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First mover in making RNA sequencing clinically actionable in oncology

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Page 1: First mover in making RNA sequencing clinically actionable ...bionj.org/wp-content/uploads/2016/05/Genomic-Expression.pdfFirst mover in making RNA sequencing clinically actionable

First mover in making RNA sequencing clinically actionable in oncology

Page 2: First mover in making RNA sequencing clinically actionable ...bionj.org/wp-content/uploads/2016/05/Genomic-Expression.pdfFirst mover in making RNA sequencing clinically actionable

Saving lives and making healthcare delivery more effective:

by selecting the best drug for the patient, and the best patient for the drug by sequencing RNA

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Only 1 out of 4 cancer treatments prolong life !

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$80 billion is spent on cancer drugs while 8 million patients die

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5

DIAGNOSED OCTOBER

2008

DIAGNOSED AUGUST

2001

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Gitte Pedersen, M.Sc.CEO & Co-founder• Big Biotech +$1B deals• MSc Chemical Engineering• Skier & surfer

Morten Pedersen, Ph.D.CTO & CO-Founder• Inventor • PhD in Genetics• Paraglider

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How can we cure cancer?

RNA

RNA

RNA

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Jesper Zeuthen, D.Sc. CMO• The Danish Cancer Society• Co-founder of GenMab & Dandrit• Leader in immune therapy• Raised > $650MM for Bankinvest• Trekker

“We can cure cancer by genetically matching the patients to a drug that actually works: Immune Therapy”

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Immune therapy is as close as we get to a cure

RNA

RNA

RNA

RNA

RNA

RNA

RNA

RNA

RNA

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$1million

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Morten Middelfart Ph.D.CIO• 2 Ph.D.’s Big Data• 25 worldwide patents • +20 years of analyzing Big Data• Skydiver

Tanya Kanigan, Ph.D. COO• Postdoc MIT• Cofounded BioTrove• Co-Inventor of OpenArray®• Weekend farmer

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July 7th, 2012RNA-seq saved Dr. Wartman’s life

July 7th, 2012

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OneRNA™ from Sample to Answer in 1 week

Isolate RNA

Sequence andanalyze data

GenerateOneRNA

report

PrepareOneRNA libraries

1/10 of the cost and 1000 x less data

Match profile to actionable

genes

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Triple-negative breast cancer

OneRNA™ identified 6 approved drugs

Our biggest moment

ONLY chemo available

very POOR

prognosis

2000 clinical trials?

1drug approved in breast

5drug approved in other

30 clinical trials

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15

2 immune therapies

Effective in 20% of the patients

Competition: DNA panels won’t work for immune therapy

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$50B14M newly

diagnosed/year

4% in clinical trials

$1B

$20B5.6 mill

developed world

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Most scalable platform in the market

Cancer Autoimmune CNS Infectious

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Gitte Pedersen, CEO

@DNABARCODE

[email protected]

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Credentials

• #2 in the Women’s Founders Pitch event in LA • Top 10 in Richard Bransons XTC, Necker Island • Top 10 Molecular Tri-Conference, San Francisco • In the top 250 Red Herring - going for top 100

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Quick Facts:

Founded: 2009 Employees: 10Company Stage: Commercial launchPatents: Issued US (6,958,217), and European patents and sev-eral new patents pending Use of Proceeds: Launch of OneRNA™ and CLIA certifica-tion.Advisors: Legal Duane Morris LLP, Accounting, Malc & Com-panyInvestors: Centurion Holding LLC, Investor Circle, Biogen founder, Seattle Women’s Im-pact Fund, Pipeline AngelsScientific Advisors: Winston Kuo, Ph.D. Director Harvard Catalyst, Ulrik Nielsen, Ph.D. Founder & CTO Merrimack; Niels Tommerup, Ph.D. Head of Centre for Functional Genome Research; Karen Brøndum-Nielsen, Ph.D., Head of Med-ical Genetics, John F. Kennedy Institute; Per Guldberg, Ph.D. Professor and Head of the Ge-nomics Lab at the Danish Can-cer Society

First mover in making RNA sequencing clinically actionable in oncology

“Saving lives and making healthcare delivery more effective by assisting doctors select the best drug for their patient, and Pharma companies select the best pa-tient for their drug “

Executive Summary: Our mission is to save lives and to make health care de-livery more efficient. The inconvenient truth in oncology is that only 1 out of 4 cancer treatments prolong life. We are providing an actionable report to the doc-tor using our OneRNA™ platform that can guide the doctor to the most efficient treatment for the individual patient. All our competitors are sequencing DNA, however DNA fails to predict response to the new immune therapies.Market: The market for genomic tools and diagnostic is $6 billion, growing more than 20% per year. RNA Analysis is the single largest application across plat-forms (Q-PCR, Arrays, Sequencing) and a well established marker species for disease diagnostic algorithms of reimbursed diagnostics in large markets such as cancer, organ transplant and cardiology. Business Model: We are currently selling the OneRNA™ platform as a tool to help pharma and key academic institutions select the right patients into clinical trails. It is the plan to launch OneRNA™ as a service for all patients which will require a CLIA certification. Partners and collaborators: We have signed up 17 beta testers among large pharma and diagnostic companies and key academic institutions and moved the first two to paying customers.Existing partnerships: Genomic Expression is working with IBM in building out our HIPAA compliment cloud platform. Our principle is to ensure safety of our partners as well as patients data. We can develop API to customers systems to leverage the power of combining genetic data with clinical data.Technology: We have re-engineered RNA-seq for clinical applications in oncol-ogy and combined that with our own proprietary bioinformatics and a database with all actionable genes in oncology. This enables us to get from samples to answer in less than a week. We have pending as well as issued patents on our technology.

Finding the right drug for the patient and the right patient for the drug by sequencing RNA

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Business Advisors: Paul Billing, former CMO Life Tech, now JnJ, Geert Cauwen-bergh, CEO at RXi Pharmaceuti-cals Cor, Torben Skarsfeldt, D.Sc. former Director, at Lund-beck A/S, Mette Skjold Rotboll, Founder and Non Executive Di-rector of Vigil Wealth Manage-ment, Mostafa Analoui, Ph.D.-Head of Healthcare at The Liv-ingston GroupCompetitorsCompetition has focused on DNA sequencing, where Foundation Medicine is a clear first mover, however DNA sequencing can not predict response to the new immune therapies in oncology. Furthermore they are using pan-els, that are being outdated due to the rapid innovation cycles, and requires re-validation to make changes due to regulatory.Exit Strategy:GEx will be an attractive ac-quisition target for a large established Genomics Tool and/or diagnostic company. Trade sales in the sequenc-ing space have been be-tween $30 million and $750 million for pre-revenue com-panies. The company may also go public depending on the market situation.

Contact: Gitte Pedersen, CEO: [email protected] Park Avenue, Suite 2607New York, NY 10152Phone USA: +1 (646) 847-9290Mobile: +1-917-873-2003

Management team with proven track record and start-up DNAGitte Pedersen, CEO is a former executive from NovoZymes. She successfully developed and launched multiple products into multiple industries world wide. She left to advise the Danish Government, and a number of Biotech compa-nies, where she structured several deals with an aggregate of +$1Billion with big pharma such at Merck, Takeda, GSK, Wyeth and others. Morten Peder-sen, CTO , PhD is the inventor of the technologies with a very strong innova-tion track record from Chr Hansen. Jesper Zeuthen, CMO, is the co-founder of GeneMap and DanDrit, IPO's, and established the Danish Cancer Society. Morten Middelfart 2 PhDs in big data and strong entrepreneurial track record. Tanya Kanigan, COO, post-doc from MIT, developed OpenArray(R), spun it out into BioTrove which was later sold to Life Technology. Geoffrey Folkerth, CFO was the former CFO of Pathway Genomics, where he raised $20 mill.

OneRNA™ Platform:Genomic Expression was the diagnostic partner in Denmark’s first large se-quence based project called “Genome Denmark”. The project was funded by the Danish Hightech Fund with $32 million.The OneRNA™ technology and vision was created as a result of this public private partnership. Access to his-toric samples in a single payer system enables Genomic Expression to devel-op disease prognostic algorithms in any disease.

OneRNA™ is portable outside oncology with an update to the cloudBecause OneRNA™ is not using baits or panels, but uniquely identify and quantify 20,000 RNA’s in ONE assay, it can keep pace with the rate of new discovery by updating the cloud. Furthermore it is also portable outside oncol-ogy with an update to the actionable database. That makes OneRNA™ the most scalable platform in the market.