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IntelGenx Receives Amended DEL License to Conduct Third-Party Testing
- Provides opportunity to address market gap, catering to growing industry demand for reliable and efficient testing services -
SAINT LAURENT, Quebec, May 17, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") a leading drug delivery company, is pleased to announce that it has received an amended Drug Establishment License (“DEL”) from Health Canada, allowing the Company to conduct third-party testing.
Analytical testing of finished products and intermediates is a significantly underserved market, which IntelGenx has decided to tap into. The Company views this as an attractive opportunity for short-term revenue generation. The amended DEL license could be of particular importance due to IntelGenx's possession of a controlled substance license. This allows IntelGenx to access a broader market for testing services, further increasing its market penetration and revenue opportunities.
"By expanding our core CDMO business to include a third-party testing services offering, our aim is to offer ‘one-stop-shopping’ to our development partners,” said Dwight Gorham IntelGenx’s CEO. “IntelGenx's testing laboratory boasts exceptional efficiency and is currently operating at under capacity. This surplus in capacity allows us to seize the opportunity to generate revenue from third-party testing without any additional investment. While testing services will not be our primary focus, the added revenue will be welcomed, while at the same time, help foster business relationships with key players in the Canadian market.”
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.
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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IntelGenx Reports First Quarter 2023 Financial Results
SAINT LAURENT, Quebec, May 11, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today reported financial results for the first quarter ended March 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.
2023 First Quarter Financial Summary:
- Revenue was $162,000, compared to $237,000 in the 2022 first quarter.
- Net comprehensive loss was $2.9 million, compared to $3.0 million in Q1-2022.
- Adjusted EBITDA loss was $2.4 million, compared to $2.1 million in the 2022 first quarter.
First Quarter and Recent Developments:
- Received FDA approval of its RIZAFILM® VersaFilm® 505(b)(2) new drug application for the treatment of acute migraine.1
- Announced various changes to its management team. Its Board appointed Dwight Gorham as CEO, following the planned retirement of its founder and former-CEO, Dr. Horst G. Zerbe. Dr. David Kideckel, MBA, has been appointed as Senior Vice President, Head of Corporate Development and Strategic Alliances, and Tommy Kenny and Karen Kalayajian, CPA were promoted to Senior Vice President, General Counsel and Vice President, Finance and Administration of IntelGenx Corp., respectively.
- Announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the submitted abbreviated new drug application (ANDA) for Buprenorphine Buccal Film. Xiromed’s CRL response is expected in the current quarter.
- Participated in the 35th Annual ROTH Conference and the 2023 Bloom Burton Conference.
- Received a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form,” from the United States Patent and Trademark Office.
- Entered into a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, Stockholm, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm® for the treatment of Parkinson’s Disease.
- Entered into an exclusive supply agreement for RIZAPORT® with ARWAN Pharmaceuticals Industries Lebanon s.a.l. (“ARWAN”) in various countries in the Middle East and North Africa region.
- 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.
“IntelGenx had another eventful quarter highlighted by the achievement of a major milestone: the FDA’s approval of RIZAFILM® for the treatment of acute migraine,” commented Andre Godin, IntelGenx’s President and CFO. “We are working closely with our commercialization partner, Gensco® Pharma, to bring this convenient, fast-acting treatment to migraine sufferers across the United States. This program is also quickly gaining momentum outside of the U.S., as evidenced by our supply agreement earlier in the quarter with ARWAN for various countries in the Middle East and North Africa region.
“We were also pleased to partner with Dr. Svenningsson on his clinical study of Montelukast VersaFilm® for the treatment of Parkinson’s disease, the second most common neurodegenerative disorder after Alzheimer's disease, which is the indication for our ongoing Phase 2a ‘BUENA’ clinical trial. We are hopeful that Montelukast VersaFilm® will prove to be efficacious for both of these devastating indications, especially given an expected increase in prevalence due to an aging global population and paucity of effective treatments.”
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 March 31, 2023 amounted to $162,000, a decrease of 32% compared to $237,000 for the three-month period ended March 31, 2022. The change is mainly attributable to decreases in R&D revenues of $63,000 and royalties on product sales of $12,000.
Operating costs and expenses were $2.8 million for the first quarter of 2023, versus $2.5 million for the corresponding three-month period of 2022. The change is mainly attributable to increases of $24,000 in R&D expenses, $2,000 in manufacturing expenses, and $211,000 in selling, general and administrative expenses, offset partially by decreases of $3,000 in depreciation of tangible assets.
For the first quarter of 2023, the Company had an operating loss of $2.6 million, compared to an operating loss of $2.3 million for the comparable period of 2022.
Net comprehensive loss for the three-month period ended March 31, 2023 was $2.9 million, or $0.02 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 March 31, 2023, the Company's cash and short-term investments totalled $3.8 million.
Conference Call Details:
IntelGenx will host a conference call to discuss these first 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) 528-011 (International), access code 655475. 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 Kilmer
Investor Relations
(647) 872-4849
This email address is being protected from spambots. You need JavaScript enabled to view it.
Or
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 and Arwan Enter into a Supply Agreement for RIZAPORT® in MENA Countries
SAINT LAURENT, Quebec, Jan. 23, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, announced today that it has entered into an exclusive supply agreement (the “Agreement”) for RIZAPORT® (the “Product”) with ARWAN Pharmaceuticals Industries Lebanon s.a.l. (“ARWAN”) in various countries in the Middle East and North Africa (“MENA”) region, including Lebanon, Kuwait, Saudi Arabia, United Arab Emirates, Jordan, Iraq, , Libya, Oman, Yemen, Qatar, Bahrain, Egypt, Sudan, Kenya, Nigeria, Mauritius, Cameroon, Afghanistan, Tajikistan, Kazakhstan, Turkmenistan, and Uzbekistan (the “Territory”).
RIZAPORT® is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt®. Rizatriptan is considered to be one of the most effective oral triptans, a class of molecules that constricts blood vessels in the brain to relieve swelling and other migraine symptoms.1 RIZAPORT® is based on IntelGenx's proprietary VersaFilm® technology. It dissolves rapidly and releases its active ingredient in the mouth. The administration method of the RIZAPORT® oral soluble film, which does not require the patient to swallow a pill or consume water, along with its neutral flavor, presents a therapeutic alternative for migraine patients, especially for those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population, and for patients suffering from dysphagia (difficulty swallowing).1
Under the terms of the Agreement, IntelGenx will supply the Product to ARWAN, which will have the exclusive right to register and commercialize it in the Territory.
“The marketing and distribution of an innovative product like RIZAPORT® requires deep insight into both the treatment and regulatory landscape within a target country,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “ARWAN knows the MENA marketplace intimately, and has a successful track record. We are looking forward to working with them."
"We are excited to bring this innovative and easy-to-administer treatment to patients in the MENA region, where migraine prevalence is similar to that in the rest of the world,” said Abdul Razzaq Yousef, President of ARWAN.
Reference
1. Láinez MJA. (2006) Rizatriptan in the treatment of migraine. Neuropsychiatr Dis Treat. 2006 Sep; 2(3): 247–259.
About ARWAN
Founded in 2009 and based in Lebanon, ARWAN develops, manufactures and markets critical care products, focusing on new generations anti-infectives, hematinics, anesthetics and analgesics, gastrointestinals, oncology, antiasthmatics, cardiovasculars, osteoporosis and wound management modalities.
ARWAN markets extend beyond Lebanon to cover the 20 countries of MENA as well as Africa, where the large Lebanese diaspora acts as a liaison in establishing businesses and forging partnership.
For more information, visit www.arwanlb.com.
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.
Or
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 Announces Research Collaboration with Renowned Neurologist to Evaluate Montelukast VersaFilm® for the Treatment of Parkinson’s Disease
SAINT-LAURENT, Quebec, Feb. 09, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx”), a leader in pharmaceutical films, today announced a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study (the “Study”) to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”).
Dr. Svenningsson will serve as the Principal Investigator for the planned Study and will sponsor it through a 20 million Swedish Crowns grant (approx. $2 million USD) awarded by the Swedish Research Council, Sweden’s largest governmental research funding body. IntelGenx will supply Dr. Svenningsson with both active and placebo films to be used in the 18-month treatment regimen for study participants. Upon completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop its Montelukast VersaFilm® program for Parkinson's disease treatment. The Study is currently expected to commence in the third quarter of 2023.
Parkinson’s disease (PD) is one of the most common movement disorders in elderly people and is the second most common neurodegenerative disorder after Alzheimer's disease (“AD”).1 It is a neurodegenerative disorder where misfolded alpha-synuclein-enriched aggregates, called Lewy bodies, are central in pathogenesis. 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.2 Montelukast is a CysLT1 antagonist which decreases neuroinflammation by inhibiting CysLT1. Early results have indicated its potential usefulness for the treatment of various neurodegenerative disorders like PD and AD.
“We believe that Montelukast VersaFilm® has the potential to be disease-modifying, not only in AD, as is being currently investigated in the Phase 2a ‘BUENA’ clinical trial, but also in PD,” said Dr. Horst G. Zerbe, CEO of IntelGenx. “Dr. Svenningsson is professor of Clinical Neuroscience at the Karolinska Institute and investigates pathogenic mechanisms of PD. He has previously conducted a clinical study utilizing the tablet form of Montelukast in the treatment of PD, and we are excited that he will be leading this new clinical study with our proprietary oral film formulation of the drug.”
References
1 Aarsland, D., Batzu, L., Halliday, G.M. et al. Parkinson disease-associated cognitive impairment. Nat Rev Dis Primers 2021: 7, 47.
2 Wallin, 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
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 Alzheimer’s Disease and PD 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.
Or
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 Receives USPTO Notice of Allowance for Loxapine Orange Book Eligible Patent
SAINT LAURENT, Quebec, Feb. 21, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx”), a leader in pharmaceutical films, today announced that the United States Patent and Trademark Office (“USPTO”) has granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form.”
This film formulation patent covers Loxapine oral film formulations designed for use in patients with anxiety and agitation associated with schizophrenia and bipolar 1 disorder, and is intended to protect IntelGenx' Loxapine VersaFilm® product.
The new, soon to be patented, Loxapine oral film technology is designed to provide quick onset and a simple administration process for schizophrenia and bipolar 1 disorder patients. Currently, the marketed loxapine product for agitation treatment in schizophrenia and bipolar mania is an inhaler that can only be administered at certified healthcare settings under supervision of a physician. IntelGenx's Loxapine VersaFilm® is intended as a rescue medication which can be administered by caregivers and, therefore, has the potential to increase availability of the drug to patients.
"The granting of this notice of allowance for a formulation specific orange book eligible patent for our Loxapine oral film validates the innovative work carried out on this project by our talented R&D team," said Horst G. Zerbe, CEO of IntelGenx. "While expanding our overall intellectual property portfolio, this new patent also solidifies the potential long-term market exclusivity of our unique Loxapine VersaFilm® product candidate."
About Loxapine VersaFilm®
Loxapine VersaFilm® is the first innovative oral thin film of loxapine for use in patients with agitation associated with schizophrenia and bipolar 1 disorder. Loxapine VersaFilm® utilizes IntelGenx’s proprietary VersaFilm® technology, allowing for an improved drug product which addresses unmet medical needs in schizophrenia and bipolar 1 disorder.
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.
Or
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 Participate in the 35th Annual Roth Conference
SAINT LAURENT, Quebec, March 09, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT), please note that the time of the fireside chat has been updated. The corrected release follows:
IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx”), a leader in pharmaceutical films, will be participating in the 35th Annual ROTH Conference, being held March 12–14, 2023 at the Ritz-Carlton Hotel in Dana Point, California.
IntelGenx’s President and CFO, Andre Godin, will participate in a fireside chat hosted by Jonathan Aschoff, Ph.D., Managing Director, Senior Research Analyst at ROTH MKM, on Tuesday, March 14, 2023, at 11:30 a.m. Pacific Time. Mr. Godin will also participate in one-on-one meetings with investors during the conference.
To arrange a one-on-one with IntelGenx, please email This email address is being protected from spambots. You need JavaScript enabled to view it. or contact your ROTH sales representative to arrange.
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.
Or
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 Announces Closing of Notes Offering
SAINT LAURENT, Quebec, March 21, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX: IGX) (OTCQB: IGXT) (the “Company” or “IntelGenx”) announces the closing of an offering by way of private placement (the “Offering”) to certain investors in the United States of convertible notes due March 1, 2027 (the “Notes”) for aggregate gross proceeds of approximately US$760,000 (C$1,000,000). The Notes will bear interest at a rate of 10% per annum, payable quarterly, and will be convertible into shares of common stock of the Company (the “Shares”) beginning six months after their issuance at a price of US$0.20 per Share.
Cantone Research, Inc. (“Cantone”) acted as placement agent in respect of the Offering.
The Company intends to use the proceeds of the Offering to finance the Company’s Rizaport and Buprenorphine programs as well as for working capital.
In connection with the Offering, the Company paid Cantone a cash commission of approximately US$53,000 in the aggregate and issued non-transferable warrants to Cantone (the “Agent’s Warrants”), entitling Cantone to purchase 304,000 Shares at a price of US$0.20 per Share until March 21, 2025.
The TSX Exchange (the “TSX”) has conditionally approved the listing of the Shares issuable upon conversion of the Notes, as well as the Shares issuable upon exercise of the Agent’s Warrants. Listing on the TSX will be subject to the Company fulfilling all of the listing requirements of the TSX.
This press release does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction where not permitted by law. Any securities described in this announcement have not been registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold in the United States, or to, or for the account or benefit of a “U.S. person” as defined in Regulation S under the U.S. Securities Act, except in transactions exempt from, or not subject to, registration under the U.S. Securities Act and applicable state securities laws.
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 more information, please contact:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
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Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
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IntelGenx to Report Fourth Quarter and Full Year 2022 Financial Results on March 30, 2023 – Conference Call to Follow
SAINT LAURENT, Quebec, March 23, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that it will release its fourth quarter and full year 2022 financial results after market close on Thursday, March 30, 2023.
An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:
| Fourth Quarter and Full Year 2022 Results Conference Call Details: | |
| Date: | Thursday, March 30, 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: | 884881 |
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.
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.
Or
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 Revises Fourth Quarter and Full Year 2022 Financial Results Reporting and Conference Call Date to March 29, 2023
SAINT LAURENT, Quebec, March 24, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) (“IntelGenx”), a leader in pharmaceutical films, today announced that, further to its press release of March 23, 2023, it now plans to release its fourth quarter and full year 2022 financial results after market close on Wednesday, March 29, 2023.
An accompanying conference call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer, to discuss the results and provide a business update. Details of the conference call and webcast are below:
| Fourth Quarter and Full Year 2022 Results Conference Call Details: | |
| Date: | Wednesday, March 29, 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: | 884881 |
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.
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.
Or
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 Reports Fourth Quarter and Full-Year 2022 Financial Results
SAINT LAURENT, Quebec, March 29, 2023 (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, 2022. 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.
"The progress we made throughout 2022 has led us to now being potentially on the cusp of a stage of anticipated rapid growth,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In April, we expect the FDA’s decisions on the Buprenorphine Buccal Film ANDA, as well as the RIZAFILM® NDA. On the development front, we are also looking forward to atai announcing topline results from its Phase 1 clinical trial of Buccal VLS-01, the first ever in-human clinical study evaluating an all thin film psychedelic drug candidate.”
2022 Fourth Quarter Financial Highlights:
- Revenue was $173,000, compared to $494,000 in the 2021 fourth quarter, mostly due to one-time licensing revenue received in 2021.
- Net comprehensive loss was $2.3 million, compared to $2.9 million in the 2021 fourth quarter.
- Adjusted EBITDA loss was $2.3 million, essentially unchanged from Q4-2021.
2022 Full-Year Financial Highlights:
- Revenue was $1.0 million, compared to $1.5 million in 2021, mostly due to one-time licensing revenue received in 2021.
- Net comprehensive loss was $11.6 million, compared to $9.8 million in 2021.
- Adjusted EBITDA loss was $8.5 million, compared to $7.1 million in 2021.
Fourth Quarter and Recent Developments:
- Received a fourth and final term loan tranche in the amount of $3.0 million pursuant to the amended and restated secured loan agreement with the Company’s strategic partner, atai Life Sciences (“atai’).
- Closed a private placement offering of convertible notes due March 1, 2027 for aggregate gross proceeds of approximately $760,000 (C$1 million).
- Received from the U.S. Food and Drug Administration (‘FDA”) a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the Agency’s review of the 505(b)(2) New Drug Application (“NDA”) for RIZAFILM® VersaFilm®.
- Participated in the 35th Annual ROTH Conference in Dana Point, California.
- Granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form,” from the United States Patent and Trademark Office.
- Entered into a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of Montelukast VersaFilm® for the treatment of Parkinson’s Disease.
- Entered into an exclusive supply agreement for RIZAPORT® with ARWAN Pharmaceuticals Industries Lebanon s.a.l. in various countries in the Middle East and North Africa region.
- Entered into a research collaboration with the University of Prince Edward Island to assess palatability, owner-perceived acceptability, and ease of administration of the Company’s VetaFilm™ platform in healthy dogs and cats.
Financial Results:
Total revenues for the three-month period ended December 31, 2022 amounted to $173,000, a decrease of $321,000, or 65%, compared to $494,000 for the three-month period ended December 31, 2021. The change is mainly attributable to decreases in revenues from licensing agreements of $249,000, R&D revenues of $43,000 and product revenues of $36,000, offset partially by an increase in royalties on product sales of $7,000. Operating costs and expenses were $2.7 million for the fourth quarter of 2022, versus $3.0 million for the corresponding three-month period of 2021. For Q4-2022, the Company had an operating loss of $2.5 million, essentially unchanged from the operating loss for the comparable period of 2021. Net comprehensive loss was $2.3 million, or $0.01 per basic and diluted share, for the fourth quarter of 2022, compared to net comprehensive loss of $2.9 million, or $0.02 per basic and diluted share, for the comparable period of 2021.
Total revenues for the twelve-month period ended December 31, 2022 amounted to $1.0 million, representing a decrease of $585,000, or 38%, compared to $1.5 million for the year ended December 31, 2021. Operating costs and expenses were $10.4 million for the full year 2022, versus $9.5 million for the corresponding twelve-month period of 2021. For the twelve-month period of 2022, the Company had an operating loss of $9.4 million, compared to an operating loss of $8.0 million for the comparable period of 2021. Net comprehensive loss was $11.6 million, or $0.07 per basic and diluted share, for the twelve-month period of 2022, compared to net comprehensive loss of $9.8 million, or $0.07 per basic and diluted share, for the comparable period of 2021.
As at December 31, 2022, the Company's cash and short-term investments totalled $2.5 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in January 2023, nor the $760,000 in gross proceeds from the private placement offering of convertible notes, which closed in March 2023.
Annual Filings:
The Company's annual report on Form 10-K and financial statements for the year ended December 31, 2022, as well as the 2023 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 29, 2023.
Conference Call Details:
IntelGenx will host a conference call to discuss these 2022 fourth quarter and full year 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 884881. 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.
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.
Or
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.
