CytoDyn Inc. · OTC:CYDY
CytoDyn — Corporate Update (October 2026)
35 slides from CytoDyn's corporate update, Oct 19, 2026
Slide 1: CytoDyn Investor Update Webinar
Company Logo CYTODYN INVESTOR UPDATE WEBINAR THE WEBINAR WILL START SOON Participants Jacob Lalezari M.D. Chief Executive Officer of CytoDyn Robert E. Hoffman Chief Financial Officer of CytoDyn Pashtoon M. Kasi M.D., M.S. Medical Director of GI Oncology, City of Hope Orange County, Irvine, Californi
Slide 2: The Next Generation of Monoclonal Antibody Therapy
Company Logo The Next Generation of Monoclonal Antibody Therapy CYTODYN.COM / OTCMKTS: CYDY
Slide 3: Forward Looking Statement
FORWARD LOOKING STATEMENT Company Logo 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 suc
Slide 4: Jacob Lalezari, M.D. Chief Executive Officer
Company Logo Jacob Lalezari, M.D. Chief Executive Officer CEO of CytoDyn Inc. since November 2023. 37 years of industry experience, including nearly 20 years of experience with leronlimab. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1996. Dr. Lalezari has serv
Slide 5: Executive Summary – leronlimab
Executive Summary – leronlimab Company Logo Novel drug candidate with multiple demonstrated mechanisms of action (MOA) Large and growing market potential across CRC, TNBC, and other solid tumor indications Well-tolerated with extensive safety database including approximately 1,700 patients enrolled
Slide 6: Colorectal Cancer (CRC)
Logo Colorectal Cancer (“CRC”)
Slide 7: CLOVER – CytoDyn's Phase 2 Study in CRC
CLOVER – CytoDyn’s Phase 2 Study in CRC logo TitleCCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Study (CLOVER) Design Phase 2, open-label, randomized (350 vs 700 mg) 60-patient study to explore safety and efficacy of leronlimab administered with Lonsurf and Ava
Slide 8: CLOVER – Endpoints Being Assessed in Study
CLOVER – Endpoints Being Assessed in Study logo Primary Objective Evaluation of the efficacy of leronlimab in combination with current standard of care (Lonsurf and Avastin) Primary Endpoint Objective Response Rate (ORR) – as assessed by responders in either arm (350 or 700 mg), or from the overall
Slide 9: Baseline Characteristics – CLOVER Study
Baseline Characteristics – CLOVER Study* logo Age 350 mg (n=33) 700 mg (n=32) Total (N=65) Median Age (Years) 57 (38 -76) 57 (31 – 79) 57 (31-79) Age <65 24 (72.7%) 21 (65.6%) 45 (69.2%) Age ³ 65 9 (27.3%) 11 (34.4%) 20 (30.8%) Primary Diagnosis Colon Cancer 19 (57.6%) 17 (51.5%) 36 (55.4%) Rectal C
Slide 10: CLOVER – ctDNA % Change Based on Signatera Exome
CLOVER – ctDNA % Change at Week 2 Based on Signatera Exome* logo Patients with Data Available in September 2026 (n=28) 0% -10% -20% Percent Change in ctDNA from Baseline -30% -40% -50% -60% -70% -80% -90% -100% -100% -99% -99% -97% -97% -96% -94% -93% -92% -90% -90% -89% -88% -87% -85% -82% -79% -78
Slide 11: CLOVER – ctDNA % Change by Dose Cohort
CLOVER – ctDNA % Change at Week 2 Based on Signatera Exome* CYTODYN 350 mg Cohort (n=14) 700 mg Cohort (n=14) Median decrease: 80% Median decrease: 90% Patients with Data Available in September 2026 *Analysis includes all available Signatera Exome ctDNA measurements within seven days of starting tre
Slide 12: CLOVER – ctDNA % Change by Prior Lines of Therapy
*Analysis includes all available Signatera Exome ctDNA measurements within seven days of starting treatment CLOVER – ctDNA % Change at Week 2 Based on Signatera Exome* Prior Lines of Therapy Patients with Data Available in September 2026 (n=28) 2 Prior Lines 3 Prior Lines 4 Prior Lines 5 Prior Lines
Slide 13: CLOVER – ctDNA responses vs Natera real-world comparator cohorts
CLOVER – ctDNA responses, Natera’s real-world comparator cohorts p = 0.01 p = 0.0005 0-4 Weeks, Molecular Residual Disease (MRD) Change from Baseline CLOVER Study Natera Real-world Cohorts MRD Change Baseline 200% 100% 0% -100% Lonsurf (n=30) Lonsurf+Bev (n=75) Lonsurf+Bev+Leronlimab (n=12) Cytodyn.
Slide 14: Preliminary Results from CLOVER – October 2026
Preliminary Results from CLOVER – October 2026 1) 96/96 (100%) of screened patients with an evaluable sample tested CCR5+, as determined by immunohistochemistry (IHC) 2) Well tolerated. No Serious Adverse Events (SAEs) related to leronlimab 3) Consistent ctDNA declines in 28 patients evaluated with
Slide 15: Current FDA-Approved Approach in 3rd Line CRC
Phase 3 SUNLIGHT study – published May 3, 2023 Lonsurf & Avastin combination (n = 246) Median Progression Free Survival (mPFS) = 5.6 months Median Overall Survival (mOS) = 10.8 months Overall Response Rate (ORR) = 6.1%, no Complete Responders Subsequent meta-analysis of real-world data – published M
Slide 16: Baseline Characteristics – CLOVER v. SUNLIGHT
Baseline Characteristics – CLOVER v. SUNLIGHT Patient Group Baseline CLOVER Study* Lonsurf & Avastin, plus leronlimab (350 or 700 mg) SUNLIGHT Study Lonsurf & Avastin Age 350 mg (n=33) 700 mg (n=32) Total (N=65) Lonsurf (n=246) Lonsurf & Avastin (n=246) Total (N=492) Median Age (Years) 57 (38 -76) 5
Slide 17: Natera Collaboration – CLOVER Study
Principal Investigator – CLOVER (Phase 2 mCRC Study) CYTODYN natera Reny Aniline Natera Sr. Director of BioPharma Business Development Oncology & RWD Solutions Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. Following the s
Slide 18: Circulating tumor DNA for molecular response intelligence
Circulating tumor DNA for molecular response intelligence Circulating tumor DNA (ctDNA) is DNA shed into the bloodstream as cancer cells die The advantages of ctDNA-based MRD detection: What is ctDNA? Real-time — reflects live cancer activity as ctDNA has a half-life of <1 hour Quantitative and dyna
Slide 19: Real-World Comparator Arms for Earlier Efficacy Signals
Real-World Comparator Arms for Earlier Efficacy Signals CYTODYN OPPORTUNITY Clinical trials for new advanced-stage or metastatic therapies aim to demonstrate longer overall survival (OS) and progression-free survival (PFS). Yet such approaches require randomized studies that are often expensive and
Slide 20: Defining real-world comparator cohorts
Defining real-world comparator cohorts Population Criteria Timepoints RW Endpoints mCRC 3L+ Pre-treatment baseline ctDNA available 1+ MRD time points within first 4 weeks of treatment initiation >3 average Signatera tests per patient (during entire duration of treatment) Molecular complete response
Slide 21: Response analysis and validation of RW comparator arms in 3L mCRC
Response analysis and validation of RW comparator arms in 3L mCRC Response Analysis Response Validation 200% 100% 0% -100% 22.3% p=0.01 -55.2% Lonsurf (n = 30) Lonsurf + Bev (n = 75) Median: +22% 95% CI: -35%, 91% Median: -55% 95% CI: -69%,-10% Risk Set Adjusted rwOS by Molecular Response (mCR/mPR/m
Slide 22: Deeper molecular response in CLOVER vs real-world cohorts
Deeper molecular response observed in the CLOVER group, relative to Natera’s real-world comparator cohorts p = 0.01 p = 0.0005 p = 0.005 p = 0.0006 Natera Real-world Cohorts CLOVER Study Natera Real-world Cohorts CLOVER Study natera TM Logo
Slide 23: Observed changes from baseline – MTM/mL
Observed changes from baseline – MTM/mL (Mean Tumor Molecules per milliliter of plasma) 0-4 weeks treatment time window Regimen Lonsurf Lonsurf + Bev CLOVER Study Lonsurf + Bev + Leronlimab N 30 75 12 Min -99.87% -100.00% -100.00% Q1 -46.59% -82.38% -96.30% Median 22.30% -55.19% -93.22% 95% CI (medi
Slide 24: Distribution of MRD change from baseline
Deeper molecular response observed in the CLOVER group, relative to Natera’s real-world comparator cohorts mCR – Molecular complete response: ctDNA clearance vs. baseline mPR – Molecular partial response: ctDNA reduction ≥90% vs. baseline mSD – Molecular stable disease: ctDNA reduction of 0% to <90%
Slide 25: Jacob Lalezari, M.D. Chief Executive Officer
CYTODYN logo Jacob Lalezari, M.D. Chief Executive Officer CEO of CytoDyn Inc. since November 2023. 37 years of industry experience, including nearly 20 years of experience with leronlimab. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1996. Dr. Lalezari has serv
Slide 26: Principal Investigator – CLOVER
Principal Investigator – CLOVER (Phase 2 mCRC Study) LOGO Dr. Pashtoon Kasi, M.D., M.S. City of Hope, Orange County Principal Investigator, CD-0-101 The Phase-2 CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Study (“CLOVER”) Medical Director of GI Medical Oncolo
Slide 27: Q&A with the Principal Investigator of CLOVER
Q&A with the Principal Investigator of CLOVER (Phase 2 mCRC Study) LOGO 1) What are your current clinical impressions as it relates to CLOVER participants at your site? 2) What are your thoughts on the ctDNA trends observed to date in the CLOVER study? 3) What is the current status of the rollover a
Slide 28: Jacob Lalezari, M.D. Chief Executive Officer
LOGO Jacob Lalezari, M.D. Chief Executive Officer CEO of CytoDyn Inc. since November 2023. 37 years of industry experience, including nearly 20 years of experience with leronlimab. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1996. Dr. Lalezari has served as Pr
Slide 29: Robert E. Hoffman, Chief Executive Officer
LOGO Robert E. Hoffman Chief Executive Officer – effective October 20, 2026 CFO of CytoDyn Inc. since May 2025. An industry veteran with decades of financial and leadership experience. Prior to joining CytoDyn, served as President and CEO of Kintara Therapeutics, Inc. Other prior executive roles inc
Slide 30: Upcoming Milestones, Approach to Calendar 2026 & 2027
LOGO Upcoming Milestones, Approach to Calendar 2026 & 2027
Slide 31: CLOVER Presentations at Upcoming Conferences
CLOVER Presentations at Upcoming Conferences CYTODYN LOGO ESMO - European Society for Medical Oncology October 23-27, 2026 | Madrid, Spain Additional clinical and ctDNA findings Additional follow-up and data maturity Real-world comparison data; further context of results relative to evolving mCRC tr
Slide 32: Recent & Upcoming Milestones
Recent & Upcoming Milestones CYTODYN logo Close $17.5 Million financing to fund continued development of leronlimab [1Q Calendar 2026] Present initial ctDNA readouts from mCRC study at AACR (San Diego) [2Q Calendar 2026] Close on strategic data collaboration with Natera, Inc. [2Q Calendar 2026] Clos
Slide 33: Calendar 2027 – Presentation of CLOVER data, FDA Approach
Calendar 2027 – Presentation of CLOVER data, FDA Approach CYTODYN logo Present durability of safety and efficacy from CLOVER Study – ESMO and ASCO GI [4Q 2026 – 1Q 2027] Assemble/present data package, subsequent communications with FDA [2H 2026 – 1H 2027] CYTODYN.COM 33
Slide 34: Market Opportunity – Key Takeaways
Market Opportunity – Key Takeaways CYTODYN logo Novel approach to immuno-oncology – a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple solid-tumor indications Well tolerated safety profile – approximately 1,700 patient safety databas
Slide 35: Question & Answer Session
CYTODYN logo Question & Answer Session 1111 Main Street, Suite 660, Vancouver, WA 98660 360-980-8524 ir@cytodyn.comCYTODYN.COM / OTCMKTS: CYDY