Gensco Pharma LLC

SAINT LAURENT, Quebec, March 21, 2024 (GLOBE NEWSWIRE) -- IntelGenx 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 under "Webcasts" in the Investors section. 1 RIZAFILM® is a Registered Trademark of Gensco® Pharma Corporation. 2 This 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 . 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 , and also filed with Canadian securities regulatory authorities at . IntelGenx assumes no obligation to update any such forward-looking statements. Source: IntelGenx Technologies Corp. For IntelGenx: Stephen Kilmer Investor Relations (647) 872-4849 stephen@kilmerlucas.com Or Andre Godin, CPA, CA President and CFO IntelGenx Corp. (514) 331-7440 ext 203 andre@intelgenx.com

SAINT LAURENT, Quebec, Nov. 09, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the third quarter ended September 30, 2023. All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise. 2023 Third Quarter Financial Summary: Revenue was $318,000, compared to $142,000 in the 2022 third quarter.Net comprehensive loss was $2.5 million, compared to $3.0 million in Q3-2022.Adjusted EBITDA loss was $2.1 million, compared to $2.2 million in the 2022 third quarter. Third Quarter and Recent Developments: Received the first purchase order for RIZAFILM®1 from Gensco Pharma (Gensco®), the Company's U.S. commercialization partner, which triggered an upfront order deposit payment and a pre-specified milestone payment.Announced a further amendment to the November 2018 license, development and supply agreement with Tilray Brands Inc. ("Tilray") for the co-development and commercialization of cannabinoid-infused VersaFilm® products, and received an initial purchase order from Tilray for three SKUs (CBD20, THC10, THC10:CBD1), settling IntelGenx's arbitration claim against Tilray.Completed patient enrollment in the ongoing Phase 2a (“BUENA”) clinical trial of IntelGenx’s Montelukast VersaFilm® in patients with mild to moderate Alzheimer’s Disease (“AD”).Announced that, as part of a research collaboration with Karolinska University Hospital, Stockholm, and Per Svenningsson, MD, PhD, the manufacturing of both active and placebo films was underway for a planned clinical trial evaluating Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).Announced that the U.S. Food and Drug Administration (“FDA” or the “Agency”) granted Xiromed LLC (“Xiromed”), the agent and affiliate of IntelGenx’s co-developer, Chemo Research SL, priority review of its amended abbreviated new drug application (ANDA) for Buprenorphine Buccal Film. Unless the Agency determines that an inspection is required, the Generic Drug User Fee Act (GDUFA) goal date is March 8, 2024.In the first major expansion of the Company’s CDMO business, entered into a binding term sheet agreement for the packaging of a pharmaceutical oral film product that its undisclosed CDMO customer is planning to commercialize in the United States.Closed the first tranche of a non-brokered private placement of units from atai Life Sciences AG (“atai”) for aggregate gross proceeds of approximately $3 million, including $750,000 to be received by the Company pursuant to a subsequent atai subscription, assuming shareholder approvals are obtained. “We have announced several positive developments over the past few months,” commented Mr. Gorham, CEO of IntelGenx. “We received from Gensco® their first RIZAFILM® purchase order, which triggered an upfront payment and a milestone payment that are both reflected in our third quarter financial results. We were also pleased with Xiromed’s successful request for the FDA’s priority review of the amended ANDA for Buprenorphine Buccal Film, and we are looking forward to the Agency’s decision. In addition, we completed patient enrollment in the ongoing Montelukast VeraFilm® Phase 2a BUENA clinical trial in AD; took another important step toward expanding our Montelukast VersaFilm® clinical program to include the treatment of PD in addition to AD; expanded our CDMO business to include oral thin film packaging services; and, earlier this week, settled our arbitration claim against Tilray, allowing the two companies to begin a new chapter of making innovative cannabinoid-infused VersaFilm® products available to consumers.” 1. RIZAFILM® (U.S. market name for RIZAPORT®) is a Registered Trademark of Gensco® Pharma Corporation 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. 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 KilmerInvestor Relations(647) 872-4849stephen@kilmerlucas.com Or Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514) 331-7440 ext 203andre@intelgenx.com

Receives first purchase order from Gensco® PharmaSAINT 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. 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, as well as other CDMO services. 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 KilmerInvestor Relations(647) 872-4849stephen@kilmerlucas.com Or Andre Godin, CPA, CAPresident and CFOIntelGenx Corp.(514) 331-7440 ext 203andre@intelgenx.com