IntelGenx Reports First Quarter 2023 Financial Results

IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the first quarter ended March 31, 2023. 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.

2023 First Quarter Financial Summary:

• Revenue was $162,000, compared to $237,000 in the 2022 first quarter.
• Net comprehensive loss was $2.9 million, compared to $3.0 million in Q1-2022.
• Adjusted EBITDA loss was $2.4 million, compared to $2.1 million in the 2022 first quarter.

First Quarter and Recent Developments:

• Received FDA approval of its RIZAFILM® VersaFilm® 505(b)(2) new drug application for the treatment of acute migraine.1
• Announced various changes to its management team. Its Board appointed Dwight Gorham as CEO, following the planned retirement of its founder and former-CEO, Dr. Horst G. Zerbe. Dr. David Kideckel, MBA, has been appointed as Senior Vice President, Head of Corporate Development and Strategic Alliances, and Tommy Kenny and Karen Kalayajian, CPA were promoted to Senior Vice President, General Counsel and Vice President, Finance and Administration of IntelGenx Corp., respectively.  
• Announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the submitted abbreviated new drug application (ANDA) for Buprenorphine Buccal Film. Xiromed’s CRL response is expected in the current quarter.
• Participated in the 35th Annual ROTH Conference and the 2023 Bloom Burton Conference.
• Received 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, Stockholm, 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. (“ARWAN”) in various countries in the Middle East and North Africa region.
• Extended the expiry date of warrants originally issued to Cantone Research Inc. on August 5, 2021 by an additional 12 months to August 4, 2024.

“IntelGenx had another eventful quarter highlighted by the achievement of a major milestone: the FDA’s approval of RIZAFILM® for the treatment of acute migraine,” commented Andre Godin, IntelGenx’s President and CFO. “We are working closely with our commercialization partner, Gensco® Pharma, to bring this convenient, fast-acting treatment to migraine sufferers across the United States. This program is also quickly gaining momentum outside of the U.S., as evidenced by our supply agreement earlier in the quarter with ARWAN for various countries in the Middle East and North Africa region.

“We were also pleased to partner with Dr. Svenningsson on his clinical study of Montelukast VersaFilm® for the treatment of Parkinson’s disease, the second most common neurodegenerative disorder after Alzheimer's disease, which is the indication for our ongoing Phase 2a ‘BUENA’ clinical trial. We are hopeful that Montelukast VersaFilm® will prove to be efficacious for both of these devastating indications, especially given an expected increase in prevalence due to an aging global population and paucity of effective treatments.”

1. RIZAFILM® (U.S. market name for RIZAPORT®) is a Registered Trademark of Gensco® Pharma Corporation

Financial Results:

Total revenues for the three-month period ended March 31, 2023 amounted to $162,000, a decrease of 32% compared to $237,000 for the three-month period ended March 31, 2022. The change is mainly attributable to decreases in R&D revenues of $63,000 and royalties on product sales of $12,000.

Operating costs and expenses were $2.8 million for the first quarter of 2023, versus $2.5 million for the corresponding three-month period of 2022. The change is mainly attributable to increases of $24,000 in R&D expenses, $2,000 in manufacturing expenses, and $211,000 in selling, general and administrative expenses, offset partially by decreases of $3,000 in depreciation of tangible assets.

For the first quarter of 2023, the Company had an operating loss of $2.6 million, compared to an operating loss of $2.3 million for the comparable period of 2022.

Net comprehensive loss for the three-month period ended March 31, 2023 was $2.9 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $3.0 million, or $0.02 per basic and diluted share, for the comparable period of 2022.

As at March 31, 2023, the Company's cash and short-term investments totalled $3.8 million.

Conference Call Details:

IntelGenx will host a conference call to discuss these first quarter 2023 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is [phone] (Canada and the United States) or (973) 528-011 (International), access code 655475. 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) [e-mail]

Or

Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.[phone] ext [e-mail]