Resverlogix Corp. · TSX:RVX
Resverlogix — Corporate Update (December 2021)
25 slides from Resverlogix's corporate update, Dec 16, 2021
Slide 1: Resverlogix 2021 Clinical and Commercialization Update
TSX: RVX Resverlogix 2021 Clinical and Commercialization Update December 16th 2021
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: Key Investment Highlights
Key Investment Highlights Apabetalone is a first-in-class Phase III asset with a demonstrated cardio-protective benefit in high-risk Cardiovascular, Diabetic and Kidney patients – utilizing advanced epigenetics to regulate expression of multiple disease-associated genes FDA- Breakthrough Therapy Des
Slide 4: Development Pipeline Overview
Development Pipeline Overview Product Candidate Preclinical Phase I Phase II Phase III Next Milestone Primary Indications Phase III BETonMACE trial previously completed for High-Risk CVD indication and supported FDA BTD High-Risk CVD Phase III BETonMACE2 T2DM, Low HDL-C and BETonMACE2 Trial Initiati
Slide 5: High-risk Cardiovascular Disease Clinical Results, Updates and Plans
High-risk Cardiovascular Disease Clinical Results, Updates and Plans
Slide 6: FDA Approves Breakthrough Therapy Designation for Apabetalone
FDA Approves Breakthrough Therapy Designation for Apabetalone As the result of very safe and promising data the FDA granted Resverlogix the coveted Breakthrough Therapy Designation UNITED POLAND RUSSIA STATES BELGIUM HUNGARY BULGARIA → “A breakthrough therapy designation is for a drug that treats a
Slide 7: Compelling Efficacy of Combining Apabetalone With SGLT2 / DPP4 Inhibitors
Compelling Efficacy of Combining Apabetalone With SGLT2 / DPP4 Inhibitors 63% Hazard Reduction Key Takeaways • Co-administration of apabetalone and SGLT2 or DPP4 inhibitors illustrated a significant reduction of events compared to placebo and SGLT2 or DPP4 inhibitors ▪ Quantified by MACE and hospita
Slide 8: Confirmed Efficacy for Treatment of High-Risk CKD Patients
Confirmed Efficacy for Treatment of High-Risk CKD Patients Key Takeaways • Apabetalone significantly reduced the risk of MACE and CHF with a 50% hazard reduction 50% Hazard • CKD patients are at high risk of poor cardiovascular outcomes Reduction and have a strong unmet need, despite current standar
Slide 9: BETonMACE2 – Design Considerations
BETonMACE2 – Design Considerations BETonMACE2 is designed to expand on the original and incorporate a greater proportion of patients with high unmet need (specifically CKD patients) The primary endpoint of BETonMACE2 will include hospitalization due to CHF alongside MACE Population Primary Endpoint
Slide 10: Targeted - Global Development Plan
Targeted - Global Development Plan BETonMACE2 Estimated to cost $30-$35 million for Resverlogix1 Interim analysis Pending interim success Targeted Patient of 300 targeted FDA approval is possible enrollment should enrollment will patient events due to the Breakthrough be completed 3-6 start H1 2022.
Slide 11: Unique Dual Mechanism COVID-19 Program Update and Progress
Unique Dual Mechanism COVID-19 Program Update and Progress
Slide 12: COVID-19 Dual Mechanism Approach – ACE2 Reduction and Cytokine Storm Calming
COVID-19 Dual Mechanism Approach – ACE2 Reduction and Cytokine Storm Calming 12
Slide 13: COVID-19 Disease Progression – Unique Dual Mechanism
COVID-19 Disease Progression – Unique Dual Mechanism Disease Progression Hyper-inflammatory Early Infection Pulmonary Phase Chronic COVID-19 Phase Asymptomatic Mild to Moderate Symptoms Severe to Critical Symptoms Ongoing Symptoms (~35%) (~45%) (~20%) (~10%) Viral Growth and Activity Host Inflammato
Slide 14: Cytokine Storm Pathways are Suppressed by Apabetalone Treatment
Cytokine Storm Pathways are Suppressed by Apabetalone Treatment Hyperinflammatory Response Drives Negative Outcomes in COVID-19 SARS-CoV-2 Inflammatory Multi-organ Infection Pathways Activated Damage Cytokine Severe Death Storm Outcomes Tissue Damage Apabetalone Deactivates Hyperinflammatory Signali
Slide 15: Key COVID-19 Trial Updates
Key COVID-19 Trial Updates PROCESS The T active portion of the Covid-19 Trial OPIC ACTION ITEMfacility began actively The UofA clinical Update 1 has commenced – 14 patients being screening patients last week. screened in Edmonton. Full trial approval was received in Brazil early this week and apabet
Slide 16: COVID-19 Scientific Advisors
COVID-19 Scientific Advisors JUDITH S. CURRIER, MD Professor of Medicine Division Chief, Infectious Diseases Director, UCLA Clinical AIDS Research and Education UCLA Health Los Angeles, California CARLOS DEL RIO, MD Executive Associate Dean Distinguished Professor Emory School of Medicine Atlanta, G
Slide 17: Continued Unmet Need in COVID-19 Treatment
Continued Unmet Need in COVID-19 Treatment “Many of the drugs we will have available to treat ambulatory COVID-19 have only demonstrated antiviral activity, and they're likely only going to be effective in a select group of patients very early in the course of their infection. The morbidity and mort
Slide 18: EVERSANA Partnership Update
EVERSANA Partnership Update 18
Slide 19: Unique Dual Activity Targeting the COVID-19 Continuum
Unique Dual Activity Targeting the COVID-19 Continuum 19
Slide 20: EVERSANA Commercialization Partnership: Compressing Time
EVERSANA Commercialization Partnership: Compressing Time ADVOCACY/ APPROVAL ACCESS AVAILABILITY ADOPTION ADHERENCE AWARENESS Ensure successful NDS- Deliver best-in-class Educate on burden of Activate COVID patients, COVID filing in Canada Ensure broad access to Establish supply chain patient experi
Slide 21: EVERSANA: Commercial Development Parallels Clinical
EVERSANA: Commercial Development Parallels Clinical Regulatory Readiness in Canada Initial discussions with Health Canada (HC) are underway to strengthen awareness of the active Phase 2 and Apabetalone. Laying groundwork to engage with HC to be considered for NDS-Covid approval program, which provid
Slide 22: EVERSANA: Commercial Development Parallels Clinical
EVERSANA: Commercial Development Parallels Clinical Pre-Trial Awareness for Global COVID-19 FDA Phase 3 Developing Facilitating Raising awareness Seeking Insights Resources to Onboarding for with COVID-19 from COVID-19 Engage Medical Clinical Trial Specialists Thought Leaders Community Investigators
Slide 23: EVERSANA Provides Expansive Commercial Infrastructure and Experience
EVERSANA Provides Expansive Commercial Infrastructure and Experience 100% of the Top 25 Bio-pharma Companies 570 500 MDs, RNs, Life Science PharmDs Clients 3,000 80 100 Employees Countries Therapeutic Served Areas 25 25 Patient Locations Service EVERSANA provides extensive Programs commercialization
Slide 24: Partnership with EVERSANA Provides Complete Commercialization Support
Partnership with EVERSANA Provides Complete Commercialization Support Patient Services End-to-end commercial Channel & Field 3PL Solutions strategy, operational excellence and a shared success delivery model: Agency Pricing Intel ✓ Minimize financial Services & Analytics exposure ✓ Keep revenues Mar
Slide 25: Resverlogix 2021 Clinical and Commercialization Update
TSX: RVX Resverlogix 2021 Clinical and Commercialization Update December 16th 2021