((RAIN)) Rainmakers-Island

[The Rainmaker]

IMUN: Orphan Drug status: The Company has retained the services Coté Orphan to assist in obtaining FDA and EMEA approvals. Cote Orphan is a boutique, full-service, lab-to-market regulatory group focused on Orphan Drugs. Team Coté is led by Dr. Tim Coté, the former Director of the FDA’s Office of Orphan Products Development (OOPD). Dr. Cote is currently working with the Company to file a briefing package and final protocols for adult and pediatric Crohn’s Disease. The Company expects to finish this process by the end of the second quarter of 2017. The Company has delayed its request for a Type B meeting with the FDA on Crohn’s Disease, as the FDA is in the process of making changes in a number of areas as it applies to both 505(2)(b) pathway development and paediatric trials. The Company is preparing its final submission and expects to have the briefing package ready in the next 90 days.