SAINT LAURENT, Quebec, Aug. 08, 2019 (GLOBE NEWSWIRE) -- 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
- 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.”
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.
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:
(514) 331-7440 ext 232
Andre Godin, CPA, CA
President and CFO
(514) 331-7440 ext 203