April 25, 2013, Vancouver, Canada—iCo Therapeutics (TSX-V: ICO), today reported financial results for the year ended December 31, 2012. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
“This past year, iCo made significant progress with its lead asset, iCo-007, for the treatment of diabetic macular edema,” said Andrew Rae, iCo’s President & CEO. “We have treated 174 patients in our phase 2 iDEAL study and expect primary endpoint data for all subjects reaching their eight month milestone in late 2013. In doing so we built significant value for our shareholders, as evidenced by our recent number one ranking in the TSX Venture Top 50 for Technology & Life Sciences sector. In 2012 we also strengthened our balance sheet and saw progress in both our iCO-008 and Oral Amphotericin B projects and in early 2013, our Israeli partner announced the initiation of a 90 patient phase 2 clinical study in ulcerative colitis involving iCo-008.”
2012 Financial & Operational Highlights
· Appointment of Douglas G. Janzen to iCo’s Board of Directors.
· Presented on the panel, Macular Edema Today and Tomorrow at the Retinal Physician Symposium conference.
· Announced a $1.1Million non-repayable financial contribution from the National Research Council of Canada to support iCo’s Oral Amphotericin B (Amp B) delivery system as novel treatment for patients with Human Immunodeficiency Virus (HIV).
· Highlighted iCo’s iDEAL study in the following JDRF publication:
· Raised $2.55 million through an Overnight Marketed Offering. At the time of our offering we concluded the fundraising at 45 cents per unit and since the offering our share price has significantly appreciated.
· Presented five posters on oral Amphotericin B delivery system at the AAPS Annual Meeting and Exposition, in Chicago, Illinois
Subsequent Events to Year End
· iCo ranked #1 among Technology & Life Science companies in the TSX Venture Top 50.
· Announced a clinical update for the Phase 2 iDEAL study for the treatment of diabetic macular edema (DME), in which there were no drug related serious adverse events among patients receiving repeat doses of iCo-007. The company also announced that it had exceeded its recruitment threshold of patients for statistical analysis of the study.
Summary Fiscal 2012 Results
We incurred a net and comprehensive loss of $3,430,427 for the year ended December 31, 2012 compared to a net and comprehensive loss of $$993,491 for the year ended 2011, representing an increase of $2,436,936. The increase in our net and comprehensive loss was principally caused by clinical trial costs associated with iCo-007.
Research and development expenses were $2,287,148 for the year ended December 31, 2012 compared to $1,126,378 for the year ended December 31, 2011, representing an increase of $1,160,770. This increase in research and development expenses based mainly on clinical costs associated with the iDEAL study for iCo-007 in diabetic macular edema.
For the year ended December 31, 2012 general and administrative expenses were $1,374,710 compared to $ 1,347,515 for the year ending December 31, 2011, representing an increase of $27,195.
Liquidity and Outstanding Share Capital
As at December 31, 2012, we had cash and cash equivalents and short-term investments of $1,260,196 compared to $ 1,326,399 as at December 31, 2011.
As at April 25, 2013, we had an unlimited number of authorized common shares with 54,727,627 common shares issued and outstanding.
For complete financial results, please see our filings at www.sedar.com.
About iCo Therapeutics
iCo Therapeutics in-licenses and redefines existing drug candidates or generics by employing reformulation and delivery technologies for new or expanded use indications. The company has exclusive worldwide rights to two drug candidates – iCo-007 for Diabetic Macular Edema (DME) and iCo-008 for other sight-threatening diseases. iCo-007 is in Phase 2 clinical studies for DME. With Phase 2 clinical history, iCo-008 is targeted for the treatment of keratoconjunctivitis and wet age-related macular degeneration. In addition, iCo holds worldwide rights to an oral drug delivery platform. The first platform candidate is the Oral Amp B Delivery system, utilizing a known anti-fungal drug to treat life-threatening infectious diseases. 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’s current beliefs as well as assumptions made by and information currently available to iCo 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 in its public securities filings; actual events may differ materially from current expectations. iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.