InMed Pharmaceuticals Inc. (INM)
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Earnings Call: Q2 2022

Feb 15, 2022

Operator

Good morning. My name is Shannon, and I will be your conference operator today. At this time, I would like to welcome everyone to InMed's second quarter fiscal 2022 financial results and business update conference call for the period ended December 31st, 2021. 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. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Thank you. Mr. Clancy, you may begin your conference.

Colin Clancy
Senior Director of Investor Relations, InMed

Thank you, Shannon, and good day, ladies and gentlemen. My name is Colin Clancy, InMed Senior Director of Investor Relations. Welcome to InMed's second quarter fiscal 2022 financial results and business update conference call. Please note our speakers are joining today from remote locations, 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 an update on our health and wellness commercial activities, together with a progress update on our pharmaceutical drug development 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 questions 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, Shane Johnson, Senior Vice President and General Manager of BayMedica, and Michael Woudenberg, Vice President of Chemistry, Manufacturing and Controls. Please be advised that certain statements in the following conference call include expectations for InMed's business operations, clinical development, key personnel, contractual arrangements, regulatory approvals, revenue opportunities, financing 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. InMed does not undertake any obligation to update any forward-looking statements during this call. I would like now to turn it over to InMed's President and CEO, Eric Adams. Eric?

Eric Adams
President and CEO, InMed

Thanks, Colin, and thank you everyone for joining us today. Since our last earnings call, we've made some significant advancements, and these are advancements that we believe have positioned InMed to be a clear leader in the rare cannabinoid space, offering a unique value proposition and investment opportunity across both the pharmaceutical and health and wellness markets. Most notably, in October, the company completed the acquisition of BayMedica, a U.S. based company that specializes in the manufacturing and commercialization of rare cannabinoids for the health and wellness sector, establishing InMed as a global leader in the research, development, manufacturing and commercialization of rare cannabinoids. Since the acquisition, we have been intently focused on ensuring an expedited integration in order to accelerate commercial activities, including product launches, with the end goal of driving revenues in the near term.

While this acquisition provides us with access to the consumer health and wellness markets, we remain a pharmaceutical company at our core. Our pharmaceutical drug development programs continue to advance in both preclinical and clinical studies, supporting sequential value creation for our shareholders as we continue to hit important milestones in drug development. We now offer shareholders the combination of near-term revenue generation combined with the longer-term value proposition associated with our pharmaceutical drug development programs. Let me start by addressing our short-term plans for commercial operations. Since closing the acquisition of BayMedica in October, our primary focus has been ensuring the smooth integration of both teams and developing an aggressive commercial plan for the coming year.

BayMedica's focus is on the business- to- business, or B2B, supply of rare cannabinoids to the consumer health and wellness markets, including nutraceuticals, cosmetics, functional food and beverages, as well as animal health markets. From a commercial perspective, our primary goals for the BayMedica business over the next few quarters include launching new products to build a robust product portfolio of rare cannabinoids, increase revenues and margins from new and existing products through B2B sales, enhance the sales and marketing infrastructure to support anticipated growth, improve margins through the technical improvements and scale-up efficiencies, develop new cannabinoid analogs for potential lead molecule identification for pharmaceutical applications. These priorities reflect the importance of developing a robust product offering, which in turn is key to attracting a larger customer base and gaining market share.

In January, we launched a second rare cannabinoid CBT and have commenced initial B2B sales to customers within the health and wellness markets. We also have several other rare cannabinoids at different stages of development and expect to roll out additional in-demand products over the coming months. We are very excited about our next two non-intoxicating products, which are CBDV and THCV, which will be coming to market shortly. We are currently working with our third-party manufacturers to produce large-scale batches to support initial demand over the coming months. As this is still a very nascent industry, it is difficult to predict the demand. However, through market research and speaking with our existing customer base, we believe that both of these products are in very high demand. Current market prices of these products range from approximately $17,000-$30,000 per kg.

Given our cost structure at large-scale commercial production, we believe we can be competitive on pricing while maintaining attractive margins. BayMedica currently leads the industry in large batch production of its first non-intoxicating rare cannabinoid, CBC or cannabichromene, with current batch sizes of more than 200 kg, and with the ability to increase to metric ton quantities as market demand increases. This expertise is something we will replicate in bringing our next products to market. As I mentioned, pipeline development is a key priority for the company. In addition to CBDV and THCV, BayMedica has several other high-value rare cannabinoids at various stages of development and scale-up, including CBL and CBGV. Our commercial strategy is to focus on high-demand, attractive margin products rather than compounds that are readily commoditized and with very low prices, such as CBD.

As the company continues to grow and add to our product portfolio, it's important to build out an appropriate sales and marketing infrastructure. The company announced today the hiring of Jerry Griffin as Vice President of Sales and Marketing at BayMedica. Jerry comes with a wealth of experience across various markets and with numerous cannabinoid products. He has a proven track record as a seasoned sales executive who has held several senior-level roles at cannabinoid-based companies, including most recently at a competitor company where he was Vice President of Sales and Business Development. The appointment of Jerry reaffirms our commitment to accelerate the company's commercial plans and grow market share in this burgeoning industry. We have seen over the last year that there is growing interest in rare cannabinoids for their potential therapeutic properties.

Health and wellness companies are looking to rare cannabinoids for their potential physiological effects beyond more common cannabinoids, such as CBD, as well as to further differentiate their products. Very few companies can produce rare cannabinoids at commercial scale, and we are one of them. We believe we are well-positioned to take an early lead as a supplier of high-quality rare cannabinoids in this rapidly growing market. As this is a relatively new market segment, we understand research and education is key to building awareness and understanding the potential benefits of cannabinoids. An example of both the growing interest in cannabinoids as well as building up the body of research is the recent announcement that the NFL is awarding $1 million towards research into cannabinoid effects. Next, I'd like to turn to our manufacturing capabilities.

With the acquisition of BayMedica, InMed now has access to multiple cannabinoid manufacturing approaches. This gives us the flexibility to select the most cost-effective method to produce a specific cannabinoid. All three of our manufacturing approaches, chemical synthesis, biosynthesis, and IntegraSyn, can produce high quality and pure cannabinoids in a consistent manner for different applications. Our team has been working closely with our contract manufacturing and development collaborator, Almac, on scaling up to larger batch sizes using the IntegraSyn process in advance of commercial scale production. To further advance the IntegraSyn scale-up, we are targeting production of a pilot batch in the first half of 2022 to further verify the process with the aim of demonstrating larger scale viability at our industry-leading cannabinoid yield. Now we'll turn to the therapeutic programs, starting with INM-755 for epidermolysis bullosa or EB.

The INM-755 cannabinol cream is a topical cream in development for EB, a devastating genetic skin disease. Since our last call, we have commenced a phase II clinical trial of INM-755. The 755 201-EB study is designed to enroll up to 20 patients. InMed will evaluate the safety of INM-755 cannabinol cream and its preliminary efficacy in treating symptoms and wound healing over a 28-day treatment period. All four subtypes of inherited EB, which are EB simplex, dystrophic EB, junctional EB, and Kindler syndrome, are eligible for the study. The study is using a within patient double-blind design whereby matched indexed areas will be randomized to receive the cream or a vehicle cream as a control. The study is planned to include 13 sites across eight countries in Austria, Germany, Greece, France, Italy, Israel, Serbia, and Spain.

Five clinical sites have been fully activated and enrollment and patient treatment began in December 2021 and is anticipated to complete during this calendar year. This phase II trial marks the first time that CBN, a rare cannabinoid, has been studied in a phase II clinical trial. Turning now to INM-088. 088 is a topical eye formulation under development for the treatment of glaucoma. The active pharmaceutical ingredient in 088 is cannabinol or CBN, the same active ingredient as in the INM-755 program. In December, we announced that a peer-reviewed scientific article entitled Cannabinol Modulates Neuroprotection and Intraocular Pressure: A Potential Multitarget Therapeutic Intervention for Glaucoma has been published in a leading international journal. These studies resulting in two key findings.

First, CBN may promote neural protection of cells in the retina that are responsible for vision. Second, CBN may normalize intraocular pressure. The article also reports on the comparison of CBN with other cannabinoids, including CBD and THC, with results indicating that CBN has a stronger effect and broader neuroprotective therapeutic range. These observations support the therapeutic potential for CBN in the treatment of glaucoma. The company is now preparing for a pre-IND meeting with the FDA in the coming weeks, and we continue to work towards completing the necessary preclinical studies in anticipation of filing in the first half of calendar year 2023 for regulatory permission to initiate human clinical trial. Looking now at some of our patents, I think it's important to point out that our pharmaceutical program also includes exploring other rare cannabinoids for their therapeutic effects.

In November, we filed an international patent application seeking commercial exclusivity for the potential treatment of important neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, and Huntington's disease, and others by demonstrating neuroprotection and promotion of neurite outgrowth in a population of affected neurons using a new rare cannabinoid. Another key asset from the BayMedica acquisition is their library of novel rare cannabinoid analogs. They have several novel analogs which we intend to evaluate for use in future therapeutic programs. There's many benefits of using these novel analogs, one of which is that new chemical entities can be patented to protect their eventual commercialization, unlike naturally occurring cannabinoids identified in the plant, where a patent covering the underlying molecule cannot be filed. This adds an additional level of IP protection to our current strategy and enhances future partnering opportunities.

Considering the commercial importance of these analogs, this is an area where we intend to place enhanced focus in the coming years. I want to touch briefly also on the impact of COVID. As with most businesses, the global pandemic has started to impact several facets of InMed's activities. Global supply disruptions relating to resources such as raw material availability and staffing issues have directly affected development timelines for our manufacturing campaigns. Our clinical EB program has also been affected by staffing issues, which have impacted patient enrollment. As a consequence, the timelines on certain programs have been slightly delayed. We continue to work with our external partners to limit any disruptions and ensure our programs continue to advance despite these global headwinds. Now just briefly, turning to the outlook.

In summary, over the course of the last quarter, we have continued to make considerable progress advancing our different programs. Over the next few months, shareholders should expect to see the following catalysts. Number one, product launches. We'll be bringing new products to the health and wellness market, and this is one of the company's key priorities over the coming months. Number two, updates on the phase II clinical trial in EB. Number three, further execution on our patent strategy, including our proprietary analogs. Four, scaling IntegraSyn to larger batch sizes in advance of commercial scale production. Before handing the call over to Bruce, I would like to take the opportunity to welcome Ms. Janet Grove to our board of directors. Janet has significant skills and experience in providing strategic, legal, and business development advice accumulated during an impressive 30-year career in the biotech industry.

Ms. Grove is a partner at Norton Rose Fulbright and is currently the Head of their Canadian Life Sciences and Healthcare Industry Practice. I'd also like to recognize Catherine Sazdanoff, who is stepping down from the board for personal reasons. Ms. Sazdanoff has served on the board since July 2019, during which time her business development and legal experience has been instrumental in navigating several key strategic initiatives for the company. On behalf of the company and shareholders, we thank her deeply for her significant contributions and dedication over the last few years. On that note, I'd like to turn the call over to our CFO, Bruce Colwill, to provide more information on our capital plans and for a review of our second quarter financial or fiscal 2022 financials. Bruce?

Bruce Colwill
CFO, InMed

Yeah. Thanks, Eric. Thanks again for everybody joining the call. By the way, just a reminder of what Colin pointed out at the beginning of this call, we do have a fiscal year-end that ends on June 30th. The consequence, these figures today represent our second quarter fiscal 2020 results. Please also note that our 10-Q is now available on our website as well as on sec.gov. Overall, for the six months ended December 31st, 2021, the company recorded a net loss of approximately $7.3 million or $0.56 per share, which compares with a net loss of $3.8 million or $0.68 per share for the six months ended December 31st, 2020.

This increase in net loss of approximately $3.5 million is largely attributed to increased R&D spending, which accounted for $2.4 million of the overall $3.5 million increase. The R&D expenses for the six months were approximately $4 million, compared to $1.8 million for the same period last year. This increase was primarily due to increased activities related to the INM-755 clinical trial, and to a lesser extent, the inclusion of approximately $600,000 of BayMedica operations following the acquisition date. Looking now at our G&A expenses. G&A expenses were approximately $3.2 million for the period, which compares with approximately $1.6 million for the same six months in the previous year.

The increase is the result of a combination of changes, including some personnel expenses, legal fees, some of those which are related to the BayMedica acquisition, investor relations expenses, substantially higher insurance fees resulting from our NASDAQ listing, which occurred partway through the equivalent period last year, and the inclusion of BayMedica operating results following the acquisition date. Turning now to our balance sheet. As of December 31st, 2021, we had cash equivalents, and short-term investments of $11.3 million, which compares to $7.4 million as at the end of our fiscal year, June 30th, 2021. The increase in this balance during the six months to December 31st was the primary result of the July 2021 private placement, partially offset, of course, by cash flows from our operating activities.

At December 31st, 2021, the company's total issued and outstanding shares were approximately 14.1 million. I'd now like to speak to BayMedica's revenues. This is the first quarter that revenues from the recent acquisition of BayMedica have been included in the company's financials. The company realized B2B sales of bulk rare cannabinoids of approximately $300,000 for the three months ended December 31st. Reported sales this quarter were impacted by the inclusion of sales only from the date of acquisition and also as a consequence of BayMedica's focus on the acquisition itself, including post-closing integration matters. Although modest, this quarter's sales, combined with previous revenue, provide a strong platform for growth over the coming quarters as we begin to roll out new products and build out the sales and marketing infrastructure.

This morning's press release announcing the hiring of a VP Sales and Marketing, as Eric mentioned, is just such an example. I think it's important to note that prior to the closing of the acquisition in October, BayMedica had cumulative revenues of $2.4 million over the 20-month timeframe ending September 2021. Keep in mind this revenue was from only one product, that being Prodiol CBC. Considering that commercial activities commenced just prior to the global pandemic, BayMedica has done a great job of growing revenue with limited resources. With the acceleration of commercial activities, including the rollout of new products, we expect to grow revenues considerably in the short to medium term.

Although it is imperative to support the growth of commercial activities, we need to find the appropriate balance of capital investments for product launches with the need to drive revenue from existing products and our ongoing programs. At this point, I'd like to make reference to the recent filing of a shelf prospectus in the amount of $50 million. Filing a shelf prospectus is a normal, typical housekeeping component of a capital market strategy for any kind of growth company. It's worth noting that the shelf is effective for up to three years. Having the shelf in place could facilitate financings over those three years, for up to three years.

I would also like to point out that while the face value of the three-year shelf is $50 million, due to market capitalization limits, we are only eligible for what is called a "B aby shelf", which means that under this shelf filing, we can only raise up to 1/3 of our market cap over any 12-month period. Looking at cash management and our guidance on this front, our cash runway guidance in yesterday's filing stated that we expect our cash and cash equivalents of approximately $11.2 million as of December 2021 to be sufficient to fund our operations into the first quarter of fiscal 2023.

This runway, which we'll of course continue to monitor closely, you know, could be extended by, one, delays in our programs, or two, exceeding our revenue expectations, or three, you know, scaling back on selected third-party research programs. With that, I'd now like to turn the call back over to Shannon as we address any questions from the analysts. As a reminder, Alex Mancini, Eric Hsu, Shane Johnson, and Michael Woudenberg are also available for questions. Shannon?

Colin Clancy
Senior Director of Investor Relations, InMed

Just briefly, before we get on to that, at the start of Bruce's remarks, he actually may have mentioned fiscal 2020. It's obviously fiscal 2022 he's been speaking about. Okay, thank you .

Operator

Thank you. As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from Ram Selvaraju with H.C. Wainwright. Your line is open.

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

Hi there. This is Mitch along for Ram. Thank you for taking our questions. The first one I wanted to ask, you know, about the 755 data, when we could get an initial look at that, and if it would be at a medical conference. Just, you know, how many of those 20 estimated enrolled patients could we see at that first readout?

Eric Adams
President and CEO, InMed

Great. Thanks for your question. Alex, why don't you take that one?

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

Yes, certainly. Yes, thanks for the question. In this study, there will be no interim analysis and so no ongoing readouts. We will be waiting until the trial is completed and the database locked, and all the data is analyzed at that time. What we have stated before was that once enrollment began, we expected enrollment to take about one year to get up to 20 patients. At that time, we will announce the results altogether. We would consider a conference at around that time if you know suitable. It's a little bit early to be predicting exactly. We will definitely have a press release, though, that discusses our results.

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

Great. Thank you. What would be considered positive data there in these EB patients? What can you point to that de-risks that 755 efficacy into the readout?

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

Okay. That's a very good question. This is a very small trial as it needs to be in a rare indication like this. We are using a within-patient study design, which means that each patient will get both the active cream as well as the vehicle cream, which acts as a control on areas in the body that are matched up. Either non-wound areas that are itchy or wounded areas that might have symptoms of pain or itch associated with them, as well as trying to look at wound healing there. Each patient is going to be their own little trial within a trial, if you will, and we will be looking at the within-patient comparison of the active and the vehicle.

With such a small number of patients in the trial and with, we are allowing different types, subtypes of EB to be enrolled, and they could present with different characteristics. They don't have to have pain and itch, for example, associated with the wound. There is quite a lot of flexibility in enrollment. We needed that for this rare disease. We will be looking very carefully at each individual patient and deciding, did they get specific benefit in the trial, for the needs that they had at the beginning of the trial? That's how we have designed this. I hope that answers your question.

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

It does. I guess, just a little bit more specifically, should we benchmark to anything else like particularly the Amryt data or anything of that nature?

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

No, I would not. No, because theirs was a phase III study, which had much bigger patient numbers. Their primary focus was on wound healing. That was one of our goals, but it is not the only goal. For example, we are including patients who don't have any active wounds, but they might have itchy areas, and then we can test to see if it has any anti-itch effect. I would say that we shouldn't try to benchmark to the Amryt results.

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

Okay.

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

There won't be a lot of-

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

Great. Thank you.

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

There's not a lot of power in such a small study with 20 patients as well.

Mitchell Kapoor
Director & Senior Biotechnology Analyst, H.C. Wainwright

Understood. Makes sense. Thank you very much.

Alexandra Mancini
SVP of Clinical and Regulatory Affairs, InMed

Okay.

Operator

Thank you. Our next question comes from Scott Henry with Roth Capital. Your line is open.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Thank you and good afternoon. I did have a couple questions. I feel like you gave a lot more visibility into the BayMedica product launches. I wanted to get a sense of the peak sales we should think about for kinda each of those four molecules. You hit on CBC, CBT, CBDV, THCV, just so we can start thinking about, you know, how big each lever is and how we should go forward with it.

Eric Adams
President and CEO, InMed

Great. Thanks for that, Scott. I'm gonna turn it over to Shane. He's a lot closer to that side of the business. Just to point out, you know, this is such early days, it's very difficult to, you know, number one, we can't even capture the actual size of the market right now because, you know, it's a moving target on a day-to-day basis. Shane, maybe you can give a little bit of color there.

Shane Johnson
SVP and General Manager, BayMedica

Well, thank you, and thank you, Scott, for the question. Yeah, I agree with what Eric said. I mean, we're not at a position yet where we can forecast, you know, the peak opportunity. When we're talking about rare cannabinoids, there is far too little data, not only data in terms of how they might be useful in health and wellness products, for instance, but data as to, you know, the markets, the market opportunities, the customer bases, et cetera. What I will say is that I think that the coming couple of launches, CBDV and THCV, are more substantial, in particular THCV, more substantial opportunities, by far relative to the couple of compounds we have launched thus far.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Okay. That's helpful right there. You know, obviously we're just looking for subjectivity and no one has all the answers. I think what we do know is it sounds like CBC prior to having it was a $1 million, $1.5 million-ish revenue generating product. I guess, you know, first, do you think that can grow for a while or is that, you know, around peak? Just trying to get a sense of that molecule. Then it sounds like the next two that you mentioned are potentially bigger. Is CBT, should we think of that, you know? Obviously, we can't predict the future, but perhaps it looks like it's in the same magnitude as CBC?

Shane Johnson
SVP and General Manager, BayMedica

CBC, I do think we can grow that. You know, we have had limited resources as I think Bruce pointed out in his comments earlier. Being able to you know dedicate additional both human capital as well as financial resources toward each of these programs is going to be inordinately valuable. And so I do believe that there is an opportunity to grow CBC revenues themselves. CBT, I would say is right now definitely still more of a wild card. We had a couple of customers asking us for it, so and it was well within our wheelhouse, so we ultimately decided to you know commercialize it.

A lot less is known about CBT in terms of underlying peer-reviewed data, you know, that somebody might use to guide thought processes around, for instance, product formulation or, you know, target consumers and alike. I think CBT is going to remain a bit more of a question mark for a period of time. It's probably same order of magnitude potential as CBC, but it's gonna take a little bit of time for that to unfold. CBDV and THCV, to the converse, both have a little bit more data around them, and therefore, I think are out of the gate going to be bigger contributors.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Okay, that's helpful. Then I did go through the 10-Q, and I think you broke it out based on BayMedica and the rest of the company. How should we think about what kind of revenues level you need for the BayMedica side of the business to be break even? You know, what level makes that a break even business?

Eric Adams
President and CEO, InMed

Bruce, you wanna jump on that?

Bruce Colwill
CFO, InMed

Yeah, I'll jump in there. Hey, Scott. Good to hear from you. You know, good question. Yeah, we did break it out. I mean, obviously, having looked at it, you realize that's given the short time frame, it's even less than a quarter worth of data in there. It's not necessarily gonna be that instructive at this point in time. You know, I think we touched on this last call as well. One of the challenges, Scott, in answering that question is, you know, we have sort of different levers that we can pull on this front.

I did sort of allude to that in my comments at the beginning of the call that, you know, there's a balance, like, to deploy capital, to launch, develop and launch new products, which of course involves a certain amount of cash burn to do that versus just, you know, pushing and supporting existing products. You know, fundamentally, Scott, we think that there's a great advantage to being a first mover and early mover in some of these products. For that reason, I think it behooves us to continue to invest in these new products despite the fact that there's gonna be some cash burn. You know, ultimately, we've had with BayMedica within our tent, you know, less than a quarter of experience. Certainly there's been a track record with their initial product, CBC.

You know, you talked about some of the historical revenues on that front. That's all been done without, for example, a dedicated salesperson. With bringing Jerry on, I think that gives the opportunity to ultimately be in a position where we can see BayMedica as a standalone entity, turn cash flow positive early, but earlier. I really think for at this point in time, Scott, you know, we would like to see more products come to market sooner rather than basically try to defer those and push those out at the time. It's kind of a long way to answer, but that's sort of a little bit sort of the capital and marketing strategy at the moment.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Okay, fair enough. I didn't quite catch, did you say the current cash balance is good through fiscal year first quarter 2023 or into fiscal first quarter 2024?

Bruce Colwill
CFO, InMed

Into.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Okay. Just wanna make sure I have that right. Final question. The R&D in 2Q was a little bit higher than it had been. Do you think that's, you know, will that contract a bit in the second half of fiscal 2022?

Bruce Colwill
CFO, InMed

Yeah, I think that's a reasonable expectation. There's, you know, a couple things at play is the timing of certain expenditures related to the INM-755 EB program. As you know, with clinical trials, they can sort of come and go. Over time, we would anticipate that those numbers would, that spend would go down. We did see an incremental R&D spend as we incorporated in the BayMedica program, that I quoted earlier as being just over $500,000 .

You know, that will vary as well. You know, we are anticipating with respect to the ocular program to see, you know, some expenses increase, but that's not gonna be in the very, very short term, not so much. You know, as we see the 755 expenditures starting to wane, you should expect to see some of the 088 ocular program expenses starting to increase. I think that will hopefully give you a little bit of guidance there, Scott.

Scott Henry
Managing Director and Senior Research Analyst, Roth Capital

Okay, thank you. That's helpful. Thank you for taking the questions.

Bruce Colwill
CFO, InMed

Yeah, thanks, Scott.

Operator

Thank you. As a reminder, to ask a question at this time, please press star then one. Our next question comes from Ken Mestemacher with Edison Group. Your line is open.

Ken Mestemacher
Director of TMT Research, Edison Group

Thank you for taking my call today. I just had three questions. First of all, you know, you were talking about CBDV and THCV as your next product launches. Can you help us understand why those two and maybe talk a little bit about the pricing dynamics associated with those?

Eric Adams
President and CEO, InMed

Sure. Glad to.

Ken Mestemacher
Director of TMT Research, Edison Group

Sure.

Eric Adams
President and CEO, InMed

Let me take it first, then I'll turn it over to Shane for a little bit more detail. You know, in the body of literature that exists today, those are two, you know, relatively well-studied products. As such, you know, it just gives companies who are looking to market products in the health and wellness space a little bit more information and direction as to, you know, how they can position those products in the market. You know, if you research something like CBT, if you did a literature search, you'd find very little. If you do a literature search on CBDV, you're coming up with dozens and dozens of peer-reviewed publications, some of which, you know, we consider to be really good science.

I think that has just helped to educate the market and give people an indication as to the potential effects. Both of them have also been studied in different human clinical trials. Again, it's just that a lot better information exists, and that gives people you know a lot of confidence in how they want to market those products. For consumers as well, you know, they read up on you know the potential effects of these things, and they're interested in trying them. Out of the gate, you have a much more you know demand-driven interest in the products. Shane, maybe you could flavor that a little bit and speak a little bit to the pricing.

Shane Johnson
SVP and General Manager, BayMedica

Sure. Well, also just to touch a little bit more on kind of the why those products. I think at the end of the day, a key driver for us in making the decision to launch both CBDV and THCV was that our existing customers have been asking us for them. That again is to me a fairly compelling rationale. In furtherance to kind of what Eric was just discussing about data, CBDV is thought to have potential application to conditions such as autism spectrum disorder. Obviously, that impacts a lot of people's lives. THCV has huge mass market potential, with data suggesting that it could play a role in appetite suppression, healthy metabolic function, and weight loss.

Anecdotal reports also suggest that THCV could function as a mild stimulant, not unlike caffeine, which could be a huge opportunity in of its own right. In fact, we recently spoke to a meaningfully large consumer brand that's looking to launch a THCV product targeting specifically this latter opportunity. Even though the same peer review data doesn't exist, they believe in some work that they've done that is going to be a valid use case and good consumer opportunity. In terms of the market dynamics, the pricing dynamics, yeah, I think it's important to understand that today, both CBDV and THCV are extremely limited in their supply.

You know, kind of thought about in a slightly different manner, the plant genetics that give us compounds like CBD and THC, the plant genetics aren't there yet for these compounds. As such, the pricing for these compounds is in the realm of, you know, ± $25,000 per kilo. We expect that we should be able to step in and fill much of that unmet demand.

Ken Mestemacher
Director of TMT Research, Edison Group

Great. Thank you. Second, wanted to talk a little bit about glaucoma. You know, it seems like a large market opportunity and, you know, one that will, you know, require larger-sized trials. You know, in your release, you noted the intent to, you know, make the regulatory applications in 2023 to start trials in humans. My question is, when do you think is the sweet spot for, you know, partnering this program? You know, what would the timing of that look like?

Eric Adams
President and CEO, InMed

Good question. It's very different for different types of diseases, different types of approaches. There's a lot of novel research going on in the field of neuroprotection, in particular for ocular diseases, that you know, we're kind of sitting right in the sweet spot for that. The opportunity to partner could come sooner than you might expect from you know, maybe the DERM program. Certainly, you know, we are open to and active in having discussions about that program. Nothing to announce. I mean, it's you know, there's always people poking around and trying to understand you know, the different approaches in the field.

Certainly the publication has helped a great deal in, you know, getting the data out there and just communicating to people why we're so excited about the program and that seems to, you know, spark some people's imaginations. It can come a lot earlier. It's not unusual to see partnerships in the ocular space coming, you know, very early on, even pre-clinically. We'll be open to that. We'll be open to those conversations. We'll be open to pursuing those dialogues. There's no guarantees unless you're the one who's writing the check, I've found over the years. Eric, do you wanna address a little bit, you know, what's going on with the 088 program and how you see things?

Eric Hsu
SVP of Preclinical Research and Development, InMed

Yes. Thank you, Eric. I just want to add that, you know, partnership discussion is always a process. Our job is keeping potential partners up to date on our progress and discuss our plans under confidentiality so they can foresee how that dovetail into their pipelines. Yeah, like Eric said, it could come earlier than expected, but at this point we're not providing updates on that until it's something meaningful to update.

Ken Mestemacher
Director of TMT Research, Edison Group

Great. Thank you.

Eric Hsu
SVP of Preclinical Research and Development, InMed

Okay.

Ken Mestemacher
Director of TMT Research, Edison Group

My last question, you know, congrats on the new hire this morning, and bringing Jerry on board to be your VP of Sales and Marketing. Can you elaborate slightly on his role and maybe the different sales channels and markets he'll be pursuing?

Eric Adams
President and CEO, InMed

Shane?

Shane Johnson
SVP and General Manager, BayMedica

Sure. Yeah, thank you. We're very excited by the addition of Jerry to our team. As you know, Bruce had noted earlier, we have not had a dedicated sales individual at BayMedica previously. We have had a couple of people where that has been among other roles and responsibilities. He will be spearheading all of our sales and marketing for both existing as well as new products. We've already started working together, for instance, to just today, this morning, you know, re-reviewing plans to implement a lead generation program. You know, as has been previously shared, most of our existing sales specifically of CBC and CBT are in the cannabinoid wellness space and predominantly to distributors. Not surprisingly, Jerry will be focused on expanding sales within that channel and segment.

Additionally, while it won't happen overnight, he'll also be taking steps to open new markets. Those would include the traditional wellness space such as personal care, the food and beverage sector, and we'll also be exploring opportunities within the vitamins, minerals, and supplements vertical. I think we see a lot of possibility and potential in terms of where we can go. A big part of what we need to do right now is you know, stay focused, identify the top priorities, which we are already working on and go after them.

Ken Mestemacher
Director of TMT Research, Edison Group

Thank you. That's all the questions I had.

Operator

Thank you. If there are no more questions, I'd like to now pass the call over to Mr. Adams for any additional closing remarks. Mr. Adams?

Eric Adams
President and CEO, InMed

Great. Thank you, Shannon. In closing, I just want to thank our shareholders for their continued support over the last six months, and in particular, it's been a very rough last couple of months in the stock market. But that said, you know, this is gonna be a year that we're really looking forward to. You're gonna see a very different InMed as we transition to a commercial operation and start reporting revenues. We think that's a very important step for the company and kind of expands us across the entire spectrum of rare cannabinoids from the commercial wellness space and through to our traditional pharmaceutical drug development programs.

We're very excited to begin executing on these plans and look forward to updating everyone on our continued progress and these future milestones over the coming months. Once again, thank you very much for listening in today and, as always, any outreach should be directed to Colin and he'll be glad to you know interact with the shareholders as needed. Thank you so much.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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