CytoDyn Inc. · OTC:CYDY
CytoDyn — Investor Presentation (April 2026)
24 slides from CytoDyn's investor presentation, Apr 30, 2026
Slide 1: Leronlimab – A Novel Therapeutic in CCR5+ Immuno-Oncology
Leronlimab – A Novel Therapeutic in CCR5+ Immuno-Oncology CYTODYN.COM / OTCMKTS: CYDY
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT 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 "believe
Slide 3: Robert E. Hoffman, Chief Financial Officer
Robert E. Hoffman Chief Financial Officer 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 include; Heron Therapeutics, AnaptysB
Slide 4: Jacob Lalezari, M.D., Chief Executive Officer
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 Princip
Slide 5: Development Profile – Leronlimab
Development Profile – Leronlimab Novel drug candidate with data supporting multiple Mechanisms of Action (MOA) Well-tolerated with extensive safety database including more than 1,600 patients enrolled across 20+ clinical studies Large market potential across mCRC, TNBC, and other solid tumors Potent
Slide 6: Colorectal Cancer (CRC)
04 CYTODYN Colorectal Cancer (“CRC”)
Slide 7: CLOVER – CytoDyn's Phase 2 Study in CRC
CLOVER – CytoDyn’s Phase 2 Study in CRC Title CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen Study (CLOVER) Design Phase 2, open-label, randomized (350 vs 700mg) 60 patient study to explore safety and efficacy of leronlimab administered with Lonsurf and Avastin
Slide 8: Early ctDNA Readouts from City of Hope Presented at AACR (April 2026)
Conference: American Association for Cancer Research (AACR) Annual Meeting (April 2026) Poster ID: 6466 Presenter: Dr. Pashtoon Kasi Early ctDNA Readouts from City of Hope Presented at AACR (April 2026) Figure 2: ctDNA Decline by Week 2 (% decline)
Slide 9: Preliminary Results from CLOVER – Phase 2 mCRC Study
Preliminary Results from CLOVER – Phase 2 mCRC Study 100% of screened patients (91/91) tested CCR5+ Well tolerated. No Grade 3 or 4 Adverse Events (AEs) or Serious Adverse Events (SAEs) related to leronlimab; no leronlimab-related dose or treatment-limiting toxicity Early ctDNA declines in first 19
Slide 10: Guest Speaker Dr. Pashtoon Kasi
Guest Speaker Dr. Pashtoon Kasi, M.D., M.S. 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 Oncology, City of Hope Orange County. Associate Clinical Professor, Department
Slide 11: Dr. Kasi (City of Hope) – Early ctDNA Readouts – CRC Patient 103-001
Dr. Kasi (City of Hope) – early ctDNA readouts – CRC patient 103-001 1st follow-up ctDNA test After one dose of leronlimab (350mg) Baseline - Day 1, First Dose of leronlimab (350mg) On treatment: leronlimab (350mg week); and backbone of Avastin and Lonsurf 2nd follow-up ctDNA test After two doses of
Slide 12: Dr. Kasi (City of Hope) – Liver Scans – CRC Patient 103-001
Dr. Kasi (City of Hope) – Liver Scans – CRC Patient 103-001 Liver scans City of Hope, CLOVER Study “After” scans were taken 8 weeks post-treatment: leronlimab (350mg once/week); and backbone of Avastin and Lonsurf Patient No. 103-001 ctDNA -97% Tumor Volume -21% Stable Disease Conference: American A
Slide 13: Dr. Kasi (City of Hope) – Lung Scan – CRC Patient 103-001
Dr. Kasi (City of Hope) – Lung Scan – CRC Patient 103-001 Lung scans City of Hope, CLOVER Study “After” scans were taken 8 weeks post-treatment: leronlimab (350mg once/week); and backbone of Avastin and Lonsurf Patient No. 103-001 ctDNA -97% Tumor Volume -21% Stable Disease Conference: American Asso
Slide 14: Dr. Kasi (City of Hope) – Biopsy Tissue – CRC Patient 103-001
Dr. Kasi (City of Hope) – Biopsy Tissue – CRC Patient 103-001 PD-L1 Staining on Biopsy Tissue City of Hope, standard of care Disclosure: The follow-up biopsy was taken at the discretion of the treating physician and this respective patient. The CLOVER study protocol only provides for a biopsy as par
Slide 15: Historical review of Lonsurf + Avastin in 3rd Line mCRC
Phase 3 Sunlight study - published May 3, 2023 https://www.nejm.org/doi/full/10.1056/NEJMoa2214963 N = 246 patients Median Progression Free Survival (mPFS) = 5.6 months Median Overall Survival (mOS) = 10.8 months Overall Response Rate (ORR) = 6.1%, no CRs Meta-analysis of real-world data - published
Slide 16: Clinical Plan in CRC
Clinical Plan in CRC 1) CLOVER – Phase 2 study in 3rd line or later, patients with MSS mCRC: Amendment #6: Study extension for stable patients; and Rollover arm for salvage therapy for patients with documented progression (Leronlimab 700mg + ICI). 2) A Phase 1/1b Single Arm Safety Lead in Study of L
Slide 17: Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (“TNBC”)
Slide 18: Leronlimab in TNBC – Retrospective clinical data (N=28)
Relative Fluorescence Units No follow up CTC samples available Clinical Outcome(s): Survival Based on PD1/PD-L1 Inhibitors Leronlimab in TNBC – *Retrospective* clinical data (N=28)
Slide 19: Leronlimab in TNBC – Clinical and Pre-Clinical Data
Leronlimab in TNBC – Clinical and Pre-Clinical Data Preclinical data: 98% reduction in metastasis in mice treated with leronlimab *Retrospective* clinical data: Reduction of CTCs in 16/28 (57%) of patients Significant upregulation of PD-L1 on CTCs observed in: 16/21 (76%) of patients irrespective of
Slide 20: Clinical Plan in TNBC
Clinical Plan in TNBC Phase 2 study of leronlimab with standard of care in 2nd line or later, HER2- patients with breast cancer Part 1 – Dose escalation: safety, PK, ctDNA, and PD-L1 (Dr. Paula Pohlmann of MD Anderson to serve as Principal Investigator) Part 2 – Contribution of components (+/- ICI)
Slide 21: Clinical Priorities, Upcoming Milestones, Approach to Calendar 2026
Clinical Priorities, Upcoming Milestones, Approach to Calendar 2026
Slide 22: Clinical Priorities
Clinical Priorities Confirm stand-alone benefit of leronlimab plus backbone, through biomarker collection, Disease Control Rate (DCR), Overall Response Rate (ORR), Progression-Free Survival (PFS) and Overall Survival (OS). Prospectively demonstrate leronlimab induction of PD-L1. Prospectively demons
Slide 23: Recent & Upcoming Milestones
Recent & Upcoming Milestones Close on Funding for Expanded Access Program [1Q Calendar 2026] 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] TNBC Expanded Access Program
Slide 24: Calendar 2026 strategy – FDA and potential partnership(s)
Calendar 2026 strategy – FDA and potential partnership(s) Confirm early safety and efficacy readouts; generate optimal data package(s) [3Q Calendar 2026] Presentation of updated biomarker and clinical data at ESMO [October 2026] Assemble data to support Fast-track and/or Breakthrough Therapy Designa