CytoDyn (CYDY) Company Report

CytoDyn reported significant progress in 2025, including operational strengthening, financial discipline, and advancements in clinical programs. The company highlighted its proposed mechanism of action for leronlimab, suggesting it can convert "cold" tumors into "hot" tumors, enabling a "prime and pair" regimen with immune checkpoint inhibitors.
The Phase II metastatic colorectal cancer (mCRC) study, launched in July 2025, has enrolled 16 patients and anticipates 20 patients by year-end 2025, with full enrollment projected around May 2026. Early results are encouraging, and the study design was amended to evaluate leronlimab as both a stand-alone and "prime and pair" agent.
CytoDyn received FDA feedback on proposed protocols for metastatic Triple-Negative Breast Cancer (mTNBC) trials, including a Phase II study and an Expanded Access Program (EAP). The EAP is expected to open for patient referral around February 2026, with costs for the first 20 patients covered by a high-net-worth individual.
The company is advancing four new initiatives with academic centers, funded partly or entirely by outside third parties, including studies in mCRC, recurrent Glioblastoma, and a 12-week pilot study for mild to moderate Alzheimer's Disease scheduled to begin screening in April 2026.

Dec 16, 2025, 1:30 PM

CytoDyn Secures $30 Million Funding Commitment from Yorkville Advisors

CYDY

CytoDyn Inc. has secured a $30 million funding commitment from Yorkville Advisors Global through a Standby Equity Purchase Agreement.
Under the agreement, CytoDyn has the discretionary right to sell up to $30 million of its common stock to Yorkville over the next 36 months, with no obligation to utilize the full amount and no warrants or derivatives associated with the arrangement.
The proceeds from these sales are expected to be used for working capital, general corporate purposes, and debt repayment.
As consideration for Yorkville's commitment, CytoDyn paid a $25,000 structuring fee and will pay a 1.00% commitment fee (of the $30 million commitment) in common stock.

Nov 3, 2025, 1:38 PM

CytoDyn Secures Funding Commitment

CYDY

New Projects/Investments

CytoDyn Inc. secured a $30 million funding commitment from Yorkville Advisors Global.
Under the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months.
CytoDyn retains sole discretion over the timing of sales, and there are no warrants, derivatives, or other share classes associated with the arrangement.
The company is not obligated to utilize any of the $30 million available, with no minimum commitments or penalties.
The funding will be utilized to further develop the program centered around leronlimab's ability to upregulate PD-L1.

Nov 3, 2025, 1:30 PM

CytoDyn Provides Update on Leronlimab Oncology Program and Appoints New CFO

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CFO Change

New Projects/Investments

CytoDyn Inc. has appointed Robert E. Hoffman as its new Chief Financial Officer.
The company is advancing leronlimab in oncology, with data presented at ESMO suggesting it induces PD-L1 expression in metastatic triple-negative breast cancer (mTNBC), potentially creating synergy with immune checkpoint inhibitors (ICIs).
A follow-up Phase II proof of concept protocol for PD-L1-negative mTNBC patients will be submitted, proposing a regimen of leronlimab with standard chemotherapy, followed by leronlimab with an ICI.
Pooled follow-up data from 28 mTNBC patients showed promising overall survival rates of 17.9% at both years 3 and 4.
CytoDyn is also progressing other clinical initiatives, including amendments to its colorectal cancer study, an advancing investigator-initiated glioblastoma study, and FDA/IRB approval for an Alzheimer's study.

Sep 30, 2025, 12:30 PM

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