April 24, 2014, Vancouver, Canada — iCo Therapeutics (“iCo” or “the Company”) (TSX-V: ICO) (OTCQX: ICOTF), today reported financial results for the year ended December 31, 2013. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
“Our team, working with world-class retinal experts, was extremely pleased with 2013 clinical progress,” said Andrew Rae, President & CEO of iCo Therapeutics. “With respect to iCo-007, our lead candidate to treat diabetic macular edema, we announced a positive interim report at the beginning of the year and enrolled the final patient in the iDEAL study midyear. We also saw our partner advance iCo-008 into the clinic for ulcerative colitis. Our Oral Amphotericin B program strengthened its patent protection, received ethics approval and moved into in vitro testing for the targeting of latent HIV reservoirs. We also strengthened our balance sheet at the beginning of 2014 establishing our strongest cash balance in the company’s history, with a cash runway into the fourth quarter of 2015. We now look forward to announcing data from our Phase 2 iDEAL study for iCo-007. As this study has been physician sponsored, we need to understand certain time constraints and extensions that come with this partnered approach and as such now expect to announce the final results from the study in the current second quarter.”
2013 Financial & Operational Highlights
- 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.
- Presented at several investor conferences, including BIO CEO, Bloom Burton, Rodman & Renshaw, LD Micro, Ophthalmology Innovation Summit and the Jefferies Ophthalmic Therapeutic Summit.
- Completed overnight marketed offering of 9,655,771 units for aggregate gross proceeds of $3,379,519.90.
- Completed enrollment of the Phase 2 iDEAL study evaluating the efficacy and safety after repeated injections of iCo-007 in patients with DME.
- Announced that patent 8,592,382 was issued for Oral AmpB providing protection around oral delivery of the drug.
- Received ethics approval and moved the Oral AmpB program into in vitro testing with study partners in Montreal to examine the role of this formulation in targeting latent HIV reservoirs which remain in individuals despite enormous therapeutic advances in the treatment of HIV/AIDS.
- Announced that common shares of iCo Therapeutics began trading on the OTCQX International under the symbol “ICOTF.”
Subsequent Events to Year End
- Completed overnight marketed offering of 16,206,483 units for aggregate gross proceeds of $6,750,000.
- Announced the final month eight patient visit in the Phase 2 iDEAL Study evaluating the efficacy and safety of iCo-007 after repeated injections in patients with DME.
Summary Fiscal 2013 Results
iCo incurred a total comprehensive loss of $5,918,965 for the year ended December 31, 2013 compared to a total loss of $3,430,427 for the year ended 2012, representing an increase of $2,488,538. The increase in our net and comprehensive loss was principally caused by clinical trial costs associated with the iDEAL study.
Research and development expenses were $4,075,840 for the year ended December 31, 2013 compared to $2,287,148 for the year ended December 31, 2012, representing an increase of $1,788,692. This increase in research and development expenses is based mainly on clinical costs associated with the iDEAL study.
For the year ended December 31, 2013 general and administrative expenses were $2,061,405 compared to $1,374,710 for the year ending December 31, 2012, representing an increase of $686,695, principally due to stock based compensation expense for employees, directors and consultants.
Liquidity and Outstanding Share Capital
As at December 31, 2013, we had cash and cash equivalents and short-term investments of $1,903,389 compared to $1,260,196 as at December 31, 2012. The company also closed a unit offering on January 27, 2014, for gross proceeds of $6,750,000.
As at April 24, 2014, we had an unlimited number of authorized common shares with 84,457,713 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” and the OTCQX under the symbol “ICOTF”. For more information, visit the Company website at: www.icotherapeutics.com.
No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods and includes, but is not limited to, statements about the intended use of proceeds of the Offering. 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 are based only on information currently available to iCo and 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 and on its website, 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, except as required by law.
|Mr. John Meekison, CFO
604-602-9414 x 224
|Michael Moore, Investor Relations