CytoDyn And Samsung BioLogics Enter Into Agreement To Manufacture $1 Billion Worth Of Leronlimab (PRO 140) To Meet Expected Demand For Future Revenues Post-Approval

VANCOUVER, Washington, April 02, 2019 -- CytoDyn Inc. (CYDY), (“CytoDyn” or the “Company”) a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced the execution of a comprehensive strategic agreement with Samsung BioLogics Co., Ltd. for the clinical and commercial manufacturing of leronlimab (PRO 140). The quantity of new leronlimab to be produced under the agreement is anticipated to be sufficient to support potential revenues for CytoDyn of approximately $1 billion based upon $120,000 per patient, per year.

The agreement commences immediately and entails, most notably, technology transfer of the fully validated commercial process and scale-up, large scale commercial production, validation, and regulatory support during the pre- and post- approval process with the U.S. Food and Drug Administration (FDA) and other global regulatory bodies.  In the last four years, Samsung BioLogics has secured 8 biologics drugs approvals from the FDA and 22 overall when including other agencies around the world.

It is believed the financial obligation to Samsung will be satisfied predominantly with sales from existing inventory of commercial grade leronlimab and non-dilutive financing. The initial contract period is from April 1, 2019 to December 31, 2027, encompassing the multitude of potential indications for leronlimab (PRO 140) for which CytoDyn anticipates pursuing regulatory approvals.

“We are elated at the distinction of partnering with the world’s preeminent biologics manufacturer for our franchise-defining drug,” stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director.  “In the last four years, Samsung BioLogics has been among the most successful, consistent and highest quality biologics manufacturers in the world.  We are thrilled beyond measure that Samsung chose to partner with us,” continued Dr. Pourhassan.  “The validation of Samsung is particularly important as we rapidly advance towards completing the rolling BLA. We are also currently evaluating several potential licensing deals for leronlimab to commercialization companies.  We are getting closer to have such agreements in place which will provide CytoDyn non-dilutive funds to execute on our vision,” concluded Dr. Pourhassan.

About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab (PRO 140) as a combination therapy with HAART for HIV-infected patients.  Leronlimab (PRO 140) is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.  Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

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