Eric Adams
Analyst · ROTH Capital. Your question please
Thank you, Colin, and thanks everybody for joining us today. Since our last investor update, InMed has announced some significant corporate developments, and has made notable advancements across each of its therapeutic and manufacturing programs. In June, the company announced it had entered into a non-binding letter of intent to acquire BayMedica, a private company based in the U.S. that specializes in the manufacturing and commercialization of rare cannabinoids. Upon closing of the merger transaction, we will have positioned the company to become a multifaceted leader for rare cannabinoids in terms of clinical development, manufacturing and commercialization in the health and wellness sector. Also, at the end of the fiscal year, the company announced a private placement with an institutional investor which closed on July 2nd, further strengthening the company's balance sheet to the tune of an additional $11 million net of expenses. Most notably, in the fourth quarter of the fiscal year, and over the last few months, we announced some pivotal milestones with respect to our manufacturing program for our proprietary IntegraSyn process. We also continue to make significant advancements in both our therapeutic programs, as we continue to establish ourselves as a global leader in the clinical development of CBN or cannabinol. Let's turn first to the BayMedica acquisition. As mentioned on June 29th, we announced the non-binding letter of intent to acquire BayMedica, and they are currently a research collaborator of ours that's based in the U.S. and they specialize in the manufacturing and commercialization of rare cannabinoids and cannabinoid analogs. And last week, on September 13th, we announced the signing of a definitive agreement associated with the acquisition. The transaction, which is subject to certain standard closing conditions, is expected to close in the coming weeks. We see this as a transformative transaction of the company, establishing InMed as a global leader within the manufacturing and development of rare cannabinoids. Joining forces with BayMedica brings together rare cannabinoid expertise and capabilities like no other. We have been working closely with BayMedica since November 2019. And when we entered into that reciprocal Research Collaboration Agreement to explore our respective technologies, it became evident very quickly, how well our teams work together and the potential synergies of our combined technologies and extensive rare cannabinoid knowhow. The BayMedica team brings with them a wealth of experience across multiple disciplines, including synthetic biology, chemical synthesis, enzyme production, molecular biology and pharmaceutical drug design and development. Key members of their team are true pioneers in the biotech industry and have laid important groundwork in synthetic biology over the last several decades. Their unparalleled cannabinoid manufacturing expertise in both chemical synthesis and biosynthesis, together with InMed's existing pharmaceutical focused team, which really set us apart from competitors in the field of rare cannabinoids. This acquisition provides InMed with complete flexibility across multiple manufacturing approaches and gives us the ability to select the most appropriate, cost-effective manufacturing method for each specific cannabinoid in its target commercial market. We will have the ability to produce multiple rare cannabinoid products for both pharmaceutical development and consumer health and wellness products. BayMedica's primary focus is the B2B wholesale commercialization of rare cannabinoids to the consumer health and wellness markets, including nutraceuticals, cosmetics, functional food and beverage, as well as animal health markets. BayMedica currently leads the industry in large batch production of its initial non-intoxicating rare cannabinoid, CBC or cannabichromene with current batch sizes of more than 200 kilograms and an ability to increase to metric ton quantities as market demand increases. Sales of BayMedica’s initial product Prodiol CBC has grown considerably with cumulative revenues in excess of $2.5 million since sales commenced in December 2019, experiencing an average 35% quarter-on-quarter growth for the year ended June 30, 2021. Considering they have commenced commercial activities just prior to a global pandemic, BayMedica has done an extraordinary job growing revenues with limited resources. Upon closing, we intend to accelerate commercial activities and we expect to grow revenues considerably in the short to medium-term. In addition to CBC, BayMedica has several high-value, non-intoxicating rare cannabinoids in various stages of commercial manufacturing scale-up including CBDV, THCV, CBN and others for the health and wellness markets. This business strategy [in this sect] (ph) has the focus on high demand, attractive margin products, rather than compounds that are easily commoditized, such as CBD. Another key aspect of the acquisition of BayMedica is their library of novel rare cannabinoid analogs. They have several novel analogs which InMed intends to evaluate for use in future therapeutic programs. The main benefit of these analogs is that new chemical entity patents have been filed to protect their eventual commercialization, which is unlike the pathway for naturally occurring cannabinoids that have been identified in the plant and cannot be patented because they occur in nature. This adds an additional level of IP protection to our current strategy that provides future partnering opportunities. So, worth to mention BayMedica provides with an immediate access to an initial yet growing revenue stream that balances InMed's longer term pharmaceutical product opportunities with short-term commercial opportunities within the health and wellness sector. It offers complete manufacturing flexibility to serve all segments of the rare cannabinoid market. It brings with it an extensive suite of new proprietary cannabinoid analogs for pharmaceutical development and extends the breadth and depth of our scientific and management teams, and it opens the door to in house laboratory facilities to enable our own development of InMed’s pharmaceutical R&D programs. Everyone at both InMed and BayMedica is very excited to see this agreement close in the coming weeks, integrating our teams and starting to work together to build a true leader in this burgeoning rare cannabinoid sector. Let's turn now for a few minutes to IntegraSyn. IntegraSyn is InMed's integrated cannabinoid manufacturing approach designed to efficiently and economically produce pharmaceutical grade bioidentical cannabinoids. Earlier this year, our IntegraSyn program reached a pivotal milestone achieving an output level of 2 grams per liter cannabinoid yield, a milestone that signaled commercial viability, and supports the advancement to large scale production. Following continued process optimization, on June 17th, we announced that we had materially improved the yield to 5 grams per liter, significantly exceeding current reported industry yields. To put this in perspective, 1 gram per liter is often referred to as the threshold for commercial viability. The impact of improved yields is a significant reduction in the overall cost of manufacturing due to the increased cannabinoid yield per batch. Our team is now focused on scaling up to larger batch sizes in advance of commercial production. Through our contract manufacturer Almac, we have become aware of a global supply chain issue relating to a certain starting material which may impact the ability to produce the previously planned 1 kilogram batch this year, I repeat, it may impact the ability. We are awaiting guidance from Almac regarding the impact on the timing and the cost of the planned 1 kilogram batch. In the meantime, we are targeting production of a pilot batch to further verify the process in reaction parameters, as we progress to commercial scale batches. The cannabinoid from this pilot batch will be used for the requisite stability testing and post integration with BayMedica may also be used for scale up processes for additional cannabinoids. As a reminder, one of the key benefits of the IntegraSyn system is the ability to utilize the initial cannabinoid that's manufactured as a basis for production of differentiated cannabinoids. In parallel, our team continues to prepare the manufacturing process to be GMP-ready for pharmaceutical quality production. Our goal has always been to achieve an efficient, scalable, flexible and economical solution to produce cannabinoids with bioidentical structures to those found in nature. With these recent developments, we believe we are on track to achieving our goal in developing IntegraSyn as a commercially viable solution for large-scale pharmaceutical grade GMP production of rare cannabinoids. Now, let's move to our therapeutic programs. We'll start with INM-755 for epidermolysis bullosa or EB. INM-755 cannabinol cream is a topical cream in development for EB, a devastating genetic skin disease. On April 28, 2021, we announced that we had submitted Clinical Trial Applications to begin a Phase 2 clinical study in multiple countries. The Phase 2 clinical trial of INM cannabinol cream for EB is on track to begin shortly. The Clinical Trial Applications have been submitted to the National Competent Authorities and Ethics Committees in Austria, France, Germany, Greece, Italy, Israel and Serbia. While the approval process for these applications is ongoing, we remain confident that we will be in a position to start enrollment into this Phase 2 trial in the coming weeks. This 755 201-EB clinical -- Phase 2 clinical trial, also referred to as the 201 trial, is designed to enroll up to 20 patients, conservatively within 12 months. It will take place at multiple clinical trial sites in the aforementioned countries. All four types of inherited EB being EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome are eligible for this study. InMed will evaluate the safety of INM-755 cannabinol cream and its preliminary efficacy in treating symptoms and healing wounds over a 28-day treatment period. This study will use a within-patient, double-blind design, whereby matched index areas will be randomized to be treated with either INM-755 cannabinol cream or a vehicle cream as a control. The start of the 201 trial will be the first time cannabinol, this rare cannabinoid, has been studied in any Phase 2 clinical trial. Switching now to INM-088. INM-088 is a topical eyedrop formulation under development for the treatment of glaucoma. The active pharmaceutical ingredient in 088 is cannabinol, CBN, the same active ingredient as in the 755 program. Current glaucoma treatments work to reduce the intraocular pressure in the eye. Our preclinical studies have indicated that 088 may provide neuroprotection, as well as reduce intraocular pressure. InMed continues to make progress in its glaucoma program. At the H.C. Wainwright Ophthalmology Conference on August 17th, we shared preclinical data showing the effectiveness of cannabinol on reducing cell death in retinal ganglion cells, an indication of potential neuroprotection, which may lead to extended retention of vision in glaucoma, and other diseases. Over the past quarter, InMed has continued with a setup of a larger manufacturing process to support the upcoming GLP studies. And we completed dose ranging studies to evaluate different dose levels and regimens, which is necessary to support these upcoming GLP studies. Topline clinical design work with InMed's clinical research organization was also conducted during this period in order to support our future clinical programs. Key preclinical data on the 088 program have been submitted to a peer reviewed journal and we look forward to sharing this with you when it is published. We continue to work towards completing our preclinical studies of our glaucoma program in preparation for human clinical trials. We estimate to file applications late in the second half of calendar 2022 to initiate human clinical testing with INM-088. In summary, over the course of this last fiscal year, we have continued to make measurable progress across all programs and announced some positive corporate initiatives that will have a transformative effect on the company moving forward. In the next few months, shareholders should expect to see the following catalysts. Number one is the closing of the BayMedica acquisition. This will allow us to integrate the two teams and start advancing commercial activities including accelerating CBC sales and launching new rare non-intoxicating cannabinoids. Second, the commencement of Phase 2 clinical trial. We are now in the final stages of study startup preparation and envisage the clinical trial to commence very shortly. As noted, this will be the first time CBN has been studied in a Phase 2 clinical trial. Three, the publication of the glaucoma data in a peer reviewed journal. This is another key milestone for our therapeutic programs, and will add notable credibility to our data in advance of initiating human studies. We anticipate the release of this data may also spark interest in collaboration. And four, as mentioned, scaling IntegraSyn to larger batch sizes in advance of commercial scale production. I also want to take a second to talk a little bit about the share price. So before we turn to the financial summary, I think it's important to comment on this and its recent decline. We are both very surprised and very disappointed to see the recent performance, especially considering the strengthening fundamentals of the company, including the BayMedica announcement. While it's difficult to ascertain the exact reason for this decline, we would like to point out that although we are a biotech pharma company, we are considered “cannabis adjacent” and our share price is strongly aligned with the market performance of cannabis company share prices. And those have experienced a significant decline over the last six months. I can assure you we are monitoring the situation closely and are allocating additional resources towards Investor Relation related activities to increase exposure, outreach and clarifying our value proposition to the investment community. As I just mentioned, we have several important catalysts over the coming months, which should have a positive impact on the fundamentals of the company. 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 a review of our year-end financials. Bruce?