CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (June 2021)
19 slides from CytoDyn's investor presentation, Jun 21, 2021
Slide 1: Investor Presentation: Vyrologix (leronlimab – PRO 140)
JUNE 21, 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 COVID-19 Long-Hauler CD15 Exploratory Symptoms/Biomarkers CD18 Phase 3: Biomarker/Symptoms/Autonomic/PFT CD19 Phase 2: Biomarker after treatment CD20 Phase 2: Biomarker/Cognitive CD21 Phase 2: Biomarker/MRI fibrosis COVID-19 trials Critically ill Severe BLA submission Ca
Slide 4: CD-15: Long-Hauler Symptoms Repeated Measures Statistical Analysis
Models for the raw ordinal data would not converge. This might be due to the study sample size and small cell sizes for each severity and treatment group combination. A model for daily change from baseline as a continuous variable was fit. Accounting for all daily data in a repeated measures model i
Slide 5: Average Joint Pain & Swelling
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Joint Pain & Swelling Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 0 2 1 3 Moderate 2 4 14 9 7 Mild 1 12 9 4 7 None 0 12 3 14 11 20 43 25 30 -23 -5 LL better 360% Repeated Measures p-value < 0
Slide 6: Average Tightness in Chest
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Tightness in Chest Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 0 6 2 3 Moderate 2 4 5 5 4 Mild 1 8 7 3 9 None 0 16 10 18 12 16 35 19 26 -19 -7 LL better 171% Repeated Measures p-value < 0.000
Slide 7: Average Tingling or Numbness
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Tingling or Numbness Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 1 5 1 1 Moderate 2 1 5 3 6 Mild 1 9 12 7 10 None 0 17 6 17 11 14 37 16 25 -23 -9 LL better 156% Repeated Measures p-value < 0.
Slide 8: Average Muscle Weakness
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Muscle Weakness Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 1 5 2 4 Moderate 2 4 15 6 8 Mild 1 14 5 8 12 None 0 9 3 12 4 25 50 26 40 -25 -14 LL better 79% Repeated Measures p-value = 0.013
Slide 9: Average Sleep Disturbance (Insomnia)
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Sleep Disturbance (Insomnia) Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 2 10 4 8 Moderate 2 1 12 4 11 Mild 1 13 4 11 7 None 0 12 2 9 2 21 58 31 53 -37 -22 LL better 68% Repeated Measures p-v
Slide 10: Average Headache
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Headache Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 1 5 3 4 Moderate 2 1 10 3 9 Mild 1 12 10 6 8 None 0 15 3 16 7 17 45 21 38 -28 -17 LL better 65% Repeated Measures p-value < 0.0001
Slide 11: Average Shortness of Breath
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Shortness of Breath Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 0 5 2 3 Moderate 2 4 10 5 8 Mild 1 11 6 6 11 None 0 13 7 15 6 19 41 22 36 -22 -14 LL better 57% Repeated Measures p-value = 0.0
Slide 12: Average Nausea
CD-15: Long-Hauler Symptoms Primary Endpoint baseline thru day 56 Average Nausea Leronlimab Leronlimab Placebo Placebo Day 56 Baseline Day 56 Baseline Severe 3 0 1 0 2 Moderate 2 0 7 1 6 Mild 1 4 5 7 6 None 0 24 15 20 14 4 22 9 24 -18 -15 LL better 20% Repeated Measures p-value = 0.028
Slide 13: Robust Pipeline – Leronlimab
Robust Pipeline – Leronlimab COVID-19 Long-Hauler COVID-19 Critically ill COVID-19 Severe Brazil India Philippines Other
Slide 14: Robust Pipeline – Leronlimab: Biomarker and Mechanism of Action
Robust Pipeline – Leronlimab Biomarker and Mechanism of Action Laboratory work finding MOA of leronlimab for each indication Dosage of leronlimab
Slide 15: Program Status: Role of Leronlimab in HIV
Program Status HIV- Monotherapy Phase 3, label expansion, protocol submitted to the US FDA HIV - PrEP One dose/month – Phase 2 – Animal study was very successful for use of leronlimab in PrEP for one dose per month. Publication has been submitted to journal and potential Phase 2 is to initiate in 20
Slide 16: BLA HIV Rolling Submission Timeline
BLA HIV Draft Dose Justification Report 30-JUN-21 Includes Virology Data Analysis Receptor Occupancy Plan CD02 and CD03 VF data with ADA and Population PK analysis Completion to allow for rolling submission: BLA Module 1 Administrative 15-Jul-21 BLA Module 2 – CTD Summaries CMC 30-Jul-21 BLA Module
Slide 17: Leronlimab Opportunity Multiple Indications
Leronlimab Opportunity Multiple Indications Triple-Negative Breast cancer results in 4-6 months NASH complete enrollment of initial 60 patients end of June NASH enrollment for biomarkers and CT1/PDFF completion Q4 2021 Long-Hauler Phase 3 completion Q4 2021
Slide 18: Leronlimab Opportunity Multiple Indications: 2021 Milestones
Leronlimab Opportunity Multiple Indications 2021 BLA submission completion Critical COVID-19 completion Severe-to-critical COVID-19 completion Long-Hauler phase 3 results HIV PrEP initiate NASH trial results MOA results with dosage finding (loading/normal dose) Breakthrough Therapy designation for m
Slide 19: Leronlimab Manufacturing: Samsung BioLogics
Deal signed April 2019 Completion of first batch of clinical grade leronlimab in June 2020 Completion of batches of commercial grade leronlimab in calendar 3Q20-4Q20 Leronlimab Manufacturing Samsung BioLogics (Commercial Partnership) Initial forecast made calendar 1Q20 Updated forecast provided quar