iCo Therapeutics announces corporate update and Q3 2014 financial results

Nov 29 2014

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 vitro effectiveness 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.