5/13/2021

speaker
Operator
Conference Operator

Good day, everyone, and welcome to today's Intelligenix Technologies Corp. First Quarter 2021 Call and Webcast. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and 1 on your touchtone phone. It is now my pleasure to turn today's program over to Stephen Kilmer, Investor Relations.

speaker
Stephen Kilmer
Investor Relations

Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Hubei, IntelligentX's CEO, and André 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 of 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 Dr. DeBay. Horst?

speaker
Dr. Horst Hubei
Chief Executive Officer

Thank you, Steve. Good afternoon, everyone, and thank you for joining us. for the Intergenic's first 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, Andre will review our Q1 2021 financial results. Then we will open up the line for your questions. I'll start with the Atai partnership. Two days ago, our shareholders approved all proposals at our annual meeting, including the investment resolution related to our partnership with Atai Life Sciences, a tech-driven biopharmaceutical company with an attractive portfolio of psychedelic and non-psychedelic compounds intended for the treatment of mental health disorders. This transaction is potentially transformational for Intergenics. It moves the company into a leadership position within the novel therapeutic field of psychedelics, while at the same time providing the needed financial resources to continue to advance our product pipeline. It also means we've gained a very significant new major shareholder. In this partnership, we will integrate our film technology with Attai's existing pipeline and work exclusively with them in the field of compounds for the prevention or treatment of mental health disorders or compounds that have psychedelic, antactogenic, and oneirophrenic properties. Just for explanation, antactogenic drugs are drugs that cause empathy, and oneirophrenic drugs cause an hallucinatory, sort of a dream-like state. Through our first collaboration with Atai, we found that our film technology can address some of the unique complexities of developing psychedelic compounds for the treatment of mental health disorders. For example, the metabolic pathway of some psychedelics requires the concomitant administration of Mio-amino oxidase, that is, inhibitors to achieve the required duration of action of the psychedelic drug. The avoidance of first pass metallization following the firm administration removes the necessity of concomitant dosing of an MAO inhibitor. The firm delivery can thus play an integral role in clearing a clinical pathway for a TIE's existing pipeline, as well as create promising development opportunities for us. The fruits of this are already materializing. A few days ago, we entered into a second feasibility agreement with Attai for the development of novel formulations of salvinorin A. Salvinorin A is a naturally occurring psychedelic compound being developed for the treatment of treatment-resistant depression and other indications. Under the terms of the second feasibility agreement, Intergenics will conduct formulation development work to provide a prototype to Attai for further clinical investigation. The agreement also contemplates a term sheet upon which the parties would, if successful, enter into an exclusive royalty-bearing commercialization license. Moving on to Resupport. In August, we expanded our Resupport Commercialization Agreement with Exceltis to include the European Union, which added 26 countries to our commercialization partnership. We have since entered into a contract manufacturing agreement with LTS in Germany for the manufacturing of commercial product for Spain and potentially other European markets. Launch preparations are commencing and are on target for product launch in Spain in early Q3. Pedanofil, the revised protocol for the irritation study that FDA requested in the CRL was submitted to the agency and recently approved. Duration of the study will be eight months. As far as PD, partnering discussions are advancing, and our goal is to finalize a partnership arrangement in the second quarter of this year. Now moving on to cannabis films. Several shareholders have inquired about the status of our relationship with Tilray. At this time, we have no indication from Tilray that they plan to resume project activities. With respect to CBD, we have renegotiated the agreement with them to remove the exclusivity, which has enabled us to enter into a deal with Heritage Cannabis for CBD. That said, we intend to reach out to the new Tilray management to explore what could be possible in the future. We obviously believe that we already have a great product to offer and that our ability to develop additional products in the cannabis space using our technology is exceptional. As I mentioned, in January, we entered into a definitive supply agreement with Heritage Cannabis for the manufacturing and supply of 10 milligram CBD film strips. Stemming from that agreement, we received our first purchase order from Heritage for 50,000 CBD film strips. This initial order was then increased to 75,000 CBD film strips, and we completed that shipment to Heritage at the end of March. That shipment was the first ever from our Montreal facility of commercial quantities of an oral thin film product based on our Versafilm technology. So it clearly marks the achievement of another important milestone for our company. With respect to THC, we announced in February that the USPTO granted a notice of allowance for US patent application 16-110,737, which covers novel disintegrating oral film formulations designed for the transmucosal absorption of drugs. This patent is intended to protect Intergenic's Disintec products. Disintec has been specifically designed by Intergenic to optimize mucosal absorption of drug by utilizing controlled erosion as a mechanism to release THC into the oral cavity. And this significantly reduces having a portion of the THC being swallowed and thereby minimizing the amount of the drug that becomes subjected to unwanted oral first pass metabolization. We continue to respond to expressions of interest in this distinct technology platform from multiple potential industry partners. Now, a few words on Montelukast. The Buena Suri study remains on a temporary recoupment hold as the target study population is considered a higher risk group for severe illness from COVID-19. We're closely monitoring the situation and will resume enrollment under our amended protocol as soon as practicable. In the meantime, we'll continue to evaluate the trial's expansion to the United States via a potential IND filing with the FDA when this is appropriate. Animal health. In February, we filed a new provisional patent application at the USPTO that covers the incorporation of high concentrations of active ingredients in products based on our proprietary Betafilm veterinary oral film technology. This higher loading capability enables formulation with a ratio of active to polymer of one to one, thereby pushing the limit of the thin film capabilities and distinguishing it from known oral film technology. Accordingly, this new patent will allow us to incorporate high amounts of drug into our film while still keeping it small enough to administer easily to companion animals. In addition, we were pleased to receive from our development partner, an undisclosed leading animal health company, very encouraging blood level results from the beta film feasibility study announced in early 2020. Like the ATAI partnership moving us into a leadership position within the novel field of intergenics, we believe this VetaFilm patent and the underlying data that supports it will help position intergenics at the forefront of the oral veterinary field. Finally, a comment regarding Suboxone since several shareholders have requested that we provide an update. The main reason for the continued delays of our suboxone program is simply that besides suboxone, we're developing another second product for endo. This other product, which I am not at liberty to disclose, has been given priority by endo. And because of our limited production capacity, we have to put the development of genetic suboxone temporarily on hold. With that, I would now like to turn the call over to Andre for a review of our financial results. Andre?

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