CytoDyn Inc. · OTC:CYDY
CytoDyn — Shareholder Meeting (September 2020)
22 slides from CytoDyn's shareholder meeting presentation, Sep 30, 2020
Slide 1: Annual Meeting of Stockholders
September 30, 2020 ANNUAL MEETING OF STOCKHOLDERS CYDY : OTCQB The pursuit of precision medicine Exhibit 99.1
Slide 2: Accomplishments over the past 12 months of the CytoDyn Team
Accomplishments over the past 12 months of the CytoDyn Team Clinical trials (2020) 1) Completed a Phase 3 investigational trial in HIV (monotherapy). 2) Initiated & enrolled 10 patients in a Phase 2 basket trial in cancer for 22 solid tumor cancers. 3) Initiated and completed a Phase 2 in COVID-19.
Slide 3: COVID-19 Phase 2, CD10 (mild-to-moderate) Population Description
Clinical Update COVID-19 – Phase 2, CD10 (mild-to-moderate) – Population Description 1 mITT – Modified Intent To Treat 2 PP – Per Protocol 86 patients were randomized but only 84 received treatment Two populations for all the analysis (mITT1 and PP2) mITT= 84 patients – 56 leronlimab vs 28 placebo P
Slide 4: COVID-19 Phase 2, CD10 (mild-to-moderate) Safety
Clinical Update COVID-19 – Phase 2, CD10 (mild-to-moderate) – Safety Leronlimab Placebo 5 patients had 8 SAEs 6 patients had 11 SAEs 5 patients out of 56 ~ 9% 6 patients out of 28 ~ 21% 8 SAE among 56 ~ 14% 11 SAEs among 28 ~ 39% 96 AEs events in both arm ~ 33.9% 96 AEs events in both arm ~ 50% 1 mI
Slide 5: COVID-19 Phase 2, CD10 (mild-to-moderate) Primary Endpoint
Clinical Update COVID-19 – Phase 2, CD10 (mild-to-moderate) – Primary Endpoint Leronlimab Placebo At Day 3 - mITT Patients had improvement ~ 63% At Day 3 - mITT Patients had improvement ~ 56% At Day 3 – PP Patients with Total Symptom score ≥ 4 Improved ~ 90% At Day 3 – PP Patients with Total Symptom
Slide 6: COVID-19 Phase 2, CD10 Secondary Endpoint (NEWS2)
Clinical Update COVID-19 – Phase 2, CD10 (mild-to-moderate) – Secondary Endpoint (NEWS2) NEWS2 National Early Warning Score 2 Based on: Respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness mITT1 – Day 3Leronlimab ~ 38%
Slide 7: COVID-19 Phase 2, CD10 Other Secondary Endpoint
Clinical Update COVID-19 – Phase 2, CD10 (mild-to-moderate) – Other Secondary Endpoint Leronlimab Placebo Incidences of hospitalization ~ 1.79% Incidences of hospitalization ~ 10.71% Need for mechanical ventilation 1/56 ~ 1.79% Need for mechanical ventilation 1/28 ~ 3.57% Did not need oxygen use ~ 8
Slide 8: CD10 Results Used to Design a Phase 3 and a New Phase 2
Clinical Update COVID-19 – CD10 Results Used to Design a Phase 3 and a New Phase 2 Next step after CD10 positive results Pursuing Phase 3 for moderate population in COVID-19 Pursuing Phase 2 for Long Hauler population in COVID-19 Pursuing EAMS (Early Access Medicine Scheme) in UK by applying first f
Slide 9: COVID-19 Phase 2b/3, CD12 (severe-to-critical) Update
Clinical Update COVID-19 – Phase 2b/3, CD12 (severe-to-critical) – Update Regulatory agency Update FDA ~220/390 Patients enrolled/total patients for trial Safety look after 100 was positive Interim after 195 (total death ~ 45) Interim analysis in October 2020 MHRA Five sites are ready to initiate tr
Slide 10: HIV Combination (BLA submission) and Monotherapy (Phase 3)
Clinical Update HIV – Combination (BLA submission) and Monotherapy (Phase 3) HIV Country Regulatory agency Meeting request Timeline US FDA BLA submission 2020 UK MHRA1 Pre-BLA meeting Oct 22 is CytoDyn’s pre-BLA meeting requested from MHRA EU EMA2 Pre-BLA meeting Preparing to file Canada HEALTH CANA
Slide 11: Cancer Phase 1b/2 and Phase 2 Basket Trial
Clinical Update CANCER – Phase 1b/2 and Phase 2 Basket Trial Basket Trial 11 enrolled - 70 Screened 9 Pending eligibility 1 site (5 sites in selection process) Compassionate Use – mTNBC 14 enrolled - 66 screened 16 pending eligibility 2 sites (4 sites in selection process) eIND – Any stage 4 cancer
Slide 12: CCR5 use in other indications: NASH
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – NASH Potential role of leronlimab in NASH “CCR5 plays a central role in all the events related to liver matrix remodeling and it has been observed that patients with chronic liver disease present high levels of CCR
Slide 13: CCR5 use in other indications: Cancer
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – CANCER Potential role of leronlimab in CANCER CCR5 is highly expressed in glioblastoma and is associated with poor prognosis of patients. CCL5/CCR5 is suggested to be an excellent new target for glioblastoma therap
Slide 14: CCR5 use in other indications: Multiple Sclerosis
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – MULTIPLE SCLEROSIS (MS) Potential role of leronlimab in MULTIPLE SCLEROSIS (MS) “Thus, chemokines appear to be associated with MS and an increased chemokine expression may further enhance disease progression by att
Slide 15: CCR5 use in other indications: Autoimmune Diseases
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – AUTOIMMUNE DISEASES Potential role of leronlimab in AUTOIMMUNE DISEASES “CCR5 may also have a role in autoimmune diseases. In rheumatoid arthritis, increased levels of CCR5 ligands CCL3, CCL4, and CCL5 are found in
Slide 16: CCR5 use in other indications: GvHD
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – GvHD Potential role of leronlimab in GvHD “Longer follow-up reveals a sustained reduction in acute GVHD incidence in maraviroc-treated patients compared with the control cohort, with a stronger effect on visceral v
Slide 17: CCR5 use in other indications: Stroke and Traumatic Brain Injury
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – Stroke and Traumatic Brain Injury Potential role of leronlimab in Stroke and Traumatic Brain Injury “CCR5 is uniquely expressed in cortical neurons after stroke.” “Post-stroke neuronal knockdown of CCR5 in premotor
Slide 18: CCR5 use in other indications: Sepsis & Seizures
Clinical Update CCR5 use in other indications – Potential indication for leronlimab – SEPSIS & SEIZURES Potential role of leronlimab in SEPSIS CCR5-deficient mice are largely resistant to lethal S. aureus infection, highlighting the importance of CCR5 targeting in S. aureus pathogenesis. Thus, deple
Slide 19: Past Publications and Abstracts
Past Publications and Abstracts HIV Monotherapy – CD01 Phase 1: Jacobson et al, J.Infect. Dis 198:1345, 2008 Phase 2a (single dose): Jacobson et al, AAC, 54:4137, 2010 Phase 2a (variable dose): J Infect Dis. May 15; 201(10): 1481–1487, 2010 GvHD https://www.bbmt.org/article/S1083-8791(17)30810-8/ful
Slide 20: HIV treatment patient numbers by regimen
www.cytodyn.com 5 2020 2021 Number of Patients Treated, ART (N) 788,374 815,875 Single-Tablet Regimens (STRs) 514,020 564,586 NNRTI-based STRs 152,945 150,121 Atripla (efavirenz/emtricitabine/TDF) 51,244 18,765 generic efavirenz/emtricitabine/TDF - 23,660 Complera (rilpivirine/emtricitabine/TDF) 14,
Slide 21: Trading History – Fund Raising – Dilution
Year Total traded $-Traded Total ($) Raised Total Dilution 2008 1,319,100 570,593 1,268,000 2009 1,443,800 1,303,837 2,222,200 2010 2,494,400 3,997,954 2,181,000 2011 5,734,100 14,358,161 4,431,861 2012 9,448,600 13,992,695 6,156,750 33,658,389 2013 6,446,800 6,101,525 15,858,500 25,457,786 2014 15,
Slide 22: Corporate Priorities: 2020 - 2021
Clinical: Conclude CD12 Phase 3 trial for COVID-19 (severe/critical) Initiate Phase 2 trial for COVID-19 Long Haulers Initiate Phase 3 trial for COVID-19 Moderate Initiate Phase 3 trial for NASH Regulatory: Complete HIV BLA filing Advance COVID-19 CD10 and CD12 results towards approval New Indicatio