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Greetings, and welcome to the Reunion Neuroscience Fiscal Third Quarter 2023 Earnings Conference Call. [Operator Instructions] It is now my pleasure to turn the call over to Edward Smith, the company's Chief Financial Officer.
Thank you. Good morning, everyone, and welcome to the fiscal third 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 any outlook presented is as of today and except as required by applicable laws, 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.
Thank you, Ed, and 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 2 top priorities out of the gate were as follows. #1, to present compelling data from a robust Phase 1 study in quarter 1 that we could use to open an IND in the United States for RE104's Phase 2 study in postpartum depression. And 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 RE104 and our earlier stage discovery portfolio. I am very pleased to report that 6 weeks into the year, we have made significant progress on both fronts. Last month, we announced top-line interim Phase 1 data for our lead drug candidate, RE104, which showed RE104 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, RE104 also demonstrated a shorter duration of psychedelic experience relative to psilocybin. In the interim data set, most participants receiving RE104 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 2 dose of RE104 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 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 2, able to build more momentum off the solid foundation and strong Phase 1 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, RE104. But 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 and 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. RE104 is the only psychodelic 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 RE104 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. 1 in 8 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 in-patient 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 psychodelic, single-dose RE104 could potentially provide mothers with fast relief and a quick return to mother-child bonding and breast feeding in an estimated 24 to 48 hours due to RE104's short duration psychoactive experience of less than 4 hours, durable efficacy and a rapid wash-out period. In addition to our work progressing RE104 in the clinic, we remain focused on advancing the development of our RE200 Series. During the fiscal third quarter, we continue to identify potential candidates in the RA200 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 5HT2A 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 2, I am thrilled to introduce our newly appointed Chief Medical Officer, Dr. Robert Alexander. Bob was a former executive of 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.
Thanks, Greg. Some of you may or may not know that I've been involved with Reunion in an advisory capacity for some time. Now with the recent Phase 1 interim data set and the company's plans to move into Phase 2, I'm delighted that Greg asked that I join the leadership team as Reunion's Chief Medical Officer. Scientific literature clearly indicates that 5HT2A receptor agonist can promote neuroplasticity and they play an important role in extended durability of antidepressant effects. Psilocybin, which is a chemical structure and pharmacology similar to RE104, has shown in the clinic that it can produce durable antidepressant outcomes. The RE104 Phase 1 data generated to date are very encouraging. In the study so far, RE104 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 2. After completing the pre-planned interim analysis and 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 2 additional planned cohorts will provide Reunion with valuable data to inform selection of a recommended Phase 2 dose. Our Phase 1 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 2 study evaluating RE104 versus placebo in the treatment of women with postpartum depression is anticipated that the multi-center 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 breast feeding 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 RE104. Once the PPD Phase 2 program is in progress, Reunion plans to share its continued RE104 development strategy in pursuit of treating additional indications. I'm really excited to serve as Reunion's Chief Medical Officer and 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 3 and 9-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, we incurred general and administrative expenses for the 3 and 9-month periods ended September 30, 2022 of CAD 3.1 million and CAD 9 million respectively, which compares to G&A expenses of CAD 4.6 million and CAD 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 RE104 entering the clinical stage. The 3-month period ended December 31, 2021, also included a reclassification of approximately CAD 2 million of G&A expenses from discontinued operations to continuing operations. Research and development for the 3 and 9-month periods ended September 30, 2022 were CAD 3.4 million and CAD 8.6 million respectively compared to CAD 1.1 million and CAD 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 1 clinical trial for RE104. Our income and expenses include interest income on Reunion's cash and cash equivalents and foreign currency gains and losses primarily attributable to our United States dollar holdings. We also recognized CAD 5.7 million and CAD 15.3 million in charges for the 3 and 9 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 0 and CAD 10.4 million for the 3 and 9-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 3 and 9-month periods ended December 31, 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 CAD 32.4 million in cash and cash equivalents, which provide a runway through 2023, inclusive of limited start-up activities related to our planned Phase 2 clinical trial for RE104 in postpartum depression. This ends our prepared remarks. I'll now ask the operator to open the lines for Q&A session.
[Operator Instructions] We have a first question from the line of Andrew Partheniou with Stifel.
Congrats on the good quarter here. Maybe we can start with just your cash burn profile. You're mostly done with Phase 1 now, you're prepping for Phase 2. Could you talk a little bit about how you see your cash burn profile over the next few quarters or the year calendar 2023?
Andrew, this is Greg. I'll clearly turn the call over to Ed to address those concepts.
Yes. I mean, 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 to 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. As we go into Phase 2 later this year, we expect our cash burn to increase, particularly in the second half of this year, once we're fully committed to the Phase 2 program in PPD. And I think consistent with the guidance I provided last quarter, we expect that once we're in Phase 2 that burn would go up to about between CAD 7 million and CAD 9 million on a quarterly basis.
And to the extent as you can, is there any kind of color that you can provide on how the escalated dose beyond the initial Phase 1 levels are going?
Yes, sure. I'll have Bob Alexander take a question on the additional cohorts.
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. And it is helping us sort of round out the profile of RE104 and refining our selection of the Phase 2 dose.
And 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 1 escalated doses before taking this meeting?
Yes, 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. But the additional cohorts, as we said, I think in what we're trying to highlight here and with the introduction and release of our top-line data in January is that we feel quite comfortable with the dose that we've identified amongst the 4 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 2 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 all -- that we will present 6 cohorts of data at the major medical meeting Congress, which we anticipate would be later in the second quarter of 2023.
And one last one for Mr. Alexander. Cognizant that you mentioned you've done some consulting work with Reunion in the past. But when taking on a permanent position like this, if you could provide your thoughts about 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 it's a great team at Reunion. I think they have a really good molecule and proprietary psychedelic, which I think is an important aspect in terms of its long-term commercial potential. And I think they're working in a very underserved and important area where there's significant unmet medical need. And we'll have -- we hope to have a pretty big impact there.
We take next question from the line of Patrick Trucchio with H.C. Wainwright.
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. It's Greg. Yes, that meeting process is already underway. I mean, again, we're comfortable moving forward with the agency based upon the 4 cohorts of data we already have. And of course, as required and as appropriate, we will share the data from the additional cohorts with the regulators.
And then just 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 the Phase 1 study should translate to the Phase 2 when you explore the RE100 in PPD patients?
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, but also I think it would -- it's a good opportunity for Nathan to comment on the importance he saw as he helped design this RE104 from its infancy.
So in our Phase 1 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. And that can be -- Nathan will elaborate, but it has 4 domains. And if you were to achieve 60% of the maximum score in each of the domains that has been labeled a complete mystical experience. And what we observed at our highest dose in the interim, the 33 milligram dose is that we had a pervasive complete mystical experience in almost all -- in most of the subjects, I should say, in the cohort. And that's been shown in a number of studies to correlate with therapeutic efficacy. Nathan, do you want to add to that?
Sure. As we've said since the beginning, there's a lot of pharmacological overlap between RE104 and psilocybin. And that pharmacology is the first basis of why we expected this to work. So looking at our molecule, when we compare to psilocybin, as Bob was saying, we see, one, 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. And as you get to the highest doses, we're in the zone where everybody is in that complete mystical experience, which is, as he said, 60% or greater, which has been tied to studies in anxiety depression and was it a smoking sensation where high [indiscernible] in patients were actually correlated back to efficacy and then used as a forward remaining tool. So we have that to lean on. We also have the fact that we included a Dose Effect Questionnaire intensity score. And that intensity score also mirrored the Mystical Experience Questionnaire. And again, matched very closely what one might see with 25 milligrams of psilocybin. So we're on the path of demonstrating that dose pharmacodynamic effects, whether it be through the DEQ or the MEQ, are consistent with the similarity in the pharmacology and everything just seems to be falling in place.
And then just one last one on the intellectual property which extends to 2041. Can you talk about the patents that you have or the patent protection that you have and just the level of confidence that this patent protection on RE104 will in fact extend to 2041?
Sure, Patrick, it's Greg. Clearly, one of our -- in addition to the overlapping safety and efficacy profile that we're seeing at psilocybin are 2 key differentiating points for Reunion Neuroscience continue to be our shorter psychedelic experience line, which we think is about half of what you're seeing in other reports from psilocybin. And then #2 is also clearly our intellectual property. As I told you in the past, from our estimate and our review, only 3 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. RE104's compound is specifically disclosed in and protected by the Reunion patent and has claims directed to the RE104 composition of matter used in manufacturing. So we're very confident that based upon this issuance that we have a valid patent out there until 2041.
We take next question from the line of Elemer Piros with EF Hutton.
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? And there is 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?
I just think the recent -- more recent development of psychedelics has the promise to be a really transformational treatment in psychiatric therapy. To the extent that current -- and just talking about depression at the moment, current therapies are -- 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. And the fact that you can give a sort of single dose treatment with an extremely rapid onset of efficacy and the sustained effect, I think has the potential to be 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 that patient takes, takes for months or years to very grief pulse treatments that have significant and important effects that can really transform patient's live. So I just think we're at the cusp of a well transformation in psychiatric treatment here.
And what do you think would take for big pharma to see the light?
I think they're already seeing the light to some extent. But I think when -- as more studies emerge that demonstrate the efficacy of these compounds, I think that will certainly get their attention.
Yes, I'd like to jump in there too. Elemer, I'd like to jump in there too. I think this management team has -- we have significant experience now in sort of what larger pharma or big biotech following the experiences out at JPMorgan, as I referenced in our prepared remarks. I mean, we've had touch points and meetings with over 10 potential partners downstream and they all want to see Phase 2 data. They all want to see continued progress here. And that's one thing I actually really love about not only what we're -- our molecule, but the clinical development program that Bob and the team are moving forward with is our ability to launch a Phase 2 program this year and return to investors a complete Phase 2 data set next year, and that's what it's going to take. But I mean, clearly, I think from our interactions, we're seeing real interest. They want to see progress. And if you're -- from the Reunion Neuroscience perspective, I think we're about a solid 18 months away from being able to deliver upon what others are going to want and need to see additional progress in the Phase 3.
Maybe Nathan, if you wouldn't mind attempting to answer. 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?
I would say it's extremely similar. It maps well with the anecdotal information about this drug. And I'd say it's not only similar from the effects of the intensity of the experience and the character, the experience is characterized by the MEQ, but the adverse event profile is very, very similar. And so 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. And do you see, Nathan, the adverse events being proportional to or the intensity of dose being proportional to the dose?
Yes. I'd say, we do see some dose response on the adverse events. As we engage the 2a receptor to greater and greater extent, we see the serotonergic effects of serotonergic drugs start to appear. So they include the hallucination, but they also include other aspects that are very, very similar to what you see with psilocybin.
Yes. And are you fully committed to examine the 6 dose cohort or it would depend on what you see with the sixth?
Yes, I'll take that, Elemer. We are committed. I think it's an opportunity for the company and it's something that investors -- the investment community can expect to see results from a sixth cohort, again, later this year when we present the full Phase 1 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 we don't know. So I'm really excited that Bob's come onboard and encouraged us to move forward and examine the sixth cohort.
We take next question from the line of Antonia Borovina with Bloom Burton.
Firstly, just following up on some of Nathan's comments. So RE104 and psilocybin have largely overlapping neurotransmitter binding profiles, but they're not identical. RE does initial binding to 1A and 2C that is greater than psilocybin. So given the clinical data you've seen so far, do you see those additional neurotransmitter bindings as not being clinically relevant or could we see differences in safety and efficacy related to the broader neurotransmitter binding?
Nathan, could you take that question from 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 going to be not significant, at least at this stage. As I said, the pharmacodynamic profile is -- maps very, very closely with psilocybin. We don't see significant differences that we could attribute to 1A or 2C. So not at this time of time.
And then 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 2 studies in TRD. So just wondering what drove that decision?
Bob, do you want to take that?
Sure. So 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 extent possible. And that's something we're going to be reviewing with the FDA to see if they concur with our assessment.
And then when do we expect the full trial design to be released?
I think it -- I mean, we have -- 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. So I think in a future call, we'll be able to update that and make sure it's promptly posted to clinicaltrials.gov. But 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. But as soon as we have 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.
We take last question from the line of Sumant Kulkarni from Canaccord Genuity.
I have a few. So the first is, now that you have Phase 1 data in hand, is there any reason to believe that the achievement of a complete mystical response or potential efficacy of RE104 could vary by sex?
Bob, do you want to take that?
Sure. We've been fortunate. We've been able to recruit women as well as men into our Phase 1 study. And so far, we haven't seen any meaningful gender differences.
And were there any common themes among people that did not have a complete mystical response?
Not that we've identified. I mean, there are -- there is sort of a natural variation in how the intensity of how people respond, particularly at lower doses. But we haven't been able to identify any predictors of that to date.
And 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 in our initial sort of test of this, we were just looking at this and understanding the duration of that. And then based on that, we could sort of further elaborate our dosing scheme.
Nathan, do you have any additional thoughts for Sumant with respect to the -- as someone who designed RE104 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. But 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 going to see the immediate response in a very, very similar manner because of the similarity and the behavior and the responses from subjects. As for the durability, I would only highlight that shorter-acting serotonergic psychedelics give long duration responses or at least similarly long duration of responses. We've seen them in the literature. We've seen them in the recent press releases. So I would expect it would be in the same ballpark. And then it's a question of optimizing treatment conditions to make sure that durable response is as long as necessary. For PPD in general, since it's not a treatment-resistant type population, I think that we could expect -- it's more of a MDD population. We could expect that potentially one dose could give 8 to 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.
So assuming that RE104 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.
Yes. I mean, I think that this -- I'll let Greg comment on that.
Sumant, could you repeat the question?
Sure. So we know that, for example, in the TRD setting, there are potentially clinics where TRD products which have psychedelics properties might be delivered. But 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. In terms of its ultimate distribution, in terms of clinics, out-patient settings in the psychiatry community, I don't -- it certainly wouldn't require the in-patient hospitalization that you're seeing with the one product that is approved in that area. And 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.
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.
Thank you, operator, and thank you to our investors and analysts for your ongoing support. Just 6 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 1 study, which demonstrated safety, tolerability, a short duration psychedelic experience in line with our expectations for selection of a recommended Phase 2 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 1 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 2 study in postpartum depression later this year. While most of our efforts remain focused on RE104 and its initial target indication of postpartum depression, we will also continue to evaluate opportunities to broaden our development pipeline through RE104 indication expansion and making progress with our RE200 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.