Company Announcements

Abstract to be presented at the 5^th annual HIV Research for Prevention Conference

Study results highlight potential for treatment

VANCOUVER, Washington, Oct. 07, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced acceptance of an abstract for presentation at the 5^th annual HIV Research for Prevention Conference. The abstract summarizes research on the potential of combining early antiretroviral therapy (ART) with a novel immunotherapy approach using broadly neutralizing antibodies (bNAbs) and leronlimab. This innovative treatment strategy was evaluated in infant rhesus macaques infected with Simian Human Immunodeficiency Virus (SHIV), offering promising insights into treatment possibilities to achieve viral control without the need for continuous ART.

Key Highlights of the Study:

• Objective: To assess whether a combination of early ART initiation with bNAbs and leronlimab can provide sustained viral control in infant rhesus macaques, potentially reducing or eliminating the need for lifelong daily medication.
• Methodology: Eighteen (18) infant rhesus macaques were infected with SHIV and then treated with various combinations of ART, bNAbs, and leronlimab. The study evaluated the efficacy of these treatments over a 27-week period, followed by a treatment interruption to monitor virus rebound.
• Results: The combination of ART, bNAbs, and leronlimab showed promising results, with no virus rebound observed in any of the treated animals, suggesting a potential for durable viral control and a significant advancement towards minimizing or eliminating the need for ongoing ART.
  

“These results demonstrate a previously unappreciated synergy between CCR5 blockade and antibody neutralization that opens the door to a new approach for an HIV cure that should be explored further,” said Jonah B. Sacha, Ph.D, Chief of the Pathobiology and Immunology Division at the Oregon National Primate Research Center at Oregon Health & Science University. The study was funded by an NIH grant awarded to OHSU and led by Dr. Nancy Haigwood, Dr. Sacha, and their collaborators.

“We are proud to report these results as we continue to progress our clinical development pipelines for leronlimab across a number of clinical indications,” said Dr. Jay Lalezari, CEO of CytoDyn. “The potential for a treatment path for HIV utilizing leronlimab that allows for long-lasting viral control and potentially reduces or eliminates the need for ongoing ART is a thrilling prospect. We’re grateful to our partners at Oregon Health & Science University and look forward to continuing this important work.”

Dr. Sacha will present the abstract at the 5^th annual HIV Research for Prevention Conference in Lima, Peru. Details on the presentation are shown below.

Title: Short-term combination immunotherapy with broadly neutralizing antibodies and CCR5 blockade mediates ART-free viral control in infant rhesus macaques
Presentation Type: Oral abstract session
Session Title: Planet of the Apes: Learning immunogenicity from animal models
Session Date and Time: October 10, 2024, 5:30-7:00PM PET

About CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.

Note Regarding Forward-Looking Statements
This news release contains forward-looking statements relating to, among other things, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Media Contacts

CytoDyn
Riyaz Lalani
Gagnier Communications
CytoDyn@gagnierfc.com