August 29, 2014, Vancouver, Canada â€” iCo Therapeutics (“iCo” or “the Company”) (TSX-V: ICO) (OTCQX: ICOTF), today reported financial results for the six months ended June 30, 2014. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
Second Quarter 2014 Highlights
- Announced top-line results related to the eight month visual acuity (VA) primary endpoint for subjects enrolled in the Phase 2 iDEAL Study evaluating the efficacy and safety of iCo-007 after repeated injections in patients with DME. Further data analysis at twelve months including secondary endpoints and sub-group patient populations will be announced in the next two months.
- Poster presentation by research collaborators at the Association of Research and Ophthalmology (ARVO) 2014 Annual Meeting titled “Demographics and Baseline Characteristics of the iDEAL Study: A Randomized, Multi-center, Phase II Study of the safety, Tolerability, and Bioactivity of Repeated Intravitreal Injections of iCO-007 as Monotherapy or in Combination with Ranibizumab or Laser Photocoagulation in the Treatment of Diabetic Macular Edema with Involvement of the FoveAL Center”.
Subsequent Events to Quarter End
- Announced that all nominees listed in the management information circular dated May 28, 2014 were elected as directors of the Company at the 2014 Annual Meeting of Shareholders, held on Friday, June 27, 2014.
- Reported results of its Oral Amphotericin B (Oral Amp B) drug candidate targeting latent HIV reservoirs The study, conducted by ImmuneCartaÂ®, the immune monitoring business unit of Caprion, evaluated in vitro effectiveness of Oral Amp B in reactivating latent HIV viral reservoirs which remain present in individuals despite intensive treatment with antiretroviral therapy.
Summary Second Quarter 2014 Results
iCo incurred total comprehensive loss of $1,617,040 (loss per share of $0.02) for the six months ended June 30, 2014 compared to a total comprehensive loss of $2,886,831 (loss per share of $0.05) for the six months ended June 30, 2013, representing a decrease of $1,269,791 in comprehensive loss. The decrease in net comprehensive loss is primarily a result of a $259,755 increase in the carrying value of our investment in Immune Pharmaceuticals, as well as a decrease in expenses associated with the iDEAL trial.
Research and development expenses were $1,026,287 for the six months ended June 30, 2014 compared to $2,189,830 for the six months ended June 30, 2013, representing a reduction of $1,163,543. This decrease in research and development expenses is based mainly on reduced expenses associated with the iDEAL study.
For the six months ended June 30, 2014 general and administrative expenses were $935,374 compared to $1,166,480 for the six months ending June 30, 2013, representing a decrease of $231,106, primarily as a result of reduced stock based compensation expense and professional fees.
Liquidity and Outstanding Share Capital
As at June 30, 2014, we had cash and cash equivalents and short-term investments of $6,480,200.
As at August 29, 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.