SAINT LAURENT, Quebec, Nov. 09, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the third quarter ended September 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 Third Quarter Financial Summary:
- Revenue was $318,000, compared to $142,000 in the 2022 third quarter.
- Net comprehensive loss was $2.5 million, compared to $3.0 million in Q3-2022.
- Adjusted EBITDA loss was $2.1 million, compared to $2.2 million in the 2022 third quarter.
Third Quarter and Recent Developments:
- Received the first purchase order for RIZAFILM®1 from Gensco Pharma (Gensco®), the Company's U.S. commercialization partner, which triggered an upfront order deposit payment and a pre-specified milestone payment.
- Announced a further amendment to the November 2018 license, development and supply agreement with Tilray Brands Inc. ("Tilray") for the co-development and commercialization of cannabinoid-infused VersaFilm® products, and received an initial purchase order from Tilray for three SKUs (CBD20, THC10, THC10:CBD1), settling IntelGenx's arbitration claim against Tilray.
- Completed patient enrollment in the ongoing Phase 2a (“BUENA”) clinical trial of IntelGenx’s Montelukast VersaFilm® in patients with mild to moderate Alzheimer’s Disease (“AD”).
- Announced that, as part of a research collaboration with Karolinska University Hospital, Stockholm, and Per Svenningsson, MD, PhD, the manufacturing of both active and placebo films was underway for a planned clinical trial evaluating Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).
- Announced that the U.S. Food and Drug Administration (“FDA” or the “Agency”) granted Xiromed LLC (“Xiromed”), the agent and affiliate of IntelGenx’s co-developer, Chemo Research SL, priority review of its amended abbreviated new drug application (ANDA) for Buprenorphine Buccal Film. Unless the Agency determines that an inspection is required, the Generic Drug User Fee Act (GDUFA) goal date is March 8, 2024.
- 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.
- Closed the first tranche of a non-brokered private placement of units from atai Life Sciences AG (“atai”) for aggregate gross proceeds of approximately $3 million, including $750,000 to be received by the Company pursuant to a subsequent atai subscription, assuming shareholder approvals are obtained.
“We have announced several positive developments over the past few months,” commented Mr. Gorham, CEO of IntelGenx. “We received from Gensco® their first RIZAFILM® purchase order, which triggered an upfront payment and a milestone payment that are both reflected in our third quarter financial results. We were also pleased with Xiromed’s successful request for the FDA’s priority review of the amended ANDA for Buprenorphine Buccal Film, and we are looking forward to the Agency’s decision. In addition, we completed patient enrollment in the ongoing Montelukast VeraFilm® Phase 2a BUENA clinical trial in AD; took another important step toward expanding our Montelukast VersaFilm® clinical program to include the treatment of PD in addition to AD; expanded our CDMO business to include oral thin film packaging services; and, earlier this week, settled our arbitration claim against Tilray, allowing the two companies to begin a new chapter of making innovative cannabinoid-infused VersaFilm® products available to consumers.”
1. RIZAFILM® (U.S. market name for RIZAPORT®) is a Registered Trademark of Gensco® Pharma Corporation
Total revenues for the three-month period ended September 30, 2023 amounted to $318,000, an increase of 124% compared to $142,000 for the three-month period ended September 30, 2022. The change is mainly attributable to increases in R&D revenues of $128,000, R&D milestone revenues of $125,000 and royalties on product sales of $2,000; offset by a decrease in product revenues of $79,000.
Operating costs and expenses were $2.7 million for the third quarter of 2023, versus $2.5 million for the corresponding three-month period of 2022. The change is mainly attributable to increases of $163,000 in R&D expenses, $134,000 in selling, general and administrative expenses, and $4,000 in depreciation of tangible assets, offset partially by a decrease of $146,000 in manufacturing expenses.
For the third quarter of 2023, the Company had an operating loss of $2.4 million, consistent with the comparable period of 2022.
Net comprehensive loss for the three-month period ended September 30, 2023 was $2.5 million, or $0.01 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 September 30, 2023, the Company's cash and short-term investments totalled $2.1 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these third quarter 2023 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (877) 545-0320 (Canada and the United States) or (973) 528-0002 (International), access code 356693. The call will also be webcast live and archived on the Company's website at www.intelgenx.com under "Webcasts" in the Investors section.
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.
Andre Godin, CPA, CA
President and CFO
(514) 331-7440 ext 203