Greetings and welcome to the Reunion Neuroscience Fiscal Third Quarter 2023 Earnings Conference Call. As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to Edward Smith, the company's Chief Financial Officer. Thank you. You may begin. Thank you. Good morning, everyone, and welcome to the fiscal 3rd quarter 2023 business update and earnings conference call for Reunion Neuroscience. Before I begin, I'm obligated to remind everyone that during this conference call, we may make some forward-looking statements that are based on current expectations and 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 our filings and disclosure materials. Any forward-looking statements should be considered in light of these factors. Please also note that any outlook presented as of today and except as required by applicable law, we do not undertake any obligations to revise any forward-looking statements in the future. In addition to myself, presenting today will be Greg Mayes, our President and Chief Executive Officer, Dr. Robert Alexander, our newly appointed Chief Medical Officer, and Dr. Nathan Bryson, our Chief Scientific Officer, are also on the line and will be participating in the Q&A. I'll now hand the call over to Greg. Greg. Thank you, Ed. Welcome everyone. Thank you for joining us this morning for our fiscal third quarter 2023 conference call. When I first joined Reunion as CEO at the end of last year, my two top priorities out of the gate were as follows. Number one, to present compelling data from a robust Phase I study in Q1 that we could use to open an IND in the United States for RE-104's Phase II study in postpartum depression. Two, to assemble a leadership team comprised of accomplished pharmaceutical executives with deep experience in drug development to build and execute a long-term development strategy with the goal of maximizing the potential of RE-104 and our earlier stage discovery portfolio. I am very pleased to report that six weeks into the year, we have made significant progress on both fronts. Last month, we announced top line interim Phase I data for our lead drug candidate, RE-104, which showed RE-104 was generally safe and well-tolerated and provided a robust psychedelic experience, which has been shown to be predictive of therapeutic efficacy with psychedelic treatment. Importantly, RE-104 also demonstrated a shorter duration of psychedelic experience relative to Psilocybin. In the interim data set, most participants receiving RE-104 at the cohort 4 dose had a short duration but complete mystical experience without any serious or severe adverse events. Based on these data, we are confident our study will likely produce a robust justification for selecting a recommended Phase II dose of RE-104 to evaluate in our planned postpartum depression clinical trial, which is expected to commence later this year. We had an opportunity to introduce this data set to the healthcare community at the JPMorgan Healthcare Conference last month in San Francisco. Based on these interactions, I believe institutional healthcare investors and potential partners are actively following Reunion's progress and believe that we continue to demonstrate safety and efficacy that mirrors that of Psilocybin with the addition of patented composition of matter out through 2041 and a shorter psychedelic experience, which is roughly half the trip time reported by Psilocybin in other studies. We are clearly moving forward into Phase II, able to build more momentum off this solid foundation and strong Phase I data debut. On the leadership team front, in addition to the key hires announced last quarter, we recently welcomed Dr. Robert Alexander, a highly accomplished pharmaceutical executive who brings to Reunion a proven track record in psychopharmacology as our Chief Medical Officer. In a few moments, I will introduce Bob, who will share his thoughts on Reunion and more specifically, RE-104. Before turning the call over to Bob, I'd like to highlight for the investor community my 2023 outlook for Reunion. As a reminder, I joined Reunion Neuroscience because of my passion for bringing to market truly innovative solutions with the potential to deliver better outcomes for the millions of patients underserved by today's standard of care treatments for depression and other mental health disorders. Novel discoveries in drug development have clearly not kept stride with the mental health crisis we continue to find ourselves in, which has only been exacerbated by the COVID-19 pandemic. Reunion is at the forefront of psychedelic drug development as a biopharmaceutical company developing proprietary novel serotonergic psychedelic compounds to treat underserved mental health conditions like postpartum depression. RE-104 is the only psychedelic asset in development that delivers 4-OH-DiPT, a compound with similar pharmacology and safety profile as Psilocybin, but potentially only requiring half the time away from home and family, an important attribute for patients, their families, treating physicians and of course, of significant relevance to potential payers in the future. As stated on our call last quarter, we have made the decision to first study RE-104 in patients suffering from postpartum depression, or what we call PPD. PPD represents a priority clinical development opportunity with a high unmet need for new therapeutic options. One in eight new mothers experience PPD, and there is only one approved FDA treatment for the condition, which is administered by continuous infusion over a 60-hour inpatient hospital stay and has a black box safety warning due to excessive sedation and potential for sudden loss of consciousness. SSRIs are also commonly prescribed for PPD, but they frequently have delayed onset, are not specifically approved for use in this setting, and may require multiple trials to find an effective solution. As a novel serotonergic psychedelic, single dose RE-104 could potentially provide mothers with fast relief and a quick return to mother-child bonding and breastfeeding in an estimated 24 to 48 hours due to RE-104's short duration psychoactive experience of less than four hours, durable efficacy, and a rapid washout period. In addition to our work progressing RE-104 in the clinic, we remain focused on advancing the development of our RE-200 series. During the fiscal third quarter, we continued to identify potential candidates in the RE-200 series to target development of novel molecules that are structurally similar to classic psychedelics, but have selective potency at the target serotonin 2A receptor and are devoid of 2B receptor agonism. The opportunity to develop a novel compound with a more specific 5-HT2A agonist profile is significant, as these compounds could potentially reach a broader patient population, enhance the safety of more chronic use indications, and clearly improve convenience. Reunion continues to evaluate this series of compounds with the goal of nominating a lead clinical candidate later this year. I am also extremely proud of the leadership team which has been assembled since my joining of the company. Now that we are preparing to enter Phase II, I am thrilled to introduce our newly appointed Chief Medical Officer, Dr. Robert Alexander. Bob was a former executive at Takeda, Pfizer, AstraZeneca, GSK, and Merck, and has extensive experience in psychopharmacology, having conducted or supervised clinical studies in a broad range of neurologic and psychiatric indications. It's my pleasure to now introduce Bob Alexander. Bob? Thanks, Greg. Some of you may or may not know that I've been involved with Reunion Neuroscience in an advisory capacity for some time. Now, with the recent Phase I interim data set and the company's plans to move into Phase II, I'm delighted that Greg asked that I join the leadership team as Reunion Neuroscience's Chief Medical Officer. Scientific literature clearly indicates that 5-HT2A receptor agonists can promote neuroplasticity and may play an important role in extended durability of antidepressant effects. Psilocybin, which has a chemical structure and pharmacology similar to RE-104, has shown in the clinic that it can produce durable antidepressant outcomes. The RE-104 Phase I data generated to date are very encouraging. In the study so far, RE-104 was safe, well-tolerated, and demonstrated the expected degree and duration of pharmacodynamic effects that support a profile that both compares favorably to published Psilocybin data and is worthy of advancement to Phase II. After completing the pre-planned interim analysis, per the recommendation of the Safety Review Committee, Reunion continued with dose escalation to seek additional safety, pharmacokinetic, and pharmacodynamic data. Exploring further doses with the 2 additional planned cohorts will provide Reunion with valuable data to inform selection of a recommended Phase II dose. Our Phase I data has also been submitted to an upcoming 2023 medical congress and shared with FDA in connection with our pre-IND interactions in preparation for initiating later this year a randomized Phase II study evaluating RE-104 versus placebo in the treatment of women with postpartum depression. It is anticipated that the multicenter trial will enroll approximately 40 patients from 20 centers across North America. There most certainly is a need for an effective, fast-acting, short-duration treatment for patients who suffer from PPD, where limiting time away from the newborn and breastfeeding are of utmost importance. An indication in PPD supports a condensed development timeline, which allows for shorter and smaller trials. Positive outcomes in PPD would also be informative as we evaluate other potential indications for RE-104. Once the PPD Phase II program is in progress, Reunion plans to share its continued RE-104 development strategy in pursuit of treating additional indications. I'm really excited to serve as Reunion's Chief Medical Officer by the prospect of improving the lives of the many patients who suffer from PPD, depression, and other underserved areas of mental health. I would now like to hand the call over to Ed to review our financial results for the quarter. Thank you, Bob, and good morning, everyone. As a reminder, all figures that I'll be discussing are in Canadian dollars and are for the three and nine-month periods ended December 31, which marks the end of our third fiscal quarter. Also as a reminder, last quarter, the company completed the spin-out of its clinics and botanical research operations into a separate company, Field Trip Health & Wellness. Operations included in the spin-out have been reported in our financials as a single line as net loss from discontinued clinic operations. Our call today will focus on Reunion's continuing operations in developing innovative therapeutic solutions for depression and other underserved mental health conditions. To that end, to that end, we incurred general and administrative expenses for the three- and nine-month periods ended September 30, 2022, of $3.1 million and $9 million, respectively, which compares to G&A expenses of $4.6 million and $7.9 million for the same periods a year ago. Changes for the periods included increased headcounts and other costs associated with becoming a Nasdaq-listed public company with increased scale of operations due to RE-104 entering the clinical stage. The three-month period ended December 31, 2021, also included a reclassification of approximately $2 million of G&A expenses from discontinued operations to continuing operations. Research and development for the three- and nine-month periods ended September 30, 2022, were $3.4 million and $8.6 million, respectively, compared to $1.1 million and $4.7 million for the same periods in 2021. Increases were attributable to personnel and third-party manufacturing and clinical research costs associated with our ongoing Phase I clinical trial for RE-104. Our income and expenses include interest income on Reunion's cash and cash equivalents and foreign currency gains and losses primarily attributable to our U.S. dollar holdings. We also recognized CAD 5.7 million and CAD 15.3 million in charges for the three and nine months ended December 31, 2022, in recognition of our estimated loss allowance for financial guarantees of certain lease obligations associated with entities that were part of our spin-out of clinic operations, and the company's equity share of loss and impairment of its investment in Field Trip Health & Wellness, respectively. As I mentioned earlier, we reported clinic operations included in the spin-out to Field Trip Health & Wellness as a net loss from discontinued operations. This loss from discontinued operations was CAD 0 and CAD 10.4 million for the three and nine-month periods ended December 31, 2022, which compares to CAD 9.1 million and CAD 28.7 million for the same periods in 2021. Our net loss from continuing operations was CAD 12.5 million Or CAD 1.07 per share, and CAD 31.6 million or CAD 2.72 per share for the three and nine-month periods ended December 31st, 2022, compared to a loss of CAD 5.9 million or CAD 0.51 per share, and CAD 11.8 million or CAD 1.02 per share for the 3 and 9-month periods ended December 31, 2021. At December 31, 2022, we had $32.4 million in cash and cash equivalents, which provided runway through 2023, inclusive of limited start-up activities related to our planned Phase II clinical trial for RE-104 in postpartum depression. This ends our prepared remarks. I'll now ask the operator to open the lines for Q&A session. Thank you. We will now begin the question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. Confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. We have our first question from the line of Andrew Partheniou with Stifel. Please go ahead. Hi. Good morning. Thanks for taking my questions. Congrats on the good quarter here. Maybe we can start with just your cash burn profile. You're mostly done with Phase I. Now you're prepping for Phase II. Could you talk a little bit about how you see your cash burn profile over the next few quarters, or the year calendar 2023? Sure. Good morning, Andrew. This is Greg. Thanks for joining us. I'll clearly turn the call over to Ed to address those concepts. Thanks for the question. As you saw, we reported CAD 32.4 million for the quarter end. Looking forward from a cash burn perspective from Reunion operations, we expect our prospective burn in the near term to be in a similar range of CAD 4 million–CAD 6 million on a quarterly basis. This figure does not include potential cash payments in connection with our lease guarantees that were part of our spin-out to Field Trip Health & Wellness, for which we have a reserve of CAD 5.3 million. You know, as we go into Phase II later this year, we expect our cash burn to increase, in, you know, in particular in the second half of this year once we're fully committed to the Phase II program in PPD. I think consistent with the guidance I provided last quarter, we expect that once we're in phase two, that the burn would go up to about between CAD 7 million–CAD 9 million on a quarterly basis. Thank you very much for that. To the extent that you can, you know, is there any kind of color that you can provide on how the escalated dose, beyond the initial Phase I levels are going? Sure. Thank you, Andrew Partheniou, for that. I'll have Bob Alexander take a, take a question on the on the additional cohorts. Yeah. Hi. I think the data that we've generated so far, with the additional cohorts is consistent, with the data we generated in the previous cohorts. It's helping us sort of round out the profile of RE-104 and refining our selection of the Phase II dose. Thanks for that. When do you believe that, you can expect to have a pre-IND meeting with the FDA? Do you need any additional data like these phase I escalated doses, before taking this meeting? Yeah, I'll take that, Andrew. I mean, we are actively in the pre-IND meeting process with the FDA. The FDA, in the context of the pre-IND meetings, will not see the additional cohorts. The additional cohorts, as we said, you know, I think, and what we're trying to highlight here and with the introduction and release of our top-line data in January, is that we feel, you know, quite comfortable with the dose that we've identified amongst the four cohorts. I view that we're in an area right now of just polishing, pushing, and really just confirming that we're in the right zone for the Phase II study. The additional cohorts, Andrew, will be also, we expect that they will be also included in the major medical meeting that we will present six cohorts of data at the major medical meeting congress, which we anticipate would be later in the second quarter of 2023. Appreciate that. One last one, for Mr. Alexander. Cognizant that, you know, you mentioned you've done some consulting work with Reunion in the past, but, you know, when taking on a permanent position like this, if you could provide your thoughts about, you know, out of all the psychedelic companies in the space here, why did you decide to partner with Reunion specifically? Well, for a variety of reasons. I think that it's a great team at Reunion. I think they have a really good molecule and a proprietary psychedelic, which I think is an important aspect in terms of its long-term commercial potential. I think they're working in a very underserved and important area where there's significant unmet medical need, and we'll have... You know, we hope to have a pretty big impact there. Thanks for that. I'll get back in the queue. Thank you. We'll take next question from the line of Patrick Trucchio with H.C. Wainwright. Please go ahead. Thanks. Good morning, and congrats on all the progress. Just a clarification question as it regards the pre-IND meeting with the FDA. Do you need the data from those higher dose cohorts before you can have that meeting, or can you have that meeting before you have that data? We can absolutely have that meeting before we have that data, Patrick. Good morning, and thank you for joining. It's Greg. Yeah. That meeting process is already underway. I mean, again, you know, we're comfortable moving forward with the agency based upon the four cohorts of data we already have. Of course, you know, as required and as appropriate, we will share the data from the additional cohorts with the regulators. Got it. That's helpful. Can you talk a bit more about the clinical meaningfulness of the complete mystical experience and further discuss the dose level that was identified for a complete mystical experience and the level of confidence that what you've seen so far in this Phase I study should translate to the Phase II of, you know, when you explore the RE-104 in PPD patients? Yeah. No, Patrick, the complete mystical experience is an important concept. I think I'd first like Bob to take a shot at answering what we saw in the clinic. Also, I think it's a good opportunity for Nathan to comment on the importance he saw as he helped design this RE-104 from its infancy. Bob. Thanks, Greg. In our Phase I study, we used the Mystical Experience Questionnaire, which is an instrument that's been used widely in the psychedelic space and particularly at Johns Hopkins. Nathan will elaborate, but it has four domains and if you achieve 60% of the maximum score on each of the domains, that has been labeled a complete mystical experience. What we observed at our highest dose in the interim, the 33 milligram dose, is that we had pervasive complete mystical experiences in most of the subjects, I should say, in the cohort. That's been shown in a number of studies to correlate with the therapeutic efficacy. Nathan, do you wanna add to that? Sure. Good morning, Patrick. Thanks for the question. You know, as we've said since the beginning, there's a lot of pharmacological overlap between RE-104 and Psilocybin. That pharmacology is the first basis of why we expected this to work. You know, looking at Our molecule when we compare to Psilocybin, as Bob was saying, we see a robust response that is dose dependent. We can see a nice, as you dose escalate, you can see an increase in the response that's predictable and consistent with the increases in dose. As you get to the highest doses, we're in the zone where everybody's in that complete mystical experience which is, as you said, 60% or greater, which has been tied to studies in anxiety, depression and, was it, smoking cessation, where high holistic responses in patients were actually correlated back to efficacy and then used as a forward leaning tool. You know, we have that to lean on. We also have the fact that we included a Dose Effect Questionnaire intensity score. That intensity score also mirrored the Mystical Experience Questionnaire, and again matched very closely what one might see with 25 milligrams of Psilocybin. We're on the path of demonstrating that those pharmacodynamic effects, whether it be through the DEQ or the MEQ, are consistent with this, the similarity in the pharmacology, and everything just seems to be falling in place. Yeah. Then just one last one on the intellectual property which extends to 2041. Can you talk about, you know, the patent that you have, you know, or the patent protection that you have and just the level of confidence that this patent protection on RE-104 will in fact extend to 2041? Yeah. No, sure. Patrick Trucchio, it's Greg Mayes. You know, clearly one of our, you know, our... In addition to the overlapping safety and efficacy profile that we're seeing with Psilocybin, our two key differentiating points for Reunion Neuroscience continue to be our shorter psychedelic experience time, which we think is about half of what you're seeing in other reports from Psilocybin. Number two is also clearly our intellectual property. As I've told you in the past, from our estimate and our review, only three companies that are in clinical development that are pursuing mental health treatments leveraging the psychedelic backbone actually have meaningful intellectual property, and we include ourselves in that category. RE-104's compound is specifically disclosed in and protected by the Reunion patent and has claims directed to the RE-104 composition of matter use and manufacturing. We are very confident that based upon this, you know, issuance, that we have a valid patent out there until 2041. Terrific. Thank you very much. Thank you. Thank you. We take next question from the line of Elemer Piros with EF Hutton. Please go ahead. Yes, good morning. Congratulations on your appointment, Bob. You were asked what specifically attracted you to Reunion. Maybe a broader question from me. What attracts you to psychedelic medicine? As a Part B to that question, in your experience, what would attract pharma companies to the space? What would they have to see for them to find these opportunities worthy of pursuing? Yeah. That's a great question. Thanks. You know, I just think the more recent development of psychedelics, you know, has a promise to be a really transformational treatment in psychiatric therapy. To the extent that, you know, current. I'm just talking about depression at the moment. You know, current therapies are, you know, they're pretty inadequate in terms of the number of patients that achieve remission or there's a significant number that don't respond at all. The fact that you can give a sort of single dose treatment with extremely rapid onset of efficacy and sustained effect, I think has the potential to be, you know, really transformational. I think we're sort of in the middle of a paradigm shift in psychiatric therapy in the sense that we're going from these chronic treatment the patient takes for months or years to very brief pulse treatments that have, you know, significant and important effects that can really transform patients' lives. I just think we're at the cusp of a real transformation in psychiatric treatment here. What do you think would take for big pharma to see the light? I think they're already seeing the light to some extent. You know, I think when as more studies emerge, that demonstrate the efficacy of these compounds, I think that will certainly get their attention. Yeah. Yeah. I'd like to jump in there too. Elemer, I'd like to jump in there too. Thank you for joining this morning. Really appreciate it. I think this management team has, we have significant experience now in sort of what larger pharma or big biotech at following the experiences out at JP Morgan, as I referenced in our prepared remarks. I mean, you know, that we, you know, we've had touch points and meetings with over 10 potential partners downstream. They all wanna see Phase II data. They all wanna see for continued progress here. That's one thing I actually really love about not only what our molecule, but the clinical development program that Bob and the team are moving forward with. Is our ability to launch a Phase II program this year and return to investors a complete Phase II data set next year. That's what it's gonna take. I mean, clearly, I think, from our interactions, we're seeing, real interest. They wanna see progress. If you're, you know, from the Reunion Neuroscience perspective, I think we're about, you know, a solid, you know, 18 months away from being able to deliver upon what others are gonna want and need to see, additional, progress into Phase III. Yeah. Yeah. Thank you for that, Greg and Bob. Maybe Nathan, if you wouldn't mind attempting to answer this. This is not a loaded question, but just on a qualitative side, do you see these healthy volunteers have a qualitatively different or similar experience than what is described for Psilocybin? Apart from the duration, of course. Yeah. Good morning. Good morning, Elemer. I would say it's extremely similar. It maps well with the anecdotal information about this drug. I'd say it's not only similar from the effects of the intensity of the experience and the character of the experience as characterized by the MEQ, but the adverse event profile is very, very similar. It, it really does map about as close as you can get as a molecule, with a short duration, that you can get to Psilocybin. Yes. Do you see, Nathan, the adverse events being proportional to or the intensity of dose being proportional to the dose? Yeah. I'd say we do see some dose response on the adverse events. As we engage the 5-HT2A receptor to greater and greater extent, we see the serotonergic effects of serotonergic drugs start to appear. They include the hallucination, but they also include other aspects that are very similar to what you see with Psilocybin. Yes. Are you fully committed to examine the sixth dose cohort, or it would depend on what you see with the fifth? Yeah. I'll take that, Elemer. We are committed. I think it's an opportunity for the company, and it's something that the investment community can expect to see results from a sixth cohort again later, you know, later this year when we present the full Phase I data complement. I think it's important. I think it's a great opportunity for us to really fine-tune what we think is already could be an optimal dose, but, you know, we don't know. I'm really excited that Bob's come on board and encouraged us to move forward and examine a sixth cohort. Yes. Thank you very much, gentlemen. Thank you. We take next question from the line of Antonia Borovina with Bloom Burton. Please go ahead. Good morning. Thank you for taking my questions. Firstly, just following up on some of Nathan's comments. RE-104 and Psilocybin have largely overlapping neurotransmitter binding profiles, but they're not identical. RE-104 does, you know, show binding to one A and two C that is greater than Psilocybin. Given the clinical data you've seen so far, do you see, you know, those additional neurotransmitter bindings as not being clinically relevant? You know, could we see differences in safety and efficacy related to that broader neurotransmitter binding? Nathan, can you take that question from Antonia? Welcome this morning, Antonia. Good morning, Antonia. I wasn't sure if Bob wanted to jump in or not. I would probably say you're probably right. I think it's, they're gonna be non-significant, at least at this stage. As I said, the pharmacodynamic profile is, maps very, very closely to Psilocybin. We don't see significant differences that we could attribute to 1A or 2C. Not at this time. Okay. My next question is with regards to the PPD trial design, the 40-patient trial. You are proposing to use placebo as a comparator instead of a low dose like Psilocybin did or like Compass did, in its Phase II studies in TRD. Just wondering what drove that decision. Yeah. Good morning, Antonia. Great question. Bob, you wanna take that? Sure. We obviously have put a lot of thought into this about, how to blind the study. We think we have, built into the study, ways of sort of, maintaining the blind to the, to the extent possible. You know, that's something that we're gonna be reviewing with FDA to see if they concur with our assessment. Okay. When can we expect the full trial design to be released? I think it- Right. I mean, I'm not sure we have disclosed that. I think what we would like to do is get the feedback, Antonia, from the FDA as part of our pre-IND meeting process, which as I mentioned earlier, is ongoing. you know, I think in a future call, we'll be able to, you know, update that and make sure it's promptly posted to ClinicalTrials.gov. Again, we're still going through the feedback process with the FDA, so it would be premature to do it now, as your question suggests. As soon as we have, you know, some level of confidence from the FDA and the IND is cleared to move forward, we will absolutely share that with you and the other interested people out there. Okay. That's all for me. Thanks. Thank you for joining this morning, Antonia. Good to hear your voice. Thank you. We take the last question from the line of Sumant Kulkarni from Canaccord Genuity. Please go ahead. Good morning. Thanks for taking my questions. I have a few. The first is, now that you have Phase I data in hand, is there any reason to believe that the achievement of a complete mystical response or potential efficacy of RE-104 could vary by sex? Bob, you wanna take that? Sure. Yeah, we've been fortunate. We've been able to recruit, women as well as men into our Phase I study. So far, we haven't seen any meaningful gender differences. Got it. Were there any common themes among people that did not have a complete mystical response? Not that we've identified. I mean, there are, you know, there is sort of a natural variation in how and the intensity of how people respond, particularly at lower doses. We haven't been able to identify any predictors of that, to date. What are your latest thoughts on what might be considered a durable response in postpartum depression? asked another way, I guess, how many treatments would you think might be required for one episode of PPD? That's a great question. I mean, We're thinking as in our initial sort of, test of this, just looking at a series and understanding the duration of that. Then based on that, we could sort of further elaborate our dosing scheme. My last question? Nathan, do you have any additional thoughts for Sumant, with respect to as a someone who designed RE-104 early on in terms of the duration and dosing for PPD that you're expecting? Honestly, I think at this stage it's very difficult to predict what the durability of the response will be. The effect, the immediate effect, given the overlap with Psilocybin, as I've said multiple times already on the call, I really believe that we're gonna see the immediate response, in a very, very similar manner because of the similarity in the behavior, and the responses from subjects. As for the durability, you know, I would only highlight that, you know, shorter acting, serotonergic psychedelics, give long duration responses or at least similarly long duration responses. We've seen them in the literature. We've seen them in the recent, press releases. I would expect would be in the same ballpark. It's a question of optimizing, you know, treatment conditions to make sure that that durable response as long as necessary. For PPD in general, you know, since it's not a treatment- resistant type population, I think that we could expect, you know, it's more of an MDD population. We could expect that, potentially one dose could give 8-12 weeks minimum and potentially long duration efficacy with no need to have additional doses or maybe just one additional dose out to a year. Got it. Assuming that RE-104 is approved, what sort of clinical infrastructure do you think might be necessary specifically within the PPD context? Do you mean, this is Bob? Do you mean clinical or commercial? Clinical. I guess, commercial infrastructure is one way to think about it, but the clinical infrastructure to actually deliver the product to people with PPD. Oh. Oh, okay. Yeah. I mean, I think that, well, I'll let Greg comment on that. Sumant, could you repeat the question? Sure. We know that, you know, for example, in the TRD setting, there are, you know, potentially esketamine clinics where TRD products which have psychedelic properties might be delivered. In a PPD context, would you assume similar sort of clinical infrastructure, or would there be something special that needs to be built? I would expect a similar architecture for PPD, and, you know, in terms of its ultimate, you know, distribution in terms of clinics, outpatient settings, in the psychiatry community. It certainly wouldn't require the inpatient hospitalization that you're seeing with the one product that is approved in that area. Ultimately, one of my views for the company is to have an architecture that would allow for home health agencies and contracting with home health agencies, to allow for the appropriate healthcare professional monitoring in the home environment, but would allow for the product to be taken in the home environment with the proper healthcare professional support that is going to be necessary for the administration of psychedelic-based mental health treatments in the future. Thank you. Ladies and gentlemen, we have reached the end of the question- and- answer session. I would now like to turn the floor back over to Greg Mayes, CEO, for closing comments. Over to you, sir. Great. Thank you, operator, and thank you to our investors and analysts for your ongoing support. Just six months ago, Reunion was created as a standalone clinical-stage biopharmaceutical company focused on the development of innovative therapies for the millions of patients who continue to suffer from depression and other mental health disorders. Earlier this quarter, we announced interim data from our placebo-controlled Phase I study, which demonstrated safety, tolerability, a short-duration psychedelic experience in line with our expectations for selection of a recommended Phase II dose. In 2023, we expect to present a more detailed analysis of our interim data set, along with additional data from the final cohorts of the Phase I study at a major medical meeting, which you can expect to occur around the middle part of this year. We are active in our pre-IND interactions, as I mentioned earlier, with the FDA, with plans to open an IND and kick off our Phase II study in postpartum depression later this year. While most of our efforts remain focused on RE-104 and its initial target indication of postpartum depression, we will also continue to evaluate opportunities to broaden our development pipeline through RE-104 indication expansion and making progress with our RE-200 series of next- generation compounds. Finally, over the last several months, we have assembled a top-notch leadership team comprised of industry veterans with deep expertise and successful track records in clinical- stage drug development. I look forward to personally sharing our progress with you over the coming quarters, and I now ask the operator to close the lines. Thank you again, and have a wonderful day. Thank you very much, sir. Ladies and gentlemen, this concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
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