April 29, 2010
VANCOUVER, Canada — iCo Therapeutics Inc. (TSX-V: ICO) today reported financial results for the year ended December 31, 2009. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).
“I am very pleased with the progress we have made with our drug candidates, in particular iCo-007. Our Phase I trial is now complete and we should receive the final study report shortly”, stated Andrew Rae, iCo’s President & CEO. “We look forward to 2010 as we prepare for our Phase II clinical trial program.”
2009 Operating Highlights
In 2009 we accomplished the following milestones:
- Raised gross proceeds of $5,767,500 through a series of three private placements which included significant investment from key corporate partners and US based financial institutions.
- Completed full patient enrollment (15 patients in four cohorts) for our Phase I, open label, dose escalation clinical trial;
- Held a Safety Evaluation Committee (“SEC”) meeting to review safety data from the fourth and final cohort (6 patients) with the SEC concluding that there were no drug related serious adverse events;
- Began the initial planning for a Phase II study program for iCo-007;
- Released interim safety and efficacy data which was presented at several influential international conferences by three of our clinical investigators;
- Had iCo-007 featured in an article in the Journal of Diabetes Science and Technology, a peer reviewed e-journal. The article investigates the potential role of antisense drugs in the treatment of Diabetic Retinopathy.
- Appointed Donald N. Buell, M.D. to Chair the Scientific Advisory Board (“SAB”) Committee to oversee the clinical development of iCo-009. Dr. Buell was previously Senior Medical Director at Astellas Pharma Inc., and held positions in the Anti-Effective Drugs Group at Pfizer and at the US Food and Drug Administration (“FDA”).
- Signed a collaboration development agreement with the Consortium for Parasitic Drug Development (“CPDD”) for up to USD $182,930 for the research and development of our oral drug delivery technology for the treatment of neglected diseases such as leishmaniasis and trypanosomiasis;
- Published results of our studies in several peer reviewed journals including the Journal of Infectious Diseases;
- In March, 2009 presented iCo-009 at a Bill & Melinda Gates Foundation sponsored event in Breckenridge, Colorado.
Summary Fiscal 2009 Results
We incurred a net and comprehensive loss of $2,308,490 for the year ended December 31, 2009 compared to a net and comprehensive loss of $2,742,374 for the year ended 2008, representing a decrease of $433,884. The decrease in our net and comprehensive loss was principally caused by a decrease in research and development and general and administrative expenses for the year ended December 31, 2009.
Interest income for the year ended December 31, 2009 was $6,354, compared to $30,529 for the year ended December 31, 2008, resulting in a decrease of $24,175. The lower interest income earned in the year ended December 31, 2009, as compared to the same periods in 2008 was a result of both significantly lower cash and short term investments balances held throughout most of the 2009 year and lower interest rates.
Research and development expenses were $1,133,696 for the year ended December 31, 2009 compared to $1,421,258 for the year ended December 31, 2008, representing a decrease of $287,562. Research and development expenses for the year ended December 31, 2009 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-009. Research and development expenses for the year ended December 31, 2009 primarily consisted of salaries, consultants’ fees, contract research organization expenses related to the Phase I clinical trial for iCo-007 and research expenses related to pre-clinical studies for iCo-009.
For the year ended December 31, 2009 general and administrative expenses were $836,947 compared to $995,297 for the year ended December 31, 2008, representing a decrease of $158,350. This decrease in the year ended December 31, 2009 compared to the year ended December 31, 2008 was attributable to decreased salaries and professional fees.
Amortization for the year ended December 31, 2009 was $116,845 compared to amortization of $115,430 for the year ended December 31, 2008.
Foreign exchange loss for the year ended December 31, 2009 was $37,710 compared to foreign exchange loss of $60,950 for the same period in 2008, representing a decrease of $23,240. The changes for the period reflect fluctuations in the exchange rate for U.S. dollars.
Stock based compensation relates to options granted under our employee stock option plan to directors, officers, employees and consultants. Compensation expense is recorded using the fair value method over the vesting period of the option. Stock based compensation for the year ended December 31, 2009 was $189,646 compared to $179,968 for the year ended December 31, 2008.
Liquidity and Outstanding Share Capital
As at December 31, 2009, we had cash and cash equivalents of $3,896,065 compared to $620,276 as at December 31, 2008. In January and February we received additional proceeds of $810,563 from the exercise of outstanding warrants. We anticipate that the combination of the cash on hand from year end and the warrant exercise will be sufficient to fund operations into the fourth quarter of 2011.
As at April 29 2010, we had an unlimited number of authorized common shares with 41,057,301 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 I for the treatment of DME; iCo-008, a product with Phase II clinical history to be developed for severe ocular allergies and age related macular degeneration; and iCo-009, an oral formulation of Amphotericin B for sight and life-threatening diseases. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenteral administered drugs to the oral route of administration. iCo was recently awarded a Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada and 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.