InMed Pharmaceuticals Inc (INM) 2020 Q3 法說會逐字稿

Good morning. My name is Colin, and I will be your conference operator today. At this time, I would like to welcome everyone to InMed's Third Quarter Fiscal Year 2020 Financial Results and Business Update Conference Call for the period ending March 31, 2020. (Operator Instructions)

Thank you. Mr. Payne, you may begin your conference.

Thank you, Colin. 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 note, our speakers are joining us from separate locations at a safe distance, so we appreciate your patience if we encounter any unexpected technical challenges.

Before we begin, we'd like to go over our disclosure statements, followed by a review of the progress on our therapeutic development in 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. A 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 the call over to InMed 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 fortunate that 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 for epidermolysis bullosa or EB. Our Phase I clinical program with INM-755 reached several important milestones in this last quarter. We completed treatment in our first Phase I study in healthy volunteers and just recently had the clinical trial application, or CTA, for our second Phase I study approved by the Dutch competent authorities. Both Phase I 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 time frame 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 may be limited to about 2 months or less.

As a reminder, INM-755 is a CBN cream intended as a topical therapy to treat EB, whereas the first Phase I study was designed to establish the local and systemic safety and pharmacokinetics of INM-755 applied daily on intact skin, the second study will look specifically at the safety of INM-755 applied on epidermal wounds to healthy volunteers. 2 strengths of the cream will be evaluated in 8 adult subjects over a 14-day treatment period. As a reminder, Alexandra Mancini, our Senior Vice President of Clinical Development and Regulatory Affairs, will be available during the Q&A session to answer any questions related to this program.

Turning now to INM-088 for glaucoma. In our last call, we described encouraging preclinical results, suggesting a possible therapeutic benefit of CBN in both relieving the intraocular pressure associated with glaucoma as well as potentially providing the additional therapeutic benefit of neuroprotection to nerve cells in the eye that are responsible for sight. This positive data related to neuroprotection is the subject of the claims in a patent filing we announced earlier this week entitled Compositions and Methods of Use for Cannabinoids for Neuroprotection, and it specifically relates to the neuroprotective effects of CBN and other cannabinoids in the treatment of glaucoma and possibly other ocular diseases.

The bulk of our current work with INM-088 is centered around completing drug pharmacology studies and selecting a final delivery technology. We have now completed the delivery formulation testing and are analyzing the data. After selecting a specific delivery technology, we intend to formulate the CBN product and, if needed, study it in additional preclinical models. Assuming positive outcomes, we intend to initiate IND-enabling toxicology studies in the second half of calendar 2020. Because our INM-755 program also uses CBN as the active pharmaceutical ingredient, we anticipate some of the GLP safety data from the dermatology program can also be used to support the ocular program.

Switching now to the biosynthesis program. We've been making significant progress in our approach for cannabinoid manufacturing in recent months. Our focus has consistently been to develop a comprehensive methodology that minimizes the number of steps required in the manufacturing process and utilizing cost-effective raw materials to achieve a low-cost, high-yield, pharmaceutical-grade cannabinoid process at commercial scale. We recently announced our working relationship with the Almac Group in the U.K. Almac is a world-leading contract development and manufacturing organization, or CDMO, that augments our internal know-how with additional expertise and significant success in enzyme engineering, process design and development and downstream purification processing under GMP conditions. Our internal scientific and pharmaceutical manufacturing team works closely with Almac and other CDMOs to explore new innovations and best practices that could enhance and accelerate our cannabinoid manufacturing program.

Together with Almac, we continue to scale up a newly developed alternative approach to cannabinoid synthesis. Our primary goal in this program is to be GMP-batch ready by the end of calendar 2020. So this relationship with Almac has already yielded exciting results, and we look forward to sharing more with you in the coming months. Dr. Eric Hsu, our Senior Vice President of Preclinical R&D, will be available during the Q&A session to answer any questions related to biosynthesis and the 088 program.

From a general corporate update standpoint, in summary, the COVID-19 pandemic and the related economic uncertainty has had minimal impact on our therapeutic programs. We anticipate our INM-755 milestones to be pushed out by approximately 2 months. Assuming we achieve this new time line, the clinical trial applications for the initial EB clinical study will be filed in several jurisdictions in late fourth quarter 2020 or in the first quarter of 2021. I should say and in the first quarter of 2021 because we'll be going out to multiple jurisdictions, and they won't all be done at the same time.

Our latest best estimate for the INM-088 program indicates minimal impact from the COVID-19 pandemic. However, investigations into additional possible indications for both drug candidates has been deprioritized for the time being. Thus far, we have been able to manage the impact of COVID-19 such that our work on biosynthesis and other innovative means of manufacturing cannabinoids has remained on track. We have a strong relationship with our vendors and collaborators and are in continuous discussion about any and all pandemic-related impact to our R&D game plan. Otherwise, the company has taken proactive measures to closely manage its cash position and extend its cash runway without critically affecting any of its core programs to this point.

I'd now like to turn the call over to our CFO, Bruce Colwill, for our financial review. Bruce?

Yes, thank you, Eric. And thanks, everybody, for joining the call today. I'd just -- as a -- I just want 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 our R&D spend, followed by a review of G&A. 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 3-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 last quarter due to the fact that in the previous quarter we incurred more expenditures in each of our Phase I clinical expenses, our preclinical work leading up to the first Phase I trial and our manufacturing costs for INM-755 material.

Now for the 9 months ended March 31, 2020, research and development expenses totaled approximately $5.8 million. So looking at that $5.8 million 9-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 9 months, these 2 categories, the external contractors and research supplies, have accounted for 80% of our total R&D expenditures, with the remaining 20% being patent-related expenses and internal salaries and benefits.

But primarily as a result of having seen our preclinical work that led up to the first Phase I trial, as we saw that preclinical work wind down, the total of our external contractors and research supplies have gone from a total of $2 million in the first quarter to $1.5 million in our second quarter to $1 million in this most recent quarter that we're discussing today. So this represents an over 50% decrease in these external contractors and research supplies expenditures from the first quarter to this third quarter. And it's this decrease that is the largest driver of the approximate $350,000 quarter-on-quarter decrease in overall R&D expenses mentioned earlier.

Turning now to our G&A. The company incurred general and administrative expenses of approximately $1 million in our third fiscal quarter, which is fairly consistent with not only the equivalent 3-month period last year but also our G&A expenditures in the prior quarter. Comparing G&A expenses for the 9 months period ending March 31, 2020, to the equivalent period in 2019, we did see an increase of just over $200,000 or slightly less than 8%. This increase in general and administrative expenses for the 9 months to March 31, 2020, was primarily due to increased accounting and legal expenses. Overall, in total for the 3 and 9 months ended March 31, 2020, the company recorded a net loss of $2.8 million and $9.5 million, or $0.02 and $0.06, respectively, per share, compared with a net loss of $3.5 million and $9 million, or $0.02 and $0.05 per share, respectively, for the 3 and 9 months ended March 31, 2019.

Turning now to our balance sheet. At March 31, 2020, the company's cash, cash equivalents and short-term investments totaled $9.9 million, which compares to $18 million as at June 30, 2019, June 30, 2019, being the end of our last fiscal year, and compares to $12 million at the end our last quarter, of course, being December 31, 2019. The decrease in cash, cash equivalents and short-term investments during the 9 months ended this quarter was primarily due to cash outflows from our operating activities, which ran at just under $900,000 a month over the last 9 months. But with the larger R&D expenses we realized in earlier quarters behind us, as I just chatted about, in this most recent quarter, our monthly cash used in operations decreased to slightly less than $700,000 per month. Our net working capital sat at $8.3 million at quarter end. At March 31, 2020, the company's total issued and outstanding shares remained at approximately 172.3 million, which is also the weighted average number of common shares used for the calculation of loss per share for both the 3- and 9-month period ended March 31, 2020.

Last quarter, we had provided guidance that our cash resources were sufficient to fund planned operations until at least into the first quarter of calendar 2021. We discussed on the last quarterly call that we have the operational flexibility to really ramp up or ramp down our expenditures, mostly driven by a relatively virtual operating structure that relies heavily on external R&D contractors. Having made certain operating adjustments, while still maintaining our internal team and key research activities, albeit on a decreasing level over time, we have the ability to extend our cash runway until at least into the third quarter of calendar 2021.

With that, I'll now hand it over to the operator for a Q&A session. But just as a reminder, as Eric mentioned, we do have Alexandra Mancini, Eric Hsu and Michael Woudenberg, are also available for questions. Operator?

(Operator Instructions) So your first question comes from Scott Henry of Roth Capital.

Just a couple. First, when we look at the pipeline for 755 for EB, when do you think -- do you think it will be reasonable to expect a filing by the end of 2022? Or might that be now 2023 given the slight delays?

Scott, thanks for the question. 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, one of 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 6, 8, 10 months from now. But right now, it's just -- it's too far out, and there's too many variables that could impact it one way or another.

Alex, would you like to add anything to that?

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

Okay. I appreciate the color on that. Another question. You've got a couple of these Phase I trials going. You've got the wounded skin data as well. What should we -- and some in vitro testing for 088, what should we expect for data readouts? Is there a form and a time when perhaps we may see that press release to present it? Just trying to get a sense on that.

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

Yes. Certainly. Well, for the Phase I healthy volunteer trials, there's one trial that we have completed already, the -- 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, well, that trial hasn't actually begun recruitment yet. Once we start, it will probably finish the in vivo phase, the actual enrollment and treatment, within about 2 months or so. It will depend on how quickly we can enroll, of course. So we will still see those results this calendar year as well, but they'll be several months after the first trial report's out.

Okay. 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 will 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.

Your next question comes from Jim Molloy of Alliance Global.

I had a question on the 755, on the study. The third quarter '20, you're looking for data. How quickly -- assuming all goes to plan, how quickly could you turn that around, you think, and start, I guess, you file your IND and get a Phase II going? 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 -- there's a few questions there in what you've asked. Thanks for those. And I'll start with the timing to get 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 1 year. The exact time might be 10 months, 9 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 3-month trial, anything that short. It will be longer because of recruitment challenges.

Is that answering your question? Or is there anything further?

No. That's excellent. Perhaps on another note, as a follow up for some more on Scott's question on Almac. When would you anticipate utilizing the biosynthesized product that you're currently getting it, obviously, not from there? When do you think that comes online and that starts being what you use? And then any thoughts on the best delivery tech for the 088 product?

Sure. I'll take the first one. Sorry, I was focused on the second one. What was the first one again? Oh, when we're going to use the cannabinoid? 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 manufacture GMP-level CBN, so that our therapeutic programs can proceed unimpeded by the status of the biosynthesis program. So first thing 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, we would probably do a crossover at the Phase III 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 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 III level.

The other question was about 088. Eric, did you want to make some comments on that?

Yes. Sure. Thank you for the question. So we have already completed the study associated with the formulation development. And right now, we're just combing through the data to make sure we capture everything. Once we decide on what formulation, we will then determine if there is additional study needed to complement those data sets. Once we have that, then we will move this program into the IND-enabling part of the study.

So right now, we're mapping those activities out. And -- but we anticipate that at the beginning of second half -- 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 filing a CTA or IND for the Phase I 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 a candidate, if indeed we're going to use an external candidate.

And your next question comes from Max Jacobs of Edison Group.

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 were expecting a ramp. Is that ramp just kind of delayed? Or is there a more secular reason for the decrease?

And which program are you talking about in particular?

No, just the R&D spend.

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

Yes. I mean -- 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 extent of preclinical work that went into preparing for that Phase I. There's still -- the spend is still coming with respect to the second Phase I study: 755-102-HV. And as Eric talked about a few minutes ago, the exact timing of when we are 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 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 few quarters?

Yes. I would say that we're continuing to watch our spend. We are committed to running the 755-102 study. There's certain 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 to certain R&D programs. So like I said, it's certainly not going to go up.

Okay. Wonderful. That was very helpful. Just -- my last question is just on kind of COVID-19 scenario planning. And so I understand that, currently, you expect about a 2-month delay in enrollment, approximately. So I was just wondering what might things look like if we see a second wave coming through, let's say, during the normal cold flu season, there are additional lockdown. And just, is there anything you would be able to do to kind of avoid any delays related to that such as focus 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 enrollment -- 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 constant contact with our collaborator there, with our center where we're conducting the study. 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 Is. 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 is 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 the wraps 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 small wounds. It's a very small sample size. It's going to be 8 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 2 weeks of treatment and 1 week of additional follow ups. 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 that would be needed to treat patients that are ill with the pandemic. But 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 pulls, 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. So that's very helpful on the 102 study. But what about the Phase I/II 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? Do you want…

No. 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 everybody is 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 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 are a little better off than some other companies and some other indications.

So we have 3 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 I trial.

Okay. Yes, thank you for that question. Well, this will be a small trial, 8 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 4 small wounds and, therefore, they will get -- for all 4 different, let's call them, treatment options, being the 2 different concentrations of the cream and 1 wound, which gets just the vehicle without drug, and then the fourth one, which gets no cream at all, and that's basically a good control, an untreated control to compare. The treatment period will be 14 days. And then there will be 1 additional week of follow-up, and so 3 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 in 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 were some complication caused 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 have said, we're going to try to get the in vivo phase of the 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 would like 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 program has always been to produce a flexible, efficient, scalable and economical viable solutions with least process steps 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 5 years can do this job, we continue to challenge ourselves to improve the process conditions, purification steps in order to reach our goal. Some of the key recent milestone that we have been reported were optimization of 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 the 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 solutions, 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 all our CDMOs, we start to learn more about Doctor or Professor Tom Moody's team and their capability and decided that we should collaborate with them to work on the alternative process, which focus on the key step to overcome some of the shortcomings that we learned while scaling up the biosynthesis process. After discussing with the Almac team, we all believe that the alternative process, in principle, is actually more aligned with the vision that we initially have for this program.

Working with Almac, we have completed proof-of-concept studies and produced cannabinoid needed to validate the alternative process, which integrate all the variable in the processes in the pharmaceutical manufacturing. The new process start with the fundamental of the biosynthesis using the E. coli system. The other feature that this integrated methodology we're pursuing included minimize number of the manufacturing steps, but also utilizing less costly manufacturing processes and involving going from the substrate, all the way to the end product.

But more importantly, we also maintained the flexibility in terms of shifting from production time of one particular cannabinoid to another cannabinoid. So the benefit for this is a simpler process, the agility to shift production to meet specific needs, and potentially reducing time and costs associated with producing a GMP pharmaceutical-grade cannabinoid.

Looking ahead, we're very encouraged and very excited about our progress with this program, and [in May] -- and also the collaboration with Almac. So we're looking forward to share more with our shareholders in the weeks ahead.

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

Thanks, Brendan. No, there's not. I mean we understand that while 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 TSX.

All right. That includes -- 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 on our various research undertakings. We remain 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 the 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 6 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.