a clinical stage biotechnology company developing ... · approved drugs in the hair loss market for...

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





$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).


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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$1 - 2.5B





$200M





$175M

TH16 Current Status


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TH18NON-PRESCRIPTION

DRUG

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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.







$1 - 2.5B





$200M





$175M

TH18 Current Status


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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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CONTACT

Jean-Philippe GravelPresident and Chief Executive [email protected]

http://triplehair.ca

a clinical stage biotechnology company developing ... · approved drugs in the hair loss market for...

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