IntelGenx Reports Second Quarter 2023 Financial Results

SAINT LAURENT, Quebec, Aug. 14, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the second quarter ended June 30, 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 Second Quarter Financial Summary:

• Revenue was $133,000, compared to $398,000 in the 2022 second quarter.
• Net comprehensive loss was $3.0 million, compared to $3.2 million in Q2-2022.
• Adjusted EBITDA loss was $2.2 million, compared to $2.0 million in the 2022 second quarter.
  

Second 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.¹
• Unveiled a number of short-term commercial objectives with the aim of maximizing long-term shareholder value, including: continuing to expand IntelGenx's core CDMO business; taking next steps to commercialize VetaFilm; and supporting the commercial launch of RIZAFILM in the United States and the continued commercialization of RIZAPORT in Spain.
• In the first major expansion of the Company’s CDMO business, entered into a binding term sheet agreement for the packaging of a pharmaceutical oral film product that its undisclosed CDMO customer is planning to commercialize in the United States. This is expected to generate approximately $9 million in revenue for IntelGenx over three years.
• Announced receipt of an amended Drug Establishment License from Health Canada, allowing the Company to conduct third-party testing.
• Announced various changes to its Board and Management team, including: the resignation of Board Director, J. Bernard Boudreau; the appointment of Dwight Gorham as CEO; the appointment of Dr. David Kideckel, MBA, as Senior Vice President, Head of Corporate Development and Strategic Alliances of IntelGenx Corp.; and the promotions of Tommy Kenny to Senior Vice President, General Counsel, and Karen Kalayajian, CPA to Vice President, Finance and Administration of IntelGenx Corp.
• Completed patient enrollment in the ongoing Montelukast VersaFilm Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (AD).
• Provided an update on its research collaboration with Karolinska University Hospital and Per Svenningsson, MD, PhD, pursuant to which the parties are planning to conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm for the treatment of Parkinson's Disease (PD).
• 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.

“We reached another major milestone this quarter with the completion of enrollment in our BUENA study,” commented Mr. Gorham. “With a Health Canada-authorized study design modification, we can utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukast VersaFilm compared to placebo. This modification will enable us to complete the trial in the first quarter of 2024 and we look forward to reporting initial trial results the following quarter.