CytoDyn Inc.

What they do

CytoDyn is a clinical-stage biotech with no approved products, developing leronlimab (PRO 140), a humanized monoclonal antibody targeting CCR5, which was acquired from Progenics in October 2012. Its lead effort is the Phase 2 CLOVER study of leronlimab combined with TAS-102 plus bevacizumab in CCR5-positive, microsatellite stable, relapsed/refractory metastatic colorectal cancer, run through CRO Syneos Health. It also supports an Expanded Access Program in triple-negative breast cancer and has presented AACR data on leronlimab in solid tumors.

Revenue drivers

• Product sales — None. Annual revenue was $0.00 in 2021 and 2023, and $266,000 in 2022; there is no commercial product.
• Leronlimab (PRO 140) — The sole pipeline asset; any future revenue depends on clinical success and FDA approval, which have not been achieved.
• Financing activities — Operations are funded by equity and convertible note issuances rather than revenue, including a private placement that incurred $1.6M of issuance costs in the nine months ended February 28, 2026.

Recent performance

In the nine months ended February 28, 2026, CytoDyn reported a net loss of $32.8M, with operating expenses of $32.9M that included an $16.6M legal settlement loss and $11.2M of research and development. The third fiscal quarter alone produced a net loss of $4.7M versus $4.8M a year earlier. Annual net income was -$210.8M in 2022, -$79.8M in 2023, -$49.8M in 2024, $3.7M in 2025, and -$42.7M in 2026. Operating cash flow was -$17.3M in 2026 versus -$8.8M in 2025. As of May 31, 2026, total liabilities were $123.7M against $11.9M of cash, leaving shareholder equity of -$109.7M.

Strategy

Management's stated strategy is to complete the Phase 2 CLOVER study in relapsed/refractory MSS colorectal cancer, run additional solid-tumor studies including metastatic triple-negative breast cancer, and pursue strategic partnerships to fund and expedite development. Fiscal 2026 initiatives included refining the oncology-focused clinical strategy, entering partnerships with industry and academic parties, building the patent portfolio, and closing financing transactions. The company says it may need significant additional funding and will pursue non-dilutive options such as license agreements and co-development partnerships alongside traditional fundraising.

Risks

• Going concern and financing — Auditors issued a going concern opinion, and management states it will have to cease operations if it cannot find adequate financing.
• No revenue or profitability — The company has a history of significant operating losses, expects to continue incurring them, and may never achieve profitability.
• Clinical and regulatory failure — Leronlimab is unapproved; the Phase 2 CLOVER study and any future trials may not generate the data needed for FDA approval.
• Balance sheet deficit — As of May 31, 2026, liabilities of $123.7M exceed cash of $11.9M and total assets of $14.0M, leaving negative shareholder equity of $109.7M.

Outlook

Management says it may need significant additional funding to execute its strategy in full and will pursue both traditional fundraising and non-dilutive license or partnership arrangements. The stated near-term path is completing the Phase 2 CLOVER study and advancing leronlimab in other solid-tumor indications such as metastatic triple-negative breast cancer. The company characterizes its cash reserves as low and does not expect substantial revenues for the foreseeable future.