phi therapeutics wk10 final nvp
TRANSCRIPT
![Page 1: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/1.jpg)
A Probiotic Approach to Effective Acne Therapy
Phi Therapeutics
December 10, 2013
Consumer interviews: 17Pharma interviews: 19KOL interviews: 14Regulatory interviews: 14IP interviews: 6Other Interviews: 22_____________________Total Interviews: 92
![Page 2: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/2.jpg)
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
Mentors:Bob DunkleKarl Handelsman
![Page 3: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/3.jpg)
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
![Page 4: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/4.jpg)
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
![Page 5: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/5.jpg)
I was happy …
.. but Nancy had other ideas
After an Important Interview
![Page 6: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/6.jpg)
• Obtain probiotic strains
• Obtain lead compounds
• IP strategy• Effective treatment
of acne• Minimal side effects• Natural and
probiotic• Non-intensive
treatment regimen
Probiotic collections
• Sales (direct relationship)
• Online and customer service
• Skincare and cosmetic companies
• Academic lab
• Regulatory agencies (FDA)
Pharmacies
Online
Mass retail
• Dermatologists
• People with moderate acne
• Male and Female, 18 and above
• Male and female 18 and below (but the decision maker/buyer are mothers)
• People with severe acne
• Mostly Male 18 and above
• Cystic acne
• 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
Week 3: Focus on Acne
![Page 7: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/7.jpg)
Acne: History (Lack of Innovation in 30 Years)
Ancient Egypt
Sulfur Benzoyl peroxide
1920s 1980s1970s
Retin AAccutane
Antibiotics
![Page 8: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/8.jpg)
• 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
•30% of adults (20-35)
• 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”
Who Are Our Customers?
Archetype #1 Archetype #2
![Page 9: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/9.jpg)
Store Online Pharmacies
Over the Counter (OTC) vs Prescription
EstheticiansSkincare Companies Dermatologists
$2.5 Billion Market $4 Billion Market
![Page 10: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/10.jpg)
![Page 11: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/11.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Initial Hypotheses
Better!
![Page 12: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/12.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Regulato
ry“Must be regulated by the FDA”
Better!
![Page 13: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/13.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Customer
Segm
ent
“Cosmetic companies aren’t going to take drugs through clinical trials”
Better!
![Page 14: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/14.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer Segments
Antibacterial
Customer
Segm
ent
Better!J&JGSKBayer, Galderma
“Cosmetic companies aren’t going to take drugs through clinical trials”
![Page 15: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/15.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsIP
“Add probiotic component to therapeutic”
Better!
Antibacterial
![Page 16: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/16.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsIP
Better!
Antibacterial+ Probiotic
“Add probiotic component to therapeutic”
![Page 17: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/17.jpg)
Value Proposition Customer Relationships
Channels
Revenue Streams
Customer SegmentsPartners
“Use dermatologist advisors to prove clinical efficacy”
Better!
Antibacterial+ Probiotic
![Page 18: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/18.jpg)
Other Discoveries
• Regulated under CBER division of FDASafety and Efficacy regulated under acne guidelinesCMC (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
DermatologistSalesforce
CreateDemand
![Page 19: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/19.jpg)
Attractive Market Opportunity
TAM = $4 Billion
SAM = $2 Billion
650 million people globally
150 million people in USA
Target Market$500 Million
25% New branded drugs capture large share of the market
![Page 20: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/20.jpg)
Preclinical Timeline
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
0 6Months
![Page 21: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/21.jpg)
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
0 6 12Months
Preclinical Timeline
![Page 22: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/22.jpg)
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
• Efficacy, penetration, safety data
• Safety and toxicology CROs• Hamsters, mini-pigs
• $100K
• 3 Months
0 6 12 15Months
Preclinical Timeline
![Page 23: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/23.jpg)
Drug Discovery
Formulation
Animal Studies
Human Pilot Trials
ConceptValidation
Requirements
Cost
Time
• Validate active ingredients
• Incubator space• Lab equipment
• $200K
• 6 Months
• Cosmetically elegant
• Formulation CROs
• $500K
• 6 Months
• Efficacy, penetration, safety data
• Safety and toxicology CROs• Hamsters, mini-pigs
• $100K
• 3 Months
• Efficacy, endpoints, monitor microbiome
• IRB• Dermatologists• 20-100 volunteers
• $500K
• 3 Months
0 6 12 15 18Months
Preclinical Timeline
![Page 24: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/24.jpg)
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
![Page 25: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/25.jpg)
Therapeutic Investment Readiness Level
IRL4
Senior customer will endorse externally
First pass canvas
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
![Page 26: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/26.jpg)
Week 1
d
• Non-toxic, fast clearing, highly specific bacterialkillers
• Can treat multi-drug resistant bacteria, and 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
• Sanitizationo Supermarketso Hospitalso Animal feeding operations, aquaculture farmso Food processsing• Animal therapyo Animal feeding operations, aquaculture farmso Veterinary medicine• Human therapyo Treating multi-drug resistant bacterial infectionso Niche bacterial infectionso Skin conditions (acne, eczema)• Prophylacticso Anti-Staph nasal sprayo Probiotics
![Page 27: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/27.jpg)
![Page 28: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/28.jpg)
![Page 29: Phi therapeutics wk10 final nvp](https://reader034.vdocuments.site/reader034/viewer/2022042522/55d53be7bb61eb6c4e8b4651/html5/thumbnails/29.jpg)
Product Market Fit (Value Proposition)- Teens and chronic acne patients need a better acne treatment
IS OUR BUSINESS IDEA VALIDATED?
Discovery-Collaborate with KOLS
Regulatory-CROs and Regulatory Consultants
- Engage big derm
Marketing-
Dermatologists
KEY Partners to make this business happen
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