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0 Investor Presentation September 21, 2016 Innovative Drug Delivery Solutions
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Page 1: Igxt sep 21 investor presentation

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Investor Presentation

September 21, 2016

Innovative Drug Delivery Solutions

Page 2: Igxt sep 21 investor presentation

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To the extent any statements made in this presentation contain information that is not historical, these statements are

forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and

Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements

on our current expectations and projections about future events. Our actual results could differ materially from those

discussed in, or implied by, these forward-looking statements.

Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will,"

"may" and other similar expressions. In addition, any statements that refer to expectations, projections or other

characterizations of future events or circumstances are forward-looking statements. Forward-looking statements

include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and

Drug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new

pharmaceutical products, the impact of competitive products and pricing, new product development and launch,

reliance on key strategic alliances, availability of raw materials and finished products, the regulatory environment, tax

rate assumptions, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from

time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities

Commission. IntelGenx undertakes no obligation to update or revise any forward-looking statement.

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Forward Looking Statements

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• IntelGenx Corp. Founded• TSX-V (IGX)• OTCQX (IGXT)• Market Capitalization • Shares Issued• Shares Fully Diluted• Insider Ownership• Cash/Equivalent

2003CAD$1.10

US$0.81US$52M

64.7M70.8M

15%US$6M

Analyst Coverage

Firm Analyst

H.C. Wainwright Swayampakula Ramakanth

Singular Research Greg Eisen

Company Snapshot

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Oral Thin Films

Oral Thin Films Provide

Significant Market Opportunities

for Improving Drug Delivery

• IntelGenx CEO co-developer of the

Listerine breath strips

• Oral films provide quicker action to relieve

symptoms

• IntelGenx’s goal to become a leader in

pharmaceutical oral film development &

manufacturing

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Clearly Defined BD Strategy

We are focused on areas where oral films

are particularly well-suited:

Develop and commercialize products that provide tangible patient benefits

leveraging oral films, such as:

• Reduced side effects

• Improved bio-availability

• Response time versus existing drugs

• Lifecycle management

• Repurpose existing drugs for new indications using oral films

• “First-to-file” Generic drugs where high technology barriers to

entry exist in reproducing branded films

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A Robust Product Pipeline to Address Significant Market Opportunities

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• High dose version of Wellbutrin XL®

• Only approved, once-daily, bupropion HCl 450mg dose

in a single tablet

• Launched commercially October 2013 in partnership

with Edgemont Pharmaceuticals

• Sold US revenue to SWK Holdings for US $6M

• Development cost $2.5M, total revenue $15M = 6-fold

ROI

• Non-dilutive source of funding, will be used to advance

film projects

Successful Monetization of First In-House Development

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For Migraines

Leverages VersaFilm™ Technology

• European Mktg Approval – November 2015

• Co-development partnership with RedHill Biopharma

• Definitive agreement signed July 2016 with

Grupo Juste for Spain & additional territories

• Term sheet signed September 21, 2016 with

Pharmatronic for South Korea

• Actively pursuing several opportunities to open new

markets - negotiations with future commercialization

partners ongoing

• Planned USA submission to FDA Q1/2017

• Expected USA launch Q3/2017

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For Erectile Dysfunction

• Containing tadalafil (Cialis® - Eli Lilly),

a leading molecule in the ED market

• Demonstrated bioequivalence to Cialis®

• Orally disintegrating films without need

for water provide unprecedented patient

convenience and a discrete dosing

alternative

• 505(b)(2) USA NDA submission in

Q1/2017

• Expected USA launch Q1/2018

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For Schizophrenia & Bipolar 1 Disorder

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• The first oral thin film using IntelGenx

proprietary drug delivery technology,

VersaFilm™, for treatment of

schizophrenia & bipolar 1 disorder

• Fast-acting loxapine oral dosage – to

treat acute agitation and anxiety in non-

institutionalized patients with

schizophrenia & bipolar 1 disorder

• Reduces risk of pulmonary problems

and potential risk of violence and injury to

patients and others

• Formulation optimization stage – results

expected Q2 2017

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Mild Cognitive Impairment

(MCI)

> 80 Mi persons

Dementia

> 30 Mi persons

Brain Degenerative DiseasesSizeable Addressable Patient Population

5

Dementia> X patients WW

Currently approved treatments for brain degenerative diseases are limited,

resulting in unmet clinical needs, which translates into a promising market

opportunity11

Alzheimer’s Disease

(AD)1 Mild > 6.5 Mi persons2 Moderate > 3.9 Mi persons3 Severe > 2.1 Mi persons

Cognitive Disorder Stage and Prevalent Population(Global Data, 2013 )

Neurodegenerative Clinical Changes(Global Data, 2013)

Issues with word selection

Misplacing of belongings

Iinability to recall recent events

Memory loss

Cognitive impairment

Functional decline

Drastic reduction in quality of life

Requires full-time support

1 Mood and personality changes

Poor judgment

Frequently getting lost

2 Difficulty recognizing family or friends

Inability to learn new concepts

Hallucinations, delusions, or paranoia

3 Inability to communicate

Poor swallowing function

Incontinence

Global Sales for AD by Patients

Category (Global Data, 2013)

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A De-Risked Product CandidateFor the Treatment of Brain Degenerative Diseases

IntelGenx is developing montelukast VersaFilm™, the first oral

thin film containing montelukast for the treatment of brain

degenerative diseases

Already Approved and Established Drug Molecule

Supporting Epidemiology Data

Strong Preclinical Evidence

IP Strategy

UNIQUE DRUG

REPURPOSING

OPPORTUNITY FOR

BRAIN DEGENERATIVE

DISEASES

Supporting Ph1 Data

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Montelukast Improves Cognitive FunctionsIn Animal Models of Brain Degenerative Diseases

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Montelukast treatment improves learning and memory in the Morris water maze test

(c)

After learningBefore learning

Hidden platform

Wading pool

Figure 1: Montelukast treatment improves learning and memory in

an animal model of mild cognitive impairment. Young (4 mo old)

and old (20 mo old) Fisher 344 rats were orally administered 10

mg/kg body weight of montelukast for 42 d. On days 35 to 41, the

Morris water test was conducted to assess the ability of spatial

learning and memory. Zone P is a defined circular area with 20 cm

diameter enclosing the former platform location. (a) Representative

tracks of the distances moved in the Morris water maze before and

after learning. (b) Time in platform quadrant (s). (c) Time in zone P

(s). (d) Number of entries in zone P. mtk, montelukast; veh, vehicle;

yg, young. * p<0.05. (Marschallinger et al., Nature Comm, 2015)

(a)

(b) (c) (d)

Similar data in an animal model of Lewy Body Dementia (Aigner, Unpublished Data)

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Clinical Data

0.0

100.0

200.0

300.0

400.0

500.0

600.0

0.00 5.00 10.00 15.00 20.00 25.00 30.00Monte

lukast

concentr

ation (

ng/m

L)

Time (hrs)

Montelukast Avg Plasma Profile

Test buccal film 10mg

Ref tablet 10mg

• First clinical study successfully completed

• Significantly increased bioavailability after administration of VersaFilm compared to

commercial tablet

• Drug crosses blood/brain barrier when given as film – patent application pending

• Phase II-a study (proof of concept) to commence Q1/2017

• First efficacy data in humans available Q4/2017

• Several Pharma companies have expressed strong interest

Before

MMSE 13:

moderate to severe

dementia

MMSE 22:

mild dementia

After 2 Months of

Montelukast

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• Licensing and development agreement entered

September 12, 2016 for three generic products

• IntelGenx granted Chemo exclusive worldwide license

to commercialize one generic product and U.S.

license for two other generic products

• IntelGenx to receive upfront, milestone, R&D

revenues and share of profits – total value of 7 digits

• Combined total market of three products is over $3B

• Chemo making a strategic move into novel drug

delivery products with IntelGenx as its partner

• Partnership could result in numerous future product

agreements

Strategic Partnership with Chemo Group

About Chemo Group:

• Founded in 1978

• 5,000 employees

• Head office in Spain

• Revenues of $1.2B annually

• Markets over 300 products

• Operating in over 40 countries

• 20 state-of-the-art facilities

• 9 specialized R&D centers

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Construction of Manufacturing Facility Completed

• 17,000 sq ft facility in Montreal -

construction completed in Q1 2016

• Facility to be fully operational by Q1 2017

• High capacity manufacturing and

packaging equipment

• Lower costs, controls quality

and de-risks investment

for new products

GROSS MARGINS of 40% PLUS

We have built a state-of-the-art

oral film development and manufacturing facility

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Strengthened Management TeamOver 20 Employees, including 7 with Ph.D.’s

Andre Godin, CPA, CA

Executive VP, CFO

• 25+ years biotech/pharma

industry experience

• Member of the Canadian

Chartered Professional

Accountants and the

Canadian Institute of

Chartered Accountants

Nadine Paiement, M. Sc.

VP, Research & Development

• Co-inventor of IntelGenx

Trilayer Technology

• 15 years experience in

product development and

technology transfer

Edward Miller, B. Comm

Director, Investor Relations

• 15 years experience in

investor relations

• 10 + years experience in

pharmaceutical / biotech

Horst G. Zerbe, Ph. D.

Chairman, President & CEO

• Co-Founder of Listerine

breath strips

• 30+ years drug delivery /

pharma experience

• Holds over 40 patents in drug

delivery and numerous

scientific publications

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Dana Matzen, Ph.D.

VP, Business & Corporate

Development

• 15 years experience in

pharmaceutical product

licensing

• Prev. Director, BD at Paladin

• Completed 13 transaction,

7 new product launches

John Durham, B. Sc.

VP, Operations

• 20+ years experience in

pharmaceutical

manufacturing, quality

management, product

development

• Held executive positions with

several Canadian and US

companies

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What Makes IntelGenx the Best in Oral Films

1. History

• Dr. Zerbe a pioneer with over 30 plus years in oral films

2. Formulation Team

• Strong in applying biopharmaceutical aspects to formulation development

• Top quality scientists: highly creative, focused on problem solving & innovative approaches

• Experienced in developing films for oral (GI), sublingual & buccal absorption

3. Clearly Defined Corporate Strategy And Business Model

• Focus on drug repurposing, lifecycle management, patient benefits, and FTF

• Provider of comprehensive pharmaceutical services to industry partners

4. Competitive Manufacturing Capabilities

• First in Canada

• New state-of-the-art manufacturing facility

• Offer one-stop-shopping to our partners with lean operations keeping costs down

• Customized manufacturing equipment

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Financial Performance

Revenue ($M)

1.51.2

5.1

1.7

0

1

2

3

4

5

6

H1 2016 H1 2015 2015 Full Year 2014 Full Year

Revenue

$M

19

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Net Comprehensive Income & Adjusted EBITDA ($M)

-1.5

-0.6

0.8

-2.2

-1.2

-0.1

1.7

-1.6

-2.5

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

H1 2016 H1 2015 2015 Full Year 2014 Full Year

Net Income Adjusted EBITDA

$M

Financial Performance

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Solid Platform for Growth

Significant Market Potential

• New manufacturing facility will offer many competitive advantages

• Strengthened management team to accelerate execution of business plan

• Implemented product sourcing strategy to identify high-value product opportunities

• Building strategic partnerships with relevant partners in the pharmaceutical industry

Solid Platform for Growth

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Thank You!www.IntelGenx.com

Contact Info:Edward Miller, B.Comm.Director, Investor Relations+1-514-331-7440 ext. [email protected]

IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com


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