CytoDyn Inc. · OTC:CYDY
CytoDyn — Shareholder Meeting (November 2021)
22 slides from CytoDyn's shareholder meeting presentation, Nov 24, 2021
Slide 1: Annual Meeting of Stockholders – CytoDyn's Presentation
November 24, 2021 Annual Meeting of Stockholders CytoDyn’s PRESENTATION The pursuit of precision medicine Humanized Monoclonal Antibody Exhibit 99.1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "e
Slide 3: Overview of Last 13 Years of CytoDyn
OVERVIEW of Last 13 Years of CYTODYN Year Total trading ($) CytoDyn’s CEO Accomplishment 2008 495,725 Allen D. Allen Cytolin Clinical Hold No Trials 2009 1,303,837 2010 3,997,954 2011 14,358,161 Kenneth Van Ness CytoFelin No Trials 2012 13,992,695 Nader Pourhassan Purchased PRO 140 CD01-Phase 2b CD0
Slide 4: Clinical Trials
Clinical Trials Patients Indication-Design Status 2 Phase 1 studies 54 Healthy patients, no safety concerns – Phase 1 Complete 1302 IV Phase 1 (P 1) 39 IV, single-dose VL reduction for 3 weeks – Phase 1 Complete 2301 IV P 2 31 IV, single-dose VL reduction for 3 weeks – Phase 2 Complete 2101 SC P 2 4
Slide 5: Leronlimab – HIV: Progenics gave up development
LERONLIMAB – HIV April 21, 2008 PROGENICS gave up development of leronlimab (PRO 140) – WHY? Progenics’ Question to the FDA FDA response:
Slide 6: Leronlimab–HIV: Our Record of Overcoming Adversity
LERONLIMAB–HIV: Our Record of Overcoming Adversity Monotherapy Combination Therapy Feb-2014 Phase 2 Feb-2015 Phase 3 pivotal - Initiated Oct-2015 Phase 3 pivotal – injected 1st patient Oct-2015 1st patient – P3-Inv. Feb-2018 Primary End Point hit – p=0.0032 TOTAL VICTORY FOR CYTODYN
Slide 7: Leronlimab–HIV: Our Record of Overcoming Adversity
LERONLIMAB–HIV: Our Record of Overcoming Adversity Monotherapy Combination Therapy Feb-2014 Phase 2 Feb-2015 Phase 3 pivotal - Initiated Oct-2015 Phase 3 pivotal - Completed Oct-2015 1st patient – P3-Inv. Feb-2018 Primary End Point hit – p=0.0032 New problem arose with potential monotherapy approval
Slide 8: Monotherapy and Combination Therapy Timeline
Monotherapy Combination Therapy Feb-2014 Phase 2 Feb-2015 Phase 3 pivotal Oct-2015 Phase 3 pivotal Oct-2015 1st patient Feb-2018 P.E. hit – p=0.0032 New Problems – If Monotherapy approval requested then we must solve the riddle – We did
Slide 9: BLA delays and refuse-to-file letter
Monotherapy Combination therapy Feb-2014 Phase 2 Feb-2015 Phase 3 pivotal Oct-2015 Phase 3 pivotal Oct-2015 1st patient Feb-2018 P.E. hit – p=0.0032 Amarex continued to delay the BLA beyond the one year even though they received expedited fees July-2018 Higher dose is better BLA delayed one year to
Slide 10: Demonstrating That We Can Solve Problems
Demonstrating That We Can Solve Problems HIV Combination Therapy PrEP Monotherapy CURE July-2021 Dose justification submitted to the FDA to avoid RTF again-This was a gift from the FDA July-2021 Dose justification submitted to the FDA to avoid RTF again-This was a gift from the FDA Aug-2021 FDA guid
Slide 11: Demonstrating That We Can Solve Problems: Manufacturing
Demonstrating That We Can Solve Problems HIV Combination Therapy PrEP Monotherapy CURE How about MANUFACTURING April 2, 2019 Samsung agreement - Side note: On 4/2/2019 CYDY=$0.52 How about MANUFACTURING April 2, 2019 Samsung agreement - Side note: On 4/2/2019 CYDY=$0.52 Signed a deal that had $20-30
Slide 12: Scientific Community Begin to Notice Leronlimab Success in HIV
Scientific Community Begin to Notice Leronlimab Success in HIV HIV Combination Therapy PrEP Monotherapy CURE Multiple presentations in ASM Microbe Multiple presentations at CROI (one of largest gatherings of top scientists in the world) Usually, we share our data with scientific community as soon as
Slide 13: Abstract Presentations
Abstract Presentations PRO 140 Single-Agent Maintenance Therapy for HIV-1 Infection: A 2-Year Update Jay Lalezar, Kush Dhody2, Ula Kowalczyk’, Kazem Kazempour?, Nader Pourhassan? and Paul J. Maddon® zAmarex Clinical Research, LLC, Germantown, MD 2CytoDyn Inc., Vancouver, WA, ‘Maddon Advisors LLC, Sc
Slide 14: Abstract Presentations
Abstract Presentations
Slide 15: Published Papers (8 Papers in ~13 Months)
Published Paper (8 Paper in ~13 Months) Publications Date International Journal of Infectious Diseases – CCR5 inhibition in critical COVID-19 patients decreases inflammatory cytokines, increases CD8 T0cells, and decreases SARS-CoV2 RNA in plasma by day 14 Oct. 2020 Infectious Diseases Society of Ame
Slide 16: Touching Human Lives
Touching Human Lives Monotherapy Video interviews of patients on Monotherapy after 2.5 years. Now 5 more than 7 years CD02 – Combination therapy 21 patients are 4-5 years in extension arm Ongoing Patient Count 350mg 12 700mg 12 Total Active 24 CD03 – Monotherapy 3 to 5 years Ongoing Patient Count 35
Slide 17: Touching Human Lives
Touching Human Lives CD02 – Combination therapy 21 patients are 4-5 years in extension arm Ongoing Patient Count 350mg 12 700mg 12 Total Active 24 CD03 – Monotherapy 3 to 5 years Ongoing Patient Count 350mg 6 525mg 14 700mg 17 Total Active 37 CD01 – Monotherapy More than 7 years Ongoing Patient Coun
Slide 18: Leronlimab – Update, Future Expectations & Timelines
LERONLIMAB – Update, Future Expectations & Timelines NASH COVID Critically ill Long Hauler Severe HIV Combination Therapy PrEP Monotherapy CURE mTNBC COVID (3) Cancer (23) HIV (4) HIV Approval 2022 very possible Filing for expanded access for a fee for MDR population BTD (Breakthrough Therapy Design
Slide 19: Leronlimab – From Indication to Indications: Potential Market Size
LERONLIMAB – From 1 Indication to 31 Indications in Just 7 years Potential Market Size From $50 Million to More Than $100 Billion Combination therapy for MDR ~ $30 million http://www.taimedbiologics.com/news/info/90#:~:text=A%20year%20ago%2C%20I%20was,based%20on%20Theratechnologies%27%20financial%20
Slide 20: Leronlimab - $3.5 Million Down Payment
Leronlimab - $3.5 Million Down Payment PRO 140 (leronlimab) was purchased for $3.5 million down payment Today CytoDyn has one molecule, leronlimab (potential 31 indications) And our Market cap is ~ $1 Billion (~300 times the down payment for leronlimab) And this is just the beginning 32 X
Slide 21: Overview of Short- and Long-Term Goals
OVERVIEW of Short- and Long-Term Goals Dec-2021 File for expanded access for HIV MDR patients in US Dec-2021 File for expanded access for HIV MDR patients in US Dec-2021 File for expanded access for mTNBC patients in US The FDA has reminded us that if we do receive BTD for our mTNBC, then we have 15
Slide 22: Executive Management Team
Nader Z. Pourhassan, Ph.D. President, CEO and Director Executive Management Team Scott A. Kelly, M.D. Chief Medical Officer, Head of Business Development and Chairman of the Board Nitya G. Ray, Ph.D. Chief Operating and Technology Officer Antonio Migliarese, C.P.A. Chief Financial Officer Christophe