VANCOUVER, Canada — iCo Therapeutics Inc. (TSX-V: ICO) (the “Company”) today reported operational and financial results for the second quarter ending June 30, 2010. Amounts, unless specified otherwise, are expressed in Canadian dollars and in accordance with Canadian Generally Accepted Accounting Principles (Canadian GAAP).
Q2 2010 Operating Highlights
The second quarter of 2010 was marked by the following highlights:
Corporate
– On April 12, 2010 we announced that the Company was awarded the Early Stage Company of the Year: Health 2010 Gold Leaf Award by BIOTECanada, the national voice of biotechnology in Canada. The award was presented to iCo Therapeutics on May 4, 2010 at the BIO 2010 International Convention in Chicago, Illinois.
– Announced on April 28, 2010, that Susan Koppy had agreed to join the Company to spearhead our iCo-007 out-licensing activities, supplementing the business development efforts of the executive team. Based in San Francisco, California, Ms. Koppy is a senior pharmaceutical business development executive with over 20 years’ experience in global biotechnology and pharmaceutical companies in the United States, Europe and Japan.
iCo- 007
– On May 17, 2010, we announced the results from the Phase I trial for iCo-007 as presented in the final study report for the Phase I trial. The trial met its primary endpoint and the intravitreal injections of iCo-007 were well tolerated. iCo-007 exhibited a good safety profile and we ultimately progressed to the maximum planned dosage of 1000 µg based on positive safety evaluation committee meetings which took place two months after each dosing level. Analysis of blood plasma in patients demonstrated that iCo-007 was not detectable in the blood plasma with any of the doses used in the Phase I trial. There were signs of biological activity in responsive patients at 24 weeks with a reduction of retinal thickness ranging between 149 and 743 microns (and 115 to 743 microns if one additional patient followed only to week 18 is included). Mean change in retinal thickness for all patients completing the 24 week follow-up (12 of 15 patients) was minus 169 microns (or 40% reduction of excess retinal thickness), a positive trend. In a number of subjects there was a transient increase in retinal edema preceding biological effect. Approximately 69% of patients completing a 24 week follow up (13 of 15 patients) had stable or improved vision, defined as -5 letters or better compared to baseline and 23% of patients experienced >5 letters of visual improvement. It should be noted that due to the small number of patients enrolled in the study (n=15) these results are not statistically significant nor can statistical significance be inferred.
– On May 25, 2010, we announced that iCo entered into a Technology Transfer Agreement with Isis Pharmaceuticals, Inc. (“Isis”) to transfer certain technology related to the manufacture of iCo-007 to iCo in support of producing clinical grade drug product for iCo’s planned Phase II clinical program. In consideration for the technology transfer, iCo issued a warrant (the “Warrant”) to Isis to purchase 235,000 shares of iCo’s Common Stock at an exercise price of $0.61. The Warrant will have a term of two years expiring May 16, 2012.
– On April 23, 2010, the Company’s Phase I clinical trial study employing iCo-007 in Diffuse Diabetic Macular Edema (“DME”) was highlighted in a presentation at the Retinal Physician Symposium 2010. The presentation was made by David S. Boyer, MD at the Atlantis Paradise Island Resort in the Bahamas and featured prominent scientists, clinicians and healthcare experts in retina care presenting new therapies and treatment strategies for retinal diseases.
Subsequent Events
– On July 26, 2010, we announced that we had received a no objection letter from the Therapeutics Products Directorate, a division of Health Canada, to conduct a Phase II clinical study in Diabetic Macular Edema with iCo-007.
Q2 2010 Financial Highlights
We incurred a net and comprehensive loss of $803,932 for the three months ended June 30, 2010 compared to a net and comprehensive loss of $556,886 for the three months ended June 30 2009, representing an increase of approximately $247,046. The increase in our net and comprehensive loss was principally caused by an increase in both research and development expenses and professional fees.
Interest income for the three months ended June 30, 2010 was $6,975, compared to $621 for the three month period ending June 30, 2009, resulting in an increase of $6,354. The higher interest income earned in the three month period ending June 30, 2010, as compared to the three month period in 2009 was a result of higher cash and short term investments balances held in our treasury in 2010.
Research and development expenses were $432,924 for the three months ended June 30, 2010 compared to $280,116 for the three months ended June 30, 2009, representing an increase of $152,808. This increase in the three months ending June 30, 2010 compared to the three months ending June 30, 2009 were attributable to a higher personnel expenses and consultants’ fees.
For the three months ended June 30, 2010 general and administrative expenses were $281,210 compared to $201,940 for the three months ending June 30, 2009, representing an increase of $79,270. This increase in the three months ending June 30, 2010 compared to the three months ending June 30, 2009 were attributable to increases in personnel salaries and professional fees.
Amortization for the three months ended June 30, 2010 was $29,333 compared to amortization of $28,825 for the three months ended June 30, 2009, an increase of $508.
Foreign exchange loss for the three months ended June 30, 2010 was $10,909 compared to foreign exchange loss of $8,918 for the same period in 2009, representing an increase of $1,991.
Stock based compensation for the three months ended June 30, 2010 was $56,531compared to $37,708 for the three months ended June 30, 2009, an increase of $18,823.
Liquidity and Outstanding Share Capital
As at June 30, 2010, we had cash and cash equivalents of $3,257,661 compared to $3,896,065 as at December 31, 2009. As at June 30, 2010, the Company had working capital of $3,091,655 compared to $3,630,719 as at December 31, 2009.
As at August 27, 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: 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.