Greetings, and welcome to Reunion Neuroscience Inc. fiscal Q1 2023 earnings conference call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Ms. Kathleen Heaney from KCSA. Thank you, ma'am. You may begin. Thank you, Laura. Good morning, everyone, and welcome to the fiscal 2023 Q1 earnings conference call for Reunion Neuroscience Inc., formerly known as Field Trip Health Limited. As the company has completed its reorganization, today's discussion will focus on Reunion. Field Trip Health & Wellness will hold a separate call later this month. Before I begin the call, I am obligated to remind everyone that during the course of this conference call, management may be making some forward-looking statements that are based on current expectations and are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations. These results are outlined in the Risk Factors section of the company's filings and disclosure materials. Any forward-looking statements should be considered in light of these factors. Please also note that the safe harbor for any outlook presented is as of today, and management does not undertake any obligations to revise any forward-looking statements in the future. Presenting today will be Ronan Levy, who has stepped into the role as Chairman and CEO of Field Trip Health & Wellness. Additionally, he will continue to serve as a member of the Board of Directors of Reunion. Joseph del Moral, Chairman and CEO of Reunion, and Donna Wong, CFO of both Reunion and Field Trip Health & Wellness will be presenting. I'll now hand the call over to Ronan, who will provide an update on the corporate reorganization. Thanks, Kathleen, and welcome everyone. Thank you for joining us this morning. I will begin my presentation with an update on the corporate reorganization. Joseph will discuss the drug discovery business, followed by Donna, who will discuss the quarter's financial results. We will then open the call to your questions. On June 27, we received shareholder approval for the spin-out of Field Trip Health & Wellness, and on June 29, we received court approval. Last Thursday, the spin-out became effective and the Nasdaq- and TSX-listed company was renamed Reunion Neuroscience Inc. The TSX Venture Exchange has now granted final listing approval for Field Trip Health & Wellness, and we expect that Reunion and Field Trip Health & Wellness will begin to trade independently on August 17. Field Trip Health & Wellness and Reunion are now two distinct companies with separate management teams and boards of directors. Reunion Neuroscience remains listed on both the Nasdaq Stock Market and the Toronto Stock Exchange and will trade under the symbol REUN, while Field Trip Health & Wellness shares will trade on the TSX Venture Exchange under the symbol FTHW. It's been a long process, and we are pleased to be moving ahead. The timing was right as both divisions were ready to operate as individual companies and emerging leaders in the psychedelics industry, one providing psychedelic-assisted therapies and the other developing next-generation psychedelic drugs. We believe the decision to split the companies is in the best interest of both organizations and our current and future shareholders. Reunion will continue to focus on the research and development of novel psychedelic molecules such as RE-104, formerly known as FT-104, while Field Trip Health & Wellness will continue its focus on developing and delivering innovative psychedelic-assisted therapies. In connection with the closing of the arrangement, Field Trip Health & Wellness completed a series of private placement financings for gross proceeds of $19.9 million, led by Oasis Management Company and Reunion. We expect this to be sufficient for us to execute on our strategy at Field Trip Health & Wellness and position ourselves as a leader in this emerging and exciting field. I will now hand the call over to Joseph to provide an update on Reunion's drug discovery programs. Thank you, Ronan. During the quarter, Reunion continued to develop innovative synthetic molecules targeting the serotonin 5-HT2A receptors, hitting some exciting milestones. In July, we announced the first successful dosings in our phase 1 clinical study of RE-104, formerly known as FT-104, being undertaken in Australia. This is an important step in our work to develop RE-104, our first molecule under development, as a potentially fast-acting treatment for postpartum and treatment-resistant depression with durable efficacy. The study aims to examine over a range of dosage levels the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of RE-104. Subjective measurements being analyzed include the intensity, duration, and feelings produced by the period of acute psychoactivity after dosing with RE-104. We expect to report results from the study in the Q4 of calendar year 2022 and are planning to seek FDA guidance on phase 2 studies, which are planned for 2023. In April, we were granted a patent for claims related to RE-104 entitled Tryptamine Prodrugs, granting Reunion exclusive rights until 2040 for the composition of matter, formulations, methods of use, and methods of manufacture for a family of hemiester compounds of hydroxytryptamines, including isoproterenol. We are also making progress with the research and development of our RE-200, formerly known as FT-200 molecule group, strengthening our IP portfolio while also seeking the optimal lead candidate for preclinical development. We have filed two provisional patents with the USPTO for the RE-200 family to protect the compositions, potential formulations, and uses of the molecules. I am proud of the efforts made by our team, which have resulted in Reunion being one of the first companies to have entered clinical trials with a novel, patent-granted psychedelic molecule. Entering our next chapter as a standalone company, we will have the singular focus and the resources to execute on our clinical development program for RE-one zero four and continue advancing our RE-two hundred pipeline. I will now turn the call over to Donna to discuss our financial results. Thank you, Joseph, and good morning, everyone. As a reminder, all figures that I will be discussing are in Canadian dollars, and the first fiscal quarter of 2023 corresponds to the three-month period ending June thirtieth, 2022. With the corporate reorganization complete, our financial results from continuing operations reflect Reunion only. On our P&L, Field Trip Health and Wellness, or the clinic operations, are excluded from the results of continuing operations and are presented as a single amount as a net loss after tax from clinic operations. Net loss from continuing operations for Reunion in the Q1 was CAD 5.2 million, compared to a net loss of CAD 3.4 million in the same period of the prior year. The increase in net loss primarily reflects an increase in operating expenses from CAD2.7 million to CAD 5 million, driven by a more than doubling of our research and development costs from CAD 1.4 million to CAD 2.9 million and higher general administration costs primarily related to public company expenses. During the quarter, we continued to ramp up on our RE-104 development costs. As you have just heard from Joseph, we entered phase 1 clinical trial and began preparing for phase 2. With respect to our financial position, Reunion had unrestricted cash equivalents, and short-term investments of CAD 52.3 million at June 30, 2022, which included CAD 4.1 million held at the clinics. Upon closing of the spin-out transaction and after its CAD 9.8 million investment in Field Trip Health & Wellness on August 11, Reunion had approximately CAD 40 million in opening cash, which we believe is sufficient to support our ongoing drug discovery work. As Field Trip Health & Wellness will host a separate earnings call later in the month, I will make a few brief comments here. During the Q1, the clinics earned patient services revenues of CAD 1.8 million, an increase of 110% over the comparative quarter in the prior year and 6% sequentially quarter-over-quarter. There were 12 clinics in operation during the quarter, compared with 6 in the same period of the prior year. Field Trip Health & Wellness reported a net loss during the quarter of CAD 8.2 million, compared with a CAD 9.1 million loss in the same period of the prior fiscal year. This decrease was primarily due to increased revenue and a more favorable foreign exchange rate, partially offset by the increase in operating costs due to the larger number of clinics in operation. This ends our prepared remarks. I'll now ask the operator to open the lines for the Q&A session. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment while we poll for questions. Our first question comes from the line of Andrew Partheniou with Stifel. You may proceed with your question. Hi, good morning, and congrats on all these milestones. Thank you, Andrew. Good morning. Maybe starting off with a little housekeeping question. Donna, could you outline any kind of one-time costs for Reunion or Field Trip Health and Wellness in the quarter? The Reunion results reflect pretty much recurring costs associated with the R&D development for RE-104 as well as our RE-200 group. With respect to Field Trip Health & Wellness, we had approximately CAD 12 million in operating expenses for the quarter, of which CAD 3.4 million were non-recurring. CAD 2.4 million related primarily to the spin-out transaction. CAD 1 million related to an impairment of fixed assets, which are disclosed in our financial notes. It reflects the impairment on our construction in progress as a result of our decision, which we previously announced, to defer the opening of our 6 clinics. In addition, there was approximately CAD 2 million in non-cash operating expenses related to depreciation and amortization and share-based compensation expense. Appreciate that. Maybe transitioning to Reunion here for a moment. Your 200 series, you filed 2 patent applications. Wondering if you can talk a little bit about what you found there and what you're still looking for in, you know, as you explore other molecules to select a final candidate. Thanks, Andrew. We'll hand that over to Nathan. Good morning, Andrew. The 200s, I'd say it's still extremely early and very exploratory, but what we are looking for and what we have found now is, I'd say, two families of molecules that respond to our initial criteria that were improved selectivity of targeting the 2A receptor, which is the one that's responsible for the hallucinations, but also the antidepressive effects of something like psilocybin or FT-104. We hope in the future to demonstrate that. Having a selectivity improved for the 2A receptor relative to the serotonin 2B receptor, which is the one that has cardiovascular liability that was put in evidence by fenfluramine, you know, back 20, 30 years ago. What we're trying to do is improve that selectivity. We have got two families that do that, including one family that has multiple examples of compounds that are actually antagonists at the 2B receptor while being very potent at the 2A. So we've been fleshing out multiple structures to build out a patent portfolio so that we can protect ourselves. Before we start describing too much about the molecules that we are actually doing, we'd like to get those patents filed and protect ourselves first. I mean, that's pretty much the process. We are going down the path of looking at multiple, you know, behavioral assays, expanding on the pharmacology, looking for off-target assays that might be a liability or benefit to the drug product. Looking at whether they induce head twitch, things of that nature. Standard assays that you might put around a serotonin 5-HT2A receptor, plus expanding a little bit more toward, you know, behavioral assays to see if there is particular aspects of the drug that might be uniquely beneficial for helping us understand where these might be the best candidates for use in a particular indication. Thank you very much for that. Maybe a question on the clinics to the extent that you're comfortable discussing. Could you talk a little bit about the ramp that you are seeing, you know, in this current environment, and more notably your earlier or older clinics, could you talk a little bit about how they are performing, and did you see any kind of acceleration as the clinics mature? For that, we'll go over to Ronan Levy, Chairman and CEO of Field Trip Health and Wellness. Thanks, Joe. Hey, Andrew. You know, what we are seeing with the clinics ramp is as before. The older and more mature clinics continue to move up the curve relatively at a faster pace than the younger clinics. They continue to seek greater engagement, which is self-reinforcing. Toronto, New York, L.A., those clinics tend to grow the client base and the patient base at a faster rate than the smaller clinics. Overall, we are seeing an increase, a significant increase in inquiries and questions coming in. You know, we could almost measurably see the impact of the release of How to Change Your Mind on Netflix in the days and weeks, and it continues afterwards. The number of inquiries and leads we're generating increased significantly relative to our normal steady state. Demand continues to increase, and then they continue to move up the curve. There certainly seems to be an element of seasonality involved in interest. The interest goes up, but converting people into, you know, clients at that point seems to be a little bit of a slower process through the summer months. We expect as we head back into the fall, we will see a relative acceleration of revenues. Thanks for that. I'll get back in the queue. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. Our next question comes from the line of Patrick Trucchio with H.C. Wainwright & Co. You may proceed with your question. Thanks. Good morning, and congrats on all the progress and getting the separation completed. I have a few follow-ups on RE-104. First, I'm just wondering if you could discuss what you would anticipate to be the potential advantages of RE-104 over psilocybin and these other short or long-acting psychoactive substances, and what data specifically do you expect from the phase one that you know would help you to better characterize those differences? Thanks, Patrick. Let's go to Nathan for the initial answer on that. Good morning, Patrick. I would hope we all know these advantages by now, and most of them we're trying to demonstrate in the phase one. I think the first and foremost is having a short-acting, a short duration of psychoactive experience. We are hoping to see something in the order of 2-3 hours. That gives us the possibility of, you know, having people in and out of the clinic in a half day compared to something like psilocybin, which is a full day. And you could only maybe use the room or the chairs once during the day for treatment. We hope to be able to, you know, double the capacity in a standard clinic. The second thing was to have intellectual property. You know, we are, as Joe highlighted in the initial statements, we're one of the first companies out there to actually be doing clinical trials with a patent granted molecule. We pushed our molecule through the USPTO on a fast track and got granted the patent in April. You know, that's really important going forward to be able to have market exclusivity and/or be able to partner with big pharma if they wanna come looking because they wanna be able to protect that market exclusivity for a certain amount of time. With this current patent, we have exclusivity out to 2040. In addition, for the phase 1, what we're really trying to see is that duration of experience, and then we're doing this over a range of doses. This is a single ascending dose. We're starting at low doses going up, looking for a range of doses that are tolerable and safe, that we can, of course, explain this, the pharmacokinetics and subjective experience on. But that range of doses will help us to select doses that we'll be using going into phase 2 studies. That's the design of all the subjective measures that we're doing, including the MEQ, and the measure of intensity of experience, which can tend to correlate to antidepressant outcomes. Yep. That's helpful. Just in the press release, it refers to phase 2 studies to be initiated in 2023 following guidance from the FDA. I'm wondering, you know, can you tell us what you would expect to be the key questions? You know, presumably, you know, of course, you need the data from the phase 1, but can you give us a flavor of what you would need answered, by the FDA regarding phase 2 studies, and how many phase 2 studies are planned and in which indications? It's a bit early to be talking about what the phase 2 questions might be right now. We have put together a study synopsis that we started to share with potential CROs for the study. We're working right now on building the full protocol. That protocol work is going with our advisory team that you can see on our website. They will help us define the questions that are gonna go around that phase 2 protocol when we open the IND. You know, they will be around design of the study. They will be around how we choose the dose and how many doses, and what, you know, what dose strength, and a little bit about, of course, you know, how much psychotherapy we might add or not add. Those questions we haven't formally formulated yet. Yep. That's helpful. Then just one last one, if I may. Just on the digital therapeutic side, how are they expected to become part of the program? Or, you know, are they part of? Is there some aspect of the phase one protocol that includes the digital part, or would that be more reserved for, you know, phase two or three trials? If it's back to me again. For the phase 1, we are not using digital. We're not working with patients, and so we're not actually doing therapy. Although we are, how would I say this? Putting our patients in somewhat of a cocoon, in a protective chamber, if you wish. They're being treated as if they were patients in separate rooms individually, right now. Just to be able to be sure that we can control the environment for them and keep them safe. I think the digital aspect, right now, we haven't yet made any formal decisions yet about how heavily we'll rely on digital when we get into clinical trials. More likely than not, it would probably be something we'd look closer at as we got closer to phase three than in phase two. I will be sure that we discuss this when we talk with our advisory board and we start thinking about our first interactions with the FDA. Great. Thank you very much. Our next question comes from the line of Sumant Kulkarni with Canaccord. You may proceed with your question. Good morning. Thanks for taking my question. I have just one. Could you remind us on why you chose the subcutaneous formulation for RE-104, and what are the actual volumes of product that need to be administered subcutaneously for the different doses you've taken in your clinical trials? Until we know the dose, I can't tell you exactly what the volume will be. Right now, we are anticipating the volumes to be significantly less than or up to 1 ml. Quite small, and not painful. We don't expect that to be a problem. The formulation is extremely fluid, and can go through a very fine needle, almost like a needle that you might take for a vaccine or for insulin. That should be not too much of a problem. We chose the subQ route of administration in order to standardize the trip. To not be beholden to variations in gastric absorption, gastrointestinal absorption, and changes to the pharmacokinetics and pharmacodynamics. That way, we can have better control over the profile of the psychoactivity and the profile of the trip, which we can see. Obviously, when we did early studies in rodents, our reproducibility in terms of where Cmax is and where the end of the trip is much more reproducible than one would expect from an oral administration. That means from a clinic perspective, you can time the duration that a person's in the chair or in the clinic. You can time the music so that its peak experience happens with the right kinds of music as we start to delve into that aspect in the treatment of patients. You can be sure how your patient flow is gonna work in the clinic. Because this is going to be only a clinic-administered drug, we don't currently expect this to be administered at home. Administration with a syringe is not that much of a problem. I will say there are other aspects like, you know, taking oral drugs like this often lead to vomiting. Through the subQ route, we might be able to reduce that, make sure that the dose stays on board and that the dose is not vomited up during a trip. That way, we can be sure that the proper dose is administered. People don't go back and doing a second dose or things like that that happen sometimes when we administer things orally in this nature. Those are some of the primary aspects of why we chose the subQ. Got it. Thank you. Ladies and gentlemen, we have reached the end of today's question and answer session. I would like to turn this call back over to Mr. Ronan Levy for closing remarks. Thank you, operator, and thank you to our investors and analysts for the ongoing support. I also want to extend a personal note of gratitude for your ongoing interest and support, as this will be my last Reunion earnings call. I look forward to seeing you all on the Field Trip Health & Wellness earnings calls going forward. It goes without saying that we are excited about the future of both Reunion and Field Trip Health & Wellness, with Reunion well-placed to progress novel psychedelic development and Field Trip Health & Wellness well-positioned to continue leading in the delivery of psychedelic-assisted therapies. Our passion to develop effective treatments for mental health disorders is only strengthened by the new opportunities the company split presents. Moving forward as separate companies, we are confident we will be able to build value over the long term for both businesses as well as for our current and future shareholders. With that, I'll ask the operator to close the lines. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation. Enjoy the rest of your day.
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