next generation hair growth therapies · that will disrupt the us$8.5 billion global hair loss...
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NEXT GENERATION HAIR GROWTH THERAPIES
Corporate PresentationMarch 2020
This presentation contains forward-looking statements that reflect the Company’s current expectationsregarding future events. There’s a risk that expectations, and the forward-looking statements on which theyare 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 couldmake actual results differ materially from those projected therein and depend on a number of factors, including, but not limited to, theCompany’s lack of history of profitability, the availability of future financing, the Company’s ability to protect its intellectual propertyrights and obtain patents, dependence on key personnel, the competitiveness of the marketplace, technological obsolescence, and otherrisks 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 toupdate forward-looking statements, except as required by applicable securities laws.
FORWARD-LOOKING STATEMENTS
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HISTORY
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 and Donna, who provided
him with their expertise and 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.
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Triple Hair was founded in 2012 by
Dr. Houfar Sekhavat, Dr. Peter Ford and Ms. Donna Steeves,
self-made New Brunswick
entrepreneurs.
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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.
• Triple Hair is already well financed with over $1.8 million in cash and access to a
$369,000 loan from ACOA.
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MANAGEMENT TEAM
Jean-Philippe Gravel, MBA
President and CEO• Over 15 years of experience in management
and business development mainly with medical, pharmaceutical and natural health product companies: CEO of TSXV-listed Mondias Natural Products; VP, Business Development at Capilia, a North American leader in hair loss solutions.
Erika Tremblay-Gagnon, CPA CA, M.Sc.
Chief Financial Officer• Over 14 years of financial executive experience,
mainly as VP, Corporate Finance with TSX-listed Stingray Group ($400 million market cap) and Senior Manager, Audit and Certification at PricewaterhouseCoopers.
CONSULTANTS
API Sourcing
Formulation / CMO Identification
Regulatory – Pathway Study Design
Clinical Manager
CRO Consultant
Tax Credits, Grants and Funding
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Satish Asotra, Ph.D., MBA
Chief Scientific Officer• Senior executive and strategic leader with a proven
track record of driving pharmaceutical development, innovation and process improvement with 25 years of experience, including more than 12 years in topical and dermatological product development, with Avicanna, AHI, Accucaps, Odan Laboratories and Taro Pharmaceuticals.
Attila Hajdu, M.Sc., MBA
Vice President, Business Development• Accomplished leader with over 20 years of
experience years in the global pharmaceutical and biotechnology industry, mainly in business development, sales, marketing, finance and medical affairs with XCO Tech, Stelvia Therapeutics, Sirona Biochem, GlaxoSmithKline and Astellas Pharma.
MARKET DYNAMICS
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.
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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
TODAY’S HAIR LOSS MARKET IMAGE
”American hair loss sufferers spend more than 3.5 billion dollars a year in
an attempt to treat their hair loss. Unfortunately, 99% of all products
being marketed in the less than ethical hair loss treatment industry are
completely ineffective for the majority of those who use them.”
-
The Washington Post
“This market segment includes everything from snake oil remedies
where an estimated 99% of products are of a dubious nature. The best
the industry has to offer is Minoxidil (Rogaine).”
-
Biotech and healthcare analyst
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Rogaine (Minoxidil)
• Over-the-counter liquid or foam to rub onto the scalp twice a day.• May be used by men (5%) and women (3%).• Effect peaks at 16 weeks and patients need to keep applying the medication to
retain benefits.
Propecia (Finasteride)
• Prescription drug indicated only for men.• Taken daily in pill form.• Many men taking finasteride experience a slowing of hair loss, and some may
show some new hair growth.• Common side effects include headache, swelling and nausea.• Serious side effects include depression, gynecomastia, impotence, erectile
dysfunction, male breast cancer and prostate cancer.
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COMPETITION – MAIN BRANDS
TH07PRESCRIPTION
DRUG
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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(2)(b).
Hypothesis
• The combination of three existing and approved drugs will
create a synergistic efficiency for hair regrowth as compared
to its components used as monotherapies.
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TH07 HYPOTHESIS AND RESULTS TO DATE
TH07 RESULTS
Regrowth Levels
Treatment Regrowth Dense Moderate Minimal None
Triple Hair (TH07) 100% 52% 30% 17% 0%
Propecia(Finasteride) 50% 0% 25% 25% 50%
Rogaine(Minoxidil) 25% 0% 0% 25% 75%
TH07 RESULTS 6-month treatment – Founder Houfar Sekhavat
BEFORE
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AFTER
TH07 RESULTS 6-month treatment – Patient RL
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BEFORE AFTER
6-month treatment – Patient GW
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TH07 RESULTS
BEFORE AFTER
2020 ------------------------------------------------• Secure sourcing of active ingredients
• Stability testing
• Pharmacokinetics testing
• Possible Pre-Phase 3 clinical trial to accelerate process and
reduce costs
2021 ------------------------------------------------• Phase 3 clinical trial
• Identify possible pharma partner to develop and market TH07
• Commercialization plan
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TH07 Product Development Strategy
TH16NATURALPRODUCT
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TH16 HYPOTHESIS AND RESULTS TO DATE
Study Process
• 6-month randomized, double-blind and
comparative study involving 33 patients
between the ages of 24 and 65.
Hypothesis
• The combination of two existing and approved
natural health products will create a synergistic
efficiency for hair regrowth as compared to its
components used as monotherapies.
Results
• Study has shown superior efficacy than
monotherapies and Minoxidil 5% (topical
gold standard).
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Product A Product B
• Non-irritating solution with no serious side effects or drug interactions.
• Can be used safely in combination with existing hair growth products such
as Rogaine (Minoxidil) to improve results.
• Superior at stopping hair loss and increasing the number, thickness and
pigmentation of hair.
• Conveniently applied once daily (Minoxidil products require twice daily
application).
• Safe for use by both women and men (Minoxidil 5% cannot be used by
women).
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TH16 Other Key Advantages
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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TH16 RESULTS
BEFORE AFTER
2020 ------------------------------------------------
• Complete market analysis
• Direct to consumer - launch TH16 via online e-commerce platform
2021 ------------------------------------------------• Retail distribution
• Private label market – International distributors
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TH16 Product Development Strategy
TH18NON-PRESCRIPTION
DRUG
Product / Study / Results
• 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.
Next Steps
• Further studies to better evaluate efficacy and safety.
• File for Health Canada and FDA Drug Identification
Number (1-year process).
TH16 (Product A + Product B)
Minoxidil 5%
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TH18 PRODUCT
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
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PROTECTING OUR INTELLECTUAL PROPERTY
Next Steps
1. Build the management and scientific team
2. Recruit board members with strong international pharma network,
M&A and licensing expertise, experience in bringing biotech start-up
companies to unicorn status (>$1 billion), and regulatory and
compliance knowledge
3. Optimize the regulatory process to maximize TH07 Phase 3 trial success
4. Complete the marketing plan and commercialize our TH16 natural
product
5. File with Health Canada to receive NPN for TH16 and DIN for TH18
6. Identify possible pharma partner to develop and market TH07
2525
NEXT STEPS
CONTACT-Jean-Philippe GravelPresident and Chief Executive Officer(514) [email protected]