Eric Adams
Analyst · HC Wainwright
Thanks, Colin, and thank you, everyone for joining us today. Since our last earnings call, we've made some significant advancements. And these are advancements that we believe have positioned InMed to be a clear leader in the rare cannabinoid space offering a unique value proposition and investment opportunity across both the pharmaceutical and health and wellness markets. Most notably, in October, the company completed the acquisition of BayMedica, a U.S.-based company that specializes in the manufacturing and commercialization of rare cannabinoids for the health and wellness sector, establishing InMed as a global leader in the research, development, manufacturing and commercialization of rare cannabinoids. Since the acquisition we have been intently focused on ensuring an expedited integration in order to accelerate commercial activities, including product launches with the end goal of driving revenues in the near term. While this acquisition provides us with access to the consumer health and wellness markets, we remain a pharmaceutical company at our core. Our pharmaceutical drug development programs continue to advance in both preclinical and clinical studies supporting sequential value creation for our shareholders as we continue to hit important milestones in drug development. We now offer shareholders the combination of near to term revenue generation, combined with a longer-term value proposition associated with our pharmaceutical drug development programs. Let me start by addressing our short-term plans for commercial operations. Since closing the acquisition of BayMedica in October, our primary focus has been ensuring the smooth integration of both teams and developing an aggressive commercial plan for the coming year. BayMedica's focus is on the business to business or B2B supply of rare cannabinoids to the consumer health and wellness markets, including nutraceuticals, cosmetics, functional food and beverages as well as animal health markets. from a commercial perspective, our primary goals for the BayMedica business over the next few quarters include launching new products to build a robust product portfolio of rare cannabinoids, increase revenues and margins from new and existing products through B2B sales, enhance the sales and marketing infrastructure to support anticipated growth, improve margins through the technical improvements and scale up efficiencies, develop new cannabinoid analogues for potential lead molecule identification for pharmaceutical applications. These priorities reflect the importance of developing a robust product offering which in turn is key to attracting a larger customer base and gaining market share. In January, we launched a second rare cannabinoid CBT and have commenced initial B2B sales to customers within the health and wellness markets. We also have several other rare cannabinoids at different stages of development and expect to roll out additional in-demand products over the coming months. We are very excited about our next two nonintoxicating products, which are CBDV and THCV, which will be coming to market shortly. We are currently working with our third-party manufacturers to produce large scale batches to support initial demand over the coming months. As this is still a very nascent industry, it is difficult to predict the demand however through market research and speaking with our existing customer base, we believe that both of these products are in very high demand. Current market prices of these products range from approximately $17,000 to $30,000 per kilogram. Given our cost structure at large scale commercial production, we believe we can be competitive on pricing while maintaining attractive margins. BayMedica currently leads the industry in large batch production of its first nonintoxicating rare cannabinoids, CBC or cannabichromene, with current batch sizes of more than 200 kilograms and with the ability to increase to metric ton quantities as market demand increases. This expertise is something we will replicate in bringing our next products to market. As I mentioned, pipeline development is a key priority for the company. In addition to CBDV and THCV, BayMedica has several other high value rare cannabinoids at various stages of development and scale up including CBL and CBGV. Our commercial strategy is to focus on high demand attractive margin products rather than compounds that are readily commoditized and with very low prices, such as CBD. As the company continues to grow, and add to our product portfolio, it's important to build out an appropriate sales and marketing infrastructure. The company announced today the hiring of Jerry Griffin, as Vice President of Sales and Marketing at BayMedica. Jerry comes with a wealth of experience across various markets and with numerous cannabinoid products. He has a proven track record as a seasoned sales executive, who has held several senior level roles at cannabinoid based companies, including most recently at a competitor company where he was Vice President of Sales and Business Development. The appointment of Jerry reaffirms our commitment to accelerate the company's commercial plans and grow market share in this burgeoning industry. We have seen over the last year that there is growing interest in rare cannabinoids for their potential therapeutic properties. Health and wellness companies are looking beyond or looking to rare cannabinoids for their potential physiological effects beyond more common cannabinoids, such as CBD, as well as the further differentiate their products. Very few companies can produce rare cannabinoids at commercial scale, and we are one of them. We believe we are well positioned to take an early lead as a supplier of high quality rare cannabinoids in this rapidly growing market. As this is a relatively new market segment, we understand research and education is key to building awareness and understanding the potential benefits of cannabinoids. An example of both a growing interest in cannabinoids as well as building up the body of research is the recent announcement that the NFL is awarding $1 million towards research into cannabinoid effects. Next, I'd like to turn to our manufacturing capabilities. With the acquisition of BayMedica, InMed now has access to multiple cannabinoid manufacturing approaches. This gives us the flexibility to select the most cost-effective method to produce a specific cannabinoid. All three of our manufacturing approaches, chemical synthesis, biosynthesis and IntegraSyn can produce high quality and pure cannabinoids in a consistent manner for different applications. Our team has been working closely with our contract manufacturing and development collaborator, Almac on scaling up to larger batch sizes using the IntegraSyn process in advance of commercial scale production. To further advance the IntegraSyn scale up, we are targeting production of a pilot batch in the first half of 2022 to further verify the process with the aim of demonstrating larger scale viability at our industry leading cannabinoid heal. Now we'll turn to the Therapeutic Programs, starting with INM-755 for Epidermolysis Bullosa or EB. The INM-755 cannabinol cream is a topical cream and development for EB a devastating genetic skin disease. Since our last call, we have commenced the Phase 2 clinical trial of INM-755. The 755 201-EB study is designed to enroll up to 20 patients. InMed will evaluate the safety of INM-755 cannabinol cream and as preliminary efficacy in treating symptoms and wound healing over 28-day treatment period. All four subtypes of inherited EB which are EB simplex, dystrophic EB, junctional EB and Kindler syndrome are eligible for the study. The study is using a within patient double-blind design, whereby matched indexed areas will be randomized to receive the cream or a vehicle cream as a control. The study is planned to include 13 sites across eight countries in Austria, Germany, Greece, France, Italy, Israel, Serbia and Spain. Five clinical sites have been fully activated and enrollment and patient treatment began in December 2021 is anticipated to complete during this calendar year. This Phase 2 trial makes it the first time that CBN or rare cannabinoid has been studied in a Phase 2 clinical trial. Turning now to INM-088. 088 is a topical eye formulation under development for the treatment of glaucoma. The active pharmaceutical ingredient in 088 is cannabinol or CBN, the same active ingredient as in the INM-755 program. In December, we announced that a peer reviewed scientifical article entitled cannabinol modulate neural protection and interocular pressure, a potential multi-target therapeutic intervention for glaucoma has been published in a leading international journal. These studies resulted in two key findings first, CBN may promote neuro protection of cells in the retina that are responsible for vision and second CBN may normalize interocular pressure. The article also reports on the comparison of CBN with other cannabinoids, including CBD and THC, with results indicating that CBN has a stronger effect and broader neuroprotective therapeutic range. These observations support the therapeutic potential for CBN in the treatment of glaucoma. The company is now preparing for a pre-IND meeting with the FDA in the coming weeks. And we continue to work towards completing the necessary preclinical studies in anticipation of filing in the first half of calendar year 2023 for regulatory permission to initiate human clinical trial. Looking now at some of our patents, I think it's important to point out that our pharmaceutical program also includes exploring other rare cannabinoids for their therapeutic effects. In November, we filed an international patent application seeking commercial exclusivity for the potential treatment of important neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and Huntington's disease and others by demonstrating neuroprotection and promotion of neurite outgrowth in a population of affected neurons using a new rare cannabinoid. Another key asset from the BayMedica acquisition is their library of novel rare cannabinoid analogs. They have several novel analogues which we intend to evaluate for use in future therapeutic programs. There's many benefits of using these novel analogs, one of which is that new chemical entities can be patented to protect their eventual commercialization, unlike naturally occurring cannabinoids identified in the plant, where a patent covering the underlying molecule cannot be filed. This adds an additional level of IP protection to our current strategy and enhances future partnering opportunities. Considering the commercial importance of these analogs, this is an area where we intend to place enhanced focus in the coming years. I want to touch briefly also on the impact of COVID. As with most businesses, the global pandemic has started to impact several facets of InMed’s activities. Global supply disruptions relating to resources such as raw material availability and staffing issues have directly affected development timelines for our manufacturing campaigns. Our clinical ED program has also been affected by staffing issues, which have impacted patient enrollment. As a consequence, the timelines on certain programs have been slightly delayed. We continue to work with our external partners to limit any disruptions and ensure our programs continue to advance despite these global headwinds. And I just briefly turning to the outlook, in summary, over the course of the last quarter, we have continued to make considerable progress advancing our different programs. Over the next few months, shareholders should expect to see the following catalysts. Number one product launches, we will be bringing new products to the health and wellness market, and this is one of the company's key priorities over the coming months. Number two updates on the Phase 2 clinical trial in EB. Number three, further execution on our patent strategy including our proprietary analogues and four scaling and IntegraSyn two larger batch sizes in advance of commercial scale production. Before I hand the call over to Bruce, I would like to take the opportunity to welcome Ms. Janet Grove to our Board of Directors. Janet has significant skills and experience in providing strategic, legal and business development advice accumulated during an impressive 30-year career in the biotech industry. Ms. Grove is a partner at Norton Rose Fulbright and is currently the head of their Canadian life sciences and healthcare industry practice. I'd also like to recognize Catherine Sazdanoff, who is stepping down from the Board for personal reasons. Ms. Sazdanoff has served on the Board since July 2019, during which time her business development and legal experience has been instrumental in navigating several key strategic initiatives for the company, on behalf of the company and shareholders we think deeply for her significant contributions and dedication over the last few years. On that note, I'd like to turn the call over to our CFO, Bruce Colwill to provide more information on our capital plans, and for review of our second quarter financial, our fiscal 2022 financials. Bruce?