IntelGenx Technologies Corp.

Greetings and welcome to the Intelligenix second quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, This is Stephen Kilmer, Investor Relations at Intelligenix. Stephen, you may begin.

Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, Intelligenix's CEO, Andre Godin, our President and CFO, Dr. David Kudickel, the company's SVP and Head of Corporate Development and Strategic Alliances, Dr. Frank P.M. Trantonio, our Director of Clinical Research, Tommy Kenney, our Senior Vice President and General Counsel, and Dr. Horst Hervé, Intelligent Nexus Chairman. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars unless otherwise mentioned, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements except as may be required by U.S. and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on these risks and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I would now like to turn the call over to Mr. Gorham. Dwight?

Thank you, Steve. Good afternoon, everyone, and thank you for joining us for the Intelligenix second quarter 2023 conference call. On today's call, I will provide a corporate update and discuss progress we've made on our key pipeline projects. Then Andre will review our financial results. Following that, we'll open up the line for your questions. So to start, I will now update you on one of our key programs, on our key programs, beginning with Aresaport. The FDA approval of our 505 new drug application for Rezafilm, the US market name for Rezaport, marked a major milestone achievement for the company. It is Intelligenic's first FDA approval for a film product developed in-house using proprietary Versafilm technology. Importantly, the FDA approval included a request that within two years we develop a five milligram pediatric version of the film and submit an application for the agency's review and approval. According to a recent issue of Practical Neurology, migraine affects up to 7 million children and adolescents in the US. In addition to reflecting the remarkable impact migraine has on younger individuals, the FDA's request affirms our belief that a film-delivered migraine treatment will be valuable to younger patients that have difficulty swallowing pills due to nausea and other factors. The commercialization of Rhizofilm in the USA as well as in Spain is one of our three short-term commercial objectives we unveiled in May. Our U.S. commercialization partner for Rhizofilm, Gensco Pharma, is planning to achieve the first saleable product later this year with full commercialization in early 2024. Exaltus, Our partner for Risaport in Spain continues to await a regulatory approval to implement a new strategy to enable product substitution at the pharmacy level. Based on the positive feedback they have received from prescribing doctors and patients, we believe, if approved, Exalta's new strategy will boost product sales. We are also pleased to announce that the work of our CDMO business development team has resulted in a binding term sheet with a CDMO customer with a packaging of pharmaceutical oral film produced that they are planning to commercialize in the United States. The expected agreement is estimated to generate approximately $9 million in revenue over three years and we look forward to providing updates as we work to finalize such agreement with them. Turning to our other CDMO business, we received in May an amended drug establishment license from Health Canada that allows us to provide third-party testing services, further supporting our short-term commercial objective to expand as part of the business. Also, on our CDMO business and subsequent to quarter end, we just signed up a customer to engage on an R&D project with the objective of advancing commercial output. We're extremely excited to embark on this new piece of immediate revenue generating business. Changing the subject and turning to our Monte Lucas program, we are thrilled to announce completion of enrollment in our Phase 2A, you know, clinical trial in patients with mild to moderate Alzheimer's disease, or AD. As you may recall, the COVID-19 pandemic effectively halted the BUNA trials recruitment for a year and a half, and the post-pandemic restrictions imposed by hospitals posed an additional challenge to trial recruitment. With the intention of avoiding any further delay in achieving the program's goal, we engaged our statistical consultant, Cog State Limited, and determined that we could decrease enrollment while still providing a basis to determine which drug effect sizes are statistically significant by adjusting the p-values to less than 0.1. The study design modifications received a no objection letter from Health Canada and we've completed study enrollment with 52 patients with 18 fewer than initially planned. We are confident that this Health Canada authorized study design modification will enable us to utilize data from fewer patients while optimizing the power of the study to detect the effects of Montelukas Versafilm compared to placebo. We are looking forward to completing the BUNO trial in the first quarter of 2024 and to report initial trial results the following quarter. Believing that Montelukas Versafilm has the potential to be disease-modifying not only in AD, but as being currently investigated in BUNO trial, but also in the Parkinson's disease, we've expanded the program. In conjunction with that, we recently announced that we that manufacturing both active and placebo films are underway in preparation for a multi-center, randomized, double-blinded, placebo-controlled clinical study to investigate the use of Monteluca's Versafilm for the treatment of PD or Parkinson's disease. The study will be conducted at the Karolinski University Hospital under our previously announced research collaboration with Dr. Pehr Sevingson, who will serve as a study's principal investigator. Dr. Sevingson previously conducted a clinical trial study utilizing the tablet form of Monte Lucas for the treatment of PD, where two tablets of 10 milligram Monte Lucas were administered twice daily for a total dose of 40 milligrams. The planned study will assess Montelukas in doses exceeding 40 milligrams, so the Montelukas Versafilm offers study participants an attractive dosing alternative to tablets, which would have them require administration of multiple tablets several times per day. Dr. Sevingson will sponsor the study through a Swedish research grant worth approximately 2 million USD. Intelligenix has the option to acquire developed IP and study data for a potential further development of Monte Lucas Versafilm for the treatment of PD. We are currently expecting the study to commence in Q3 2023 and will provide more details on its design when they are available. ZyroMed. In April, we announced that Chemo Research, through its agent and affiliate, Zyromed, received a complete response letter from the FDA. They submitted a abbreviated new drug application for buprenorphine bucofilm. Buprenorphine bucofilm is a generic version of buca, an opioid that is used to manage pain. It's fair enough to require daily, around-the-clock, long-term treatment, with an opioid when other pain treatments are inadequate. Balbuca was approved by the FDA in 2015 and is applied to the oral or buccal mucosis every 12 hours. Buprenorphine buccal film incorporates our Versa technology in a novel formulation and is designed to be bioequivalent lower cost alternative for patients. ZyroMed's CRL response is expected in the current quarter. Animal health. As mentioned on our previous earnings call, our newly appointed Senior VP and Head of Corporate Development Strategy, Dr. David Cadigo, is in advanced discussions to engage a potential major animal health partner over a multi-year period. We expect to be able to announce more details on this during the next quarter. With that, I would like to now turn the call over to André for a review of our financial results. André.