iBio Reports on Filing of Annual Report and Subsequent Event Amendment of Collaboration with Fraunhofer
NEWARK, Del., Oct. 7, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO), a biotechnology company focused on commercializing its proprietary transformative recombinant platform technology for development and production of biologics using transient gene expression in unmodified green plants, today confirmed, as required by Section 610(b) of the NYSE MKT Company Guide, the receipt of an audit opinion for its year ended June 30, 2013, containing a going concern qualification. This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended June 30, 2013.
On September 6, 2013 the Company and its long-time research and development partner, Fraunhofer USA, Inc. ("Fraunhofer"), completed an amendment (the "Amendment") of the principal agreement first executed in 2003 (the "TTA") governing their relationship. The Amendment substantially altered financial obligations under the TTA and repurposed the TTA in order to better serve the prospective focus of the Company to use its completed technology platform for the development by or on behalf of the Company of individual proprietary products. Prior to the September 6, 2013 Amendment, the TTA was designed and served to facilitate research and development for the creation, expansion and refinement of iBio's proprietary platform. That was accomplished over a period of ten years and entailed funding directed to Fraunhofer in excess of $100 million principally from the Company, Fraunhofer's parent organization, U.S. government, and the Bill and Melinda Gates Foundation.
As reflected in Note, 17, Subsequent Events, to the Financial Statements included in the Company's 2013 Annual Report, and as disclosed in the Form 8-K filed by the Company on September 18, 2013, among the effects of the Amendment were the elimination of approximately $2.9 million of liabilities from the Company's books, elimination of $1 million in prepaid expenses, and the increase of $1.9 million in stockholders' equity of the Company. All of the foregoing post-June 30, 2013 events and adjustments will be reflected in the Company's Financial Statements for the quarter ended September 30, 2013.
Operationally, the Amendment provides the Company with the right and power, pursuant to a pre-agreed pricing and control mechanism in the form of a Master Services Agreement, for the Company to select and direct product development projects to be executed collaboratively with Fraunhofer. The Company has committed to engage Fraunhofer and Fraunhofer has agreed to provide at least $3 million of services in connection with such product development work by December 31, 2015. The Company expects funding for such product development to be provided by the Company for its product candidates and by licensees or other collaborators of the Company for the respective product candidates they license from the Company.
The first such project for a Company product candidate was initiated in July 2013 and is currently advancing a recombinant form of C1 esterase inhibitor, made using iBio's proprietary technology platform, through preclinical IND enabling studies with the goal to file an IND and thereafter proceed to human clinical trials. Remaining work for the first phase, through filing of an IND, is expected to be completed by late 2014. C1 esterase inhibitor, currently made by others from human blood plasma, is approved for the treatment of hereditary angioedema. The Company's recombinant form of C1, made in unmodified green plants using the iBioLaunch technology, avoids the use of human blood plasma as a starting material, retains full enzyme inhibition activity and is a more homogeneous product than products derived from human blood plasma. The Company expects its iBioLaunch produced recombinant product to exhibit improved properties at a lower cost versus plasma-derived proteins.
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. Additionally, iBio is developing select product candidates that have been derived from the iBioLaunch platform. The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. The iBioModulator platform is complementary to the iBioLaunch platform and is designed to significantly improve vaccine products with both higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. Further information is available at: www.ibioinc.com.
STATEMENTS INCLUDED IN THIS NEWS RELEASE RELATED TO IBIO, INC. MAY CONSTITUTE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. SUCH STATEMENTS INVOLVE A NUMBER OF RISKS AND UNCERTAINTIES SUCH AS COMPETITIVE FACTORS, TECHNOLOGICAL DEVELOPMENT, MARKET DEMAND, AND THE COMPANY'S ABILITY TO OBTAIN NEW CONTRACTS AND ACCURATELY ESTIMATE NET REVENUES DUE TO VARIABILITY IN SIZE, SCOPE AND DURATION OF PROJECTS. FURTHER INFORMATION ON POTENTIAL RISK FACTORS THAT COULD AFFECT THE COMPANY'S FINANCIAL RESULTS CAN BE FOUND IN THE COMPANY'S REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
SOURCE iBio, Inc.