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A CLINICAL STAGE BIOTECHNOLOGY COMPANY DEVELOPING INNOVATIVE THERAPIES FOR TREATING ALOPECIA
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
This presentation contains forward-looking statements that reflect the Company’s current expectations regardingfuture events. There’s a risk that expectations, and the forward-looking statements on which they are based, will notprove to be accurate.
Readers are cautioned not to place undue reliance on forward-looking statements, as they involve risks and uncertaintiesthat 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, theCompany’s ability to protect its intellectual property rights and obtain patents, dependence on key personnel, thecompetitiveness of the marketplace, technological obsolescence, and other risks described from time to time in theCompany’s documents.
While Triple Hair acknowledges that future events and developments may cause its views to change, it undertakes noobligation to update forward-looking statements, except as required by applicable securities laws.
Forward-Looking Statements
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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.
About Hair Loss
Houfar Sekhavat, MDFounder and Hair Loss Sufferer
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Types of Hair Loss
Alopecia AreataAutoimmune
Induced Balding
ChemotherapyPartial or No
Hair Recovery
Androgenic Alopecia
Pattern Baldness
Scalp TraumaScarring from
Injuries/ Surgery
1-2%of hair loss incidents
Small % of chemo patients experience permanent hair
loss>90%
of hair loss incidents
Burn victims, head surgeries, head trauma
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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
his research, which led to the creation of Triple Hair.
After many years of research and trials, Triple Hair has
succeeded in creating effective products to stimulate hair
growth, namely its TH07 prescription drug that will
undergo FDA Phase 3 clinical trials.
Triple Hair was founded in 2012 by
Dr. Houfar Sekhavat and Peter Ford,
self-madeNew Brunswick entrepreneurs.
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Jean-Philippe Gravel, MBAPresident and CEO
Houfar Sekhavat, MDFounder
Peter Ford, Pharma DCo-Founder
Erika Tremblay-Gagnon, CPA CAChief Financial Officer
Satish Asotra, PH.D., MBAChief Scientific Officer
Attila Hajdu, M.Sc., MBAVP Business Development
Team
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• 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.
Overview
• 68% of the hair loss market consists of topical and oral therapies,
including Rogaine and Propecia.
• Minoxidil (Rogaine) and Finasteride (Propecia) are the only 2 FDA
approved drugs in the hair loss market for the past 20+ years.
• Rogaine and the private label Minoxidil versions control 98% of
the topical hair growth market in the U.S., with sales of close to
$870 million (2017).
• 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.
HAIR LOSS MARKET
GLOBAL:US$8.5 billion (2018)
NORTH AMERICA:US$3.9 billion (2018)
GLOBAL PROJECTED:US$12.4 billion (2025)
Source: Grand ViewResearch 2019
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Market Dynamics
TH07PRESCRIPTION
DRUG
Completed Phase 2 Study
• 6-month randomized, double-blind and
comparative study involving 40 men
between the ages of 24 and 65.
Results
• Study has shown superior efficacy and
safety vs Finasteride (oral) and Minoxidil
(topical gold standard), with single daily
topical dosage.
• Based on these outstanding results, the FDA
has given a roadmap for Triple Hair to start a
Phase 3 under 505(b)(2).
TH07 Clinical Results
R E S U L T S R E G R O W T H L E V E L S
T R E A T M E N T R E G R O W T H D E N S E M O D E R A T E M I N I M A L N O N E
Triple Hair (TH07) 100% 52% 30% 17% 0%
Propecia(Finasteride) 50% 0% 25% 25% 50%
Rogaine(Minoxidil) 25% 0% 0% 25% 75%
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TH07 Results
BEFORE AFTER
6-month treatment – Founder Houfar Sekhavat
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TH07 Results
BEFORE AFTER
6-month treatment – Patient RL
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TH07 Results
BEFORE AFTER
6-month treatment – Patient GW
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C A N D I D A T E I N D I C A T I O N P H A S E 1 P H A S E 2 P H A S E 3 Next Milestone Target Patient Population
Potential Peak Sales Revenue
TH07 Androgenetic alopecia
Product development -chemistry, manufacturing and controls (CMC) completed in Q1 2021
Pivotal phase 3 clinical trial beginning in Q3 2021
Prescription ProductMen 19-65 years
$1 - 2.5B
TH16 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$200M
TH18 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$175M
TH07 Current Status
Registration-enabling
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Androgenic Alopecia C U R R E N T & F U T U R E C O M P E T I T I V E L A N D S C A P E
Key Value Driver: Endpoints
Minoxidil(2% launched in 1986 & 5% in 1993)
Finasteride(Approved Dec 1997)
ALM12845/P3074(Launch date: 2020 or early 2021 in Europe)
SM04554 (Phase 3 data expected in Jan 2021)
TH07(Nov 2019 – Jun 2020)
Efficacy 15% improvement 12% improvement 20% change in target area hair count
Phase 3 trial not published although reported improvement in phase 2
Stimulates new hair growth & prevents further hair loss with 50% improvement
Safety Pruritis & dermatitis Label warnings for sexual adverse events No difference in sexual function Application site erythema,
pruritis and paresthesiaSimilar safety profile to topical minoxidil
Patient Benefits Quality of life improvement Slowed progression of hair loss
Fewer adverse events with similar efficacy
Novel WNT pathway could be promising
Superior efficacy and similar safety profile to existing topical treatments
Tolerability Well tolerated Well tolerated Well tolerated
Appeared well tolerated with little systemic exposure Well tolerated
Payer Value Market leader Long term efficacy and safety established
Niche market for patients suffering from oral finasteride Follicular neogenesis Fixed dose combination
Dosing Topical Oral Topical Topical Topical
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TH16NATURALPRODUCT
Completed Phase 2 Study
• 6-month randomized, double-blind and
comparative study involving 33 patients
between the ages of 24 and 65.
Results
• Study has shown superior efficacy than
monotherapies and Minoxidil 5% (topical gold
standard).
TH16 Clinical Results
R E S U L T S R E G R O W T H L E V E L S
T R E A T M E N T R E G R O W T H D E N S E M O D E R A T E M I N I M A L N O N E
Triple Hair (TH16) 100% 50% 33% 17% 0%
Minoxidil 5% 25% 0% 0% 25% 75%
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TH16 Results
BEFORE AFTER
6-month treatment – Patient GB
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TH16 Results
BEFORE AFTER
3-month treatment – Patient SB
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TH16 Results
BEFORE AFTER
3-month treatment – Patient ME
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C A N D I D A T E I N D I C A T I O N P H A S E 1 P H A S E 2 P H A S E 3 Next Milestone Target Patient Population
Potential Peak Sales Revenue
TH07 Androgenetic alopecia
Product development -chemistry, manufacturing and controls (CMC) completed in Q1 2021
Pivotal phase 3 clinical trial beginning in Q3 2021
Prescription ProductMen 19-65 years
$1 - 2.5B
TH16 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$200M
TH18 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$175M
TH16 Current Status
Registration-enabling
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TH18NON-PRESCRIPTION
DRUG
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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.
C A N D I D A T E I N D I C A T I O N P H A S E 1 P H A S E 2 P H A S E 3 Next Milestone Target Patient Population
Potential Peak Sales Revenue
TH07 Androgenetic alopecia
Product development -chemistry, manufacturing and controls (CMC) completed in Q1 2021
Pivotal phase 3 clinical trial beginning in Q3 2021
Prescription ProductMen 19-65 years
$1 - 2.5B
TH16 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$200M
TH18 Alopecia / Hair Loss
Scaling up manufacturing, regulatory filing, launch
Over the Counter / Cosmetic
Women 20-50 yearsMen 19-65 years
$175M
TH18 Current Status
Registration-enabling
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Patent agent: Gowling wlg
TH07 - International patent issued
TH07 - Canadian patent issued
TH07 - Chinese patent issued
TH07 - US patent issued
TH07 - European patent issued
TH07 - Macau patent issued
TH07 - India patent issued
TH16 - Canadian patent filed
TH16 - US patent issued
TH16 - European patent filed
TH16 - Hong Kong patent filed
TH16 - Chinese patent filed
Protecting ourIntellectual Property
Triple Hair is continually filing new patents in markets with significant commercial potential as we develop our products through their life cycle
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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
TH16
TH18
TH07
Key Event Timeline
IND Filed
Data Readout
Launch
Slide 26
PRODUCT LAUNCH
PRODUCT LAUNCH
Product DevelopmentChemistry, Manufacturing & Controls
Phase 3 Androgenetic Alopecia n=1,000
Oct
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Triple 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
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