On August 8, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, reported financial results for the second quarter ended June 30, 2019 (Press release, IntelGenx, AUG 8, 2019, View Source [SID1234538500]). 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.
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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.