VANCOUVER, April 24, 2014 /PRNewswire/ - 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
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
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
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.
SOURCE iCo Therapeutics Inc.