Science and Business Do Mix: The Rimon Therapeutics Story
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Transcript of Science and Business Do Mix: The Rimon Therapeutics Story
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Michael H. May PhDMichael H. May PhD
President and Co-FounderPresident and Co-Founder
Science and Business Do MixScience and Business Do Mix
Entrepreneurship 101, MaRS, Nov 28Entrepreneurship 101, MaRS, Nov 28thth, 2007, 2007
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“The beginning of awe is wonder and the beginning of wisdom is awe”
Rabbi Abraham Joshua Heschel
Wonder Awe Wisdom
Why a Scientist/EntrepreneurWhy a Scientist/Entrepreneur
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Modest beginnings…Modest beginnings…
Key Messages:Key Messages: Entrepreneurial interest
was sparked by awe of science
I did my PhD to start a company
Rimon started from a single experimental observation
The Theramer™ Company
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Modest beginnings…Modest beginnings…
Key Messages:Key Messages: Entrepreneurial interest
was sparked by awe of science
I did my PhD to start a company
Rimon started from a single experimental observation
The Theramer™ Company
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MotivationMotivation
After 4 weeks of MI-SorbAfter 4 weeks of MI-Sorb™™ treatment treatment
Prior to treatment with MI-SorbPrior to treatment with MI-Sorb™™ DressingDressing
“I have been doing research for 30 years and this is the first time that something I have worked on is being tested on humans”
Professor. Michael Sefton, Co-Founder
- after a long day with the Board on clinical trial design and patient recruitment
The Theramer™ Company
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Spun-out of the University of Toronto in 2000
5 core technologies Potential partners engaged for
several product concepts 11 patents issued or pending, own
rights to all IP Extensive R&D network around local
biomaterials centre of excellence
Corporate BackgroundCorporate Background
The Theramer™ Company
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The TheramerThe Theramer™ Company™ Company
Theramers™ are medical polymers that have inherent biological activity without the incorporation of pharmaceuticals or cells.
Core TechnologiesCore Technologies:: MI - MMP inhibition AM - antimicrobial activity Angiogenic – new blood vessel formation ThermaGel™ - temperature responsive
Competitive Advantages:Competitive Advantages: Regulated as devices not drugs Versatile chemistry – broad application Non-biologic, non-eluting Localized activity, no systemic
consequences Easy to manufacture
The Theramer™ Company
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Drug-likeDrug-like
Activity/MarginsActivity/Margins
DeviceDevice
TimelinesTimelines
Versatility ofVersatility of
PolymersPolymers
Unique Value PropositionUnique Value Proposition
The Theramer™ Company
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Corporate Feasibility
Licensing Revenue
Stent Restenosis Catheter
Infection
Research Partners
Joint Disease
NewPolymer Design
ProductFocus
Pre-Clinical ValidationClinical
Validation
Eye Disorders
Chronic Skin Wounds
Rimon In-house
Theramer
Product #2
H22007
Strategic Partnership
Product PipelineProduct Pipeline
Market sizes: all large markets with substantial segmentsMarket sizes: all large markets with substantial segments
The Theramer™ Company
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Key Features:Key Features: Inhibits MMPs Easy to apply and remove Absorbent Non-adherent Non-toxic, non-sensitizing, non-
irritating, non-hemolytic
MI-SorbMI-Sorb™™ Dressing Dressing
The Theramer™ Company
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Overall Objective:Overall Objective: Demonstrate MI-Sorb™ Dressing safety and efficacy
RIM001 Clinical TrialRIM001 Clinical Trial
A
B
C
D
RIM001 is a randomized, multi-centre pilot studyRIM001 is a randomized, multi-centre pilot study
Outcomes:Outcomes: Recorded Adverse Events Wound MMP Activity Change in wound bed appearance
and wound size
Wound Types:Wound Types:A. Venous Stasis Ulcers (VSU)B. Diabetic Ulcers (DU)C. Pressure Sores (PS)D. Miscellaneous Wounds (Misc)
The Theramer™ Company
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Grouped MMP analysis:Grouped MMP analysis: Significant treatment effect
compared to baseline (from week 4 onwards)
MI-SorbMI-Sorb™™ Efficacy Efficacy
Pooling by treatment regime:Pooling by treatment regime: Significant reduction in active
MMP fraction with MI-Sorb™ vs. control treatment
The Theramer™ Company
0
5
10
15
20
25
30
MI-SorbTM
TreatmentControl
Treatment
Increasing MMP Activity
MI-SorbTM
treatment lowers wound MMP activity by 77% compared to control treatment*.
* A commercially available foam dressing
0
5
10
15
20
25
30
MI-SorbTM
TreatmentControl
Treatment
Increasing MMP Activity
MI-SorbTM
treatment lowers wound MMP activity by 77% compared to control treatment*.
* A commercially available foam dressing
Aim to be “Best in Class” Aim to be “Best in Class” in a new approach to in a new approach to move chronic wounds move chronic wounds towards a healing towards a healing pathwaypathway
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MI-SorbMI-Sorb™™ Efficacy Efficacy
Baseline
MMP-2 Masson’s
MMP-2 Masson’s
After 4 weeks of MI-SorbTM Treatment
Migrating, less friable wound edges; pink and firm granulation tissue
Reduced MMP-2 staining (brown)
Organised collagen (blue); little fibrin (red); reduced cellularity
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MI-SorbMI-Sorb™™ Commercialization Commercialization
Next Steps:Next Steps:
Leverage data into additional applications and next round of financing
ISO 13485 certification CE Mark, 510k Commercial manufacturing Marketing and distribution
The Theramer™ Company
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Some Important Success FactorsSome Important Success Factors
The Theramer™ Company
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Some Important Success FactorsSome Important Success Factors
Key Corporate Values:Key Corporate Values:
Recognize Opportunity Keep it Simple Be Persistent Focus on Execution
The Theramer™ Company
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Opportunity in the UnexpectedOpportunity in the Unexpected
The Theramer™ Company
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Opportunity in the UnexpectedOpportunity in the Unexpected
Key Messages:Key Messages: Rimon was founded on a
serendipitous observation Many of our most
valuable results came from unplanned observations
Innovation = something unexpected with value
The Theramer™ Company
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Simple is BestSimple is Best
The Theramer™ Company
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Simple is BestSimple is Best
Key Messages:Key Messages: Simple is easier to defend
and validate Simple is time efficient Simple is much easier to
sell
But, it is hard to be simple
The Theramer™ Company
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There is Always a WayThere is Always a Way
Key Messages:Key Messages: Survival is an achievement We have been most
innovative when “our backs were to the wall”
Persistence and endurance build credibility
The Theramer™ Company
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VSU- ControlVSU- Control
0
200
400
600
800
1000
1200
1400
1600
2 3 4 5 6Study Week
Normalized MMP Units
VSU- MI-SorbVSU- MI-Sorb™ ™
MI-SorbMI-Sorb™™ Efficacy Efficacy
Patient-Based MMP AnalysisPatient-Based MMP Analysis:: Examines MI-Sorb™ efficacy on a
wound-by-wound basis
Decreased MMP activity relative to underlying inflammation
Increased MMP activity relative to underlying inflammation
MI-Sorb™ reduces the active MI-Sorb™ reduces the active MMP fraction relative to MMP fraction relative to underlying inflammationunderlying inflammation
>
The Theramer™ Company
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Execute, Execute, ExecuteExecute, Execute, Execute
The Theramer™ Company
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Execute, Execute, ExecuteExecute, Execute, Execute
Key Messages:Key Messages: Under promise and over
achieve Create back-up plans for
what is out of your control Achievements bring
validation and credibility
The Theramer™ Company
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$
timeHigh Risk of Failure (“Pit of Hell”)
1 in 3000
Execution = Risk MitigationExecution = Risk Mitigation
Value = Next FinancingValue = Next FinancingRisk Mitigation =Value CreationRisk Mitigation =Value Creation
F1 F2 F3
Profile of an R&D Start-upProfile of an R&D Start-up
The Theramer™ Company
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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
The Value of an IdeaThe Value of an Idea
The Theramer™ Company
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Corporate Feasibility
Licensing Revenue
Research Partners
Polymer Design
ProductFocus
Pre-Clinical ValidationClinical
Validation
Rimon In-house
Strategic Partnership
Execution Mitigates RiskExecution Mitigates Risk
p< 80%
p< 80%
p< 10%
p< 33% p< 10%
IP Protection
Freedom to Operate
Scale-up
Manufacturing
Regulatory
Re-imbursement
POC Material Development
POA Material Development
POP Material Development
p< 25% p< 50% p< 80%
p< 60%
p< 33%
The Theramer™ Company
Overall probability of Overall probability of success is very low!success is very low!
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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%
Mitigating Risk Enhances ValueMitigating Risk Enhances Value
$
time
The Theramer™ Company
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OCE
MaRS
Two key features of a Two key features of a small-world network:small-world network:
• Strong close links built on trust (e.g., research
collaborators, service providers)
• A few links that are connected widely (e.g., directors, world-renowned
scientists)
Me, Myself and My NetworkMe, Myself and My Network
The Theramer™ Company
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• Overlap technical networkOverlap technical network
• basic science into ideas
• ideas into technologies
• technologies into products
• products into a company
• Expand networkExpand network
• shareholder, customers
• Strengthen networkStrengthen network
• Flow of information, resources, $, products
Build network towards a “tipping point”Build network towards a “tipping point”
High Tech EntrepreneurshipHigh Tech Entrepreneurship
The Theramer™ Company
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• Take care of the hard science first• Championing a start-up is a full-time job• Early-stage start-ups are an intense learning
environment• Focus first on the people that will help build and
strengthen your network (e.g., lawyers, accountants)• Practise communicating/negotiating• Develop a thick skin• Be bold – graduate student entrepreneurs are an
untapped, coachable source of entrepreneurs• Just get going!
Final ThoughtsFinal Thoughts
The Theramer™ Company
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“No pessimist ever discovered the secret of the stars or sailed an uncharted land, or opened a new doorway for the human spirit...Life is either a daring adventure or nothing”
Helen Keller
Thank You!Thank You!
The Theramer™ Company