Good morning. My name is Collin, and I will be your conference operator today. At this time, I would like to welcome everyone to the InMed’s Third Quarter Fiscal Year 2020 Financial Results and Business Update Conference Call for the period ending March 31, 2020. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and answer-session. [Operator Instructions] Thank you. Mr. Payne, you may begin your conference.

Thank you, Collin and good day, ladies and gentlemen. My name is Brendan Payne, InMed’s Director of Investor Relations, and welcome to InMed’s third quarter fiscal year 2020 financial results and business update conference call. Please not our speakers are joining us from separate locations of the safe distance. So, we appreciate your patience if we encounter any unexpected technical challenges. Before we begin, we would like to go over our disclosure statements, followed by a review of the progress on our therapeutic development program and cannabinoid manufacturing programs, which will be led by our President and CEO, Eric Adams. Mr. Bruce Colwill, our Chief Financial Officer, will then review the financial results of operations. Following that, we will be available for a question-and-answer session. Also joining us today to address your questions will be Eric Hsu, Senior Vice President of Preclinical Research and Development; Alexandra Mancini, Senior Vice President, Clinical and Regulatory Affairs; and Michael Woudenberg, Vice President of Chemistry Manufacturing and Control. Please be advised that certain statements in the following conference call regarding expectations for InMed’s business operations, clinical development, key personnel, contractual arrangement, 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. InMed does not undertake any obligation to update any forward-looking statements made during this call. I’d like now to turn over the call to InMed’s President and CEO, Eric Adams. Eric?

Great. Thank you, Brendan and I appreciate everyone joining us today. In the period since our last investor update, a lot has changed in the world, but I’m pleased to report today that we continue to make important progress in both of our CBN-based therapeutic development programs as well as our innovative cannabinoid manufacturing program, despite these many challenges from the COVID-19 pandemic. InMed is fortunatethat our research activities are conducted virtually, and our executive and scientific teams have experienced minimal impact in the transition to working remotely. Consequently, we have several accomplishments in this last fiscal quarter and anticipate little change in our guidance to key milestones in the second half of fiscal 2020. Let’s start off with an update on INM-755 or epidermolysis bullosa or EB. Our Phase 1 clinical program with INM-755 reaches several important milestones in this last quarter. We completed treatment in our first Phase 1 study in healthy volunteers and just recently, had the clinical trial application or CTA for our second Phase 1 study approved by the Dutch competent authorities. Both Phase 1 trials are being conducted at the Centre for Human Drug Research in the Netherlands while this dedicated clinical trial site has experienced some limitations to its activities related to the ongoing pandemic. Our CTA was submitted, reviewed, and approved within the anticipated timeframe according to our original guidance. The Dutch government has recently begun easing certain social restrictions. So, overall, our latest best estimate is that any COVID-19 related delays maybe limited to about two months or less. As a reminder, INM-755 as a CBN cream intended as a topical therapy to treat EB, whereas the first Phase 1 study was designed to establish the local and systemic safety and pharmacokinetics of INM-755 applied daily on intact skin; the second…

Thank you, Eric and thanks everybody for joining the call today. Just to remind you that as a Canadian-based and regulated company that all the figures that I will present in today’s call are expressed in Canadian dollars. and also by way of reminder, please note that we have a fiscal year that ends on June 30. So, as a consequence, these figures are as at March 31, 2020, which represents our third quarter results. So obviously, the complete set of financial statements and MD&A are available both on our website as well as on SEDAR now. So, moving to our financial results, I’m going to first review of our R&D spend followed by a review of G&A, and then I’ll touch on the balance sheet as well. R&D expenses came in at approximately $1.6 million for both this most recent quarter and the equivalent three-month period last year. But notably, the $1.6 million of Q3 R&D spend represents an approximate $350,000 decrease over the prior quarter R&D, which was of course, our second quarter results. Our research and development expenses were lower this quarter relative to the last quarter due to the fact that in the previous quarter, we incurred more expenditures in each of our phase 1 clinical expenses. Our preclinical work leading up to the first phase 1 trial and our manufacturing costs for INM-755 material. Now for the nine months ended March 31, 2020, research and development expenses totaled approximately $5.8 million. So, looking at that $5.8 million nine-month R&D spend a little closer, the key driver is the combination of our external contractors, which includes our CDMOs clinical trial site costs and our research supplies, which is primarily the API and related formulations for our trials. for the last nine months, these two categories, the…

Thank you. [Operator Instructions] Okay. So, your first question comes from Scott Henry of ROTH Capital. Scott, please go ahead.

Hello and thank you for taking the questions. Just a couple; first, when we look at the pipeline for 755 for EB, when do you think – do you think it would be reasonable to expect the filing by the end of 2022 or might that be now 2023 given it was a spike delays?

Scott, thanks for the questions. This is Eric. I think it’s a little too far out to project exactly when a filing, and I think you mean an NDA would be submitted to seek commercial approval. One of the key criteria when the key variables when you’re working in an orphan disease like this is how rapidly you can enroll patients into your clinical trials. And that tends to be the rate limiting step and at this point, it’s just too early for us to give any strong guidance as to how quickly we can get through these various trials. We’ll know quite a bit more as we ramp up for our first EB trial when we have a chance to discuss the protocols, the inclusion and exclusion criteria with different physicians, who may be interested in participating. So that’s the kind of question I think we’ll be in a better position to answer six, eight, 10 months from now. But right now, it’s just too far out and there’s too many variables that that could impact it one way or another. Alex, would you like to add anything to that?

I think you’ve covered it well, Eric, it’s too early to be able to project the filing time for an NDA.

Okay. Well thank you. I appreciate the color on that. Another question, you’ve got a couple of these phase 1 trials going, you get the wounded scan data as well. What should we add some in vitro testing for 088, what should we expect for data read-outs? Is there a form and a time when perhaps we may see that press release to present it kind of get a sense on that?

Yes. Alex, maybe, you could provide some color to that.

Yes, certainly. Well, for the phase 1 healthy volunteer trials, there’s one trial that we have completed already. I call it the 101 trial; it’s the one, where we are testing on intact skin. We haven’t completed the data analysis yet, because we haven’t been able to complete and lock the database. Monitoring is a little bit delayed, because of the pandemic. But we will be reporting out those results in the second half of 2020. Yes, it definitely will be – in the summer, I would say, is the best time to project when those results will be out. The second trial for the testing on epidermal wounds, that trial hasn’t actually begun recruitment yet. Once we start probably finish the in vivo phase, the actual enrollment and treatment within about two months or so, it’ll depend on how quickly we can enroll of course. So, we will still see those results this calendar year as well, but there will be several months after the first trial reports out.

Okay. Thank you. That’s helpful. And then the final question, I know you just announced the manufacturing agreement with Almac. Could you give us a sense of how that agreement works as far as money exchanging hands back and forth, just trying to get a sense of what are the levers in that agreement and how we should think about that within the income statement?

Sure. So, just to be clear, there is no commercial agreement in place. We consider them to be collaborators in assisting us develop the processes that we need to scale up for GMP. So, at this time, InMed retains all commercial rights to the entire program and we consider – we think it’ll stay that way for the foreseeable future. We think what we’re developing is a highly valuable asset and as such, we’re willing to make the full investment ourselves behind developing it. So while they are collaborators, we work exceptionally closely with them and they’ve been tremendous in performing underneath our collaboration. We retain full ownership of the entire process.

Okay. Thank you for that color and thank you for taking the questions.

Thank you.

Your next question comes from Jim Molloy of Alliance global. Jim, please go ahead.

Hey guys, thanks for taking my questions. I have a question on the 755 study, the third quarter 2020, looking for data, how quickly, assuming all those, the plan, how quickly could you turn that around and you think and start I guess filing IND and you can get a phase 2 billing and can you speak to some of the challenges in this patient population of recruitment. You mentioned that’s one of the key hurdles for getting to an NDA at some point?

Sure. Alex?

Sure, I’ll take that. Well, just to have a few questions there and what you’ve asked. Thanks for those. And I’ll start with the timing to get a filing, you say filing an IND for example. So, we are still on track for filing clinical trial applications. An IND would be one type for the U.S., but we’ll be doing the EB trial, the first EB trial in several countries, because of the challenge in recruitment. So, we’ll be filing those clinical trial applications starting in the fourth quarter of this year and continuing into the first quarter of next year. Our planning is just underway now. We are dealing; we are in the process of working with CRO selection, for who will run that trial and site selection, all the rest of that. But looking at the performance of other companies, who have run studies in EB and just using that as our guide. I think we should be able to complete a first study in EB in approximately one year. The exact time might be 10 months, nine months, 11 months, 14 months, I don’t – can’t say precisely right now. but in that ballpark, it’s not going to be a three-month trial, anything’s about short. It’ll be longer, because of recruitment challenges. Is that answering your question or is there anything further?

Excellent, thank you. Perhaps on the – on another note, as a follow-up for some more on Scott’s question on Almac, what would you anticipate in utilizing the biosynthesized product that you’re currently getting it? That was enough from there. When do you think that comes online and then that starts being used? And then any thoughts on the best delivery tech for the 088 product? Thank you.

Sure. I’ll take the first one. Sorry, I was focused on the second one. What was the first one again? When we’re going to use the cannabinoids, okay. Yes. So, what’s really key for any pharmaceutical company is to make sure that they have a security of supply for the compounds that they are testing and we’ve been successful in doing that for CBN, albeit from external sources. So, we have a primary and a secondary supplier that can manufacturer GMP level, CBN so that our therapeutic programs can proceed unimpeded by the status of the biosynthesis program. So, first things first, we have that security of supply. When will we be able to use cannabinoids from the biosynthesis program in our own development programs? If we want to use our internally produced biosynthesis for CBN in our clinical program around, we would probably do a crossover at the phase 3 level. So, it’s still a couple – probably a couple of years away before we need to have that online. Again, the exact timing and the timing of all the clinical trials is a pretty much up in the air until we get involved a little bit deeper in EB clinical trials, but we would see the crossover from our external source to our internal source if needed to take place probably at the phase 3 level. The other question was about 088, Eric, do you want to make some comments on that?

Yes, sure. Thank you for the question. So, we have already completed a study associated with the formulation development. And right now, we’re just combing through the data to make sure we captured everything. Once we decide on the formulation, we will then determine if there’s additional study needed to compliment those datasets. Once we have that, then we will move this program into the IND-enabling toxicology study. So right now, we’re mapping those activities out, but we anticipate that at the beginning of second – at the second half of 2020, we will most likely initiate the IND-enabling toxicology study and this could run through the first half of 2021 and the follow on will be following CTA or IND for the phase 1 trial and that we anticipate will be at the second half of 2021. So, in terms of the formulations, we have multiple candidates that we’ve been testing both internal and external candidates. And so we’ll have to see which one we choose as the one we prefer. We’re not making public what those formulations are just yet. The internal one of course is the hydrogel that we’ve patented. But the external ones we’re going to stay quiet on that until we’ve selected and secured the candidate if indeed we’re going to use an external candidate.

Thank you for taking the questions.

Sure. Thanks Jim.

And your next question comes from max Jacobs of Edison group. Please go ahead.

Hi guys. Thanks for taking my questions. I just have a question on R&D. So yes, it’s fallen sequentially. So, I was just wondering like going forward, how should we think about it as kind of we’re expecting a ramp. Is that ramp just kind of delayed or is there more secular reason for the decrease?

And which program are you about in particular?

No, just the R&D spend.

The R&D spend, I’ll turn that over to the money guy. Bruce?

Yes, I mean it’s – hey, max. As we chatted about a few minutes ago on this call, we have seen it come down as we had the heavy lifting behind us with some of the extensive preclinical work that went into preparing for that phase 1. There’s still – the spend is still coming with respect to the second phase 1 study, 755-102-HV. And as they’re talking about a few minutes ago, exact timing of when we’re able to initiate that is to be determined, but the overall, we don’t give specific quarter-to-quarter guidance on particular programs or overall R&D. But suffice it to say, you should not expect to see that number increase over the coming quarters. that’s for sure.

Okay. So, it should be relatively flat over the next three quarters.

Yes. I would say that we’re continuing to watch our spend, we’re – we are committed to running the 755-102 study. There are certain of other R&D expenditures that we have more flexibility on. And we’re just continuing to watch what’s going on in the capital markets, watch our balance sheet and have been making some game day decisions subject to certain R&D programs. So, like I said, it’s certainly, it’s certainly not going to go up.

Okay, wonderful. That was very helpful. My last question is just on, kind of COVID-19 scenario planning. And so I understand that currently, you expect about two months delay in enrollment approximately. So, I was just real wondering what might things look like if we see a second wave coming through, let’s say, during the normal cold flu season in their additional lockdown. And just is there anything that you would be able to do to kind of avoid any delays related to that, such as focused on some countries that haven’t had COVID-19 lockdowns?

Yes. I mean, that’s a really great question. I’m sure everyone is asking themselves the same question right now. We of course – we don’t have a crystal ball. We can just kind of react to how things develop externally and try to be in the best position possible to act as soon as feasible. A good example is the 102-HV study. We are slated to begin enrolment in our original guidance would have us in the next week or so initiating recruitment. But we know that’s been postponed and we’ve been in contact with our collaborator there with our center, where we’re conducting the study. Excuse me. But there’s a number of things we can do to make sure that as the window opens back up, we’re the first one to jump through it and we’ve been working diligently with them given the overall low risk of this trial versus other Phase 1s you can imagine if you’re given a drug intravenously or other methods, it’s going to be more difficult to do that given the current situation. But having a topically applied cream, it was a little bit less risky. And so we may have an opportunity to move to the front of the queue as the window opens up to get our study done as soon as possible. So, we can’t really speak to if and when, and how a second wave might hit in the pandemic. If you pay attention to what some of the experts are saying and that it’s going to be in the fall, we should be able to have this study under routes and completed prior to that happening. But again, it’s all speculation at this time. Alex, do you have any additional thoughts on that?

Perhaps just a couple, I think you’ve covered the essence of it, our 102 trial to use our internal shorthand is the trial with the small wounds, it’s a very small sample size. It’s going to be eight subjects. So and as Eric has mentioned, it will be viewed as a low risk trial, because it’s topical therapy and for each subject that comes into the trial, there’s two weeks of treatment and one week of additional follow-up. So that period of time, once they’re in is very quick and then they’re out. So, we’re optimistic that we can get in as once the door opens, we will be one of the first trials to be able to start. We’re not being – it’s not being conducted in a hospital setting. So, if another wave occurred of the pandemic, the trial would not be taking away resources would be needed to treat patients that are ill with the pandemic. But yes, I think, we are pretty optimistic that we’re going to get this trial done during the summer months. The actual in vivo part, where subjects are coming in and being treated, the data side of things, data analysis, database close, all that that can happen as it has been happening for our 101 study, even with people working from home. So, I think our timing is good.

Okay, great. That’s very helpful on the 102 study, but about the Phase 1/2 that would begin next year, just because that I would think would be a little more challenging?

It’s a very good question. Do you want to take that Eric?

No. If you want, please go ahead.

Okay. We’re already talking about that with the CROs that we’re interviewing. We haven’t made our choice yet on who we’re going to work with. This is a challenge for everyone in the world right now running clinical research, and yes, everybody’s working through it together. So, I think that this population of patients with EB will be – there might be some additional precautions for them, but the trial that we’re designing will be a home based kind of trial for the most part they will have to come to the clinics very seldom. That was going to be the case anyway, because for these subjects, especially the ones with the most severe disease. They’re not traveling around a lot. And so we’re trying to get them in, get the trial started and then everything else is happening at home for them until the very final visit. So, I think that there will be – there will be challenges globally for all clinical trials. I think we are still in a good position, because of using a topical therapy. It will not be viewed as high risk to the subjects. Very little is going to get into systemic circulation. So, concerns about immunosuppression and things like that will not be top of mind for people looking at the trial design. So, I think in that respect, we’re a little better off than some other companies in some other indications.

Okay, great. That was extremely helpful. Thank you so much.

So, we have three questions that have been submitted online. The first is, sort of expanding on Alexandra what you were just describing. This individual would like to know a little bit more about the protocol design for the second Phase 1 trial.

Okay. Yes, thank you for that question. Well, this will be a small trial, eight subjects as we’ve mentioned already. The focus is to evaluate the safety of our cream on the small epidermal wounds and we’re looking at local tolerance as well as wound healing to see if there’s any change in how the wound heals. So, what we are trying to do by keeping the number, we want to keep the number of subjects very small. And in order to do that, we want to deal with the variance that occurs with different skin types. And so a traditional parallel group design was not a good option, because there can be a lot of differences from one subject to the next, just because of their skin type. So, what we’re having is that each subject will get four small wounds and therefore, they will get four – all four different, let’s call them treatment options that being the two different concentrations of the cream and one which – one wound, which gets just the vehicle without drugs, and then the fourth one, which gets no cream at all, and that’s basically a good control and an untreated control to compare. Yes, the treatment period will be 14 days. And then there will be one additional week of follow-up. And so three weeks for each subject once they are in the trial. We are following the evaluation of the wounds with a number of imaging techniques as well as clinical assessments. So, we’re going to gather quite a bit of data quite quickly, and a small number of subjects. And I think this will be the best way for us to demonstrate the safety on open wounds and move forward into the EB subjects. We did not want to move into EB subjects without first doing this in healthy volunteers. I think it’s just an ethical consideration that people with EB have very sensitive skin already and a lot of difficulty with pain and we – in case, there was some complication crossed by our product, we certainly did not want to add to that. So, this is a fast way to get in and do it in healthy volunteers because we can enroll healthy volunteers very quickly. And as we said, we’re going to try to get the in vivo phase of this study done this summer.

Great. Thank you, Alex. The next question is directed towards Dr. Hsu, in addition to the financial terms and the intellectual property aspects of the Almac relationship, you already spoke to this individual likes to know more just about sort of the technical roles of InMed and Almac as it relates to the development of this alternative manufacturing process.

Well, thank you for your questions. Let me just start by summarizing some of the work that we have done for our traditional biosynthesis process, with the E. coli system, then talk more about the alternative process and the relationship with Almac. Our vision for the biosynthesis pogrom has always been to produce a flexible, efficient, scalable and economical viable solution, with these process depths and fastest production cycle in order to make the cannabinoid that we are – that are biological, identical to those found in nature. While the E. coli system that we have been developing for the last five years can do this job. We continue to challenge ourselves to improve the process condition purification steps in order to reach our goal. Some of the key recent milestones that we have been reported were optimization, the bioreactor fermentation conditions, downstream process purification development process development, and patent applications and prosecution around our processes. The Almac Group that we recently announced our collaboration with is a world-class multinational CDMO that works not only with a small, innovative biopharmaceutical company to support their commercial goals, but you can see from their track record that they also have worked with large international pharmaceutical company as well. Unlike some of the traditional CDMO, Almac’s team is able to offer a wide range of discovery tools and a solution, which together, with their experience in process development and GMP manufacturing, make them a very attractive collaborators. We initially engaged in Almac on the process development and scale up activities associated with our E. coli biosynthesis program, but through the RFP or request for proposal process that we typically do with our CDMOs, we start to learn more about doctor or professor Tom Moody’s team and their capability, and decided that we should…

Perfect. Thank you, Eric. The final question is directed towards the CFO. Our current share values is there any concern about remaining listed the Toronto Stock Exchange?

Thanks, Brendan. No, there’s not. I mean, we understand that, well, certain exchanges have minimum share price requirements, there’s no such restrictions on the TSX. So, we’re fully in line and compliant with all the continuous listing requirements of the TSX.

All right. That concludes our online questions. back to the operator.

[Operator Instructions] There are no further questions at this time, please proceed.

Great. Well, I’d just like to thank everybody for participating today and their continued interest in InMed, and also like to express our excitement at the progress we continue to make, in these unusual times, our team has demonstrated exceptional diligence in minimizing the impact of the COVID-19, our various research undertakings. We remained in excellent communication with our vendors and collaborators, and we are in continuous dialogue with them trying to find ways to achieve our milestones with minimal impact. Finally, we’re confident that we have operating flexibility in our plans as well as ways to further extend our cash runway should they need arise. So once again, thank you so much for participating and we look forward to keeping you informed as we move towards several significant milestones in the next six to 12 months. Thank you very much.

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