CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (March 2018)
19 slides from CytoDyn's investor presentation, Mar 26, 2018
Slide 1: First self-administered antibody therapy for HIV in late-stage clinical development
® www.cytodyn.com First self-administered antibody therapy for HIV in late-stage clinical development March 2018 PRO 140 Exhibit 99.1
Slide 2: Forward-looking statements
www.cytodyn.com This presentation includes forward-looking statements and forward-looking information within the meaning of United States securities laws. These statements and information represent CytoDyn’s intentions, plans, expectations and beliefs, and are subject to numerous known and unknown r
Slide 3: Investment Highlights for PRO 140 (leronlimab)
Large U.S. market ($20 billion) for HIV therapies PRO 140 is currently under development for two different HIV indications: Combination with HAART – primary endpoint achieved in February 2018 BLA filing in 2018, expected approval in 2019 with BTD Potential market size is estimated at $1 billion Mono
Slide 4: CCR5 is the Entry Receptor for R5 Strain of HIV
www.cytodyn.com CCR5 is the Entry Receptor for R5 Strain of HIV Binds to CCR5 co-receptor on white blood cells PRO 140 blocks entry of the R5 strain of HIV into white blood cells PRO 140 CCR5 CD4 T-Cell HIV-R5 Humanized monoclonal antibody PRO 140 – A Humanized Monoclonal Antibody HAART
Slide 5: Current HIV Market Environment
www.cytodyn.com Current HIV Market Environment Viral Load (VL) of an HIV patient = HIV particles per milliliter of the blood (copies/mL) A major goal of current therapy is to reduce transmission: If VL<50 copies/mL, then transmission rate about zero Transmission of HIV remains high due to liabilitie
Slide 6: PRO 140 Advantages Over HAART
Vision www.cytodyn.com PRO 140 No serious side effects and no serious adverse events (SAEs) in >400 patients in 8 clinical trials Ranges from mild to severe (Diarrhea, nausea, lethargy, depression) Negligible toxicity Problems with short- and long-term toxicity (hepatic toxicity, myelosuppression) N
Slide 7: PRO 140 Viral Load Reduction
PRO 140 Viral Load Reduction CytoDyn >400 HIV Patients (8 clinical trials) g-aciing, pe monthly PRO 140 1302 Placebo (n=9) Jacobson et al., J. Infect. Dis. 0.5 mg/kg single dose (n=10) 198:1345, 2008 2.mg/kg single dose (n=10) 5.mg/kg single dose (n=10) PRO 140 2301 IV Placebo (n=11) Jacobson et al.
Slide 8: PRO 140 Clinical and Regulatory Path
Initial Approval and Label Expansion Study Design / Findings Status Phase 2b/3 Pivotal HIV Trial Initial Approval Combination Trial Patients failing on HAART 1 week efficacy + 24 weeks safety Primary endpoint achieved (p<0.01) Phase 2b/3 Investigative HIV Trial Label Expansion Monotherapy Switch Tri
Slide 9: CD02 Pivotal Phase 2b/3 Combination Trial
Primary Efficacy Endpoint: Three-fold VL drop at one week Phase 3 Rollover Treatment Protocol Completion: Patients with undetectable viral loads Week 1 Week 25 PRO 140 + HAART Path to 1st FDA approval of PRO 140 Potential for Breakthrough Therapy Designation by FDA Patient enrollment completed Prima
Slide 10: CD03 Phase 2b/3 Investigative Monotherapy Trial
HI Long-term efficacy from CD01 Phase 2b study which has patients in a Monotherapy extension study for over 3 years 48 Weeks | N = 300 Primary Endpoint: Proportion of patients who remain on PRO 140 without experiencing virologic failure Secondary Endpoint: Efficacy, safety and tolerability data Safe
Slide 11: Current HAART and the Role of Entry Inhibitors
Current HAART and the Role of Entry Inhibitors www.cytodyn.com NRTI NNRTI INTI PI HAART 3 Drugs from 2 Different Classes EI Maraviroc Ibalizumab PRO 140 Four Classes of Drugs Interference with HIV Life Cycle Inside of T-cells Entry Inhibitors
Slide 12: Most Commonly Prescribed HAART Drugs
www.cytodyn.com Most Commonly Prescribed HAART Drugs STR (Single Tablet Regimen) Atripla Triumeq* • Stribild Quad* • Complera Nucleoside reverse transcriptase inhibitors (NRTI) • Truvada • Epzicom • Viread Non-Nucleoside reverse transcriptase inhibitors (NNRTI) • Sustiva • Intelence • Edurant Protea
Slide 13: Entry Inhibitors versus HAART Combinations in Daily Single Pill Formulations
(33/37 patients in ongoing trail) Entry Inhibitors versus HAART Combinations in Daily Single Pill Formulations www.cytodyn.com HAART-Viral Life Cycle Inhibitors First-line Treatment Patients Daily Single Pill Suppressed viral load (48-week trial) Combivir 73% Atripla 82% Complera 86% Stribild 87% Tr
Slide 14: Current HIV Status in U.S.
Current HIV Status in U.S. (Source: GlobalData) www.cytodyn.com Year Number of HIV patients in US HIV Patients using ART New cases in US 2003 1,021,840 575,883 51,818 2004 1,030,428 580,723 52,076 2005 1,039,791 586,000 52,169 2006 1,049,343 591,383 52,360 2007 1,081,789 609,669 52,510 2008 1,102,63
Slide 15: Market Potential for PRO 140
Market Potential for PRO 140 www.cytodyn.com Initial approval Combination Therapy U.S. Market Potential HAART failures: ~ 70,000 pts with two or more drug class resistances 70,000 pts x 70% (R5-HIV strain) = 49,000 HIV pts R5 eligible 49,000 pts x $24,000 (current market pricing) = ~ $1.2 billion La
Slide 16: PRO 140 for Immunologic Indications (Non-HIV)
www.cytodyn.com CCR5 – responsible for T-cell migration to sites of inflammation T-cell migration plays a crucial role in inflammatory responses Transplantation rejection reactions Autoimmunity Chronic inflammation Tumor metastases Transplantation reaction, GvHD, is the first immunologic indication
Slide 17: Graft versus Host Disease (GvHD)
www.cytodyn.com (OTCQB: CYDY) Bone marrow transplant required due to aggressive cancer therapy GvHD occurs due to imperfect tissue match Mild: Cutaneous Severe: Liver & gut involvement Examples of Mild GvHD (OTCQB: CYDY) www.cytodyn.com 17 Graft versus Host Disease (GvHD)
Slide 18: Effect of PRO 140 on Xeno-GvHD
P < .01 P < .01 (OTCQB: CYDY) www.cytodyn.com 18 Effect of PRO 140 on Xeno-GvHD Human BM transplanted into immuno-deficient mice
Slide 19: PRO 140 Important Milestones 2018/2019
HIV Breakthrough Therapy Designation (BTD) www.cytodyn.com Milestones Target Dates Phase 2b/3, Pivotal HIV Combination Trial Primary Endpoint Completed Medical Conference Presentations (CROI and ASM Microbe) Completed Published studies – GvHD (Preclinical study) Completed Orphan Drug Designation for