IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the
"Company" or "IntelGenx"), a leader in pharmaceutical films, today
reported financial results for the second quarter ended June
30, 2019. All dollar amounts are expressed in U.S. currency and
results are reported in accordance with United
States generally accepted accounting principles except where
noted otherwise.
2019 Second Quarter Financial
Summary:
- Revenue was $197,000, compared
to $234,000 in the second quarter of 2018
- Adjusted EBITDA was ($2.1
million), compared to ($1.9 million) in Q2-2018
- Cash and short-term investments
totaled $6.1 million as at June 30, 2019 compared to
$3.7 million in Q2-2018
Recent Developments:
- Received its first shipment of cannabis extract from Tilray,
Inc. (NASDAQ:TLRY) (“Tilray®”), providing sufficient quantities for
ongoing R&D batch production of cannabis-infused
VersaFilm®.
- In connection with its ongoing Montelukast clinical program,
announced that a poster, entitled “The BUENA Study: A Phase 2a
Clinical Trial to Test Safety and Efficacy of Montelukast
VersaFilm® in Alzheimer’s Patients,” will be presented in
collaboration with Prof. Dr. Ludwig Aigner’s group from the
Paracelsus Medical University in Salzburg at the 12th edition of
Clinical Trials on Alzheimer’s Disease (CTAD2019), to be held in
San Diego, California, from December 4-7, 2019.
- Entered into a definitive worldwide agreement with Aquestive
Therapeutics, Inc. (NASDAQ:AQST) for the co-development and
commercialization of Tadalafil oral films for the treatment of
erectile dysfunction.
- Filed a non-provisional U.S. patent application for
newly-developed platform that enables the incorporation of
oil-based (lipophilic) active ingredients into oral film
formulations.
- Received a second U.S. Patent for its topical oral film
technology platform.
- Company remains on track to resubmit the RIZAPORT® new drug
application in Q3, which will address the questions contained in
the U.S. Food and Drug Administration’s Complete Response letter
IntelGenx received in Q2.
- Promoted its oral films CDMO services at CPhI North America and
received significant interest from potential partners for the
development and manufacture of novel oral film products based on
its proprietary VersaFilm® technology platform.
“We made progress on two key VersaFilm® programs
recently, with the addition of BUENA clinical trial sites in Ottawa
and Peterborough, and the commencement of cannabis-infused
VersaFilm® R&D production as part of our worldwide partnership
with Tilray®,” commented Dr. Horst G. Zerbe, CEO
of IntelGenx. “We believe our oral cannabis-infused films
offer a discrete, precise and convenient option for adult-use and
medical cannabis consumers, putting IntelGenx in a strong position
among the many other companies preparing to launch edible cannabis
products soon after their legalization in Canada later this year.
Now approaching a period of anticipated growth, we look forward to
updating our stakeholders as we continue to make progress towards
bringing these and other VersaFilm® products to market.”
Financial Results:
Total revenues for the three-month period
ended June 30, 2019 amounted to $197,000, a decrease
of $37,000 compared to $234,000 for the three-month
period ended June 30, 2018. The decrease is mainly
attributable to the $37,000 decrease in R&D revenues.
Operating costs and expenses were $2.5 million
for the second quarter of 2019, versus $2.4 million for the
corresponding three-month period of 2018. The increase for the
three-month period ended June 30, 2019 is mainly
attributable to a $325,000 increase in R&D expenses
primarily related to the Montelukast clinical program.
For the second quarter of 2019, the Company had
an operating loss of $2.3 million, compared to an operating loss of
$2.1 million for the comparable period of 2018.
Net comprehensive loss for the three-month
period ended June 30, 2019 was $2.5 million,
or $0.03 on a basic and diluted per share basis, compared
to $2.4 million, or $0.04 on a basic and diluted per share
basis, for the comparable period of 2018.
As of June 30, 2019, the Company’s cash and
short-term investments totalled $6.1 million.
Conference Call Details:
IntelGenx will host a conference call to
discuss these 2019 second quarter financial results today
on August 8, 2019, at 4:30 p.m. ET. The dial-in number
for the conference call is (833) 231-8269
(Canada and United States) or (647) 689-4114
(International), conference ID 5684153. A live and archived webcast
of the call will be available on IntelGenx’s website at
www.intelgenx.com under “Presentations” in the Investors
section.
About IntelGenx:
IntelGenx is a leading drug delivery company
focused on the development and manufacturing of pharmaceutical
films.
IntelGenx’s superior film technologies,
including VersaFilm®, VetaFilm™ and transdermal, allow for next
generation pharmaceutical products that address unmet medical
needs. IntelGenx’s innovative product pipeline offer significant
benefits to patients and physicians for many therapeutic
conditions.
IntelGenx's highly skilled team provides
comprehensive pharmaceuticals services to pharmaceutical partners,
including R&D, analytical method development, clinical
monitoring, IP and regulatory services. IntelGenx's
state-of-the-art manufacturing facility offers full service by
providing lab-scale to pilot- and commercial-scale production. For
more information, visit www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking
information about IntelGenx's 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's 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's 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's annual report on Form
10-K, filed with the United States Securities and Exchange
Commission and available at www.sec.gov, and also filed with
Canadian securities regulatory authorities at www.sedar.com.
IntelGenx assumes no obligation to update any such forward-looking
statements.
Each of the TSX Venture Exchange and OTCQX has
neither approved nor disapproved the contents of this press
release. Neither TSX Venture Exchange nor its Regulation
Services Provider (as that term is defined in the policies of the
TSX Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Source: IntelGenx Technologies Corp.
For more information, please
contact:
Stephen KilmerInvestor Relations (514) 331-7440
ext 232stephen@intelgenx.com
Or
Andre Godin, CPA, CAPresident and CFOIntelGenx
Corp.(514) 331-7440 ext 203andre@intelgenx.com
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