Eric Adams
Analyst · Edison Group. Please go ahead
Right. Thank you, Bruce and good day to everyone. We appreciate you joining us for our quarterly conference call today. I'd like to open the call today with an update on our INM-755 program for the treatment of Epidermolysis Bullosa, or EB. As you may recall, earlier in the year we announced the transition of our EB program to a single cannabinoid formulation, rather than a two cannabinoid approach. This single cannabinoid product is referred to as INM-755. We’re in the process of finalizing over 20 clinical trial application enabling preclinical safety pharmacology and toxicology studies. The results of which are required for the regulatory filing begin human clinical trials later this calendar year. We are on track with all studies and are actively integrating the study outcome into the regulatory filing. Over the course of the summer, we determined that conducting initial human clinical trials in the Netherlands afforded the company the best probability of adhering to our aggressive drug development timelines. The regulatory review time and process in the Netherlands is well-established and we have selected a host site for the trials that has significant experience and access to a large volunteer population. The initial human studies will be comprised of two separate studies. Study number 755-101-HV is a healthy volunteer study, designed to establish the systemic and local safety in pharmacokinetics of INM-755 on intact in. We will be testing two strings of INM-755 in about 20 healthy adult volunteers. This study is double blinded and vehicle controlled. The second study, number 755-102-HV will focus on local safety on wounds in a small number of subjects, again using two different drugs concentrations. These two initial studies will be conducted in series. The 101 intact skin study is scheduled for initiation prior to the end of the calendar year and initiation and treatment of patients in the 102 study is anticipated to take place the second to third quarter of calendar 2020. It's important to mention that, once the healthy initial -- the initial healthy volunteer studies are completed, the company will then be positioned to explore additional indications or uses for INM-755 topical cream beyond to just EB. This significant investment of both time and money that we've made into the product in the form of numerous formulations, developments, toxicology studies can be leveraged into other dermatological conditions that may benefit from 755, which may include reduction in inflammation, pain, and itch. We're currently exploring the initiation of preclinical studies to understand these benefits in other disease models, and look forward to providing additional information in due course. Assuming there are no untoward outcomes in the healthy volunteer studies, we currently anticipate following a regulatory application for the Phase I/II study in EB patients in the fourth quarter of calendar year 2020. This multinational study will be a safety and efficacy study in EB patients' of all subtypes. Alexandra Mancini, InMed's Senior Vice President of Clinical and Regulatory Affairs as well as Michael Woudenberg, our VP of CMC will be available at the conclusion of the formal presentation for Q&A on the EB program. Now switching to glaucoma, since our last quarterly update, the company has formally switched from INM-085 to a new candidate for the ocular program named INM-088. The 088 is a single cannabinoid product, which in subsequent preclinical testing proved to confer specific advantages over 085, in terms of in-vitro results for the potential to treat glaucoma. We're targeting the potential effects of this cannabinoid to both reduce intraocular pressure as well as provide neuroprotection for the retinal ganglion cells and other optic nerve tissues. Based on the results we've seen thus far, we are very enthusiastic, that this product candidate may have effects, well beyond just glaucoma. We are moving to advanced preclinical testing in the second half of 2019 to further understand the pharmacological activity of this cannabinoid. We're also testing, other drug delivery formulations in addition to our own Hydrogel to ensure that we select the most promising delivery technology. Looking into next year, we anticipate completing formulation development, and proof-of-concept in-vivo studies in the first half of 2020. Thereafter, we expect that we will be in a position to commence clinical trial enabling pharmacology and toxicology studies. The company will provide additional updates on this program early next year. As with INM-755 in dermatology, we believe that INM-088 -- its product characteristics that we've seen in early testing maybe beneficial across a number of different ocular diseases. Now, I'd like to turn your attention to the biosynthesis program. InMed's aim is to build and sustain a leadership position in cannabinoid manufacturing. At this point, we continue to retain all rights in commercial upside for our bacterial biofermentation system with only a small royalty going to the University of British Columbia. During the quarter ended, 30th of June 2019, we continued on a path forward scale up of our biosynthesis process. We've optimized several fermentation parameters in order to maximize production yield. Such parameters include, but aren’t limited to the inducer concentration induction time, aperture, media time and incubation time. We believe we have most of these parameters nailed down. However, we still require a little more time to finalize some other conditions. As we scale up fermentation to larger vessel, some of these conditions will still need to be slightly modified to fit the various vessel sizes. We also initiated the downstream purification work with various contract organizations. This process is still on track to be completed by the end of 2019. As mentioned in our last quarterly call, we are also exploring an alternative biosynthesis manufacturing process in addition to our existing E.coli biosynthesis process, which may confer certain benefits either costs, yield, speed, or all of the above when pursuing specific types of cannabinoids. We are agnostic, as to which pathway we’ll eventually commercialize and we’ll continue to follow where our innovation leads us as we continue to build a leadership position in the space. We're in the process of filing provisional patents on this new approach, and we'll be in a position to provide further details over the course of 2020. Note that Dr. Eric Hsu, InMed Senior Vice President of Preclinical R&D is available during the Q&A session to answer questions related to the INM-088 program, and the biosynthesis program. Now for a general quarter update. Recently we've had a few changes in personnel, and I'd like to touch on that briefly. In July, we announced the addition of Catherine Sazdanoff to the Board of Directors. Catherine has a tremendous track record in the pharmaceutical industry, having led several major acquisitions, including the acquisitions by Takeda of Millennium Pharmaceuticals and Nycomed. She was also part of the team that acquired Knoll Laboratory and its leading drug candidate Humira for Abbott Labs. Catherine brings experiences and skill sets to the InMed Board including business development, legal affairs and litigation, global enterprise risk assessment, and ethics and compliance programs. She will participate on all of our boards committees, including serving as a Chair of the Nominations and Governance Committee. In early September we announced that Martin Bott decided to step down from the board due to increasing personal and professional responsibilities. Martin has been a tremendous director for the company, and we are all very thankful for his insights and the diligence he brought to every meeting. We wish him all the best. In August, we announced hiring Bruce Colwill as the CFO of the company. Bruce has a successful track record in growing companies in several different industries, biotech, FinTech, mining and others. He replaces Jeff Charpentier who has diligently served as CFO for the last several years. Jeff will continue to support the company as a VP of Finance. We also departure of Josh Blacher, who served as our Chief Business Officer for 18 months. Josh was recruited back in the Investment Management Industry in New York City with what he referred to as an offering he just can't refuse. We wish him all the best and we look forward to a lasting relationship with him and his new employer. Now, I'd like to turn the call over to our new CFO, Bruce Colwill for a review of the financials.