Annual Information Form
Total Page:16
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Annual Information Form Fiscal Year Ended April 30, 2017 July 20, 2017 Table of Contents Note Regarding 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 Enrolling ................................................................................................................... 7 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 .......................................................................................................................................................................... 12 Chronic Kidney Disease and End-Stage Renal Disease ........................................................................................................................ 13 Diabetes Mellitus .................................................................................................................................................................................... 13 Fabry Disease .......................................................................................................................................................................................... 13 Neurodegenerative Disease ................................................................................................................................................................... 14 Competitive Environment........................................................................................................................................................................ 14 Key Products in Development (Resverlogix and Competitors) .............................................................................................................. 16 General Development of the Business ................................................................................................................................... 16 Recent Clinical Developments ................................................................................................................................................................ 16 Summary of Phase 2 Clinical Trials ........................................................................................................................................................ 21 Completed Apabetalone (RVX-208) Clinical Trials ................................................................................................................................. 22 Current or Planned Apabetalone (RVX-208) Clinical Trials ................................................................................................................... 23 Scientific Developments ......................................................................................................................................................................... 23 Potential Orphan Disease Indications .................................................................................................................................................... 24 Regulatory Affairs .................................................................................................................................................................................... 25 Intellectual Property ................................................................................................................................................................................ 25 Clinical and Scientific Advisory Boards .................................................................................................................................................. 25 Financing ................................................................................................................................................................................................. 28 Licensing .................................................................................................................................................................................................. 29 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 .............................................................................................................................................. 41 Common Shares ...................................................................................................................................................................................... 41 Preferred Shares ..................................................................................................................................................................................... 41 Market for Securities ............................................................................................................................................................... 43 Escrowed Securities and Securities Subject to Contractual Restrictions on Transfer ........................................................ 43 2 Directors and Executive Officers ............................................................................................................................................. 44 Name, Occupation and Security Holdings .............................................................................................................................................. 44 Audit Committee Matters ........................................................................................................................................................................ 45 Cease Trade Orders, Bankruptcies, Penalties or Sanctions ................................................................................................................. 46 Conflicts of Interest ................................................................................................................................................................................. 47 Interests of Management and Others in Material Transactions ........................................................................................... 47 Transfer Agent and Registrar .................................................................................................................................................. 47 Material Contracts ................................................................................................................................................................... 48 Interests of Experts .................................................................................................................................................................. 48 Additional Information ............................................................................................................................................................. 48 Schedule “A” – Audit and Finance Committee Charter ......................................................................................................... 49 Glossary ...................................................................................................................................................................................