April 13, 2012, Vancouver, Canada—iCo Therapeutics (TSX-V: ICO), a Vancouver-based drug reprofiling company, today reported financial results for the year ended December 31, 2011. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
“The Company underwent serious advancement with its lead program in 2011,” commented Andrew Rae, iCo’s President & CEO. “We are now running the largest study of its kind in Diabetic Macular Edema and doing so at some of the leading eye centers in the world. We also strengthened our balance sheet, as well as our board of directors, with the appointment of Doug Janzen.”
2011 Financial & Operational Highlights
· Successfully completed manufacturing activities as part of the initial steps to progress with the Phase 2 clinical program for iCo-007.
· Presented on panels at several scientific and financial conferences including Retinal Physician Symposium, BioFinance, Drug Repositioning Conference, Ophthalmology Innovation Summit and the American Association of Pharmaceutical Scientists.
· Executed licensing deal with Immune Pharmaceuticals for Bertilimumab (iCo-008), with a $500,000 up front payment, 600,000 shares and 200,000 warrants and $32 million in milestones, plus royalties.
· Initiated a US physician-sponsored Phase 2 clinical trial studying iCo-007 in Diabetic Macular Edema (DME) – the iDEAL study – to be conducted across multiple sites throughout the United States.
· Entered into a research collaboration agreement with JDRF (Juvenile Diabetes Research Foundation), the worldwide leader for research to cure, treat, and prevent type 1 diabetes (T1D), to support the Phase 2 investigator sponsored clinical trial investigating iCo-007 in DME.
· Completed a non-brokered private placement in the amount of $1,115,000 through the issuance of 5,575,000 Units at a subscription price of $0.20 per Unit. Each Unit consisted of one common share and one Common Share purchase warrant. Each warrant entitled the holder, on exercise, to purchase one additional Common Share, at any time on or prior to the date which is 24 months after the Closing Date, at an exercise price of $0.25 per share at any time on or prior to the 12 month anniversary of the Closing Date and $0.30 per share at any time after the 12 month anniversary of the Closing Date on or prior to the 24 month anniversary of the Closing Date.
· Appointment of Douglas G. Janzen, President, Chief Executive Officer and a Director of Cardiome Pharma Corp. (NASDAQ:CRME, TSX:COM), Director of NEOVASC Inc. and director of various industry trade associations, including Chairman of the board of directors of Life Sciences British Columbia, to iCo’s Board of Directors.
· Presented on the panel, Macular Edema Today and Tomorrow at the Retinal Physician Symposium conference.
· Announced key details outlining the iDEAL study to evaluate the drug iCo-007 for the treatment of Diabetic Macular Edema. The study is being conducted at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine. The Phase 2 clinical trial is a multi-center study chaired by Quan Dong Nguyen, MD, MSc, Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, and will study as many as 208 patients with DME at up to 30 clinical sites across the United States. In addition, the Retinal Imaging Research and Reading Center (RIRRC) at the Wilmer Eye Institute serves as the Reading Center for the iDEAL Study.
Summary Fiscal 2011 Results
We incurred a net and comprehensive loss of $993,491 for the year ended December 31, 2011 compared to a net and comprehensive loss of $3,104,641 for the year ended 2010, representing a decrease of $2,111,150. The decrease was driven primarily by an offsetting increase in non-recurring income related to the Sub-licence of iCo-008 to Immune Pharmaceuticals.
Research and development expenses were $1,126,378 for the year ended December 31, 2011 compared to $1,770,623 for the year ended December 31, 2010, representing a decrease of $644,245. Research and development expenses for the year ending December 31, 2011 were lower than the same period for the previous year primarily due to a decrease in salaries and research and development costs associated with iCo-007.
For the year ended December 31, 2011 general and administrative expenses were $1,347,515 compared to $1,435,633 for the year ending December 31, 2010, representing a decrease of $88,118. This decrease in the year ended December 31, 2011 compared to the year ended December 31, 2010 was attributable to decreased professional fees and salaries.
Liquidity and Outstanding Share Capital
As at December 31, 2011, we had cash and cash equivalents and short-term investments of $1,326,399 compared to $2,040,707 as at December 31, 2010.
As at April 13, 2011, we had an unlimited number of authorized common shares with 46, 632,301 common shares issued and outstanding.
For complete financial results, please see our filings at www.sedar.com.
About iCo Therapeutics
iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications. iCo has exclusive worldwide rights to three products: iCo-007, in Phase 2 for the treatment of Diabetic Macular Edema (DME), iCo-008 (Bertilimumab), a product with Phase 2 clinical history to be developed for sight threatening diseases; and an oral Amphotericin B delivery system for life-threatening infectious diseases. Immune Pharmaceuticals licensed systemic rights to iCo-008 in June 2011. iCo trades on the TSX Venture Exchange under the symbol “ICO”. For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this release. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo Therapeutics’ current beliefs as well as assumptions made by and information currently available to iCo Therapeutics and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo Therapeutics in its public securities filings; actual events may differ materially from current expectations. iCo Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.