iCo Therapeutics Announces Third Quarter 2013 Financial Results

November 27, 2013, Vancouver, Canada—iCo Therapeutics (TSX-V: ICO), today reported financial results for the quarter ended September 30, 2013. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).

“While the past quarter was quiet from a news flow perspective, we were very busy following the completion of enrollment of the iDEAL Study in June,” said Andrew Rae, iCo’s President & CEO. “The completion of enrollment initiated the countdown to our primary endpoint for the study: eight month visual acuity as compared to baseline, and we expect to announce this in March or April. This is a very large phase two study in diabetic macular edema that has to date demonstrated a strong safety profile, with no drug-related serious adverse events and will represent the largest value inflection point in the company’s history.”

Third Quarter 2013 Financial & Operational Highlights

  • Presented at the Rodman & Renshaw 2013 Annual Global Investment Conference. More than 200 public and private companies from around the world presented in front of an audience of over 1,500 attendees

Subsequent Highlights

  • Announced management’s presentation at the 5th Annual Ophthalmology Innovation Summit – an invitation only corporate presentation, highlighting the Company’s Phase 2 iDEAL Study for diabetic macular edema to a who’s who of the ophthalmology space
  • Announced the exercise of 3,207,000 warrants from the November 1st 2011 financing which were exercisable at $0.30 and due on November 1, 2013, for total proceeds of approximately of $962,000

Summary Third Quarter 2013 Results
iCo incurred a net and comprehensive loss of $5,220,617 for the nine months ended September 30, 2013, compared to a net and comprehensive loss of $2,335,886 for the same period last year. The increase was driven primarily by costs associated with the Phase 2 clinical trial, a loss in the fair value of our investment in Immune Pharmaceuticals Inc. (“IMMUNE”) as well as share based compensation. This was partially offset by the gain on the value of our IMMUNE warrants in other investments.

Research and development expenses were $3,558,167 for the nine months ended September 30, 2013 compared to $1,321,383 for the same period last year, representing an increase of $2,236,784. This increase in research and development expenses is due to higher costs relating to the iDEAL Phase 2 clinical trial.

General and administrative expenses primarily comprise salaries, stock based compensation and benefits for company employees not involved in research and development, professional fees such as legal and accounting expenses, and expenses related to office overheads. For the nine months ended September 30, 2013 general and administrative expenses were $1,589,172 compared to $1,020,091 for the nine months ending September 30, 2012, representing an increase of $569,081. The higher expenses are due to increased stock based compensation and professional fees.

Liquidity and Outstanding Share Capital
As at September 30, 2013, we had cash and cash equivalents and short-term investments of $2,143,000 compared to $1,260,196 as at December 31, 2012. This does not include the exercise of warrants subsequent to the end of our third quarter.

As at November 27, 2013, we had an unlimited number of authorized common shares with 67,811,230 common shares issued and outstanding and 15,765,918 warrants outstanding with exercise prices ranging between $0.40 and $0.60 and expiry dates ranging from July 4, 2014 to May 17, 2018.

As at November 27, 2013, we had 2,965,000 options outstanding. Each option entitles the holder to purchase one additional common share at exercise prices ranging from $0.18 to $0.73 and expiry dates ranging from February 14, 2014 to September 5, 2018.

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: 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 statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. 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. 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.

iCo Therapeutics
604-602-9414 x 224