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Pharma interactions: 25
Chagas KOL interactions: 25
Veterinary interactions: 20
Diagnostic interactions: 5
TOTAL interacti...
Mentors:

Steve Richards
Karl Handelsman

Jair L. Siqueira-Neto, PhD
UCSF Specialist, Kinetoplastid Core Director

Patrick...
INSPIRATION
Identifying/Defining the Pain
1 million
250 K
10 K

8-10
million

10 K
Business Model Canvas
WEEK 1
Ecosystem: Wk1
Direct sales to
pet owners

IP for
human
mkt
Initial
Funding

IP to
developing
countries

Pharma
(human; de...
Ecosystem: Wk1
Direct sales to
pet owners

IP for
human
mkt
Initial
Funding

IP to
developing
countries

Pharma
(human; de...
Ecosystem: Wk10
Access to
cmpd libraries

PARTNER
IP for
human
mkt

PARTNER: Human Pharma
END USER

PR

IP to
developing
c...
PRODUCT
Chemotherapy vs Vaccine

VS

● Could repurpose existing drug
● Existing pharma infrastructure
● Easily distributed...
PRODUCT
Chemotherapy vs Vaccine

VS

● Could repurpose existing drug
● Existing pharma infrastructure
● Easily distributed...
MARKET
Developed vs Developing World

Developing
● Majority of patients found here
● High awareness & treatment
● PR for d...
MARKET
Developed vs Developing World

Developing

Developed

● Majority of patients found here
● Human market would drive ...
Veterinary Market

● Peripheral/supplementary market
● Hampered by low awareness
● Infection rates uncertain
Veterinary Market

● Peripheral/supplementary market
● Hampered by low awareness
● Infection rates uncertain (~5-15%)
Main...
Business Model Canvas
WEEK 5
KEY PARTNERS
Sources of Non-dilutive Funding

Generating Awareness to Build Market

R&D Collaborator

Bringing Product to ...
Business Model Canvas
WEEK 10
Strategy
2014
Q1

Q2

Q3

$ 800 K

2015
Q4

Q1

Q2

Q3

2016
Q4

$ 2.6 M

Q1

Q2

Q3

2017
Q4

Q1

Q2

Q3

2018
Q4

Q1

Q2...
Ecosystem: Wk10
PARTNER

PARTNER

Access to
cmpd libraries

IP for
human
mkt

END USER

PR

IP to
developing
countries

PR...
INVESTOR READINESS
“Proof of Relevance” Path to Revenue Fully Articulated
High Fidelity MVP
Business Case Defined
“Left Si...
Multi-Sided Market
Philanthropic Organizations
Endemic Countries (Gov)

Patient
Heart Failure
Life Threatening

Global Hea...
NEXT STEPS

Eric Chatelain

Robert Don

Bernard Pécoul

Head of
Drug Discovery

Discovery &
Pre-Clinical Director

Discove...
Business Model Canvas
WEEK 1
Finance Operations
Year 1

Year 2

Year 3

Discovery Phase

$ 300 K

$ 400 K

$0

Hit to Lead

$ 200 K

-

-

Lead Optimiz...
Finance Operations
Year 1

Year 2

Year 3

Total Cost

$ 800 K

$ 2.6 mil

$ 2.5 mil

Funding

$ 800 K

$ 2.6 mil

$ 3.6 m...
Veterinary Market Size

TAM = $500 Million

50 million dogs in
endemic regions

SAM = $100 Million

10 million dogs in
USA...
Revenue model

Norm:

<
Investment

>

Revenue
Cost Breakdown
Research
Experiment

Preclinical
Cost

Experiment

Clinical
Cost

$100 k

in vivo PK (mice, dogs)

$500 k

...
Metrics that Matter
Unit

Quantity

Total

$ 1 / compound

100K compounds

$ 100K

$ 1K / series

10 scaffolds

$ 10K

Lea...
Key Partner Hypotheses
Partner

Why do we need?

Why will they
partner?

Cost of
partnership?

DNDi

Funds and network for...
Learning about partners
Partner

Hypothesis

Experiment

Result

DNDi

Our current
chemotherapeutics are an
attractive sca...
ASTMH Conference Notes
● DNDi is interested
o Currently reviewing data internally
o Profile of project matches what they a...
Early Stage Cash Flow
Year 1

Year 2

Year 3

NIH & similar

$300k

$300k

$1 million

DNDi

$500 k

$1 million

$1 millio...
Veterinary Market
Vet. Pharma

● Min market size: $5-8mil annually (no risk, must produce results <6mo)
● IP: only license...
Human Market
Pharma Companies
● Chagas chemotherapeutic DOES represent acquisition target
● DNDi TPP is basis of most comp...
Sol padis dec10-llp-2013
Sol padis dec10-llp-2013
Sol padis dec10-llp-2013
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Sol padis dec10-llp-2013

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  • Chagas Disease is a condition that affects humans and animals and is caused by the parasite Trypanosoma cruzi. The disease is endemic in parts of Latin America, but there are a growing number cases around the world. Chagas is classified as a neglected parasitic infection (NPI) meaning there is a great need for new therapeutics
  • &quot;this is our canvas from week 1, we had a pretty simplified view of where solpadis fit into this ecosystem
    We thought we would reach the end patient directly...&quot; etc etc
  • &quot;this is our canvas from week 1, we had a pretty simplified view of where solpadis fit into this ecosystem
    We thought we would reach the end patient directly...&quot; etc etc
  • but instead, after 10 weeks we were more able to clearly define this relationship network-- partners, customers, collaborators, etc
    and it was much more complex than we thought
    the rest of the presentation will go through the details of each of these, as well as how we arrived at values and types of relationship
  • Most funders are interested in chemotherapy instead of vaccine
    Difficulty of disseminating vaccine is a hurdle. More so, funders were wary of scientific risks (immune system component)
  • This just represents the human population
    CDC not interested in travellers recommendation for Chagas (2 cases ever?)
    The lack of diagnosis, approved diagnostics, and low awareness in primary physicians make developed world market a non-starter
  • This represents just the human population
    CDC not interested in travellers recommendation for Chagas (2 cases ever?)
    The lack of diagnosis, approved diagnostics, and low awareness in primary physicians make developed world market a non-starter
  • 1 - First-pass canvas
    define clinical problem the technology solves
    define early data customers consider gating
    define best partners (like CROs) for outsourcing activities
    quick check on IP
    2 - Low fidelity MVP
    KOL discussions
    Multiple pre-clinical and clinical paths identified
    Independent data confirming base technology works
    3 - Problem/solution validation
    discussions with all pharma/large biotech
    identify strategic need/fit at company level
    present independent data
    specific pre-clinical and clinical path/data needed
    internal experts engaged
    external experts identified
    best outsourcing for this project
    additional immediate data opportunities
    4 - Product/market fit
    timeline to preclinical data and clinical data points
    rough cost to each data point
    value of program at each data point
    non-dilutive money sources engaged
    strengths/weakness compared to competition
    probability and go/no go criteria at each stage
    5 - Right side of canvas
    present new data to top five customers
    review development plan data points
    final definition of pre-clinical and clinical path
    “proof of relevance” criteria/data/stages/quality
  • Valuable* and desirable!
    (Crowdfunding?) we should test this hypothesis
  • 50 million dogs :: 10% infected paying $100 per treatment = $500 million revenue
    10 million dogs in endemic USA :: 10% infected paying $100 per treatment = $100 million revenue
    If only 20% of the infected dogs are actually diagnosed and treated, the market would be around $20 million revenue
  • This is a viable business model
  • Secret is non-dilutive fundings!!!
  • Partners:
    - who do we have to talk to to form that partnership?
    - how much money can we get from them
    Customer:
    - who do we have to talk to to get them interested in our product?
    - what do we need to show them “”
    - how much money would they invest in studies?
  • Spoke with leadership of 3 mid-sized animal health players
    Parnell Living Sciences
    $10M/year is the low end, must consider Incidence vs Prevalence
    Manufacturability is key prior to partnership
    Chronic therapy is more interesting to a Vet Pharma than a prophylaxis
    Nika Biochemicals
    Wanted more information about product and intellectual property considerations
    Will most likely have to sign an NDA to proceed with this company
    Dechra Veterinary Products
    Want to perform market research for us based on the information we provide
    Have the ability to conduct clinical trials
    Interesting in paring the diagnostic and treatment
    Who we need to talk to next:
    Veterinarians
    Determine awareness in various geographical areas
    Current treatment strategies (if any)
    Who makes vaccine recommendations?
    Animal Health Pharmaceutical Manufacturers
    What type of data are they looking for to ‘get excited’
    How the approval process differs from human treatments
  • Who pays for Chagas?
    Dx is a pain
    Need better active infection Dx
    Poor compliance
    Ideal drug: at the very least same #s as benz w/o side effects
  • Transcript of "Sol padis dec10-llp-2013"

    1. 1. Pharma interactions: 25 Chagas KOL interactions: 25 Veterinary interactions: 20 Diagnostic interactions: 5 TOTAL interactions: 75 December 10, 2013
    2. 2. Mentors: Steve Richards Karl Handelsman Jair L. Siqueira-Neto, PhD UCSF Specialist, Kinetoplastid Core Director Patrick Symmonds UCSF/UC Berkeley Translational Medicine Candidate Paul Novick Stanford PhD Candidate Susanna Wen Stanford PhD Candidate
    3. 3. INSPIRATION Identifying/Defining the Pain 1 million 250 K 10 K 8-10 million 10 K
    4. 4. Business Model Canvas WEEK 1
    5. 5. Ecosystem: Wk1 Direct sales to pet owners IP for human mkt Initial Funding IP to developing countries Pharma (human; developed country) Traveler’s Medicine Initial Funding Initial Funding Military Initial Funding IP for human mkt Endemic Country Gov’t (in endemic areas) END USER
    6. 6. Ecosystem: Wk1 Direct sales to pet owners IP for human mkt Initial Funding IP to developing countries Pharma (human; developed country) Traveler’s Medicine Initial Funding Initial Funding Military Initial Funding IP for human mkt Endemic Country Gov’t (in endemic areas) END USER
    7. 7. Ecosystem: Wk10 Access to cmpd libraries PARTNER IP for human mkt PARTNER: Human Pharma END USER PR IP to developing countries PR Initial Funding ~$2-$3mil to s s rie s a ce libr Ac d p cm PARTNER: Dx Company Increase value of product Create mkt Initial Funding ~$600,000 IP Initial Funding ~$1-$2mil IP for human mkt PARTNER Endemic Country Gov’t for An im Co al Ma lla bo rk e $2 t 0-3 rat 0m ion il PARTNER: Vet Pharma
    8. 8. PRODUCT Chemotherapy vs Vaccine VS ● Could repurpose existing drug ● Existing pharma infrastructure ● Easily distributed ● Lifetime immunity ● Fewer doses
    9. 9. PRODUCT Chemotherapy vs Vaccine VS ● Could repurpose existing drug ● Existing pharma infrastructure ● Easily distributed Funder Preference ● Lifetime immunity ● Fewer doses Scientifically Risky
    10. 10. MARKET Developed vs Developing World Developing ● Majority of patients found here ● High awareness & treatment ● PR for developed country-based pharma Developed ● Human market would drive value of drug ● Traveller/tourist market ● Military use
    11. 11. MARKET Developed vs Developing World Developing Developed ● Majority of patients found here ● Human market would drive value of drug ● High awareness & treatment ● Traveller/tourist market ● PR for developed country-based ● Military use pharma Lack of approved Dx & low Developing country gov’t as customer awareness in primary care MD
    12. 12. Veterinary Market ● Peripheral/supplementary market ● Hampered by low awareness ● Infection rates uncertain
    13. 13. Veterinary Market ● Peripheral/supplementary market ● Hampered by low awareness ● Infection rates uncertain (~5-15%) Main driver of company value
    14. 14. Business Model Canvas WEEK 5
    15. 15. KEY PARTNERS Sources of Non-dilutive Funding Generating Awareness to Build Market R&D Collaborator Bringing Product to Market
    16. 16. Business Model Canvas WEEK 10
    17. 17. Strategy 2014 Q1 Q2 Q3 $ 800 K 2015 Q4 Q1 Q2 Q3 2016 Q4 $ 2.6 M Q1 Q2 Q3 2017 Q4 Q1 Q2 Q3 2018 Q4 Q1 Q2 Q3 TAM = $500 Million $ 3.6 M SAM = $100 Million Vet Clinical Trials $ 1.0 M Discovery (Screening) Development (Lead Opt & DMPK-Tox) PCC Human Clinical Trials $ 100 M $ 600 K Q4 $ 3.8 M $ 2.6 M SAM = $20 Million
    18. 18. Ecosystem: Wk10 PARTNER PARTNER Access to cmpd libraries IP for human mkt END USER PR IP to developing countries PR Initial Funding ~$2-$3mil to s s rie s a ce libr Ac d p cm PARTNER Increase value of product Create mkt Initial Funding ~$600,000 IP Initial Funding ~$1-$2mil IP for human mkt PARTNER Endemic Country Gov’t for An im al Co lla $2 bor 0-3 at 0m ion il Ma rk e t CUSTOMER
    19. 19. INVESTOR READINESS “Proof of Relevance” Path to Revenue Fully Articulated High Fidelity MVP Business Case Defined “Left Side of the Canvas” Build KOL network Deeper IP review and strategy Due diligence on partners Deeper cost analysis to each data point Team talent gaps identified “Right Side of the Canvas” Product Market Fit Problem/Solution Validation Low Fidelity MVP First Pass Canvas IRL6
    20. 20. Multi-Sided Market Philanthropic Organizations Endemic Countries (Gov) Patient Heart Failure Life Threatening Global Health; Reduce Care Costs $ Pet well-being Life Threatening $ Pet Owner Pet well-being Life Threatening $ Veterinary
    21. 21. NEXT STEPS Eric Chatelain Robert Don Bernard Pécoul Head of Drug Discovery Discovery & Pre-Clinical Director Discovery & Executive Director Talk to KOLs and apply for funding
    22. 22. Business Model Canvas WEEK 1
    23. 23. Finance Operations Year 1 Year 2 Year 3 Discovery Phase $ 300 K $ 400 K $0 Hit to Lead $ 200 K - - Lead Optimization (exploratory SAR) $ 100 K $ 400 K - $0 $ 1.7 mil $ 2 mil in vivo studies - $ 200 K $ 2 mil Matter synthesis & Scale up - $ 1 mil - Formulation - $ 500 K - Others (People + Space + etc) $ 500 K $ 500 K $ 500 K TOTAL $ 800 K $ 2.6 mil $ 2.5 mil Development Phase
    24. 24. Finance Operations Year 1 Year 2 Year 3 Total Cost $ 800 K $ 2.6 mil $ 2.5 mil Funding $ 800 K $ 2.6 mil $ 3.6 mil NIH & similiar (US Gov’t funding) $ 300 K $ 600 K $ 600 K DNDi $ 500 K $ 1 mil $ 1 mil Gates/Carlos Slim Foundation - $ 500 K $ 1 mil Brazilian Gov’t Partner - $ 500 K $ 1 mil Vet Pharma Partner - - end of yr $0K $0K $ 1.1 mil WORKING CAPITAL Viable business via non-dilutive funding!
    25. 25. Veterinary Market Size TAM = $500 Million 50 million dogs in endemic regions SAM = $100 Million 10 million dogs in USA endemic states SAM = $20 Million 20% of the dogs diagnosed and treated
    26. 26. Revenue model Norm: < Investment > Revenue
    27. 27. Cost Breakdown Research Experiment Preclinical Cost Experiment Clinical Cost $100 k in vivo PK (mice, dogs) $500 k $1 mil in vivo tox. (fertility, $2 mil Lead optimization $500 k teratogenicity, carcin, etc) in vitro PK $500 k Prelim. formulation Hit/Lead identification Human vet exposure in vitro tox (AMES, HERG, etc) Rodent efficacy model TOTAL $500 k $0 - 100k $100 k $2,200,000 ($200,000) TOTAL $3,100,000 (< $600,000)
    28. 28. Metrics that Matter Unit Quantity Total $ 1 / compound 100K compounds $ 100K $ 1K / series 10 scaffolds $ 10K Lead Optimization $ 500K / series 2 series $ 1 mil In vitro PK $ 100K / series 2 series $ 200K In vivo PK & Toxicology $ 100K / series 1 series $ 100K In vivo PD (rodent efficacy) $ 100K / molecule 2 molecules $ 200K GMP Synthesis & scale up $ 1 mil / molecule 1 molecule $ 1 mil In vivo Pre-clinical package $ 2 mil / molecule 1 molecule $ 1 mil Formulation $ 500K / molecule 1 molecule $ 500K Screening & Hits identification Hit-to-Lead IP $ 100K $ 100K People (4 scientists) $ 320K / year 3 years $ 960K Space & Infrastructure $ 200K / year 3 years $ 600K TOTAL ~$ 6 mil
    29. 29. Key Partner Hypotheses Partner Why do we need? Why will they partner? Cost of partnership? DNDi Funds and network for preclinical and clinical research Currently looking for additional anti-parasitic Chagas scaffolds IP for human patients in developing nations NIH, foreign similars Need funds for preclinical and clinical research History of funding Chagas disease research None Vet pharma companies Distribution of therapy, potential acquirer Improve product pipeline IP for animal market in developed countries Human pharma companies Access to compound libraries, screening resources History of partnerships in Chagas disease research Potential IP for human partnerships developing nations, developed nations Diagnostics companies Increased awareness and diagnosis of disease Opportunity to sell more diagnostics Exclusive partnership? Academic epidemiology researchers Increased awareness and market size validation Looking for Chagas therapies in the marketplace None Universities/CROs R&D resources and manpower Fee for service relationships Price of R&D efforts FDA Insight into exactly what is needed in IND package Orphan, Breakthrough, etc designations None
    30. 30. Learning about partners Partner Hypothesis Experiment Result DNDi Our current chemotherapeutics are an attractive scaffold for DNDi Data review with DNDi influencers/directors One of our projects is likely fundable, and are desperate for more pipeline projects NIH, foreign similars Our research projects are attractive funding projects Discussions with focus group heads, applied for SBIR A promising Chagas chemotherapeutic is a fundable project Vet pharma companies Vet pharma would be interested in licensing a Chagas therapeutic Discussions with Biz Dev employees Depends on prevalence/ market size, and which company Human pharma companies Big pharma will provide research resources Discussions with external partnership coordinators Compound libraries, screening resources, etc could be donated Diagnostics companies Interested in partnership with therapeutics company Attempted interviews with 4 quick test producers Still scheduling interviews Academic epidemiology researchers Can firmly estimate the prevalence of Chagas disease in canines Discuss with leading researchers Not a consensus on how prevalent disease is Universities/CROs These partners will operate on a fee for service basis Interviews and quotes for projects These are reliable, inexpensive research option FDA
    31. 31. ASTMH Conference Notes ● DNDi is interested o Currently reviewing data internally o Profile of project matches what they are looking for ● GSK is ready to partner o Analogue screening can begin soon o Encouraging us to apply to Open Lab Foundation ● Neither would be interested in retaining vet IP, developed world IP o GSK might not even want Brazil, Mexico (WIPO guidelines) ● US vet market may be more primed than previously thought o Higher awareness than we believed o Louisiana, in addition to Texas (and likely other states)
    32. 32. Early Stage Cash Flow Year 1 Year 2 Year 3 NIH & similar $300k $300k $1 million DNDi $500 k $1 million $1 million Vet Pharma Partnership end of year Total Revenue $800k $1.3 million $2 million G&A $300k $400k $500k Rodent IND Study $400k Large Mammal IND Study $1.3 million Formulation & Manufacture $400k (?) $400k (?) Total Costs ($700 k) ($1.2 million) ($1.8 million) Working Capital $100k $200k $400k
    33. 33. Veterinary Market Vet. Pharma ● Min market size: $5-8mil annually (no risk, must produce results <6mo) ● IP: only license animal health rights ● What is the demand? Profit margin? Veterinarians ● ● ● ● Difficult to assess incidence & prevalence of Chagas - low awareness AVMA: guidelines for recommended vaccines & treatments for animals Currently no FDA-approved treatment options available Modes of transmission - congenital seems to be a big problem Diagnostic ● Collaboration/partnership? (est $30-50K to develop simple Dx w/ vet pharma)
    34. 34. Human Market Pharma Companies ● Chagas chemotherapeutic DOES represent acquisition target ● DNDi TPP is basis of most company’s TPPs Clinicians ● ● ● ● ● Who pays for Chagas? Need a better active infection Dx High prevalence in select US populations Poor compliance (toxicity) Need to increase awareness among 1’ care and ID doctors ○ Often too late to treat by the time cardiologists see patients Insurance Companies ● Provide data showing superiority to benznidazole ● Physician required to submit positive tests before authorization of charge
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