Good morning. My name is Joanna, and I will be your conference operator today. At this time, I would like to welcome everyone to the InMed Pharmaceuticals Fourth Quarter and Full Year Fiscal 2019 Financial Results and Business Update. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and answer-session. [Operator Instructions] Thank you. Mr. Bruce Colwill, you may begin your conference.

Thank you, Joanna, and good day, ladies and gentlemen. My name is Bruce Colwill. I am InMed’s Chief Financial Officer, and welcome to InMed’s fourth quarter and fiscal year end 2019 financial results and business update conference call. But before we begin, I would like to go over our disclosure statements, followed by a review of the progress on our biosynthesis and R&D programs, which will be led by our President and CEO, Eric Adams. I will then review the financial results of operations. Following that, we'll be available for a question-and-answer session. Also joining us to address your questions today will be Alexandra Mancini, our Senior VP of Clinical & Regulatory Affairs. We have Eric Hsu, Senior VP of Pre-Clinical R&D. And we also have Michael Woudenberg, Vice President, Chemistry, Manufacturing & Controls Please be advised that certain statements in the following conference call regarding expectations for InMed’s business operations, clinical development, key personnel, contractual relationships, regulatory approvals, revenue opportunities and cash runway all constitute forward-looking statements. Such statements are not historical facts, but rather predictions about the future, which inherently involve assumptions, risks and uncertainties. Actual results may differ materially from those contained in the forward-looking statements. Description of these risks can be found in our latest disclosure documents and recent press releases, all of which are filed on SEDAR and on InMed’s website. InMed does not undertake any obligation to update any forward-looking statements made during this call. I would like to now turnover to President and CEO, Eric Adams. Eric?

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…

Thanks Eric, and thank you all for joining today's call. As, you know, this is my first quarterly call since starting with this mid-last month, and I'm very excited to be on board. The talent that Eric has brought together to develop InMed asset is really quite impressive, absolutely from the perspective of their experience, but also because of the passion for what the Company's trying to accomplish. So I'm really pleased to be here. So moving on, I would like to remind you that the figures I will present in today's call are expressed in Canadian dollars. Also please recall that our fiscal year end is June 30th. So together with our quarterly financials, I'll also be reporting on today's call our full-year fiscal 2019 financials. Please note that the complete financial statements and MD&A are also available on our website under the Investors tab as well of course on SEDAR. So operationally, I will first touch on our research and development activities. R&D expenses were CAD2.45 million for the three months ended June 30th, 2019 compared to CAD580,000 for the three months ended June 30, 2018. Well for the 12 months ended June 30th, 2019, our R&D expenses totaled CAD5.64 million, compared with CAD1.93 million for full year fiscal 2018. This substantial increase in R&D expense is primarily due to increase in spending on those preclinical safety pharmacology and tox studies for INM-755, which, as Eric mentioned earlier, are required for the regulatory filing to initiate human clinical trials later this year. In addition, in advance of our planned clinical trials, we incurred higher costs with the purchase of the active pharmaceutical ingredient in INM-755. As well, we incurred higher R&D personnel compensation as a result of increased R&D staffing. Looking now at our G&A activities. On a…

Thank you. [Operator Instructions] Your first question is from Max Jacobs from Edison Group. Please go ahead.

Hi guys. Thanks for taking my question. Just wondered why did you have to break up the Phase I into two parts? And is it possible to do those in parallel in order to save time?

It's a good question. Thank you, Max. Alex, I'll throw that one over to you.

Okay. Thank you. Yeah. It is a good question. Well, first of all, the -- as Eric has explained the first study will be on intact skin, the second one on wounded skin. So, it is important to do intact skin first and not to be doing them in parallel. We will learn information about the tolerability of the product on the intact skin. And that will inform us as to the suitability of -- on the wounded skin as well. So, we have to do the good skin before the bad skin, so to speak. And then one additional consideration was that for -- just in terms of what -- you know that we had a choice to whether can put them in one protocol just Parts A and B or whether to split them out as two studies. And we've chosen to split them out as two studies, because it allows us to move more quickly. It takes a little bit longer from a manufacturing perspective to make the sterile cream that would be required for the wounded skin application. For intact skin, we don't need sterile cream. So we can move faster and that's what we're doing by splitting the trials. It is putted into two trials rather than a Part A and B, the two parts always would have to be separated anyway, though, because of the safety considerations, we have to do the intact skin before we do the broken skin. Does that answer your question?

Yes it does. That actually makes perfect sense. And then also I just want -- so you're going through The Netherlands. So, I was just wondering what that means with regards to like the CTA and the IND in terms of timing of that filing?

Okay. Thank you for that question too. I can clarify that. So, yes, we are filing in the Netherlands. Their process is called a Clinical Trial Application. The IND language that we all use sort of as a generic term is really specific to the U.S. application. So, a Clinical Trial Application in The Netherlands is quite a good and simple process and it is a very well-defined process, well-defined timelines and it's very quick. The Ethics Committee will be reviewing in parallel with the Health Authority, the National Health -- we call the National competent authority in the Netherlands. They will review everything in parallel, and therefore the oversight is quite quick. And in the Netherlands, we do not need any further reviews to support cannabinoids, whereas, in some other jurisdictions you often need a license to deal with cannabinoids. So the Netherlands is a more friendly environment for working with this class of compound.

Okay, great. And so for like the Phase I, II in EB patients will that be done still in the Netherlands? Is it going to be in like the U.S. or Canada? And so just when will those filings that will enable those studies happen?

Yes. That's another good question. Thanks. That one will have to be a global trial, because EB is a very rare disease and we would need to enroll in many centers around the world. And, therefore, we will be putting in multiple regulatory applications for that. One might think, why does it take so long to do -- go from the healthy volunteer studies to go into the EB patients? And it's because of the required process for filing these applications globally. We have to have the full data base. For example, you have to submit the clinical trial reports, but not only the reports, but the full databases as well in the U.S. as the full electronic submission. And -- but each country has their own requirements. So our regulatory applications will go in, somewhat in parallel, but they will be processed on different schedules and the sites will eventually for the EB trial will start up at different times globally. So we believe we, put together an aggressive schedule here for our program, but we're confident that we can make these timelines.

And so you would expect kind of like the global filings to be completed by like around fourth quarter of 2020?

Yes.

Okay. Okay, great. Thanks Alexandra. That definitely answers my questions.

Okay. Thanks.

Thank you. Your next question is from Jerry Isaacson from ROTH Capital. Please go ahead.

Hey, good morning, guys. Thanks a lot for taking my questions. I appreciate it. Certainly I want to start by congratulating you on the addition of Catherine and Bruce to the team. Definitely looks like very nice additions, and is appreciated. Next thing is, last time we spoke, there was not enough expertise on the call, and Eric you promised to bring in the team this time, and so I really appreciate that. So I’m going to start by directing a question to the other Eric. And one of the things I wanted to talk about before is, if you could talk, there's a lot of hype around the yeast biosynthesis of cannabinoids right now and you're obviously focused on the bacterial side. And I wonder if you could just talk to me about the differences that you see and maybe why you see advantages in the E. coli synthesis?

Thanks for the question Jerry. So, yes, you're correct. There are a lot of hypes around the E system for good reason, but if you look historically, a lot of biological product that's used now are being produced in E.coli. So there is a lot of knowhow in terms of scale-up, in terms of downstream process, that's all been developed with a bacterial fermentation. And as we were able to show that the cannabinoid can be produced in E.coli, it was an obvious choice for us to go after. I'll give you a good example is that, if you look at E.coli fermentation, time that's required to produce a batch is significantly less than the yeast timeline. So, that gives advantage when we go into the clean room to produce these drug products -- drug substance. Thank you.

So, Eric, what sort of milestones should we be looking for potentially in the next year or so that would tell us that, whether it'd be InMed or whether it'd be somebody else that tells us that there's significant progress being made?

Yes, I'll take that one. Thanks, Jerry. Well, I mean, we continue to make pretty significant progress here and I think we may be one of the few companies that are actually in the process of scaling up to commercial scale. So, we have a couple of key milestones that we want to hit by the end of this year, in terms of locking in the upstream process, which is the fermentation process. We want to lock those parameters down at larger scale. And we also want to finalize what the downstream purification process is. So, once you ferment, and have the broth, you need to separate out the drug from everything else and that's the purification process. So we're working with a couple of pharmaceutical contract manufacturers to identify and solidify those processes. We're on track to complete that by the end of the year. And we also mentioned that we're looking at alternatives to what we would say is traditional biosynthesis and our R&D efforts have led us down a path to say, well, there may be another way to do this. And so, we're pursuing that as well and we should be in a position to kind of decide, one way or the other, whether we stay with the traditional process or the alternative process by the end of the year. Based on which way we go, then we'll be scaling up towards commercial scale next year. So, I don't have any specific dates I could give you. I mean, its science, it doesn't always adhere to the timelines we wish, but we're making great progress on that program right now.

So Eric, I'm intrigued, you're mentioning this new approach, anything else that you might be able to say about it.

Well, I'll turn it over to the other Eric who's in charge of that program. We'll let him handle that one.

Thanks, Jerry. So, while we're scaling up the biosynthesis process, we discovered that there is actually a ceiling with the whole system. That's with regard to how much protein or some of these protein it produce and how much cannabinoid it can generate. And that's because some of these cannabinoid could be toxic to themselves. So, we will refer to the limitation or dislimitation as a biological burden. So the threshold actually exists, regardless if it's E.Coli the host or yeast or algae. So it's going to be there. So because of this, we actually spend a lot of time optimizing fermentation parameter in order to just increase the cell mass in general. Working with one of our contract research organizations, we discussed how to overcome these kind of constraints with a bio burden and we discover that there may be a better way just to produce the overall production yield. Of course right now we're working through the provisional stage of the pattern. So, I'm not in the liberty to go in the details on the alternate process. But rest assured that we're actually working both on the traditional and alternate bio fermentation process in parallel right now. And then we are -- we already invested and -- in the E.coli fermentation and have a lot of intellectual property and know-how surrounding that. So, our first choice will be continue with the E.coli process even applied to the new approach. Thank you.

Okay, great. Yeah, no that's actually really great detail, I appreciate that. So, I hope you don't mind I have a couple more questions. I'm going to take advantage of everybody who's on the call today.

Sure, go ahead.

So, Ms. Mancini what I'm curious about is how is the EB community kind of connected? Because I know it's a rare disease and kind of what are the centers-of-excellence? And how do you kind of organize the community? Is there -- a patient advocacy group that you're working with? I just wonder if you give me a little background on that.

Yeah, that's a great question. Thank you. It's always as you can imagine that's the basis of your question, I'm sure. It's always a challenge and an orphan indication to pull it together when you do a global trial. But one really important and positive situation here for the EB community is that they are already very well-connected and there is a group called Debra -- D-E-B-R-A International. And if you go to their website you will see that the umbrella organization Debra is, sort of, Dystrophic EB Research Association -- is one version of the acronym and they have coordinated and now in many countries of the world, there is a local Debra organization as well. And they are very focused on patient support and connecting families to medical care in their community because it's very hard for the families to know where to get help. And basically the Debra Groups are amazing to work with and they will be definitely part of our group that we work with as we go forward to roll-out the clinical trial. There is a -- Congress and an international Congress for EB coming in January of 2020 and our company is a sponsor of one of many, but we are a sponsor of that Congress in London, England. And at that time -- excuse me, we will be able to be meeting investigators from all over the world. They'll be coming for that. This will be a great Congress because it will be the first time they're holding one meeting which is directed at the physicians and also the patients and their families, and the basic researcher, so it's all areas of EB be coming together. So, we will be definitely meeting with investigators at that meeting and starting to discuss our clinical trial. That's a lot of lead-time before the regulatory applications will go in the second half of the year. So, that's good. We're getting a good head start on that.

Well, now that was much more information than expected. Thank you. I appreciate that. No -- and yeah, hopefully, I'll be able to attend. So, I also -- because since I have -- since he's on the call, I want to nail-down Mike, a little bit too. I think that at the end of the day, you can't control your efficacy or your safety, but you can control your CMC. And so I was hoping that Mike would maybe give us an update on, kind of, everything that you're doing to make sure that as the trials progress that that's an area that we don't have to worry about?

Sure. Yeah. Thanks for question, Jerry. So, with regards to supply for our materials, so we've spend a considerable amount of effort and resources in terms of finding contractors, who could support our drug development program, but also our API supply. So with regards to the cannabinoid or API supply, I’ve identified and setup a primary and a backup supplier for that. This required a lot of effort, there's within the industry for cannabinoid supplies and GMP. There’s a limited number of companies, who can support such efforts. We identified two of those as a primary and backup and we now have a supply of GMP material that's scalable to our clinical through the commercial development programs for that. On the drug product supply, we've also established relationships with testing labs and also manufacturers to support the drug product for our Phase I, and that is on track to meet our trials for this year.

Okay. Perfect. Yeah, I've already taken up enough of all of your time. Like I said before, I appreciate you making so many members of the team available. Thanks for taking my questions.

Thank you, Jerry. We've got some questions that were submitted online. I'd like to address one of those now. There was some question about, when our patents will issue and what the status for various patents are? And it's awfully difficult to project that kind of thing. So I thought Eric, maybe you could take a minute or two just to talk about what the process is. And why we can't really predict when they're going to be issued but where we are in the process.

Thank you. Thank you for the question. Just to follow-up, Eric's comment from last week from New York, InMed's building important suite of patent portfolio to protect our technology and our product. So this is also augmented with a significant amount of knowhow that's proprietary to the company. So, just briefly talking about the patent process, after entity like InMed, feel like we're creating something inventive. That means, it's either novel or non obviousness then we typically file a provisional patent application. The provisional patent is a ways for an entity protect its invention, beginning with the date that's file. The process also allow the entity to basically have another 12 months to produce additional supported information for the patent application. After the 12 months, we will then typically convert the provisional into a Patent Cooperation Treaty call a PCT applications. The PCT system is that -- for filing a patent is actually recognized simultaneous by numerous country around the world. So the application then will be hidden for about 18 months before it was actually published. Now, the PCT application is filed. The International Search Authority will initially conduct the written opinion based on the prior searches. It's important to keep in mind that these opinions are not necessarily going to be used by various patent office. Normally the different patent office will form their own opinions, once the patent office forms, these opinions, they'll then contact the inventor or the entity regarding the patent, and they go through a process called office action. The applicant then will have opportunity to address specific novelty, or obviousness questions or concerns raised by the patent office. This process can go back and forth several rounds, so it could -- the entire process of patenting could take up to few years. So, currently we anticipate that several of our PCT patents will start to receive [indiscernible] from various jurisdictions that we file. In addition, we have several other provisional applications that are still not converted to PCT yet. So because the process is so long, it's really difficult for us to predict when will we start to receive allowances for these patents at this time.

So we've got several in process. We’ve got several in the queue. We've got several provisionals that we're going to roll over into PCTs, and many more behind that. So I think it's important that we continue to build this portfolio of know-how and proprietary know-how, and that's going to help protect the company and the commercialization of its product. So, it's never a sure bet, but we're in the process and we just have to keep plugging away at getting those things move forward. There was one other question, I'll just take briefly from -- that was submitted online. Someone sent in a question about our bioinformatics platform and when we plan to monetize that through licensing. So, I think, the easy answer is, that's not something that we're pursuing right now. We had the opportunity in the past, in discussions with another company, to out-license this kind of know-how and what occurred to us very quickly is that, there's no way to really protect it. So once you let us know-how out of the barn, you can't harness it anymore. And whoever has it can then kind of run with it and do whatever they want. It's very difficult to control. So what we decided back then was that, we wouldn't be licensing any know-how, but we will license patents down the road. Once you have a patent that kind of restricts someone's ability to work in your space. It's much easier to control what they do or don't do with that know-how. So we're going to take our know-how. We're going to patent it, and once we have the patents then we'll be in a position to talk about licensing opportunities or other ways of monetizing our internal know-how. So, no immediate plans on anything with the bioinformatics platform. Okay, I think we could take another question.

Thank you. Your next question on the phone is from George Ingram from Ingram Initiative Incorporated. Please go ahead.

Good afternoon. And in regards to your capital and raising capital, I see that we've got 2020 warrants coming up. Does that look like a viable option to help you? Or do you foresee additional capital raises?

I believe those warrants are priced at CAD1.25, so I would be thrilled if those were actually converted into shares, which we would have to be above CAD1.25 for anyone to want to do that. We endeavour on a daily basis to get up to that level, but right now, I'd have to say, that might be a remote possibility, just depending on what happens in the markets. Absent that, we're considering other avenues towards acquiring additional capital. I don’t know, Bruce, if you maybe want to touch on that a little bit.

Yes, sure. I mean, I touched on it earlier in the call that, we ended the quarter or the fiscal year with CAD18 million on the balance sheet. So the bottom line, we're reasonably well positioned right now, sort of looking down the pipe, as far as what we're working on with the three programs that the rest the teams already covered off. We're certainly going to be able to progress those with the capital that we have on the balance sheet today. That being said, now if there's an opportunity to bring additional capital on the balance sheet, opportunistically, then certainly we would absolutely consider that. That might take the form of an additional equity offering. Although, we're very cognizant of our share price, potentially looking at, if there's a little third party strategic investment or while it's less likely potentially licensing opportunity. So, I mean -- we're right now with 2018 on the balance sheet. We're feeling okay, but we continue to monitor absolutely.

Excellent. And then the second question I would like to ask is in regards to your delivery system, your Hydrogel formation, you mentioned that you are considering other. Could you talk a little bit more? Is that a licensable technology as well?

Well, we continue to develop that. But as we are heading towards more advanced preclinical testing for 088, we certainly want to make sure that we have the best delivery technology, one that is adequate and patent-protected. So, we're actually looking at a couple other delivery technologies and we're going to be comparing those head-to-head with our Hydrogel technology. I think it's a nice, it's a very refined approach, the Hydrogel, but it's hard to say whether it's the best and that's going to come down to the ability to deliver drug over the timeframe needed into the eye. So, it's still in the hopper, but we want to make sure we make the best decision for the product.

Okay. Thank you all very much.

Thank you.

Thank you. We have no further questions on the phone. You may proceed.

Great. Well, I want to thank everyone for taking the time today. The company continues to make really good progress both in terms of the scientific advancement as well as building the team out for what lies ahead and being able to execute on that. So, I think as Bruce said we're in a good position from a cash perspective, we're able to go very aggressively after the opportunities that are in front of us and we look forward to updating you next time on the advancements and the milestones that we reach. So, thank you everyone very much.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and we ask that you please disconnect your lines.