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Sol padis dec10-llp-2013
 

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

Sol padis dec10-llp-2013 Sol padis dec10-llp-2013 Presentation Transcript

  • Pharma interactions: 25 Chagas KOL interactions: 25 Veterinary interactions: 20 Diagnostic interactions: 5 TOTAL interactions: 75 December 10, 2013
  • 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
  • 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; 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
  • 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
  • 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
  • PRODUCT Chemotherapy vs Vaccine VS ● Could repurpose existing drug ● Existing pharma infrastructure ● Easily distributed ● Lifetime immunity ● Fewer doses
  • PRODUCT Chemotherapy vs Vaccine VS ● Could repurpose existing drug ● Existing pharma infrastructure ● Easily distributed Funder Preference ● Lifetime immunity ● Fewer doses Scientifically Risky
  • 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
  • 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
  • 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 driver of company value
  • Business Model Canvas WEEK 5
  • KEY PARTNERS Sources of Non-dilutive Funding Generating Awareness to Build Market R&D Collaborator Bringing Product to Market
  • 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 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
  • 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
  • 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
  • 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
  • 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
  • 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 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
  • 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!
  • 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
  • Revenue model Norm: < Investment > Revenue
  • 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)
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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)
  • 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