Sol padis dec10-llp-2013
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Pharma interactions: 25Chagas KOL interactions: 25Veterinary interactions: 20Diagnostic interactions: 5
TOTAL interactions: 75 December 10, 2013
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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
Mentors:
Steve RichardsKarl Handelsman
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1 million
8-10 million
250 K
10 K
10 K
INSPIRATIONIdentifying/Defining the Pain
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Business Model CanvasWEEK 1
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Initial Funding
IP to developingcountries
Endemic Country Gov’t
IP for human
mkt
END USERIP for
human mkt
Initial Funding
Initial Funding
Pharma (human; developed country)
Ecosystem: Wk1
Initial Funding
Direct sales to pet owners
Traveler’s Medicine
Military (in endemic areas)
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Initial Funding
IP to developingcountries
Endemic Country Gov’t
IP for human
mkt
END USERIP for
human mkt
Initial Funding
Initial Funding
Pharma (human; developed country)
Ecosystem: Wk1
Initial Funding
Direct sales to pet owners
Traveler’s Medicine
Military (in endemic areas)
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Ecosystem: Wk10
PARTNER:Dx Company
IP for Animal Market
Initial Funding
~$2-$3mil
Collaboration
$20-30mil
IP to developingcountries
Endemic Country
Gov’t
Initial Funding
~$600,000
PARTNER
PARTNER: Vet Pharma
Initial Funding
~$1-$2mil
PARTNER
PARTNER: Human Pharma
Acces
s to
cmpd
libra
ries
IP for human
mkt
Increase value of product
END USER
Access to
cmpd libraries
PR
PR
Create mkt
IP for human
mkt
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VS
● Could repurpose existing drug● Existing pharma infrastructure● Easily distributed
● Lifetime immunity● Fewer doses
PRODUCTChemotherapy vs Vaccine
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PRODUCTChemotherapy vs Vaccine
VS
● Could repurpose existing drug● Existing pharma infrastructure● Easily distributed
● Lifetime immunity● Fewer doses
Scientifically RiskyFunder Preference
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MARKETDeveloped vs Developing World
● Human market would drive value of drug● Traveller/tourist market● Military use
Developed● Majority of patients found here● High awareness & treatment● PR for developed country-based
pharma
Developing
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● Human market would drive value of drug● Traveller/tourist market● Military use
Developed
Lack of approved Dx & low awareness in primary care MD
● Majority of patients found here● High awareness & treatment● PR for developed country-based
pharma
Developing
Developing country gov’t as customer
MARKETDeveloped vs Developing World
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Veterinary Market
● Peripheral/supplementary market● Hampered by low awareness● Infection rates uncertain
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Veterinary Market
● Peripheral/supplementary market● Hampered by low awareness● Infection rates uncertain (~5-15%)
Main driver of company value
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Business Model CanvasWEEK 5
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KEY PARTNERS
Sources of Non-dilutive Funding
Generating Awareness to Build Market
R&D Collaborator
Bringing Product to Market
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Business Model CanvasWEEK 10
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$ 800 K$ 2.6 M
$ 3.6 M
Strategy
Discovery(Screening)
Development(Lead Opt & DMPK-Tox)
PCC
Vet Clinical Trials
Human Clinical Trials
2014 2015 2016 2017 2018Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
TAM = $500 Million
SAM = $100 Million
SAM = $20 Million
$ 600 K$ 3.8 M $ 2.6 M
$ 1.0 M
$ 100 M
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PARTNER
IP for Animal Market
Initial Funding
~$2-$3mil
Collaboration
$20-30mil
IP to developingcountries
Endemic Country
Gov’t
Initial Funding
~$600,000
PARTNER
CUSTOMERInitial Funding
~$1-$2mil
PARTNER
PARTNER
Acces
s to
cmpd
libra
ries
IP for human
mkt
Increase value of product
END USER
Access to
cmpd libraries
PR
PR
Create mkt
IP for human
mkt
Ecosystem: Wk10
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INVESTOR READINESS
IRL6
First Pass Canvas
Low Fidelity MVP
Problem/Solution Validation
Product Market Fit
“Right Side of the Canvas”
“Left Side of the Canvas”
Business Case Defined
High Fidelity MVP
“Proof of Relevance” Path to Revenue Fully Articulated
Build KOL networkDeeper IP review and strategyDue diligence on partnersDeeper cost analysis to each data pointTeam talent gaps identified
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Multi-Sided Market
Patient
Pet Owner
Veterinary
Philanthropic OrganizationsEndemic Countries (Gov)
Global Health; Reduce Care Costs
Heart FailureLife Threatening
Pet well-beingLife Threatening
Pet well-beingLife Threatening
$
$
$
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NEXT STEPS
Eric ChatelainHead of
Drug Discovery
Robert DonDiscovery &
Pre-Clinical Director
Bernard PécoulDiscovery &
Executive Director
Talk to KOLs and apply for funding
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Business Model CanvasWEEK 1
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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 -
Development Phase $ 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
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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
WORKING CAPITAL $ 0 K $ 0 K $ 1.1 mil
Viable business via non-dilutive funding!
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Veterinary Market Size
TAM = $500 Million
SAM = $100 Million
50 million dogs in endemic regions
10 million dogs in USA endemic states
SAM = $20 Million 20% of the dogs diagnosed and treated
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Revenue model
Norm:<
Investment Revenue
>
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Cost Breakdown
Research Preclinical Clinical
Hit/Lead identification
Lead optimization
in vitro PK
in vitro tox (AMES,
HERG, etc)
Rodent efficacy model
in vivo PK (mice, dogs)
in vivo tox. (fertility,
teratogenicity, carcin, etc)
Prelim. formulation
Human vet exposure
Experiment Cost Experiment Cost
TOTAL TOTAL$2,200,000 $3,100,000
$100 k
$1 mil
$500 k
$500 k
$100 k
$500 k
$2 mil
$500 k
$0 - 100k
($200,000) (< $600,000)
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Metrics that Matter
Unit Quantity Total
Screening & Hits identification $ 1 / compound 100K compounds $ 100K
Hit-to-Lead $ 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
IP $ 100K $ 100K
People (4 scientists) $ 320K / year 3 years $ 960K
Space & Infrastructure $ 200K / year 3 years $ 600K
TOTAL ~$ 6 mil
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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
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Learning about partnersPartner 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
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● DNDi is interested o Currently reviewing data internallyo Profile of project matches what they are looking for
● GSK is ready to partnero Analogue screening can begin soono Encouraging us to apply to Open Lab Foundation
● Neither would be interested in retaining vet IP, developed world IPo GSK might not even want Brazil, Mexico (WIPO guidelines)
ASTMH Conference Notes
● US vet market may be more primed than previously thoughto Higher awareness than we believedo Louisiana, in addition to Texas (and likely other states)
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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
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Veterinary Market
Vet. Pharma
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)
● Min market size: $5-8mil annually (no risk, must produce results <6mo)● IP: only license animal health rights● What is the demand? Profit margin?
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Human Market
● Chagas chemotherapeutic DOES represent acquisition target
● DNDi TPP is basis of most company’s TPPs
Pharma Companies
Clinicians
Insurance Companies● Provide data showing superiority to benznidazole● Physician required to submit positive tests before authorization of charge
● 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