Good morning. My name is Sylvie and I will be your conference operator today. At this time, I would like to welcome everyone to the InMed’s Second Quarter Fiscal Year 2020 Financial Results and Business Update Conference Call for the period ending December 31, 2019. Note that 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. Payne you may go ahead and begin.

Thank you, Sylvie, and good day, ladies and gentlemen. My name is Brendan Payne. InMed’s Director of Investor Relations. Welcome to InMed’s second quarter fiscal year’s 2020 financial results and business update conference call. Before we begin, we would like to go over our disclosure statements, followed by a review of the progress on our biosynthesis and therapeutic development programs, which will be led by our President and CEO, Eric Adams. Mr. Bruce Colwill, our CFO 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 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. 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, President and CEO, Eric Adams. Eric?

Thank you, Brendan and thank you all for joining us today. In the period since our last investor update, we've made significant strides in advancing both our innovative biosynthesis platform and our clinical development programs to treat diseases with high unmet medical needs. In January of this year, based on encouraging data from more than 30 pre-clinical pharmacology and toxicology studies, we revealed that cannabinol or CBN is the active ingredient in our lead therapeutic programs. CBN is one of the more than 100 cannabinoid compounds present in the cannabis plant, albeit at very low levels, which classifies it as a rare or minor cannabinoid. In total, all rare cannabinoids are estimated to make up less than 1% of the cannabis plant. Through our significant preclinical R&D studies and review of publications comparing different cannabinoids, we have identified several unique properties of CBN that may translate into important physiological benefits in humans. For example, when compared to other cannabinoids CBN can act with higher potency when interacting with certain receptor systems in the body while acting with lower potency for others. And while the major cannabinoids, THC and CBD have established therapeutic benefits in certain instances, our data support CBN having distinct advantages as potential treatment for Epidermolysis Bullosa and glaucoma. Based on published literature, as well as our own safety testing, CBN is considered to be nonpyschoactive. Turning to INM-755 for Epidermolysis Bullosa. With the approval of our clinical trial application in December of 2019, we initiated our first human clinical trial Study 755-101-HV or Study 101, which is a Phase I trial for examining the safety of INM-755 in healthy volunteers. In doing so, we became the first company to announce the advancement of a pharmalogical formulation of CBN in two clinical trials. This initial trial is designed…

Thanks, Eric. Thank you all for joining the call today. As the Canadian-based and regulated company, I remind you that the figures that I will present during today's call are expressed in Canadian dollars. And also by the way, a reminder, please note that we have a fiscal year that ends on June 30. So, as a consequence these figures which are as of December 31, 2019, represent our fiscal second quarter results. Please also note that the completed financial statements and MD&A are now available on our website as well as on SEDAR of course. And now, moving to our operational expenditures, I'll first review our research and development spend. R&D spending came in at approximately CAD1.9 million for this most recent quarter, which compares with approximately CAD1 million for the three months ended December 31, 2018, the same period last year. While for the six months ended December 31, research and development expenses totaled approximately CAD4.3 million, which compares with approximately CAD1.6 million for the equivalent six-month period last year, so fiscal 2019. The increase in research and development expenses in our second fiscal quarter as well as for the six months ended December 2019 compared to the equivalent periods last year or fiscal 2019, was primarily driven by the increased spending on clinical trial enabling preclinical safety pharmacology and tox studies as well as the manufacturing costs for INM-755 material, which is all incurred leading up to the commencement of our Phase I clinical trial. In addition, the company's biosensors program expenditures also increased compared to the equivalent period in fiscal 2019. Looking now at general and administration or G&A. Company incurred G&A expenses of approximately CAD1 million for our second fiscal quarter compared with CAD900,000 for the three months ended December 31, 2018. While for the…

Thank you. [Operator Instructions] And your first question will be from Maxim Jacobs at Edison Group. Please go ahead.

Hi, guys. Thanks for taking my question. So first I just wanted to ask what sort of response do you get from clinicians and patients at the EB Congress?

Hey. This is Alexandra. I will take that question. Thank you. We had an excellent response. It was a very helpful conference in many ways. Just a little bit of background for those who aren't familiar with the Congress, there were about 700 attendees from over 50 countries and the Congress was organized to include people involved in EB in many ways physicians or other medical support specialists basic researchers and of course the EB community which is the patient's caregivers and National Devra staff, which is a patient advocacy group. So we had a huge audience there. It was an excellent opportunity for us to introduce our development program for INM-755. As a sponsor of the Congress, we had a booth and it was very well attended. We were one of the few with a booth that actually had data in it. We had four posters that are now on our website that provided an overview of our research data to date as well as our clinical plans for 2020. So in terms of the response we got, there was a lot of interest in a topical cream. First of all, the way of delivering therapy is very attractive in this space. There was a lot of interest also in a cannabinoid-based product. And we did speak with many clinicians and research experts. And in general, I can say, they were very impressed with the extensive non-clinical program that we have run. The careful thought that we put into the range of studies we did, including some that were done a little earlier than one might have thought in this program. And, particularly, the good results that we obtained in our preclinical studies. They were also very pleased with our clinical development plan, particularly the fact that we are starting our trials in healthy volunteers, because we can collect a lot of safety data to frequent blood sampling, et cetera, which you don't want to do in patients with fragile skin. So they were very pleased to see that we're starting in healthy volunteers. Overall, their impression was that we had a well-designed and comprehensive program. And there's a lot of enthusiasm for patients who wanted to be in our study going forward when we start in EB patients, as well as physicians wanting to be part of our global trial, because we will need multiple clinical standards. We were very pleased with the whole conference.

Great. Thank you. That was very helpful. And then, another question on INM-755, I believe, Eric mentioned that you'll be releasing data from the healthy volunteers with normal intact skin trial in the second half. Do you expect to be releasing data from that and the one with healthy volunteers of small wound trial at the same time?

The results of the two different studies, one for intact skin and one for small wounds. The results would be released at different times, because we will release the results as soon as they are available. And the first study that we are doing in intact skin will come out first. That should be early in the second half of the year.

Okay. And then, just on biosynthesis. You mentioned in the press release that you've identified several prospective pathways that maybe even more attractive methods for the production of your cannabinoids. So I was just wondering, are those separate from kind of the, I guess, the original process and the alternative process that you've previously mentioned? And if they are different, like, how different are they? Is this -- what will those entail?

Thank you. This is Eric Hsu and I will address that question. So the traditional biosynthesis require you modify the organism following by -- once the cannabinoid is produced, then you have your downstream process to extract and isolate those specific cannabinoids. And you do that with every single cannabinoid. So to achieve that you're going to have to go back when you move to another cannabinoid to, again, modify those organisms, so that you can get to that specific cannabinoid you're looking for. So with the alternative process, as Eric Adams mentioned earlier, we're focusing on been on several things. One is, making sure the cost is down and you can address that by looking at what kind of steps are involved, you can also look at how much you need access to the GMP facility to be able to achieve the production at the level that we're looking at. And then finally is the yield. So the alternative process actually take all that into consideration and design it to be flexible that we could address production of cannabinoid at a low cost. But as well as being flexible when we move to another cannabinoid production.

Thank you. Great. And I just wanted to understand, so in the press release you mentioned several prospective pathways. So is this -- are those just kind of variations within the two processes you've already mentioned? Or are they kind of potential alternative processes.

So, primarily, we're focusing on those two processes. And in the last quarter, the focus was to generate data sets in the fermenters, when it comes to biosynthesis. So the upstream purification -- upstream production process we have completed. We also developed a downstream process. And that activity is also complete. The third thing, we're try to generate data on was the alternative process. So that, when we gather all these data, when we complete the studies, we'll be able to compare specific parameters head-to-head for us to make a decision whether or not the biosynthesis going to be helping us get to the specific cannabinoid we're looking for, or the alternative is actually better. So we expect to be able to have that conclusion in a couple of weeks. And once we do all our diligence, we'll be able to release those information.

Okay. Wonderful. Thank you for clearing that up. And then, this is going to be kind of a complete -- a request for some sort of forward-looking statements. So feel free to -- so you can't really make it. But I was just wondering, when do you think it might be economical for you to supply your own CBN rather than using outside parties.

Mike, do you want to take this?

Sure. Yeah. Yeah. So I can respond to that question. Thanks for the question. So the selection setup manufacture and supply the drug substance is obviously critical to meet our requirements for our pipeline and for supply material. To support this, we proactively selected world-class cGMP contract and development manufacturing organization or CMOs, they're commonly known as to supply the material. So the choice of a CMO requires organization to have expertise to make the CBN, but also to having place development capabilities, quality systems, best equipment, storage, designed -- properly designed room to utilities, operating procedures and other systems along with the staff, highly skilled staff to operate and maintain compliance through regulations. So the contractors we're working had a very successful track record and the development scale up commercialization and supply of GMP drug substances. Each of our clinical developments will involve increasing control as we move through the pathway and optimization to ensure the CBN's made in a repeatable and consistent or validated method to make sure compliance is achieved. So prior to the launch of our drug product containing CBN, all of the related development of clinical data and manufacturing processes will be reviewed by the agencies. And then obviously the CDMO that's making that one-to-go regulatory inspection or pre-approval inspection to verify the people systems facility and the process is compliant. So upon approval of this, then that development path will provide us with a commercial process to produce or supply the CBN. So it's the one pathway. The other pathways that, if InMed chooses to provide CBN to external companies from a process, just this could be accomplished at various stages of development with providing different qualities or grades of CBN depending on the customer needs. So an example of this could be for material notes pharmaceutical-grade for research medicinal or recreational use. This material will be of high purity, but will not have been produced necessarily in full compliance with its cGMP requirements for a pharmacy-approved product or one that's going through a clinical trial. When the process -- CBN process is developed for the CBN drug substance as CMO, a drug master file containing all the technical details and specs can be filed with the regulatory agency. This gives any reference by our customers for their clinical trial application or using their products. This will then provide the data needed support at least to the CBN and the programs and provide the solution with regards to using the cannabinol.

So to sum that up, Mike likes to be very thorough about things. The fact that we have a primary supplier in place for our ongoing needs is really important. That's paramount to everything else that we're doing. So we have security of supply for all of our R&D and potentially our commercial needs if we need it. The purpose of the biosynthesis is to provide access to rare cannabinoids in general. And in particular the ones that we want to pursue ourselves. So we're starting with CBN. We're not finishing with CBN. We're going to be looking at a lot of different rare cannabinoids as therapeutic -- potentially therapeutic products. So in terms of where we are right now, we're going to continue with our external supply. And we'll reach a point where there may be a dovetailing of our biosynthesis with our clinical programs. So that would typically would be something that happens in between your phases of trials. So probably for instance it might be just before Phase III trials just to start. And this is not unusual. This happens frequently in the pharmaceutical world where you start with one supplier or one process for your API or your active pharmaceutical ingredient and you switch your clinical development. So, there's a number of steps and procedures. Mike alluded to the importance of the different parameters for the manufacturers, but from a clinical standpoint, there's bridging studies. Sometimes it's simply chemical analysis. Sometimes it may require some kind of in vitro assay, on rare occasions it requires some in vivo or even clinical work to verify and it's the same product. So we're -- first and foremost, the key message is we have a good supply and we're able to move full steam ahead without waiting for the biosynthesis to catch up. Now the second point is the biosynthesis will catch up, and we'll find the best point possible to dovetail the two aspects of the company.

Wonderful. That was very helpful. And thank you so much for taking my questions.

Great. Thank you.

Thank you. Next question will be from Jason McCarthy at Maxim Group. Please go ahead.

Hi. This is Michael Okunewitch on for Jason. Thanks for taking the questions. So my first question, I'll let focus a bit on the EB space at large. I know you've seen much of the focus on gene therapies like those from Abeona & Krystal Biotech. I'd like to see if you could walk us through some of the advantages of a cannabinoid-based therapy and where INM-755 could really fit into this market?

Hey, thank you for that question. It's a very relevant question of course. So what we did learn more at the Congress in London. Excuse me, so, a big event in my throat here. There are some very exciting gene therapy projects that I think my own personal opinion is they likely will be successful someday they are -- there will be three that are in Phase III this year. I call them localized gene-correction therapies because the goal is to help patients with either with recessive dystrophic EB or junctional EB which are very severe forms of with a way to get corrected skin in a particular location on their body. Of course even after they've had that if it takes and if the skin transplant basically after they've grown the new skin. If it works it stays, the patient may still be symptomatic. Our therapy is dealing ideally, hopefully in future it will be proven to show that it in symptom relief. So, even after gene-correction therapy in a local spot like the back or the boat or something, there may still be local inflammation and pain and other symptoms occasional opening of wounds and things. So, there will still be a need I believe and others do as well for therapies like ours. Gene therapy will not be available for many patients just because of the high cost. And then there's other elements about medically being eligible to get that kind of therapy. Not all patients would be able to have it. So, local symptom relief remains a very high clinical need. We heard a lot about that at the Congress. The things that were mentioned as being the major daily challenges our blisters, wound, pain, itch. These are things that patients with all types of EB have in a variety of severities. So, I don't view the gene therapy success which I hope they do have frankly as being something that would limit the value and use of a product like ours.

Thank you very much. It's very helpful. For the next one actually I'd like to move on to glaucoma. So, let's get your thoughts on choosing a rare cannabinoid like CBN over something like THC because we have seen efficacy from THC and some THC-based therapies in glaucoma. So, what would be the major advantages of using CBN over a THC-based approach? Would it be largely regulatory or also in terms of the overall chemical profile?

Thank you, Michael. This is Eric and I'll take that question. So, when we started this exercise we're agnostic on what cannabinoid can avenue to go after. So, we actually perform a screen for the retinal ganglion cells to look at which cannabinoid actually performs the best in terms of neuroprotection. And in our screen of the cannabinoids that we look at including PC as well as CBD. CBN outperformed in those screen when it comes to neuroprotection. We then verify that to see whether or not the cannabinoid we chose actually have the impact on IOP reduction in terms of looking at a primary salient. Without going into too much detail basically at the end CBN in our screen outperformed. So, we're actually taking this approach as very data driven. Rather than just looking at a panel cannabinoid and the literature and decide which cannabinoid can perform the best. So, that's how we approached it. In terms of the chemical profile, obviously, CBN will be different from THC. From our EB study which also use CBN as a primary API. We have shown that CBN is quite stable as well. So, that's going to facilitate the CMC aspect of the drug product and also CBN in our preclinical study that was done for EB. It has -- it basically shows there's no neurotoxicity. So, from that perspective, that's I think another advantage over THC.

Yes. It's very interesting, especially the neuroprotection part on it. I'd actually like to see if you could -- could we expect to see any additional preclinical neuroprotection data in the near-term? Because that's kind of like the Holy Grail of treatment in glaucoma something that can reduce IOP and in part neuroprotection?

Yes. So, the short answer is we are performing a lot of activities both in vitro/in vivo. And so in time we'll be able to release those data. But keep in mind that in the glaucoma space when you talk about preclinical model. There are quite a lot of options but none of the model really reflects what's truly in the human. So, in short, we will do quite a bit of those study and when the data is already, we'll be able to release to the public.

All right. Thank you. And then I have one last one more on the regulatory side if you guys don't mind. I'd like to see how CBN is treated regulatory-wise in the U.S. because it's not as you said it's not psychoactive? And we know that CBD has been made available pretty much everywhere in the U.S. while the remains controlled. So where would CBN as the cannabinoid fall in the spectrum?

Okay. Thank you for that question. I'll take that one. Well, it will vary from one country to the next is the first part of the answer. If we talk about the U.S., this is a new chemical entity. And because it is in the class of cannabinoids, and therefore, it will start as a scheduled product and therefore be very controlled. Over time, it just has happened for CBD, if you can show the adequate safety and efficacy. There is a medical value for it then it can be changed in terms of the level on the scheduling and that's what happened for CBD. But when that happened for CBD, it happened only for the specific product for the specific approved indication. It wasn't for all uses of CBD. So that's the past. It's very confusing in the U.S. at times because of the farm bill. They're still sorting all this out whether things come from hemp or not it's very complicated. But we will be doing our trials in EB around the world and different jurisdictions have different ways of handling cannabinoids. Our current study in the Netherlands we've not had any complications with being able to run that study. Does that answer your question?

Yeah. Thank you. And then thank you for taking my questions. Congratulations on the progress.

Thank you.

Thank you. Next question will be from Jacque Fletcher [ph], Investor. Please go ahead.

Thank you. Good morning, madam and gentlemen. My question relates to how in the past the company directly or indirectly has benefited from grant money. And with the progress the company has made, one would think that the earlier source or sources of grant money would take notice. Is there a realistic chance that part of your future capital needs might be supplied from a source or sources of additional grants?

Yes, thanks for the question Jacque. Yes, in the past, we have been successful in securing non-dilutive funding through a number of different programs available to Canadian companies. It's something that on a project-by-project basis, we pay close attention to and try to identify potential funding sources. We've not received any for EB. There are some programs out there. But every grant program has different criteria. So we've not really been able to dovetail our program with some of the grant requirements for EB. For Biosynthesis, we have received some attractive grants from the NRC IRAP program in Canada, which is a tremendous program. I can't say enough about how much it's helped early biotech companies. And that's been very supportive of our efforts in biosynthesis. So the answer is yes, we will continue to pursue that. We can't really provide any guidance on it, because it's a grant process. So it has to be written up submitted, defended and negotiated and that's just something that takes time. And as we're successful, we'll communicate that to people. But we do keep an active eye open to find those kinds of funding sources.

Thanks sir and congratulations on your progress so far keep up the good work.

Thank you very much. I appreciate the comments.

Thank you. If there are no more questions from our call-in attendees, I'd like to now pass the call over to Mr. Payne for any additional questions submitted online. Mr. Payne?

Yes. So in closing I'd just like to thank everyone for taking the call and being with us today. Again, feel free to reach out to us, if you have any additional questions. And with that, I'd just like to pass the call back to Eric Adams our CEO if he has any further closing statements.

No. It's been a very active quarter very active year. We're making progress on all fronts and it's a very exciting time to be at the company. I can't say enough about the staff sitting around the table here with me. And their level of dedication and professionalism and it's the kind of thing that makes a difference for a company of our size to be successful. So I'm very thankful to all the individuals that have joined me today on the call. And to our investors. Thank you very much. We think it's going to be a tremendously exciting year. We have more milestones than we've ever had in the past and we look forward to communicating those and sharing those with investors and hope everyone shares the same excitement level that we have. So once again, thank you very much and we look forward to speaking with you again soon.

Thank you. Ladies and gentlemen, this does indeed conclude your conference call for today. Once again, thank you for attending. And at this time, we do ask that you please disconnect your lines. Have yourselves a great weekend.