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
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
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
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
27.
28.
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