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Innovative Leader in Pharmaceutical Film
I n v e s t o r P r e s e n t a t i o n | N o v e m b e r 2 0 1 8
W E M A K E A P P R O V E D D R U G S B E T T E R
Forward-Looking Statements
To the extent any statements made in this presentation contain information that is not historical, these statementsare forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statementson our current expectations and projections about future events. Our actual results could differ materially fromthose 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 othercharacterizations of future events or circumstances are forward-looking statements. Forward-looking statementsinclude, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food andDrug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for newpharmaceutical 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 detailedfrom time to time in the Company's filings with the Securities and Exchange Commission and the Ontario SecuritiesCommission. IntelGenx undertakes no obligation to update or revise any forward-looking statement.
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Company Snapshot
31) As at October 31, 2018
IntelGenx Corp. Founded 2003
TSX-V (IGX)1
CDN$0.83
OTCQX (IGXT)1
US$0.65
Market Capitalization1 CDN$76M
Shares Issued1 92M
Outstanding Warrants1 13M
Insider Beneficial Ownership1 11%
Cash/Short Term Investments1
Approximately US$12M
Analyst CoverageFirm Analyst
H.C. Wainwright Swayampakula Ramakanth
Maxim Group Jason McCarthy
SEC Registered
4
We Make Approved Drugs BetterIntelGenx’s VersaFilm™ Drug Delivery Technology Platform
Rapidly disintegrating films improving
drug performance and easing administration
without the need for water
Oral Thin FilmsSlow release buccal films improving
drug absorption and avoiding first pass
metabolism
Buccal Films
Oral Film Formulations Offer Tangible Medical BenefitsThin Oral Films as a Better Alternative to Conventional Dosage Forms
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We are focused on areas where oral films are particularly well suited:
• Reduced side effects
• Improved bioavailability
• Enhanced efficacy
• Response time versus existing drugs
• Convenience
• Especially useful for patients with difficulty in swallowing or chewing solid dosage forms, e.g. the elderly and children
Products with Therapeutic
Advantages to Patients
Lifecycle Management
Repurposing Existing Drugs
for New Indications
First-to-file Generics with
High Technology Barriers to Entry
VersaFilm™ Technology Focused on Four Growth StrategiesOral Films are Value-Added Alternative Dosage Forms with Multiple Advantages
6
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State-of-the-ArtFilm Manufacturing Facility
• 17,000 sq ft facility in Montreal fully GMP compliant
• Health Canada certified – Drug Establishment License (DEL) obtained in December 2017
• Customized manufacturing equipment
• Health Canada approved dealer’s license for controlled substances
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ComprehensiveService Portfolio
R&D• Formulation
• Feasibility Study
• Analytical Method Development
ClinicalTrials
• CTA / IND Applications
• Trial monitoring
Operations• State-of-the-Art
Manufacture
• Full Scale Manufacturing
• Finished Product Testing
• Cost Effective
Regulatory& Quality
• Dossiers in Multiple Territories (EU, US)
• Compliant to ICH, GMP & ISO
• Health Canada Approved Mfg Site
IP• Patented Products
& Technologies
• Patent Filings
Manufacturing AbilitiesValidation of Strategic Shift
9
• Agreements with commercialization partners (e.g. ENDO, Exeltis and Tilray®) validate IntelGenx’sstrategic shift from an exclusively R&D company (dependent on royalty and license revenues) to a full-service company
• Our added manufacturing ability represents a profitable business opportunity
• Definitive agreement with Tilray® to manufacture commercial volumes of cannabis-infused film products for adult-use and medicinal purposes
Low RiskTargeted Business Model
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• Commercial deals are usually structured such that partners are granted exclusive rights to market and sell products in exchange for potential upfront and milestone payments, together with a share of partner’s net profits or a royalty on net sales
• IntelGenx retains manufacturing rights for its film products
• Payments would be received as the contracted services are performed or when certain agreed-upon 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 product development and obtaining regulatory approval
• IntelGenx may also receive R&D tax credits for product development
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Accomplished Management Team>40 Employees
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
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
Dana Matzen, Ph.D.
VP, Business & Corporate Development
• 15 years experience in pharmaceutical product licensing
• Prev. Director, BD at Paladin • Completed 13 transactions,
7 new product launches
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Robust Product PipelineAddressing Significant Market Opportunities
IndicationPartnering
StatusFormulation
DevelopmentClinical Filing Launch Partner
Migraine – Rizaport® (Rizatriptan)
Availableex-ES & SK
Erectile Dysfunction(Tadalafil)
Available
Schizophrenia (Loxapine)
Available
Neurodegenerative Brain
Diseases(Montelukast)
Available
Opioid Dependence(Buprenorphine/ Naloxone)
Partnered
Undisclosed Partnered
Undisclosed Partnered
Undisclosed Partnered
Adult-Use and Medical(Cannabinoids)
Partnered
Tab
lets Hypertension Partnered
Pain(Dronabinol)
Availableex-US/ CAN
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RIZAPORT® VersaFilm™For Migraines
Leverages VersaFilm™ Technology
• Oral Film containing 10 mg Rizatriptan
• Marketing Approval granted in Spain in October 2018
• Definitive agreement for Spain signed July 2016 with Grupo Juste (now Exeltis Healthcare)
• Definitive agreement for South Korea signed Dec 2016 with Pharmatronic
• US Patent granted in April 2016 and EP Patent granted in October 2018 protecting RIZAPORT®
• US FDA PDUFA goal date – April 1, 2019
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Tadalafil VersaFilm™Erectile Dysfunction: Significant Market Opportunity
• Pilot Phase 1 clinical trial for safety and pharmacokinetics successfully completed, confirming bioequivalence to Cialis® Tablets (Eli Lilly)
• 2 patent applications protecting Tadalafil VersaFilm™ pending
• Tadalafil market in the US estimated at $1.7B
• Tadalafil substance patent expired, but Orange Book ‘166 dosing patent still in force until October 2020
• IntelGenx has an exclusive license to ‘166 dosing patent will allow entry of Tadalafil VersaFilm™ into the ED US market upon FDA approval, potentially before the market entry of Cialis® generic competitors
• Commercialization subject to FDA approval
$1,703 $1,429
$175
$11 $48 $18
Cialis
Viagra
Levitra
Staxyn
Stendra
Edex
US ED Market by Sales ($M)
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Cannabis-infused VersaFilm™For Medicinal and Adult-Use Purposes
• IntelGenx signed a definitive license, development and supply agreement with Tilray® to develop and manufacture cannabis-infused Versafilm™ for medical and adult-use use in human applications
• Dissolvable films are a highly unique and relevant approach to consuming cannabis, appealing to both medicinal and adult-use markets
• We believe that a significant portion of those likely to use cannabis will find a dissolvable film appealing, due to its ease-of-use, discreetness and lack of harmful smoke
The market for cannabis is expected to see significant growth under the new Canadian legal regime, both in terms of number of participants and dollar value
* From Statistics Canada, based on a total Canadian population of 35,151,728
For Adult-UsePurposes
For MedicinalPurposes
SPEND PER YEAR $1,212 $1,476
INCIDENCE 17% 12%
LEGAL AGE POPULATION*
26,469,251 26,469,251
ANNUAL SPEND $5,453,724,514 $4,688,233,770
TOTAL ANNUAL SPEND $10,141,958,284
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AdVersa® Mucoadhesive TabletFor Pain Management
Dronabinol
• 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 patents
• Competitive advantages vs. capsules
®
Montelukast for Mild-to-Moderate Alzheimer's Disease Major Repurposing Opportunity
• Blocks the action of leukotriene D4 (and secondary ligands LTC4 and LTE4) on the cysteinyl leukotriene receptor CysLT1
• Evidence that leukotriene receptor antagonists have the potential to reduce neuroinflammation and restore brain cell function
• Montelukast has potential to be the first disease modifying treatment for Alzheimer’s Disease (AD)
Global Sales for AD by Patients Category
(Global Data, 2013)
MCI
Mild
Moderate
2 Severe
57%
10%
23%
10%
68%
15%
12%
5%
2013Total: $4.9bn
2023Total: $13.3bn
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Already Approved and Established Drug
Supporting Epidemiology Data
Strong Preclinical Evidence
Supporting Ph1 Data
IP Strategy
Improves Learning and Memory in aged animals
Crosses the Blood-Brain Barrier in rats and humans
Restores Blood Vessel Structural Integrity
Returns Generation of New Neurons
Restores Learning and Memory in a Model of LewyBody dementia
Improves function in a number of models of acute andchronic neurodegenerative diseases
Note: MMSE = Mini-Mental State Examination; is a test to measure cognitive impairment19
Improves Cognitive Functions & Structural Integrityof the Brain
Early Clinical EvidencePreclinical Demonstration
Before:MMSE 13: moderate to severe dementia
After 2 Months: MMSE 22: Mild
Dementia
CSF ng/mL
Avg at 3hrs 3.6
Avg at 7hrs 4.2
A Single-Dose, Non-Randomized, Open-Label, Two-Way, Pilot, Comparative Bioavailability Study of Montelukast 10 mg Oral Film (IntelGenx Corp.) and Singulair® 10 mg Film-coated Tablet (Merck & Co., Inc., approved for Asthma in 1998) in Healthy Male and Non-pregnant Female Volunteers under Fasting Conditions
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Phase I Clinical Study CompletedPositive Results
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 30.00
Mo
nte
luka
stco
nce
ntr
atio
n (
ng/
mL)
Time (hrs)
Montelukast mean plasma profile
Test buccal film 10mg
Ref tablet 10mg
CSF level measured for Buccal Film (avg of 8)
Safety Results: A total of 2 possibly related adverse events to the buccal film were reported. A total of 2 subjects experienced somnolence when taking the buccal film.
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Phase IIa Clinical StudyUnderway
A randomized Phase IIa, multi-center, double-blind, placebo-controlled study to assess the safety, feasibility, tolerability, and efficacy of a new buccal film of Montelukast in patients with mild to moderate Alzheimer’s Disease
• Study protocol approved by Health Canada
• Study Drug: 10 mg Montelukast VersaFilm™ buccal film and matching placebo
• Treatment duration for each patient: 26 weeks
• Assessment of the treatment effect: SIB, MMSE, ADCS-CGIC, ADCS-ADL23 and NPI
• Number of patients: 70 (35 per arm)
• Patients: ≥50 years of age with mild to moderate Alzheimer’s Disease and treated daily with donepezil, rivastigmine or galanthamine for ≥3 months
• 8 Canadian sites; retained services of contract research organizations Cogstate and JSS Medical Research
• Patient screening and enrolment commenced Q3-2018
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IntelGenx AdvantageIn Summary
1. Leadership
- Leader in oral film development and manufacturing with 30+ years experience
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 (gastrointestinal), sublingual & buccal absorption
3. Clearly Defined Corporate Strategy & Business Model
- Focus on lifecycle management, patient benefits, first-to-file generics and drug repurposing
- Provider of comprehensive pharmaceutical services to industry partners
4. Competitive Manufacturing Capabilities
- New, Health Canada approved, state-of-the-art, GMP compliant manufacturing facility
- Offering one-stop-shopping to partners with lean operations keeping costs down
- Customized manufacturing equipment
Thank You!
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Stephen KilmerInvestor Relations+1-514-331-7440 ext. 232Stephen@intelgenx.com
André GodinExecutive VP & CFO +1-514-331-7440 ext. 203Andre@intelgenx.com
Dana Matzen, Ph.D. VP Corp & BD+1-514-331-7440 ext. 220Dana@intelgenx.com
IntelGenx Corporate Offices6420 AbramsSaint-Laurent (Quebec)H4S 1Y2 Canadawww.intelgenx.com
Contact Information
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