nx-prenatal molecular diagnostics - 2013 q1

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Q4: 2012 Molecular Diagnostics for Preterm Birth Risk Alan M. Ezrin, Ph.D. Chief Executive Officer 305-321-4333 mobile 888-418-NXPG toll free [email protected] Brian D. Brohman Chief Business Officer 502-741-5047 mobile 888-418-NXPG toll free [email protected] v15Nov2012 Venture Capital Intro Slides

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  • 1. Molecular Diagnostics for Preterm Birth RiskVenture Capital Intro Slides Alan M. Ezrin, Ph.D. Chief Executive Officer 305-321-4333 mobile 888-418-NXPG toll free [email protected] Brian D. Brohman Chief Business Officer 502-741-5047 mobile 888-418-NXPG toll freeQ4: 2012 [email protected] v15Nov2012
  • 2. Investment HeadlinesNX Prenatal has: Generated breakthrough human clinical data identifying and verifying maternal serum biomarkers predictive of preterm birth outcomes Enabled the early identification of pregnant women (as early as week 15 of gestation) that could benefit from prophylactic progesterone dosing and intensified MFM directed follow-up, saving the top 5 US health insurers $1B-$2B per year in NICU costs Formalized and scaled a truly novel first-in-class technical approach, based on the proteomic analysis of circulating exosomes shed from the placenta Functionalized key vendor relationships to mitigate execution risk BYour Series A investment will fund: The capital-efficient assay optimization and validation of the NeXosomeTM Preterm Birth Risk Assay, enabling a late 2014 launch of the industrys first and only early warning system for preterm birth risk The opportunity to address a $500M US market (+ROW), while exploiting significant current strategic partner interest for early exit potential CONFIDENTIAL 2
  • 3. Unmet Need / Vision ) Ideal to start by wk 16-20 CONFIDENTIAL 3
  • 4. Product / Solution NeXosomeTM Preterm Birth Risk Assay CONFIDENTIAL 4
  • 5. Scientific Rationale: Circulating ExosomesA successful pregnancy represents and exquisite balance between a numberof physiological systems including the dynamic immunological status ofhost and fetus at the placenta interface Exclusively licensed work indicates that: Subtle changes in this balance can be reflected in the identification of a unique set of blood derived biomarkers found only in pregnancies that end prematurely Circulating placental exosomes appear to be important ) features of intercellular communication between the maternal immune system and the fetus, and the protein biomarkers composing exosomes may be critical Fetal-maternal cross-talk is mediated by exosomes regulating the immune determinants of potential pregnancy outcomes protection of the fetus. These exosomes are microparticles circulating The profiling of exosomal-bound proteins circulating in in maternal blood that are shed by the syncytiotrophoblast, which is the main pregnant women provides early markers predicting preterm and most important cell type in the birth, and also provides insight into the molecular pathways placenta that has direct contact with maternal blood. associated with such outcomesSource: (2002, 2006, 2011 privileged communications) CONFIDENTIAL 5
  • 6. Product Profile Maternal Exosome Proteomic Predictive Blood Isolation Markers Algorithm Sample Same visit @ Stable, wk 15-17 as abundant Quad Test / particles AFP Test LC/MS/MS Proprietary ) 1ml serum methods: 30 Term Preterm min isolation Sent to (no 30hr spin) Central lab Intense Data = only interest in new thing idealfor patient & biomarker doctor packages CONFIDENTIAL 6
  • 7. IP Position / Strategy Maternal Exosome Proteomic Predictive Blood Isolation Markers Algorithm Sample Multi-pronged IP strategy being ) prosecuted by SFO-based counsel Exclusive WW licenses executed in 2011 with university tech partners CONFIDENTIAL 7
  • 8. Key CustomersTop 5 US Private Health Insurers WellPoint: 515,610 United Health: 367,200 Aetna/Coventry: 359,550 ) Cigna: 174,420 Humana: 165,240 CONFIDENTIAL 8
  • 9. Value Proposition: Multi-Billion SavingsTop 5 Payers: 1.6M Births12% Preterm = 200k Births 50k 150k Early Preterm Late Preterm ( 500 peer- antepartum management of reviewed articles. complex pregnancies. CONFIDENTIAL 11
  • 12. Clinical Data OverviewUniversity Pilot Study: Nested case-control study of 3,992 pregnant women n=42 (21 preterm delivering vs. 21 matched pair term) 2D-DIGE, LC/MS/MS, functional assessments, Western Blot 18 unique proteins claimed (licensed PCT/US2012/055166)NXPG Independent, Blinded, Third Party Studies: Similar design; n=48 in two phases; LC/MS/MS open proteome Clear differential proteomic ) fingerprint of Term vs. Preterm populations Replicated in First Pregnancy and Second Pregnancy Phases Replicated in 2 separate labs CONFIDENTIAL 12
  • 13. Accuracy: 2012 Human Clinical Study (n=48) Probability Accurate Out of Expected Accurate Out of Actual Factors Term Preterm Term Preterm 0.05 20/24 21/24 20/23 21/25 0.01 22/24 22/24 22/24 22/24 0.005 23/24 23/24 ) 24/25 23/23 83-100% accuracy range in stratifying patients into proper term vs. preterm cohort based on blinded blood samples taken at week 15-17 gestation Reflects of LC/MS/MS proteomic data output and proper familial grouping of samples into two distinct cohorts based on protein expression patterns generated by the Rosetta Elucidator Protein Expression Data Analysis software CONFIDENTIAL 13
  • 14. Development PlanKey Vendors Functionalized Optimize and validate targeted mass spectrometry-based methods in support of clinical studies in GLP environment Launch Program exportable to 3rd party CLIA lab if desired CLIA/LDT path Assay Validation Distrib. channel ) ~1,500pt selection prospective study Assay Optimization PI: Dr. Baha