SAINT LAURENT, Quebec, Nov. 10, 2022 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSX: IGX) (OTCQB: IGXT) (the “Company” or “IntelGenx”) today announced its financial results for the third quarter ended September 30, 2022. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are presented in accordance with United States generally accepted accounting principles, unless otherwise indicated.
Financial summary for the third quarter of 2022:
Revenue was $142,000, compared to $593,000 in the third quarter of 2021.
Overall net loss was $3.0 million, compared to $2.2 million in Q3-2021.
Adjusted EBITDA loss was $2.2 million, compared to $1.4 million in the third quarter of 2021.
Third quarter and recent developments:
Filed a provisional patent application with the United States Patent and Trademark Office entitled “Advanced Oral Film Formulations”, containing new inventive claims relating to the delivery of cannabinoids for faster onset of action.
Announced that its previously undisclosed development candidate, Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) had been filed by Chemo Research SL (“Chemo”) through its agent and affiliate Xiromed LLC, received a U.S. Food and Drug Administration (“FDA”) Generic Drug User Fee Act (“GDUFA”) date April 28, 2023.
Obtained U.S. Patent No. 11,471,406, with claims for modulation of drug absorption in the form of an oral film designed for the sublingual delivery of various pharmaceuticals, including certain cannabinoids.
Response Submitted to FDA’s March 2020 Full Response Letter for its 505(b)(2) New Drug Application for RIZAFILM® (formerly RIZAPORT®) VersaFilm®.1
The company’s collaboration with atai Life Sciences culminated in the initiation of the first-ever human clinical study of a thin-film oral psychedelic drug candidate.
Reached halfway through the patient enrollment process in the ongoing Montelukast VersaFilm® Phase 2a clinical trial (“BUENA”) in patients with mild to moderate Alzheimer’s disease.
“The third quarter was productive for IntelGenx, marked by the achievement of several development milestones and the strengthening of our patent portfolio,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “Our ongoing BUENA trial is halfway through patient enrollment, while our partnership with Chemo has resulted in a GDUFA date being awarded in the second quarter of next year. quarter, we reached an important milestone with atai’s initiation of the first-ever human clinical study of a psychedelic administered via oral film. We look forward to the first half of 2023, when we await results from the phase 1 trial of atai and the FDA decision on ANDA Buprenorphine Buccal Film.
1. RIZAFILM® is a registered trademark of Gensco® Pharmaceutical company
Total revenues for the three-month period ended September 30, 2022 amounted to $142,000, a decrease of 76% compared to $593,000 for the three-month period ended September 30, 2021. The variation is mainly attributable to lower sales stage revenue of $320,000. and R&D revenue of $141,000, partially offset by product revenue increases of $9,000 and product sales royalties of $1,000.
Operating costs and expenses were $2.5 million for the third quarter of 2022, compared to $2.2 million for the corresponding three-month period of 2021. The variation is mainly attributable to increases in $542,000 of selling, general and administrative expenses which are mainly attributable to the Devaluation of the dollar, partially offset by decreases of $170,000 in R&D expenses, $70,000 in manufacturing expenses and $3,000 in depreciation of assets bodily.
For the third quarter of 2022, the Company recorded an operating loss of $2.4 million, compared to an operating loss of $1.6 million for the comparable period of 2021.
Comprehensive net loss for the three-month period ended September 30, 2022 was $3.0 million, or $0.02 per basic and diluted share, compared to a comprehensive net loss of $2.2 million , or $0.01 per basic and diluted share, for the comparable period of 2021.
As of September 30, 2022, the Company’s cash and short-term investments totaled $4.7 million.
Conference call details:
IntelGenx will host a conference call to discuss these third quarter 2022 financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (844) 369-8770 (Canada and United States) and (862) 298-0840 (international), access code INTELGENX. 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 specializing in the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®DisinteQ™VetaFilm™ and transdermal VevaDerm™, enable next-generation pharmaceuticals that address unmet medical needs. IntelGenx’s pipeline of innovative products provides significant benefits to patients and physicians for numerous therapeutic conditions.
IntelGenx’s highly skilled team provides comprehensive pharmaceutical services to pharma partners, including R&D, analytical method development, clinical oversight, intellectual property, and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale, pilot-scale, 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, goals, 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 such forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied. implied by such 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 formu 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.govand also filed with the Canadian securities authorities at www.sedar.com. IntelGenx undertakes no obligation to update these forward-looking statements.
Source: Intel Genx Technologies Corp.
For Intel Genx:
André Godin, CPA, CA
President and Chief Financial Officer
(514) 331-7440 ext. 203