CytoDyn Inc. Files Proxy Materials

TL;DR

CYDY filed more proxy docs, shareholders need to check for updates before voting.

AI Summary

CytoDyn Inc. filed a Definitive Additional Materials proxy statement on September 30, 2025. This filing relates to the company's proxy statement for its annual meeting, which is typically held to elect directors, ratify auditors, and discuss other corporate matters. The filing does not contain specific financial figures or new proposals but serves as supplementary material to the main proxy statement.

Why It Matters

This filing is important for shareholders as it provides additional information related to the company's governance and upcoming shareholder votes, ensuring transparency in corporate decision-making.

Risk Assessment

Risk Level: low — This filing is a routine proxy statement supplement and does not introduce new financial risks or significant corporate actions.

Key Players & Entities

• CytoDyn Inc. (company) — Registrant
• 0001104659-25-095132.txt (document) — Filing identifier
• 20250930 (date) — Filing date

FAQ

Filing Documents

• cydy-20250930xdefa14a.htm (DEFA14A) — 70KB
• cydy-20250930xdefa14a_b001.jpg (GRAPHIC) — 6KB
• 0001104659-25-095132.txt ( ) — 79KB

From the Filing

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant Filed by a Party other than the Registrant Check the appropriate box: Preliminary Proxy Statement Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) Definitive Proxy Statement Definitive Additional Materials Soliciting Material Pursuant to 240.14a-12 CytoDyn Inc. (Name of Registrant as Specified In Its Charter) (Name of Person(s) Filing Proxy Statement, if other than the Registrant) Payment of Filing Fee (Check the appropriate box): No fee required. Fee paid previously with preliminary materials. Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a6(i)(1) and 0-11. Exhibit 99.1 September 30, 2025 September 2025 Letter to Shareholders Dear Shareholders, As this pivotal year continues to take shape for CytoDyn Inc. ("CytoDyn" or the "Company"), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evidence. From laboratory insights to encouraging patient survival observations, our story is compelling and one of consistent validation. The data presented over the past several months marks a watershed moment for both patients and our Company, providing evidence that leronlimab has the potential to reshape treatment paradigms in solid tumor oncology. With multiple clinical trials advancing, we are moving with discipline and urgency along a well-defined path forward. Strengthening Our Leadership To support this next chapter, we welcomed Robert E. Hoffman as our new Chief Financial Officer. An industry veteran with decades of financial and leadership experience, holding various executive and board positions in his biotech career, Robert has already brought significant value to CytoDyn. His expertise in capital markets and strategic planning strengthens our ability to execute, network, and expand our pipeline. We are delighted to have him aboard. Scientific Progress and Clinical Development At the heart of leronlimab's promise is a novel mechanism of action ("MOA") associated with prolonged survival observed in a group of patients with Metastatic Triple-Negative Breast Cancer ("mTNBC"). Supporting data, presented at a poster session at the European Society for Medical Oncology ("ESMO") breast cancer meeting in Munich, suggest that leronlimab induces PD-L1 expression, creating synergy with immune checkpoint inhibitors (ICIs), a potential breakthrough in solid tumor treatment. This finding not only opens new therapeutic opportunities for leronlimab, but also represents a significant market opportunity for the Company. For additional information on this novel MOA and the status of our clinical initiatives and publications, please see the science update included with this letter. One indication that carries the potential for significant value return is leronlimab in mTNBC, the most aggressive form of breast cancer, with 5-year survival rates around 15% . Based on the positive data presented at ESMO, we will shortly submit a follow-up Phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. These patients, currently ineligible for ICI therapy, will receive leronlimab plus standard chemotherapy, followed by a regimen of leronlimab with an ICI. We look forward to sharing more details after the FDA review of the protocol and briefing package that provides a complete summary of CytoDyn's oncology data. In parallel, we will be submitting an Expanded Access Protocol ("EAP") to enable treatment for patients with second-line, or later, mTNBC, who are ineligible or otherwise unable to participate in our Phase II study. I am pleased to announce that we will be working with an individual benefactor to fund the launch of this compassionate- use program. This benefactor has also expressed interest in supporting an investigator-initiated study in patients with recurrent glioblastoma with an anticipated start date in 2026. Beyond breast cancer, leronlimab continues to advance in the treatment of metastatic Colorectal Cancer (mCRC). Enrollment in our Phase II study is underway with five sites initiated and several more onboarding in the next several weeks. The enrollment of our fifth patient in the trial will trigger the Data Safety Monitoring Board (DSMB) safety review, which could then open study randomization to include the 700 mg dose. Importantly, we will be closely tracking PD-L1 levels of enrolled patients to further validate our MOA across solid tumors. With that in mind, we have prepared a rollover protocol to ensure that CRC

View Full Filing

View this DEFA14A filing on SEC EDGAR