Aethlon Medical Corporate Overview

 Investor Relations

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1. OTCQB:  “AEMD”     Recent  stock  price  (10/13/11):   $0.075   52-­‐week  low/high:                $0.0375  -­‐  $0.32   Market…
  • 1. OTCQB:  “AEMD”     Recent  stock  price  (10/13/11):   $0.075   52-­‐week  low/high:                $0.0375  -­‐  $0.32   Market  capitalization:   $8.5  mil   Website:          Aethlon   Medical   is   a   revenue-­‐stage   organization   that   creates   therapeutic   devices   to   address   unmet   needs   in   cancer,   infectious  disease,   and   sepsis.     The   Company’s   lead   product,   the   Aethlon   ADAPT™   system   represents   the   intersection   of   modern   medical  device   technology   and   affinity   drug   mechanisms.     This   technology   platform   originates   a   new   class   of   therapies   that   permit   the  selective   removal   of   disease   enhancing   particles   from   the   entire   circulatory   system   without   drug   toxicity.   The   Aethlon   ADAPT™  system  is  marketed  to  government  health  and  military  agencies  with  programs  to  address  life-­‐threatening  disease  conditions,  as  well  as   to   biotechnology   and   pharmaceutical   organizations   that   wish   to   pursue   a   medical   device   regulatory   and   commercialization  pathway  for  their  drug  agents.    Beyond  revenue  generation,  the  ADAPT™  system  allows  Aethlon  to  create  an  expansive  yet  cohesive  pipeline   of   proprietary   therapeutics.     At   present,   the   Aethlon   ADAPT™   pipeline   includes   the   Aethlon   Hemopurifier®   to   address  infectious  disease  and  cancer,  HER2osome™  to  target  HER2+  breast  cancer,  and  a  medical  device  to  prevent  sepsis  in  combat-­‐injured  soldiers  that  is  being  developed  under  a  $6.8  million  contract  award  from  the  Defense  Advanced  Research  Projects  Agency  (DARPA).   INVESTMENT HIGHLIGHTS   Therapeutic   Innovation:     Products   created   from   the     Aethlon   ADAPT™   system   address   unmet   medical   needs   by    Aethlon   ADAPT™   System   Therapies   Address   Large   delivering   therapeutic   mechanisms   that   are   beyond   the   Markets  with  Significant  Therapeutic  Voids:   reach  of  drugs  or  medical  devices  alone.     Unique   Business   Model:     The   Aethlon   ADAPT™   system   The  Global  Market  Opportunity  for     provides   a   basis   for   corporate   and   government      Aethlon  ADAPT™  System  Products   relationships   that   generate   revenue   as   pipeline   products        HCV  –  170m  infected   are  advanced  to  market.          HIV  –  33m  infected      Sepsis  –  18m  cases  per  year     Established   Delivery   Network:     Aethlon   ADAPT™   system      Cancer–  12m  new  diagnosis  per  year   therapies   are   designed   for   use   within   the   established           infrastructure   of   dialysis   and   CRRT   machines   already       located  in  hospitals  and  clinics  worldwide.   THE HEMOPURIFIER® AN AETHLON ADAPT™ THERAPY  The   Aethlon   Hemopurifier®   is   a   first-­‐in-­‐class   medical   device  with   broad-­‐spectrum   capabilities   against   viral   pathogens,  including   the   human   immunodeficiency   virus   (HIV),   hepatitis  C  virus  (HCV)  and  numerous  bioterror  and  pandemic  threats.  Human   studies   have   demonstrated   the   Hemopurifier®   to   be  safe  and  provide  average  viral  load  reductions  of  greater  than  50%   during   four-­‐hour   treatment   periods   in   both   HCV   and   HIV  infected   individuals   without   the   administration   of   antiviral  drugs.    The  device  is  currently  the  subject  of  a  human  clinical  study   in   India   to   evaluate   its   ability   to   accelerate   viral   load  depletion  when  utilized  in  combination  with  HCV  standard  of  care  drug  therapy.    An  investigational  device  exemption  (IDE)  to   initiate   clinical   studies   in   the   United   States   has   been  submitted  to  the  U.S.  Food  and  Drug  Administration  (FDA).  In  vitro  studies  have  also  documented  that  the  Hemopurifier®   exosomes  from  the  blood  of  advanced-­‐stage  cancer  patients.    captures   exosomes   underlying   cancer,   including   colorectal,   The   study   will   evaluate   25   patients,   five   patients   with  lymphoma,   melanoma,   ovarian,   and   breast   cancer.     Aethlon   metastatic   cancer   of   the   following   types;   non-­‐small   cell   lung  has   expanded   its   exosome   research   programs   through   a   cancer,   prostate   cancer,   melanoma,   head   and   neck   cancer,  collaborative   agreement   with   the   Sarcoma   Oncology   Center   and   sarcoma.    Exosomes   released   by   cancers   have   emerged  (SOC),   based   in   Santa   Monica,   California.   The   SOC   to  become  an  important  therapeutic  target  in  cancer  care,  as  collaboration   is   studying   the   ex   vivo   effectiveness   of   the   they  are  implicated  in  promoting  cancer  survival,  growth,  and  Aethlon   Hemopurifier®   to   remove   immunosuppressive   metastasis.    
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HER2OSOME™ AN AETHLON ADAPT™ THERAPYHER2osome™   provides   a   therapeutic   strategy   to   maximize   the   ability   of   the   immune   system   and   established   drug  therapies   to   combat   HER2+   breast   cancer,   which   is   characterized   by   aggressive   growth   and   poor   prognosis   resulting  from  the  over-­‐expression  of  HER2  protein.    HER2osome™  is  a  novel  medical  device,  whose  goal  is  to  inhibit  HER2+  breast  cancer  progression  by  reducing  the  circulatory  presence  of  HER2  protein  and  tumor-­‐secreted  exosomes  that  contribute  to   the   development   and   progression   of   breast   cancer.     Research   publications   indicate   that   breast   cancer   exosomes  suppress   the   immune   response,   stimulate   angiogenesis,   contribute   to   the   spread   of   metastasis,   and   inhibit   the  therapeutic   benefit   of   Herceptin®   (trastuzumab),   a   leading   monoclonal   antibody   treatment   against   the   HER2+   breast  cancer.    As  an  adjunct  therapeutic  candidate,  HER2osome™  offers  to  fill  an  unmet  medical  need  and  enhance  the  benefit  of   Herceptin®   and   standard   of   care   chemotherapies   without   adding   drug   toxicity   or   interaction   risks.     HER2osome™  leverages  the  Aethlon  ADAPT™  system  to  allow  the  immobilization  of  a  HER2  antibody  and  an  exosome  targeted  affinity  agent  to  provide  a  mechanism  to  clear  both  targets  from  the  circulatory  system  of  HER2+  breast  cancer  patients.    Like  all  Aethlon   ADAPT™   derived   therapies,   HER2osome™   will   operate   dialysate   free,   will   not   require   replacement   fluids,   and  can  be  utilized  on  dialysis  machines  or  CRRT  systems  already  located  in  hospitals  and  clinics  worldwide.   DARPA SEPSIS PROGRAMAethlon   Medical   has   been   awarded   a   $6.8   million   contract   from   the   Defense   Advanced   Research   Projects   Agency  (DARPA)  to  develop  a  therapeutic  device  to  reduce  the  incidence  of  sepsis,  a  fatal  bloodstream  infection  that  is  often  the  cause   of   death   in   combat-­‐injured   soldiers.     The   contract   program   will   utilize   the   Aethlon   ADAPT™   system   as   a   core  technology   component   underlying   an   extracorporeal   blood   purification   device   that   selectively   clears   multiple   sepsis-­‐enabling   particles   from   circulation   to   promote   recovery   and   prevent   sepsis.     The   resulting   device,   which   is   being  advanced  under  DARPA’s  Dialysis  Like  Therapeutics  (DLT)  program,  is  expected  to  dramatically  decrease  the  morbidity  and  mortality  of  sepsis,  thereby  saving  thousands  of  lives  and  billions  of  dollars  in  the  United  States  each  year.  Sepsis  also  represents  global  medical  issue  with  an  annual  incidence  estimated  at  18  million.   ABOUT THE AETHLON ADAPT™ SYSTEMThe  Aethlon  ADAPT™  (Adaptive  Dialysis-­‐like  Affinity  Platform  Technology)  system  provides  the  foundation  for  an  entirely  new   class   of   therapeutics   that   target   the   selective   clearance   of   harmful   agents   from   the   entire   circulatory   system.    Therapies   that   evolve   from   the   Aethlon   ADAPT™   system   overcome   the   historic   limitation   of   extracorporeal   strategies  that   indiscriminately   adsorb   or   remove   particles   solely   by   molecule   size.     In   function,   our   device   platform   allows   the  immobilization  of  single  or  multiple  affinity  drug  agents  in  the  outer-­‐capillary  space  of  plasma  membrane  technologies  as  a  means  to  provide  rapid  real-­‐time  clearance  of  corresponding  targets  without  adding  drug  toxicity  or  interaction  risks  to  established  therapies.    Beyond  providing  a  novel  regulatory  and  commercialization  pathway  for  affinity  drug  agents,  Aethlon  ADAPT™  products  address  unmet  medical  needs  and  offer  to  improve  the  benefit  of  standard  of  care  therapies.                                           R E C E N T   E V E N T S                                                                             • An  HCV-­‐treatment  study  with  the  Hemopurifier®  is  • $6.8  million  contract  award  from  DARPA  on   being  advanced  at  the  Medanta-­‐Medicity  Institute   9/30/11.   in  Delhi,  India.  • Introduction  of  HER2osome™  therapy  to  address   • Aethlon  met  with  the  FDA  to  discuss  initiation  of   HER2+  breast  cancer  on  9/21/11.   Hemopurifier®  clinical  programs  on  7/19/11.  • Announced  Hemopurifier®  cancer  program  with  the   • Aethlon  disclosed  that  it  intends  to  license  or  sell   Sarcoma  Oncology  Center  to  study  sarcoma,  lung   diagnostic  tools  developed  by  the  Company  to   cancer,  prostate  cancer,  metastatic  melanoma,  and   indentify  and  quantify  the  presence  of  exosomes.   head  and  neck  cancer  on  8/24/11.                                                
  • 3. E X E C U T I V E   T E A M  James   A.   Joyce,   Founder,   Chairman   and   CEO:     Under   Mr.   In   2004,   he   initiated   the   development   of   a   second-­‐generation  Joyce’s   leadership,   Aethlon   has   transformed   the   concept   of   a   home   hemodialysis   system   in   partnership   with   DEKA   Research  selective   therapeutic   filtration   device   (The   Aethlon   &   Development   Corporation.     In   2007,   the   assets   of   Aksys   Ltd.  Hemopurifier®)   into   the   reality   of   treating   both   HIV   and   HCV   were  acquired  by  DEKA,  where  Mr.  Kenley  was  employed  prior  patients  in  a  clinical  setting.       to  joining  Aethlon.          Mr.   Joyce   has   originated   numerous   collaborative   relationships   Mr.   Kenley   is   the   recipient   of   more   than   30   patents   and   has  with   government   and   non-­‐government   research   organizations,   been   a   frequent   presenter   at   international   symposia   regarding  has   authored   supporting   publications   and   reports,   and   raised   the   provision   of   dialysis,   the   design   of   dialysis   equipment   and  capital  resources  to  support  the  mission  of  Aethlon  Medical.    He   designing   medical   equipment   according   to   FDA   guidelines.     He  has   represented   the   Company   on   CNN,   NBC,   ABC,   and   other   has   lectured   at   the   Kellogg   School   of   Management   at  media   outlets   and   has   testified   before   Congress   on   issues   Northwestern   University   and   at   other   business   schools   on  related   to   Project   BioShield   legislation   and   the   deployment   of   entrepreneurship.     He   received   a   BA   in   Biology   and   Chemistry  the   Aethlon   Hemopurifier®   as   a   countermeasure   against   from  Wabash  College,  a  Master  of  Science  degree  in  Molecular  biological   weapons.     His   efforts   on   Capitol   Hill   were   Biology   from   Northwestern   University   and   a   Masters   of  instrumental   in   expanding   the   definition   of   treatment   Management  from  the  Kellogg  School  of  Management.  countermeasure   in   Project   BioShield   legislation   to   include    medical  devices.       Richard  H.  Tullis,  Ph.D.,  Chief  Science  Officer:    Dr.  Tullis  has     extensive  biotechnology  management  and  research  experience  In   May   2011,   the   Company   introduced   the   Aethlon   ADAPT™   and   is   founder   of   Syngen   Research,   a   wholly   owned   subsidiary  system   to   advance   Mr.   Joyce’s   vision   of   an   expansive   device   of   Aethlon   Medical.     Dr.   Tullis   became   VP   and   Director   of  platform   that   converges   affinity   drug   agents   with   plasma   Aethlon  Medical  in  January  of  2000  and  Chief  Scientific  Officer  membrane   technology   to   create   new   candidate   therapies   in  June  of  2001.      against  life-­‐threatening  disease  conditions.           Dr.   Tullis   co-­‐founded   Molecular   Biosystems,   where   he   was  From  February  1993  until  founding  Aethlon  Medical,  Mr.  Joyce   Director   of   R&D,   Director   of   Oligonucleotide   Hybridization,  was   CEO   of   James   Joyce   &   Associates.   Previously   he   was   Senior  Research  Scientist  and  member  of  the  board  of  directors.  founder   and   CEO   of   Mission   Labs,   Inc.,   and   was   a   principal   at   He   developed   and   patented   the   first   application   of  London   Zurich   Securities.     Mr.   Joyce   is   a   graduate   of   the   oligonucleotides   to   antisense   antibiotics   and   developed   new  University  of  Maryland.   methods   for   the   chemical   synthesis   of   DNA   via   methoxy-­‐   phosphorochloridites.     He   also   co-­‐developed   the   first  Rodney   S.   Kenley,   President:     Mr.   Kenley   has   33   years   of   applications   of   covalently   coupled   DNA-­‐enzyme   conjugates  experience   in   healthcare,   most   in   the   extracorporeal   blood   using  synthetic  oligonucleotides.    purification   arena.     He   held   various   positions   at   Baxter    Healthcare   (Travenol)   from   1977-­‐1990,   including   International   In  1985,  Dr.  Tullis  founded,  and  served  as  President  and  CEO  of  Marketing  Manager,  Business  Unit  Manager  for  Peritoneal  and   Synthetic   Genetics,   Inc.,   a   pioneer   in   custom   DNA   synthesis,  Hemodialysis   products,   Manager   of   New   Business   which  was  sold  to  Molecular  Biology  Resources  in  1991.    He  also  Development,  Director  of  Worldwide  Product  Planning,  Director   served  as  interim-­‐CEO  of  Genetic  Vectors,  which  completed  its  of   Advanced   Product   Development,   and   VP   of   Electronic   Drug   IPO   under   his   management,   and   was   co-­‐founder   of   DNA  Infusion.    During  this  tenure,  he  conceived  of  and  managed  the   Sciences,  a  company  that  was  acquired  by  Genetic  Vectors.  launch   of   several   highly   successful   commercial   products,    including  the  HomeChoice  peritoneal  dialysis  cycler.       Dr   Tullis   received   his   Ph.D.   in   Biochemistry   and   Cell   Biology     from   the   University   of   California   at   San   Diego,   and   has   done  Mr.   Kenley   founded   Aksys   Ltd.   in   1991   to   develop   and   extensive   post-­‐doctoral   work   at   UCSD,   USC,   and   The   Scripps  commercialize  his  concept  of  a  daily  home  hemodialysis  system,   Research  Institute.  which   was   commercially   launched   in   2002   as   the   PHD   system.       Company Contacts Investor Contact Jim Frakes Jim Joyce Lippert/Heilshorn & Associates CFO Chairman, CEO Jody Cain (858) 459-7800, x300 (858) 459-7800 x301 (310) 691-7100 The   information   contained   herein   was   obtained   from   the   management   of   Aethlon   Medical   and   other   sources   Lippert/Heilshorn   &   Associates   (LHA)   believes   to   be   reliable.     This   does   not   constitute   the   solicitation   of   the   purchase   or   sale   of   securities.   LHA   is   employed   by   Aethlon   Medical   as   its   investor   relations   firm.     Except   for   the   historical   information   contained   herein,   the   matters   discussed   in   this   document   are   forward-­‐looking   statements,   the   accuracy   of   which   is   subject   to   risks   and   uncertainties.    Please  see  Aethlon  Medical’s  most  recent  filings  with  the  SEC  for  additional  information  about  the  Company  and  related  risks.    
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