Phi therapeutics wk10 final nvp

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

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

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

Week 1

d







•Website




I was happy …

.. but Nancy had other ideas

After an Important Interview

• 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

Acne: History (Lack of Innovation in 30 Years)

Ancient Egypt

Sulfur Benzoyl peroxide

1920s 1980s1970s

Retin AAccutane

Antibiotics

• 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

Store Online Pharmacies

Over the Counter (OTC) vs Prescription

EstheticiansSkincare Companies Dermatologists

$2.5 Billion Market $4 Billion Market

Value Proposition Customer Relationships

Channels

Revenue Streams

Customer Segments

Antibacterial

Initial Hypotheses

Better!


Channels

Revenue Streams

Customer Segments

Antibacterial

Regulato

ry“Must be regulated by the FDA”

Better!


Channels

Revenue Streams

Customer Segments

Antibacterial

Customer

Segm

ent

“Cosmetic companies aren’t going to take drugs through clinical trials”

Better!


Channels

Revenue Streams

Customer Segments

Antibacterial

Customer

Segm

ent

Better!J&JGSKBayer, Galderma

“Cosmetic companies aren’t going to take drugs through clinical trials”


Channels

Revenue Streams

Customer SegmentsIP

“Add probiotic component to therapeutic”

Better!

Antibacterial


Channels

Revenue Streams

Customer SegmentsIP

Better!

Antibacterial+ Probiotic

“Add probiotic component to therapeutic”


Channels

Revenue Streams

Customer SegmentsPartners

“Use dermatologist advisors to prove clinical efficacy”

Better!

Antibacterial+ Probiotic

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

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

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

Drug Discovery

Formulation

Animal Studies

Human Pilot Trials

ConceptValidation

Requirements

Cost

Time



• $200K

• 6 Months

• Cosmetically elegant

• Formulation CROs

• $500K

• 6 Months

0 6 12Months


Drug Discovery

Formulation

Animal Studies

Human Pilot Trials

ConceptValidation

Requirements

Cost

Time



• $200K

• 6 Months



• $500K

• 6 Months

• Efficacy, penetration, safety data

• Safety and toxicology CROs• Hamsters, mini-pigs

• $100K

• 3 Months

0 6 12 15Months


Drug Discovery

Formulation

Animal Studies

Human Pilot Trials

ConceptValidation

Requirements

Cost

Time



• $200K

• 6 Months



• $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


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

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

Week 1

d







•Website




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

Education

Phi therapeutics wk10 final nvp