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InMed Pharmaceuticals Inc. Q3 FY2020 Earnings Call

InMed Pharmaceuticals Inc. (INM)

Earnings Call FY2020 Q3 Call date: 2020-03-31 Concluded

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Operator

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

Brendan Payne Head of Investor Relations

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 note our speakers are joining us from separate locations for safety, 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 arrangements, 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 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 1 clinical program with INM-755 reached 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 may be limited to about two months or less. As a reminder, INM-755 is 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 study will look specifically at the safety of INM-755 applied on epidermal wounds to healthy volunteers. Two strengths of the cream will be evaluated in eight 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. Switching 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 eyes 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 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 on INM-088 is centered around completing drug pharmacology studies and selecting the 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 the INM-088 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 to 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 utilizes 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 UK. 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 Pre-Clinical 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 two months. Assuming we achieve this new timeline, 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 have been de-prioritized 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 impacts 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?

Thank you, Eric, and thanks everybody for joining the call today. Just to remind you that as a Canadian-based and regulated company, all the figures that I will present in today’s call are expressed in Canadian dollars. 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. The complete set of financial statements and MD&A are available both on our website as well as on SEDAR now. Moving to our financial results, I’m going to first review 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. 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. 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 external contractors, or 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. So primarily, as a result of having seen our preclinical work that led up to the first Phase 1 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. 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 three-month period last year, but also our G&A expenditures in the prior quarter. Comparing G&A expenses for the nine-month 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 nine months to March 31, 2020, was primarily due to increased accounting and legal expenses. Overall, total for the three and nine 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 three and nine 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 of our last quarter, of course, being December 31, 2019. The decrease in cash, cash equivalents, and short-term investments during the nine months ended this quarter was primarily due to the cash outflows from our operating activities, which ran at just under $900,000 a month over the last nine months. However, with the larger R&D expenses 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 three and nine-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 also available for questions.

Operator

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

Speaker 4

Hello, and thank you for taking the questions. Just a couple; first, when we look at the pipeline for 755 for EB, 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 in 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 variables when you’re working in an orphan disease like this is how rapidly you can enroll patients into your clinical trials. 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, or ten months from now. But right now, it’s just too far out, and there are too many variables that could impact it one way or another. Alex, would you like to add anything to that?

Speaker 5

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

Speaker 4

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 expect for data read-outs? Is there a form and time when perhaps we may see that press release to present it, can you give a sense on that?

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

Speaker 5

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, we’ll 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.

Speaker 4

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 in developing 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 think it’ll stay that way for the foreseeable future. We believe 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 under our collaboration. We retain full ownership of the entire process.

Speaker 4

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

Thank you.

Operator

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

Speaker 6

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 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?

Speaker 5

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 selecting our CROs for who will run that trial and site selection, and 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, or 14 months; I can’t say precisely right now. But in that ballpark, it’s not going to be a three-month trial, it’ll be longer because of recruitment challenges. Does that answer your question or is there anything further?

Speaker 6

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

Speaker 7

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 manufacture 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 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 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. 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 studies needed to complement 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 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 we anticipate that will be in 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. We’ll see which one we choose for the preferred candidate. 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’ll stay quiet on that until we’ve secured the candidate if indeed we’re going to use an external candidate.

Speaker 6

Thank you for taking the questions.

Sure. Thanks, Jim.

Operator

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

Speaker 8

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

Which program are you asking about in particular?

Speaker 8

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. As they were talking about a few minutes ago, the exact timing of when we’re able to initiate that is to be determined. But overall, we don’t give specific quarter-to-quarter guidance on particular programs or overall R&D. Suffice it to say, you should not expect to see that number increase over the coming quarters; that’s for sure.

Speaker 8

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 committed to running the 755-102 study. There are certain other R&D expenditures that we have more flexibility on. 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 not going to go up.

Speaker 8

Okay, wonderful. That was very helpful. My last question is just on kind of COVID-19 scenario planning. I understand that currently, you expect about a two-month delay in enrollment approximately. So, I was just really wondering what might things look like if we see a second wave coming through during the normal cold flu season in their additional lockdown. Is there anything that you would be able to do to kind of avoid any delays related to that, such as focusing 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 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 initiating recruitment within the next week or so. But we know that’s been postponed, and we’ve been in contact with our collaborator there regarding the center where we’re conducting the study. Excuse me. There are a number of things we can do to ensure that as the window opens back up, we’re the first one to jump through it. 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 through other methods, it would be more difficult to do that given the current situation. However, 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 to complete our study as soon as possible. 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, it’s going to be in the fall. We should be able to have this study underway and completed prior to that happening. But again, it’s all speculation at this time. Alex, do you have any additional thoughts on that?

Speaker 5

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 will involve eight subjects. As Eric mentioned, it will be viewed as a low-risk trial because it’s a topical therapy, and for each subject coming into the trial, there’s two weeks of treatment and one week of additional follow-up. The period of time for each subject is very quick and then they are out. So, we’re optimistic that we can enter as soon as the door opens. We’re not taking away resources needed to treat patients that are ill with the pandemic. We think our timing is good.

Speaker 8

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

Brendan Payne Head of Investor Relations

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.

Speaker 5

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. We are trying to keep the number of subjects very small. Due to that, we want to deal with the variance that occurs with different skin types. 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, we’re having each subject get four small wounds, thus they will get four—all four different treatment options being the two different concentrations of the cream, one which gets just the vehicle without drugs, and then the fourth one that receives no cream at all, and that’s a good control and an untreated control to compare against. The treatment period will be 14 days, and there will be one additional week of follow-up. So three weeks for each subject once they are in the trial. Moreover, we will follow the evaluation of the wounds with a number of imaging techniques as well as clinical assessments. We’re going to gather quite a bit of data quite quickly from 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 initiate this in EB subjects without first doing this in healthy volunteers. It’s an ethical consideration, as individuals with EB have very sensitive skin already and much difficulty with pain. We certainly did not want to add to that. This is a fast way to proceed with healthy volunteers because we can enroll them very quickly, and as we said, we’re going to try to get the in vivo phase of this study done this summer.

Brendan Payne Head of Investor Relations

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, which 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.

Speaker 7

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 economically viable solution with these process depths and fastest production cycle in order to make the cannabinoid that we are—biologically 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 conditions and purification steps to reach our goal. Some of the key recent milestones that we have reported were optimization of the bioreactor fermentation conditions, downstream process purifying development process development, and patent applications and prosecution around our processes. The Almac Group with whom we recently announced our collaboration is a world-class multinational CDMO that works not only with small, innovative biopharmaceutical companies to support their commercial goals, but you can see from their track record that they also have worked with large international pharmaceutical companies as well. Unlike some of the traditional CDMOs, Almac’s team is able to offer a wide range of discovery tools and solutions which together, coupled with their experience in process development and GMP manufacturing, make them very attractive collaborators. We initially engaged with 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 conduct with our CDMOs, we learned more about Dr. Tom Moody’s team and their capabilities and decided that we should hire him to work on the alternative process, which focuses on key steps to overcome some of the shortcomings we learned while scaling up the biosynthesis process. After discussions with the Almac team, we all believe that the alternative process in principle is actually more aligned with the vision that we initially had for this program. Working with Almac, we have completed proof-of-concept studies and produced cannabinoids needed to validate the alternate process, which integrates all the variables in pharmaceutical manufacturing. The new process starts with the fundamental biosynthesis using the E. coli system. Another feature of this integrated methodology is to minimize the number of many action steps, utilize less costly manufacturing processes, and involve transitioning from the substrate all the way to the end product. More importantly, we also aim to create flexibility in terms of shifting production time from one cannabinoid to another cannabinoid. The benefit for this is a simpler process, the agility to shift production to meet specific needs, and potentially reducing time and costs while producing a GMP pharmaceutical-grade cannabinoid. Looking ahead, we’re very encouraged and excited about our progress with this program and the collaboration with Almac. We look forward to sharing more with our shareholders in the weeks ahead. Thank you.

Brendan Payne Head of Investor Relations

Perfect. Thank you, Eric. The final question is directed towards the CFO. Our 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, 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.

Brendan Payne Head of Investor Relations

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

Operator

There are no further questions at this time, please proceed.

Great. Well, I’d just like to thank everybody for participating today and for their continued interest in InMed. I would 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 COVID-19 on our various research undertakings. We have remained in excellent communication with our vendors and collaborators and are in continuous dialogue with them trying to find ways to achieve our milestones with minimal impact. Finally, we’re confident that we have operational 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 six to twelve months. Thank you very much.

Operator

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