Earnings Labs

InMed Pharmaceuticals Inc. (INM)

Q2 2021 Earnings Call· Thu, Feb 11, 2021

$0.72

-1.72%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-0.37%

1 Week

-18.32%

1 Month

-19.07%

vs S&P

-20.40%

Transcript

Operator

Operator

My name is Anes, and I will be your conference operator today. At this time, I would like to welcome everyone to InMed's second quarter 2021 financial results and business update conference call for the fiscal quarter ended December 30, 2020. [Operator Instructions] Thank you. Mr. Payne, you may begin your conference. [Operator Instructions]

Brendan Payne

Analyst

Thank you, Anes. Good day, ladies and gentlemen. My name is Brendan Payne. I'm InMed's Director of Investor Relations. Welcome to InMed's Second Quarter 2021 Financial Results and Business Update Conference Call. Please note our speakers are joining us today from remote locations, 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 and cannabinoid manufacturing programs, which will be led by our President and CEO, Eric Adams. 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 of 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. Should there be any discrepancies between any statements made during this teleconference and statements made in the audited financial statements, the listener is instructed to rely on the audited financial statements for accuracy. InMed does not undertake any obligation to update any forward-looking statements made during this call. I'd now like to turn the call over to InMed President and CEO Eric Adams. Eric?

Eric Adams

Analyst

Thank you, Brendan. And thank you, everyone, for joining us today. Before we dive into the many key events and milestones that InMed achieved in the final calendar quarter of 2020, I would be remiss if I didn't acknowledge the tragedy and challenges that everyone worldwide is facing with the COVID-19 pandemic and the changes we are all making to limit the spread of the virus. We thank all of the dedicated frontline workers and health professionals that share our values and priorities in improving people's health and wellness. In the early days of the pandemic nearly a full year ago, we were fortunate to have experienced minimal impact on our operations. With the second wave of infections in the fall of 2020, a few of our third-party service providers experienced restrictions and/or temporary shutdowns in an effort to restrict the spread of the virus, which has had both direct and indirect effects on some of our time lines. While we continue to make every effort to minimize delays across all of our programs, it is important to note that none of the delays we have encountered are reflective of our own R&D efforts. Rather, they are simply the result of having to adapt to the regulations and limitations that we are all facing. Despite these minor delays, we achieved several key clinical formulation and business development milestones across our therapeutic drug and manufacturing programs in the last 3 months of calendar 2020, which represents InMed's second quarter of fiscal year of 2021. This included the successful closing of an $8 million financing that coincided with the new listing on the NASDAQ exchange under the symbol INM. We've since added additional funds to our capital reserves with the recently announced $4.5 million private placement. The terms of the second financing…

Bruce Colwill

Analyst

Thanks, Eric. As was mentioned at the top of the call, in November 2020, we successfully closed a public offering of our shares, and we began trading on NASDAQ under the trading symbol INM. We also became a U.S. registrant at this point, so that's we are now reporting, including on today's call, in U.S. dollars and in accordance with U.S. GAAP. In that November 2020 public offering, InMed issued approximately 1.8 million common shares, together with the company warrants, at a public offering price of $4.50 per share, for total gross proceeds of approximately $8 million. We have been pleased with the impacts of this listing, including an increase in overall volume as well as more capital markets flexibility. This was evidenced last week when, facilitated in part by demand from institutional investors that participated in our November NASDAQ IPO, we were able to raise another $4.5 million of similar terms as the funds raised in November, bringing our total fundraising to $12.5 million over the last 4 months. InMed intends to use the proceeds from the offering -- or offerings together with our existing cash resources for general corporate purposes, funding our preclinical and clinical development, advancing our IntegraSyn program and for working capital purposes. As a reminder and as Brendan noted at the beginning of the call, we have a June 30 fiscal year-end. Therefore, these figures are as at December 31, 2020, and represent our second quarter of our fiscal 2021 year. Please also note that our 10-Q is now available on our website and at sec.gov. Looking first at our research and development expenditures. Our R&D expenses came in a little over $900,000 for this quarter, which is largely unchanged relative to the most recent quarter and a decrease of approximately $700,000 compared to the…

Eric Adams

Analyst

Sorry. Technical glitch. Thanks for that, Bruce.

Bruce Colwill

Analyst

[indiscernible].

Eric Adams

Analyst

So while considerable global uncertainty remains around COVID-19 and other events, the company continues to navigate a steady and exciting path of progress in the therapeutic arenas, which is cannabinoid medicines, that has a growing value recognition. I would like to thank our shareholders for their support as we continue to advance our programs. We are making significant measurable progress across all of our business lines and are actively advancing towards later-stage studies with our therapeutic candidates while making key refinements and novel innovations in our cannabinoid manufacturing program. With that in mind, we are confident in the value we are creating for shareholders through the events from this last quarter and the weeks since, as described on today's call and in today's press release, and those that we see on the near-term horizon. The fundamentals remain strong for the company and are getting stronger. 2021 promises to be a very eventful time for the company and we are excited by the possibilities that lie ahead. With that, I'll turn the call back over to the operator for a Q&A session.

Operator

Operator

[Operator Instructions] The first question is from Scott Henry with ROTH Capital.

Scott Henry

Analyst

Just a couple questions. First, on the INM-755 program, what geographical area do you expect to conduct that Phase II trial in?

Eric Adams

Analyst

Alex, would you like to grab that one?

Alexandra D. Mancini

Analyst

Yes, certainly. Yes, we have been looking, of course, at different parts of the world to decide where it would be most appropriate to run the study. And we looked at a number of factors, including costs, of course. And we have selected the European area as going to be the most cost-effective and most efficient area for us to run the study.

Scott Henry

Analyst

Okay. And do you have to have a meeting prior to that study beginning, or is it just filing the CTA?

Alexandra D. Mancini

Analyst

Good question. We do not require a meeting before filing if we believe that we have all the information that we are going to need, and we do believe we have all that information. We do need to put applications into each country that we choose where we will have a clinical site, so there will be multiple applications going in. They will have the same core content for the main documents but some slight regional differences as required by country.

Scott Henry

Analyst

Okay, great. And then on the IntegraSyn program, would you expect to have additional partnerships in calendar year 2021? Or would that be more of a 2022 calendar year event?

Eric Adams

Analyst

Yes, that's a good question. So with this BayMedica collaboration, what we're doing is just trying to let other people test it in their own hands to see if they're seeing the same kind of increased yields that we've experienced and that we've seen in our tests with Almac. So we think that just as an underlying approach using this new either gene sequence or the enzyme itself that we can manufacture is a way to increase yields regardless of the type of system that's being used, whether it's E. coli biosynthesis or yeast biosynthesis or even some chemical approaches. So we're interested in discussing this with other manufacturers. Whether they're interested or not, that's always a different matter. So we will be engaging other cannabinoid manufacturers to initiate discussions, but whether that actually results in any kind of collaboration or licensing agreement remains to be seen.

Scott Henry

Analyst

Okay. And then final question, on the spending side. The G&A kind of bounces around a little more, particularly from Q1 to Q2. The $960,000 for 2Q, is that representative? Or perhaps there are some offering costs in there. How should I think about that line item going forward?

Bruce Colwill

Analyst

There are definitely some operating -- there are definitely some costs in there from the financings. Our G&A have been pretty stable quarter-to-quarter historically. We are seeing now with the financing and -- we are going to have some increased costs on the, for example, increased insurance costs, the increased compliance costs with the consequence of being dual listed. So that number that we're seeing is going to be more indicative on a go-forward basis than what we have seen in the past. So it definitely will be a little higher going forward than it was historically.

Operator

Operator

[Operator Instructions] Your next question is from Max Jacobs with Edison Group.

Maxim Jacobs

Analyst

I'm just wondering. With regards to the -- for the Phase II, do you anticipate any changes to the trial design just based on your learnings from the Phase I data?

Alexandra D. Mancini

Analyst

I'll take that. Well, we have completed our trial design. And we -- as we were developing the trial design for the Phase II efficacy and safety study in patients with EB, we were building off the data we had from our Phase I healthy volunteer studies and what we learned with respect to the study design in particular with respect to the second study we did with open wounds. So I think -- I wouldn't say there's any big changes from what we had envisioned before, but we've definitely factored in what we learned.

Maxim Jacobs

Analyst

Okay, wonderful. And then just a quick question on BayMedica. You might not be able to answer this, but just sort of, I mean, when would you expect any sort of like feedback on the ability to -- of IntegraSyn to help improve yields, lower costs, et cetera?

Eric Adams

Analyst

Yes, thanks for that. Those efforts are ongoing right now. We don't have a specific time line under which they are obligated to conduct and report back to us. I would suppose that that's going to take place over the first half of this year. And likewise as we investigate their cannabinoid analogs, we'll be structuring and conducting studies on our end over the first half of the year. So I think that's a good time frame, and maybe sometime by midyear, we'll be able to report back on the findings.

Operator

Operator

There are no [ future ] questions at this time. Mr. Payne, you may proceed.

Brendan Payne

Analyst

Thank you. We actually have 2 questions that were submitted independently. One of them is in regards to the GW Pharmaceuticals acquisition and if the team could potentially explain a little bit more how that relates to InMed and its therapeutic development programs.

Eric Adams

Analyst

Yes. Glad to take that one. It's really interesting to see a company that really led the way in cannabinoid drug research all those years ago and kind of paved the path for a lot of us to follow. I think really what that reflects is, if you look at the values that have been created, it's all been through a pharmaceutical drug approach. And it's no surprise to those of us who've been around the industry for a long time, but things like manufacturing, like IntegraSyn that we're looking at, those are nice to haves, but really the true value of any company like ours, and as demonstrated by GW pharma, comes from the pharmaceutical research. So if you have the ability to create a drug that's very meaningful for patients and brings significant benefit, that's really where the value is built. And we've all known this. This is again our group has been doing this for 20, 30 years in other ventures. So I think it's just reflective of the fact that they've built a really nice product. I know they have another product, but really all the focus has been on the CBD oil. They've built a nice revenue stream and they were able to sell the company for 15x what their revenue stream is. You're not going to see that kind of huge return on manufacturing operations, but certainly from pharmaceutical drug development and commercialization, that's really where the home runs come from. So I think it's really encouraging, and I think that's the path that we're on. And I think it's it just really bodes well for our future.

Brendan Payne

Analyst

Perfect. And the next question that we have that was submitted independently is in regards to the BayMedica collaboration. Can you discuss prospectively what we could see come out of that?

Eric Adams

Analyst

Yes. So it's -- at this point, it's a research collaboration. So as I mentioned, we are looking at their cannabinoid analogs. They have a very extensive library of new chemical entities, and we think there may be some potential for some of those to be developed as pharmaceutical products. In return, as I mentioned, they are looking at our IntegraSyn enzymes for a way to boost their manufacturing. So at this point, there's no licensing agreements in place. It's more just of a collaboration for us to test and see if there's interest, and the same from their side. And we'll be able to work together to sort through the results that each of us find. And should we be interested in pursuing either us licensing their analogs or them licensing the IntegraSyn system, that opportunity is open. As I mentioned earlier, it's probably going to take the first half of this year to get any meaningful results on either side, upon which we could base future potential licensing deals.

Brendan Payne

Analyst

Great, thank you. Operator, that's the end of the questions that were submitted independently.

Operator

Operator

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.