Loxapine

SAINT LAURENT, Quebec, March 29, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the three- and twelve-month periods ended December 31, 2022. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise. "The progress we made throughout 2022 has led us to now being potentially on the cusp of a stage of anticipated rapid growth,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In April, we expect the FDA’s decisions on the Buprenorphine Buccal Film ANDA, as well as the RIZAFILM® NDA. On the development front, we are also looking forward to atai announcing topline results from its Phase 1 clinical trial of Buccal VLS-01, the first ever in-human clinical study evaluating an all thin film psychedelic drug candidate.” 2022 Fourth Quarter Financial Highlights: Revenue was $173,000, compared to $494,000 in the 2021 fourth quarter, mostly due to one-time licensing revenue received in 2021. Net comprehensive loss was $2.3 million, compared to $2.9 million in the 2021 fourth quarter. Adjusted EBITDA loss was $2.3 million, essentially unchanged from Q4-2021. 2022 Full-Year Financial Highlights: Revenue was $1.0 million, compared to $1.5 million in 2021, mostly due to one-time licensing revenue received in 2021. Net comprehensive loss was $11.6 million, compared to $9.8 million in 2021. Adjusted EBITDA loss was $8.5 million, compared to $7.1 million in 2021. Fourth Quarter and Recent Developments: Received a fourth and final term loan tranche in the amount of $3.0 million pursuant to the amended and restated secured loan agreement with the Company’s strategic partner, atai Life Sciences (“atai’). Closed a private placement offering of convertible notes due March 1, 2027 for aggregate gross proceeds of approximately $760,000 (C$1 million). Received from the U.S. Food and Drug Administration (‘FDA”) a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the Agency’s review of the 505(b)(2) New Drug Application (“NDA”) for RIZAFILM® VersaFilm®. Participated in the 35th Annual ROTH Conference in Dana Point, California. Granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form,” from the United States Patent and Trademark Office. Entered into a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm® for the treatment of Parkinson’s Disease. Entered into an exclusive supply agreement for RIZAPORT® with ARWAN Pharmaceuticals Industries Lebanon s.a.l. in various countries in the Middle East and North Africa region. Entered into a research collaboration with the University of Prince Edward Island to assess palatability, owner-perceived acceptability, and ease of administration of the Company’s VetaFilm™ platform in healthy dogs and cats. Financial Results: Total revenues for the three-month period ended December 31, 2022 amounted to $173,000, a decrease of $321,000, or 65%, compared to $494,000 for the three-month period ended December 31, 2021. The change is mainly attributable to decreases in revenues from licensing agreements of $249,000, R&D revenues of $43,000 and product revenues of $36,000, offset partially by an increase in royalties on product sales of $7,000. Operating costs and expenses were $2.7 million for the fourth quarter of 2022, versus $3.0 million for the corresponding three-month period of 2021. For Q4-2022, the Company had an operating loss of $2.5 million, essentially unchanged from the operating loss for the comparable period of 2021. Net comprehensive loss was $2.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2022, compared to net comprehensive loss of $2.9 million, or $0.02 per basic and diluted share, for the comparable period of 2021. Total revenues for the twelve-month period ended December 31, 2022 amounted to $1.0 million, representing a decrease of $585,000, or 38%, compared to $1.5 million for the year ended December 31, 2021. Operating costs and expenses were $10.4 million for the full year 2022, versus $9.5 million for the corresponding twelve-month period of 2021. For the twelve-month period of 2022, the Company had an operating loss of $9.4 million, compared to an operating loss of $8.0 million for the comparable period of 2021. Net comprehensive loss was $11.6 million, or $0.07 per basic and diluted share, for the twelve-month period of 2022, compared to net comprehensive loss of $9.8 million, or $0.07 per basic and diluted share, for the comparable period of 2021. As at December 31, 2022, the Company's cash and short-term investments totalled $2.5 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in January 2023, nor the $760,000 in gross proceeds from the private placement offering of convertible notes, which closed in March 2023. Annual Filings: The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2022, as well as the 2023 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 29, 2023. Conference Call Details: IntelGenx will host a conference call to discuss these 2022 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0062 (Canada and the United States) or (973) 528-0011 (International); access code 884881. The call will be also be webcast live and archived on the Company's website at under "Webcasts" 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®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers 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 . Forward-Looking Information and 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 , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com