Corporate Strategy

• Complete the Phase 1 trial evaluating safety and potential immunomodulatory effects following the intranasal administration of Foralumab in healthy volunteers (for neurodegenerative disease indications such as MS), initiated in November 2018. Topline results from this study are expected in Q3 2019.
• Advance the clinical development of orally-administered Foralumab for the treatment of NASH and Crohn’s disease by using a novel and proprietary oral formulation by initiating a Phase 1 trial in the third quarter of 2019 and a Phase 2 trial in 2Q 2020.
• Progress the clinical development and obtain regulatory approval for our lead oncology product candidate, Milciclib, as a monotherapy in HCC and as a combination therapy for the treatment of refractory solid tumors (cancers which are non-responsive or become resistant to treatment). This can be accomplished by completing the ongoing Phase 2a trial as a monotherapy and initiating a planned Phase 2b trial in combination with Sorafenib.
• Continue preclinical development of our fully human mAb targeting the IL-6R (binds to both soluble and membrane bound IL-6R) for treatment of inflammatory, rheumatoid arthritis and as an oncology indicator.
• Identify additional pipeline opportunities by acquiring or in-licensing complimentary product(s) and technology candidate(s).
• Seek orphan drugs fast track or breakthrough designation for our product candidates where warranted.