CytoDyn Executes Exclusive Supply and Distribution Agreement with Chiral Pharma Corporation to Provide Up to 200,000 vials of Leronlimab to Philippines

Under Compassionate Special Permit (CSP) in Philippines, CytoDyn is well positioned to generate significant revenues

VANCOUVER, Washington., April 15, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today it has executed an exclusive supply and distribution agreement with Chiral Pharma Corporation to supply up to 200,000 vials of leronlimab to critically ill COVID-19 patients in the Philippines under CSP authorizations. This agreement will accelerate the delivery of leronlimab upon an expanded authorization under CSP.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased how quickly we reached agreement with our commercial partner, Chiral Pharma in the Philippines. Chiral has been working diligently with the Philippine FDA to ensure the regulatory path is cleared so we can provide leronlimab to thousands of critically ill COVID-19 patients under CSP authorization. Upon quick recovery of the first Filipino patient critically ill with COVID-19 treated with leronlimab, Chiral is continuously receiving CSP requests and is hoping to accelerate the availability of leronlimab under CSP to thousands of critically ill COVID-19 patients. In parallel, we are using data generated from our CD12 open-label extension to pursue EUAs in multiple countries experiencing surges in critically ill COVID-19 patients. The Company will accelerate manufacturing of leronlimab at Samsung BioLogics upon such approval.”

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (nonalcoholic steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).