Superior Film Technologies Addressing Unmet Medical Needs

Study completion and initial data anticipated in Q1 and Q2 2024, respectively

SAINT LAURENT, Quebec, Aug. 01, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that it has completed patient enrollment in the ongoing Montelukast VersaFilm^® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”).

The Company successfully enrolled 52 patients in the study, 18 fewer than initially planned, in a study design modification that received a No Objection Letter (“NOL”) from Health Canada. The NOL provided authorization to proceed with the study changes. IntelGenx, in consultation with its statistical consultant, Cogstate Ltd., determined that adjusting the p-value (which determines whether a drug effect exists) to p<0.1 will provide a basis for determining the extent to which effect sizes (the size of the drug effect) of 0.6 or greater (0.5 to <0.8 are considered ‘medium’ effect sizes, while 0.8 or greater are considered ‘large’ effect sizes¹) are statistically significant.

“While there have been exciting recent advancements in the treatment of AD, there is no question that significant unmet medical need remains in this large and growing patient population,” said Dwight Gorham, IntelGenx’s CEO. “As the COVID-19 pandemic effectively halted the BUENA trial’s recruitment for approximately 18 months, followed by imposed post-pandemic restrictions from hospitals, our rationale behind decreasing study enrollment was to avoid any further delay in achieving the program’s goal. We are confident that this Health Canada-authorized study design modification will enable us to utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukast VersaFilm^® compared to placebo. We are looking forward to completing the BUENA trial in the first quarter of 2024 and to reporting initial trial results the following quarter.”

GlobalData recently reported that the AD market is expected to reach $13.7 billion in 2030 across the eight major markets (U.S., France, Germany, Italy, Spain, U.K., Japan, and China), representing a compound annual growth rate of 20.0% from $2.2 billion in 2020. The expansion is primarily attributed to the significant unmet needs posed by AD, combined with the introduction of new therapies, including the recently approved Leqembi and donanemab, which is expected to be approved by year-end.

Reference

¹ Sullivan GM, Feinn R. Using Effect Size-or Why the P Value Is Not Enough. J Grad Med Educ. 2012 Sep;4(3):279-82.

About Montelukast VersaFilm^®

Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx's proprietary VersaFilm^® technology is especially suited for special needs patient populations, and the Montelukast VersaFilm^®product offers many distinct advantages over tablets for AD and Parkinson’s Disease patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.

In Phase 1 studies, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx's oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

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
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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SAINT LAURENT, Quebec, Aug. 07, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its second quarter 2023 financial results after market close on Monday, August 14, 2023.

An accompanying conference call will be hosted by Dwight Gorham, Chief Executive Officer, Andre Godin, President and Chief Financial Officer, and Dr. Horst G. Zerbe, Chairman, to discuss the results and provide a business updateDetails of the conference call and webcast are below:

Second Quarter 2023 Results Conference Call Details:

Date:	Monday, August 14, 2023

Time:	4:30 p.m. ET

Live Call:	1-888-506-0062 (Canada and the United States)
	1-973-528-0011 (International)

Access Code:	570916

The call will also be broadcast 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.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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Expected to generate approximately $9 million in revenue for IntelGenx over three years

SAINT LAURENT, Quebec, Aug. 10, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that it has 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. IntelGenx will package (film in pouch) the product at its cGMP manufacturing facility in Montreal.

Subject to satisfaction of remaining conditions, the parties will endeavor to enter into a definitive agreement as soon as is practicable.

“In addition to providing us with a meaningful new revenue stream, this first commercial-scale packaging agreement helps validate our ability to further expand our CDMO business by providing additional services to both end-to-end CDMO services clients as well as on a stand-alone project basis to key players in the Canadian and U.S. markets,” commented Dwight Gorham, IntelGenx’s CEO. “We are looking forward to building a strong partnership.”

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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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.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

SAINT LAURENT, Quebec, Aug. 31, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx” or the “Company”) announces the closing of the first tranche of a non-brokered private placement (the “Offering”) of units (“Units”) from atai Life Sciences AG (“atai”) for aggregate gross proceeds of approximately US$3 million, including US$750,000 to be received by the Company pursuant to the Subsequent atai Subscription (as defined below) once the Shareholder Approvals (as defined below) have been obtained.

Pursuant to the Offering, (i) United States subscribers can subscribe for Units (the “US Units”) at a price of US$1,000 per US Unit, each US Unit being comprised of a US$1,000 principal amount convertible promissory note (the “US Notes”) and 5,405 common stock purchase warrants (the “US Warrants”); and (ii) Canadian and other subscribers located outside the United States can subscribe for Units (the “Cdn Units”) at a price of C$1,000 per Cdn Unit, each Cdn Unit being comprised of a C$1,000 principal amount convertible promissory note (the “Cdn Notes” and, together with the US Notes, the “Notes”) and 4,000 common stock purchase warrants (the “Cdn Warrants” and, together with the US Warrants, the “Warrants”).

The US Notes and Cdn Notes are convertible into shares of common stock of the Company (the “Shares”) at the option of the holder at a price of US$0.185 (the “US Conversion Price”) and C$0.25 per Share, respectively, at anytime from the date that is six (6) months following their issuance up to and including August 31, 2026, and bear interest at 12% per annum, payable quarterly, in arrears, with first payment due September 30, 2023 and every 3 months thereafter. The US Warrants and the Cdn Warrants entitle the holders thereof to purchase Shares at a price of US$0.26 and C$0.35 per Share, respectively, for a period of 3 years following their issuance.

atai, a significant shareholder and partner of the Company, subscribed, on the date hereof, for 2,220 US Units for aggregate gross proceeds to the Company of US$2,220,000 (the “Initial atai Proceeds”). In addition, atai committed to subscribe for an additional 750 US Units for additional aggregate proceeds to the Company of US$750,000 (collectively with the Initial atai Proceeds, the “atai Proceeds”) on the same terms (the “Subsequent atai Subscription”), subject to the Company obtaining the Shareholder Approvals (as defined below).

IntelGenx may complete one or more additional closings of the Offering, up to the sum of US$2,970,000 and C$1,400,000 in aggregate gross proceeds (inclusive of the atai Proceeds), before October 13, 2023, and intends to use the proceeds of the Offering to fund the Company’s wholly-owned Canadian subsidiary, continuing formulation and development efforts related to ongoing collaborations between IGXT and atai as well as working capital and expenses related to the Offering.

All securities issued in connection with the Offering, including Shares issuable pursuant to the conversion of the Notes or exercise of the Warrants, are subject to a 6-month hold period, during which time trading in the securities is restricted in accordance with applicable securities laws.

The Toronto Stock Exchange (the “TSX”) has conditionally approved the Offering and the listing of the Shares, subject to the General Cap and the Insider Cap (each as defined below). The Offering and the listing of the Shares issuable in connection with the Offering, including Shares issuable pursuant to the conversion of the Notes or exercise of the Warrants, subject to the General Cap and Insider Cap, are subject to final approval of the TSX upon satisfaction of customary closing conditions.

Amendment to the Amended and Restated Loan Agreement

On August 31, 2023, the Corporation entered into an amending agreement (the “Amending Agreement”) in respect of the amended and restated loan agreement dated as of September 14, 2021 (the “Loan Agreement”) between the Corporation, as borrower, and atai, as lender pursuant to which, among other things, the maturity date of the Loan Agreement was extended from January 5, 2024 to January 5, 2025, and the Corporation granted additional security to atai over any non-licensed intellectual property of the Corporation (the “Loan Amendment”).

The Corporation and atai also agreed, subject to obtaining TSX approval, to enter into a second amendment to the Loan Agreement (the “Second Amendment”) to provide, among other things, for the ability for atai to convert the principal and accrued interest outstanding under the Loan Agreement into Shares at the US Conversion Price (the “Conversion Feature”). Assuming the Second Amendment is entered into between the Company and atai prior to the Shareholder Approvals being obtained (as defined below), the Second Amendment will include the same “blocker” provisions as those included in the Notes and the Warrants (see below “Shareholder Approvals”).

Call Option

The Corporation and atai agreed, subject to obtaining TSX approval and the Shareholder Approvals (as defined below), to enter into an amendment (the “Subscription Agreement Amendment”) to the subscription agreement entered into by and between the Company and atai in connection with the Offering to provide atai with the right (the “Call Option”) to purchase up to an additional 6,013 US Units (the “Call Option Units”) at any time prior to August 31, 2026. The Call Option Units, to the extent atai exercises the Call Option in whole or in part, will be issued on the same terms as the US Units, including with respect to the US Conversion Price, maturity date, interest rate and the number of warrants issued in connection therewith. The Subscription Agreement Amendment will provide that the issuance of any Call Option Units will result in a corresponding reduction in atai’s remaining purchase right pursuant to the amended and restated securities purchase agreement dated May 14, 2021, which such right to be reduced by the number of Shares issuable upon the conversion of the principal amount outstanding under such issued Call Option Units.

Shareholder Approvals

The Notes and the Warrants include “blocker” provisions to ensure that, unless securityholder approval is obtained in accordance with the rules of the TSX, (i) the aggregate number of Shares issuable in connection with the Offering (upon conversion of the Notes, exercise of the Warrants and/or the payment of interest on the Notes in Shares, as the case may be) is limited to 43,664,524 Shares, which equals 24.99% of the issued and outstanding Shares (on a non-diluted basis) as of the date hereof (the “General Cap”), and (ii) the aggregate number of Shares that may be issued to “insiders” of the Company (as such term is defined in the policies of the TSX) pursuant to the Offering (upon conversion of the Notes, exercise of the Warrants and/or the payment of interest on the Notes in Shares, as the case may be), is limited to 17,465,809 Shares, which equals 9.99% of the issued and outstanding Shares as of the date hereof (the “Insider Cap”).

In accordance with the terms of the Notes and the Warrants, the Company intends to seek (i) securityholder approval of the issuance of Shares in connection with the Offering (upon conversion of the Notes, exercise of the Warrants and/or payment of interest on the Notes in Shares, as the case may be) above the General Cap, in accordance with Section 607(g)(i) of the TSX Company Manual (the “General Shareholder Approval”), and (ii) disinterested securityholder approval of the issuance of Shares to “insiders” of the Company (as such term is defined in the policies of the TSX), as of the date hereof, pursuant to the Offering (upon conversion of the Notes, exercise of the Warrants and/or the payment of interest on the Notes in Shares, as the case may be) above the Insider Cap, in accordance with Section 607(g)(ii) of the TSX Company Manual (the “Insider Shareholder Approval”).

In addition, approval of the securityholders of the Company will be required in connection with the Conversion Feature, the Call Option and to authorize the Subsequent atai Subscription on the same terms as the Offering (together with the General Shareholder Approval and the Insider Shareholder Approval, the “Shareholder Approvals”).

The Corporation will seek to obtain the Shareholder Approvals at an upcoming special meeting of Shareholders to be held as soon as practicable after the date hereof.

Related Party Transactions

atai is an insider of the Company as a result of its beneficial ownership of, or control or direction over, directly or indirectly, greater than 10% of the outstanding Shares. The participation of atai in the Offering, the Loan Amendment, the Subsequent atai Subscription and the Conversion Feature, both considered independently as well as together as a whole, constitute a “related party transaction” within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) which, absent any available exemption, would require a formal valuation and minority approval under MI 61-101. The board of directors of the Company unanimously determined that the Company may rely on the “financial hardship” exemption from the formal valuation and minority approval requirements set out in Section 5.5(g) and Section 5.7(e) of MI 61-101 with respect to such transactions, given that the Company is in serious financial difficulty, the participation of atai in the Offering, the Loan Amendment, the Subsequent atai Subscription and the Conversion Feature are designed to improve the financial position of the Company, and the exemption provided for in Section 5.5(f) of MI 61-101 is not available, as the transactions contemplated are not subject to court approval under bankruptcy or insolvency law. In addition, the Company has one or more independent directors who have determined that the terms and conditions of the participation of atai in the Offering, the Loan Amendment, the Subsequent atai Subscription and the Conversion Feature are reasonable for the Company in the circumstances and are in its best interests. The Company did not file a material change report in respect of the related party transaction 21 days in advance of closing of the offering because insider participation had not been determined at that time. The shorter period was necessary in order to permit the Company to close the Offering in a timeframe consistent with usual market practice for transactions of this nature.

Early Warning Disclosure

This press release is also being issued pursuant to National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues (“NI 62-103”) in connection with the acquisition by atai (Wallstraße 16, 10179 Berlin, Germany) of certain convertible securities, convertible into Shares of the Company (the “Acquisition”). The Acquisition occurred on a private placement basis. In connection with the Acquisition, atai purchased 2,220 US Units (consisting of 2,220 US Notes (the “Initial Notes”), the principal of which is convertible into 12,000,000 Shares, and 11,999,100 warrants (the “Initial Warrants”), agreed to purchase an additional 750 Units (consisting of 750 US Notes (the “Subsequent Notes”), the principal of which is convertible into 4,054,054 Shares, and 4,053,750 warrants (the “Subsequent Warrants”), upon the satisfaction of certain conditions, and entered into an agreement, pursuant to which the Company has agreed to enter into the Second Amendment (which will permit atai to convert the outstanding balance under the Loan Agreement into Shares) and grant atai the Call Option to purchase additional convertible notes and warrants (which reduces the Shares purchasable under atai’s current securities purchase agreement with the Company).

Immediately prior to the Acquisition, atai had ownership and control over 37,300,000 Shares and securities convertible into approximately 153,800,000 Shares representing approximately 58.2% of the issued and outstanding Shares, on a partially diluted basis. Assuming the conversion and/or exercise of the principal amount of the Initial Notes (but excluding interest that may accrue), Initial Warrants, the principal amount of the Subsequent Notes (but excluding interest that may accrue), Subsequent Warrants, the outstanding balance of the Loan Agreement and the Call Options (and underlying securities), atai would beneficially own or control in aggregate 269,152,849 Shares representing approximately 66.2% of the issued and outstanding Shares of the Company, on a partially diluted basis.

atai’s acquisitions and dispositions were made for investment purposes. In accordance with applicable securities laws, atai may, from time to time and at any time, acquire additional shares and/or other equity, debt or other securities or instruments (collectively, “Securities”) of the Company in the open market or otherwise, and reserves the right to dispose of any or all of its Securities in the open market or otherwise at any time and from time to time, and to engage in similar transactions with respect to the Securities, the whole depending on market conditions, the business and prospects of the Company and other relevant factors.

An early warning report will be filed under the Company’s profile on the SEDAR+ website at www.sedarplus.ca. To obtain more information or to obtain a copy of the early warning report filed in respect of this press release, please contact atai by email at This email address is being protected from spambots. You need JavaScript enabled to view it..

This press release does not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the Units in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of any such jurisdiction. This press release does not constitute an offer of securities for sale in the United States. The Units have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such Units may not be offered or sold within the United States absent registration under U.S. federal and state securities laws or an applicable exemption from such U.S. registration requirements.

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

This document may contain forward-looking information which 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. All statements, other than statements of historical fact, contained in this press release including, but not limited to, statements regarding (i) the closing of additional tranches of the Offering and the receipt of additional proceeds therefrom, (ii) the proposed use of proceeds for the Offering, (iii) Subsequent atai Subscription, (iv) the receipt of the TSX approvals, (v) the entering into the Second Amendment, (vi) the Conversion Feature, (vii) the entering into the Subscription Agreement Amendment, (viii) the Call Option, (ix) the receipt of the Shareholder Approvals, and (x) generally, the “About IntelGenx” paragraph which essentially describe the Corporation’s outlook and objectives, constitute “forward-looking information” or “forward-looking statements” and are based on necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. 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’ actual results, objectives and plans 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’ 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.sedarplus.ca. IntelGenx assumes no obligation to update any such forward-looking statements. Moreover, all forward-looking information contained herein is subject to certain assumptions. There can be no assurance that such approvals will be obtained.

For more information, please contact:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

SAINT LAURENT, Quebec, Sept. 19, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today provided a regulatory update on Buprenorphine Buccal Film, for which an abbreviated new drug application (“ANDA”) has been filed with the U.S. Food and Drug Administration (“FDA” or the “Agency”) by its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”).

As previously announced, Xiromed received a Complete Response Letter (“CRL”) from the FDA in April 2023. In response to the CRL, Xiromed submitted to the FDA an Amendment to the ANDA, requesting priority review. In an Amendment Acknowledgement received from the FDA by Xiromed, the FDA granted priority review with a Generic Drug User Fee Act (“GDUFA”) goal date for review of the Amendment of March 8, 2024, unless the Agency determines that an inspection is required. Alternatively, if the FDA determines that an inspection is required, the GDUFA goal date is July 8, 2024.

“We are pleased with our partner Xiromed’s prompt and fulsome response to the CRL, and are looking forward to the Agency’s decision,” commented Dwight Gorham, IntelGenx’s CEO. “Given the recent pre-approval inspection in March 2023 and subsequent approval of our Rizatriptan oral film, we are optimistic that the FDA will decide to review this Amendment without the need for an additional inspection of our facility.”

About Buprenorphine Buccal Film

Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm^® technology in a novel formulation, is a generic version of Belbuca^®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca^® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

About Xiromed

Xiromed LLC, located in Florham Park, NJ, is the U.S. generic division of Insud Pharma, S.L., a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on developing and commercializing high quality generic pharmaceutical products for the US market. In addition to its commercial portfolio of generics available in the U.S., Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products. Learn more at http://www.xiromed.com/usa.

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.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

Receives first purchase order from Gensco® Pharma

SAINT LAURENT, Quebec, Sept. 21, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that it has received the first purchase order (“PO”) for RIZAFILM^®1 from its commercial partner in the United States, Gensco Pharma (“Gensco^®”).

The PO triggers an upfront order deposit payment. A pre-specified milestone payment to IntelGenx from Gensco^® is also payable upon transfer of NDA. Both payments will be reflected in the Company’s Q3-2023 financial results. IntelGenx expects to ship the ordered RIZAFILM^® product to Gensco^® in Q1-2024 for immediate launch.

“We have been impressed with the progress Gensco^®has made, and remain convinced that it is the right partner to help us bring this innovative migraine therapeutic to U.S. patients seeking convenient administration and quick pain relief,” commented Dwight Gorham, IntelGenx’s CEO. “We are also pleased that our balance sheet will be strengthened in the current quarter by the deposit and milestone payments triggered by Gensco^®’s PO for RIZAFILM^®.”

Gensco^®’s Chairman and CEO, Paul Zimmerman, MD, commented, “Our team has been working closely with its talented colleagues at IntelGenx to lay the groundwork for what we believe will be a very successful commercial launch of RIZAFILM^®, the first oral thin film approved for the treatment of acute migraines in the U.S. Beyond that, we continue to look forward to building a successful long-term partnership with IntelGenx.”

¹ RIZAFILM® is a Registered Trademark of Gensco^® Pharma Corporation

² Reports and Data, Migraine Drugs Market, https://www.reportsanddata.com/sample-enquiry-form/2515

About RIZAFILM^®

RIZAFILM^® (U.S. market name for RIZAPORT^®) is a proprietary oral thin film formulation of rizatriptan benzoate. RizaFilm^® oral soluble film does not require a drink for swallowing and has ease of use which facilitates rapid administration and relief from migraine symptoms. RizaFilm^®’s active ingredient has been clinically proven to be effective for migraine associated nausea, photophobia and phonophobia. The global migraine drugs market was valued at nearly $3 billion in 2021 and is expected to reach nearly $11 billion by 2030, representing a compound annual growth rate of 15.6%.² According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

SAINT LAURENT, Quebec, Nov. 02, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its third quarter 2023 financial results after market close on Thursday, November 9, 2023.

An accompanying conference call will be hosted by Dwight Gorham, Chief Executive Officer, Andre Godin, President and Chief Financial Officer, and Dr. Horst G. Zerbe, Chairman, to discuss the results and provide a business update. Details of the conference call and webcast are below:

Third Quarter 2023 Results Conference Call Details:
Date:	Thursday, November 9, 2023
Time:	4:30 p.m. ET
Live Call:	1-877-545-0320 (Canada and the United States) 1-973-528-0002 (International)
Access Code:	356693

The call will also be broadcast 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.

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.sedarplus.ca. IntelGenx assumes no obligation to update any such forward-looking statements.

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
647-872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
514-331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

IntelGenx to Manufacture and Supply Three New Filmstrip Products: CBD20, THC10, and THC10:CBD10

SAINT LAURENT, Quebec, Nov. 06, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that it and Tilray Brands Inc. (“Tilray”) have entered into a further amendment (the “Second Amendment”) to their November 2018 license, development and supply agreement for the co-development and commercialization of cannabinoid-infused VersaFilm^® products, settling IntelGenx’s arbitration claim against Tilray.

Pursuant to the Second Amendment, IntelGenx has received an initial purchase order from Tilray for three SKUs (CBD20, THC10, THC10:CBD 10), with each SKU totalling 130,000 filmstrips. The Second Amendment also allows for IntelGenx’s co-development and commercialization of CBD (pursuant to a previous amendment), THC, and combination THC:CBD products with additional partners. The Second Agreement removes any royalties paid to or from Tilray.

“This partnership and settlement represent a significant milestone in building our relations with Tilray, and we are excited to begin this new chapter of the companies making innovative cannabinoid-infused oral thin film products available to consumers,” said Dwight Gorham, IntelGenx’s CEO.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

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
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

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^®1from 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

Financial Results:

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.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

Forward-Looking Information and Statements

Source: IntelGenx Technologies Corp.

For IntelGenx:

Stephen Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
This email address is being protected from spambots. You need JavaScript enabled to view it.

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NEWS RELEASE

IntelGenx Completes Enrollment for ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease

IntelGenx to Report Second Quarter 2023 Financial Results on August 14, 2023 – Conference Call to Follow

IntelGenx Announces First Agreement for CDMO Packaging Services

IntelGenx Reports Second Quarter 2023 Financial Results

IntelGenx Announces Closing of First Tranche of Non-Brokered Private Placement From Strategic Partner for Approximate Aggregate Gross Proceeds of US$3 Million (Including US$750,000 to be Received by the Company Once Shareholder Approvals Have Been Obtained)

IntelGenx Provides Regulatory Update for Xiromed-Partnered Development Candidate, Buprenorphine Buccal Film

IntelGenx Provides RIZAFILM® U.S. Commercialization Update

IntelGenx to Report Third Quarter 2023 Financial Results on November 9, 2023 – Conference Call to Follow

IntelGenx Announces Co-development and Commercialization of Cannabinoid-Infused VersaFilm® Products with Tilray

IntelGenx Reports Third Quarter 2023 Financial Results