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 second quarter."
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 iCo-007.
- 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 HIV/AIDS.
- 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.