SAINT LAURENT, Quebec, Nov. 07, 2019 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (IGX.V)(IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, today reported financial results for the third quarter ended September 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 Third Quarter Financial Summary:
- Revenue was $61,000, compared to $700,000 in the third quarter of 2018
- Adjusted EBITDA was ($2.3 million), unchanged from Q3-2018
- Cash and short-term investments totaled $4.3 million as at September 30, 2019 compared to $2.2 million as at September 30, 2018
- Received approval for prototype cannabis-infused VersaFilm® product from co-development partner, Tilray® (TLRY), and initiated manufacturing scale-up work
- Announced that its 505(b)(2) New Drug Application (“NDA”) for RIZAPORT® VersaFilm® for the treatment of acute migraines was accepted for review by the U.S. Food and Drug Administration (“FDA”) and that the FDA assigned a March 26, 2020, Prescription Drug User Fee Act (“PDUFA”) goal date for completion of the review
- Received a positive Data Safety Monitoring Board recommendation that the Company’s Montelukast VersaFilm® Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease continue
- Presented an overview of the Company’s business at the H.C. Wainwright 21st Annual Global Investment Conference
“In many respects, we are now just nearing the starting line with the anticipated commercialization of our two lead VersaFilm® products,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “The initiation of scale-up work for the cannabis-infused VersaFilm® product we are co-developing with our worldwide partner, Tilray®, and receipt of a PDUFA goal date for completion of the FDA’s review of the RIZAPORT® NDA, mark important milestones. We are looking forward to unveiling details about our cannabis-infused oral film as we approach product launch, and as always, to updating our stakeholders as we continue to make progress toward bringing our VersaFilm® products to market.”
Total revenues for the three-month period ended September 30, 2019 amounted to $61,000, compared to $700,000 for the three-month period ended September 30, 2018. The decrease is mainly attributable to a $639,000 decrease in Research and Development (“R&D”) revenues.
Operating costs and expenses were $2.6 million for the third quarter of 2019, versus $3.3 million for the corresponding three-month period of 2018. The decrease for the three-month period ended September 30, 2019 is mainly attributable to a $610,000 decrease in R&D expenses and a $153,000 decrease in Selling, General and Administrative expenses.
For the third quarter of 2019, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.6 million for the comparable period of 2018.
Net comprehensive loss for the three-month period ended September 30, 2019 was $2.9 million, or $0.03 on a basic and diluted per share basis, compared to $3.0 million, or $0.04 on a basic and diluted per share basis, for the comparable period of 2018.
As of September 30, 2019, the Company’s cash and short-term investments totalled $4.3 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2019 third quarter financial results today 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 5068946. 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