CytoDyn Inc. · OTC:CYDY
CytoDyn — Biotech Showcase January 2019
20 slides from CytoDyn's conference presentation, May 2, 2019
Slide 1: HIV - Cancer Biotech Showcase January 2019
OTCQB: CYDY www.cytodyn.com HIV - Cancer BIOTECH SHOWCASE January 2019 Professor Richard G. Pestell M.D., Ph.D., MB., B.S., F.A.C.P., F.R.A.C.P., F.A.A.A.S., M.B.A. Vice Chairman and Chief Medical Officer Nader Pourhassan, Ph.D. Director, President & CEO ® Leronlimab (PRO 140) ® Trading Symbol CYDY
Slide 2: Forward-Looking Statements
www.cytodyn.com Forward-Looking Statements 2 www.cytodyn.com Trading Symbol: CYDY
Slide 3: CytoDyn Overview
3 www.cytodyn.com CytoDyn Overview PHASE 2 – Initiated Unmet Medical Need PHASE 3 - Completed World’s first self-injectable for Unmet Medical Need Population PHASE 3 - Monotherapy Several patients on monotherapy for > 4.5 years HIV HIV GvHD PHASE 1b/2 – Initiated Unmet Medical Need TNBC PHASE 2 IND
Slide 4: Blocking HIV entry receptor (CCR5) with leronlimab
4 www.cytodyn.com Blocking HIV entry receptor (CCR5) Blocking CCR5/CCL5 interaction with leronlimab for use in CANCER Binds to CCR5 co-receptor on white blood cells Blocks HIV entry into white blood cells Leronlimab CCR5 CD4 T-Cell HIV Humanized monoclonal antibody Leronlimab (PRO 140) – A Humanized
Slide 5: Leronlimab vs HAART: safety, resistance, compliance
5 www.cytodyn.com Leronlimab (PRO 140) No serious side effects and no drug related serious adverse events (SAEs) in >740 patients in 8 clinical trials Ranges from mild to severe (Diarrhea, nausea, lethargy, depression) Negligible toxicity in 740 patients Problems with short- and long-term toxicity N
Slide 6: CD02 Pivotal Combination Trial Phase 3 Completed
www.cytodyn.com CD02 Pivotal Combination Trial with Leronlimab (PRO 140) Trading Symbol: CYDY Pivotal Phase 3 Completed Primary Efficacy End Point Hit - p=0.0032 Safety of 24 weeks completed - With 81% of patients with suppressed viral load as compared to 43% last approved drug for this population N
Slide 7: CD03 Investigative Monotherapy Trial
7 www.cytodyn.com CD03 Leronlimab (PRO 140) Investigative Monotherapy Trial R5 patients w/suppressed viral load replacing HAART for leronlimab monotherapy Leronlimab monotherapy – One dose (2 consecutive injections), once a week High responder’s rate – non-responders return to their original regimen
Slide 8: Effect on Xeno GvHD-Human BM Transplanted Into Mice
P < .01 P < .01 www.cytodyn.com Effect of Leronlimab (PRO 140) on Xeno GvHD-Human BM Transplanted Into Immuno-Deficient Mice Results Published TRIAL TO RE-INITIATE WITH MODIFIED DOSE/PROTOCOL IN MAY 2019
Slide 9: Expansion into Cancer Indications
Expansion into Cancer Indications 9 www.cytodyn.com Named world-renowned oncologist Dr. Richard Pestell Chief Medical Officer and Vice Chairman (https://www.youtube.com/watch?v=98J1HgCm8wU) Leads leronlimab (PRO 140) non-HIV development programs Led 2 National Cancer Institute-designated cancer cent
Slide 10: CCR5 is Expressed in >50% of Breast Cancer
CCR5 is Expressed in >50% of Breast Cancer Metastatic cancer. 50% of breast cancers CCR5+ Leronlimab (PRO 140) reduces breast cancer invasion in pre-clinical studies 0 200 400 600 800 1000 Control PRO140 Vicriviroc Distance of Invasion (mm) P<0.001 P<0.001 Control Leronlimab PRO140 (1/500) Vicriviro
Slide 11: Blocks Breast Cancer Ca+2 signaling
Control PRO140 (1/100) 20 sec before adding CCL5 60 sec after adding CCL5 240 sec after adding CCL5 60 sec after adding FBS 0 200 400 600 800 1000 CCL5 FBS 0 200 400 600 800 1000 CCL5 FBS Control PRO140 A B C Time (Sec) Time (Sec) -1 0 1 2 3 -1 0 1 2 3 Relative FI of Fluo-4 Relative FI of Fluo-4 Ler
Slide 12: CCR5 Antagonists Block Breast Cancer Metastasis
CCR5 Antagonists Block Breast Cancer Metastasis Time (weeks) 1 2 3 4 Control Maraviroc 12 www.cytodyn.com Professor Richard Pestell, PhD, MD Trading Symbol: CYDY
Slide 13: Anti-CCR5 Therapy in Colorectal Cancer Metastases
advanced-stage metastatic colorectal cancer who are refractory to standard chemotherapy, including regorafenib Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients Cancer Cell. 2016 587-601 Objective Tumor Response, Phas
Slide 14: CCR5 Antagonists Block Metastasis
CCR5 Antagonists Block Metastasis 14 www.cytodyn.com Professor Richard G. Pestell Professor Richard Pestell, PhD, MD Trading Symbol: CYDY 0 1 2 3 6 5 7 weeks 4 Control Leronlimab Maraviroc
Slide 15: Breast Cancer Trial
Leronlimab (PRO 140) Breast Cancer Trial November 2018-December 2019 Phase II Breakthrough (unmet need) April 2019-July 2021 (Phase III) Pro-140 525 mg 1sc/week Carboplatin AUC 2q week x3 28 days cycle TNBC Rx Refractory CCR5+ CTC Endpoints OS PFS’ Decreased CTC 15
Slide 16: Clinical studies updates: TNBC breast cancer
1. AACR presentation April 1 Atlanta Georgia. CCR5 associated with HER2 in circulating tumor cells (CTCs) is a novel biomarker for patients with metastatic breast cancer (MBC) . CTCs were found positive (≥5) in all seven MBC patients with a range of numbers between 124 and 442 Clinical studies updat
Slide 17: Trial open to accrual measuring CTC
Trial open to accrual measuring CTC
Slide 18: Trial sites open to accrual
1. Pacific Hematology Oncology Associates Dr. Milana Dolezal mdolezal@phoamd.com 2100 Webster street suite 220, San Francisco, ca 9411 david@PHOAMD.COM 415-923-3012 Other sites to open: Northwestern University Medical School, Methodist Houston, Vanderbilt University, Sidney Kimmel Cancer Center. Tri
Slide 19: Important Milestones for HIV and Cancer 2019
19 www.cytodyn.com Milestones Target Dates BLA submission – HIV combination therapy – unmet medical need 3Q2019 Revenue potential of about $480 million 2020 Initiate first ever monotherapy Phase 3 pivotal trial 1H2019 Triple-Negative Breast Cancer study first patient injected 2Q2019 Triple-Negative
Slide 20: HIV - Cancer Biotech Showcase January 2019
OTCQB: CYDY www.cytodyn.com HIV - Cancer BIOTECH SHOWCASE January 2019 Professor Richard G. Pestell M.D., Ph.D., MB., B.S., F.A.C.P., F.R.A.C.P., F.A.A.A.S., M.B.A. Vice Chairman and Chief Medical Officer Nader Pourhassan, Ph.D. Director, President & CEO ® Leronlimab (PRO 140) ® Trading Symbol CYDY