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