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16 bioc Presentation Transcript

  • 1. The  CEE  Solu+on   Personalized  Medicine  from  a  Liquid  Biopsy  
  • 2. Forward–Looking  Statements   This  presenta+on  contains,  and  any  accompanying  oral  presenta+on  would  no  doubt   contain,  forward-­‐looking  statements,  within  the  meaning  of  the  Private  Securi+es   Li+ga+on  Reform  Act  of  1995,  regarding  us  (Biocept,  Inc.)  and  our  business.     Forward-­‐looking  statements  include  all  statements  that  are  not  historical  facts  and   generally  can  be  iden+fied  by  terms  such  as  an+cipates,  believes,  could,  es+mates,   expects,  intends,  may,  plans,  poten+al,  predicts,  projects,  should,  will,  would,  or  the   nega+ve  of  those  terms  and  similar  expressions.   Forward-­‐looking  statements  involve  known  and  unknown  risks,  uncertain+es  and   other  factors  which  may  cause  our  actual  results,  performance  or  achievements  to   be  materially  different  from  any  future  results,  performance  or  achievements   expressed  or  implied  by  the  forward-­‐looking  statements.    For  details  about  these   risks,  please  see  our  SEC  filings.   All  forward  looking  statements  contained  in  this  presenta+on  speak  only  as  of  the   date  hereof,  and  except  as  required  by  law,  we  assume  no  obliga+on  to  update  these   forward-­‐looking  statements  whether  as  a  result  of  any  new  informa+on,  future   events,  changed  circumstances  or  otherwise.   2  
  • 3.  Business  Overview   CLIA  facility  in     San  Diego,  CA   Genomic  test  results   sent  to  physicians                                                                                          R&D   Clinical   Development   CLIA  Lab   R  and  D,  test  kits     manufactured  and     samples  analyzed   Manufacturing   3  
  • 4. Investment  Highlights   •  OncoCEE™:  measures  circula+ng  tumor  cells  (CTCs)     •  OncoCEE-­‐BR™  :  first  commercialized  test  for  breast  cancer     •  CEE-­‐Selector™:  plaorm  expansion  for  muta+on  analysis   •  Robust  test  pipeline  focused  on  solid  tumor  genomic  diagnos+cs   including  lung,  breast,  colon,  prostate  and  melanoma   •  Established,  cer+fied  and  scalable  CLIA  lab   •  Clear  path  to  market  penetra+on   •  Established  research  collabora+ons  and  strategic  partnerships   •  IPO  completed  February  2014;  gross  proceeds  of  $19  million   4   Commercial  stage  cancer  diagnos0cs  company  with  ground-­‐breaking   technology  pla9orm  u0lizing  a  simple  blood  test  
  • 5. Mul+faceted  Growth  Strategy   •  Commercializa+on   –  Clinical,  Commercial     –  Biopharma   –  Partnerships   •  Test  Menu  Build  Out   –  test  valida+on     –  Clinical  u+lity  studies     –  Plaorm  expansion   •  Opera+onal  Efficiency   –  Automa+on   –  Process  improvements   –  Increase  Gross  Margin   5  
  • 6. Biocept  Execu+ve  Team   6   Michael  Nall                 President  and  CEO     Lyle  Arnold,  Ph.D. SVP,  R&D  and  CSO   Farideh  Bischoff,  Ph.D.     VP  TranslaEonal  Research  and   Clinical  Development   Bill  Kachioff                                 SVP,  Finance  and  CFO   David  Hale   ExecuEve  Chairman   •   More  than  25  years  in  healthcare  sales,  marke+ng  and  commercial  opera+ons   •   14  years  in  cancer  diagnos+cs  and  genomics   •   Most  recently  GM  N.  American  Sales  and  Marke+ng  for  Clarient,  a  GE  Healthcare  Company   •   Senior  R&D  Leadership  at  Gen-­‐Probe,  Incyte  Genomics,  Genta   •   Founder/  Co-­‐founder  Oasis  Biosciences,  Molecular  Biosystems,  Aegea  Biotechnologies   •   Former  faculty  member,  UCSD  School  of  Medicine  and  member,  UCSD  Cancer  Center   •   39  issued  US  and  140  issued  and  pending  patents  worldwide   •   Former  Associate  Professor  and  member,  Cancer  Center  at  Baylor  College  of  Medicine   •   Postdoc  at  MD  Anderson  and  Baylor  College  of  Medicine   •   More  than  130  peer  reviewed  papers  and  book  chapters   •   Chairman  and  CEO  of  Hale  BioPharma  Ventures  with  over  35  years  as  a  healthcare  visionary   •   Chairman  of  Santarus  (acquired  by  Salix),  Conatus,  Micromet  (acquired  by  Amgen),  and     SkinMedica      (acquired  by  Allergan)   •   CEO  of  Hybritech  (acquired  by  Lilly)  ,  Gensia  (acquired  by  Teva)     •   More  than  20  years  life  sciences  experience   •   14  years  of  experience  in  public  company  finance   •   Abboj  Labs,  Cutera,  Coulter  Pharmacue+cal,    Althea,  Vivus   •   Diverse  finance  and  opera+ons  management  experience     Raaj  Trivedi     VP  Commercial  OperaEons   •   More  than  15  years  in  healthcare  sales,  marke+ng  and  business  development     •   Served  as  VP  of  Marke+ng  and  then  VP  of  Business  Development  at    Clarient   •   Life  Technologies  Commercial  Leader  for  Oncomine  Biomarker  Discovery  Plaorms  
  • 7. US  Market  Opportunity   7   Cancer   Type   New   Cases/   Year   Living  with   Cancer   Deaths/   Year   Breast 232,340 2,829,041 39,620 Prostate 238,590 2,617,682 29,720 Lung 228,190 399,431 159,480 Colorectal 142,820 1,154,481 50,830 Melanoma 76,690 921,780 9,480 Total 918,630 7,922,415 289,130 *  Incidence,  prevalence  and  deaths  data  provided  by  Na+onal  Cancer  Ins+tute:      hjp://seer.cancer.gov/staacts/  
  • 8. Molecular  Cancer  Tes+ng  Market   8   *GEN  Magazine,  Bold  Predic+on  for  Future  Cancer  Tests                  *Frost  and  Sullivan  –  Market  Research  2011   **Jain  Pharma  Biotech  June  2011   CAGR   22.9%  for  US   0   0.5   1   1.5   2   2.5   3   2010   2015   2017   N.  America*   Global**   $  Billions   Market  Characteris9cs:   •  Increased  reliance  on  molecular  diagnos+cs  for  treatment  decisions   •  Expanding  use  of  targeted  therapies   •  Greater  sophis+ca+on  of  oncology  diagnos+cs   •  Limited  by  need  for  tumor  +ssue  
  • 9. Limita+ons  of  Tissue  Biopsy   Cancer  is  a  heterogeneous  disease   –  Molecular  proper+es  differ  within  a  tumor   –  Primary  tumor  biopsy  may  not  reflect  current  disease  condi+on   –  Therapy  causes  changes  in  tumor  cells   Biopsy  is  invasive   –  May  not  be  feasible  based  on  pa+ent  condi+on  or  tumor  accessibility   –  Imprac+cal  for  periodic  monitoring    for  progression  /  recurrence   Biopsy  +ssue  is  limited   –  Greater  demand  due  to  molecular  profiling   –  Surgery  is  costly       9   Liquid  Biopsy  Addresses  Limita9ons  in  Standard  of  Care  
  • 10. New  Molecular  Paradigm  –  Liquid  Biopsy     •  ctDNA  -­‐  CTCs  –  Circula+ng  Tumor  Cells,  cell  free  Circula+ng  tumor  DNA   •  ctDNA:  demonstrated  surrogate  for  tumor  +ssue  biopsy   •  Can  be  captured  and  characterized  for  biomarkers,  similar  to  +ssue   •  Liquid  biopsy  repeatable  throughout  treatment,  par+cularly  when  +ssue  unavailable     •  66%  of  researchers  say  analysis  of  CTCs  will  be  standard  of  care  in  the  next  4  years*     10   *CTC  industry  overview  –  Hanson  and  Wade    2013   Solid  tumors  shed   CTCs  and  ctDNA   into  blood   CTCs  and  ctDNA  travel   via  bloodstream   CTCs  &  ctDNA  analyzed  for   pa+ent  treatment   decisions   Breast  cancer  CTC  
  • 11. OncoCEE™  Personalized  Genomic  Diagnos+cs   11      Personalized  Treatment   EGFR/ALK/ROS1    K-­‐ras    B-­‐raf    ZELBORAF®     (vemurafenib)      TARCEVA®  (erlo+nib)                                &        IRESSA®  (gefi+nib)  /        XALKORI  ®(crizo+nib)                    ERBITUX®                    (cetuximab)                                    &                    VECTIBIX®                          (panitumumab)                                                                                              HER2    HERCEPTIN®     (trastuzumab  )     The  Right  Therapy  for  the  Right  Pa9ent  at  the  Right  Time  OncoCEE-­‐BR™   Breast  Cancer      OncoCEE-­‐ME™   Melanoma    OncoCEE-­‐CR™   Colorectal  Cancer      OncoCEE-­‐LU™   Non-­‐small  Cell  Cancer    
  • 12. Intellectual  Property   12   CEE-­‐SelectorTM   Muta+on  Analysis   Patent  pending   Biocept  Developed  SoluEons   Patented     CEE®   Microfluidic  Channel   CEE-­‐Sure™   Stability     Transport  Tube   Patent  pending   OncoCEE™   Chemistry:  An+body   Cocktail   Patent  pending   One  US  and  associated   foreign  patents  pending   Two  issued  US  patents  and   two  issued  foreign  patents;   mulEple  pending  US  and   foreign    patents   Two  US  and    associated   foreign  patents  pending  for   capture;  one  US  and   associated  foreign  patents   pending  for  detecEon   One  US  and  associated   foreign  patents  pending  
  • 13. CEE-­‐Selector™  Plaorm   •  Allows  for  both  CTC  and  cell  free  ctDNA  analysis   •  Detects  1  muta+on  out  of  >10,000  normal  DNA   •  Works  with  various  nucleic  acid  targets  (DNA  and  RNA)   •  Compa+ble  with  sequencing  and  PCR  instruments   •  Mul+plexing  reduces  costs  and  enhances  reimbursement   •  Poten+al  applica+ons  in  all  stages  of  cancer     13   MutaEon  determinaEon  sensiEvity  10-­‐100x  beSer   than  compeEng  plaTorms* *  Biocept  internal  data  
  • 14. 14   OncoCEE-­‐BR™   2015  2013   2014   Product  Valida9on-­‐  CLIA  Product  Development-­‐  R&D  and  TCD   OncoCEE-­‐BR™  (DTC)     OncoCEE-­‐PR™     OncoCEE-­‐LU™   OncoCEE-­‐CR™   OncoCEE-­‐ME™   Breast  cancer   Bone  marrow  for  breast  cancer   Prostate  cancer   Non-­‐small  cell  lung  cancer   Melanoma   Colorectal  cancer   HER2   OncoCEE-­‐GA™   Gastric  cancer   Product  Development  Pipeline   Muta9on  FISH   ER   PR   Pre-­‐2013  
  • 15. 15   OncoCEE™  Product  Profiles   Product   Tumor  Type   OncoCEE™  CTC   CEE-­‐Selector™   OncoCEE-­‐BRTM                                      (launched)   Breast   Enumera+on    of  CTCs  ,     HER2,  ER,  PR   Currently  no  clinically  ac+onable   muta+ons  iden+fied   OncoCEE-­‐GATM   Gastric   Enumera+on  of  CTCs,  HER2   Currently  no  clinically  ac+onable   muta+ons  iden+fied     OncoCEE-­‐LUTM   Lung   Enumera+on  of  CTCs,  ALK,   ROS1   EGFR,  K-­‐ras,  B-­‐raf  muta+ons     OncoCEE-­‐CRTM   Colon   Enumera+on  of  CTCs,  EGFR   K-­‐ras,  B-­‐raf  muta+ons   OncoCEE-­‐PRTM   Prostate   Enumera+on  of  CTCs,  AR,  and   PTEN  dele+on  (blood  or  bone   marrow)   Currently  no  clinically  ac+onable   muta+ons  iden+fied   OncoCEE-­‐METM   Melanoma   Enumera+on  of  CTCs   B-­‐raf  and  N-­‐ras  muta+ons  
  • 16. 16   Targeted  Commercializa+on  Strategy   •  Raise  awareness  of  the  value  of  ctDNA   •  Drive  OncoCEE  adop+on   – Market  directly  to  oncologists   – Develop  key  opinion  leader  speakers   •  Build  rela+onships  with  pa+ent  advocacy  groups     •  Publish  studies  with  major  cancer  centers   •  Par+cipate  in  medical  mee+ngs  /  symposia   •  Deepen  payor  rela+onships  and  expand  reimbursement  coverage   •  Expand  strategic  partnerships  with  pharma  and  biotech  for  personalized   diagnos+cs    
  • 17. 17   Driving  Adop+on  for  Growth   12  Month  Commercial  Team   Build   •  Head  of  sales  and   marke+ng   •  Regionally  based  sales   team       •  Sales  team  for  Pharma     •  Managed  care  expert     •  Internal  marke+ng     •  Leverage  partner  sales   forces      
  • 18. 18        Dana-­‐Farber   •  Metasta+c  Breast  Cancer  pa+ents  with  HER2  nega+ve  primary  biopsy   •  CTC  HER2  posi+ve  pa+ents,  as  detected  with  OncoCEE  BR,  placed  on  Hercep+n   •     Sponsored  by  Genentech   •     Results  expected  in  2014014        MD  Anderson   •     Recently  diagnosed  breast  cancer  pa+ents   •  15%  of  CTC  and  28%  of  DTCs  have  HER2  discordance  with  primary  tumor   •     Published  in  Cancer  Medicine  –  April  20132013  Other  studies   •  Four  addi+onal  peer  reviewed  published  studies  valida+ng  technology   •     Addi+onal  pending  studies  with  collaborators   •     Planned  study  in  Non  Small  Cell  Lung  Cancer   • Planned  study  in  Non  Small  Cell  Lung  Cancer   Clinical  U+lity  Studies  
  • 19. Investment  Highlights   •  OncoCEE™:  measures  circula+ng  tumor  cells  (CTCs)     •  OncoCEE-­‐BR™  :  first  commercialized  test  for  breast  cancer     •  CEE-­‐Selector™:  plaorm  expansion  for  muta+on  analysis   •  Robust  test  pipeline  focused  on  solid  tumor  genomic  diagnos+cs   including  lung,  breast,  colon,  prostate  and  melanoma   •  Established,  cer+fied  and  scalable  CLIA  lab   •  Clear  path  to  market  penetra+on   •  Established  research  collabora+ons  and  strategic  partnerships   •  IPO  completed  February  2014;  gross  proceeds  of  $19  million   19   Commercial  stage  cancer  diagnos0cs  company  with  ground-­‐breaking   technology  pla9orm  u0lizing  a  simple  blood  test  
  • 20. The  CEE  Solu+on   Personalized  Medicine  from  a  Liquid  Biopsy