IntelGenx Technologies Corp. (TSX VENTURE: IGX)(OTCBB: IGXT)
("IntelGenx") today announced its financial results for the three
and six month periods ended June 30, 2011 and highlighted recent
business developments. All amounts are in U.S. dollars, unless
otherwise stated.
"We had a very busy second quarter, completing fundraising
activities to raise over $3 million, filing the resubmission of our
NDA 505(b)(2) as required for the approval of our lead product
CPI-300, successfully completing another bio-study for a VersaFilm
product for insomnia and executing a term-sheet with RedHill
Biopharma to co-develop and license our anti-psychotic oral thin
film," commented Dr. Horst G. Zerbe, President and Chief Executive
Officer of IntelGenx. "Another major milestone in our goal to
commercialize CPI-300 was recently realised when Pillar5 Pharma
passed a pre-approval inspection by the FDA and we now look forward
to the FDA's response targeted for November 13, 2011."
RECENT DEVELOPMENTS:
Financing:
On June 22, 2011, we announced the closing of two concurrent
private placement offerings in the U.S. and Canada. We issued
approximately 4.8 million shares of common stock at $0.67 per share
and three-year warrants to purchase up to approximately 2.4 million
shares of common stock at an exercise price of US$0.74 per share,
for aggregate gross proceeds of approximately US$3.2 million. We
intend to use the net proceeds to support our strategic development
projects and for working capital.
Subsequent to the end of the second quarter, warrants and stock
options have been exercised for a total of 920,652 common shares
for cash consideration of approximately $0.5 million.
CPI-300 Antidepressant Tablet:
On May 16, 2011, we announced that we had submitted our reply to
the Complete Response Letter ("CRL") issued in February 2010, by
the FDA, and on June 14, 2011, we announced that the FDA has
accepted the resubmission of our NDA 505(b)(2) in response to the
CRL. In addition, the FDA has established November 13, 2011, as its
target action date under the Prescription Drug User Fee Act
("PDUFA").
Subsequent to the end of the quarter, on August 2, 2011, we
announced that Pillar5 Pharma Inc. ("Pillar5") successfully passed
a pre-approval inspection by the FDA for CPI-300. Pillar5, the
contract manufacturing organization ("CMO") selected by IntelGenx
for the manufacture of CPI-300, successfully responded to all
queries from the FDA for its pre-approval site inspection.
Anti-Psychotic Film:
On February 7, 2011, we announced the completion of a pilot
study that indicates we have successfully developed a novel oral
film, INT0022, which is likely to be bioequivalent to a leading
anti-psychotic in a pivotal bioequivalency study. INT0022 has been
developed using our proprietary immediate release "VersaFilm" drug
delivery technology.
On June 14, 2011, we announced the execution of a binding
term-sheet with RedHill Biopharma Ltd. ("RedHill"), an Israeli
corporation, to co-develop and license our anti-psychotic oral thin
film. The term-sheet sets forth the main criteria to be
incorporated into a license agreement, under which RedHill would
obtain exclusive worldwide rights to market and sell our rapidly
dissolving anti-psychotic oral film product. In exchange, we would
receive upfront, milestone and external development fees totalling
up to U.S.$2.3 million from RedHill. Upon commercialization of the
product, we would receive up to 50% of all proceeds including all
sales milestones and income from the product world-wide.
Insomnia Film:
On April 6, 2011, we announced the completion of a pilot
biostudy indicating that we have developed a novel oral film,
INT0020, which suggests bioequivalency to a leading branded product
for the treatment of insomnia. INT0020 has been developed using our
proprietary immediate release "VersaFilm" drug delivery
technology.
FINANCIAL HIGHLIGHTS:
U.S. $ Millions except Per Share Data
--------------------------------------------
As of six month period ended:
June 30, 2011 June 30, 2010
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Cash Equivalents $ 3.2 $ 0.4
Revenue $ 0.1 $ 0.3
Expenses $ 1.3 $ 2.0
Net Loss $ 1.2 $ 1.7
Loss Per Share $ 0.03 $ 0.05
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About IntelGenx:
IntelGenx is a drug delivery company focused on the development
of oral controlled-release products as well as novel rapidly
disintegrating delivery systems. IntelGenx uses its unique multiple
layer delivery system to provide zero-order release of active drugs
in the gastrointestinal tract. IntelGenx has also developed novel
delivery technologies for the rapid delivery of pharmaceutically
active substances in the oral cavity based on its experience with
rapidly disintegrating films. IntelGenx' research and development
pipeline includes products for the treatment of severe depression,
hypertension, erectile dysfunction, benign prostatic hyperplasia,
migraine, insomnia, bipolar disorder, idiopathic pulmonary
fibrosis, allergies and pain management. More information is
available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about
IntelGenx' operating results and business prospects that involve
substantial risks and uncertainties. Statements that are not purely
historical are forward-looking statements within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended. These
statements include, but are not limited to, statements about
IntelGenx' plans, objectives, expectations, strategies, intentions
or other characterizations of future events or circumstances and
are generally identified by the words "may," "expects,"
"anticipates," "intends," "plans," "believes," "seeks,"
"estimates," "could," "would," and similar expressions. All forward
looking statements are expressly qualified in their entirety by
this cautionary statement. Because these forward-looking statements
are subject to a number of risks and uncertainties, IntelGenx'
actual results could differ materially from those expressed or
implied by these forward looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to, those discussed under the heading "Risk Factors" in
IntelGenx' annual report on Form 10-K for the fiscal year ended
December 31, 2010, filed with the United States Securities and
Exchange Commission and available at www.sec.gov, and also filed
with Canadian securities regulatory authorities and www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTC Bulletin Board has
neither approved nor disapproved the contents of this press
release.
Contacts: IntelGenx Technologies Corp. Dr. Horst G. Zerbe
President and CEO +1 514-331-7440 (ext. 201) +1 514-331-0436 (FAX)
horst@intelgenx.com www.intelgenx.com
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