Cytodyn Inc (CYDY)

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https://www.cytodyn.com/media/press-releases/detail/312/cytodyn-announces-productive-conference-call-with-fda

Successful interim results in the 700 mg monotherapy arm prompted the FDA to allow CytoDyn to switch all remaining combination therapy patients from CD02-Extension study from 350 mg to 700 mg dose

CytoDyn is in negotiations for post-approval sales distribution channels with potential upfront payment to CytoDyn

VANCOUVER, Washington, Feb. 01, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection and potentially disrupting cancer metastasis, announces that it had a productive conference call meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) submission. This was the first follow-up meeting since its June 2018 pre-BLA meeting regarding the Company’s planned submission of its BLA and the positive interim data of its 700 mg monotherapy trial. The FDA recognized that the higher dosage of 700 mg in the monotherapy trial had a much higher response rate than the 350 mg dose used in the combination therapy trial. In order to avoid a long delay in the BLA filing, the FDA agreed to accept safety data from 100 patients in the monotherapy trial with the 700 mg dose, which enables the BLA submission for the combination therapy to use 700 mg instead of the original 350 mg dose.

CytoDyn currently has 45 patients enrolled in monotherapy with 700 mg, 29 additional patients who have switched from lower doses to the 700 mg dose and over 40 patients currently in screening to initiate 700 mg dose arm of monotherapy trial. The FDA also gave CytoDyn permission to upgrade all ongoing patients who are currently on 350 mg in the combination therapy to 700 mg dose.

“We are extremely appreciative of the agency’s guidance for the approval process for the world’s first self-injectable antibody for HIV,” said Nader Pourhassan, Ph.D., CytoDyn President and CEO of CytoDyn.

“The safety data requested by the FDA for 100 patients at the 700 mg dose was extremely favorable to our drug development timeline. We are also pleased to report that we have initiated planning meetings with potential commercialization partners to provide their distribution channels for sales of leronlimab immediately following our anticipated approval. The anticipated partnership structure may take the form of upfront investment in CytoDyn in exchange for a royalty post approval. All the structures we are considering are in line with our desire to pursue non-dilutive financing options. We are also negotiating with several large manufacturing companies to add $500 million worth of inventory to our current commercial inventory for deferred payments after approval.”

Dr. Pourhassan continued, “We believe we can realize significant revenue opportunities by 2020 assuming the first approval of leronlimab (PRO 140). CytoDyn has a platform technology in HIV, cancer, graft-versus-host disease (GvHD), and a prostate cancer prognostic test. We believe leronlimab will also positively affect many lives in the triple negative breast cancer population, which is an unmet medical need population and therefore, we are very hopeful for a very strong 2019 and expect to achieve many important milestones.”