Update on HIV-BLA-PDUFA

FDA requested more information to complete a substantive review. No additional trials required. CytoDyn plans to submit the requested information and will ask for a Type A meeting with the FDA per the agency’s suggestion - Seite 2

Drs. Nader Pourhassan, Scott Kelly (Chief Medical Officer), Nitya Ray (Chief Technology Officer), and Kush Dhody (Sr. Vice President, Clinical Operations, Amarex Clinical Research, LLC) will host an investment community conference call on Monday, July 13, 2020 at 1:00 pm PT / 4:00 pm ET to provide an update on these regulatory developments.  Management will dedicate approximately 45 minutes to address questions from analysts and investors after opening remarks by the CEO. 

Date:  Monday, July 13, 2020
Time:  1:00 pm PT / 4:00 pm ET
Dial-In:  877-407-8291 US / 201-689-8345 International

A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link:

https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/ ...

A replay of the conference call will be available until August 13, 2020. To access the replay, interested parties may dial 877-660-6853 (US) / 201-612-7415 (International) and enter conference identification number 13707052.

About Coronavirus Disease 2019
CytoDyn has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and enrollment continues in its Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.