VANCOUVER, Nov. 28, 2014 /PRNewswire/ - 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.
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.
SOURCE iCo Therapeutics Inc.