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0 TSX-V: IGX OTCQX: IGXT WE MAKE APPROVED DRUGS BETTER Investor Presentation September 2017 Innovative Drug Delivery Solutions

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Page 1: Innovative Drug Delivery Solutionss2.q4cdn.com/790425727/files/doc_presentations/2017/09/... · 2017-09-13 · Innovative Drug Delivery Solutions. 1 2 ... Products Directorate approvals,

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TSX-V: IGX OTCQX: IGXT

WE MAKE APPROVED DRUGS BETTER

Investor PresentationSeptember 2017

Innovative Drug Delivery Solutions

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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 finishedproducts, 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)1

• OTCQX(IGXT)1

• MarketCapitalization• SharesIssued• SharesFullyDiluted• InsiderBeneficialOwnership• Cash/Equivalent

(AsofJune30,2017)

2003CAD$1.25US$0.97

CAD$83M66.6M70.8M18.7%

CAD$3.7M*

Analyst CoverageFirm AnalystH.C. Wainwright Swayampakula RamakanthSingular Research Greg Eisen

Company Snapshot

1 As at June 30, 2017

* Does not include proceeds from July-August 2017 convertible debenture offering

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

Andre Godin, CPA, CAExecutive 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

Stephen KilmerInvestor Relations

• 20+ years experience in healthcare IR and PR

• President of Kilmer Lucas, a health-care only investor relations and capital markets advisory company

Horst G. Zerbe, Ph. D.Chairman, President & CEO

• 30+ years drug delivery / pharma experience (Lohmann Therapy Systems, 3M Pharmaceuticals, Smartrix Technologies)

• Pioneer in development and manufacturing of oral films and transdermal products

• Numerous patents and 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

Rodolphe Obeid, M. Eng., Ph.D.Senior Director Operations• 5+ years experience in

manufacturing & scale-up of oral film products

• Previously Director, R&D and Process Development at IntelGenx

• Author and co-author of numerous scientific papers, patents, book chapters, and scientific communications

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We Make Approved Drugs Better

IntelGenx Drug Delivery Technology Platforms

Rapidly disintegrating films improving drug performance and easing administration

without the need for water

Films

VersaFilm™

TabletsControlled-release tablets for oral absorption

over an extended time period

AdVersa™

We Make Approved Drugs Better

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VersaFilmTM Oral Films

Oral Films Provide Significant Market Opportunities for Improving Drug Delivery

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• IntelGenx CEO co-developer of the Listerine breath strips

• Oral films ideal for elderly, children, patients who have difficulty swallowing traditional tablets

• Quicker action to relieve symptoms

VersaFilm™ Oral Films

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Advantages of Oral Thin Film Delivery

We are focused on areas where oral films are particularly well-suited:

Develop and commercialize products that provide therapeutic advantages to patients leveraging oral films, such as:

• Reduced side effects • Improved bio-availability • Response time versus existing drugs

• Abuse resistant• Convenience

• 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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Clearly Defined BD StrategyBalancing Risks and Opportunities for an Optimized Portfolio

Overall Risk

Time to MarketSlow Fast

Low

High

Drug Repurposing

Patient Benefits

Lifecycle Mgmt

FTF Generics

IntelGenx Future FocusDeal Value

Low

Medium

High

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We Offer Full Service to Foster the Growth of our Partners

We Offer Full Service

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• IntelGenx grants partners exclusive rights to market and sell its products in exchange for upfront and milestone payments, together with a share of the partner’s net profits or a royalty on net product sales

• IntelGenx retains manufacturing rights for its products

• Payments are received as the contracted services are performed or when certain milestones are achieved:

• FDA submission• FDA approval• Commercial launch• Annual net sales target, etc.

• Partners pay for part or all of the R&D expenses associated with developing a new product and to obtain regulatory approval

Low Risk Development Model

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State-of-the-Art Oral Film Facility EstablishedFor Development & Manufacturing

• 17,000 sq ft facility in Montreal -construction completed in Q1 2016

• High capacity manufacturing and packaging equipment

• Lower costs, controls quality and de-risks investment for new products

GROSS MARGINS of 40% PLUS

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For Migraines

Leverages VersaFilm™ Technology

VersaFilmTM

Rizaport

• European Marketing Approval – November 2015

• Co-development partnership with RedHill Biopharma− Definitive agreement signed July 2016 with Grupo Juste for Spain

& additional territories − Definitive agreement signed Dec 2016 with Pharmatronic for

South Korea − Actively pursuing several opportunities to open new markets

• Patent granted in April 2016 protecting Rizaport

• Re-submission of 505(b)(2) NDA planned for Q4 2017

• PDUFA date expected in early 2018

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For Erectile DysfunctionVersaFilmTM

Tadalafil

• A high value, pleasantly flavored, and convenientVersaFilm™ dosage form of 2.5, 5, 10 and 20 mg tadalafil that can be administered without water

• Pilot phase 1 clinical trial for safety and pharmacokinetics have been successively completed, confirming bioequivalence to Cialis® (Eli Lilly)

• 2 patents protecting Tadalafil VersaFilm pending

VersaFilmTM

Tadalafil

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Fr Erectile Dysfunction

• Tadalafil market in the US estimated at $1.7B

• Nov 2017 Lilly’s tadalafil composition patent to expire, but orange book dosing patent still in force until April 2020

• IntelGenx’ exclusive license to Lilly’s tadalafil ED dosing patent ‘166 will allow entry of Tadalafil VersaFilm™ into the ED US market upon FDA approval, potentially before the market entry of Cialis® generic competitors

• 505(b)(2) USA NDA submission in H2/2017

• Expected US FDA approval H1/2018

$1,703 $1,429

$175 $11

$48

$18

US ED Market by Sales ($M)

Cialis

Viagra

Levitra

Staxyn

Stendra

Edex

VersaFilmTM

Tadalafil Significant Market Opportunity

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For Schizophrenia & Bipolar 1 Disorder

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• Fast-acting loxapine oral dosage

• For treatment of 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

• US patent & PCT applications submitted

• Formulation optimization stage – results expected H2 2017

VersaFilmTM

Loxapine

VersaFilmTM

Loxapine

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Mild Cognitive Impairment(MCI)

> 80 Mi persons

Dementia> 30 Mi persons

Cognitive Disorder Stage and Prevalent Population in nine major markets. (Global Data, 2013 )

Neurodegenerative Clinical Changes(Global Data, 2013)

Issues with word selectionMisplacing of belongingsInability to recall recent events

Memory lossCognitive impairmentFunctional declineDrastic reduction in quality of lifeRequires full-time support

1 Mood and personality changesPoor judgmentFrequently getting lost

2 Difficulty recognizing family or friendsInability to learn new conceptsHallucinations, delusions, or paranoia

3 Inability to communicatePoor swallowing functionIncontinence

Global Sales for AD by Patients Category (Global Data, 2013)

VersaFilmTM

Montelukast Brain Degenerative DiseasesSizeable Addressable Patient Population

Currently approved treatments for brain degenerative diseases are limited, resulting in unmet clinical needs, which translates into a promising market opportunity.

Alzheimer’s Disease(AD)

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

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VersaFilmTM

Montelukast 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 DataStrong Preclinical Evidence

IP Strategy

UNIQUE DRUG REPURPOSING OPPORTUNITY FOR BRAIN DEGENERATIVE DISEASES

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VersaFilmTM

Montelukast Rationale for MontelukastAn Anti-Brain Aging Molecule

Leukotrienes

Neurodegenerationeg Schapira et al. 2011

Neuroinflammationeg Hirsch et al. 2009

Blood Brain Barriereg Zlokovic et al. 2008

Neurogenesiseg Regensburger et al. 2014

Neurotransmissioneg Calabresi et al. 2007

DemyelinationAxonal Damage

eg Franklin et al. 2008

Mon

telu

kast

Dementia> X patients WW

Montelukast SodiumLeukotriene receptor inhibitorSingulair ®, FDA approved since 1998For the chronic treatment of asthma

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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 30.00Mon

telu

kast

conc

entra

tion

(ng/

mL)

Time (hrs)

Montelukast Avg Plasma Profile

Test buccal film 10mg

Ref tablet 10mg

VersaFilmTM

Montelukast

• Phase 1 clinical study in human successfully completed• Significantly increased bioavailability after administration of VersaFilm™ compared to

commercial tablet • Drug crosses blood/brain barrier when given as film• Phase II-a study (proof of concept) to commence Q4/2017• First efficacy data in humans available H1/2018• Several pharma companies have expressed strong interest

Before

MMSE 13: moderate to severe

dementia

MMSE 22: mild dementia

After 2 Months ofMontelukast

Completed Phase 1 StudyIncreased bioavailability using VersaFilm™ Oral Film

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Mucoadhesive TabletFor Pain Management• AdVersa® mucoadhesive tablet adheres to the oral

mucosa and releases the drug onto the site of application at a controlled rate

• Repurposing of synthetic THC dronabinol for use in pain

• Protected by several issued and pending patents

• Competitive advantages vs. Marinol® capsules (Abbvie)

Marinol® (dronabinol) capsule Dronabinol AdVersa®

Conventional oral dosage form AdVersta® mucoadhesive tablet

High rate of metabolization Limited first-pass metabolism

Limited bioavailability Improved bioavailability

Undesired psycho activity Reduced gastro-intestinal exposureand side-effects

Limited shelf life Enhanced product stability

AdVersaTM

DronabinolDronabinol

Mucoadhesive TabletFor Pain ManagementAdVersaTM

DronabinolDronabinol

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• Licensing and development agreements entered for four generic products

• IntelGenx granted Chemo exclusive worldwide license to commercialize two generic tablets and U.S. license for two other generic oral films

• IntelGenx to receive upfront, milestone and R&D revenues – total value of 7 digits

• IntelGenx will receive shared profits at commericalization

• Combined total market of four products is over $7B

• Chemo making a strategic move into novel drug delivery products with IntelGenx as its partner

• Partnership could result in numerous future product agreements

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

Strategic Partnership with Chemo Group

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Robust Product Pipeline Addressing Significant Market Opportunities

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Migraine – Rizaport® (Rizatriptan)

Availableex-ES & SKR

Erectile Dysfunction(Tadalafil) Available

Schizophrenia (Loxapine) Available

Neurodegenerative Brain Diseases(Montelukast) Available

Opioid Dependence - gSuboxone®

(Buprenorphine/ Naloxone) Partnered

Undisclosed Partnered

Undisclosed Partnered

Undisclosed Partnered

Major Depressive Disorder - Forfivo XL®

(Bupropion)

Availableex-US

Hypertension(undisclosed) Partnered

Pain (undisclosed) Partnered

Pain(Dronabinol)

Availableex-US/ CAN

Vers

aFilm

TMTa

blet

s

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The IntelGenx Advantage

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 Results

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Financial Performance: Revenue

$M

2.5

1.5

5.2 5.1

0

1

2

3

4

5

6

First Half 2017 First Half 2016 2016 Full Year 2015 Full Year

Revenue

REVENUE ($M)

2326

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Net Comprehensive Income & Adjusted EBITDA ($M)

$M

Financial Performance: Income & EBITDA

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-1

-1.5 -1.5

0.8

-0.5

-1.2

-0.3

1.7

-2

-1.5

-1

-0.5

0

0.5

1

1.5

2

First Half 2017 First Half 2016 2016 Full Year 2015 Full Year

Net Income Adjusted EBITDA

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Conclusion

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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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ThankYou!www.IntelGenx.com

ContactInfo:

StephenKilmerAndréGodinInvestorRelationsExecutiveVP&CFO+1-514-331-7440ext.232+1-514-331-7440ext.203Stephen@intelgenx.com [email protected]

IntelGenx CorporateOffices6420AbramsSaint-Laurent(Quebec)H4S1Y2Canadawww.intelgenx.com