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Archive - Apr 28, 2020

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CytoDyn Submits Completed BLA* to FDA for Leronlimab As Combination Therapy, with HAART, for Highly-Treatment-Experienced HIV Patients; In FDA Review Period, Cytodyn Will Dedicate All Resources to Ensure Availability of Leronlimab for COVID-19 Patients

On Monday, April 27, 2020, CytoDyn Inc. (OTC.QB: CYDY), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that the Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA (*biologics license application) to the FDA for leronlimab as a combination therapy, with HAART (highly active antiretroviral therapy),** for highly-treatment-experienced HIV patients. The FDA previously granted both Fast-Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication. “The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization. We are excited about the opportunity to introduce a novel therapeutic to HIV patients. In addition to the BLA submission, once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients has reached its objectives, we plan to initiate a registration-directed study. Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential,” said Nader Pourhassan, PhD, President and Chief Executive Officer of CytoDyn. “With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer, and immunology. The BLA filing is a monumental achievement for our Company, and was made possible through the sheer determination and commitment of CytoDyn’s team and the Amarex Clinical Research (https://www.amarexcro.com/services.html) team led by Dr.