IGX Intelgenx Technologies Corp

IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the third quarter ended September 30, 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.

2022 Third Quarter Financial Summary:

• Revenue was $142,000, compared to $593,000 in the 2021 third quarter.
• Net comprehensive loss was $3.0 million, compared to $2.2 million in Q3-2021.
• Adjusted EBITDA loss was $2.2 million, compared to $1.4 million in the 2021 third quarter.

Third Quarter and Recent Developments:

• Filed a provisional patent application with the United States Patent and Trademark Office entitled “Advanced Oral Film Formulations,” containing new inventive claims with respect to administering cannabinoids for quicker onset of action.
• Announced that its previously undisclosed development candidate, Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) had been filed by Chemo Research SL (“Chemo”) through its agent and affiliate Xiromed LLC, received a U.S. Food and Drug Administration (“FDA”) Generic Drug User Fee Act (“GDUFA”) date of April 28, 2023.
• Was granted U.S. Patent No. 11,471,406, with claims for modulating drug absorption in oral film dosage form designed for sublingual administration of various pharmaceuticals, including some cannabinoids.
• Submitted response to the FDA’s March 2020 Complete Response Letter for its 505(b)(2) New Drug Application for RIZAFILM® (formerly RIZAPORT®) VersaFilm®.1
• Saw the Company’s collaboration with atai Life Sciences culminate in the initiation of the first-ever in-human clinical study of an oral thin film psychedelic drug candidate.
• Reached the halfway mark in patient enrollment in the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease.

“The third quarter was a productive one for IntelGenx, marked by the achievement of several development milestones and the strengthening of our patent portfolio,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our ongoing BUENA trial reached the halfway patient enrollment mark, while our partnership with Chemo resulted in the assignment of a GDUFA date during the second quarter of next year. Subsequent to quarter end, we achieved a significant milestone with atai’s commencement of the first-ever in-human clinical study of a psychedelic administered via oral film. We are looking forward to the first half of 2023, when we expect the results of atai’s Phase 1 trial and the FDA’s decision on the Buprenorphine Buccal Film ANDA.”

1. RIZAFILM® is a Registered Trademark of Gensco® Pharma Corporation

Financial Results:

Total revenues for the three-month period ended September 30, 2022 amounted to $142,000, a decrease of 76% compared to $593,000 for the three-month period ended September 30, 2021. The change is mainly attributable to decreases in sales milestone revenues of $320,000 and R&D revenues of $141,000, partially offset by increases in product revenues of $9,000 and royalties on product sales of $1,000.

Operating costs and expenses were $2.5 million for the third quarter of 2022, versus $2.2 million for the corresponding three-month period of 2021. The change is mainly attributable to increases of $542,000 in selling, general and administrative expenses which is mainly attributable to the Canadian Dollar devaluation, offset partially by decreases of $170,000 in R&D expenses, $70,000 in manufacturing expenses, and $3,000 in depreciation of tangible assets.

For the third quarter of 2022, the Company had an operating loss of $2.4 million, compared to an operating loss of $1.6 million for the comparable period of 2021.

Net comprehensive loss for the three-month period ended September 30, 2022 was $3.0 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $2.2 million, or $0.01 per basic and diluted share, for the comparable period of 2021.

As at September 30, 2022, the Company's cash and short-term investments totalled $4.7 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these third quarter 2022 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (844) 369-8770 (Canada and the United States) and (862) 298-0840 (International), access code INTELGENX. The call will also be webcast live and archived on the Company's website at www.intelgenx.com 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 www.intelgenx.com.

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 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.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen KilmerInvestor Relations(647) 872-4849stephen@kilmerlucas.com

Or

Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514) 331-7440 ext 203andre@intelgenx.com