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DNA-Guided Medicine
                                              15 September 2011




Why are We Investing in Personalized Medicine?
 DNA-Guided Healthcare in All-Too-Real-time

         Gualberto Ruaño, M.D., Ph.D.
                 President, Genomas Inc.
     Director of Genetics Research, Hartford Hospital
                                                                  1
Genomas Overview
Bringing DNA-Guided Medicine to Healthcare Today

 Genomas has developed and is marketing a unique biomedical platform that
   utilizes proprietary biomarkers, treatment algorithms, and a web-based
   physician portal delivery system to provide clinical decision support for
            physicians and personalized drug treatment for patients

  Products are DNA-guided to improve the therapeutic benefit of widely used
   prescription drugs while also reducing the risk of significant side effects
  Patented technology platform, proprietary algorithms and physician interface
   portal can be extended to a wide range of drug categories
  Powerful technology platform initially offered for mental health and already
   extended to diabetes medications (lipid and glucose lowering)
  Currently focusing primarily on Mental Health: Antidepressants (SSRIs,
   SNRIs), Neuroleptics (first and second generation antipsychotics), Stimulants
  Technology platform applicable to numerous disease states; current pipeline
   in Cardiovascular and Diabetes: Statins, TZDs, Incretins
  Founded in 2004, located at in Hartford Hospital, Hartford CT

                                                                                   2
Hartford Hosp., IOL, CLP, THOCC, UPR
Genomas Partners in DNA-Guided Medicine

        Biotechnology                  DNA-Guided
        Pharmaceutical                  Medicine


    Discovery    Development    Diagnostic    Treatment

    Technology   Biologicals   Personalized    Healthcare
    Databases      Drugs       Prescription   Management




                                                            3
Genetic Prescription System: Drug GPS
PhyzioType Systems + DNA-Guided Medicine


            PHYZIOTYPE         S Y S T E M S




      LABORATORY OF
   PERSONALIZED HEALTH                  Prescribe Right




           LPH

   Bringing DNA-Guided Medicine to Healthcare Today
                                                          4
PhyzioType Systems
Medical Device for DNA-Guided Medicine

          PHYZIOTYPE        S Y S T E M S



                                                      PERSONALIZED HEALTH




                                                             PHP
                                                         P   O R   T A L
                 SB12789




                                   SB12781
                  SB1501

                  SB1825




                  SB1541

                  SB1727

                  SB1461



                                             SB3039
                    CR-1
                      233
                      202
                      126
                      192
                      227
                      145

                      215
                      225
                      238


                      169


                      149
                      110

                      121
                      104
                      200
                      218
                      168
                      241
                      105
                      214
                      148
                      191
                      132
                      216
                       29
                       26


                       21
                       72
                       40
                       55
                       81
                       58

                       74
                       50

                       54




                       80

                       16
                       34
                       70
                     C2




                     C3

                     C1
                        2




 SNP Ensemble    Biomathematical                       Physician
    Assays          Algorithms                         Interface
                                                                            5
LPH Laboratory of Personalized Health
Clinical Lab, Commercial Launchpad
    Pioneering high complexity              LABORATORY OF
                                          PERSONALIZED HEALTH
     pharmacogenetics laboratory +
     clinical practice
    Anchor for commercialization of
     PhyzioType Systems throughout
     New England and nationally                        LPH
                                         Licensed by CT Dept of Public
    Referral Center for Institute of     Health (#CL-0644) + R.I.
                                         CLIA certified and registered
     Living + Mood Disorders Program      (Clinical Laboratory Improvement
                                          Amendments)
                                         ID #07D1036625 CMS (Centers for
    CT-wide distribution and             Medicare and Medicaid)
                                         4 successful biannual inspections
     reimbursement agreement with          (most recent June 2011)

     Clinical Lab Partners
    Reimbursement rate >95%
    Used by 195 Clinicians in 2010
    1141 Patients referred in 2010      53 patient service centers in CT
                                         Subsidiary of Hartford Healthcare 6
    3272 PhyzioType tests in 2010
LPH Laboratory of Personalized Health
Clinical Lab, Commercial Launchpad

                               CLP Patient                Laboratory of               Personalized
     Physician           1                            2                          3
                                 Service                  Personalized                   Health
     Clinician
                                + Billing                    Health                      Portal

   Physician requests        Phlebotomist acquires                                     Genomas prepares
  HILOmet PhyzioType         sample and enters the          Messengers bring         reports for uploading
   System and sends           requisition into the          blood sample to           into the PHP, sends
  patients for a blood       CLP system, including        Genomas CLIA lab for        hard copy results to
  draw to CLP patient         activation of claims.        DNA extraction and        requesting physician.
    service centers.                                          genotyping.




                               PAYORS
     CLP files 3 claims per HILOmet PhyzioType System with payors
        based on generic molecular diagnostic codes. CLP remits
      payment to Genomas at a contractually agreed upon rate per
                                                                                                             7
                             component test.
                                                                                                         7
PHP Personalized Health Portal
Decision Support for Clinical Practice
                         M.D.
                                M.D. M.D.
    Patient         M.D.                                 Clinical
   Referral               M.D.        M.D.
                                 M.D.
                              M.D.                       Practice
      LABORATORY OF      M.D.       M.D.
   PERSONALIZED HEALTH                          PERSONALIZED HEALTH




                            DNA-Guided
                             Medicine                   PHP
              LPH                                  P    O R   T A L




               PHYZIOTYPE               S Y S T E M S

     DNA Typing                             Decision Support
                                                                      8
DRUG SELECTION TABLE: 80 Brands


ANTIDEPRESSANTS: Generic (Brand) & Drug Selection




                                                    9
HILOmet PhyzioType System
  Continued Successful Growth Track
                       Cumulative Test Volume by Quarter
               2008                                           2009                                   2010
3500                                     3500                                      3500
3000                                     3000                                      3000
2500                                     2500                                      2500
2000                                     2000                                      2000
1500                                     1500                                      1500
1000                                     1000                                      1000
500                                      500                                       500
  0                                        0                                         0
       Qtr 1   Qtr 2     Qtr 3   Qtr 4          Qtr 1      Qtr 2   Qtr 3   Qtr 4          Qtr 1    Qtr 2   Qtr 3   Qtr 4


                                                        Ordering Tests Patients
                                                        Ordering                                  Tests/
                                                        Clinicians Ordered Tested
                                                           Docs                                    Doc
                       2008 Actual                          44       339    124                    7.7
                       2009 Actual                          92       820    293                    8.8                10
                       2010 Actual                         195      3272    1141                   16.7
The BioMed Model in Healthcare
IT + Dx, Translational Medicine Critical to CT
                                        PhyzioTypeTM
                                          Systems




              Health Personalized
     Decision Support for Drug Precision Treatment
        Mental Illness, Diabetes/Cardiovascular
                                                       11
Business Models in Healthcare Industry
Attractive features of the BioMed business

            BioMed                        BioTech
      Doctors and Hospitals               Big Pharma
        Personalized health            Blockbuster drug
         $10M investment               $100M investment
       Utility clinical studies     Phase I-III Clinical trials
        2 years to revenue            10 years to revenue
     CLIA or device approval          FDA drug approval
      IP on diagnostics and IT         IP on biologicals
           New industry             Acquisition by Pharma
     1,000’s service tech jobs    100’s selective science jobs


                                                                  12
Drivers for Personalized Medicine
Alignment of Quality Healthcare, Insurance
                PhyzioType Systems



  Diagnosis                          Treatment

  Doctors                            Patients
  Improved                             Better
 Patient Care                         Outcome

                Reimbursement

                     Payers
                 Superior Value on
                 Health Insurance                13
Drivers for Personalized Medicine
The Consumer formerly known as Patient

• Genomics is expected to
  arrive at the clinic
• New medication diagnostics
  may be required for patient
  safety
• Personalized healthcare will
  be expected by patients
• Health spending accounts
  and personal choice on
  healthcare use

                                         14
Drivers for Personalized Medicine
FDA and Regulatory Policy
              “The FDA and the drug industry both
              foresee a time when physicians will
              tailor drug treatments for individual
              patients based on variations in their
              DNA sequence.”




                                                      15
                        7 January 2004
Drivers for Personalized Medicine
Entrepreneurs




                                    16
DNA-Guided Medicine: Beyond Average
Medical GPS: Genetic Prescription System
                      20th Century:          21st Century:
                      Public Health         Personal Health

                      AVERAGE             INDIVIDUALIZED
Number of People




                                You are
                                 Here

                                                              You are
                                                               Here
                     SD          SD




                   Side Effect Risk       Side Effect Risk         17
Thank You !
g.ruano@genomas.net
     860-545-3773
 www.genomas.com

DNA-Guided Medicine   18

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CVG’s Venture Connection-Gualberto Ruano on the opportunity for innovation in the translation of Biomedics into clinical practice

  • 1. DNA-Guided Medicine 15 September 2011 Why are We Investing in Personalized Medicine? DNA-Guided Healthcare in All-Too-Real-time Gualberto Ruaño, M.D., Ph.D. President, Genomas Inc. Director of Genetics Research, Hartford Hospital 1
  • 2. Genomas Overview Bringing DNA-Guided Medicine to Healthcare Today Genomas has developed and is marketing a unique biomedical platform that utilizes proprietary biomarkers, treatment algorithms, and a web-based physician portal delivery system to provide clinical decision support for physicians and personalized drug treatment for patients  Products are DNA-guided to improve the therapeutic benefit of widely used prescription drugs while also reducing the risk of significant side effects  Patented technology platform, proprietary algorithms and physician interface portal can be extended to a wide range of drug categories  Powerful technology platform initially offered for mental health and already extended to diabetes medications (lipid and glucose lowering)  Currently focusing primarily on Mental Health: Antidepressants (SSRIs, SNRIs), Neuroleptics (first and second generation antipsychotics), Stimulants  Technology platform applicable to numerous disease states; current pipeline in Cardiovascular and Diabetes: Statins, TZDs, Incretins  Founded in 2004, located at in Hartford Hospital, Hartford CT 2
  • 3. Hartford Hosp., IOL, CLP, THOCC, UPR Genomas Partners in DNA-Guided Medicine Biotechnology DNA-Guided Pharmaceutical Medicine Discovery Development Diagnostic Treatment Technology Biologicals Personalized Healthcare Databases Drugs Prescription Management 3
  • 4. Genetic Prescription System: Drug GPS PhyzioType Systems + DNA-Guided Medicine PHYZIOTYPE S Y S T E M S LABORATORY OF PERSONALIZED HEALTH Prescribe Right LPH Bringing DNA-Guided Medicine to Healthcare Today 4
  • 5. PhyzioType Systems Medical Device for DNA-Guided Medicine PHYZIOTYPE S Y S T E M S PERSONALIZED HEALTH PHP P O R T A L SB12789 SB12781 SB1501 SB1825 SB1541 SB1727 SB1461 SB3039 CR-1 233 202 126 192 227 145 215 225 238 169 149 110 121 104 200 218 168 241 105 214 148 191 132 216 29 26 21 72 40 55 81 58 74 50 54 80 16 34 70 C2 C3 C1 2 SNP Ensemble Biomathematical Physician Assays Algorithms Interface 5
  • 6. LPH Laboratory of Personalized Health Clinical Lab, Commercial Launchpad  Pioneering high complexity LABORATORY OF PERSONALIZED HEALTH pharmacogenetics laboratory + clinical practice  Anchor for commercialization of PhyzioType Systems throughout New England and nationally LPH  Licensed by CT Dept of Public  Referral Center for Institute of Health (#CL-0644) + R.I.  CLIA certified and registered Living + Mood Disorders Program (Clinical Laboratory Improvement Amendments)  ID #07D1036625 CMS (Centers for  CT-wide distribution and Medicare and Medicaid)  4 successful biannual inspections reimbursement agreement with (most recent June 2011) Clinical Lab Partners  Reimbursement rate >95%  Used by 195 Clinicians in 2010  1141 Patients referred in 2010  53 patient service centers in CT  Subsidiary of Hartford Healthcare 6  3272 PhyzioType tests in 2010
  • 7. LPH Laboratory of Personalized Health Clinical Lab, Commercial Launchpad CLP Patient Laboratory of Personalized Physician 1 2 3 Service Personalized Health Clinician + Billing Health Portal Physician requests Phlebotomist acquires Genomas prepares HILOmet PhyzioType sample and enters the Messengers bring reports for uploading System and sends requisition into the blood sample to into the PHP, sends patients for a blood CLP system, including Genomas CLIA lab for hard copy results to draw to CLP patient activation of claims. DNA extraction and requesting physician. service centers. genotyping. PAYORS CLP files 3 claims per HILOmet PhyzioType System with payors based on generic molecular diagnostic codes. CLP remits payment to Genomas at a contractually agreed upon rate per 7 component test. 7
  • 8. PHP Personalized Health Portal Decision Support for Clinical Practice M.D. M.D. M.D. Patient M.D. Clinical Referral M.D. M.D. M.D. M.D. Practice LABORATORY OF M.D. M.D. PERSONALIZED HEALTH PERSONALIZED HEALTH DNA-Guided Medicine PHP LPH P O R T A L PHYZIOTYPE S Y S T E M S DNA Typing Decision Support 8
  • 9. DRUG SELECTION TABLE: 80 Brands ANTIDEPRESSANTS: Generic (Brand) & Drug Selection 9
  • 10. HILOmet PhyzioType System Continued Successful Growth Track Cumulative Test Volume by Quarter 2008 2009 2010 3500 3500 3500 3000 3000 3000 2500 2500 2500 2000 2000 2000 1500 1500 1500 1000 1000 1000 500 500 500 0 0 0 Qtr 1 Qtr 2 Qtr 3 Qtr 4 Qtr 1 Qtr 2 Qtr 3 Qtr 4 Qtr 1 Qtr 2 Qtr 3 Qtr 4 Ordering Tests Patients Ordering Tests/ Clinicians Ordered Tested Docs Doc 2008 Actual 44 339 124 7.7 2009 Actual 92 820 293 8.8 10 2010 Actual 195 3272 1141 16.7
  • 11. The BioMed Model in Healthcare IT + Dx, Translational Medicine Critical to CT PhyzioTypeTM Systems Health Personalized Decision Support for Drug Precision Treatment Mental Illness, Diabetes/Cardiovascular 11
  • 12. Business Models in Healthcare Industry Attractive features of the BioMed business BioMed BioTech Doctors and Hospitals Big Pharma Personalized health Blockbuster drug $10M investment $100M investment Utility clinical studies Phase I-III Clinical trials 2 years to revenue 10 years to revenue CLIA or device approval FDA drug approval IP on diagnostics and IT IP on biologicals New industry Acquisition by Pharma 1,000’s service tech jobs 100’s selective science jobs 12
  • 13. Drivers for Personalized Medicine Alignment of Quality Healthcare, Insurance PhyzioType Systems Diagnosis Treatment Doctors Patients Improved Better Patient Care Outcome Reimbursement Payers Superior Value on Health Insurance 13
  • 14. Drivers for Personalized Medicine The Consumer formerly known as Patient • Genomics is expected to arrive at the clinic • New medication diagnostics may be required for patient safety • Personalized healthcare will be expected by patients • Health spending accounts and personal choice on healthcare use 14
  • 15. Drivers for Personalized Medicine FDA and Regulatory Policy “The FDA and the drug industry both foresee a time when physicians will tailor drug treatments for individual patients based on variations in their DNA sequence.” 15 7 January 2004
  • 16. Drivers for Personalized Medicine Entrepreneurs 16
  • 17. DNA-Guided Medicine: Beyond Average Medical GPS: Genetic Prescription System 20th Century: 21st Century: Public Health Personal Health AVERAGE INDIVIDUALIZED Number of People You are Here You are Here SD SD Side Effect Risk Side Effect Risk 17
  • 18. Thank You ! g.ruano@genomas.net 860-545-3773 www.genomas.com DNA-Guided Medicine 18