CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (July 2021)
23 slides from CytoDyn's investor presentation, Jul 22, 2021
Slide 1: Vyrologix (leronlimab – PRO 140) Investor Presentation
JULY 22, 2021 INVESTOR PRESENTATION Vyrologix (leronlimab – PRO 140) The pursuit of precision medicine Humanized Monoclonal Antibody CytoDyn Inc. Exhibit 99.2
Slide 2: Forward-Looking Statements & Information
Forward-Looking Statements & Information This presentation contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words s
Slide 3: Robust Pipeline – Leronlimab
Robust Pipeline – Leronlimab 1) Cancer program mTNBC & Compassionate use Testimonies Follow up with FDA Basket trial 2) COVID-19 Long-Hauler Will send Phase 3 protocol to FDA Bio marker data 3) COVID-19 trials in Brazil (different definitions) Critical – 316 patients Severe - 612 patients 4) COVID-1
Slide 4: Cancer Program – Leronlimab
Cancer Program – Leronlimab 1) Cancer program mTNBC & Compassionate use Testimonies Follow up with the FDA Basket trial
Slide 5: Preliminary Interim Task Report: Pre-Analysis of mTNBC from Trial 756 and Trial 706
Preliminary Interim Task 1 Report: Pre-Analysis of mTNBC from Trial 756 (Compassionate Use) and Trial 706 (mTNBC) CytoDyn July 15th, 2021
Slide 6: Overviewing mTNBC relapse clinical data
Overviewing mTNBC relapse clinical data mPFS=1.5-2.6 : mOS= 5.8-7.7 Proprietary and Confidential mPFS=2.3 (2.3-2.5) mOS=6.6 (6.3-7.2) Probability of OS (%) 0 75% 50% 25% 6 12 18 24 100% 0% Probability of PFS (%) 0 75% 50% 25% 6 12 18 24 100% 0% mPFS mTNBC at 3rd line therapy mPFS mTNBC at 3rd line t
Slide 7: Comparing CCR5 expression from Tissue Samples
Comparing CCR5 expression from Tissue Samples Probability of PFS (%) 0 75% 50% 25% 0% 3 6 8 12 PFS Based on CCR5% in Tissue 100% Proprietary and Confidential OS Based on CCR5% in Tissue Time from First Dose (Months) 0 3 6 8 12 HR=3.0 (95%CI 1.0-9.1) P=0.09112 HR=0.8 (95%CI 0.2-2.9) P=0.9767 Probabil
Slide 8: Circulating Stromal Cells (CAMLs) at First Dose
Circulating Stromal Cells (CAMLs) at First Dose Probability of PFS (%) 0 75% 50% 25% 0% 3 6 8 12 PFS Based on CTCs/CAMLs at First Dose 100% Proprietary and Confidential Time from First Dose (Months) 0 3 6 8 12 HR=1.2 (95%CI 0.5-3.3) P=0.7885 HR=1.5 (95%CI 0.5-5.2) P=0.6971 Probability of OS (%) 75%
Slide 9: Change in Circulating Stromal Cells (CAMLs) at 30 days
Probability of PFS (%) 0 75% 50% 25% 0% 3 6 8 12 100% Proprietary and Confidential Time from First Dose (Months) 0 3 6 8 12 HR=3.8 (95%CI 0.9-15.4) P=0.1350 HR=15.4 (95%CI 2.2-1186.6) P=0.0243 Probability of OS (%) 75% 50% 25% 0% 100% n=18 n=7 n=18 n=7 Time from First Dose (Months) OS Based on Chang
Slide 10: Predicting Outcomes using LifeTracDx Algorithm
Probability of PFS (%) 0 75% 50% 25% 0% 3 6 8 12 100% Proprietary and Confidential Time from First Dose (Months) 0 3 6 8 12 HR=4.6 (95%CI 1.3-16.0) P=0.0358 HR=11.1 (95%CI 2.4-51.9) P=0.0074 Probability of OS (%) 75% 50% 25% 0% 100% n=21 n=8 n=21 n=8 Time from First Dose (Months) OS Based on Change
Slide 11: Summary
Summary Goal of Interim Analysis is to compare PFS and OS in relation to Standard of Care (SOC) or Sacituzumab Govitecan (SG) Trial Goal one: Have a mPFS >2.3 (SOC) or >5.6 (SG) Goal two: Have a mOS >6.7 (SOC) or >12.1 (SG) CCR5 in Tissue Staining Low CCR5 in tissue partially predicted treatment res
Slide 12: Long-Hauler - Leronlimab Responses to COVID-19
COVID-19 Long-Hauler - Leronlimab Responses to COVID-19 (1) Appropriate inflammation response balanced by appropriate healing. A normal release of cytokines causes blood vessel walls to become leakier to promote healing of damaged tissue via inflammation. (2) Inappropriately high inflammation A cyto
Slide 13: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 14: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 15: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 16: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 17: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 18: Long-Hauler – Leronlimab
COVID-19 Long-Hauler – Leronlimab
Slide 19: Long-Hauler - Leronlimab Results
COVID-19 Long-Hauler - Leronlimab Results: Symptom improvement noted on daily diary Baseline dysregulated Immune function in control and treated groups Down regulated T cells Immune system shifted Th2 M2 monocyte polarization predominant up to 66% Biomarkers correlating with symptom improvement Rest
Slide 20: Trials – Leronlimab
COVID-19 Trials – Leronlimab 3) COVID-19 trials in Brazil (different definitions) Critical – 316 patients Severe - 612 patients 4) COVID-19 (Philippines – India)
Slide 21: Trials – Leronlimab: BLA submission process
COVID-19 Trials – Leronlimab 5) BLA submission process Final timeline for completion (Oct-15-2021)
Slide 22: NASH Trial– Leronlimab
NASH Trial– Leronlimab 6) NASH trial CT1 and PDFF + Biomarker
Slide 23: Diagnostic Lab for CytoDyn by Dr. Recknor – Leronlimab
Diagnostic Lab for CytoDyn by Dr. Recknor – Leronlimab 7) Biomarker Diagnostic test Lab Dr. Chris Recknor a) Receptor Occupancy Test