CytoDyn (CYDY) 16th Annual LD Micro Invitational Conference summary

Key milestones and strategic focus

• Advancing leronlimab, a first-in-class monoclonal antibody targeting CCR5, with ongoing phase II trials in colorectal cancer and plans to initiate studies in triple-negative breast cancer later this year.

• Completed enrollment of a 60-patient phase II colorectal cancer study, with rapid enrollment indicating strong physician interest and patient need.

• Multiple near-term milestones expected in 2024, including phase II readouts in Q2 and Q3, and presentations at ESMO (Q4) and ASCO GI (Q1 2027).

• Closed a $17.5 million financing round to support ongoing development and initiated an Expanded Access Program for triple-negative breast cancer.

• Actively pursuing Fast Track and Breakthrough Therapy designations with the FDA and seeking global partnership opportunities.

Clinical data and pipeline insights

• Leronlimab has demonstrated a strong safety profile, with over 1,600 patients tested and no Grade 3/4 adverse events in the current phase II colorectal cancer study.

• Early data show significant ctDNA declines (median 70% at two weeks) and tumor shrinkage in colorectal cancer patients, with 100% of patients screened testing CCR5 positive.

• Retrospective data in triple-negative breast cancer show five out of five patients who upregulated PD-L1 and received a checkpoint inhibitor are alive after 5+ years, with three showing no evidence of disease.

• Leronlimab increases PD-L1 expression, potentially unlocking eligibility for PD-1 therapies like KEYTRUDA in previously ineligible patients.

• Investigator-initiated studies are planned in glioblastoma and pancreatic cancer, with prominent institutions involved.

Market opportunities and industry context

• Colorectal cancer incidence is rising, now the leading cause of cancer death in the U.S. under age 50, with a projected global market exceeding $25 billion by 2030.

• Triple-negative breast cancer represents a $7 billion market opportunity by 2030, with limited current standard of care.

• Current standard therapies for late-stage colorectal cancer have low response rates, highlighting the need for new treatments.

• Collaborations and real-world data partnerships are being pursued to strengthen clinical evidence and support regulatory submissions.

• Expansion into new indications, including Alzheimer's disease, is under consideration with academic partners.