Superior Film Technologies Addressing Unmet Medical Needs

MONTRÉAL, Oct. 02, 2024 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (the “Company” or “IntelGenx”), a leading drug delivery company focused on the development and manufacturing of pharmaceutical films, announces that the Company and its subsidiary IntelGenx Corp. (“IGX” and, together with the Company, the “IGX Entities”) have obtained on September 30, 2024 an approval and vesting order (the “Approval and Vesting Order”) from the Superior Court of Québec (Commercial Division) (the “Court”) issued in connection with the previously announced proceedings instituted pursuant to the Companies’ Creditors Arrangement Act (the “CCAA”).

The Approval and Vesting Order approved the previously announced transactions (collectively, the “Transaction”) contemplated in the sale proposal from atai Life Sciences AG (“atai”), as well as the implementation of a reorganization of the IGX Entities that involves: (a) the incorporation of two new entities (“Residual IGX” and “New ParentCo”) to ultimately hold certain excluded liabilities of IGX and certain excluded assets, and (b) the exchange of the shares of IGX, on a one-for-one basis, for common shares of New ParentCo.

Pursuant to the Transaction, which closed on October 2, 2024, atai acquired all of the issued and outstanding shares of IGX. The Transaction was structured as a credit bid, whereby atai agreed that its senior secured debt in IntelGenx was discharged in exchange for IGX shares. No atai equity or cash was exchanged in connection with this Transaction.

Based on the terms of the Transaction and the consideration received by New ParentCo, holders of the Company’s shares will not receive any payments for, or distributions on, their shares in connection with the CCAA proceedings. It is also expected that the Company, Residual IGX and New ParentCo, entities that will hold the remaining assets and liabilities that atai chose not to purchase as part of the Transaction, will file for bankruptcy in the coming weeks under the laws of their respective jurisdictions.

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 pharmaceutical 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 https://www.intelgenx.com/ and connect with us on X and LinkedIn.

IntelGenx Forward-Looking Statements

Contact:

Andre Godin, President & CFO, This email address is being protected from spambots. You need JavaScript enabled to view it.

SAINT LAURENT, Quebec, March 21, 2024 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the three- and twelve-month periods ended December 31, 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.

"We successfully executed against key strategic priorities in 2023, the most important of which was to lay the groundwork for our product pipeline and services portfolio to start generating significant revenues in 2024,” commented Dwight Gorham, IntelGenx’s CEO. “To that end, we expect that our commercial partner for RIZAFILM^®1, Gensco Pharma, will be launching the product in the United States in Q2-2024, an anticipated inflection point for our business.”

2023 Fourth Quarter Financial Summary:

Revenue was $426,000, up from $173,000 in the 2022 fourth quarter.
Net comprehensive loss was $1.7 million, down from $2.3 million in the fourth quarter of 2022.
Adjusted EBITDA loss was $1.7 million, compared to $2.3 million in Q4-2022.

2023 Full-Year Financial Summary:

Revenue was $1.04 million, compared to $950,000 in 2022.
Net comprehensive loss was $10.1 million, down from $11.6 million in 2022.
Adjusted EBITDA loss was $8.3 million, compared to $8.5 million in 2022.

Fourth Quarter and Recent Developments:

Closed a non-brokered private placement financing with atai Life Sciences AG (“atai”) for aggregate gross proceeds of $750,000, and announced an amended and restated loan agreement (the “Loan Agreement”) with atai, pursuant to which IntelGenx received a first tranche of $1 million and is eligible to receive a second tranche of $1 million in future upon the achievement of a pre-defined milestone.

Launched a Regulation A offering of up to 2 million shares of Series A Convertible Cumulative Preferred Stock, par value $0.00001 per share, at an offering price of $10.00 per share (the “Regulation A Offering”).²

Entered into a further amendment to its 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:CBD 10), with each SKU totalling 130,000 filmstrips.

Entered into development and license agreements with a wholly-owned subsidiary of Covenant Animal Health Partners, LLC for VetaFilm^®.

Received approvals from the Swedish Medical Products Agency, the Swedish Ethical Review Authority, and the Regional Biobank Centre to conduct the ’MONTPARK’ Montelukast VersaFilm^® Phase 2 clinical trial in patients with Parkinson's Disease.

Announced positive results from a proof-of-concept study, conducted through a research collaboration with the University of Prince Edward Island, that validated the advantages of administering drugs to pets via its VetaFilm^® platform.

Announced changes to its Board, appointing Sahil Kirpekar, M.D., atai’s Chief Business Officer, and Ryan Barrett, atai’s Senior Vice President and General Counsel, as atai’s new designees.

Financial Results:

Total revenues for the three-month period ended December 31, 2023 amounted to $426,000, an increase of $253,000, or 146%, compared to $173,000 for the three-month period ended December 31, 2022. The change is mainly attributable to an increase in research and development (“R&D”) revenues. Operating costs and expenses were $2.4 million for the fourth quarter of 2023, versus $2.7 million for the corresponding three-month period of 2022. For Q4-2023, the Company had an operating loss of $2.0 million, down from $2.5 million for the comparable period of 2022. Net comprehensive loss was $1.7 million, or $0.01 per basic and diluted share, for the fourth quarter of 2023, compared to net comprehensive loss of $2.3 million, or $0.01 per basic and diluted share, for the comparable period of 2022.

Total revenues for the twelve-month period ended December 31, 2023 amounted to $1.04 million, representing an increase of $89,000, or 6%, compared to $950,000 for the year ended December 31, 2022. Operating costs and expenses were $10.5 million for the full year 2023, versus $10.4 million for the corresponding twelve-month period of 2022. For the twelve-month period of 2023, the Company had an operating loss of $9.5 million, compared to an operating loss of $9.4 million for the comparable period of 2022. Net comprehensive loss was $10.1 million, or $0.06 per basic and diluted share, for the twelve-month period of 2023, compared to net comprehensive loss of $11.6 million, or $0.07 per basic and diluted share, for the comparable period of 2022.

As at December 31, 2023, the Company's cash and short-term investments totalled $2.3 million. Subsequent to year-end, IntelGenx announced the launch of the Regulation A Share Offering and received $1 million pursuant to its Loan Agreement with atai.

Annual Filings:

The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2023, as well as the 2024 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 21, 2024.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2022 fourth quarter and full year financial results today at 8:30 a.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 321268. The call will be also be webcast live and archived on the Company's website at www.intelgenx.com under "Webcasts" in the Investors section.

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

²This press release does not constitute an offer to sell nor a solicitation of an offer to purchase any securities in any jurisdiction in which such an offer or solicitation is not authorized and does not constitute an offer within any jurisdiction to any person to whom such offer would be unlawful.

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
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Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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MONTREAL, July 19, 2024 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (the “Company” or “IntelGenx”) (OTC: IGXT), a leading drug delivery company focused on the development and manufacturing of pharmaceutical films, announced today that the Phase 1 Non-Binding LOI Submission Deadline set for 5:00 p.m. (EDT) on July 15, 2024 in connection with the previously announced sale and investment solicitation process (“SISP”) has lapsed. As Phase 1 of the SISP did not result in alternative superior bids, IntelGenx and atai Life Sciences AG (“atai”) have now initiated the process to complete the purchase and sale transaction. The parties currently expect to obtain final approval from the Québec Superior Court (Commercial Division) and close the transaction prior to September 30, 2024.

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 pharmaceutical 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 https://www.intelgenx.com/ and connect with us on X and LinkedIn.

IntelGenx Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to closing of the transaction with atai and the approval from the Québec Superior Court (Commercial Division) in connection thereto. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company. IntelGenx assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IntelGenx’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR+ at http://www.sedarplus.ca and on EDGAR at http://www.sec.gov/edgar

Contact:

Andre Godin, President & CFO, This email address is being protected from spambots. You need JavaScript enabled to view it.

Source: IntelGenx Technologies Corp.

MONTREAL, July 03, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), has successfully completed the BUENA Alzheimer’s disease (AD) study. The BUENA study was designed as a Phase 2a proof of concept study to investigate the extent to which different doses of Montelukast (MTK) could improve cognition in adults with AD as well as to provide information on the safety and tolerance of the buccal film in this patient group. The BUENA study enrolled 59 adults with mild to moderate severity AD, of which 52 completed 26 weeks treatment with “standard of care” cholinesterase inhibitors and Montelukast buccal film (10mg per day or 30mg twice daily) or cholinesterase inhibitors and placebo. Cognition was assessed using a battery of neuropsychological tests developed by Cogstate, a neuroscience company focused on optimizing cognitive assessment in clinical trials.

Although the final study report, which includes the analysis of all safety and efficacy information, is planned for completion and release at the beginning of third quarter 2024, IntelGenx has obtained the outcome of a topline analysis of the efficacy data from the BUENA study.

The summary study results indicated that when considered across all doses of MTK, no benefit to general cognition was observed when compared to change under placebo. However, when the data from the neuropsychological tests was analysed separately for each dose, adults with AD who received at least 80% of 30-mg twice-daily doses of MTK showed a statistically significant improvement in general cognition compared to placebo with the benefit being d= 0.5 in magnitude.

“Given the relatively small sample size and the mild to moderate clinical disease severity of the study sample, interpretation of the results should be based on consideration of the treatment effect observed on the composite neuropsychological measure of cognition,” said Paul Maruff, PhD, Chief Innovation Officer at Cogstate. “This preliminary analysis suggests that treatment with MTK 30-mg twice-daily, based on the ‘per treatment’ analyses (treatment compliers), was associated with an experimentally important benefit to cognition. Given this, further study of this 30-mg MTK twice-daily dose with consistent treatment will be of value.”

Prof. Ludwig Aigner (head of the Institute of Molecular Regenerative Medicine at Paracelsus Medical University in Salzburg, Austria) our key scientific drug development partner, has over the years contributed to the IntelGenx’s MTK program, and established and published preclinical evidence of the use of MTK in neuroinflammatory and neurodegenerative diseases, including in AD transgenic mice. Prof. Aigner was quite pleased that the BUENA study has provided some first human evidence - although preliminary - for the use of MTK buccal film as a treatment modality and option for patients with mild to moderate AD, which seems to suggest that neuroinflammation could play a role in the pathogenesis of AD and potentially other neurodegenerative diseases.

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 monoclonal antibody therapies.

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 neuroinflammatory and 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.

About IntelGenx

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:

Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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MONTREAL, June 11, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), was granted protection pursuant to an order (as amended or amended and restated from time to time, the “Initial Order”) under the Companies’ Creditors Arrangement Act (the “CCAA” and the “CCAA Proceedings”) by the Superior Court of Québec (the “Court”). EY was appointed as monitor (in such capacity, the “Monitor”).

On May 27, 2024, the Court granted an order (the “SISP Order”) which i) approved a sale and investment solicitation process to be conducted in respect of the business and/or assets of the Company (the “SISP”), and ii) approved the agreement of purchase and sale between IntelGenx, as vendor, and atai Life Sciences AG, as purchaser, solely for the purpose of constituting the “stalking horse” bid under the SISP (the “Stalking Horse Bid”). The Stalking Horse Bid establishes a baseline price and deal structure for the solicitation of superior bids from qualified interested parties and provides certainty that a going-concern solution for the business of IntelGenx has already been identified.

Ernst & Young Orenda Corporate Finance Inc. and its affiliate, Ernst & Young Corporate Finance (Canada) Inc. shall be assisting the Company and the Monitor in connection with the SISP process.

The SISP is a two-phased process with the Phase 1 bid deadline set for July 15, 2024. Parties interested in the opportunity should contact the Monitor via one of the persons listed below to get further details.

Jatinder Wadhwa⁽¹⁾ Senior Vice President +1 416 943 3078 This email address is being protected from spambots. You need JavaScript enabled to view it.	Mansa Singh Senior Associate +1 416 932 4902 This email address is being protected from spambots. You need JavaScript enabled to view it.	Jessica Jingwei Analyst +1 416 932 4424 This email address is being protected from spambots. You need JavaScript enabled to view it.
Martin Rosenthal Senior Vice President +1 514 879 6549 This email address is being protected from spambots. You need JavaScript enabled to view it.	Martin Carrière Senior Vice President +1 514 879 3254 This email address is being protected from spambots. You need JavaScript enabled to view it.This email address is being protected from spambots. You need JavaScript enabled to view it.	Alexandre Ferland Director +1 514 943 0929 This email address is being protected from spambots. You need JavaScript enabled to view it.

Copies of the SISP Order and the SISP procedures may be obtained from the website of the Monitor at www.ey.com/ca/intelgenx.

(1) Any inquiries by U.S. persons should be directed to Ernst & Young Corporate Finance (Canada) Inc. through Jatinder Wadhwa.

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 pharmaceutical 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 https://www.intelgenx.com/ and connect with us on X and LinkedIn.

MONTREAL, May 28, 2024 (GLOBE NEWSWIRE) -- As previously announced on May 17, 2024, IntelGenx Technologies Corp. (the “Company” or “IntelGenx”) (OCTQB: IGXT; TSX: IGX), a leading drug delivery company focused on the development and manufacturing of pharmaceutical films, was granted protection pursuant to an initial order (as amended, the “Initial Order”) issued under the Companies' Creditors Arrangement Act (“CCAA”) by the Québec Superior Court (Commercial Division) (the “Court”). The Initial Order appointed Ernst & Young Inc. as monitor (the “Monitor”) and authorized interim debtor-in-possession financing (DIP) financing provided by atai Life Sciences AG in order to allow the Company to continue its operations during the restructuring process and implement the necessary restructuring measures.

On May 27, 2024, IntelGenx obtained an order from the Court (the “SISP Approval Order”) approving the implementation of a sale and investment solicitation process intended to generate interest in either the business or the assets of IntelGenx, or in a recapitalization of IntelGenx, with the goal of implementing one or more transaction(s) (the “SISP”). The SISP Approval Order provides that the SISP will be conducted by the Monitor.

As part of the SISP Approval Order, the Court also approved the agreement of purchase and sale between IntelGenx, as vendor, and atai Life Sciences AG, as purchaser, solely for the purpose of constituting the “stalking horse” bid under the SISP (the “Stalking Horse Bid”). The Stalking Horse Bid establishes a baseline price and deal structure for the solicitation of superior bids from qualified interested parties and provides certainty that a going-concern solution for the business of IntelGenx has already been identified.

All qualified interested parties will be provided with an opportunity to participate in the SISP. The SISP is intended to solicit interest in and opportunities for a broad range of executable transaction alternatives involving the business and assets of IntelGenx, through one or more sales or partial sales of all, substantially all, or certain portions of the business and assets, and/or an investment in, restructuring, recapitalization, refinancing or other form of reorganization of IntelGenx or its business.

The SISP will be conducted as a two-phase process with the Phase 1 Non-Binding LOI Submission Deadline set for 5:00 p.m. (Montréal Time) on July 15, 2024.

Copies of the order approving the SISP and the SISP procedures may be obtained from the Monitor’s website: www.ey.com/ca/intelgenx.

Further news releases will be provided on an ongoing basis throughout the CCAA proceedings as required by law or otherwise as may be determined necessary by the Company or the Court. Documents relating to the restructuring process such as the Initial Order, the Monitor’s reports to the Court as well as other Court orders and documents shall also be published and made accessible on the Monitor’s website: www.ey.com/ca/intelgenx.

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 pharmaceutical 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 https://www.intelgenx.com/ and connect with us on X and LinkedIn.

IntelGenx Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to: (i) the outcome of the CCAA proceedings, (ii) the obtaining of the approval of the Court to initiate a formal sale and investment solicitation process to secure additional financing, sell assets, or a combination thereof, (iii) the ability of the Company to secure additional financing or otherwise enter into one or more transaction(s), and (iv) halt trading of the common shares and review of the TSX regarding the suitability of the Company for listing on the TSX and any outcome of such review. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including the outcome of the CCAA proceedings and the capacity of the Company to enter into one or more transaction(s) that would allow the Company to pursue its activities as a going concern and the continued listing of its common shares on a stock exchange. IntelGenx assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IntelGenx’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at http://www.sedar.com and on EDGAR at http://www.sec.gov/edgar

View source version on businesswire.com:

Source: IntelGenx Technologies Corp.

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MONTREAL, May 17, 2024 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (the “Company” or “IntelGenx”) (OCTQB: IGXT; TSX: IGX), a leading drug delivery company focused on the development and manufacturing of pharmaceutical films, announced today that its Board of Directors has authorized the Company and its subsidiary to bring an application in the Québec Superior Court (Commercial Division) (the “Court”) to seek protection from creditors under the Companies’ Creditors Arrangement Act (“CCAA”) to give the Company sufficient time and breathing room to implement a review of its strategic alternatives.

After a careful review of all available alternatives and following thorough consultation with its legal and financial advisors, the Company’s Board of Directors determined that it was in the best interest of IntelGenx and its stakeholders to file an application for creditor protection under the CCAA. The protection afforded by the CCAA is intended to provide the Company with the time and breathing room necessary to implement a strategic review process under the oversight of the Board of Directors and with the advice of IntelGenx’s professional advisors. In this regard, IntelGenx anticipates that it will seek Court approval to initiate a formal sale and investment solicitation process intended to generate interest in either the business or the assets of IntelGenx, or in a recapitalization of IntelGenx, with the goal of implementing one or more transaction(s). The implementation of one or more transaction(s) may be in addition to, or as an alternative, to a CCAA plan of compromise or arrangement, to maximize return in respect of IntelGenx’s business and assets.

The initial Court order sought is expected to include a stay of creditor claims and exercise of contractual rights with a view to provide the Company some breathing room to implement its strategic review process. It is also expected to authorize interim debtor-in-possession (DIP) financing in order to allow the Company to continue its operations during the restructuring process and implement the necessary restructuring measures.

Trading in the common shares of the Company on the Toronto Stock Exchange (the “TSX”) has been halted and it is anticipated that the trading thereof will continue to be halted until a review is undertaken by the TSX regarding the suitability of the Company for listing on the TSX.

Furthermore, the Company has announced changes to its board of directors as Clemens Mayr, Sahil Kirpekar and Ryan Barrett have resigned from the Board of Directors of the Company, effective immediately.

The Company will provide an update on this matter once more information is available.

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 pharmaceutical 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 https://www.intelgenx.com/ and connect with us on X and LinkedIn.

IntelGenx Forward-Looking Statements

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to: (i) the outcome of the CCAA proceedings, (ii) the obtaining of the approval of the Court to initiate a formal sale and investment solicitation process to secure additional financing, sell assets, or a combination thereof, (iii) the ability of the Company to secure additional financing or otherwise enter into one or more transaction(s), and (iv) halt trading of the common shares and review of the TSX regarding the suitability of the Company for listing on the TSX and any outcome of such review. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including the outcome of the CCAA proceedings and the capacity of the Company to enter into one or more transaction(s) that would allow the Company to pursue its activities as a going concern and the continued listing of its common shares on a stock exchange. IntelGenx assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IntelGenx’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at http://www.sedar.com and on EDGAR at http://www.sec.gov/edgar

Source: IntelGenx Technologies Corp.

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SAINT LAURENT, Quebec, May 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX: IGX) (OTCQB: IGXT) (the “Company” or “IntelGenx”) announces that, at the annual meeting of shareholders of the Company held on May 7, 2024 (the “Annual Meeting”), shareholders voted in favour of all items of business put forth by the Company, including the election of the directors by a majority of the votes cast by shareholders present or represented by proxy.

The Annual Meeting was held in a virtual-only format, for those who were shareholders of the Company at the close of business on March 11, 2024 (the “Record Date”), pursuant to notice and proxy materials duly communicated to them. As of the Record Date, there were 174,658,096 shares outstanding of the Company’s common stock at $0.00001 par value (the “IntelGenx Common Stock”). Shareholders as of the Record Date holding 109,675,659 shares (62,794%) of the IntelGenx Common Stock were present at the Annual Meeting or per proxy. Each such shareholder was entitled to one vote for each share of the IntelGenx Common Stock held on the Record Date.

At the Annual Meeting, the following matters were submitted to votes of the Company’s shareholders:

	(i)	the election of eight directors;
	(ii)	the ratification of Richter LLP as the Company’s independent auditors for the fiscal year ending December 31, 2024;
	(iii)	the advisory vote on executive compensation; and
	(iv)	the passing of a resolution to approve all unallocated PRSUs.

Detailed voting results on the election of directors are as follows:

Name of Nominee	For		Against		Abstain
	Number	%	Number	%	Number	%
Horst G. Zerbe, Ph.D.	75,711,268	96.96	1,982,893	2.54	388,516	0.50
Bernd J. Melchers	75,750,832	97.01	1,437,429	1.84	894,416	1.15
Clemens Mayr	76,121,283	97.49	1,469,578	1.88	491,816	0.63
Mark Nawacki	76,244,152	97.65	1,359,609	1.74	478,916	0.61
Monika Trzcinska, Ph.D.	76,447,263	97.91	1,157,118	1.48	478.296	0.61
Sahil Kirpekar, Ph.D.	76,298,523	97.71	1,255,347	1.61	528,807	0.68
Ryan Barrett.	76,142,943	97.52	1,378,427	1.76	561,307	0.72
Dwight Gorham	75,922,577	97.23	1,611,018	2.06	549,082	0.70

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

Source: IntelGenx Technologies Corp.

For more information, please contact:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
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Ingrid Zerbe
Corporate Secretary
IntelGenx Technologies Corp.
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SAINT LAURENT, Quebec, April 08, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that Montelukast VersaFilm^® has been administered to the first Parkinson’s Disease (“PD”) patients in the Phase 2 (‘MONTPARK’) clinical trial.

MONTPARK (EudraCT number 2023-504278-39-00) is a Phase 2, randomized, double-blind, placebo-controlled, parallel arm, multicentre trial that will investigate the efficacy of oral high-dose Montelukast on the progression of early-to-moderate PD. The study will enroll up to 90 patients who will receive 30 mg Montelukast VersaFilm^® or placebo twice daily for 18-months, followed by a 3-month washout period. Eligible candidates must be on levodopa treatment at the time of enrolment and may also be on other dopaminergic symptomatic agents. MONTPARK is being conducted at the Karolinska University Hospital and at three other Swedish University affiliated institutions under IntelGenx’s previously announced research collaboration with Per Svenningsson, MD, PhD, who is serving as the study’s Lead Principal Investigator.

“Dosing of the first PD patients in the Phase 2 MONTPARK trial represents a major milestone in the clinical development of Montelukast VersaFilm^®, which is also being investigated for the treatment of mild to moderate Alzheimer’s Disease, or AD, in the ongoing ‘BUENA’ Phase 2a study,” said Dwight Gorham, IntelGenx’s CEO. “As treatment options for neurodegenerative diseases like PD and AD remain limited, with studies such as MONTPARK and BUENA, we are taking significant steps closer to providing patients with a novel, disease-modifying treatment that also offers a dosing method that is especially suited to their needs.”

About Parkinson’s Disease

PD is the second most common neurodegenerative disease after AD, with an estimated 9 million patients globally and 1 million patients in the United States.^1,2 In the United States it is estimated that 90,000 new patients will be diagnosed with PD every year.² No neuroprotective or disease-modifying treatments are currently available. The current standard treatment of PD motor dysfunction is based on the enhancement of dopaminergic transmission and involves the administration of L-dopa. Evidence from multiple patient studies and animal models has shown a significant immune component during the course of the disease, highlighting immunomodulation as a potential treatment strategy.³ Montelukast is a CysLT₁ antagonist which decreases neuroinflammation by inhibiting CysLT₁.

About Montelukast VersaFilm^®

Montelukast 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, such as PD and AD, 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 PD and AD 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.

References

¹World Health Organization: https://www.who.int/news/item/14-06-2022-launch-of-who-s-parkinson-disease-technical-brief#:~:text=Globally%2C%20the%20prevalence%20of%20Parkinson,million%20individuals%20living%20with%20PD

² Parkinson’s Foundation: https://www.parkinson.org/understanding-parkinsons/statistics

³Wallin, J; Svenningsson, P. Potential Effects of Leukotriene Receptor Antagonist Montelukast in Treatment of Neuroinflammation in Parkinson’s Disease. Int. J. Mol. Sci. 2021, 22, 5606

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
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SAINT LAURENT, Quebec, April 05, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the “Company” or “IntelGenx”) today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

The CRL includes a request for additional Pharmaceutical Quality information. The FDA confirmed that no additional inspection of IntelGenx’s facility is required at this time.

“Our partner is committed to providing the FDA with a response to the CRL as soon as is practicable,” commented Dwight Gorham, IntelGenx’s CEO.

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 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

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 SEC and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedarplus.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.

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NEWS RELEASE

IntelGenx is Granted Court Approval of the Sale Proposal from atai Life Sciences AG

IntelGenx Reports Fourth Quarter and Full-Year 2023 Financial Results

IntelGenx Provides Update on Previously Announced Sale and Investment Solicitation Process

IntelGenx Obtains Preliminary Efficacy Results for the ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease

IntelGenx Announces Initiation of the Sale and Investment Solicitation Process

IntelGenx Obtains Court-Approval of a Sale and Investment Solicitation Process

IntelGenx Initiates Restructuring Proceedings Under the CCAA to Implement a Review of its Strategic Alternatives

IntelGenx Announces Voting Results on Election of Directors

IntelGenx Announces First Parkinson’s Disease Patients Dosed with Montelukast VersaFilm® in Phase 2 ‘MONTPARK’ Clinical Trial

IntelGenx Updates Status of Buprenorphine Buccal Film ANDA