Published Paper Indicates Leronlimab Shows Activit

Published Paper Indicates Leronlimab Shows Activity Against 4-Class Drug Resistant HIV-1 From Heavily Treatment Experienced (“HTE" Subjects

CytoDyn previously hit a primary endpoint in a pivotal Phase 3 HIV trial with some HTE patients; over 20 patients remain in an extension arm study for up to 4 years

CytoDyn will include some findings from this study in its BLA submission for HIV approval

CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that a research paper entitled “Leronlimab (PRO 140) activity against 4-class drug resistant HIV-1 from Heavily Treatment Experienced Subjects” has been accepted, peer reviewed and is available as a journal pre-proof on ScienceDirect. ScienceDirect provides access to a large bibliographic database of scientific and medical publications of the Dutch publisher Elsevier. This article is available for purchase from Elsevier through a link on CytoDyn’s website:

LERONLIMAB (PRO 140) ACTIVITY AGAINST 4-CLASS DRUG RESISTANT HIV-1 FROM HEAVILY TREATMENT EXPERIENCED SUBJECTS - ScienceDirect

This project was a collaborative effort among scientists and researchers from:

University of Milan, Milan, Italy
University of Siena, Siena, Italy
University of Rome Tor Vergata, Rome, Italy
San Raffaele Vita-Salute University, Milan, Italy
Lazzaro Spallanzani National Institute for Infectious Diseases, Rome, Italy
Azienda Ospedaliera San Paolo, Milan, Italy
University of Perugia, Perugia, Italy; 8 Santa Maria Annunziata Hospital, Florence, Italy; 9 University of Brescia, Brescia, Italy.
The study was conducted as an in-vitro study of 25 HIV-1-infected patients harboring a documented 4-class drug-resistance nucleoside reverse transcriptase inhibitors (“NRTIs”), non-nucleoside reverse transcriptase inhibitors (“NNRTIs”), protease inhibitors (“PIs”), and integrase strand transfer inhibitors (“INSTIs”) enrolled in the Italian PRESTIGIO Registry.

Significant findings from the study and observations from the authors include:

Leronlimab maintained full activity in the presence of extensive resistance to the four main antiviral classes.
Leronlimab IC50 did not appear significantly altered by previous or current exposure to maraviroc.
In vitro, leronlimab and maraviroc have been reported to have synergistic activity, further corroborating the different mechanism of the two drugs despite the same CCR5 target.
In vitro susceptibility to leronlimab is not affected by extensive drug resistance and exposure to maraviroc.
Leronlimab may have some advantages over maraviroc as a clinically valuable CCR5 antagonist, including lower toxicity, less drug-drug interaction issue and less frequent dosing.
Leronlimab can play a key role in subjects with very limited therapeutic options and CCR5-tropic virus.
“We would like to thank our Italian colleagues for understanding the importance of leronlimab in the treatment of HIV. This is further proof that leronlimab can benefit CCR5 tropic HIV patients, including those patients with multidrug resistance. HIV patients deserve the opportunity for multiple, effective treatment options,” said CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “I would like to thank Dr. Stefano Rusconi, who had reached out to us to do this study. We are grateful to him and his colleagues for producing what we believe to be further evidence that leronlimab can play a vital role in the treatment of HIV. We believe leronlimab has many advantages, including protecting healthy cells from viral entry, prevention of HIV transmission, convenience, lower toxicity, and the ability to treat patients across the full spectrum of disease from treatment-naive to 4-class resistant HIV. Many HIV patients could also be in danger of developing NASH and, with our recent 350 mg open label NASH trial having achieved its primary (PDFF) and secondary (cT1) endpoints, we believe that all HIV patients may benefit from a CCR5 product as part of their medication. We also believe leronlimab’s potential role in cancer treatment could help HIV patients with a long history of HIV (especially heavily treatment experienced HIV), which increases their risk of developing cancer.”