Jefferies London Healthcare Conference

Corporate Presentation

NASDAQ/TSX - BLU

November 20, 2019

Forward Looking Statements

Certain statements contained in this presentation, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations and other applicable securities laws. Forward-looking statements are frequently, but not always, identified by words such as "expects," "anticipates," "believes," "intends," "estimates," "potential," "possible," "projects," "plans," and similar expressions. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health's control. Risk factors that may affect BELLUS Health's future results include but are not limited to: the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health does business, stock market volatility, heavy dependence on licensed intellectual property, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights , achievement of forecasted pre-clinical and clinical trial milestones, reliance on third parties to conduct preclinical studies and clinical trials for BLU-5937 and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health's product candidates development process, their market size and commercial value, as well as the sharing of proceeds between BELLUS Health and its potential partners from potential future revenues, if any, are dependent upon a number of factors. Moreover, BELLUS Health's growth and future prospects are mainly dependent on the successful development, regulatory approval and commercialization of its product candidate BLU-5937. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health believes that expectations represented by forward- looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this presentation. These forward-looking statements speak only as of the date made, and BELLUS Health is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation.

Please see BELLUS Health's public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health and its business.

2

Company Overview

BELLUS Overview

Lead Program: BLU-5937

Highly Selective P2X3 Antagonist for Chronic Cough:

  • Large population with significant unmet need
  • Indication of interest by big pharma (e.g. Merck and Bayer)
  • Phase 1 suggests best-in-class potential
  • Clinically validated target reduces clinical risk
  • Phase 2 underway with data expected in mid 2020

Pipeline within a Molecule

2nd indication in chronic pruritus associated with atopic dermatitis with potential for broad applicability in hypersensitization disorders

Cash Runway Beyond Proof-of-Concept

~$100M (C$132M)1 cash position

Robust IP

Patent estate including composition of matter covering BLU-5937 and related compounds expiring in 2034

Experienced Team

Management with track record of execution

4

1as of June 30, 2019 and proforma to September 5th, 2019 financing

Strong Leadership and Advisory Group

Management

Roberto Bellini

President & Chief Executive Officer

Dr. Catherine Bonuccelli

Chief Medical Officer

Dr. Denis Garceau

Senior Vice President, Drug Development

François Desjardins

Vice President, Finance

Tony Matzouranis

Vice President, Business Development

Board of Directors

Dr. Francesco Bellini

Roberto Bellini

Dr. Youssef Bennani

Chair

Franklin Berger

Dr. Clarissa Desjardins

Chau Q. Khuong

Pierre Larochelle

Joseph Rus

Clinical Advisory Board

Dr. Jacky Smith (Chair) , MB, ChB, FRCP, PhD

Dr. Lorcan McGarvey , MD, FRCP

University of Manchester

Queen's University of Belfast

Dr. Alan Goldsobel, MD

Dr. Alyn Morice , MD

UCSF; Stanford Medical School

Hull York Medical School

Dr. James Hull , BSc, MBBS, FRCP, PhD, FACSM

Dr. Mandel Sher , MD

Royal Brompton Hospital

University of South Florida

5

BLU-5937: Pipeline Within a Molecule

PROGRAM

DEVELOPMENT

STATUS

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Worldwide

Next Anticipated Milestone

Rights

BLU-5937

Refractory

Mid-2020: Topline data

Chronic Cough

Chronic Pruritus

Associated withQ2 2020: Phase 2 initiation

Atopic Dermatitis

  • Clinical results demonstrate that BLU-5937, a highly selective P2X3 antagonist, is a differentiated product candidate that has little to no impact on taste perception
  • Phase 2 clinical trial to assess the efficacy, safety and tolerability of BLU-5937 in refractory chronic cough patients is underway with results expected in mid-2020

6

P2X3 and Chronic Cough

Problem: Refractory Chronic Cough

Cough lasting >8 weeks 0 therapies that are safe

  • effective

"I see patients that have been coughing 2

months to 30 years. Within that group, there is a good portion where I am the 8th or 10th doctor."

  • Chronic Cough KOL

Significant impact on

quality of life

2.6M

Patients in U.S. with longstanding refractory chronic cough

Multi $B

Market potential

Report 2018 Bluestar BioAdvisors (formerly known as Torreya Insights)

8

P2X3 Receptor: A Key Target in Chronic Cough

ATP gated ion channel in the peripheral sensory nervous system

Key sensory receptor in transmitting upper airway irritation and triggering cough reflex

Targeting P2X3 with an antagonist is a clinically validated approach to treating refractory chronic cough

9

Proof-of-Mechanism Established by First-in-Class P2X3 Antagonist MK-7264

MK-7264

Effective in reducing cough but with Taste Side Effects

Mechanism:

P2X3 antagonist

Acquired in 2016 for $1.25B

($500M upfront) based on P2 data

and currently in two P3 trials

Cough

Taste

57%

81%

reduction in cough

of patients have

frequency from

taste alteration or

baseline

loss

37%

placebo adjusted reduction in cough frequency

Merck & Co., Inc. (2017). Merck Announces Presentation of Phase 2 Results for MK-7264, an Investigational, P2X3 Receptor Antagonist, Being Evaluated for the Treatment of Chronic

10

Cough. [Press Release]. Retrieved from http://www.mrknewsroom.com/news-release/research-and-development-news/merck-announces-presentation-phase-2-results-mk-7264-inve

Lack of P2X3 Selectivity Results in Taste Effect

P2X3 and P2X2/3: ATP-gated ion channels that transmit sensory signals

COUGH REFLEX:

TASTE:

P2X3 homotrimers have primary

P2X2/3 heterotrimers have

role in cough

major role in taste

OPPORTUNITY:

Highly selective P2X3 antagonist to reduce cough (P2X3 inhibition) and maintain taste (no P2X2/3 inhibition)

11

Our Solution: BLU-5937

Our Solution: Highly Selective P2X3 Antagonist

BLU-5937 is a highly selective P2X3 antagonist with key characteristics to treat chronic cough

BLU-5937

HIGHLY POTENT

HIGHLY SELECTIVE

P2X3 antagonist

P2X3 antagonist

Low nM IC50

~ 1500X selectivity vs P2X3

EQUIVALENT

LITTLE / NO

reduction in cough1

impact on taste2

1vs. MK-7264 in animal studies (see slide 17)

2Bellus Phase 1 data at estimated therapeutic doses of 50-100mg

13

BLU-5937 Selectivity Resulted in Differentiated Taste Profile

Incidence and Severity of Taste Effect AEs at Estimated

Comparative Therapeutic Doses1

BLU-5937(50-100 mg)

MK-72642 (50 mg)

(n=24)

(n=63 )

TRIAL

NCT03638180

NCT02612610

DOSE(S)

50 and 100 mg single dose

50mg BID arm for 12 weeks

and 7 day BID cohorts

SUBJECTS

Healthy volunteers

Refractory chronic cough

TASTE ALTERATION

<5%

48%

PARTIAL TASTE LOSS

0%

24%

COMPLETE TASTE

0%

21%

LOSS

ALL TASTE

<5%

81%

ADVERSE EVENTS

At estimated therapeutic doses and based on clinical trial results to date:

BLU-5937 has significantly improved taste effect profile versus MK-7264

1No head to head clinical trials have been conducted; data derived from different clinical trials in different patient populations and with different dosing

regimes and protocols.

14

2Merck & Co Presentation of gefapixant Phase 2b data at American Thoracic Society 2017

Clinical Data Further Validates P2X3 Target

P2X3 is a clinically validated target, with multiple positive Phase 2 trials, with low and high selectivity P2X3 antagonists

Selective S-600918 Has Comparable Efficacy to Low

Inhibition of P2X3 Linked to Efficacy

Selectivity MK-7264

Inhibition of P2X2/3 Linked to Taste Effect With Low

Selectivity MK-7264

MK-7264

S-600918

Phase 2b Trial

Phase 2a Trial

57%

53%

vs Baseline

vs Baseline

37%*

32%**

Placebo Adjusted

Placebo Adjusted

Merck & Co ATS Presentation, May 22

Research and Development at

2017; *p<0.01

Shionogi Presentation, March 14,

2019; **p=0.055

15

Market and Competitive Landscape

P2X3 Competitive Landscape1

Best in class selectivity for P2X3 supports potential favorable clinical and commercial profile

1ST IN CLASS P2X3

2ND GENERATION P2X3

BEST IN CLASS

ANTAGONIST

ANTAGONISTS

SELECTIVITY FOR P2X3

Company

Candidate

MK-7264

BAY '080 &

S-600918

BLU-5937

BAY '607

Dosing

15mg /

BID

50mg / 150mg /

50 / 100mg BID

45mg BID

300mg QD

P2X3 vs. P2X2/3

3-7x

17-126x2

~ 250x3

~ 1500x

Selectivity

Cough efficacy4

High

High

High

High

Taste side effect4

High

Moderate/Low

Moderate/None

Low/None

Developmental Phase

Phase 3

Phase 2

Phase 2

Phase 2

1No head to head clinical trials have been conducted; data derived from different clinical trials in different patient populations and with different dosing regimes and protocols.

2Bayer selectivity range of most characterized P2X3 antagonists described in Bayer US patent 10,183,937 (may not be BAY1817080/BAY1902607)

3S-600918 Phase 2a Presentation, ERS, September 29, 2019

17

4Effect on taste and anti tussive effect are company estimates based on animal data, clinical data, dose, human P2X3 potency and human P2X3 vs P2X2/3 selectivity

Chronic Cough Market

Potential multi-billion dollar refractory chronic cough market

Large Addressable Patient Population

Comparable Products

263M U.S. adults

Payer discussions and comparable product analysis support $300-$600 per month pricing

10% or 26.3M

2.6M Primary

chronic cough

addressable patients:

patients

treatment refractory

>1 year

Report 2018 Bluestar BioAdvisors (formerly known as Torreya Insights)

18

BLU-5937 Clinical Program

BLU-5937: Phase 1 Trial Design

Design: A randomized, double-blind,placebo-controlled, escalating single dose followed by escalating multiple dose Phase 1 trial conducted in 90 healthy adult subjects

Objective: To test the safety, tolerability, and pharmacokinetic profile of BLU-5937

Single Ascending Dose (SAD)

  • N=60 healthy subjects
  • 6 cohorts of 10 subjects (8 active; 2 placebo) administered single doses of 50mg to 1200mg
  • Food effect tested at 200mg in one cohort

Multiple Ascending Dose (MAD)

  • N=30 healthy subjects
  • 3 cohorts of 10 subjects (8 active; 2 placebo) administered multiple doses of 100mg, 200mg, and 400mg BID for 7 days

20

Phase 1 PK Profile and Dosing

35000

Cmax

( ng/mL)

30000

25000

20000

15000

Cmax

10000

5000

0

0

200

400

600

800

1000

1200

1400

Dose (mg)

300000

AUC

(ng*h/mL)

250000

200000

150000

100000

AUC

50000

0

0

200

400

600

800

1000

1200

1400

Dose (mg)

PK Profile:

  • BLU-5937is rapidly absorbed (Tmax ~1h )
  • Systemic exposure increases dose-proportionally
  • Plasma half-life of 4-9 hours supports BID dosing
  • No significant effect of food on PK
  • No significant systemic accumulation over 7 days

Dosing:

  • Projected therapeutic dose of 50-100mg BID
  • Based on achieving targeted receptor inhibition & comparative drug blood levels at effective doses in preclinical and clinical studies of validated comparator

2

21 1

BLU-5937:Well-Tolerated in Phase 1

Incidence of Most Frequent Adverse Events (>5% Incidence) in All Cohorts (SAD + MAD)

AEs

Placebo

50mg

100mg

200mg

400mg

800mg

1200mg

Total BLU-5937

N (%)

(n=18)

(n=8)

(n=16)

(n=16)

(n=16)

(n=8)

(n=8)

(n=72)

Taste Alteration

0 (0%)

0 (0%)

1 (6%)

0 (0%)

6 (38%)

5 (63%)

2 (25%)

14

(19%)

Headache

1 (6%)

0 (0%)

2 (13%)

1 (6%)

1 (6%)

2 (25%)

2 (25%)

8 (11%)

Hypoaesthesia

0 (0%)

0 (0%)

0 (0%)

3 (19%)

2 (13%)

3 (38%)

0 (0%)

8 (11%)

Dizziness

0 (0%)

0 (0%)

0 (0%)

0 (0%)

2 (13%)

1 (13%)

1 (13%)

4

(6%)

Nausea

1 (6%)

0 (0%)

0 (0%)

1 (6%)

1 (6%)

2 (25%)

2 (25%)

6

(8%)

Dyspepsia

0 (0%)

0 (0%)

1 (6%)

0 (0%)

2 (13%)

1 (13%)

0 (0%)

4

(6%)

  • No serious adverse event; >80% of AEs were mild; no significant effect on vital signs, ECG, laboratory
  • Potential P2X3 class-related side effects include: taste effects, hypoaesthesia, nausea
  • One subject had mild liver enzyme elevation (400mg BID) that normalized at follow up; not associated with increased bilirubin

22

22

BLU-5937: Minimal Taste Effect at Therapeutic Doses

Incidence of Taste AEs (All SAD and MAD Cohorts)

50mg

100mg

200mg

400mg

800mg

1200 mg

(n=8)

(n=16)

(n=16)

(n=16)

(n=8)

(n=8)

One subject out of 24 (4%)

reported taste alteration at

Taste

0 (0%)

1 (6%)

0 (0%)

6 (38%)

5 (63%)

2 (25%)

the anticipated therapeutic

Alteration

doses (50-100 mg)

Partial

No taste loss or taste

0 (0%)

0 (0%)

0 (0%)

1 (6%)

1 (13%)

0 (0%)

alteration at 200 mg

Taste Loss

No complete taste loss at

Complete

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

0 (0%)

any dose

Taste Loss

Minimal incidence of taste AEs at doses to be studied in Phase 2

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RELIEF Phase 2 Trial Design

Phase 2 recruiting with topline data expected in mid-2020

65 refractory chronic cough patients; at >1 year coughing

16 sites in UK and US

Primary endpoint:

Reduction in awake cough frequency using cough recorder

2 patient arms

4 dose levels with forced escalation at 4-day intervals (25/50/100/200mg twice daily)

Safety and tolerability assessment, including taste effect

Matching

Matching

Matching

Matching

Placebo

Placebo

Placebo

Placebo

Matching

Matching

Matching

Matching

Placebo

Placebo

Placebo

Placebo

Cough Recording

24

BLU-5937: Beyond Chronic Cough

Potential for Broad Applicability and Building Pipeline in a Product

P2X3 sensitization contributes to irritation and pain

OTHER INDICATIONS LINKED TO P2X3 HYPERSENSITIZATION

  • Bladder pain
  • Bronchoconstriction
  • Chronic pruritus
  • Endometriosis pain

Hypersensitive cough

  • Hypertension
  • IBS
  • Migraine
  • Neuropathic pain
  • Sleep apnea

Active development at Bellus

Active development at Merck

26

Chronic Pruritus Associated with Atopic Dermatitis

Mechanistic Similarities Between Cough and Itch

Animal POC - Atopic Dermatitis Mouse Model

140

scratches

120

100

*

spontaneous

(60 min.)

80

60

***

of

40

No.

20

***

***

0

Vehicle

BLU-5937

BLU-5937

BLU-5937

U50,488

3gm/kg

2mg/kg

10mg/kg

50mg/kg

Number of spontaneous scratches in 60 min of day 8 Calcipotriol (MC903) treated mice pre-injected with vehicle, 2, 10, or 50 mg/kg test BLU-5937, or 3 mg/kg U50,488. (n = 10 mice per group),*p < 0,05, ***p < 0.0001, one-way ANOVA. Data are represented as mean ± S.E.M. U50,488: kappa opioid

agonist

Poster presented at European Society for Dermatological Research on

September 21st, 2019

27

AD Chronic Pruritus Market

Large Diagnosed Patient

Population in the US…

16.9M

3M

2.25M

…with 40-50% Patients

Having Residual Itch

Limitations of Current Therapies

Corticosteroids

Significant side effects

Antihistamines

Limited effect

Immuno-

Toxicity

suppressants

Dupixent

Cost & low

reimbursement rate

Report 2019 Bluestar BioAdvisors

Phase 2 proof of concept trial in ~100 mild/moderate atopic dermatitis

patients with moderate/severe chronic pruritus expected to start in Q2 2020

28

IP and Corporate Summary

Robust Intellectual Property Portfolio

Composition of matter IP in place to 2034

U.S. and international patent estate covering BLU-5937 and related compounds

Composition of matter patent for BLU- 5937 and related imidazopyridines granted in the U.S., Europe, Japan and China

Composition of matter patents for BLU- 5937 expire in 2034 (not including potential patent term extension)

30

Stock and Financial Information

Capital Structure1

55.4M basic shares

59.8M fully diluted shares

1as of September 23rd, 2019

Cash Position

Cash position of $100M / C$132M1

1as of September 30, 2019

31

Potential Catalysts

Key Anticipated Milestones Over Next 12 Months

Past Execution

  • Animal POC in cough (June 2017)
  • C$20M financing (December 2017)
  • BLU-5937Phase 1 data with potential strong taste profile (November 2018)
  • C$35M financing (December 2018)
  • Phase 2 recruiting (July 2019)
  • Animal POC in pruritus associated to atopic dermatitis (July 2019)
  • $79M NASDAQ IPO (September 2019)

12 Months Milestones

BLU-5937 in chronic cough:

  • Phase 1 abstracts at ATS (May 21) and ACC (June 8)
  • KOL Event with Phase 2 Principal Investigator Dr. Jacky Smith (July 16th in New York City)
  • Phase 2 first patient enrolled (July 2019)
  • Phase 2 top-line data expected (mid 2020)

BLU-5937 in chronic pruritus associated with AD

  • Animal POC poster presentation at European Society for Dermatological Research Conference (Sept 21)
  • Phase 2 first patient enrolled (Q2 2020)

Competitor catalysts:

  • Shionogi Phase 2 data
    Bayer Phase 2 data
    Merck MK-7264 pipeline: Phase 2 in endometriosis pain

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Disclaimer

BELLUS Health Inc. published this content on 20 November 2019 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 November 2019 22:05:04 UTC