Many IMNP shareholders have been asking about our vision and implementation plan for Cytovia. We now have a clear strategic business plan, validated by a leading consulting firm and by industry experts, to create a global specialty immuno-oncology pharmaceutical company around our core asset Ceplene. As the plan is implemented, Cytovia would focus on commercialization and late stage development of immuno-oncology drugs while Immune would focus on clinical proof of concept development for immuno-inflammation and immuno-dermatology drugs. Both Immune and Cytovia would become pure play companies with significant improved operational focus, ability to attract investors and create shareholder value. Immune shareholders may benefit from both pure play opportunities.
Cytovia’s lead asset, Ceplene, is fully owned in North and Latin America as well as Israel. The FDA has guided for a single pivotal study toward approval in combination with low dose Proleukin (interleukin 2) for Remission Maintenance in patients with Acute Myeloid Leukemia. Cytovia would have the opportunity, leveraging the European Medicine Agency approval, to commercialize in Latin America through a regional commercial partner. Cytovia would also pursue opportunities in other regions through strategic alliances and acquisition of complementary commercial assets. Cytovia would become a new specialty oncology pharmaceutical company with product sales and licensing revenues to fuel its growth. Other earlier stage oncology programs would be developed primarily through external funding and partnerships.
We are considering a plan to create a second well capitalized public company through a spin off process which would allow IMNP shareholders to receive shares in Cytovia proportionally to what they own in Immune Pharmaceuticals at the record date to be established. Spin off strategies have been successfully implemented both in biotech and in other industries to unlock to shareholders the value of assets which require distinct business strategies, management and financing. We would also consider additional options to finance the ambitious growth for Cytovia through joint-venture and merger & acquisition transactions at the appropriate time to maximize shareholder value. We are excited to move forward with the Cytovia strategic plan and expect to announce shortly the specifics of the implementation process and the first partnership transactions.