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Phi Therapeutics
A Probiotic Approach to Effective Acne Therapy
Consumer interviews: 17
Pharma interviews: 19
KOL interviews: 14
Regulatory interviews: 14
IP interviews: 6
Other Interviews: 22
_____________________
Total Interviews: 92

December 10, 2013
Mentors:
Bob Dunkle
Karl Handelsman

Yug Varma, PhD
UCSF Postdoc, Microbiome Researcher

Nancy Van Prooyen, PhD
UCSF Postdoc, Immunologist
Joan Zape

UCSF PhD Candidate, Cell Biologist
Nilam Patel
Genentech, Technology Engineer
Week 1

• Non-toxic, fast
clearing,
highly specific bacterial
killers
• Can treat multi-drug
resistant bacteria, and
d
drugs targeting
emerging resistance
can be found quickly
and cheaply
• More effective and
penetrating than topical
antibacterials
• Can be used for
antibacterial treatment
in applications where
antibiotics are banned
(eg. Animal farms in the
EU)

• Analysis of initial
samples

• Regular monitoring
of client site

•Website
•Site visits to collect
samples
• Direct mail to ship
probiotics to client

• Sanitization
o Supermarkets
o Hospitals
o Animal feeding
operations, aquaculture
farms
o Food processsing
• Animal therapy
o Animal feeding
operations, aquaculture
farms
o Veterinary medicine
• Human therapy
o Treating multi-drug
resistant bacterial
infections
o Niche bacterial
infections
o Skin conditions
(acne, eczema)
• Prophylactics
o Anti-Staph nasal
spray
o Probiotics
Week 1

• Non-toxic, fast
clearing,
highly specific bacterial
killers
• Can treat multi-drug
resistant bacteria, and
d
drugs targeting
emerging resistance
can be found quickly
and cheaply
• More effective and
penetrating than topical
antibacterials
• Can be used for
antibacterial treatment
in applications where
antibiotics are banned
(eg. Animal farms in the
EU)

• Analysis of initial
samples

• Regular monitoring
of client site

• Sanitization
o Supermarkets
o Hospitals
o Animal feeding
operations, aquaculture
farms
o Food processsing
• Animal therapy
o Animal feeding
operations,

aquaculture farms
•Website
•Site visits to collect
samples
• Direct mail to ship
probiotics to client

o Veterinary medicine
• Human therapy
o Treating multi-drug
resistant bacterial
infections
o Niche bacterial
infections
o Skin conditions (acne,
eczema)
• Prophylactics
o Anti-Staph nasal
spray
o Probiotics
After an Important Interview

I was happy …

.. but Nancy had other ideas
Week 3: Focus on Acne
• Skincare and
cosmetic companies

• Obtain probiotic
strains
• Obtain lead
compounds
• IP strategy

• Dermatologists

• Regulatory agencies
(FDA)

• Effective treatment
of acne
• Minimal side effects
• Natural and
probiotic
• Non-intensive
treatment regimen

• Sales (direct
relationship)
• Online and customer
service

• People with moderate
acne
• Male and
Female, 18
and above
• Male and
female 18 and
below (but the
decision
maker/buyer
are mothers)

Pharmacies

• Academic lab

• People with severe
acne
• Mostly Male 18
and above
• Cystic acne

Probiotic collections
Online
Mass retail

• Skincare/cosmetic
companies

• Probiotic selection and production
• Formulation of probiotic cream
• QC and testing

• Antibacterial to kill „bad‟ acne-causing strains
• Probiotic to add back „good‟ protective strains
Acne: History (Lack of Innovation in 30 Years)

Sulfur

Ancient Egypt

Benzoyl peroxide

1920s

Retin A

1970s

Accutane
Antibiotics

1980s
Who Are Our Customers?
Archetype #1

Archetype #2

•30% of adults (20-35)

• 80% Teenagers (13-19)
• Persistent acne, affects daily life: social
and school-related
•Tried other treatments – either didn‟t
work or relapsed
• Willing to try regular skincare regimen

• Persistent acne, serious
therapeutics interventions: lessened
acne, or relapse of chronic acne
• Affects daily life – social and
professional
• Desperate for effective treatment, “will
try anything”
Over the Counter (OTC) vs Prescription

Estheticians

Skincare Companies

Dermatologists

Online

Pharmacies

Store

$2.5 Billion Market

$4 Billion Market
Phi therapeutics wk10 final nvp
Initial Hypotheses
Value Proposition

Customer Relationships

Channels

Better!
Revenue Streams

Customer Segments
“Must be regulated by the FDA”
Value Proposition

Customer Relationships

Channels

Better!

Revenue Streams

Customer Segments
“Cosmetic companies aren‟t going to take drugs through
clinical trials”
Value Proposition

Customer Relationships

Channels

Better!

Revenue Streams

Customer Segments
“Cosmetic companies aren‟t going to take drugs through
clinical trials”
Value Proposition

Customer Relationships

Customer Segments

Channels

Better!

Revenue Streams

J&J
GSK
Bayer, Galderma
“Add probiotic component to therapeutic”
Value Proposition

Customer Relationships

Channels

Better!

Revenue Streams

Customer Segments
“Add probiotic component to therapeutic”
Value Proposition

Customer Relationships

Channels

Better!

Revenue Streams

Customer Segments
“Use dermatologist advisors to prove clinical efficacy”
Value Proposition

Customer Relationships

Channels

Better!

Revenue Streams

Customer Segments
Other Discoveries
• Regulated under CBER division of FDA
Safety and Efficacy regulated under acne guidelines
CMC (Chemistry, Manufacturing, and Controls) regulated under
live vaccine division
• Regulatory consultants and CROs are partners
• Virtualize Operations
• Human Pilot Trials
• Salesforce required to create demand

Create
Demand
Dermatologist
Salesforce
Attractive Market Opportunity

TAM = $4 Billion

650 million people globally

SAM = $2 Billion

150 million people in USA

Target Market
$500 Million

25% New branded drugs
capture large share of the
market
Preclinical Timeline

Drug
Discovery

Concept
Validation

Requirements

Formulation

• Validate active
ingredients

• Incubator space
• Lab equipment

Cost

• $200K

Time

• 6 Months

0

6

Months

Animal
Studies

Human Pilot
Trials
Preclinical Timeline

Drug
Discovery

Concept
Validation

Animal
Studies

Formulation

• Validate active
ingredients

• Cosmetically
elegant

• Incubator space
• Lab equipment

• Formulation
CROs

Cost

• $200K

• $500K

Time

• 6 Months

• 6 Months

Requirements

0

6

Months

12

Human Pilot
Trials
Preclinical Timeline

Drug
Discovery

Concept
Validation

Animal
Studies

Formulation

• Validate active
ingredients

• Cosmetically
elegant

• Efficacy,
penetration,
safety data

• Incubator space
• Lab equipment

• Formulation
CROs

• Safety and
toxicology CROs
• Hamsters,
mini-pigs

Cost

• $200K

• $500K

• $100K

Time

• 6 Months

• 6 Months

Human Pilot
Trials

• 3 Months

Requirements

0

6

Months

12

15
Preclinical Timeline

Drug
Discovery

Concept
Validation

Animal
Studies

Formulation

Human Pilot
Trials

• Validate active
ingredients

• Cosmetically
elegant

• Efficacy,
penetration,
safety data

• Efficacy, endpoints,
monitor microbiome

• Incubator space
• Lab equipment

• Formulation
CROs

• Safety and
toxicology CROs
• Hamsters,
mini-pigs

• IRB
• Dermatologists
• 20-100 volunteers

Cost

• $200K

• $500K

• $100K

• $500K

Time

• 6 Months

• 6 Months

• 3 Months

• 3 Months

Requirements

0

6

Months

12

15

18
What Are We Going To Do Next?
• Financial
SBIR grants, VCs
Corporate Partners
• Operational
Lab space, hire technical team
• Structural
Incorporate, freedom-to-operate analysis, provisional
patents
Therapeutic Investment Readiness Level

Senior customer will endorse externally
Customer partners highly interested
Talent recruited to fill gaps
Cost analysis and KOL network
Proof of relevance data path defined
Timeline and cost to data points
Identify strategic need/fit at company level
Base technology independently confirmed
First pass canvas

IRL4
Week 1

• Non-toxic, fast
clearing,
highly specific bacterial
killers
• Can treat multi-drug
resistant bacteria, and
d
drugs targeting
emerging resistance
can be found quickly
and cheaply
• More effective and
penetrating than topical
antibacterials
• Can be used for
antibacterial treatment
in applications where
antibiotics are banned
(eg. Animal farms in the
EU)

• Analysis of initial
samples

• Regular monitoring
of client site

•Website
•Site visits to collect
samples
• Direct mail to ship
probiotics to client

• Sanitization
o Supermarkets
o Hospitals
o Animal feeding
operations, aquaculture
farms
o Food processsing
• Animal therapy
o Animal feeding
operations, aquaculture
farms
o Veterinary medicine
• Human therapy
o Treating multi-drug
resistant bacterial
infections
o Niche bacterial
infections
o Skin conditions
(acne, eczema)
• Prophylactics
o Anti-Staph nasal
spray
o Probiotics
Phi therapeutics wk10 final nvp
Phi therapeutics wk10 final nvp
IS OUR BUSINESS IDEA VALIDATED?
Product Market Fit (Value Proposition)
- Teens and chronic acne patients need a better acne treatment

Competition
-Epiduo (leader) is simply a combination of benzoyl peroxide
and retinoic acid

- This market space has not seen a novel and more efficacious
treatment of acne in the last 30 years

KEY Partners to make this business happen
Discovery
-Collaborate
with KOLS

Regulatory
-CROs and Regulatory
Consultants
- Engage big derm

Marketing
-Dermatologists

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Phi therapeutics wk10 final nvp

  • 1. Phi Therapeutics A Probiotic Approach to Effective Acne Therapy Consumer interviews: 17 Pharma interviews: 19 KOL interviews: 14 Regulatory interviews: 14 IP interviews: 6 Other Interviews: 22 _____________________ Total Interviews: 92 December 10, 2013
  • 2. Mentors: Bob Dunkle Karl Handelsman Yug Varma, PhD UCSF Postdoc, Microbiome Researcher Nancy Van Prooyen, PhD UCSF Postdoc, Immunologist Joan Zape UCSF PhD Candidate, Cell Biologist Nilam Patel Genentech, Technology Engineer
  • 3. Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site •Website •Site visits to collect samples • Direct mail to ship probiotics to client • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • 4. Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms •Website •Site visits to collect samples • Direct mail to ship probiotics to client o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • 5. After an Important Interview I was happy … .. but Nancy had other ideas
  • 6. Week 3: Focus on Acne • Skincare and cosmetic companies • Obtain probiotic strains • Obtain lead compounds • IP strategy • Dermatologists • Regulatory agencies (FDA) • Effective treatment of acne • Minimal side effects • Natural and probiotic • Non-intensive treatment regimen • Sales (direct relationship) • Online and customer service • People with moderate acne • Male and Female, 18 and above • Male and female 18 and below (but the decision maker/buyer are mothers) Pharmacies • Academic lab • People with severe acne • Mostly Male 18 and above • Cystic acne Probiotic collections Online Mass retail • Skincare/cosmetic companies • Probiotic selection and production • Formulation of probiotic cream • QC and testing • Antibacterial to kill „bad‟ acne-causing strains • Probiotic to add back „good‟ protective strains
  • 7. Acne: History (Lack of Innovation in 30 Years) Sulfur Ancient Egypt Benzoyl peroxide 1920s Retin A 1970s Accutane Antibiotics 1980s
  • 8. Who Are Our Customers? Archetype #1 Archetype #2 •30% of adults (20-35) • 80% Teenagers (13-19) • Persistent acne, affects daily life: social and school-related •Tried other treatments – either didn‟t work or relapsed • Willing to try regular skincare regimen • Persistent acne, serious therapeutics interventions: lessened acne, or relapse of chronic acne • Affects daily life – social and professional • Desperate for effective treatment, “will try anything”
  • 9. Over the Counter (OTC) vs Prescription Estheticians Skincare Companies Dermatologists Online Pharmacies Store $2.5 Billion Market $4 Billion Market
  • 11. Initial Hypotheses Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 12. “Must be regulated by the FDA” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 13. “Cosmetic companies aren‟t going to take drugs through clinical trials” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 14. “Cosmetic companies aren‟t going to take drugs through clinical trials” Value Proposition Customer Relationships Customer Segments Channels Better! Revenue Streams J&J GSK Bayer, Galderma
  • 15. “Add probiotic component to therapeutic” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 16. “Add probiotic component to therapeutic” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 17. “Use dermatologist advisors to prove clinical efficacy” Value Proposition Customer Relationships Channels Better! Revenue Streams Customer Segments
  • 18. Other Discoveries • Regulated under CBER division of FDA Safety and Efficacy regulated under acne guidelines CMC (Chemistry, Manufacturing, and Controls) regulated under live vaccine division • Regulatory consultants and CROs are partners • Virtualize Operations • Human Pilot Trials • Salesforce required to create demand Create Demand Dermatologist Salesforce
  • 19. Attractive Market Opportunity TAM = $4 Billion 650 million people globally SAM = $2 Billion 150 million people in USA Target Market $500 Million 25% New branded drugs capture large share of the market
  • 20. Preclinical Timeline Drug Discovery Concept Validation Requirements Formulation • Validate active ingredients • Incubator space • Lab equipment Cost • $200K Time • 6 Months 0 6 Months Animal Studies Human Pilot Trials
  • 21. Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation • Validate active ingredients • Cosmetically elegant • Incubator space • Lab equipment • Formulation CROs Cost • $200K • $500K Time • 6 Months • 6 Months Requirements 0 6 Months 12 Human Pilot Trials
  • 22. Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation • Validate active ingredients • Cosmetically elegant • Efficacy, penetration, safety data • Incubator space • Lab equipment • Formulation CROs • Safety and toxicology CROs • Hamsters, mini-pigs Cost • $200K • $500K • $100K Time • 6 Months • 6 Months Human Pilot Trials • 3 Months Requirements 0 6 Months 12 15
  • 23. Preclinical Timeline Drug Discovery Concept Validation Animal Studies Formulation Human Pilot Trials • Validate active ingredients • Cosmetically elegant • Efficacy, penetration, safety data • Efficacy, endpoints, monitor microbiome • Incubator space • Lab equipment • Formulation CROs • Safety and toxicology CROs • Hamsters, mini-pigs • IRB • Dermatologists • 20-100 volunteers Cost • $200K • $500K • $100K • $500K Time • 6 Months • 6 Months • 3 Months • 3 Months Requirements 0 6 Months 12 15 18
  • 24. What Are We Going To Do Next? • Financial SBIR grants, VCs Corporate Partners • Operational Lab space, hire technical team • Structural Incorporate, freedom-to-operate analysis, provisional patents
  • 25. Therapeutic Investment Readiness Level Senior customer will endorse externally Customer partners highly interested Talent recruited to fill gaps Cost analysis and KOL network Proof of relevance data path defined Timeline and cost to data points Identify strategic need/fit at company level Base technology independently confirmed First pass canvas IRL4
  • 26. Week 1 • Non-toxic, fast clearing, highly specific bacterial killers • Can treat multi-drug resistant bacteria, and d drugs targeting emerging resistance can be found quickly and cheaply • More effective and penetrating than topical antibacterials • Can be used for antibacterial treatment in applications where antibiotics are banned (eg. Animal farms in the EU) • Analysis of initial samples • Regular monitoring of client site •Website •Site visits to collect samples • Direct mail to ship probiotics to client • Sanitization o Supermarkets o Hospitals o Animal feeding operations, aquaculture farms o Food processsing • Animal therapy o Animal feeding operations, aquaculture farms o Veterinary medicine • Human therapy o Treating multi-drug resistant bacterial infections o Niche bacterial infections o Skin conditions (acne, eczema) • Prophylactics o Anti-Staph nasal spray o Probiotics
  • 29. IS OUR BUSINESS IDEA VALIDATED? Product Market Fit (Value Proposition) - Teens and chronic acne patients need a better acne treatment Competition -Epiduo (leader) is simply a combination of benzoyl peroxide and retinoic acid - This market space has not seen a novel and more efficacious treatment of acne in the last 30 years KEY Partners to make this business happen Discovery -Collaborate with KOLS Regulatory -CROs and Regulatory Consultants - Engage big derm Marketing -Dermatologists