CytoDyn Inc. · OTC:CYDY
CytoDyn — Shareholder Meeting (November 2018)
26 slides from CytoDyn's shareholder meeting presentation, Nov 9, 2018
Slide 1: CytoDyn Annual Meeting of Stockholders
® First self-administered antibody therapy for HIV in late-stage clinical development In early-stage development for cancer indications and other immunological disorders CytoDyn Annual Meeting of Stockholders November 8, 2018 Nader Pourhassan Ph.D., President & CEO & Professor Richard G. Pestell M.D
Slide 2: Forward-looking statements
(OTCQB: CYDY) 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 risks
Slide 3: CytoDyn Past Performance
3 www.cytodyn.com CytoDyn Past Performance ~Funds raised 2012 Purchase PRO 140 $6 million 2013 PRO 140 transfer all process and products to CytoDyn PRO 140 potential to be a game changer NIH-funds return Phase 2 abandon $16 million Combination therapy Monotherapy Others trials ~Funds raised 2014 Pha
Slide 4: Pivotal Combination Trial w/PRO 140 (leronlimab) – 1st Approval
www.cytodyn.com Pivotal Combination Trial w/PRO 140 (leronlimab) – 1st Approval Double Blinded Trial – Gold Standard Primary efficacy endpoint: Very positive results - p =0.0032 24-week open-label with all patients on weekly PRO 140 with optimized HAART 81% with VL<50cp/mL as compare to 43% with oth
Slide 5: MDs' unmet needs in HIV treatment align well with PRO 140 strengths
MDs’ unmet needs in HIV treatment align well with PRO 140 strengths Unmet need differs based on suppression status. While the vast majority (80%) of virologically suppressed are highly satisfied with existing HIV treatment, patients with multiple failures are much less satisfied. Physicians’ top sta
Slide 6: Patients show a strong PRO 140 call to action
(OTCQB: CYDY) www.cytodyn.com However, patients show a strong PRO 140 call to action Patient Reactions to PRO 140 (pre-video review) Monotherapy Patients Combo Therapy Patients PRO 140 is a significant improvement vs. current options 55% 55% Highly likely to start a conversation with my doctor 70% 6
Slide 7: Most MDs will trial PRO 140 monotherapy within months of launch
Most MDs will trial PRO 140 monotherapy within 3 months of launch, while 2 out of 3 will adopt its use within the 1st year Estimated Time to Trial and Adoption of PRO 140 Executive Summary *Benchmark data based on BioVid’s proprietary Demand database (full database) 43% 69% 65% 40% Base size: Total
Slide 8: Monotherapy – 525 mg vs 700 mg
2 LOWER DOSE (525 mg) = 78% HIGHER DOSE (700 mg) = 92% . Monotherapy – 525 mg vs 700 mg 8 www.cytodyn.com
Slide 9: Monotherapy – 525 mg vs 700 mg - Rescue Arms
9 www.cytodyn.com 525 mg rescue arm for 350mg patients with VF Patients rescued from 350mg (after VF) into 525mg 55 Patients who achieved complete suppression w/VL of about <50cp/ml 22 40% Patients who had VF after rescue arm in place 22 40% 700 mg rescue arm for 525mg patients with VF Patients resc
Slide 10: Leronlimab on Xeno-GvHD
P < .01 P < .01 10 www.cytodyn.com Leronlimab on Xeno-GvHD Human BM Transplanted Into Immuno-Deficient Mice Leronlimab (alive) Control (death)
Slide 11: Leronlimab in GVHD Phase 2
11 www.cytodyn.com 2. Phase 2 Leronlimab in GVHD 2. GVHD Phase 2 graph-versus-host disease (GvHD) Modified protocol to improve enrollment and reflect positive preclinical findings
Slide 12: Expansion into Cancer Indications
3 Expansion into Cancer Indications 12 www.cytodyn.com Dr. Richard Pestell (Chief Medical Officer) Lead leronlimab in non-HIV development programs Led 2 National Cancer Institute-designated cancer centers Lombardi Comprehensive Cancer Center at Georgetown University Sidney Kimmel Cancer Center at Th
Slide 13: CCR5 is Expressed in >50% of Breast Cancer
CCR5 is Expressed in >50% of Breast Cancer Metastatic cancer 50% of breast cancers CCR5+ Leronlimab reduces breast cancer invasion 0 200 400 600 800 1000 Control PRO140 Vicriviroc Distance of Invasion (mm) P<0.001 P<0.001 Control PRO140 (1/500) Vicriviroc CCL5 13 www.cytodyn.com
Slide 14: CCR5 Antagonists Block Breast Cancer Metastasis
CCR5 Antagonists Block Breast Cancer Metastasis Time (weeks) 1 2 3 4 Control Maraviroc 14 www.cytodyn.com
Slide 15: CCR5 Antagonists Block Prostate Cancer Metastasis
CCR5 Antagonists Block Prostate Cancer Metastasis Control Maraviroc 15 www.cytodyn.com
Slide 16: Leronlimab Blocks Colon Cancer Growth in Mice
SW480 Human Colon Carcinoma Xenografts in NCr Nude Mice PRO 140, 2 mg i.p. twice/week, started day 1, n=16 tumors/group p=0.014 p=0.272 Tumor Volume in mm3 (mean ± SE) 0.2 mg dosing 2 mg dosing Leronlimab Blocks Colon Cancer Growth in Mice 16 www.cytodyn.com
Slide 17: Objective Tumor Response, Phase 1 Trial
Advanced-stage metastatic colorectal cancer who are refractory to standard chemotherapy, including regorafenib Objective Tumor Response, Phase 1 Trial 17
Slide 18: Objective Tumor Response, Phase 1 Trial
Objective Tumor Response, Phase 1 Trial 18 Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients Cancer Cell. 2016 587-601
Slide 19: PRO 140 Breast Cancer Study
Pro140 Breast Cancer Study March 2019 Phase Ib/II Breakthrough (unmet need) August 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 19 November 2018 Protocol /IND
Slide 20: CytoDyn Prostate Cancer Prognostic Test
CytoDyn Prostate Cancer Prognostic Test
Slide 21: CytoDyn Prognostic Test
CytoDyn Prognostic Test Clinical Problem: 220,800 new cases of prostate cancer will be diagnosed in the USA in 2015* Current standard for risk assessment is Gleeson score combined with serum PSA and tumor stage/grade Gleason score intermediate - is a weak predictor of outcome Recommendation to add g
Slide 22: Superior Prognostic Test Discrimination Proven in Three Independent Data Sets
Superior Prognostic Test Discrimination Proven in Three Independent Data Sets Accuracy AUC Hazard Ratio* P value Group size CytoDyn **Distant metastasis. (16 gene #) *Biochemical Recurrence *Biochemical Recurrence 0.8, 0.88 # 0.64 0.69 11.6** 4.1* 9.2* 2.5x10-2 3x10-4 9x10-15 130 79 139 4Kscore® 4 p
Slide 23: Prognostic Test Competitive Environment
Prognostic Test Competitive Environment High hazard ratio indicates a better discrimination between good vs. poor outcome Survival probability HR= 9.2 0.0 0.2 0.4 0.6 0.8 1.0 0 4 8 12 Recurrence-free survival time (years) CytoDyn Survival probability 0.0 0.2 0.4 0.6 0.8 1.0 0 4 8 12 Time after RP (y
Slide 24: CytoDyn Cancer Opportunities
24 www.cytodyn.com CytoDyn Cancer Opportunities 3. Cancer- CCR5 Targeted Therapeutics New, broader focus with PRO 140 to include cancer Promising preclinical (in vitro) results in BREAST CANCER Great preclinical (animal) results in COLON CANCER Cancer- Diagnostics Prostate Cancer Prognostic test- cu
Slide 25: Future Milestones
25 www.cytodyn.com Future Milestones BLA – Combination therapy - CROI - Publication Commercialization – PRO 140 - $1.2 Billion and Monotherapy $4 Billion Monotherapy pivotal - CROI – Pivotal Trial TNBC - Publication ProstaGene Closing (Dec. 7) Prognostic test – Publication
Slide 26: 2018 Annual Meeting of Stockholders Questions
2018 Annual Meeting of Stockholders Questions