IntelGenx Technologies Corp - IGXT stock
OTC Symbol: IGXT | OTC Tier: OTCQB
Overview[edit]
The drug delivery business IntelGenx Technologies Corp. (OTC: IGTX) specializes in creating and producing innovative oral thin film products for the pharmaceutical industry. It provides INT0008/2008, an oral film product containing rizatriptan for the treatment of migraines; INT0046/2018 for adult use; INT0007/2006, an oral film product for the treatment of erectile dysfunction; INT0043/2015, an oral film containing montelukast for the treatment of Alzheimer's, INT0027/2011 to treat opioid addiction, INT0010/2006 for the treatment of neuropathic pain and nausea in Additionally, INT0039/2013, INT0040/2014, INT0052/2020, INT0053/2020, and INT0054/2020 are being developed.[1]
The business has a development arrangement with Cynapsus Therapeutics Inc. and a licensing, development, and supply deal with Tilray, Inc. It was established in 2003, with its headquarters in Canada Montreal.[1]
Products[edit]
Migraine - RIZAPORT®[edit]
Approved for migraine treatment, RIZAPORT® marks the inaugural rizatriptan oral disintegrating film to secure marketing approval in the European Union. This product is crafted utilizing VersaFilm™, a proprietary oral film technology developed by IntelGenx. Rizatriptan, a selective 5-HT1B/1D receptor agonist, is recommended for alleviating migraines. Notably, compared to alternative triptan-based oral medications, rizatriptan showcases superior efficacy and boasts the shortest Tmax, ensuring rapid onset of action for individuals grappling with migraines.[2]
Erectile Dysfunction[edit]
Approved for the treatment of erectile dysfunction, Tadalafil VersaFilm® is a product developed utilizing IntelGenx's proprietary thin film technology and tadalafil, one of the primary PDE5 inhibitors prescribed for this condition. Following clinical trials involving different tadalafil film formulations to refine pharmacokinetics and formulation, IntelGenx's latest formulation has shown bioequivalence to the Cialis® tablet in a preliminary study. IntelGenx plans to introduce its Tadalafil film to the market prior to the expiration of the Cialis® patent..[2]
Schizophrenia[edit]
Loxapine VersaFilm® is the first innovative oral thin film of loxapine designed specifically for individuals with agitation linked to schizophrenia and bipolar I disorder. This product, utilizing IntelGenx's proprietary VersaFilm® technology, represents an advancement in addressing the unmet medical needs within these conditions. Agitation accompanying schizophrenia or bipolar mania, if not treated, can quickly escalate into physically aggressive behavior, posing potential risks to both the affected individual and others. Loxapine, a widely recognized antipsychotic medication, is often utilized in clinical settings to manage agitation associated with schizophrenia and bipolar mania.[2]
Neurodegenerative Brain Diseases[edit]
Recommended for the management of degenerative brain conditions such as dementia, Alzheimer's disease, and moderate cognitive impairment, Montelukast VersaFilm® offers a pioneering therapeutic alternative. IntelGenx is reformulating Montelukast using VersaFilm®, its patented thin film technology, to serve as a treatment option for neurodegenerative disorders.[2]
Montelukast is currently known as Singulair® (Merck & Co.), a once-daily pill used for seasonal allergic rhinitis and persistent asthma. With a notably favorable safety profile, it received initial approval from the US Food and Drug Administration in 1997. As a leukotriene receptor antagonist, montelukast mitigates inflammation triggered by bronchoconstriction resulting from leukotrienes. Leukotriene signaling is believed to contribute to brain inflammation, and montelukast may offer benefits in alleviating memory impairment by addressing inflammatory processes in the brain. In a recent Phase I trial, IntelGenx demonstrated the safety and tolerability of administering Montelukast via film, showcasing its ability to reduce the first-pass effect and providing a 52% higher bioavailability compared to the Montelukast pill. IntelGenx's Montelukast VersaFilm® also crosses the blood-brain barrier, a crucial attribute for treating degenerative brain conditions.[2]
IntelGenx is currently preparing for a Phase 2a proof-of-concept study to evaluate the safety, feasibility, tolerability, and efficacy of Montelukast VersaFilm® in patients with mild to moderate Alzheimer's disease. Additionally, IntelGenx intends to establish a strategic partnership for the development and subsequent commercialization of a branded, differentiated Montelukast film product, Montelukast VersaFilm®.[2]
Partnerships[edit]
IntelGenx has a research collaboration agreement with the University of Prince Edward Island (“UPEI”) to assess the palatability, owner-perceived acceptability, and ease of administration of IntelGenx’s VetaFilm™ platform in healthy dogs and cats. Ensuring consistent medication administration to dogs and cats is a common concern among pet owners and veterinarians alike. There are limited prescribed medications that dogs and cats willingly consume, and forcibly administering capsules, tablets, or liquids can be stressful for both the pet and its owners. Moreover, many owners find it increasingly challenging to medicate their pets with each dose, resulting in reduced owner compliance, missed doses, and potential treatment failures. IntelGenx's VetaFilm™, a proprietary veterinary oral film technology, offers a novel and potentially superior method for medicating companion animals.[3]
The collaboration will conduct a series of studies to assess several factors, including: (1) the initial acceptance rate of different VetaFilm™ placebo formulations in dogs and cats; (2) the preference for flavors among VetaFilm™ placebo formulations in dogs and cats; (3) changes in acceptance rates over extended periods; and (4) owner perceptions regarding the ease of administration, acceptance, and other behaviors associated with VetaFilm™ placebo formulations.[3]
Financing[edit]
Series A Preferred Stock[edit]
On February 20, 2024, IntelGenx announced the commencement of a Regulation A offering, intending to issue up to 2,000,000 shares of Series A Convertible Cumulative Preferred Stock at an offering price of $10.00 per share. Holders of the Series A Preferred Stock will be entitled to receive cumulative dividends amounting to $0.20 per share every quarter, equivalent to an annual rate of 8%. Each share of Series A Preferred Stock will be convertible into twenty (20) shares of the Company's common stock. The company has the right to redeem the outstanding shares of the Series A Preferred Stock at a call price equivalent to 150% of the original issue price.[4]
Loan Agreement[edit]
IntelGenx entered into a loan agreement on March 8, 2024, which amends the second amended and restated loan agreement dated September 30, 2023. This agreement involves atai Life Sciences AG, wherein atai has committed to providing (i) an additional term loan of US$1,000,000 to IntelGenx Corp., and (ii) another term loan of US$1,000,000 to be disbursed upon the accomplishment of a predefined milestone. The loan are set to mature on February 1, 2026. The loan agreement also provides for the conversion of the loan to shares of IntelGenx stock.[5]
Management[edit]
Dwight Gorham[edit]
Dwight Gorham became Chief Executive Officer in April 2023 and brings 30 years of experience in the Life Sciences industry. Past leadership roles inclue President and CEO of Pillar 5 Pharma Inc., Senior Vice President and General Manager Global Operations of Pharmascience Inc., and President and CEO at Accucaps Industries Ltd.
Andre Godin, CPA, CA - President and Chief Financial Officer[edit]
Mr. Godin has over 25 years in the pharmaceutical industry and has served as President and CFO of Intelgenx since 2019. [6]
Horst G. Zerbe, Ph.D - Founder and CEO[edit]
Since April 2006, Dr. Zerbe has served as IntelGenx Technologies Corp.'s chairman and chief executive officer. He is a founder of IntelGenx Corp. and, since 2005, Dr. Zerbe has held the positions of CEO and Director of the company's Canadian subsidiary. [6]
- ↑ 1.0 1.1 Yahoo Finance. IGXT Stock Profile. Retrieved on 12/18/2022.
- ↑ 2.0 2.1 2.2 2.3 2.4 2.5 Intelgenx. Product Overview. Retrieved on 12/18/2022.
- ↑ 3.0 3.1 Globenewswire. IntelGenx Announces Collaboration with UPEI to Evaluate Acceptance and Preference of VetaFilm™ Platform in Dogs and Cats. December 07, 2022.
- ↑ Yahoo Finance. UPDATE -- IntelGenx Launches Preferred Share Regulation A Offering. February 20, 2024.
- ↑ Yahoo Finance. IntelGenx Enters Into a Third Amended and Restated Loan Agreement With atai Life Sciences. March 11, 2024.
- ↑ 6.0 6.1 Intelgenx. About Us Management. Retrieved on 12/18/2022.
