Biomarkers for Osteoarthritis James L. Cook, DVM, PhD Director, Comparative Orthopaedic Lab & Mizzou BioJoint Center cookjl@health.missouri.edu Biomarkers for Osteoarthritis

Osteoarthritis (OA): Everyone’s Problem

Markets Canine Human 78M companion dogs in US (2015 APPA Survey) 20% of dogs over 1 year of age diagnosed with OA $15B spent in 2014 on vet care (APPA) Companion animal diagnostic industry = $3B (US is 59% of market) Canine OA Diagnostic = $40M - $80M per year NO OA Biomarkers currently available Human ~1 in 2 develop symptomatic OA by age 85; 2 in 3 if obese 52.5 million in US alone, 67 million by 2030 >$90 billion per year in related healthcare costs Sources: CDC, AVMA

Unmet Clinical Need: Lack of Early Detection What happens currently? What are the problems? Too late Decision making Options Describe a market need/unmet clinical need you plan to supply with the business idea. Explain the problem or unmet need (current or emerging) that you are going to solve, or opportunity you are going to exploit.

What if we could be “Arthritis Fortune Tellers”? Value Proposition Slide: Describe the technology, secret sauce or magic behind your product or service. Aim for less text and more diagrams, schematics, and flowcharts on this slide. White papers and objective proofs of concept are helpful here (Guy Kawasaki). If you can briefly demonstrate your solution or showcase a sample or prototype (briefly), this is the place to do it (MU Coulter Program). What unique benefit will you provide to what set of customers to address what particular need? Clarify your target markets and show how your unique technology/solution adds value to the target market. When you’re done with this slide, there should be no question about what business opportunity your are pursuing. The only questions that should remain are the details of HOW you are going to do it (MU Coulter Program). Competitors Slide: Provide a complete view of the competitive landscape. Too much is better than too little. Never dismiss your competition. Everyone – customers, investors, employees – wants to hear why you’re good, not why the competition is bad (Guy Kawasaki).

Value Proposition Biomarker Panels for OA Canine Human Biomarkers Business Model Slide: Explain how you make money – who pays you, your channels of distribution and your gross margins. In general, a unique, untested business model is a scary proposition. If you truly have a revolutionary business model, explain it in terms of familiar ones. This is your opportunity to drop the names of organizations that are already using your product or service (Guy Kawasaki). Do you complement commonly-used technologies, or do you displace them? Do you change the way certain business processes get executed, or do you just do them the same way, but faster, better and cheaper? Do you disrupt the current value chain, or do you fit into established channels? Who exactly is the buyer, and is that person different than the user? (MU Coulter Program) Describe a minimum viable product. Market Strategy and Sales Slide: Explain how you will reach your customer and your marketing leverage points. Convince the audience that you have an effective go-to-market strategy that will not break the bank (Guy Kawasaki). What is your plan for getting your solution to market? Will you form a start-up? Do you have a potential licensee? Who is it, have they supported the project, are the supporting the project? Who are other potential licensees? Have you reached out to any foundations or government organizations that might be interested in helping you get your solution to patients? (MU Coulter Program)

Delivering the Solution Why? Canine – Registries, differential diagnosis, treatment monitoring, staging Human – Early diagnosis, differential diagnosis, treatment monitoring, personalized medicine Who? Nutramax VCA Antech Qiagen Abaxis Roche PennHIP How? Central Lab mail out Point-of-care ELISA IDEXX ThermoFisher Zoetis Heska OFA Clients Business Model Slide: Explain how you make money – who pays you, your channels of distribution and your gross margins. In general, a unique, untested business model is a scary proposition. If you truly have a revolutionary business model, explain it in terms of familiar ones. This is your opportunity to drop the names of organizations that are already using your product or service (Guy Kawasaki). Do you complement commonly-used technologies, or do you displace them? Do you change the way certain business processes get executed, or do you just do them the same way, but faster, better and cheaper? Do you disrupt the current value chain, or do you fit into established channels? Who exactly is the buyer, and is that person different than the user? (MU Coulter Program) Describe a minimum viable product. Market Strategy and Sales Slide: Explain how you will reach your customer and your marketing leverage points. Convince the audience that you have an effective go-to-market strategy that will not break the bank (Guy Kawasaki). What is your plan for getting your solution to market? Will you form a start-up? Do you have a potential licensee? Who is it, have they supported the project, are the supporting the project? Who are other potential licensees? Have you reached out to any foundations or government organizations that might be interested in helping you get your solution to patients? (MU Coulter Program)

Intellectual Property Patent Claims are directed to OA diagnostic kits, reagents, profiles, and associated methods MU is pursuing patents in major healthcare markets Patent will soon issue in Australia Patent Applications are pending in the US, Europe, Japan, Canada, and Australia Unique method of analysis and reporting Intellectual Property Slide: Depending on your solution, you might need a separate slide to convince investors that no one else can easily duplicate or surpass your solution (assuming that’s actually true). This is usually some combination of proprietary technology, unique team domain expertise, and unique partnership. Boil this down to simple elements and terms, devoid of jargon. Do not walk the audience through a detailed tour of your product architecture. Instead, highlight the elements of your technology that give you unique potential for leverage and scale as you grow (Garage Technology Ventures TM). Proprietary Technology Slide: Describe any proprietary technology, unique team domain expertise, or unique partnerships with key suppliers, distributors, etc. Boil this down to simple elements and terms, devoid of jargon. There is no need to walk the audience through a detailed tour of your technology. Instead, highlight the elements of your technology that give you unique potential to dominate or compete in your target market(s). The purpose of this slide is to convince investors that no one else can easily duplicate or surpass your solution (MU Coulter Program).

Financial Projections and Milestones CANINE Q4 2016 Q4 2018 $25K $50K Knee CCLD OA Ready for Licensing CHD Early Diagnosis Ready for Licensing Q4 2016 CED Early Diagnosis Ready for Licensing Q4 2018 HUMAN Q2 2016 Q1 2017 Q2 2018 $75K $250K $500K Proof of Principle Studies Treatment Monitoring Ready for Licensing OA Staging Ready for Licensing Early Diagnosis Ready for Licensing Milestones Slide: List all milestones to research, develop, and/or commercialize a minimum viable product or to commercialize the technology. Financial Projections and Key Metrics Slide: Provide a three- to five-year forecast containing not only dollars but also key metrics, such as number of customers and conversion rate. Do a bottom-up forecast. Include long sales cycles and seasonality. Making people understand the underlying assumptions of your forecast is as important as the numbers you’ve fabricated (Guy Kawasaki). Include the funding and amount of time it will take to achieve each milestone (MU Coulter Program). Identifyunding opportunities as support sources to complete those milestones.

The Team