CytoDyn Inc (OTCQB: CYDY) is a clinical-stage biopharmaceutical company developing leronlimab, a single product candidate being studied across multiple disease indications. The company has generated no product revenue since inception, operating entirely on capital raised through equity and convertible debt. CytoDyn reported no revenue for the fiscal year ended May 31, 2025, and carried an accumulated deficit of $887.8 million as of that date. The company recorded net income of $3.7 million in FY2025, but this resulted from a non-recurring recovery of approximately $25.0 million in clinical expenses tied to the settlement of litigation with contract research organization Amarex. Cash used in operating activities was $8.8 million in FY2025, down from $10.9 million in FY2024. Outstanding convertible notes carried interest expense of $4.4 million in FY2025. The company trades on the OTCQB marketplace and had approximately 1,000 holders of record as of June 30, 2025. Substantial doubt about the company's ability to continue as a going concern is disclosed in the FY2025 10-K filed July 25, 2025.

Revenue model

No product revenue has been generated since inception, per the 10-K filed July 25, 2025. Operations are funded through equity issuances, convertible notes, and other financing activities.

Products and services

Leronlimab, a single biologic product candidate, is the company's sole asset under development. No products are approved or commercially sold as of the fiscal year ended May 31, 2025.

Customers and end markets

No commercial customers as of May 31, 2025. Target end markets include treatment of serious or life-threatening conditions for which leronlimab is being studied, subject to FDA approval.

Value-chain role

Clinical-stage drug developer. Relies on third-party contract research organizations (CROs) and third-party manufacturers for clinical trial execution, manufacturing of pre-clinical and clinical supplies, and quality control. Has a limited number of internal research and development personnel.

Geographic exposure

Headquartered in the United States. Regulatory focus on FDA approval. The filing references potential engagement with drug regulatory agencies in other countries, but no specific international operations are described.

Source: SEC 10-K, filed 2025-07-25

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