The BNGO card: DD for the Fellowship of the Saphyr and Bionanians to the Moon!

My Position:

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tl;dr: A LIFE SAVING COMPANY THAT WILL REWRITE AND REPLACE THE CURRENT CYTOGENETIC STANDARDS!

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BNGO – # OF INSTALLED SAPHYR'S = 108

Hi all, SUPE here (pronounced as soup), with my first official post with all the general DD you need, but don’t want to search for.

I am supporting BNGO because of their disruptive technology that is advancing the entire Genomics’ sector by revolutionizing cytogenetics, and identifying disease-causing genes to develop new therapeutic strategies via optical genome mapping with Saphyr.

Top DD by other supporters

Institutional & Insider Ownership

  • Institutional Shares 43,478,276 – 15.60%
  • Insider Shares 6,121,340 shares – 2.20%

Fintel

Fidelity

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BNGO beyond optical genome mapping

Illumina’s sequencing patents – “'973 patent is expected to expire in 2023, and the '444 patent in 2024”

NANONOZZLE DEVICE ARRAYS – “future system mapping + sequencing” = Illumina + Pacific Biosciences + Oxford Nanopore Technologies

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FAQ

What projects is Saphyr currently being used in?

Vertebrate Genomes Project (VGP), an effort to generate high-quality, complete reference genomes for all ~70,000 extant vertebrate species.

The Telomere-to-Telomere (T2T) consortium focuses on the first gapless assembly of a human genome, finishing each chromosome from one end to the other.

Human Pangenome Reference Consortium aims to develop a better representation of sequence diversity in the human population, starting with 350 diverse humans.

Plant Genome Research – the Genomics group at Corteva Agriscience is a certified provider with a focus in agricultural genomics and extensive experience in a wide range of plants and animals.

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A chromosome-scale assembly of the sorghum genome using nanopore sequencing and optical mapping demonstrates that informative assemblies of complex plant genomes can be generated by combining nanopore sequencing with DLS optical maps.

Will ARK invest?

  • Although Cathie Woods, the CEO of ARK Invest, believes in disruptive innovation, her analyst, Simon Barret, is covering the Genomic sector and believes that Pacific Biosciences long read sequencing (LRS) technology will improve in 5 years time.

Saphyr is used to validate LRS and the Saphyr 2.0 prototype will be available in 2023.

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Do we need FDA Approval?

  • No, diagnostic tests called "lab developed tests" or LDTs give companies that develop and conduct a diagnostic test in a single lab the ability to avoid submitting their tests to the FDA before using them on patients.

Bionano Genomics Acquires Diagnostics Services Provider Lineagen, Inc. to Accelerate Clinical Adoption of Saphyr for Digital Cytogenetics

Is there insurance reimbursement for Saphyr?

  • The Z-codes allow for a path for Medicare coverage and private insurance reimbursement for OGM with Saphyr of patients with suspected genetic disease

Praxis Genomics is first CLIA Lab to become a Bionano Certified Service Provider, will use Saphyr in its goal to help end diagnostic odyssey for patients.

Praxis Genomics, LLC received DEX Z-codes from Palmetto MolDX for its entire testing menu of laboratory developed tests (LDTs) based on Saphyr.

When is the Q2 2021 Earnings?

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Is BNGO included in the Russell Index?

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Senior management

Erik Holmlin, PhD

PRESIDENT AND CHIEF EXECUTIVE OFFICER

o Experience

  • GenVault Corporation (CEO)
  • Exiqon A/S (CCO)
  • Becton Dickinson (vice president of marketing and development)

o Highlights

  • In 2001, led the formation and financing efforts of GeneOhm Sciences, Inc
  • In 2006, orchestrated the company’s acquisition by Becton Dickinson

Mark Oldakowski

CHIEF OPERATING OFFICER

o Experience

  • 20-years overall in the development of systems for life sciences and medical device
  • 13-years at Life Technologies (now part of Thermo Fisher Scientific)

o Highlights

  • Led a global team at Brooks Life Science Systems in the development of sample analyzers, high-throughput screening solutions, and chemical storage & biobank systems
  • Launched the array platform that is widely used today for GWAS and other genomics applications with AffyMetrix (acquired by Thermo Fisher Scientific)

Christopher Stewart

CHIEF FINANCIAL OFFICER

o Experience

  • 20 years of experience spanning finance, accounting, and strategic planning for commercial-stage operating businesses
  • Controller
  • V.P. of Finance
  • CFO

o Highlights

  • Served as head of the Maxwell Ultracapacitors business unit after Maxwell Technology was acquired by Tesla

Alka Chaubey, PhD, FACMG

CHIEF MEDICAL OFFICER

o Experience

  • Double board-certified in clinical cytogenetics/genomics and clinical molecular genetics/genomics by the American Board of Medical Genetics and Genomics (ABMGG)
  • Head of Cytogenomics at PerkinElmer Genomics
  • Director of the Cytogenomics Laboratory at the Greenwood Genetic Center
  • Scientific Director of the Georgia Esoteric and Molecular Laboratory
  • Scientific Director of the Cytogenetics Laboratory of the Augusta University Medical Center
  • Adjunct Assistant professor of Pathology of the medical College of Georgia at Augusta University

o Highlights

  • Launched the CNGnome test (low-pass whole genome sequencing)
  • Developed a new FSHD assay utilizing Saphyr
  • FDA Laboratory Developed Test (LDT-EUA) submissions for COVID-19 assays
  • Serves on the Board of Directors for the Cancer Genomics Consortium
  • Acting Genetics Subdivision Nominating Committee representative of the Association of Molecular Pathologists (AMP)
  • Central in the FDA clearance for the first IVD whole genome microarray, CytoScan DX from Affymetrix (now part of Thermo Fisher Scientific)

Jason Priar

CHIEF Commerical OFFICER

o Experience

  • Leadership positions at GeneDx, Sema4 and PerkinElmer Genomics
  • Scaling businesses from early stage to hundreds of millions in revenue
  • Understanding of how to penetrate clinical and research markets including genetic diseases and cancer

o Highlights

  • GeneDx’s revenue grew from $8M to over $225M
  • Obtained coverage and maximized reimbursement for testing
  • Launched Sema4’s commercial business

Saphyr

  • An optical genome mapping instrument that detects structural variations ranging from 500bp to megabase pairs in length and offers assembly and discovery algorithms.
  • The current (Gen 2) Saphyr System (P/N 60325) allows for two Saphyr Chips to be loaded on the instrument simultaneously.

Joe Butler (Sales Manager for the UK at Bionano Genomics)

Size comparison video of Short Read Sequencing, Long Read Sequencing, and Saphyr

INNOVATION – Improvements over the Irys System

  • Software updates increased Saphyr’s throughput to 96 human genomes per week
  • Saphyr Assure for Monitoring System Health

Direct Label and Stain

A new nondestructive chemistry for labeling genomic DNA that improves every aspect of Bionano genome mapping. The DLS chemistry leaves sample DNA intact, eliminating systematic molecule breaks, an improvement over nicking endonucleases to make sequence-specific nicks, which are fluorescently labeled and then repaired. Resolving nicking and problems processing through "flow-chips", causing false positives /false negatives throughout the read.

SAPHYR CHIP G2.3

  • Each genome is contained within its own flow cell.
  • Each Saphyr chip holds three flow cells, and 100x coverage of 3 human genomes is collected in less than 6 hours.

That means 12 human samples at 100x coverage per day, or up to 96 per week.

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Whole genome analysis is currently performed using Karyotyping, FISH, and Array based techniques which leaves many patients misdiagnosed or undiagnosed due to the lack of resolution and sensitivity.

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o Applications

  • Cancer
  • Genetic Diseases
  • Genome Assembly

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o Clinical Research

  • Enfocus FSHD analysis
  • Cytogenomics

Bionano Genomics consolidates the traditional cytogenetic assays into a single workflow!

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Revenue by Geography via Ortex

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Financial Highlights

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Total addressable market based on Saphyr adoption per CEO Erik Holmlin

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Upcoming Milestones for 2021 – Initiatives to Drive Global Adoption of Saphyr

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Upcoming Events

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Fellowship of the Saphyr video

tl;dr: BNGO IS IS A GREAT OPPORTUNITY FOR INVESTORS LONG TERM WHO WANT TO SUPPORT A GLOBAL LIFE SAVING COMPANY!

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