Corporate Overview. March 2017

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Transcription:

Corporate Overview March 2017

Bionano Genomics Overview Commercial-stage company developing and selling instruments & consumables for whole genome analysis Addressing the needs for: A better understanding of genome biology More actionable results from genome analyses Enabling researchers & clinicians to see large structural variations for biomarker discovery & clinical diagnosis Market sizes range from $5 billion to over $100 billion 2

Unlocking the Promise of Precision Medicine Requires Better Tools THE DRIVER OF THE GENOMICS MARKET WHAT WOULD UNLOCK GENOMICS POTENTIAL? THE KEY $5B market $110B market * Precision Medicine Closing of the Genome Analysis Gap Improving Our Understanding of Genome Biology Which Will Require Better Tools * Midpoint of JPMorgan s research & clinical market opportunity (ILMN report, May 2016). 3

Something s Missing In Genomics Today = What s missing? The ability to see all genome variants 4

The Gaps Are Evident In a patient population of presumptive genetic disease: 74% Undiagnosed 26% Diagnosed 74% of genetic disorders go undiagnosed with sequencing Dec. 2014; 312:1880-1887 5

Bionano Sees the Variants that Sequencing Misses Bionano provides the longrange genomic information that reveals the missing genome variants 6

Bionano Delivers Unprecedented Long-Range Genomic Information at Throughput Comparable with Illumina 10000 Read Length Gb Per Run (Log Scale) 1000 100 10 1 0.1 0.01 Throughput 0.001 0.0001 1 Kbp 1 Mbp Length (Log Scale) 7

A Powerful Combination: Bionano NGM Sees What Illumina Misses NGS NGM Variation Type SNPs & Indels (<2kb) Variation Type SVs (>2kb) Size of Variant All SNPs, Indels & SVs Bionano Customer Presentation: This graph depicts the density of SVs found (y axis) relative to the size of the SV found (x axis) for NGM (solid lines) against NGS (dotted lines). For SVs greater than 2,000bp, NGS has very significant drop in detection. NGM s ability to see SVs picks up where NGS drops off. 8

Bionano NGM Sees Large SVs with Analytical Performance that Is Unbeatable Throughout Genomics Sensitivity 7.3x Improvement in Sensitivity for SVs over Illumina Insertions Deletions Homozygous 99.0% 75.6% Heterozygous 83.6% 43.0% Homozygous 99.6% 82.8% Heterozygous 92.3% 67.3% 1,570 SVs Found (>5kb) 215 Publication: biorxiv, Rapid Automated Large Structural Variation Detection in a Diploid Genome by Nanochannel Based Next-Generation Mapping, 2017. Publication: Genetics, UCSF, 2016. 9

Examples of How Bionano Is Making a Significant Impact Duchenne Muscular Dystrophy Eric Vilain, M.D., Ph. D. Prostate Cancer Vanessa Hayes, Ph.D. Seminal data presented at 2017 AGBT 11 presumed genetic disorder patients that had been on long diagnostic odysseys were included in the study Whole genome, arrays and multiplex PCR had all failed in providing a diagnosis Bionano revealed that 2 of the 11 patients had novel SVs that explained each patient s developmental phenotype 8 year-old boy: a deletion and 2 deep intronic mutations in MED17 gene 13 year-old girl: a deletion in EZH1 gene associated with skeletal development Dr. Vilain commented on the amazing prowess and clinical usefulness of Bionano s tool Groundbreaking results released in March 2017 Bionano was added to an NGS-driven prostate cancer study effort that had been searching for putative SVs for years Within the first few patients tested, Bionano found hundreds of potentially important SVs (90% of which were missed by Illumina) Importantly, compared to Illumina, SVs called by Bionano had a 100x greater likelihood of impacting a putative oncogene Dr. Hayes now seeking to open the first-in-the-world Cancer Genome Mapping Facility based around the Bionano Genomics technology 10

Digital Solution for Karyotyping and FISH Example: Bionano can replace dual method (karyotyping & FISH) for finding the 8 lesions of AML Karyotyping Bionano DISEASE SVs DUAL METHOD TEST AML del(5q) inv(3) inv (16) t(8,21) t(15,17) t(9,11) t(6,9) t(1,22) Chromosome analysis (Karyotyping) + Fluorescence In Situ Hybridization (FISH) FISH Systematic SV detection to simplify hematological malignancy detection 11

Clinical Partnership in China with Berry Genomics to Create Digital Cytogenetic Products Genetic Disorders and Cancer Develop Submit Market Bionano and Berry will provide CFDA-approved alternatives to karyotyping, FISH and microarrays in reproductive health, inherited diseases and oncology in China and pave the way for U.S. FDA-cleared systems 12

Most Recent Accomplishments 60th Strategic alliance established VGP announces thousands of vertebrate genomes to be run on Bionano Bionano instrument installed Publication of Bionano s >90% SV sensitivity vs. PacBio s 54% Global product launch Aug 2016 Sep 2016 Oct 2016 Nov 2016 Dec 2016 Jan 2017 Feb 2017 Mar 2017 Former Illumina CSO becomes Bionano Chairman First purchase of next-generation beta instrument by Berry $7M Record annual revenues achieved UCLA presents putative SVs found in undiagnosed children Garvan publishes 10x more SVs found versus NGS in prostate cancer 13

Bionano s Installed Base Includes Leading Academic and Industrial Genome Researchers Around the World EXAMPLES OF USERS 68 Bionano systems adopted 14

Bionano s Key Technology: Nanochannels Bionano s chips are fabricated from standard semiconductor silicon wafers A Bionano chip contains up to 150,000 nanochannels, each 50 nanometers wide DNA is deposited into the well of the chip and moved into the nanochannels via electrophoresis As the DNA passes into the nanochannel, it linearizes and is then imaged 15

Bionano Workflow 16

Bionano Genomics Overview Commercial-stage company developing and selling instruments & consumables for whole genome analysis Addressing the needs for: A better understanding of genome biology More actionable results from genome analyses Enabling researchers & clinicians to see large structural variations for biomarker discovery & clinical diagnosis Market sizes range from $5 billion to over $100 billion 17

Appendix 18

Mapping Was a Foundational Concept Limited By Throughput & Cost Until Now FISH RFLP BAC YAC acgh 70 s-90 s Genome Mapping 2000 s Shotgun Sequencing & SBS 2013-2017 Next-Generation Mapping RFLP, FISH, BAC, YAC, acgh Mapping + Nanotechnology NGS, SNPs, Genes Optical Mapping + Nanotechnology 2013 Launch 2014 1/3 Human/Day 2015 1 Human/Day 2017 10 Humans/Day 19

Genome Complexity Is the Issue 55% of human genome is repeats 55% repeats Repeats hide the order & orientation of functional elements of the genome, including genes NGS spans only 5% of repeats 5% NGS misses the Structural Variations (SVs) that drive biology and pathology Illumina primarily provides SNP & small SV detection. Going beyond requires long-range information 20

A Mosaic of Technologies Is Needed to Succeed NGS SNPs Small SVs Mapping Small to Long SVs CNVs Bionano Mapping Is Being Readily Added to the Mosaic Because of Its: Arrays Gene Expression Synthetic Reads Additional Small SVs Long Read Sequencing Small to Medium SVs Proven utility Straight forward adoption Ease of use Low cost per genome 21

SNP Detection Alone Is Not Enough: SVs Need to Be Seen Which Requires Additional Technology SNPs: Biology of Therapeutic Response SVs: Biology of Disease 22

Comprehensive Genome Assembly Bionano Complements All Three NGS Approaches APPROACH 1 APPROACH 2 APPROACH 3 NGS NGM Unprecedented levels of completion for human and non-human genome assemblies Eliminates need for laborious, time-consuming and extremely costly clone methods (BAC, YAC, etc) Essential for creating gold standards for biomarker discovery and for building reference genomes for non-model organisms Bionano is the essential component for achieving these results 23

Bionano Selected By Dr. Erich Jarvis to Be an Anchor Technology for 66,000 Vertebrate Genome References 24

Management Erik Holmlin, PhD President & Chief Executive Officer Han Cao, PhD Founder & Chief Scientific Officer Mike Ward Chief Business Officer Mark Borodkin VP Systems Development Sean Paolino VP Finance Domain Associates Exiqon BD GeneOhm Applied Proteomics Xagenic Dupont Princeton U Penn Peking Univ USTC Credit Suisse Wasserstein Leerink Partners Brooks Life Science Affymetrix Siemens Healthcare Life Technologies Life Technologies Applied Biosystems 25

Board and Scientific Advisors David Barker, PhD Chairman; Independent Director Former CSO Illumina Darren Cai, PhD Legend Capital Brian Halak, PhD Domain Associates Albert Luderer, PhD Independent Director CEO Integrated Dx Pui-Yan Kwok, M.D., Ph.D. Henry Bachrach Distinguished Professor, University of California, San Francisco Charles Lee, Ph.D. Director, The Jackson Laboratory for Genomic Medicine Co-chair of the Structural Genomic Variation Analysis group for the 1000 Genomes Project (www.1000genomes.org) 26

Historical and Projected Financials In million of U.S. dollars 27

Thank You! Contact: Erik Holmlin, Ph.D., CEO eholmlin@bionanogenomics.com 28