A CLINICAL STAGE BIOTECHNOLOGY COMPANY DEVELOPING INNOVATIVE THERAPIES FOR TREATING ALOPECIA - Triple Hair
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C O R P O R A T E P R E S E N T AT I O N - J U N E 2 0 2 0 A CLINICAL STAGE BIOTECHNOLOGY COMPANY DEVELOPING INNOVATIVE THERAPIES FOR TREATING ALOPECIA
Forward-Looking Statements
This presentation contains forward-looking statements that reflect the Company’s current expectations regarding
future events. There’s a risk that expectations, and the forward-looking statements on which they are based, will not
prove to be accurate.
Readers are cautioned not to place undue reliance on forward-looking statements, as they involve risks and uncertainties
that could make actual results differ materially from those projected therein and depend on a number of factors,
including, but not limited to, the Company’s lack of history of profitability, the availability of future financing, the
Company’s ability to protect its intellectual property rights and obtain patents, dependence on key personnel, the
competitiveness of the marketplace, technological obsolescence, and other risks described from time to time in the
Company’s documents.
While Triple Hair acknowledges that future events and developments may cause its views to change, it undertakes no
obligation to update forward-looking statements, except as required by applicable securities laws.
2
About Hair Loss
AS MUCH AS 20% OF THE
HUMAN POPULATION SUFFERS
FROM HAIR LOSS, CLINICALLY
REFERRED TO AS ALOPECIA.
Despite these large numbers,
solutions have historically
been inadequate.
Houfar Sekhavat, MD
Founder and Hair Loss Sufferer
3
Types of Hair Loss
Alopecia Areata Chemotherapy Androgenic Scalp Trauma
Autoimmune Partial or No Scarring from
Induced Balding Hair Recovery
Alopecia Injuries/ Surgery
Pattern Baldness
1-2% Small % of chemo patients
experience permanent hair >90% Burn victims, head
surgeries, head trauma
of hair loss incidents loss of hair loss incidents
4
Our Story
Dr. Sekhavat was balding and tried several known
treatments, which led to disappointing results. Through his
medical background, he decided to start his own research
by combining known molecules to achieve better efficacy.
He shared his theories with Peter Ford, a pharmacist, who
provided him with his expertise and the tools he needed for
Triple Hair was his research, which led to the creation of Triple Hair.
founded in 2012 by
Dr. Houfar Sekhavat After many years of research and trials, Triple Hair has
and Peter Ford, succeeded in creating effective products to stimulate hair
self-made growth, namely its TH07 prescription drug that will
New Brunswick
undergo FDA Phase 3 clinical trials.
entrepreneurs.
5
Jean-Philippe Gravel, MBA Houfar Sekhavat, MD Peter Ford, Pharma D
President and CEO Founder Co-Founder
Team
Erika Tremblay-Gagnon, CPA CA Satish Asotra, PH.D., MBA Attila Hajdu, M.Sc., MBA
Chief Financial Officer Chief Scientific Officer VP Business Development
6
Overview
• Triple Hair is developing the next generation topical hair growth therapies
that will disrupt the US$8.5 billion global hair loss market.
• Triple Hair is the only company to develop effective topical products for both
the prescription drug market (TH07) and the over-the-counter (OTC) market
(TH16 and TH18):
- TH07 is a 3-in-1 prescription drug based on effective and approved known
active ingredients.
- TH16 is a natural product based on known natural active ingredients.
- TH18 is a newly created non-prescription drug.
7
Market Dynamics
• 68% of the hair loss market consists of topical and oral therapies,
including Rogaine and Propecia.
HAIR LOSS MARKET
• Minoxidil (Rogaine) and Finasteride (Propecia) are the only 2 FDA GLOBAL:
US$8.5 billion (2018)
approved drugs in the hair loss market for the past 20+ years.
NORTH AMERICA:
• Rogaine and the private label Minoxidil versions control 98% of US$3.9 billion (2018)
the topical hair growth market in the U.S., with sales of close to GLOBAL PROJECTED:
US$12.4 billion (2025)
$870 million (2017).
Source: Grand View
Research 2019
• In Canada, the hair growth product industry is estimated at $170
million.
• Patents have expired for Rogaine and Propecia, allowing
Triple Hair to efficiently compete in this large market.
• Hair growth products are lifetime-use products: clients on
average will easily spend $5,000 per year over a 20-year
period.
8
TH07 PRESCRIPTION DRUG
TH07 Clinical Results Completed Phase 2 Study
• 6-month randomized, double-blind and
comparative study involving 40 men
RESULTS REGROWTH LEVELS between the ages of 24 and 65.
Results
TREATMENT REGROWTH DENSE MODERATE MINIMAL NONE
• Study has shown superior efficacy and
Triple Hair
100% 52% 30% 17% 0% safety vs Finasteride (oral) and Minoxidil
(TH07)
(topical gold standard), with single daily
Propecia
50% 0% 25% 25% 50% topical dosage.
(Finasteride)
Rogaine
25% 0% 0% 25% 75% • Based on these outstanding results, the FDA
(Minoxidil)
has given a roadmap for Triple Hair to start a
Phase 3 under 505(b)(2).
10TH07 Results
6-month treatment – Founder Houfar Sekhavat
BEFORE AFTER
11TH07 Results
6-month treatment – Patient RL
BEFORE AFTER
12TH07 Results
6-month treatment – Patient GW
BEFORE AFTER
13TH07 Current Status
Potential
Target Patient
CANDIDATE INDICATION PHASE 1 PHASE 2 PHASE 3 Next Milestone Peak Sales
Population
Revenue
Product development -
chemistry, manufacturing and
controls (CMC) completed in Prescription
Androgenetic
TH07 alopecia
Q1 2021 Product $1 - 2.5B
Men 19-65 years
Pivotal phase 3 clinical trial
beginning in Q3 2021
Over the Counter
/ Cosmetic
Alopecia / Scaling up manufacturing,
TH16 Hair Loss regulatory filing, launch Women 20-50
$200M
years
Men 19-65 years
Over the Counter
/ Cosmetic
Scaling up manufacturing,
Alopecia / Hair
TH18 Loss
regulatory filing, launch
Women 20-50
$175M
years
Men 19-65 years
Registration-enabling
14Androgenic Alopecia
CURRENT & FUTURE COMPETITIVE LANDSCAPE
Key Value Driver: Minoxidil Finasteride ALM12845/P3074 SM04554 TH07
(2% launched in 1986 & 5% in (Launch date: 2020 or early 2021 in (Phase 3 data expected in Jan
Endpoints 1993)
(Approved Dec 1997)
Europe) 2021)
(Nov 2019 – Jun 2020)
Phase 3 trial not published Stimulates new hair growth
20% change in target area hair
Efficacy 15% improvement 12% improvement although reported & prevents further hair loss
count
improvement in phase 2 with 50% improvement
Label warnings for sexual Application site erythema, Similar safety profile to
Safety Pruritis & dermatitis
adverse events
No difference in sexual function
pruritis and paresthesia topical minoxidil
Superior efficacy and
Slowed progression of Fewer adverse events with Novel WNT pathway could
Patient Benefits Quality of life improvement similar safety profile to
hair loss similar efficacy be promising
existing topical treatments
Appeared well tolerated
with little systemic
Tolerability Well tolerated Well tolerated Well tolerated Well tolerated
exposure
Long term efficacy and Niche market for patients
Payer Value Market leader
safety established suffering from oral finasteride
Follicular neogenesis Fixed dose combination
Dosing Topical Oral Topical Topical Topical
15TH16 NATURAL PRODUCT
TH16 Clinical Results
Completed Phase 2 Study
• 6-month randomized, double-blind and
RESULTS REGROWTH LEVELS comparative study involving 33 patients
between the ages of 24 and 65.
TREATMENT REGROWTH DENSE MODERATE MINIMAL NONE
Results
Triple Hair
(TH16)
100% 50% 33% 17% 0% • Study has shown superior efficacy than
monotherapies and Minoxidil 5% (topical gold
Minoxidil 5% 25% 0% 0% 25% 75%
standard).
17TH16 Results
6-month treatment – Patient GB
BEFORE AFTER
18TH16 Results
3-month treatment – Patient SB
BEFORE AFTER
19TH16 Results
3-month treatment – Patient ME
BEFORE AFTER
20TH16 Current Status
Potential
Target Patient
CANDIDATE INDICATION PHASE 1 PHASE 2 PHASE 3 Next Milestone Peak Sales
Population
Revenue
Product development -
chemistry, manufacturing and
controls (CMC) completed in Prescription
Androgenetic
TH07 alopecia
Q1 2021 Product $1 - 2.5B
Men 19-65 years
Pivotal phase 3 clinical trial
beginning in Q3 2021
Over the Counter
/ Cosmetic
Alopecia / Scaling up manufacturing,
TH16 Hair Loss regulatory filing, launch Women 20-50
$200M
years
Men 19-65 years
Over the Counter
/ Cosmetic
Scaling up manufacturing,
Alopecia / Hair
TH18 Loss
regulatory filing, launch
Women 20-50
$175M
years
Men 19-65 years
Registration-enabling
21TH18 NON-PRESCRIPTION DRUG
TH18 Clinical Results
Product / Study / Results
• TH18 is a blend of TH16 and Minoxidil 5%.
• Study done on a small group of patients for information
gathering purposes.
• Preliminary results to date show even better results
than by using TH16 alone.
23TH18 Current Status
Potential
Target Patient
CANDIDATE INDICATION PHASE 1 PHASE 2 PHASE 3 Next Milestone Peak Sales
Population
Revenue
Product development -
chemistry, manufacturing and
controls (CMC) completed in Prescription
Androgenetic
TH07 alopecia
Q1 2021 Product $1 - 2.5B
Men 19-65 years
Pivotal phase 3 clinical trial
beginning in Q3 2021
Over the Counter
/ Cosmetic
Alopecia / Scaling up manufacturing,
TH16 Hair Loss regulatory filing, launch Women 20-50
$200M
years
Men 19-65 years
Over the Counter
/ Cosmetic
Scaling up manufacturing,
Alopecia / Hair
TH18 Loss
regulatory filing, launch
Women 20-50
$175M
years
Men 19-65 years
Registration-enabling
24Protecting our
Intellectual Property
Patent agent: Gowling wlg
TH07 - International patent issued
TH07 - Canadian patent issued
TH07 - Chinese patent issued TH16 - Canadian patent filed
TH07 - US patent issued TH16 - US patent issued
TH07 - European patent issued TH16 - European patent filed
TH07 - Macau patent issued TH16 - Hong Kong patent filed
TH07 - India patent issued TH16 - Chinese patent filed
Triple Hair is continually filing new
patents in markets with significant
commercial potential as we develop our
products through their life cycle
25Slide 26
Key Event Timeline
Data
Readout
Q 1 -2 0 2 0 Q 2 -2 0 2 0 Q 3 -2 0 2 0 Q 4 -2 0 2 0 Q 1 -2 0 2 1 Q 2 -2 0 2 1 Q 3 -2 0 2 1 Q 4- 2 0 2 1
Launch
TH16 PRODUCT LAUNCH
TH18 PRODUCT LAUNCH
TH07 Product Development IND Phase 3 Androgenetic
Chemistry, Manufacturing & Controls Filed Alopecia n=1,000
Oct
26Triple Hair’s Business
Model for Value Creation
COMMERCIALIZE INNOVATIVE COMBINATION PRODUCTS FOR THE
PRESCRIPTION DRUG AND COSMETIC OVER THE COUNTER MARKETS
Accelerate commercialization globally in partnership with leading pharmaceutical
companies with sales and marketing infrastructure in major markets
License assets for upfront, milestone and royalty payments
Maximize value through flexibility in deal structure
Generate revenue quickly by launching into cosmetic and over the counter markets
27CONTACT Jean-Philippe Gravel President and Chief Executive Officer info@triplehair.ca
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