CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (March 2017)
21 slides from CytoDyn's investor presentation, Mar 30, 2017
Slide 1: Investor Presentation, March 2017
Exhibit 99.1 First self-administered Investor March 1(OTCQB:2017 Presentation CYDY) 1 www.cytodyn.com antibody therapy for HIV in late-stage clinical trials
Slide 2: Forward-Looking Statements
Forward-Looking www.cytodyn.com (OTCQB:CYDY) T expectations looking required differences products future regulators potential justified, marketing CytoDyn and fail nature 2Annual histo trends; presentation provide clinical ofReport statements by and of may its disclaims is or, applications, potentia
Slide 3: CytoDyn: Late-stage HIV development company
(2) CytoDyn www.cytodyn.com (OTCQB:CYDY) Late-stage Large Big Gilead GSK BMS JNJ Merck CytoDyn’s 1.3 Efficacious Safe Minimal Ease Source: 3(3) million players 9% of 16% 12% market 8% 56% compliance (1) Compilation toxicity side and development PRO (3) http://www.transparencymarketresearch.com/hiv-m
Slide 4: Once infected, HIV requires lifelong treatment; HAART problems
www.cytodyn.com (OTCQB:CYDY) Once Viral IfVL<40 High Effective Treatment HIV Different HAART Problems Side Compliance Source: 4Toxicity %20Results%20of%20a%20Systematic%20Review%20(CATIE).pdf is half replication Effects Load viral HIV a(1) is virus copies/mL life antiretroviral classes with options
Slide 5: PRO 140 advantages vs. HAART
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Slide 6: PRO 140: humanized monoclonal antibody binding CCR5
www.cytodyn.com (OTCQB:CYDY) HI Humanized Binds Blocks 6PRO 22 HIV6 Cell CD4 CCR5 140 toHIV CCR5 –Amonoclonal entry Monoclonal co-receptor into white antibody Antibody on blood whitecells that blood Binds cellsto theHIV Entry Receptor -CCR5
Slide 7: PRO 140 proof of concept
PRO proof www.cytodyn.com (OTCQB:CYDY) Subcutaneous First 7self-administrable 140 Viral of concept Administration Load weekly Reduction for aHIV long-acting, drug in >200 HIV Patients (7 clinical trials)
Slide 8: FDA Fast Track and development overview
www.cytodyn.com (OTCQB:CYDY) FDA Currently and PRO Development Viral Very No HIV Ongoing 8Phase resistance for R5 low Fast 140 load 2b/3 an strain Phase toxicities Overview evaluated under Track drop alternative Pivotal Investigative of observed represents as 2b development designation PRO much mono
Slide 9: PRO 140 clinical trials overview
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Slide 10: Phase 2b Monotherapy trial results
Phase www.cytodyn.com (OTCQB:CYDY) 40 Trial No Evaluate Shifted Time PRO Evaluation 4TreatmentInterruption 11 50% 98% After11 0% 75% Patient 10weeks weeks patients drug-related completed 140 of 2b failures to weeks, the Monotherapy Monotherapy PRO previously efficacy, due 21 140 in serious patients
Slide 11: Viral load suppression in monotherapy patients
Viral www.cytodyn.com 17(OTCQB:CYDY) 10 Successful 11patientsViral patient patients loadViral measured Monotherapy analyzed load load ~<with with 21 cp/mL 3 40 cp/mL cp/mL for enhanced, assay overcapable 2 years single of RNA detecting copya assay single virus
Slide 12: Phase 2b/3 Investigative Monotherapy Trial
Phase www.cytodyn.com (OTCQB:CYDY) Protocol 300 Failure 48-weekInvestigativetrial PRO140toreplaceHAART 12 patients 2b/3 criteria: cleared Investigative well-controlled viral by FDA; suppression Monotherapy first byof HAART of several >200 Trial atpatients cp/mL up to 30 blood treated clinical two in
Slide 13: Phase 2b/3 Pivotal Combination Therapy Trial
Phase First To reduction 13 www.cytodyn.com (OTCQB:CYDY) enroll path 2b/3PivotalCombination 30 in forHIV treatment-experienced approval viral load for PRO fromTherapy 140 baseline HIV Trial patients (0.5 logpoorly in 1 week) controlled Secondary by HAART endpoints: therapy. Tolerability About 40and
Slide 14: PRO 140 Clinical and Regulatory Strategy
PRO www.cytodyn.com (OTCQB:CYDY) Combination 1st Monotherapy Several Clinical underway 14 patient 140patients trial Clinical Supported injected for Therapy concludedand first and inapproval by October Phase Regulatory long-term 2b/3 2015 areInvestigative Strategy now viral 1stpatients in load a(HIV)
Slide 15: PRO 140 CCR5 activity: non-HIV indications
PROtransplantation CCR5 activity Chronic Autoimmunity Animal The (OTCQB: 15 target 140 triggering models inflammation for binds CYDY) of Immunologic PRO to (mice) plays CCR5 140 15 reaction, www.cytodyn.com for aiscrucial without CCR5, these Indications GvHD, diseases role the triggering receptor in
Slide 16: Transplantation GvHD: Bone marrow transplant
Transplantation GvHD: Bone CCR5 FDA transplantation and 1st (OTCQB: 16 patients efficacy approved marrow has Graft CYDY) been expected ofversus transplant protocol: PRO implicated Indication 16Host 140 towww.cytodyn.com enroll patients randomized, for Disease, –asGvHD—Phase prophylaxis aincentral 2H
Slide 17: Experienced Management Team
Experienced Anthony pharmaceutical Nader Michael Denis Tom development Nitya manufacturing (OTCQB: 17 Boyd, Ray, Burger, Pourhassan, Mulholland, Caracciolo, CYDY) Ph.D., Ph.D., Management ofPh.D., and sciences small SVP-Manufacturing BLA 17 Ph.D., quality Vice Executive CFO: molecules www.cytodyn.co
Slide 18: World-Class Expert Advisors
World-Class www.cytodyn.com (OTCQB:CYDY) Robert Paul Daniel An Professor Trials 18 inventor Maddon, Group Kuritzkes, Schooley, of of Medicine, Medicine HIV (ACTG), MD, PROMD Expert MD PhD 140; at Associate Chief Advisors Brigham discovered of Division Editor & Women’s CD4for ofand Journal Infectious
Slide 19: Potential Addressable Market for PRO 140
Potential www.cytodyn.com (OTCQB:CYDY) ~$0,5b ~$11b ~$1b Combination *32ndline Sources:(GlobalData.com CombinationTherapy: Total Assumes Monotherapy: Patientsfor Source: 19classes 2ndline number Projections therapy* https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report
Slide 20: Upcoming Milestones and Events
Upcoming www.cytodyn.com (OTCQB:CYDY) ODD: BTD: Phase Non-HIV 20 Breakthrough 2b/3 2b 2 Orphan GvHD Monotherapy indications Milestones Combination Monotherapy Drug 1st patient Designation Therapy 3 publications extension Therapy Investigative treated DesignationEvents arm ODD PIVOTAL 2Trial publicat
Slide 21: Investment Highlights
Investment U.S. Only PRO Once-weekly, to Phase Pipeline Source: (OTCQB: 21 PRO market 140 56% 2b/3 140 (1) opportunities addresses CYDY) on Pivotal Investigative Highlights http://www.transparencymarketresearch.com/hiv-market.html size HAART self-administered for21 combination HAART HIV www.cytodyn.