Execu&ve  Summary  

§  Cearna’s  OcuMend  is  a  very  compelling  product  that  will  garner  significant  interest  from  strategics  §  A@rac&ve  market  condi&ons  to  improve  aesthe&c  outcomes  

§  Emerging  pharmaceu&cal  drug  delivery  company  with  barriers  to  entry  and  significant  IP    §  Compelling  value  proposi&on  as  a  innovator  in  post-­‐surgery  bruising,  scarring,  and  swelling  treatment    §  Proven  success  in  ini&al  cosme&c  ver&cal  §  Posi&oned  for  expansion  into  new  ver&cals  (surgery  recovery  market)    §  Compelling  market  and  financial  profile  with  meaningful  growth  opportuni&es    §  Product  has  scarcity  value  in  today’s  marketplace  §  Line  extensions  planned  to  maximize  u&lity  in  other  anatomical  areas/  markets  

Cearna  in  exploring  a  transac&on  for  OcuMend  in  aesthe&cs,  dermatology  and  plas&c  surgery  markets  to  maximize  value    

Benefits  of  a  transac&on  

Posi&oning  

Value  Considera&ons  

The  Issue  •  Extreme  bruising  and  swelling  are  side  

effects  in  dermatology,  plas&c  and  reconstruc&ve  surgery  following  various  non-­‐invasive  and  invasive  procedures  

•  3  most  common  therapies  (JAMA  2013)  –  Eleva&ng  the  head  –  Ice  –  Arnica  

•  Previous  arnica  products  were  weak,  ineffec&ve  and  inconsistent  

The  Solu&on  •  OcuMend®  Clinically  proven  to  

reduce  bruising  •  Arnica:  Only  ac&ve  that  addresses  

bruising,  pain  and  swelling  •  Patented  Ultra-­‐penetra&ng  

Nanotechnology    •  50X  the  potency  

Ac&ve  Ingredient  Arnica  •  Sesquiterpene  Lactones    inhibit  the  P65  subunit  thus  preven&ng  transcrip&on  NF-­‐Kappa  B1,2,3  

•  Shuts  down  the  inflammatory  cytokine  pathway  

1) Hall, I. H.; Starnes, C. O., Jr.; Lee, K. H.; Waddell, T. G. Mode of action of sesquiterpene lactones as antiinflammatory agents. J. Pharm. Sci. 1980, 69, 537-543. 2) Lyss, G.; Schmidt, T. J.; Merfort, I.; Pahl, H. L. Helenalin, an anti-inflammatory sesquiterpene lactone from Arnica, selectively inhibits transcription factor NF-B. Biol. Chem. 1997, 378, 951-961. 3) Garcia-Pineres, A. J.; Castro, V.; Mora, G.; Schmidt, T. J.; Strunck, E.; Pahl, H. L.; Merfort, I. Cysteine 38 in p65/NFkappaB plays a crucial role in DNA binding inhibition by sesquiterpene lactones. J. Biol. Chem. 2001, 276, 39713-39720.

Aesthe&cs  Market    

International Society of Aesthetic Plastic Surgeons 2013

U.S.    17%  

Brazil  9%  

EU  7%  

Mexico  4%  

Other  63%  

•  23.5 million procedures world wide •  Eye lift surgery •  Nose lift surgery •  Liposuction surgery •  Non-surgical procedures

•  4 million in the U.S. •  Procedure cost $1000-$10,000 •  Predominantly cash based

Compe&tors  Name   OcuMend   SinEcch*   VitaMedica  Topical   x   x  Ultra-­‐penetra<ng  Nanotechnology   x          

UltraHigh  Potency   x  

Clinical  Trials  

 

89%  of  pa&ents  recovered  faster  

 

No  improvement  in  

recovery  

 

 

 

Facelie  –  1  day  post  surgery  

Untreated area

Treated area

Placebo  

PREVENTS  THE  BRUISING  WITH  SAME  IMPACT  

The  pain  and  swelling  are  equally  reduced  

Product  Posi&oning  •  Faster  pa&ent  recovery  

-­‐  Quicker  reduc&on  in  swelling  and  bruising  

•  Be@er  pa&ent  outcomes,  pa&ent  sa&sfac&on  •  Can  be  used  for  non-­‐surgical  and  surgical  cosme&c  procedures  

Significant  bruising  aeer  filler  injec&ons  •  Taylor  SC,  Burgess  CM,  Callender  VD.  Efficacy  of  variable-­‐  par&cle  hyaluronic  acid  dermal  fillers  in  pa&ents  with  

skin  of  color:  a  randomized,  evaluator-­‐blinded  compara&ve  trial.  Dermatol  Surg  2010;36:741–9.  •  Narins  RS,  Brandt  F,  Leyden  J,  Lorenc  ZP,  et  al.  A  randomized,  double-­‐blind,  mul&center  comparison  of  the  efficacy  

and  tolerability  of  Restylane  versus  Zyplast  for  the  correc&on  of  nasolabial  folds.  Dermatol  Surg  2003;29(6):588–95.  

•  Hede´n  P,  Fagrell  D,  Jernbeck  J,  et  al.  Injec&on  of  stabilized  hyaluronic  acid-­‐based  gel  of  non-­‐animal  origin  for  the  correc&on  of  nasolabial  folds:  comparison  with  and  without  Lidocaine.  Dermatol  Surg  2010;36:775–81.  

•  Brandt  F,  Bank  D,  Cross  SL,  Weiss  R.  A  lidocaine-­‐containing  formula&on  of  large-­‐gel  par&cle  hyaluronic  acid  alleviates  pain.  Dermatol  Surg  2010;36(suppl  3):1876–85.  

•  Weiss  R,  Bank  D,  Brandt  F.  Randomized,  double-­‐blind,  split-­‐face  study  of  small-­‐gel-­‐par&cle  hyaluronic  acid  with  and  without  Lidocaine  during  correc&on  of  nasolabial  folds.  Dermatol  Surg  2010;36:750–9.  

•  Narins  RS,  Coleman  WP  3rd,  Rohrich  R,  Monheit  G,  et  al.  12-­‐  Month  controlled  study  in  the  United  States  of  the  safety  and  efficacy  of  a  permanent  2.5%  polyacrylamide  hydrogel  soe-­‐&ssue  filler.  Dermatol  Surg  2010;36(Suppl  3):1819–29.  

•  Dover  JS,  Rubin  MG,  Bha&a  AC.  Review  of  the  efficacy,  durability,  and  safety  data  of  two  nonanimal  stabilized  hyaluronic  acid  fillers  from  a  prospec&ve,  randomized,  compara&ve,  mul&center  study.  Dermatol  Surg  2009;35(Suppl  1):322–31.    

OcuMend  reduces  bruising,  leading  to  quicker  recovery  

Strong  KOL  Support  •  “Most  pa9ents  who  have  experienced  pronounced  bruising  in  the  past  experience  li=le  to  no  

bruising  with  the  use  of  these  arnica-­‐infused  patches.    OcuMend  has  quickly  become  an  integral  part  of  my  post-­‐injec9on  protocol.”      Tina  Alster  M.D.  

•  My  pa9ents...benefit  from  the  use  of  OcuMend...  it  seems  to  help  drama9cally.    They  come  back  to  see  me  one  week  later  with  very  li=le  bruising.    In  fact,  I  have  seen  a  pa9ent  on  3  days  aJer  surgery  who  had  significant  bruising  right  aJer  the  surgery  and  she  was  almost  clear  of  any  ecchymosis  (bruising).    Wendy  Lee  M.D.  

•  “The  use  of  OcuMend  has  decreased  the  amount  of  bruising  and  swelling  in  the  post-­‐opera9ve  period.  This  has  led  to  a  no9ceable  improvement  in  the  recovery  of  my  cosme9c  blepharoplasty  pa9ents.”      William  Mack,  M.D.  

 

Intellectual  Property  •  Patents  

– Mayer  Brown  &  Brinks  Gilson  – 10  patents  filed,  1  awarded  to  date  – Very  broad  claims:  All  high  potency  arnica  gels  –  Interna&onal  and  U.S.  patents  (EU,  Japan,  China,  India,  etc.  )  

– U.S.  Office  ac&ons  in  process  

Regulatory  •  FDA  

– Hogan  and  Lovells  –  Exis&ng  FDA  OTC  monograph  for  Arnica  –  FDA  website:“Once  a  final  monograph  is  implemented,  companies  can  make  and  market  an  OTC  product  without  the  need  for  FDA  pre-­‐approval.”  

– Verified  with  FDA  assigned  monograph  commi@ee  – Monograph  with  unusually  broad  approved  claims:  bruising,  pain,  swelling,  black  eyes,    and  inflamma&on  

 

Supply  Chain      •  Third  party  gel  manufacturer  with  10X  needed  capacity  

–  Largest  independent  hydrogel  manufacturer  in  the  U.S.  –  40  years  experience  

•  FDA  registered  3rd  party  distribu&on  –  Warehousing  –  Order  processing  –  Delivery  –  24  hour  customer  support  

Barriers  to  entry  •  FDA  regula&on  for  OcuMend  completed  

–  Many  strategics    spend  >7  years  and  >$150MM  investment  –  The  Cearna  Aesthe&cs  Pipeline  does  not  require  addi&onal  

submissions  •  Exclusive  agreement  with  only  U.S.  OEM  manufacturer  with:  

–  Technology  –  High  volume  capacity  

•  Granted  and  pending  patents  that  are  designed  to  prevent  entry  into  the  market.  

 

Strong  Management  Team  •  CEO:  Dr.  Josephine  Polich  

•  Director  of  Engineering,  Prac&cing  Physician    •  Fortune  10  consultant  for  opera&ons,  management,  and  sourcing  of  high-­‐tech  start-­‐ups  

•  Licensing  Lead:    David  Crean,  Ph.D.,  MBA  •  Allergan/  Actavis  and  Aqua  /  Almirall  •  Completed  >  30  transac&ons  covering  Aesthe&cs,  Dermatology,  Neurology  and  Ophthalmology  

•  CFO:    Randy  Anderson  •  Serial  Entrepreneur  •  Booth  MBA,  CPA  

•  Financial  Advisor:    Vic  Miller  •  V-­‐P  Finance  Neos  Therapu&cs  •  $60m  Series  B/B1/C  VC    funding    •  Business  Development  

 

Partnerships  •  Cearna  is  seeking  strategic  partnerships  to  maximize  OcuMend  use  in  

dermatology,  plas&c  surgery  and  oculoplas&c  markets  as  sole  use  or  as  an  adjunct  to  exis&ng  products  to  improve  aesthe&c  outcomes  related  to  bruising  

•  Territories:  Worldwide  available  •  Cearna  will  retain  other  fields  of  use  •  Partners  will  have  strong  commercial  presence  and  products/  procedures  in  

dermatology,  aesthe&c  and  ophthalmology/  oculoplas&c  fields  •  Partners  will  have  resources  to  drive  significant  sales,  marke&ng  and  promo&on  of  

OcuMend  in  the  territory  and  fields  of  use  •  Timeline  for  comple&on  of  partnering  Agreement:  Q3-­‐Q4  2015    

Timelines  •  Non-­‐Confiden&al  Memorandum  to  Strategics  (Tiers  A,  B,  C)-­‐  March/June  •  Non-­‐Disclosure  Agreements-­‐  March/July  •  Confiden&al  data  sharing-­‐  April/  July  •  Non-­‐binding  LOI/  term  sheets-­‐  August/  September  •  Contract  draeng  and  nego&a&on-­‐  September/  December  •  Close  of  transac&on-­‐  December/  January  •  Alliance  Management/  Joint  Commi@ee-­‐  January/  March