CytoDyn to Hold Webcast on May 18 to Discuss FDA’s Statement on Leronlimab

Rhea-AI Summary

CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for May 18, 2021, led by CEO Nader Pourhassan and other executives. The presentation will address ongoing communications with the FDA regarding trial design, focusing on the CD12 trial results for the COVID-19 treatment, leronlimab. The trial did not meet primary endpoint criteria; however, secondary endpoints in a critically ill sub-population showed promise. Investors are encouraged to submit questions before and during the webcast.

Positive

• Management is actively engaging with the FDA to refine trial designs, indicating a proactive approach to regulatory compliance.
• Secondary endpoints were met in a critically ill subset, suggesting potential for leronlimab's efficacy in targeted populations.

Negative

• The CD12 trial did not meet its primary mITT endpoints, raising concerns about the overall efficacy of leronlimab.

VANCOUVER, Washington, May 17, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman and Chief Medical Officer and Chris Recknor, M.D., Chief Operating Officer will host an investment community webcast on Tuesday, May 18, 2021.

Management will provide an update on ongoing work with the United States FDA and other regulatory agencies on using sub-population data to ensure future adequate trial design, in order to continue to further its clinical development of leronlimab in the treatment of patients with COVID-19. As indicated by the FDA and the Company previously, the CD12 trial did not meet mITT endpoints. The Company will provide further clarification on the secondary endpoints met in the critically ill pre-specified sub-population. As we continue to work with the FDA and other regulatory agencies, we ask investors to limit their outreach and respect the regulatory approval processes.

Management will dedicate approximately 60 minutes to address questions submitted online by analysts and investors.

Date: Tuesday, May 18, 2021
Time: 1:00 pm PT / 4:00 pm ET
Dial-In: None.
Questions:

• Prior to the webcast, questions can be submitted online to CYDY_Team@cytodyn.com
• During the webcast, questions can be submitted through the webcast link below.

This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. Please note the below webcast link will not be operational until approximately 60 minutes prior to the start of the webcast, which can be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/45209/indexl.html

The replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until June 18, 2021.

CONTACTS
Investors:
Cristina De Leon
Office: 360.980.8524
cdeleon@cytodyn.com

FAQ

What is the date and time of CytoDyn's upcoming webcast?

The webcast is scheduled for May 18, 2021, at 1:00 PM PT / 4:00 PM ET.

What will CytoDyn discuss in the webcast?

CytoDyn will provide updates on interactions with the FDA regarding trial designs and share insights on leronlimab's clinical development.

What are the results of the CD12 trial related to CytoDyn?

The CD12 trial did not meet the primary mITT endpoints, but secondary endpoints were met in a critically ill subgroup.

How can investors submit questions for the CytoDyn webcast?

Investors can submit questions online to CYDY_Team@cytodyn.com before and during the webcast.