iBio Provides Updates on Its IBIO-CFB03 Fibrosis Drug Candidate and Other Activities for the 2014 Annual Shareholders Meeting - Seite 2

4. Programs involving government and NGO sponsorship. Phase 1 clinical trials of a malaria transmission-blocking vaccine and a hookworm vaccine are underway, both of which are non-commercial products fully funded by third parties. These and potential new programs provide valuable data on medically important applications of iBio's proprietary technology.

Overview of iBio's development of IBIO-CFB03. iBio has collaborated with Dr. Feghali-Bostwick, the inventor of IBIO-CFB03, at the Medical University of South Carolina (MUSC) during 2014 to develop this drug candidate for clinical trials. Dr. Feghali-Bostwick previously published data demonstrating that specific endostatin-derived peptides inhibit and reverse fibrosis in preclinical mouse models of fibrosis as well as in human skin. iBio obtained an exclusive, worldwide license to the patents and pending patents underlying these discoveries and inventions, and initiated an aggressive and now successful program to produce the active pharmaceutical ingredient, and potentially valuable derivatives, in plants using its iBioLaunch™ technology. Several lead formulations are under evaluation for clinical development, and work necessary to file an investigational new drug application (IND) with the FDA is being conducted, a process the company expects to complete by mid-2015.

iBio has determined that preclinical efficacy results and lack of significant toxicity in experiments conducted to date justify high priority advancement of the product into clinical trials. The serious unmet medical need potentially addressed by this breakthrough product justify investment in a Phase 1 clinical trial that will not only evaluate safety in healthy volunteers, but also seek evidence of efficacy on a preliminary basis in patient volunteers. In consultation with its clinical advisory board, iBio believes that such a strategy will not only accelerate overall clinical development of IBIO-CFB03, but also provide the basis for pursuing at least two clinical indications in parallel in subsequent clinical trials.

The development program will be assisted by a world-class clinical advisory board established by the company during 2014. The board includes Dr. Thomas A. Medsger, Jr., an internationally recognized expert on the epidemiology, clinical and laboratory features and natural history of systemic sclerosis and localized forms of scleroderma, Raynaud disease and polymyositis/dermatomyositis. Richard M. Silver, M.D., one of the world's leaders in clinical care and investigation of systemic sclerosis, Timothy Blackwell, M.D., an internationally recognized expert in IPF and other lung diseases, and Dr. J. Terrill Huggins, a leading clinical investigator in the field of IPF.