IntelGenx Technologies Corp.

Greetings. Welcome to Intelligenix's third 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 call is being recorded. I will now turn the conference over to your host, Stephen Kilmer, Investor Relations at Intelligenix. You may begin.

Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, Intelligent Nexus CEO, Andre Gauden, our President and CFO, Dr. Frank P. Antonio, our Director of Clinical Research, Tommy Kemi, our Senior Vice President and General Counsel, and Dr. Horster Bay, Intelligent Nexus Chairman. Before we begin, I would like to remind you all that the 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 they be required by U.S. and Canadian security 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 Commission. 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 third quarter 2023 conference call. On today's call, I will provide a corporate update and discuss the progress we've made on our key pipeline projects consistent with what we had previously committed to shareholders. Then Andre will review our financial results. Following that, we will open up the line for your questions. I will now update you on our key programs, beginning with ResaPort. During the quarter, we received the first purchase order for ResaFilm, the U.S. market name for ResaPort, from our U.S. commercial partner, Gensco Pharma. This represents a significant milestone for the company, as it is our first purchase order for commercial supply of a pharmaceutical oral film. The purchase order triggered both an upfront order deposit payment, as well as a pre-specified milestone payment, both of which are reflected in our Q3 2023 financial results. We expect to ship the ordered RESA film product to Gensco in Q1 2024 for immediate launch to market. Production of the RESA film is expected to commence in December 2023. Also, Exaltus, our partner for Resupport in Spain, received this week the regulatory approval to implement a new strategy that enables product substitution at the pharmacy level. Based on the positive feedback they received from prescribing doctors and patients, we believe Exaltus' new strategy will ultimately boost product sales. We are eager to see this new strategy implemented to increase product substitution at the pharmacy level and the corresponding increase in resupport sales in Spain. Turning to our buprenorphine buccal film program, Zyromed, the agent and affiliate of our co-development partner, Chemo Research, submitted to the FDA an amendment to the abbreviated new drug application requesting priority review. The FDA granted priority review with a generic drug user fee act or GDUFA goal date of March 8th, 2024. However, if the agency determines that an inspection is required, the GDUFA date is July the 8th, 2024. But given the March 2023 pre-approval inspection of our facility, and the subsequent approval of resitriptin oral film, we are relatively confident that the FDA will decide to review this amendment without the need for an additional inspection. Now, turning to our cannabis business, we are happy to have entered into a settlement agreement with Tilray. The settlement agreement includes a purchase order for three new product, BBD 20, THC 10, and a 10-10 combined CBD THC and was entered into concurrently with an amendment to our licensing and development and supply agreement with Tilray that renders the relationship non-exclusive for both parties. Clearly, this represents a new stage in our relationship with Tilray. However, we have worked hard this year to develop these three products and are looking forward to having them available to medical cannabis patients. Next, turning to animal health, we have discussed during the previous call that we are under discussions with a potential partner for an important development and license agreement for an animal health product using our VetaFilm technology. These discussions are still ongoing, and with the substantial progress we have made to date, we anticipate being able to announce this animal health partnership later this year. Finally, With respect to our commercial activities, we expanded our CDMO offering by signing a binding term sheet for the packaging of a pharmaceutical oral film product that an undisclosed CDMO customer is planning to commercialize in the US. Intelligenix will package the product at our GMP manufacturing facility in Montreal. Moving on to R&D and specifically turning to our Monte Lucas program, We have completed enrollment of 52 patients in our Phase 2a BUNA clinical trial in patients with mild to moderate Alzheimer's disease. With the intention of efficiently achieving the program's goal, we've made a Health Canada authorized study design modification where we adjust the p-value to less than 0.1. This modification enabled us to decrease enrollment while optimizing the power of the study to detect the effects of Monte Lucas Versafilm compared to placebo. We are looking forward to completing the BUNIS trial dosing in the first quarter of 2024 and to report initial trial results the following quarter. Additionally, manufacturing of both placebo and active films are ongoing in preparation for a clinical study to investigate the use of Monte-Lucas Versafilm for the treatment of Parkinson's disease, or PD. The multicenter randomized double-blinded placebo-controlled trial will be conducted at the Karolinska University Hospital in collaboration with principal investigator Dr. Piers Sivingsson, who will sponsor the study through a Swedish Research Council grant worth approximately $2 million USD. The planned study will assess a Monte Lucas Versafilm as an alternate to the tablet form of Monte Lucas. We currently expect the study to commence in Q4 2023 with dosing to be initiated in Q1 2024 and we will provide more details on its design when they are available. Lastly, We also engage an R&D customer to advance their product to commercial output and are proud to have secured the immediate, albeit small, revenue-generating business. With that, I would like now to turn the call over to Andre for a review of our financial results. Andre?