For Immediate Release April 29, 2011
VANCOUVER, Canada — iCo Therapeutics Inc. (TSX-V: ICO) today reported financial results for the year ended December 31, 2010. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).
2010 Operating Highlights
iCo- 007:
· Successfully completed a Phase I, open label, dose escalation clinical trial;
· Released safety and efficacy data which was presented at several influential international conferences by management and three of our clinical investigators;
· Began the initial phases of a Phase II clinical program, including completing the technology transfer to support the fill finish and drug product stability; (ii) preparing the fill / finish of drug product; (iii) commencing the selection process for clinical research providers through an RFP process; (iv) preparing various regulatory filings required to commence a Phase II trial; and (v) working with patient advocacy/ philanthropic organizations and key opinion leaders to provide additional leverage and awareness of the iCo-007 DME program.
· Received a No Objection Letter response regarding its Phase II DME Clinical Trial Application (CTA) with the Therapeutic Products Directorate, a division of Health Canada.
iCo-008
· In December 2010, iCo granted Immune Pharmaceuticals Corp. (IMPH) an option to an exclusive license for the development and commercialization rights to the systemic uses of iCo-008, while iCo retained worldwide exclusive rights to all uses and applications in the ocular field. IMPH paid iCo a non-refundable option fee creditable upon conversion against an upfront license fee payment of US $1 million, and iCo may receive up to an additional US$32 million in milestone payments as well as royalties on net sales of licensed products.
iCo- 009
· iCo-009 was granted Orphan Drug status for the treatment of Visceral Leishmaniasis (VL) by the US Food and Drug Administration.
· iCo appointed Dr. Thomas Walsh, Dr. Coleman Rotstein, and Dr. Jack Sobel to the Scientific Advisory Board (SAB) committee overseeing the development of iCo-009. The SAB is chaired by Dr. Don Buell.
· Concluded a collaboration with the Consortium for Parasitic Drug Development (“CPDD”) for 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 and notable scientific conferences.
Subsequent Events
· In February 2011, iCo completed drug product manufacturing activities as part of its Phase II clinical program investigating multiple doses and injections of iCo-007 in patients with diabetic macular edema (DME).
· In April 2011, the Company announced that it had entered into an Equity Line Facility (“ELF”) with Dutchess Opportunity Cayman Fund Limited (“Dutchess”) to provide up to $10 million of equity capital over a three year period, subject to certain conditions.
Summary Fiscal 2010 Results
We incurred a net and comprehensive loss of $3,104,641 for the year ended December 31, 2010 compared to a net and comprehensive loss of $2,308,490 for the year ended 2009, representing an increase of $796,151. The increase in our net and comprehensive loss was principally caused by an increase in research and development, general and administrative expenses and stock-based compensation for the year ended December 31, 2010.
Interest income for the year ended December 31, 2010 was $26,543, compared to $6,354 for the year ended December 31, 2009, resulting in an increase of $20,189. The higher interest income earned in the year ending December 31, 2010, as compared to the same periods in 2009 was a result of higher cash balances.
Research and development expenses were $1,593,638 for the year ended December 31, 2010 compared to $1,133,696 for the year ended December 31, 2009, representing an increase of $459,942. Research and development expenses for the year ending December 31, 2010 were higher than the same period for the previous year primarily due to an increase in salaries and research and development costs associated with iCo-007. Research and development expenses for year ended December 31, 2010 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, 2010 general and administrative expenses were $1,222,720 compared to $836,947 for the year ending December 31, 2009, representing an increase of $385,773. This increase in the year ended December 31, 2010 compared to the year ended December 31, 2009 was attributable to increased salaries and professional fees.
Amortization for the year ended December 31, 2010 was $117,555 compared to amortization of $116,845 for the year ended December 31, 2009.
Foreign exchange loss for the year ended December 31, 2010 was $24,928 compared to foreign exchange loss of $37,710 for the same period in 2009, representing a decrease of $12,782. 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, 2010 was $272,343 compared to $189,646 for the year ended December 31, 2009.
Liquidity and Outstanding Share Capital
As at December 31, 2010, we had cash and cash equivalents and short-term investments of $2,040,707 compared to $3,896,065 as at December 31, 2009. Surplus cash is invested in redeemable, short-term money market investments.
As at April 29, 2011, 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, moving into Phase 2 for the treatment of DME, iCo-008; a product with Phase 2 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 granted a license option for iCo-008 systemic uses to Immune Pharmaceuticals in December 2010. 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 is a Canada’s Top 10™ Competition winner. iCo trades on the TSX Venture Exchange under the symbol “ICO”. For more information, visit the Company website at: icotherapeutics.cdmail.biz.
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.