CytoDyn (CYDY) Investor update summary

CLOVER study and biomarker findings

• Phase II open-label randomized study: 350 mg vs. 700 mg leronlimab with LONSURF and Avastin in 60 patients with third-line MSS metastatic colorectal cancer; enrollment completed in April.

• Most participants were fourth-line or later; ~90% had prior bevacizumab.

• In 28 patients with paired Signatera samples, median ctDNA fell 86% by week two; reported activity appeared across RAS mutations and prior treatment lines.

• Natera's separate analysis of 12 CLOVER patients found an average 93% ctDNA reduction, maintained through week eight; its real-world LONSURF plus bevacizumab cohort had a median 55% decrease, while LONSURF alone had a 22% increase.

• About three-quarters of patients with week-eight scans showed tumor shrinkage or stable disease; no serious adverse events related to leronlimab were reported in CLOVER.

Clinical observations and combination approach

• All evaluable screened patients were CCR5-positive using a 1% expression threshold; future oncology studies will not use immunohistochemistry as a treatment eligibility gate.

• Three heavily pretreated patients at the investigator's site were referred for potentially curative surgery after greater-than-expected, durable clinical benefit; two had liver metastases and one had lung metastasis.

• The CLOVER rollover arm is active across sites, allowing dose escalation to 700 mg and addition of pembrolizumab after progression; at least two patients at the investigator's site had started.

• The proposed prime-and-pair approach combines leronlimab with checkpoint inhibitors; early rollover observations were described as promising, with further data expected at ASCO GI.

Development plans and milestones

• Updated CLOVER clinical and biomarker data were scheduled for ESMO Congress, Oct. 23–27, 2026; broader population and Natera comparator updates are planned for ASCO GI in January 2027.

• Plans include a dose-escalation study in metastatic triple-negative breast cancer, additional colorectal cancer studies in 2027, and an FDA data package.

• PRE-ISPY plans a metastatic TNBC study combining leronlimab, a checkpoint inhibitor and either TRODELVY or gemcitabine/carboplatin; I-SPY plans a neoadjuvant leronlimab monotherapy study in HER2-negative breast cancer.

• Additional academic oncology work is being developed in glioblastoma, pancreatic cancer, HPV-associated head and neck cancer, and acute myelogenous leukemia; a Cornell Alzheimer's study was ~halfway enrolled.