IntelGenx Technologies Corp.

Greetings. Welcome to the IntelliGenX fourth quarter and full year 2023 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, Stephen Kilmer, Investor Relations at IntelligenX.

Good morning, everyone, and thank you for joining us on today's call. With me on the line are Dwight Gorham, IntelligenX's CEO, Andre Godin, our President and CFO, Dr. Frank Pietrantonio, our Director of Clinical Research, and Tommy Kenney, our Senior Vice President and General Counsel. 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 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 morning, everyone, and thank you for joining us for the Intelligenix fourth quarter and full year 2023 conference call. On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline project consistent with what we have 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 third quarter of 2023, we received the first purchase order for the ResaFilm, the U.S. market name for ResaPort, from our commercial customer, Gensko Farmer. This represents a significant milestone for the company as it was our first purchase order for the commercial supply of a pharmaceutical oral film. We commenced production in December 2023 and expect to ship the ordered Reza film product to Gensco in Q2 2024 for immediate launch to market. Unfortunately, as of the end of 2023, we saw no appreciable progress by Exaltus, our partner for Resupport in Spain. Consequently, by mutual agreement with Exaltus, we have jointly started the process of finding a new commercial partner with production promotion capabilities, ideally suited to maximize Resupport's commercial success on the European market and expand the product's commercial availability in EU markets beyond Spain. Turning to our buprenorphine buccal film program, we understand from ZyroMed, the agent and affiliate of our co-development partner, Chemo Research, that it's still in discussion with the FDA regarding the amended abbreviated new drug application submitted to the agency in September. We will, of course, update investors on the status of the ANDA as additional information becomes available. Now turning to our cannabis business, we are happy we have entered into a settlement agreement with Tilray in November. The settlement included a purchase order for three new products, namely CBD-20, THC-10, and a 10-10 combined CBD-THC. Due to subsequent requests by Tilray, we should be in a position to complete the updated formulation work by May, June, and the products will then be scheduled for production and delivery. Turning to animal health, we are delighted to advance that important business via development and licensing agreements signed in December with a wholly owned subsidiary of Covenant Animal Health. Under the terms of the development agreement, Covenant Animal Health will fund development and manufacturing of the Betafilm-based drug product. The license agreement will give Covenant Animal Health exclusive rights to exploit the product in the field for non-human applications. In return, Intelligenix will receive royalties on a worldwide net sales of the product. Ahead of commercialization, Intelligenix will manufacture the product on a worldwide basis for clinical development. The parties also anticipate entering into a subsequent commercial supply agreement, pursuant to which Intelligenix will supply the product to Covenant Animal Health. As much as we are excited by this current partnership with an industry leader like Covenant Health, we also think that it could eventually prove to be an important revenue inflection point for our overall VEDA film business. Covenant is a well-recognized player in the space, and as such, the partnership should help open the doors to several additional commercial opportunities for proprietary VitaFilm drug delivery platform as it advances towards becoming a standard administration method for companion animals in the future. In support of that, last month we unveiled very encouraging results from a VitaFilm proof of concept study, which was conducted through a research collaboration with UPEI, one of North America's leading veterinary universities. As we have discussed in the past, the reliable administration of medications to dogs and cats is a concern for many owners and veterinarians. As I am sure many of you can tell, there are few prescription medications that dogs and cats will legally accept, and forced administration of capsules, tablets, and liquids may be stressful for both the pet and its owner or owners. Additionally, many owners report that medicating the pet becomes more difficult with each dose, often leading to decreased owner compliance, missed doses, and potentially treatment failures. The purpose of the research collaboration with UPEI was to assess palatability, owner perceived acceptability, and ease of administration of the vet of healthy dogs and cats. Specifically, the study evaluated one, exception rate of various vita film placebo formulations in dogs and cats at first exposure. Two, preference between flavors of vita film placebo formulations in dogs and cats. Three, changes in acceptance rates over longer periods. And four, owner perception of ease of administration and acceptance and other behaviors associated with vetafilm placebo formulations. Overall, 100% of dog owners and 67% of cat owners felt the administration of vetafilm oral films was very easy or easy. And 95% of dog owners and 82% of cat owners identified vetafilm as the preferred method of medication administration. Moving on to R&D, we have completed dosing in the Buna Montelukas Versafilm 2A clinical trial in patients with mild to moderate Alzheimer's disease this month, and expect to report initial trial results next quarter. Additionally, having now received approvals from the Swedish Medical Products Agency, the Swedish Ethical Review Authority, and the Regional Biobank Center to conduct Amont Park Montelukas Versafilm Phase 2 Clinical Trial in Patients with Parkinson's Disease. We currently expect dosing in the study to be initiated before the end of the current quarter. The multi-centered randomized double-blinded placebo trial, which is designed to assess Montelukas Versafilm as an alternative to the tablet form of Montelukas, will be conducted at the Karolinska University Hospital in collaboration with principal investigator, Dr. Per Sevingson, who will sponsor the study through a Swedish Research Council grant worth approximately 2 million USD. Finally, earlier this month, the Phase 1b trial for our oral transmucosal film formulation of DMT was initiated. The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics, and pharmacodynamics of an optimized film formulation compared to intravesous DMT. Top line results for the Phase 1b study are expected in the second half of this year. With that, I would like to turn the call over to Andre for a review of our financial results. Andre?