Entrepreneurship 101: Dancing in the Gap
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The document discusses entrepreneurship and the challenges of developing new technologies, referring to the example of Rimon Therapeutics. It describes Rimon's focus on developing novel polymer-based medical devices called "Theramers" for applications like wound healing. The document outlines Rimon's business strategy, pipeline of Theramer products in development, clinical trial results, and upcoming milestones.
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Entrepreneurship 101: Dancing in the Gap
- 1. Entrepreneurship 101: Dancing in the Gap October 10th, 2006, MaRS Discovery District, Toronto Michael H. May PhD President & Co-Founder Rimon Therapeutics Ltd
- 2. If medicine is the next driver of wealth… Knowledge-Driven Wealth Juan Enriquez, As The Future Catches You, 2000
- 3. Companies like Rimon will be the vehicles According to Enriquez, wealth can be measured by the number of people it takes to generate a patent: • USA – 5,000 • Canada 8,000 • Mexico 1.2 million • Rimon – 0.6 Companies like Rimon and science-based entrepreneurs like you will drive future wealth generation for Canada
- 4. Dancing in “The Gap” Bus ines s nce Scie Viable products Excellent “The Gap” that help science people
- 5. “The Gap” is a all about… …risk mitigation, survival and endurance $ 1 in 3000 time The Gap High Risk of Failure
- 6. The value of your “idea”…. Market Size - $1 billion Growth – 5 % annually Licensing partner’s share – 33 % Adoption rate – 75 % License fee – 20 % Number of key technologies – 2 Cost to market - $4 million over 3 years Timeline – 10 years Net Present Value (NPV) - $30 million
- 7. Example: Rimon’s focus in “The Gap” Product Polymer Clinical Pre-clinical Focus Design Validation Validation Proof-of-product Proof-of-concept material development material development Proof-of-application material development
- 8. Execution lowers uncertainty Product Polymer Clinical Pre-clinical Focus Design Validation Validation Proof-of-product material development p < 80 % Proof-of-concept material development Proof-of-application p < 25 % material development p < 50 %
- 9. There is much uncertainty (risk) Product Polymer Clinical Pre-clinical Focus Design Validation Validation Bench studies p < 10 % IP Protection Animal efficacy Freedom to Operate Animal safety p < 80 % p < 50 % Proof-of-product material development p < 80 % Proof-of-concept material development Scale-up Manufacturing Proof-of-application p < 25 % Regulatory Re-imbursement material development Licensing deal p < 50 % p < 10 %
- 10. True value is discounted by risk • NPV of idea discounted for risk (80%) - < $200,000 • NPV is negative with less than 1 year delay in plan • NPV is negative if costs underestimated by < 10% $ 1 in 3000 time The Gap RISK
- 11. “The Gap” is about risk mitigation • Value creation is risk mitigation • Execution mitigates risk • One idea/technology/product is not enough • Ideas are worth very little – don’t get greedy • If you can get early stage financing – take it • One financing will not get you out of “The Gap” • Survival is a great accomplishment
- 12. Step 1: Generate a business plan • Understand your audience • Keep it simple, clear and brief – Create a 1-page strategic plan first • Focus on people, plan, cash and the wow! • Focus on products • Under promise and over perform • Note: BP are easier to craft when something has been accomplished – execution brings credibility
- 13. Step 2: Execute, execute, execute Do you what you said you were going to do!!! • Make milestones achievable and measurable
- 14. Step 2: Execute, execute, execute This is difficult when you are responsible for… • Business plan and vision • Financials and budgeting • Human resources and team-building • Financing • Management and administration • Business development and deal-making • Research and product development • Intellectual property protection • Regulatory and re-imbursement • And everything else that must be done…
- 15. Step 2a: Know that you don’t know And focus your first sales pitch on those that can help: • Lawyers • Accountants • Directors • Investors • Service providers • Anyone that has done it before
- 16. Step 3: Be innovative There is always a way…
- 17. Build scientific and business “metaphors” ofondisenregneristehfogsarsthefnceeoreth Of on side greener is of fence the grass other the The grass is greener on the other side of the fence • Scientists are great at reduction, less skilled at innovation • Metaphors contain the greatest amount of value using the least number of resources • Metaphors are built, not discovered
- 18. Step 4: Strategize for survival • Much assistance is available for start-up companies • The stakeholders, rules, and constraints are often the focus of discussions about commercialization (e.g., money, people, facilities, IP) • Heavily constrained systems can be “played” an infinite number of ways • Strategy is critical • Control the centre and think three steps ahead
- 19. Step 5: Manage stakeholder risk Scientific Financial Entrepreneur Business
- 20. Step 5: Managing Stakeholder Risk Important considerations: • Determine stakeholder risk tolerance, objectives, limitations and agendas • Manage expectations – Under promise, over perform • Communication is key – Disclose everything (good and bad) quickly – Interact regularly • Include stakeholders in solutions and decisions • Stay calm
- 21. Everyone Will Take Risks… …it just depends on the song and the partner…
- 22. Step 6: Network • Networking is difficult, but gets easier over time • It is a great way to get help (which we all need) • Buzz = success = air time – “The medium is the message” – Example: http://rimon.blogware.com • “Small world phenomenon” depends on: – Inner network built on trust (e.g., links through volunteerism) – Broad network created by few highly linked individuals (e.g., Kevin Bacon)
- 23. Rimon Started from … …a single experimental observation
- 24. A New Paradigm – Polymers that Heal Theramers™ are novel medical polymers that have drug-like properties – Next generation materials that are active - not simply drug delivery vehicles Theramers™ are regulated as devices – Drug-like products in 2-5 years for a fraction of the development cost of conventional therapeutics Rimon’s portfolio of Theramers™ target large markets with significant unmet needs – Initial targets are all multi-$ billion markets – Versatility of polymer chemistry enables broad application The Theramer™ Company
- 25. Unique Value Proposition Drug-like Device Margins Timelines Versatility of Polymers The Theramer™ Company
- 26. Corporate Overview • Spun-out of the University of Toronto in 2000; strong ties to local biomaterials centre of excellence • 5 core technologies, 4 products in development • Potential partners engaged for all product concepts • 11 patents issued or pending, own rights to all IP • Revenue generation through licensing • Extensive research network: The Theramer™ Company
- 27. Commercial Strategy Advance a robust pipeline that offers products at various stages of development: • unique medical products that are close to market • novel polymers that enhance the value of existing medical devices, and • novel polymers for co-development of partner- defined product concepts The Theramer™ Company
- 28. Core Technologies • MI Theramer™ Activity: Inhibits the degradation of tissue Mechanism: Binds matrix metalloproteases (MMPs) selectively and strongly Applications: Wound healing, joint injectables for osteoarthritis and rheumatoid arthritis, coating for stents and ophthalmology products • AM Theramer™ Activity: Kills bacteria without harming human cells Mechanism: Disrupts bacterial cell membrane Applications: Medical device related infections (e.g., wound dressings, in-dwelling catheters, contact lenses) The Theramer™ Company
- 29. Core Technologies • Angiogenic Theramer™ Activity: Induces development of new blood vessels Mechanism: Stabilization of endogenous growth factors, stimulation of macrophages Applications: Wound healing, regenerative medicine, and implant integration into tissue • ThermaGel™ Activity: Changes from liquid to soft gel reversibly around body temperature Applications: Wound healing, biological filler, drug delivery The Theramer™ Company
- 30. Initial Focus on Chronic Wound Healing Rationale: • Significant unmet needs in wound care market • Best prospect for validating Theramer™ concept and generating revenue in the near-term – Fast track to human trials and the market Theramer™-based wound care “toolkit” Angiogenic Theramer MI Theramer AM Theramer The Theramer™ Company
- 31. MI-Sorb™/MI-Gel™ Dressings MI-Gel™ MI-Sorb™ • Inhibit enzymes (MMPs) that chew apart wounds faster than they can heal • Positive preliminary clinical data The Theramer™ Company
- 32. MI-Sorb™ Clinical Trial Objectives: B • Safety • Reductions in MMP activity • Trends towards healing A Wound Types: D A) Venous stasis ulcers (VSU) B) Diabetic ulcers (DU) C) Pressure Sores (PS) Miscellaneous (Misc) C D) The Theramer™ Company
- 33. MI-Sorb™ Clinical Trial Design * Dressings changed every 2-3 days MI-Sorb* & Secondary Dressings* N=24 Secondary Dressing N=32 Baseline Secondary Dressings* N=8 6 wk Visit 2 wk Visit Measure (versus baseline): • MMP levels in wound fluid (weekly) and tissue (as possible) • Wound size, characteristics of exudate and quality of wound bed • Bacterial colonization by swab and biopsy • Nurse and patient satisfaction The Theramer™ Company
- 34. Clinical Data Summary – P19 • Male, 43 yrs old, MVA paraplegic 4.00 • Pressure sore – 2 years old • Multiple previous clinical trials 3.50 • 85% reduction in wound volume • 52% reduction in MMP activity Wound Volume (cm) 3.00 3 • Enhanced wound bed quality 2.50 • Strong endorsement from patient, primary caregiver and study nurse 2.00 1.50 1.00 Baseline MI-Sorb™ Treatment 0.50 0.00 0 1 2 3 4 5 6 7 Time (weeks) The Theramer™ Company
- 35. Trends Towards Healing Patient MMP-2 in MMP Presence and tissue activity in appearance of (brown stain) exudate collagen (blue stain) Week 0 Week 6 Week 0 Week 6 ↓ 3DU ↑ 4DU ↓ 14VSU The Theramer™ Company
- 36. Trends Towards Healing Patient MMP-2 in MMP Presence and tissue activity in appearance of (brown stain) exudate collagen (blue stain) Week 0 Week 6 Week 0 Week 6 ↓ 15VSU ↓ 26Misc ↔ 27Misc The Theramer™ Company
- 37. Pipeline Products MMP-Inhibiting Joint Injectable Market: • Potential revenues of ~ $30-60 million in 2-4 years with single partner Competitive Advantages: • Compatible with existing products • Should not compromise device designation of existing products • Clear and testable therapeutic effect Key Results: • Validation from wound healing application • Demonstrated enhancement of existing products in vitro • Demonstrated activity using human synovial fluid The Theramer™ Company
- 38. Pipeline Products Anti-Microbial Catheter Coating Market: • Potential revenues of $12-15 million in 2-4 years based on a single catheter product (e.g., venous access catheters) Competitive Advantages: • Long-lasting • Compatible with medical device regulatory and technical experience • Non-toxic to human cells Key Results: • Up to 99.9% reductions in viability of gram +ve and –ve bacteria (for up to 60 days) • Low hemolysis, and good blood compatibility • Synthesized numerous versions with varying physical properties • Independently validated by a potential partner The Theramer™ Company
- 39. Pipeline Products MMP-Inhibiting Stent Coating Market: • Potential revenues of $60 million with single partner Competitive Advantages: • No drugs (regulatory and commercial advantages) • More compatible with medical device culture and processes • Less expensive • Enables other stenting applications (e.g., peripheral stenting) • Compatible with drug delivery, if multiple targets are required Key Results: • Synthesized materials with excellent mechanical properties and durability • Demonstrated in vitro inhibition of relevant MMPs The Theramer™ Company
- 40. Key Milestones Achieved With $3.5 million, we have executed our plan to: • Scale-up and manufacture clinical batch of MI-Sorb™ • Commence clinical trial of MI-Sorb™ with world- renowned dermatologist, Dr. Gary Sibbald • Obtain device designation for MI-Sorb™ from the USFDA and commence regulatory approval in Canada and US • Build pipeline through invention, in-licensing and initiating product development • Demonstrate pre-clinical efficacy and safety of all core technologies • Engage partners in product development The Theramer™ Company
- 41. Key Upcoming Milestones During the next 12 months, we plan to: • Conclude the MI-Sorb™ clinical trial • License MI-Sorb™ to global wound care company • Raise $5 million • Advance and expand pipeline products through co- development/licensing agreements with partners • Generate new Theramers™ and build Theramer™ brand The Theramer™ Company
- 42. Summary • Building a company is hard and is not a part-time job • Mixing science and business is exhilarating • The role of entrepreneur is to manage risk and survive “the Gap” – execution – innovation – networking Bus ines s – persistence nce Scie
- 43. Summary • Take care of hard science first • Seek out coaches and help from others • Polish communication skills • Learn to negotiate • Develop a thick skin Bus ines s nce Scie
- 44. Need Inspiration? Quotations from Helen Keller: • “Life is either a daring adventure or nothing” • “No pessimist ever discovered the secret of the stars or sailed an uncharted land, or opened a new doorway for the human spirit” • “The most beautiful world is always entered through the imagination”
- 45. Entrepreneurship 101 Imagine the possibilities if some of you try “Dancing in the Gap”…. MaRS circa 2010
- 46. The Theramer™ Company Michael H. May 416-977-6363 may@rimontherapeutics.com