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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
“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™™ treatmenttreatment
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
DeviceDevice
TimelinesTimelines
Versatility ofVersatility of
PolymersPolymers
Unique Value PropositionUnique Value Proposition
The Theramer™ Company
Corporate
Feasibility
Licensing
Revenue
Stent
Restenosis Catheter
Infection
Research
Partners
Joint
Disease
New
Polymer
Design
Product
Focus
Pre-Clinical Validation
Clinical
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™™ DressingDressing
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™™ EfficacyEfficacy
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
Treatment
Control
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
Treatment
Control
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 toin a new approach to
move chronic woundsmove chronic wounds
towards a healingtowards a healing
pathwaypathway
MI-SorbMI-Sorb™™ EfficacyEfficacy
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™™ CommercializationCommercialization
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 6
Study Week
Normalized MMP Units
VSU- MI-SorbVSU- MI-Sorb™™
MI-SorbMI-Sorb™™ EfficacyEfficacy
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 activeMI-Sorb™ reduces the active
MMP fraction relative toMMP 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
$
time
High Risk of Failure
(“Pit of Hell”)
1 in 3000
Execution = Risk MitigationExecution = Risk Mitigation
Value = Next FinancingValue = Next Financing
Risk 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
Product
Focus
Pre-Clinical Validation
Clinical
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 ofOverall 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 aTwo 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

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Science and Business Do Mix: The Rimon Therapeutics Story

  • 1.
  • 2. 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
  • 3. “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
  • 4. 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
  • 5. 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
  • 6. MotivationMotivation After 4 weeks of MI-SorbAfter 4 weeks of MI-Sorb™™ treatmenttreatment 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
  • 7.  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
  • 8. 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
  • 10. Corporate Feasibility Licensing Revenue Stent Restenosis Catheter Infection Research Partners Joint Disease New Polymer Design Product Focus Pre-Clinical Validation Clinical 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
  • 11. 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™™ DressingDressing The Theramer™ Company
  • 12. 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
  • 13. Grouped MMP analysis:Grouped MMP analysis:  Significant treatment effect compared to baseline (from week 4 onwards) MI-SorbMI-Sorb™™ EfficacyEfficacy 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 Treatment Control 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 Treatment Control 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 toin a new approach to move chronic woundsmove chronic wounds towards a healingtowards a healing pathwaypathway
  • 14. MI-SorbMI-Sorb™™ EfficacyEfficacy 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
  • 15. MI-SorbMI-Sorb™™ CommercializationCommercialization 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
  • 16. Some Important Success FactorsSome Important Success Factors The Theramer™ Company
  • 17. 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
  • 18. Opportunity in the UnexpectedOpportunity in the Unexpected The Theramer™ Company
  • 19. 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
  • 20. Simple is BestSimple is Best The Theramer™ Company
  • 21. 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
  • 22. 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
  • 23. VSU- ControlVSU- Control 0 200 400 600 800 1000 1200 1400 1600 2 3 4 5 6 Study Week Normalized MMP Units VSU- MI-SorbVSU- MI-Sorb™™ MI-SorbMI-Sorb™™ EfficacyEfficacy 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 activeMI-Sorb™ reduces the active MMP fraction relative toMMP fraction relative to underlying inflammationunderlying inflammation > The Theramer™ Company
  • 24. Execute, Execute, ExecuteExecute, Execute, Execute The Theramer™ Company
  • 25. 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
  • 26. $ time High Risk of Failure (“Pit of Hell”) 1 in 3000 Execution = Risk MitigationExecution = Risk Mitigation Value = Next FinancingValue = Next Financing Risk 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
  • 27.  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
  • 28. Corporate Feasibility Licensing Revenue Research Partners Polymer Design Product Focus Pre-Clinical Validation Clinical 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 ofOverall probability of success is very low!success is very low!
  • 29.  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
  • 30. OCE MaRS Two key features of aTwo 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
  • 31. • 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
  • 32. • 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
  • 33. “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