November 28, 2014, Vancouver, Canada — iCo Therapeutics (“iCo” or “the Company”) (TSX-V: ICO) (OTCQX: ICOTF), today reported financial results for the nine months ended September 30, 2014. Amounts, unless specified otherwise, are expressed in Canadian dollars and presented under International Financial Reporting Standards (“IFRS”).
Management also announced that it has wound down its Phase 2 diabetic macular edema (“DME”) activities related to iCo-007. iCo will continue to investigate other potential use indications for its licensed technology, which targets the C-Raf kinase pathway.
“The Phase 2 iCo-007 DME data that has been presented, along with our internal analysis, has not demonstrated any subgroup response rates that warrant further financial investment by iCo in the DME program at this time,” said Andrew Rae, President & CEO of iCo Therapeutics. “Since day one at iCo, we have been focused on redefining existing drug candidates for new or expanded use indications. We continue with that same model as we prepare for an oral Amphotericin B (“Oral AmpB”) clinical study, while concurrently investigating the ability to expand our proprietary oral delivery platform and assessing complimentary assets which the Company may consider in-licensing or acquiring.”
Management continues to anticipate additional Bertilimumab (iCo-008) Phase 2 clinical data related to ulcerative colitis and bullous pemphigoid, based on the guidance provided by its NASDAQ-listed partner Immune Pharmaceuticals. iCo currently owns 654,486 shares and 123,649 warrants of Immune Pharmaceuticals [NASDAQ: IMNP] and the opportunity to earn up to $32M in milestone payments as its partner progresses through clinical milestones.
Third Quarter 2014 Highlights
- Reported results of its Oral AmpB drug candidate targeting latent HIV reservoirs. The study evaluated in vitroeffectiveness of Oral AmpB in reactivating latent HIV viral reservoirs which remain present in individuals despite intensive treatment with antiretroviral therapy.
Subsequent Events to Quarter End
- Announced plans to complete pre-clinical studies and regulatory filings in preparation for moving Oral AmpB into an initial Phase 1A clinical trial. The program will utilize approximately $700,000 of funding and technological advice from the National Research Council of Canada Industrial Research Assistance Program (NRC-RAP), under the Canadian HIV Technology Development (CHTD) Program.
- Presented findings on the Company’s Oral AmpB program at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition held in San Diego.
Summary Third Quarter 2014 Results
iCo incurred total comprehensive loss of $1,223,363 (loss per share of $0.02) for the nine months ended September 30, 2014 compared to a total comprehensive loss of $5,220,617 (loss per share of $0.07) for the nine months ended September 30, 2013, representing a decrease of $3,997,254 in comprehensive loss. The decrease in net comprehensive loss is primarily a result of an 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 $1,112,007 for the nine months ended September 30, 2014 compared to $3,558,167 for the nine months ended September 30, 2013, representing a reduction of $2,446,160. This decrease in research and development expenses is based mainly on reduced expenses associated with the iDEAL study.
For the nine months ended September 30, 2014 general and administrative expenses were $1,264,070 compared to $1,589,172 for the nine months ending September 30, 2013, representing a decrease of $325,102, primarily as a result of reduced stock based compensation expense and professional fees.
Liquidity and Outstanding Share Capital
As at September 30, 2014, we had cash and cash equivalents and short-term investments of $5,729,313.
As at November 28, 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, Bertilimumab (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.