IntelGenx Technologies Corp.

Good day, ladies and gentlemen, and welcome to the IntelligenX Technologies Corporation second quarter 2021 call. All lines have been placed on a listen-only mode, and the floor will be open for questions and comments following the presentation. If you should require assistance throughout the conference, please press star zero on your telephone keypad to reach a live operator. At this time, it is my pleasure to turn the floor over to your host, Abby Hardy. Ma'am, the floor is yours.

Thank you, Operator. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Zurb, IntelligenX CEO, and Andre Godin, our President and CFO. 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 Commission. I would now like to turn the call over to Dr. Zurb.

Thank you, Abby. Good afternoon, everyone, and thank you for joining us for the Intergenics second quarter 2021 conference call. On today's call, I will provide a corporate update and discuss the progress we've made on our key pipeline projects. Following that, André will review our Q2 2021 financial results. Then, and as always, we will open up the line for your questions. I'll begin with our Thai partnership. Our strategic partnership with our Thai life sciences expanded during the second quarter when we entered into a second feasibility agreement, this time for the development of a novel formulation for salvinorin A. Salvinorin A is a naturally that is being developed for the treatment of treatment-resistant depression and other indications. Under this agreement, Intergenics will conduct formulation development work and provide a prototype to Atai for further clinical investigation. If this work is successful, the parties would enter into an exclusive royalty-bearing commercialization license as contemplated in the agreement. This agreement represents another opportunity to integrate our film technology with Atai's existing pipeline while further establishing intergenics as a leader in the novel therapeutic field of psychedelics. We look forward to continuing to work exclusively with Atai on psychedelic and actogenic and or on neurophrenic compounds for the prevention or treatment of mental health disorders. Because the film application reduces and sometimes completely eliminates first-pass metabolism, Concomitant administration of monoamino oxidase inhibitors with psychedelics will likely not be necessary, which we believe can add significant value to Atai's development programs to the extent that they involve our film technology. Earlier today, we were pleased to announce the appointment of two Atai delegates to our Board of Directors. Dr. Srinivas Rao has over 19 years of professional experience in the pharmaceutical and biotechnology industries, and he currently serves as the co-founder and chief scientific officer at Atai. Frank Stegert is currently Atai's vice president of investment management and operations. On behalf of the board and of everyone at the company, I'm very pleased to welcome Srini and Frank to our team. We look forward to their contributions as we continue to execute on our growth strategy. Now, moving on to ResaPort, we continue to work with Exceltis, our ResaPort commercialization partner in 27 European Union countries, and LTS, our Germany-based contract manufacturing partner, to prepare for the commercial launch of ResaPort in Spain early in the third quarter. Consistent with Exceltis' right to commercialize the product in most other European countries, LTS has the potential and the capacity for other European markets. First, I'll read the report. In Spain, the first commercial batch has been successfully manufactured and was shipped to Exceltis for the Spanish launch. The second and third batch are being manufactured, as we speak. Now, since most businesses are closed in Spain during the month of August, as a matter of fact, Spain as a whole is practically closed. Exceltis has decided to launch the product in September when business activities resume. As far as U.S., the first resubmission batch was successfully completed and has been placed on stability. Batches two and three are being manufactured. And upon completion of six months accelerated civility testing, we plan to meet with FDA to agree on details of the resubmission. Moving on to Tadalafil, the revised protocol for the irritation study that FDA requested in the complete response letter was submitted to the agency and recently approved. Duration of the study will be eight months. On the BD front, partnering discussions are advancing, and our goal is to finalize a deal with our prospective commercialization partner in the third quarter of 2021. A term sheet was recently signed, and the parties are working on the definitive licensing and supply agreement. Now a few words on cannabis. We reported previously the manufacturing industry and shipment of product for the planned launch of our CBD film in Australia via our commercialization partner, Heritage. And to clarify, Heritage is not gonna commercialize itself in Australia. Rather, they do that through partnerships with two Australian companies. A short while ago, we received an order from Heritage for the manufacturing of launch quantities for the intended launch of the product in Canada. Manufacturing of those batches is ongoing. Now moving on to Montelukast. A little bit of introduction. We, over the past weeks and months, received a number of inquiries from shareholders and stakeholders regarding the resumption of our Buena study, which, as you know, had been put on hold mostly due to COVID. So we decided to look into resuming the study, and last week we announced that we received subscriptions from investors in the United States for 2.1 million U.S. principal amount of 8% convertible notes due July 31st, 2021. That money will be exclusively earmarked for the continuation and the completion of the UENASA. That was the sole purpose of raising that money. We plan to resume the study under the amended protocol with a higher daily dose and have submitted stability data for the high-dose film to Health Canada in order to obtain approval for shelf life extension, which is required to continue the study. We are also in discussions with the involved in the monitoring of the study to prepare for the resumption of the recruitment later in the fall. In the meantime, we continue to evaluate the trial's expansion to the United States via an IND filing, and we requested an IND number from the FDA. Now, on animal health, we entered into a Materials Transfer Agreement with an undisclosed global veterinary health company who will evaluate our VetaFilm platform in cats. If the evaluation is successful, we intend to enter into negotiations with this partner for a development agreement in the veterinary field. And this agreement represents another step toward establishing Betafilm as a new standard for pets and helps position Intelligenix at the forefront of the oral veterinary film field. With that, I would now like to turn the call over to André for a review of our financial results. André?