Science and Business Do Mix: The Rimon Therapeutics Story
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Transcript of Science and Business Do Mix: The Rimon Therapeutics Story
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 28 thth, 2007, 2007
“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
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
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
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
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
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
Drug-likeDrug-like
Activity/MarginsActivity/Margins
Drug-likeDrug-like
Activity/MarginsActivity/Margins
DeviceDevice
TimelinesTimelines
DeviceDevice
TimelinesTimelines
Versatility ofVersatility of
PolymersPolymers
Versatility ofVersatility of
PolymersPolymers
Unique Value PropositionUnique Value Proposition
The Theramer™ Company
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
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
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
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
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
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
Some Important Success FactorsSome Important Success Factors
The Theramer™ Company
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
Opportunity in the UnexpectedOpportunity in the Unexpected
The Theramer™ Company
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
Simple is BestSimple is Best
The Theramer™ Company
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
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
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
Execute, Execute, ExecuteExecute, Execute, Execute
The Theramer™ Company
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
$
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
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
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!
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
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
• 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
• 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
“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