14 th Annual General Meeting May 7 th , 2019 Corporate Update - - PowerPoint PPT Presentation

14th Annual General Meeting May 7th, 2019 Corporate Update

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Disclaimer

• 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.

Annual General Meeting – Agenda

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Tuesday, May 7th, 11:00 am

• Call to Order and Opening Remarks
• Establishment of Quorum
• Proposal One: Election of Directors
• Proposal Two: Ratification of Appointment of Independent Registered Public Accounting Firm
• Proposal Three: Advisory Vote Regarding Executive Compensation
• Proposal Four: Other Business
• Report of Inspector of Elections
• Closing of Formal Meeting
• Dr. Horst Zerbe to Give Update
• Question & Answer Period
• Closing

2018 Key Events (1)

Operations/Quality Management

• Completed qualification of manufacturing and packaging equipment
• Completed manufacturing of pivotal batches for US Rizatriptan film re-submission
• Ongoing manufacturing of scale-up batches for undisclosed partnered program
• Completed manufacturing of clinical phase II batches of Montelukast buccal film
• Improved materials planning process and production scheduling
• Conducted vendor qualification of key suppliers of API, excipients and packaging components
• Identified packager for secondary packaging and serialization of narcotic-based products
• Submitted GDUFA application

R&D/Regulatory

• Commenced dosing for Montelukast Phase IIa POC study
• Filed ANDA for undisclosed partnered program
• Re-submitted (505)(b)(2)NDA for Rizatriptan film (US)
• Obtained market authorization for Rizatriptan oral film in Spain
• Obtained 3 US film patents, submitted 8 US applications and 32 worldwide applications

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2018 Key Events (2)

BD

• Signed definitive agreement with Tilray to form an exclusive, world-wide partnership for

cannabis-infused VersaFilm products (adult-use and medical applications)

• Signed definitive agreement with Gensco Pharma to commercialize Rizatriptan in the US

including ROFR for China Financial Operations

• Cash reserves of $11M at December 31, 2018
• Closing of Private Placement of $3.2M (May 2018)
• Closing of Equity financing of $12.6M (October 2018)
• Closing of Tilray’s Private Placement of $1M (November 2018)

2019 Objectives (1)

Operations/Quality Management

• Complete scale-up and engineering batches and prepare for commercial production of Cannabis film
• Complete manufacturing of undisclosed partnered program
• Start manufacturing of submission batches for undisclosed partnered program
• Achieve readiness for commercial launch of Rizatriptan film
• Implement a data acquisition system for two computerized production coaters to comply with FDA 21

CFR part 11 regulation

• Successfully pass PAI/FDA inspection for undisclosed partnered program
• Complete the implementation of the Preventive Maintenance Program
• Identify alternative/backup suppliers for key active ingredients
• Streamline procedures to improve process flow
• Improve Compliance of Supplier Qualification Program
• Improve employee use of risk management principles

continued…

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R&D

• Advance non-ANDA programs
• Respond to FDA’s CRL on Rizatriptan
• Commence dosing of phase I clinical Study for THC tablets
• Complete recruitment of Montelukast phase II clinical study
• Conduct midpoint evaluation of first 10 Montelukast patients
• Obtain approval for manufacturing site change for Rizatriptan in Spain (Exceltis)

BD

• Sign licensing deal for Tadalafil oral film for the US
• Increase utilization of manufacturing capacity by engaging in contract development and

manufacturing services for pharmaceutical oral films

• Strengthen competitive advantage by entering new markets, such as transdermal or animal health

Financial Operations

• Strengthen company’s balance sheet
• Expand company’s awareness outside North America
• Up-list to major US exchange
• Increase analyst coverage

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2019 Objectives (2)