Resverlogix Corp. · TSX:RVX
Resverlogix — Investor Presentation (March 2019)
31 slides from Resverlogix's investor presentation, March 2019
Slide 1: Resverlogix Corp. Corporate Presentation
TSX: RVX Resverlogix Corp. Corporate Presentation March, 2019
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation may contain certain forward-looking information as defined under applicable Canadian securities legislation, that are not based on historical fact, including without limitation statements containing the words "believes", "anticipates", "plans", "intends",
Slide 3: Resverlogix at a Glance
Resverlogix at a Glance Snapshot Profile • Late-stage clinical biotechnology company that has built a leadership position in epigenetics Toronto Stock Exchange: Listing • Lead product candidate is Apabetalone, a first-in- RVX class small molecule selective bromodomain extra-terminal (BET) protein in
Slide 4: Our Clinical Development Pipeline
Our Clinical Development Pipeline Apabetalone Phase 2 Pre-clinical Phase 1 Phase 3 Status Est. Indication Ready Acute Coronary Initiation: 2015 Syndrome (ACS) - Trial completion BETonMACE estimate: H1 2019 Vascular Cognitive 19% of BETonMACE participants in VCD subgroup Initiation: H2 2019 Dementia*
Slide 5: Addressing a Critical Unmet Need
Addressing a Critical Unmet Need Cardiovascular disease The Diabetes Epidemic Cardiovascular disease is still the number one killer of both males and females and costs the US healthcare system over $500B per year Current CVD Therapies • Statins are the top medication used to treat CVD • Despite maxi
Slide 6: Overview of Epigenetics
Overview of Epigenetics • The epigenetic code refers to modifications to chromatin components that regulate its activity • Turning genes on or off is regulated by these modifications • BET (Bromodomain and Extraterminal Domain) proteins recognize these modifications and turn genes on TSX: RVX RESVER
Slide 7: Our Differentiated BET Platform
Our Differentiated BET Platform • Resverlogix has discovered compounds that selectively bind the bromodomains of BET proteins – Bromodomain selectivity: Resverlogix’s Apabetalone selectively targets BD2 – BET (BRD2, BRD3, BRD4) protein selectivity: Our expertise in medicinal chemistry and epigenetic
Slide 8: Unique Mechanism of Action
Unique Mechanism of Action Genome Editing The mechanism is based on cutting and pasting undesired/desired sequences into or out of the DNA, thereby altering the gene sequence and then re-introducing the modified DNA into the body. CRISPR – gene editing within a cell sub population Transcriptional Re
Slide 9: Rationale for Kidney Disease Program
Rationale for Kidney Disease Program • Apabetalone has demonstrated reductions in alkaline phosphatase (ALP; a strong marker of CKD risk) and improvements in estimated glomerular filtration rate (eGFR) in CKD patients (eGFR < 60 mL/min/1.73m2) with CVD in the phase 2 ASSURE and SUSTAIN trials All Pa
Slide 10: Kidney Disease Phase I Study
Kidney Disease Phase I Study A Phase I, Open-Label, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of a Single Oral Dose of Apabetalone in Subjects with Severe Renal Impairment Cohort 1 Previously diagnosed with CKD (stage IV) and not on dialysis (eGFR <30 mL/min/1.73m2) N=8 Apabet
Slide 11: SOMAscan Analysis of Plasma Proteome in CKD Patients
SOMAscan® Analysis of Plasma Proteome in CKD Patients IPA Canonical Pathways IL6 Signaling Dendritic cell maturation Th1 pathway NF-kB Signaling Acute Phase Response D>10% p≤0.05 Wasiak et al., 2017 TSX: RVX RESVERLOGIX.com 11
Slide 12: SOMAscan Analysis of Plasma Proteome
SOMAscan® Analysis of Plasma Proteome IPA Canonical Pathways: Top 5 Pathways Upregulated at Baseline IL6 Signaling Dendritic cell maturation Baseline Th1 pathway NF-kB Signaling Acute Phase Response D>10% p≤0.05 Wasiak et al., 2017 TSX: RVX RESVERLOGIX.com 12
Slide 13: SOMAscan Analysis of Plasma Proteome
SOMAscan® Analysis of Plasma Proteome IPA Canonical Pathways: Top 5 Pathways Downregulated with Apabetalone IL6 Signaling Dendritic cell maturation Apabetalone Th1 pathway NF-kB Signaling Acute Phase Response D>10% p≤0.05 Wasiak et al., 2017 TSX: RVX RESVERLOGIX.com 13
Slide 14: SOMAscan Analysis of Plasma Proteome – Phase 1 Trial
SOMAscan® Analysis of Plasma Proteome – Phase 1 Trial Apabetalone Reduces CVD and CKD Biomarkers Subjects with CKD (stage Matched Control IV) (n=8) treated with 100 Subjects (n=8) treated Gene mg Apabetalone with 100 mg Apabetalone Protein Name Symbol % D from baseline % D from baseline p-value p-va
Slide 15: BET Inhibition Impacts Pathways Driving Cardiovascular and Kidney Diseases
BET Inhibition Impacts the Pathways that Drive Cardiovascular Disease and Kidney Diseases Apabetalone, a bromodomain extra-terminal (BET) protein inhibitor, regulates the expression of genes and restores the function of pathways underlying the pathogenesis of CVD and kidney disease Reductions in the
Slide 16: Critical Conclusions from our Phase 2 CVD Trials
Critical Conclusions from our Phase 2 CVD Trials (ASSERT, ASSURE and SUSTAIN) Nicholls et al. 2018 Am J Cardiovasc Drugs Incidence of MACE in total patient group MACE in elevated CRP @ baseline subgroup Placebo (n=242) Placebo Elevated CRP (n=133) Apabetalone (n=556) Apabetalone Elevated CRP(n=290)
Slide 17: BETonMACE Phase 3 Trial
BETonMACE Phase 3 Trial Enrollment Complete; Trial completion expected H1 2019 2,400 + subjects atorvastatin Apabetalone 200mg daily + standard of care safety follow-up or • double blinded rosuvastatin • 1-2 week statin run-in run-in placebo + standard of care safety follow-up standard of care inclu
Slide 18: Apabetalone Target Product Profile
Apabetalone Target Product Profile High Risk ACS with Diabetes and Low HDL-C High Risk Acute Coronary Syndrome (ACS) Patients with a Type II Diabetes Mellitus (DM) Comorbidity and Low High-Density Lipoprotein Cholesterol (HDL-C) • Primary endpoint: Time to the first occurrence of Major Adverse Cardi
Slide 19: BETonMACE Commenced November 2015
BETonMACE Commenced November 2015 UNITED RUSSIA POLAND STATES BELGIUM BULGARIA HUNGARY MEXICO SERBIA TAIWAN GERMANY CROATIA SLOVAKIA CROATIA ARGENTINA Apabetalone has already been tested in over 1,900 patients in 18 countries around the world, 14 countries have already approved Phase 3 usage TSX: RV
Slide 20: BETonMACE Clinical Trial Analysis Points and Time Lines
BETonMACE Clinical Trial Analysis Points and Time Lines 1 Maintain existing safety profile until trial completion, last dosing expected H1 2019 2 Trial completion – trial to continue until 250+ narrow MACE events have occurred 3 Narrow, three point MACE event accumulation stands at over 220 Adjudica
Slide 21: Committee Members for BETonMACE
Committee Members for BETonMACE Clinical Advisory Board Recent High Profile Publications Prof. Kausik K. Ray, BSc (hons), MBChB, MD, MPhil Apabetalone downregulates factors and pathways associated (Cantab), FACC, FAHA, FESC, FRCP; with vascular calcification – Atherosclerosis 2018 Chairman Imperial
Slide 22: Our First Three Initial Opportunities
Our First Three Initial Opportunities Top 8 Markets (U.S., Top 5 EU, Japan & Canada) Apabetalone is a first-in-class, small molecule that is a selective BET inhibitor that produces a specific set of biological effects with important benefits while maintaining a well described safety profile. It is c
Slide 23: Additional Indications
Additional Indications • Complement Mediated Disease: orphan indication • Neurofibromatosis – Malignant Peripheral Nerve Sheath Tumors (MPNST): orphan indication • Pulmonary Arterial Hypertension: orphan indication • Muscular Dystrophy/Facio Scapulo Humeral Dystrophy: orphan indication • Fabry Disea
Slide 24: Business Development Strategy
Business Development Strategy • Partnered Apabetalone in Greater China (China, Hong Kong, Taiwan and Macau) with Shenzhen Hepalink Pharmaceutical, a ~US$4 billion market cap company listed in China – US$35M initial equity investments in Resverlogix (total now exceeds US$100M) – >US$400M in projected
Slide 25: Management Team
Management Team Donald McCaffrey Dr. Norman C.W. Wong, M.D., FRCP, A. Brad Cann, CA, Chief Financial President & Chief Executive Officer Chief Scientific Officer & Co Founder Officer • Co-founded Resverlogix in 2001 with • Co-founded Resverlogix in 2001 with • Has over 20 years of experience Dr. Nor
Slide 26: Investment Highlights
Investment Highlights 1 Global leader in epigenetic research and drug development 2 Apabetalone is a first-in-class BET inhibitor with potentially broad applicability across multiple disease indications 3 Addresses critical unmet need with 12 million+ patients in top 8 markets 4 Lead program has com
Slide 27: Appendix
Appendix
Slide 28: Apabetalone Clinical Trials to Date
Apabetalone Clinical Trials to Date Completed Trials Current and Planned Trials Phase 2 Phase 2b Phase 2b Phase 2b Phase 1 Chronic Vascular Pulmonary Phase 1a Phase 1 BE Phase 1 BE Phase 1b/2a Phase 3 Fabry ASSERT SUSTAIN ASSURE Pre-Diabetes PK Study Kidney Cognitive Arterial BETonMACE Disease - Dis
Slide 29: BET Literature Impact Growing CVD and Renal Risk
BET Literature Impact Growing CVD and Renal Risk Increase in CVD and CKD Risk Factors Adapted from: Campbell, AE. et al. 2017 on TSX: RVX RESVERLOGIX.com 29
Slide 30: Recent High Profile Publications
Recent High Profile Publications • Recent high profile publications illustrate apabetalone-induced activation of latent HIV-1 in vitro and ex vivo • Suggest that Apabetalone synergistically reactivated latent HIV-1 and could combine with cART drugs to inhibit viral infection TSX: RVX RESVERLOGIX.com
Slide 31: BET Technology Goes Mainstream
BET Technology Goes Mainstream Zenith Epigenetics TSX: RVX RESVERLOGIX.com 31