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.
"We also executed on the short-term commercial objectives we announced during the quarter by entering into a binding term sheet agreement with a CDMO customer for our oral film packaging services. Expected to generate approximately $9 million over three years, this agreement will provide an important revenue stream for IntelGenx as we continue to execute on our growth strategy."
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 June 30, 2023 amounted to $133,000, a decrease of 67% compared to $398,000 for the three-month period ended June 30, 2022. The change is mainly attributable to decreases in R&D revenues of $260,000 and royalties on product sales of $5,000.
Operating costs and expenses were $2.7 million for the second quarter of 2023, versus $2.6 million for the corresponding three-month period of 2022. The change is mainly attributable to increases of $27,000 in R&D expenses and $101,000 in selling, general and administrative expenses, offset partially by decreases of $45,000 in manufacturing expenses and $1,000 in depreciation of tangible assets.
For the second quarter of 2023, the Company had an operating loss of $2.5 million, compared to an operating loss of $2.2 million for the comparable period of 2022.
Net comprehensive loss for the three-month period ended June 30, 2023 was $3.0 million, or $0.02 per basic and diluted share, compared to net comprehensive loss of $3.2 million, or $0.02 per basic and diluted share, for the comparable period of 2022.
As at June 30, 2023, the Company's cash and short-term investments totalled $1.3 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these second 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) 528-0011 (International), access code 570916. 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 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
