takes  over.  Vaccines  only  train  the  body  into  producing  an9bodies  against  the  virus  in  the  vaccine.  Because  an9bodies  are  highly  specific,  an9bodies  and  vaccines  are  easily  overcome  by  viruses  due  to  rapid  muta9ons  in  the  field.  Note  that  the  2015  influenza  seasonal  vaccine  was  only  23%  effec9ve!    

In  contrast,  a  nanoviricide  should  work  against  all  strains  of  the  virus  because  they  s9ll  bind  the  same  way  to  the  same  host  cell  receptor.  A  nanoviricide  aBacks  the  virus  with  hundreds  of  virus-­‐binding  sites  on  its  surface.  The  nanoviricide  is  capable  of  dismantling  the  virus  in  the  same  way  as  strong  soap  solu9ons  do,  and  the  resul9ng  complexes  are  fully  biodegradable  in  the  body.      

Leveraging  Breakthrough  Biomime=c  Nanotechnology  to  Create  Powerful  Novel  Treatments  Against  Viruses  Results  in  Strong   In-­‐Vivo  Effec=veness  in  Animal  Studies  As  an  example,  our  preclinical  studies  with  FluCide™  have  shown  substan9ally  superior  survival  and  viral  load  reduc9on  results  versus  the  standard-­‐of-­‐care,  treatment.  For  both  H1N1  and  H3N2.  FluCide  is  expected  to  be  effec9ve  against  most,  if  not  all,  strains  of  influenza  A,  even  novel  strains  that  can  cause  epidemics.      

Our  preclinical  studies  with  HerpeCide  have  recently  shown  remarkable  85%  to  100%  survival  of  lethally  infected  animals  in  repeated  studies  in  a  skin  infec9on  model.  We  are  now  op9mizing  the  HerpeCide  drug  candidate  to  define  poten9al  clinical  leads.    

Strong  Safety  Established  in  Mul=ple  Animal  Studies  and  Mul=ple  Animal  Species    Injectable  FluCide  was  found  to  be  well  tolerated  in  mice  even  at  maximum  feasible  dosage  levels  in  a  non-­‐GLP  safety/toxicology  study.  Thereaqer,  a  non-­‐GLP  tox  study  in  rats  found  that  a  related  drug  candidate  was  also  safe  at  as  much  as  a  total  of  4,200mg/kg  

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NOVEL  BIOMIMETIC  NANOVIRICIDE  TECHNOLOGY  ADDRESSING  UNMET  MEDICAL  NEEDS

LARGE  MARKETS.  SAFE  and  HIGHLY  EFFECTIVE  TREATMENTS.  SCALABLE  MANUFACTURING.  

100% Survival on FluCide Treatment

100% Dead at 8 days on Oseltamivir Treatment

100% Dead at 5 days with No Treatment

Viral Load Reduction: 1,000X on FluCide,

only 2X on Oseltamivir

Complete Survival on FluCide Treatment with > 1,000-fold Viral Load Reduction after lethal Influenza Infection    .  

Disease/Virus $Billions

HIV/AIDS $ 25 B

Influenzas $ 10 B

Eye Drops Antiviral $ 1~5 B

Herpes “Cold Sores” Skin Cream & Gel $ 2˜5 B

Hepatitis C $ 5˜10 B

Dengue, Rabies, other NTD’s $ 1˜5 B

Ebola/Marburg/VHF $ 1 B

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given  in  14  days.  This  study  was  completed  at  BASi  Toxicology  Services,  IN,  a  CRO.  In  all  animal  studies  and  in  all  of  our  programs  conducted  since  the  beginning,  no  evidence  of  toxicity  has  been  found  even  at  very  high  dosage  levels.    

Safety  is  built  into  the  nanoviricide’s  structure.  The  polymer  is  based  on  PEG  in  the  backbone  and  faBy  chains  forming  the  “belly”  of  the  nanoviricide.  PEG  is  well  known  and  is  used  in  virtually  all  an9body  drugs  as  well  as  many  nanomedicines  to  protect  the  drug  from  aBack  by  the  body’s  re9culoendothelial  system  (RES).  We  design  the  ligands  as  well  to  avoid  toxicity  issues.    

Effec=veness  in  Human  Clinical  Trials  is  An=cipated,  based  on  Effec=veness  in  Animal  Studies  because  a  nanoviricide  works  directly  against  the  virus  par9cle  in  circula9on  or  outside  cells,  and  not  on  host  targets.  A  nanoviricide  works  independently  of  the  host.    

Strong  Global  Intellectual  Property  Posi=on  with  First  Drug  Patents  to  Expire  Beyond  2036  NanoViricides  has  exclusive  worldwide  licenses  to  field-­‐defining,  pioneering,  global  patent  applica9ons,  that  have  already  issued  into  61  patents  in  countries  including  the  U.S.,  Australia,  Japan,  China,  Canada,  and  all  of  Africa.  Issued  patents  are  “first-­‐in-­‐class”  with  no  prior  art,  showcasing  the  Company’s  leadership  posi9on  in  this  field.  The  patents  cover  broad  composi9ons  of  maBer,  methods  of  making,  and  uses.  The  first  of  the  fundamental  patents  has  expira9on  date  in  2026.  We  also  intend  to  patent  each  of  our  drug  candidates  separately.  The  first  of  our  individual  drug  patents  would  not  expire  before  2036.  This  provides  substan9al  runway  for  commercial  realiza9on.    

As  of  December  31,  2015,  the  Company  had  approximately  $28  million  in  cash  and  equivalents  (unaudited,  es9mated  numbers),  which  management  believes  is  sufficient  to  fund  ini9al  clinical  trials  for  the  first  two  of  its  leading  drug  candidates.  In  addi9on,  the  Company  has  approximately  $12  million  in  fixed  assets  net  of  deprecia9on.  The  Company  currently  spends  only  approximately  $1.7  million  per  quarter.  The  expenditure  rate  is  expected  to  increase  as  we  move  closer  to  IND  filings,  and  then  into  clinical  trials.  Long  term  debt  stands  at  about  $11  million  and  is  conver9ble  into  common  stock.    

Eight  Drugs  in  Our  Broad  Pipeline    Injectable  FluCide  for  Hospitalized  Pa9ents  is  our  most  advanced  drug  candidate,  and  is  in  Tox  Package  and  other  IND-­‐enabling  studies.  Scale-­‐up  and  characteriza9on  studies  are  in  progress.    

Our  HerpeCide™  program  has  matured  towards  mul9ple  drug  indica9ons,  namely  (a)  an9-­‐HSV  skin  cream  to  treat  oral  “cold  sores”  (primarily  HSV-­‐1),  (b)  Eye  Drops  to  treat  ocular  Herpes  Kera99s,  (c)  skin  cream  to  treat  genital  lesions  (primarily  HSV-­‐2),  and  (d)  an9-­‐VZV  skin  cream  to  treat  Shingles  outbreak.  We  are  in  the  final  stages  of  op9mizing  these  drug  candidates  to  define  clinical  leads.  In  addi9on,  we  are  developing  an9-­‐HIV  and  an9-­‐Dengue  virus  drugs.  We  have  also  developed  an  orally  available  nanoviricide  drug  to  treat  influenza.    

Thus  to  date,  NanoViricides  has  developed  eight  drug  candidates.  We  also  have  research  programs  for  Ebola,  Rabies,  MERS,  and  other  viruses.    

Complex  Nanomachine  R&D  to  a`ack  virus  only  everywhere  sparing  host    All  our  current  nanoviricides  work  primarily  on  the  virus  in  circula9on.  However,  the  targeted  nanoviricide  technology  can  be  harnessed  to  aBack  only  virus-­‐infected  cells,  sparing  normal  cells,  because  the  infected  cells  present  viral  an9gens  to  which  nanoviricides  can  bind.  The  nanoviricide  technology  has  the  ability  to  encapsulate  (hold)  ac9ve  ingredients  that  could  kill  or  disrupt  virus  produc9on  inside  infected  cells  only.  Our  leading  R&D  in  this  field  should  lead  to  the  best  ever  an9viral  medicines  in  the  future.        

“Accurate  Drug  In  Field™”  (ADIF™)    Our  ADIF  technology  is  designed  to  avoid  epidemics  such  as  the  recent  Ebola  from  happening  all  together.  A  drug  against  a  novel  pathogen  can  be  developed  directly  in  the  field,  or  selected  from  our  library,  only  using  simple  tests,  with  no  need  to  study  the  pathogen  in  detail.  We  intend  to  develop  this  program  further  when  financing  is  available.

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GLOBAL,  STRONG,  PIONEERING  INTELLECTUAL  PROPERTY  POSITION  WITH  RUNWAY  BEYOND  2036

STRONG  FINANCIAL  POSITION  -­‐  SUFFICIENT  CASH  FOR  INITIAL  CLINICAL  TRIALS

BROAD  AND  DEEP  NANOVIRICIDES  PRODUCT  PIPELINE

Slide © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-mkt: NNVC)

X

Broad Drug Pipeline Advancing Rapidly...

One Drug for All Influenzas

Conjunctivitis/Keratitis

Skin Cream & Gel - Oral, Genital Herpes

HIVCide™ “Functional Cure”?

DengueCide™ Avoid ADE Effect

Current Mkt Size > $8B $1B-$5B >$2B >$22B >$1B

Injectable: $1B est, if effective drug

market will expand if effective drug

market will expand if effective drug

market size should decrease as HIV is

controlled

Est > $10B global if effective drug

Oral: to >$20B est, for effective drug

HSV-1 linked to Alzheimer’s Disease

however, market will increase until

cure

Orphan Drug Benefits in US and EU

1. HSV Cold Sores

2. HSV Herpes Keratitis

3. VZV Shingles

4. HSV Genital Lesions

FluCide™5. Injectable

6. ORAL 7. DengueCide™

Avoid ADE8. HivCide™

“Functional Cure?”

For Hospitalized & Out

Patients

Dermal Topical Lotion

Eye Drops

Dermal Topical Cream

Genital Lesions Topical Cream

West Nile Virus, Yellow Fever Virus,

Jap. EncephalitisHIV

HSV Drugs

Franchise in

Development

Post-Discovery...

Hepatitis C

RabiesMERS

Coronovirus

Many More to Do

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2015  GOALS  ACCOMPLISHED

Eugene  Seymour,  MD,  MPH,  Chief  Execu=ve  Officer  –  Working  in  the  HIV  field  since  the  very  first  AIDS  cohort  was  iden9fied  in  Los  Angeles.  NNVC  is  his  2nd  public  company,  aqer  Stat-­‐Sure,  Inc.  

Anil  R.  Diwan,  PhD,  President  and  Chairman  –  Invented  and  developed  novel  nanomedicine  technologies.  PhD  from  Rice  University  and  a  B.Tech  from  IIT  Bombay.    20+  years  experience  running  entrepreneurial  businesses  and  R&D.    

Meeta  R.  Vyas,  SB,  MBA,  CFO  –  Former  CEO  of  Signature  Brands,  a  public  company  she  turned  around,  was  acquired  by  Sunbeam  Corp;  ex  GM  of  GE  Appliances  Range  products  with  sales  over  $1  Billion,  she  doubled  opera9ng  income;  ex  Principal  with  Gores  Opera9ons  Group,  a  PE  firm  based  in  Los  Angeles.    

Randall  W.  Barton,  PhD,  Chief  Scien=fic  Officer  –  Ex-­‐Director  of  In-­‐Vivo  Cardiovascular  Research  at  Boehringer-­‐Ingelheim.  An  expert  in  receptor-­‐based  drug  design.  More  than  60  scien9fic  publica9ons,  5  patents  and  3  patent  applica9ons.    

Jayant  Tatake,  PhD,  Vice  President  of  R&D  –  Co-­‐inventor  of  the  Company’s  nanomedicine  technologies.  Over  23  years  experience  with  produc9on  of  pharmaceu9cals  from  lab  scale  through  cGMP  manufacture.  PhD  from  UICT-­‐Bombay.  

HIGHLY  EFFECTIVE  MANAGEMENT  TEAM STRONG  INDEPENDENT  BOARD  OF  DIRECTORS

Milton  Boniuk,  MD  -­‐  Caroline  F.  Elles  Chair  Professor  of  Ophthalmology  at  Baylor  College  of  Medicine,  TX.  Successful  entrepreneur.  Established  the  Boniuk  Ins9tute  for  the  Study  and  Advancement  of  Religious  Tolerance  at  Rice  University.  Investor  and  long  term  supporter  of  NanoViricides,  Inc.  Stanley  Glick,  CPA  -­‐    Chairman  of  the  Audit  CommiBee.  Experienced  prac9cing  finance,  accoun9ng  and  tax  professional.    

Mukund  Kulkarni,  MBA,  PhD  –  Chancellor  of  Penn  State  University,  Harrisburg,  PA.  Professor  of  Finance.  Accomplished  administrator,  scholar,  and  teacher.      

In  addi9on,  the  execu9ves  Eugene  Seymour,  and  Anil  Diwan  are  elected  members  of  the  Board  and  serve  on  the  Execu9ve  Team.  

In  FY  2015,  and  through  December  end  2015,  we  moved  all  opera9ons  to  the  new  facility  in  Shelton,  CT,  in  a  phased  manner,  over  a  period  of  several  months.  We  have  added  several  key  members  to  our  staff  both  at  NanoViricides  and  at  our  associates,  with  the  combined  strength  of  more  than  30  as  of  now.  We  have  engaged  in  significant  training  exercises  for  the  new  members  of  our  team  as  well  as  for  the  overall  team.  Also,  we  developed  manufacturing  control  and  quality  analysis  methods  for  our  polymer  manufacturing  processes  at  approximately  500g  scale.  In  addi9on,  we  are  con9nuing  the  non-­‐GLP  tox  package  studies  for  FluCide.  We  are  con9nuing  to  work  on  FluCide  scale-­‐up  to  kilogram  scale,  quan99es  required  for  our  tox  package  studies,  because  of  the  strong  safety.  Most  importantly,  we  have  achieved  substan9al  successes  in  our  HerpeCide  project,  demonstra9ng  complete  survival  of  lethally  infected  animals  in  a  special  skin  infec9on  model.  This  has  transformed  the  HerpeCide  project  into  a  mul9-­‐drug  franchise.  We  are  developing  (a)  an9-­‐HSV  skin  cream  for  control  of  oral  “cold  sores”,  (b)  an9-­‐HSV  skin  cream  for  healing  genital  herpe9c  lesions,  (c)  Eye  Drops  to  treat  Herpes  Kera99s,  and  (d)  an9-­‐VZV  skin  cream  to  treat  Shingles  outbreak,  under  this  project.  We  are  now  in  the  final  stages  of  op9miza9on  of  drug  candidates  in  these  programs.  All  of  the  Herpes  program  drug  candidates  are  expected  to  require  substan9ally  smaller  drug  quan99es  for  their  tox  package  studies  as  well  as  for  clinical  trials.  These  programs  are  therefore  an9cipated  to  develop  more  rapidly  than  the  FluCide  programs.  

2016  GOALS  ANTICIPATEDWe  intend  to  advance  the  mul9ple  drug  candidates  in  the  HerpeCide  programs  further.  We  an9cipate  we  will  need  rela9vely  small  quan99es  of  the  HerpeCide  program  drug  candidates  for  Tox  Package  studies,  because  of  their  topical  nature.  We  will  need  to  develop  standard  opera9ng  procedures,  implement  quality  assurance  and  quality  control  systems.  We  are  therefore  developing  most  of  our  processes  at  about  500g  scale  at  present.  We  are  developing  several  collabora9ons  and  contract  rela9onships  for  the  study  of  these  Herpes  and  VZV  drug  candidates  in  suitable  animal  models  to  complete  the  candidate  op9miza9ons  and  thereaqer  to  characterize  declared  clinical  candidates  in  IND-­‐enabling  studies.  We  an9cipate  being  able  to  declare  Herpes  and  VZV  program  clinical  drug  candidates  in  the  ensuing  year.  In  contrast,  we  need  to  produce  mul9-­‐kilogram  quan99es  of  FluCide  for  GLP  Tox  Package  studies.  We  intend  to  advance  the  FluCide  scale-­‐up  process  development  further.  We  also  need  to  perform  substan9al  addi9onal  efficacy  studies  against  different  influenza  virus  subtypes,  as  needed  for  the  IND  filing.  Other  drug  programs  will  con9nue  at  lower  priori9es.    Note:  The  ac9vi9es  described  have  a  strong  dependence  on  factors  outside  the  Company’s  control.  Also,  the  Company  does  not  have  all  the  personnel  or  facili9es  needed  for  conduc9ng  these  projects.  Hiring,  training,  purchasing  and  bringing  into  opera9on  new  equipment,  reactors,  controllers,  se{ng  up  data  acquisi9on  systems,  seeing  up  quality  control  and  assurance  systems,  etc.  may  cause  significant  delays.  In  addi9on,  the  program  costs  may  be  substan9ally  greater  than  the  Company  an9cipates.  The  Company  may  adjust  its  priori9es  due  to  such  constraints  resul9ng  in  delays  in  accomplishments.

Disclosure  Statement  NanoViricides,  Inc.  (“the  Company”)  is  a  publicly  traded  company  (NYSE  MKT  stock  symbol:  NNVC.)    This  fact  sheet  not  an  offering  memorandum  and  should  not  be  construed  as  such.  It  is  provided  as  a  non-­‐confiden9al  document  for  informa9onal  purposes  only.  NanoViricides,  Inc.(www.nanoviricides.com)  is  a  development  stage  company  that  is  crea9ng  special  purpose  nanomaterials  for  an9-­‐viral  therapeu9cs.  The  Company's  novel  nanoviricide®    class  of  drug  candidates  are  designed  to  specifically  aBack  enveloped  virus  par9cles  and  to  dismantle  them.    This  document  contains  forward-­‐looking  statements  that  reflect  the  current  expecta9on  of    the  Company  regarding  future  events.  Actual  events  could  differ  materially  and  substan9ally  from  those  projected  herein  and  depend  on  a  number  of  factors.  Certain  statements  are  “forward-­‐looking  statements”  within  the  meaning  of  Sec9on  27A  of  the  Securi9es  Act  of  1933  and  Sec9on  21E  of  the  Securi9es  Exchange  Act  of  1934.  You  should  not  place  undue  reliance  on  forward-­‐looking  statements  since  they  involve  known  and  unknown  risks,  uncertain9es  and  other  factors  that  are,  in  some  cases,  beyond  the  Company's  control  and  that  would  materially  affect  actual  performance  or  achievements.  The  Company  assumes  no  obliga9on  to  publicly  update  or  revise  these  forward-­‐looking  statements  for  any  reason,  or  to  update  the  reasons  actual  results  could  differ  materially  from  those  an9cipated,  even  if  new  informa9on  becomes  available  in  the  future.  Important  factors  that  could  cause  actual  results  to  differ  materially  from  the  company's  expecta9ons  include,  but  are  not  limited  to,  factors  that  are  disclosed  under  the  heading  "Risk  Factors"  and  elsewhere  in  documents  filed  by  the  Company  from  9me  to  9me  with  the  U.S.  Securi9es  and  Exchange  Commission  and  other  regulatory  authori9es.  Although  it  is  not  possible  to  predict  or  iden9fy  all  such  factors,  they  may  include  the  following:  demonstra9on  and  proof-­‐of-­‐principle  in  preclinical  trials  that  a  nanoviricide  is  safe  and  effec9ve;  successful  development  of  our  product  candidates;  our  ability  to  raise  addi9onal  financing  when  needed;  our  ability  to  seek  and  obtain  regulatory  approvals,  including  with  respect  to  the  indica9ons  we  are  seeking;  the  successful  commercializa9on  of  our  product  candidates;  and  market  acceptance  of  our  products.  

Contact

Investors Dr.  Eugene  Seymour,  [email protected]  

General:  [email protected]  

Strategic Dr.  Anil  R.  Diwan,    [email protected]  

Website:    www.nanoviricides.com  

Business  Development

Dr.  Randall  W.  Barton,    [email protected]

Address:  1  Controls  Drive,  Shelton,  CT  06484.