Company Summary: CytoDyn Inc.

Overview

• Type: Clinical-stage biotechnology company
• Focus: Development of innovative treatments based on its product candidate, leronlimab (PRO 140), a humanized monoclonal antibody targeting the CCR5 receptor.
• Primary Business: Clinical development of leronlimab for various indications, with the goal of pursuing regulatory approval and potential commercialization.

Core Product

• Leronlimab (PRO 140):
  • Binds specifically to the CCR5 receptor.
  • Mechanism: Blocks calcium channel signaling of CCR5, which may impede the metastatic spread of cancers and modulate immune responses.
  • Differentiation: Competitively inhibits CCR5 without activating immune function (target-specific, does not act as an agonist).
  • Potential applications being studied:
    • Solid tumor cancers (e.g., colorectal cancer, triple-negative breast cancer, glioblastoma).
    • HIV/AIDS (historical focus, formulation-related patents expiring around 2031).
    • COVID-19, Graft-versus-host disease (GvHD), and other inflammatory conditions (patent expiration around 2040+).
    • Other indications like MASH (multiple advanced or emerging uses).

Current Development & Clinical Focus

• Cancer:
  • Colorectal Cancer (CRC):
    • Phase II trial initiated; enrolled patients with relapsed/refractory microsatellite stable (MSS) metastatic CRC.
    • Encouraging previous data indicating partial/complete responses and long-term survival in some patients.
  • Triple-Negative Breast Cancer (TNBC):
    • Phase 1b/2 trials; observed survival benefits and increased PD-L1 expression on circulating tumor cells.
  • Glioblastoma Multiforme (GBM):
    • Preclinical studies; moving towards a pilot clinical trial based on supportive early data.
• Other Indications:
  • Solid tumors in general, with studies and preclinical work ongoing.
  • Leveraging a partnership to develop longer-acting versions of leronlimab using AI-driven drug discovery.

Corporate Strategy

• Continue clinical trials for current indications.
• Explore additional solid tumor and inflammatory indications.
• Develop modified, longer-acting formulations.
• Seek regulatory approval in the US and other markets.
• Pursue partnerships, licensing, and non-dilutive financing to fund R&D and clinical trials.

Recent Corporate Developments

• Hired a new CFO (Robert E. Hoffman).
• Resolved a dispute with a clinical research organization, Amarex.
• Engaged strategic partners for clinical development and manufacturing scaling.
• Dosed the first patient in upcoming Phase II CRC trial (June 2025).
• Reported encouraging results in prior compassionate use for CRC and TNBC, including durable responses and survival up to 5+ years.

Financial and Operational Details

• Employees: 13 as of June 30, 2025.
• Stockholders: Approximately 1,251.5 million shares of common stock outstanding as of June 30, 2025.
• Revenue: No product sales revenue reported; company still in development phase.
• Income: Net income of approximately $3.7 million for the fiscal year ended May 31, 2025.
• Market Cap (as of most recent reporting): ~$134.5 million (market value of voting and non-voting stock held by non-affiliates as of Nov 30, 2024).

Key Points

• Focused on clinical development with notable progress in CRC and TNBC.
• Engaged in efforts to optimize product delivery (long-acting formulations).
• No current commercial production or sales; still in the clinical trial and development phase.
• Has a limited workforce, primarily engaged in R&D and clinical activities.
• Heavy reliance on partnerships, licensing, and external manufacturing.

Note: The company does not presently have any revenue from product sales and remains in the research and development stage, with ongoing clinical trials and strategic collaborations.