FOLLICA

(FOL-004, FOL-005)

TRIAL PHASE
Product Candidate
PureTech Ownership
Initial Indications
Preclinical
Phase 1
Phase 2
Phase 3
FOL-004
77.9% (Follica) R
Androgenetic Alopecia

Initial Indication(s):

Androgenetic alopecia

Patient Population:

~65M

Collaborators:

Penn

Key Differentiation:

Pioneering technology focused on the creation of new hair follicles via skin disruption and subsequent treatment to enhance effect

FOL-005
77.9% (Follica) R
Skin Rejuvenation

Initial Indication(s):

Skin rejuvenation

Patient Population:

~3.9M

Collaborators:

Penn

Key Differentiation:

Pioneering technology focused on the creation of new hair follicles via skin disruption and subsequent treatment to enhance effect



FOL-004
Androgenetic Alopecia
77.9% (Follica) R
2

Initial Indication(s):

Androgenetic alopecia

Patient Population:

~65M

Collaborators:

Penn

Key Differentiation:

Pioneering technology focused on the creation of new hair follicles via skin disruption and subsequent treatment to enhance effect

FOL-005
Skin Rejuvenation
77.9% (Follica) R
2

Initial Indication(s):

Skin rejuvenation

Patient Population:

~3.9M

Collaborators:

Penn

Key Differentiation:

Pioneering technology focused on the creation of new hair follicles via skin disruption and subsequent treatment to enhance effect



Enabling follicle neogenesis and skin rejuvenation through immune response to wounding

Founded by PureTech, Follica’s regenerative biology platform is based on seminal findings from the University of Pennsylvania that demonstrated the creation of skin organs (hair follicles) in adult mammals after abrasion. This technology is being applied to treat androgenetic alopecia, skin rejuvenation, and other aesthetic-related indications. Follica’s technology is the first, to PureTech’s knowledge, observed to create new follicles and hair followed by the application of specific compounds to enhance the effect. Follica completed three human clinical studies of patients with androgenetic alopecia to demonstrate hair follicle neogenesis via biopsy following skin disruption, and hair growth through target area hair count. Follica has been optimizing its device and conducting tests in androgenetic alopecia and other medical indications and is further developing and testing compounds that enhance the newly formed follicles and hairs.

We have preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation. We completed our clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimization study. Further phases of pre-clinical testing are also ongoing towards the prioritization and development of next-generation, proprietary compounds based on our intellectual property. Our RAIN pivotal study is expected to commence following the completion of the optimization study.

  • Patient Need & Market Potential
    • Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 65 million people who are eligible for treatment in the U.S. alone.
    • Only two drugs, both with limited regrowth efficacy, are currently approved for the treatment of androgenetic alopecia. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible.
    • As a result, Follica believes that there is significant unmet need for safe, effective, non-surgical treatments which grow new hair.
    • Follica’s regenerative biology platform has applications beyond hair growth to other aging-related conditions and wound healing.
  • Our Approach to Solving the Problem
    • Follica’s approach is based on generating an “embryonic window” in adults via a series of skin disruptions, stimulating stem cells causing new hair follicles to grow. 
  • Intellectual Property
    • Follica’s regenerative biology program has broad worldwide intellectual property coverage, including ninety-two (92) patent applications, including thirty-three (33) issued patents, in ten (10) families of patent filings, which are company-owned or exclusively licensed.
    • The intellectual property covers composition of matter and methods of treatment including combination therapies employing disruption approaches and active agents, as well as devices to promote hair follicle regeneration.
  • Team
    • Follica is led by Jason Bhardwaj (previously Bain & Company) and team members Jonathan Bissett (previously NeoSync) and David Chastain (previously Cambridge Consultants and Continuum).
    • Key advisors include Dr. R Rox Anderson (Director of MGH Wellman Labs and Inventor of CoolSculpting by Zeltiq), Dr. George Cotsarelis (University of Pennsylvania Medical School and Founder of Kythera), and Dr. Ken Washenik (Bosley Medical Group and previously Aderans Research Institute).
  • Milestones Achieved
    • Follica announced positive interim data from an ongoing safety and optimization study of its lead candidate FOL-004 to treat hair loss in male androgenetic alopecia. In addition to being well tolerated and informing key treatment parameters, an analysis of 20 male study participants with androgenetic alopecia showed that Follica’s approach achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment compared to baseline. Additionally, blinded head-to-head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. 
    • The product concept originated from ground-breaking science demonstrating new mammalian skin formation in adult mice following abrasion. The results were published in the top tier medical science journal, Nature.
  • Expected Milestones and Timing
    • A pivotal study of FOL-004 is expected to initiate at the end of 2019 subject to continued safety and efficacy in the optimization study

       

Follica has preclinical data which show the potential for proprietary compounds to further enhance the effect of new hair follicle formation. Follica completed its clinical-stage development of a device and drug combination product for androgenetic alopecia, which is currently in an optimization study. Further phases of preclinical testing are also ongoing towards the prioritization and development of proprietary compounds based on Follica’s intellectual property. Follica’s pivotal study is expected to commence following the completion of the optimization study.


Skin disruption to create new hair follicle