Cytodyn Inc (CYDY)

[JPG77]

In summary, we are excited about 2017 and have the following expectations:
• Completing enrollment in our Phase 3 PRO 140 combination trial and reporting initial efficacy results during the first half of 2017;
• Advancing recruitment in our Phase 3 monotherapy trial;
• Request a meeting with the FDA in the early part of the second quarter to discuss BLA submission;
• Presenting Phase 2b monotherapy results at CROI on February 15 and participating in a themed discussion session in elite company on February 16;
• Receiving notice from the FDA on Orphan Drug designation for PRO 140 in treatment-experienced HIV patients;
• Injecting the first patient in the Phase 2 GvHD trial;
• Submitting animal data in support of Orphan Drug Designation for GvHD;
• Announcing the publication of new animal data that further validates the effectiveness of PRO 140 in autoimmune disease and cancer; and
• Submitting all three sections of BLA to the FDA and request approval of PRO 140.