December 2025 Letter to Shareholders

Core Insights - CytoDyn has made significant progress in 2025, particularly in demonstrating the potential of leronlimab in solid tumor oncology, especially for metastatic Triple-Negative Breast Cancer (mTNBC) [1][2][3] - The company is optimistic about 2026, anticipating important clinical and regulatory milestones that could enhance its position in the biotech industry [8][9] Operational Strengthening - In 2025, CytoDyn focused on regulatory preparations, clinical strategy refinement, and internal process improvements, including data integrity and trial oversight [4] - The company engaged more constructively with regulators and investigators to enhance operational efficiency [4] Clinical Program Advancement - CytoDyn's scientific team made foundational progress in therapeutic areas, improving study designs and aligning with clinical experts to create a realistic roadmap for future success [5] - The Phase II study for metastatic colorectal cancer (mCRC) was launched in July 2025, with early results showing promise [12][13] Financial Discipline - The company maintained prudent financial management in 2025, focusing on extending its financial runway and directing resources toward high-potential programs [6] Future Outlook - CytoDyn is preparing for several clinical and regulatory inflection points in 2026, including advancements in ongoing studies and data readouts to confirm the proposed mechanism of action for leronlimab [8][9] - The company plans to open an Expanded Access Program (EAP) for leronlimab in early 2026, pending FDA approval, to provide treatment options for patients who have exhausted other therapies [16] Collaborative Initiatives - CytoDyn is collaborating with various academic centers on multiple studies, including a pilot study for recurrent Glioblastoma and a project for Alzheimer's Disease, indicating a broadening of its research focus [17][18][19]