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Annual Information Form Annual Information Form Fiscal Year Ended April 30, 2019 July 26, 2019 Table of Contents Advisories ................................................................................................................................................................................... 4 Forward-Looking Information .................................................................................................................................................... 4 Corporate Structure ................................................................................................................................................................... 6 Name and Incorporation ............................................................................................................................................................................ 6 Inter-Corporate Relationships .................................................................................................................................................................... 6 Description of Business ............................................................................................................................................................. 6 The Drug Development Process ................................................................................................................................................................ 6 Resverlogix Current Development Stage: Phase 3 Nearing Completion ................................................................................................. 8 Apabetalone (RVX-208) .............................................................................................................................................................................. 8 Epigenetic Mechanism of Action: Single Therapeutic Target with Multiple Biological Effects ............................................................... 8 BET Inhibition Targets Pathways and Markers That Are Linked to CVD .................................................................................................. 9 Resverlogix’s Drug Development Strategy and Commercial Rationale ................................................................................................ 11 Cardiovascular Disease .......................................................................................................................................................................... 11 Chronic Kidney Disease and End-Stage Renal Disease ........................................................................................................................ 12 Diabetes Mellitus .................................................................................................................................................................................... 12 Fabry Disease .......................................................................................................................................................................................... 13 Neurodegenerative Disease ................................................................................................................................................................... 14 Competitive Environment........................................................................................................................................................................ 14 Key Products in Development (Resverlogix and Competitors) .............................................................................................................. 16 General Development of the Business ................................................................................................................................... 17 History of Apabetalone Clinical Development ........................................................................................................................................ 17 Recent Clinical Developments ................................................................................................................................................................ 18 Apabetalone Phase 2 Clinical Trial History ............................................................................................................................................ 21 Completed, Current and Planned Apabetalone (RVX-208) Clinical Trials ............................................................................................ 22 Recent Scientific Developments............................................................................................................................................................. 22 Potential Orphan Disease Indications .................................................................................................................................................... 24 Regulatory Affairs .................................................................................................................................................................................... 25 Intellectual Property ................................................................................................................................................................................ 25 Clinical and Scientific Advisory Boards .................................................................................................................................................. 26 Financing ................................................................................................................................................................................................. 28 Licensing .................................................................................................................................................................................................. 29 Recent Developments ............................................................................................................................................................................. 30 Public Offering of Units ........................................................................................................................................................................... 30 Risk Factors ............................................................................................................................................................................. 30 Risks Relating to Our Business............................................................................................................................................................... 30 Risks Relating to our Intellectual Property ............................................................................................................................................. 39 Risks Relating to Owning our Common Shares ..................................................................................................................................... 40 Dividends.................................................................................................................................................................................. 41 Description of Capital Structure .............................................................................................................................................. 42 Common Shares ...................................................................................................................................................................................... 42 2 Preferred Shares ..................................................................................................................................................................................... 42 Market for Securities ............................................................................................................................................................... 43 Directors and Executive Officers ............................................................................................................................................. 44 Name, Occupation and Security Holdings .............................................................................................................................................. 44 Audit Committee Matters ........................................................................................................................................................................ 46 Cease Trade Orders, Bankruptcies, Penalties or Sanctions ................................................................................................................. 47 Conflicts of Interest ................................................................................................................................................................................. 48 Interests of Management and Others in Material Transactions ........................................................................................... 48 Transfer Agent and Registrar .................................................................................................................................................. 48 Material Contracts ................................................................................................................................................................... 48 Interests of Experts .................................................................................................................................................................
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  • The SOLID-TIMI 52 Randomized Clinical Trial
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