Mr. Andre Godin reports

INTELGENX REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS

IntelGenx Technologies Corp. has release its 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 (GAAP) except where noted otherwise.

2023 first quarter financial summary:

• Revenue was $162,000, compared with $237,000 in the 2022 first quarter.
• Net comprehensive loss was $2.9-million, compared with $3.0-million in Q1 2022.
• Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) loss was $2.4-million, compared with $2.1-million in the 2022 first quarter.

First quarter and recent developments:

• Received U.S. Food and Drug Administration (FDA) approval of its RizaFilm VersaFilm 505(b)(2) new drug application for the treatment of acute migraine;
• Announced various changes to its management team. The board appointed Dwight Gorham as chief executive officer, following the planned retirement of its founder and former chief executive officer, Dr. Horst G. Zerbe. Dr. David Kideckel, MBA, has been appointed as senior vice-president, head of corporate development and strategic partnerships, and Tommy Kenny and Karen Kalayajian, CPA, were promoted to senior vice-president, general counsel, and vice-president, finance and administration, of IntelGenx, respectively;
• Announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC, received a complete response letter (CRL) from the 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. in various countries in the Middle East and North Africa region;
• Extended the expiry date of warrants originally issued to Cantone Research Inc. on Aug. 5, 2021, by an additional 12 months to Aug. 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 chief financial officer. "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."

Financial results

Total revenues for the three-month period ended March 31, 2023, amounted to $162,000, a decrease of 32 per cent compared with $237,000 for the three-month period ended March 31, 2022. The change is mainly attributable to decreases in R&D (research and development) 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 with 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 two cents per basic and diluted share, compared with net comprehensive loss of $3.0-million, or two cents 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 888-506-0062 (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 under webcasts in the investors section.

About IntelGenx Technologies Corp.

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-scale and commercial-scale production.

We seek Safe Harbor.