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CYDY • CIK 0001175680
Corporate History/Business Overview CytoDyn Inc. (together with its wholly owned subsidiary, the “Company”) was originally incorporated under the laws of Colorado on May 2, 2002, under the name RexRay Corporation and, effective August 27, 2015, reincorporated under the laws of Delaware. The Company is a clinical-stage biotechnology company focused on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab (also referred to as PRO 140), a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5 (“CCR5”). The preclinical and early clinical development of PRO 140 was led by Progenics through 2011. The Company acquired the asset from Progenics in October 2012. In November 2018, the United States Adopted Names Council adopted “leronlimab” as the official nonproprietary name for PRO 140. Our principal business office is located at 1111 Main Street, Suite 660, Vancouver, Washington 98660. Our website can be found at www.cytodyn.com. We make available on our website, free of charge, the proxy statements and reports on Forms 8-K, 10-K and 10-Q that we file with the Securities and Exchange Commission (“SEC”), as soon as reasonably practicable after such materials are electronically filed with or furnished to the SEC. By making this and other references to the Company’s website, we do not intend to incorporate by reference any information posted on our website into this Form 10-K. The website should not be considered part of this Form 10-K. The consolidated financial statements included in this Form 10-K include the accounts of CytoDyn Inc. and its wholly owned subsidiary CytoDyn Operations Inc. Business Overview The Company is a clinical-stage biotechnology company focused on the clinical development and potential commercialization of its product candidate, leronlimab, which is being studied for its potential in solid-tumor oncology. Leronlimab targets CCR5, a receptor increasingly recognized for its role in tumor progression, metastasis and immune regulation, providing the Company with the opportunity to explore a potentially differentiated therapeutic approach across multiple solid tumor indications. Our current business strategy is to continue to pursue the clinical development of leronlimab, which may include the following: 1. Complete our Phase 2 study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer, also known as the CLOVER study; 2. Conduct additional studies exploring leronlimab and its therapeutic potential in other solid-tumor oncology indications, including but not limited to metastatic triple-negative breast cancer; and 3. Pursue strategic partnerships that will fund, advance and/or expedite clinical development and regulatory progress towards the prospective commercialization of leronlimab. We may need significant additional funding to execute the above business strategy in full, which may include conducting a variety of additional preclinical studies and clinical trials, in furtherance of our efforts to obtain FDA approval to commercialize leronlimab. In addition to traditional fundraising, the Company will pursue non-dilutive financing opportunities, such as license agreements and co-development or strategic partnerships, to help implement its strategy. Recent Corporate Developments On April 21, 2026, we announced the successful completion of enrollment in our Phase 2 clinical study evaluating leronlimab in combination with trifluridine and tipiracil (TAS-102) plus bevacizumab in patients with CCR5-positive, microsatellite stable (MSS), relapsed/refractory metastatic colorectal cancer (mCRC), also known as the “CLOVER study”– CCR5-targeting Leronlimab With Oral Chemotherapy and VEGF-inhibitor Enriched Regimen (ClinicalTrials.gov Identifier: NCT06699836). On April 19–21, 2026, we presented data at the American Association for Cancer Research (AACR) Annual Meeting 2026. The research presented at AACR examined the growing potential around leronlimab’s role in solid-tumor oncology. The presented abstracts were: Leronlimab induces PD-L1 expression and is associated with long-term survival with an ICI in PD-L1 low metastatic TNBC (Dr. Richard Pestell as lead author); and Preliminary results of a 4 phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer (Dr. Pashtoon Kasi as lead author).…