Reunion Neuroscience, Inc. (NASDAQ:REUN) Q2 2023 Earnings Conference Call November 14, 2022 8:30 AM ET
Company Participants
Phil Carlson – IR, MD, KCSA Strategic Communications
Greg Mayes – President and CEO
Edward Smith – CFO
Nathan Bryson – Chief Scientific Officer
Conference Call Participants
Andrew Partheniou – Stifel
Patrick Trucchio – H.C. Wainwright
Antonia Borovina – Bloom Burton & Co.
Michael Okunewitch – Maxim
Operator
Greetings, and welcome to Reunion Neuroscience Fiscal Second Quarter ’23 Earnings Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this call is being recorded.
It is now my pleasure to introduce your host, Mr. Phil Carlson, Managing Director, KCSA. Thank you. You may begin.
Phil Carlson
Good morning, everyone, and welcome to the second fiscal quarter 2023 earnings conference call for Reunion Neuroscience, Inc.
Before I begin the call, I’m 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 any outlook presented is as of today and except as required by applicable laws, management does not undertake any obligations to revise any forward-looking statements in the future.
Presenting today will be Greg Mayes, who was appointed President and CEO on September 28, and Edward Smith, the newly appointed Chief Financial Officer. Dr. Nathan Bryson, Chief Scientific Officer, is also on the line and will be participating in the Q&A.
I’ll now hand the call over to Greg. Greg, please go ahead.
Greg Mayes
Thank you, Phil, and welcome, everyone, to our fiscal second quarter 2023 conference call. Thank you for joining us this morning. I joined Reunion Neuroscience on September 28 as its President and Chief Executive Officer because the mental health crisis that is going on in this world is personal to me. And I believe Reunion has a molecule that can bring about the change in available mental healthcare treatments that this world so desperately needs. In less than two months, I have made a number of significant observations that, when taken together, confirm my belief that Reunion has the potential to play an integral role in the development of new treatments for mental health that leverage the psychedelic mechanism of action.
This morning, I would like to share some of these observations with you. First, based on the discussions that I’ve had with industry professionals and experts in the field, there is a growing and uniform consensus that psychedelics will ultimately offer a new approach for treating mental health disorders. Prior to COVID, there were over 300 million people worldwide suffering from depression. As the pandemic led to an even greater rise in mental health conditions, we believe the ineffectiveness of traditional treatments became more apparent. Despite the abundance of traditional antidepressant medications that are available, treatment resistance occurs in roughly 30% of patients with depression.
Second observation. The medical and scientific community as well as mainstream media have increasingly come to accept that psychedelic therapy holds great promise for the treatment of mental health. Over the past decade and now more than ever, eyes are on psychedelics as mounting clinical data continues to build credibility and demonstrate their effectiveness for several mental health conditions where traditional treatments such as SSRIs have shown resistance, failed to act or even taken too long to act.
My third observation, the regulatory environment for the development of psychedelics as mental health treatments is now evolving in a very positive way, and we believe companies like Reunion with innovative compounds will increasingly receive positive attention and support from regulators.
I am personally thrilled to see the FDA’s Division of Psychiatry recognizing psychedelic developers with breakthrough designation status and providing meaningful feedback on the design and implementation for pivotal registration studies. Reunion is well positioned to capitalize on these positive regulatory changes, and we believe will be on the forefront and meeting the unmet needs of patients in the medical community as we seek to adopt and follow the regulatory precedents that are being developed.
Fourth, as I continue to speak with the investment community and potential strategic partners, it appears that many high-quality healthcare investors are still looking to allocate funds to the psychedelic sector, and potential strategic partners are closely watching the positive data that is now emerging. While we believe those investors and strategic partners recognize that psychedelics hold huge potential as a treatment for mental health conditions, there is a desire to see seasoned biopharmaceutical leadership, meaningful and enduring IP protection and shorter durations of administration before large investments and partnerships are made.
I believe Reunion can satisfy all of these criteria as investors and potential strategic partners continue to evaluate the space and begin to deploy their resources.
My fifth observation involves intellectual property. I do not believe investors have recognized the importance of intellectual property as they assess the sector. In my opinion, Reunion’s strongest competitive advantage lies in the robust patent protection of our novel serotonergic psychedelic therapies, which include a Composition of Matter patent for RE-104 that has already been issued and provides exclusivity through 2041 with the ability for us to grow protection for RE-104 beyond that time point.
Just to provide some deeper perspective on the value of our IP, I think it’s important to know there are currently 33 publicly listed companies developing psychedelic therapies today. Of those, only three psychedelic companies that are in clinical development hold issued Composition of Matter patents. Reunion is one of these three companies.
This is critical. Having spent years in business development roles in both large pharma and big biotech, I cannot envision a scenario where either large pharma or big biotech will be interested in partnering or further investing in mental health medicine companies that leverage the psychedelic mechanism of action without adequate IP protection. Again, IP is an area of clear strength and differentiation for Reunion.
Six, RE-104 is uniquely formulated as the only 4-hydroxy DiPT prodrug in development. This is important. No other company can or is developing a 4-hydroxy DiPT prodrug, and we believe this fact provides a massive advantage for Reunion. Our molecule’s pharmacologic profile supports quick onset of action with a limited duration of psycho activity compared to many other psychedelic-based molecules with the potential to improve convenience for patients and physicians while reducing the additional time and expense on payers and providers.
We remain confident in our choice of Reunion-104 and the outcomes it may bring for the following five reasons. The chemical structure and pharmacology of RE-104 is extremely similar to psilocybin. Anecdotal information has shown that psilocybin and 4-hydroxy DiPT produce similar psychedelic experiences, albeit the duration of the RE-104 psychedelic experience is much shorter.
Clinical evidence that long and shorter-acting psychedelics such as DMT or 5-MeO-DMT can produce rapid antidepressant outcomes. Psilocybin has shown in the clinic that it can produce durable antidepressant outcomes. And five, scientific literature clearly indicates that nearly all 5-HT2A receptor agonists, such as RE-104 are capable of supporting neuroplasticity which is believed to be a potential explanation for the extended durability of the antidepressant effects produced by 5-HT2A receptor agonists like for 4-hydroxy DiPT.
When I joined the company in September, my first priority was to ensure the timely completion of our Phase I clinical trial for RE-104, and be positioned to share the top line data in Q1 2023. I’m pleased to report today that we have made considerable progress and have completed dosing of the four pre-specified cohorts, which represents 32 subjects for our planned interim analysis to be released in the first calendar quarter of 2023. The study is not your garden variety Phase I study. It aims to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of RE-104 over a range of four dosage levels.
Results of subjective measurements using validated FDA measurements, including intensity, duration and feelings produced by the period of acute psycho activity after administration of RE-104 will be used to select an appropriate recommended Phase II dose. Per the Phase I protocol, and based on findings from the interim analysis, up to two additional dosing cohorts may be evaluated based on pharmacokinetics, pharmacodynamics and safety.
If this option remains available to us, we will proceed to further confirm our Phase I findings in at least one additional dosing cohort that would report out in the first half of 2023. This extra cohort will help us confirm that we have the right dose when Phase II begins in the second half of 2023. Bottom line, the Phase I readout will immediately elevate Reunion to a select group of developers of mental health medicines that leverage the psychedelic mechanism of action with available human clinical data from 32 subjects.
We are excited to achieve this key development milestone and look forward to sharing details on these results next quarter. These results will pave the way for the commencement of the investigational new drug application process with the FDA and the start of our Phase II clinical trial for RE-104, which will begin later next year. Beyond Phase I, we have chosen to advance the RE-104 clinical development program initially for postpartum depression, where we believe the need for a fast-acting short duration treatment is especially important to limit time away from the newborn. And RE-104 can provide a compelling opportunity.
The selection of postpartum depression was key as it brings forth a large treatment market with considerable unmet needs. In addition, this indication supports a condensed development time line, which allows for shorter and smaller trials, which are less costly. In addition, this disease state presents limited competition, and we believe is an ideal patient profile for a potentially fast eliminating drug, allowing mothers to quickly return to their infant and resume breast feeding.
We also remain focused on advancing the development of our RE200 series. During the second fiscal quarter, we progressed work to identify potential candidates in the RE200 series to target development of novel molecules that are structurally similar to classical psychedelics but have selective potency at the target serotonin 2A receptor and are devoid of 5-HT2B 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 improve convenience.
We have filed five provisional patents with the United States Patent and Trademark Office for the RE200 series to protect the compositions, potential formulations and uses of the molecules, which have since formed the basis for a utility filing with the U.S. PTO. We plan to nominate our first RE200 series lead clinical candidate in the second half of 2023.
Before we move forward towards our financial results, I would just like to highlight the strength of our executive clinical and regulatory team. During and subsequent to the end of the second quarter, we brought in and strengthened the development and depth of our executive team. Following my appointment as President and CEO, Ed Smith was appointed Chief Financial Officer. Dr. Aviva Asnis-Alibozek was appointed Vice President of Medical Affairs; and Curtis Weber was appointed General Counsel. These highly skilled veterans bring forth decades of collective experience in the biotech industry and are uniquely qualified to help improve the visibility of Reunion, a new company and prepare us for Phase II development.
I would now like to hand the call over to Ed to review our financial results for the quarter. Ed?
Edward Smith
Thank you, Greg, and good morning, everyone. As a reminder, all figures that I will be discussing are in Canadian dollars and are for the three and six month periods ended September 30, which marks the end of our second fiscal quarter.
For those new to the Reunion and as a reminder to those who have been following us, on August 11, 2022, the company completed its previously announced spinout of its clinics and botanical research operations into a separate company, Field Trip Health & Wellness. Operations included in the spinout 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 and patented therapeutic solutions for underserved mental health conditions.
To that end, we have incurred general and administrative expenses for the three and six months periods ended September 30, 2022, of CAD3.7 million and CAD5.9 million, respectively, which compares to G&A expenses of CAD1.9 million and CAD3.3 million for the same period a year ago. Increases were attributable to increased headcount and other costs associated with becoming a NASDAQ-listed public company and increased scale of operations due to RE-104 entering the clinical stage.
Research and development for the three and six month periods ended September 30, 2022, were CAD2.2 million and CAD5.1 million respectively, compared to CAD2.2 million and CAD3.6 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. Other income and expenses included interest income on Reunion’s cash, cash equivalents and investment balances and foreign currency gains primarily attributable to our U.S. dollar holdings.
We also recognized CAD1.9 million and CAD7.6 million in noncash charges for the three and six months ended September 30, 2022, in recognition of our financial guarantee of certain lease obligations associated with entities that were part of the spinout of clinical 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 spinout of Field Trip Health & Wellness as a net loss from discontinued operations. This loss from discontinued operations was CAD2.6 million and CAD10.4 million for the three and six month periods ended September 30, 2022, respectively, compared to CAD10.5 million and CAD19.6 million for the same period in 2021.
Our net loss from continuing operations was CAD13.9 million or CAD1.20 per share and CAD19.2 million or CAD1.65 per share for the three and six month periods ended September 30, 2022, which compares to a loss of CAD2.5 million or CAD0.22 per share and CAD5.9 million or CAD0.51 a share for the three and six month periods ended September 30, 2021. At September 30, 2022, we had combined cash, cash equivalents and investments of CAD36.7 million, which provided cash runway through 2023, inclusive of limited start 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 the Q&A session. Thank you.
Question-and-Answer Session
Operator
Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question is from the line of Andrew Partheniou with Stifel. Please go ahead. State your question.
Andrew Partheniou
Hi, good morning. Congrats on the quarter. Thanks for taking my questions. Just wanted to first ask some housekeeping items here. I think you mentioned Reunion 200, the nomination for that could be in the second half of 2023. Is this calendar or quarter — or fiscal?
Nathan Bryson
Calendar.
Andrew Partheniou
Perfect.
Nathan Bryson
Hi, Andrew, this is Nathan. Sorry, just said it quick, calendar.
Andrew Partheniou
That’s what I needed. The next one is just on the P&L. Could you state if there was any kind of onetime costs we should be thinking about when working in our model, perhaps legal costs related to the divestiture that’s embedded in G&A or anything else that we should keep in mind?
Greg Mayes
Ed, do you want to take a shot at that?
Edward Smith
Yes, I got — yes, in terms of cost, I think if you look at the split between G&A and R&D, I think if you look at the last three and six months, it’s probably a little bit on the high side. I think as we look at the burn prospectively, it’s our expectation that we should see about CAD4 million to CAD6 million, which will ultimately ramp to somewhere between CAD7 million and CAD9 million as the company enters Phase II. But I think importantly, and to your question, as we start to look forward at the split between G&A and R&D, I think you’ll see the company split between the two, be more of a 60-40 in favor of R&D, and that will migrate upwards to like a 70-30 split between R&D and G&A as the company enters into Phase II.
Andrew Partheniou
That’s definitely great. And in this quarter, in particular, were there anything that we should be thinking about that’s non-recurring costs in G&A, for example?
Edward Smith
Yes. I mean, look, the company had a spinout that took place over the last quarter and also some legal costs associated with its NASDAQ listing, et cetera. So I think that — as I said, I think the legal and costs associated with those items were a bit higher for the quarter. And I think as you look about the total burn for the quarter or cost as you look at the combined company, we’re at the high end of the CAD4 million to CAD6 million range that I provided a moment ago.
Andrew Partheniou
Okay. Much appreciated. And thinking about perhaps more of a scientific question here, Compass recently published its Phase IIb trial results in the journal. And although Reunion 104 is a different molecule, do you see any kind of read-through from their trial results for your program in particular?
Greg Mayes
Yes, I’m going to ask Nathan to give a shot at that, Andrew.
Nathan Bryson
I mean, the — we always learn something from these publications, and we’ll take as much as we can and build it into our programs. Beyond that, it’s really difficult to sit here and — I’m not going to criticize. It’s nice to see that they completed a fairly large trial with some nice endpoints that have satisfied the FDA’s requirement and has provided them a pathway forward. So as such, it provides us a nice clean pathway for our program in Phase II and gives us confidence that we should be able to have ongoing good conversations with the FDA around the endpoints and the pathway, understanding, of course, that we are looking at a different indication.
Andrew Partheniou
Yes, of course. And maybe one last one for me, and I’ll get back in the queue is just it seems that the time line for your program did extend just a little bit. It doesn’t seem too material for us, but just wondering if you could talk a little bit about how it’s going. I think you mentioned dosing. You’ve successfully dosed multiple cohorts. Understanding that your top line results are going to be later in Q1, not expecting much discussion about that right now. But if you could provide any kind of additional color on that, just to contextualize the time line here.
Greg Mayes
Yes, Andrew, it’s Greg. I’m going to have to respectfully disagree with you a little bit on that the time lines have been pushed out. We’ve completed enrollment in the first four cohorts, and we’ll be preparing that data. So from my perspective, the planned analysis that we had always timed for to be complete, we wanted the study to be complete in Q4 with an announcement in Q1, I believe we’re still right on time before. So there’s three things — there’s three time line driven approaches right now or things that the company needs to get done. And I think we’re right on time.
I’m a very time line focused CEO, and I think my team is as well. So we’re going to have the plan — the readout will be in Q1, but the analysis data, enrollment and all the ingredients for the Phase I will be completed this year, and that’s very important. Number two, we’re going to get our IND on file with the FDA and we’re going to open up the postpartum depression study in the second half of the year.
So from my perspective, the train is running on time here at Reunion and that’s something that I think you guys will come to appreciate as we move forward. Nathan, do you have anything else you want to add?
Nathan Bryson
No, I think that’s perfectly correct. We always intended that we’d have the first four cohorts done at the end of the year. That’s been met. We’ve got really good recruitment. Everything has been going quite smoothly. And we’re finishing up the fourth. We’re actually considering the fifth right now. Maybe even get that done before the end of the year, but it won’t be part of the readout. That will be part of our documentation that will go into the IND at a later date.
Andrew Partheniou
Understood. Thanks and I’ll get back in the queue.
Greg Mayes
Great, thanks Andrew for the great questions.
Operator
Thank you. Our next question is from the line of Patrick Trucchio with H.C. Wainwright. Please proceed with your question.
Patrick Trucchio
Thanks. Good morning. I have a few follow-up questions on RE-104. The first is just the interim analysis that’s available or expected to be available in first quarter of 2023. Can you tell us how many patient data is expected for this interim analysis? And as well, there was some discussion around the data to be generated in addition to safety and tolerability. Can you frame for us what additional data that you would be expecting to report would tell us about RE-104? And is it going to be available at the time of that interim? Or would you need the full dataset for that data?
Nathan Bryson
I missed part of that. But the dataset will include data from 32 patients, four cohorts of eight. Of those 32, 24 — six times four — of 24 patients will have received active substance. And the balance eight patients, eight subjects will have received placebo. We included placebo because we wanted to get an initial readout on what — how patients might respond in a placebo siting relative to our cohorts that had been dosed actively. What was the rest of the question?
Patrick Trucchio
What kind of end points?
Nathan Bryson
The endpoints themselves? Yes, as we said, clearly, these endpoints in Phase I tend to be safety and pharmacokinetics, which of course, we’re going to read out here in these healthy volunteers. But we have the advantage here with the psychoactive substance to also measure using the DEQ, which is a drug effect questionnaire, essentially asking how high are you?
Or do you feel any drug effect? To get a readout on the intensity of the drug effect over time. It’s one that’s done at every blood draw plus one or two time points, and allows us to draw a profile of the intensity of the effect itself. Also setting us up to measure the duration of the experience because we can see when it cuts in at the beginning and when it cuts out at the end when a patient says, I’m no longer feeling the drug effect. And therefore, we’ll be able to calculate sort of the duration of the experience itself using this tool.
And then we’ll have the Mystical Experience Questionnaire, which most of you on the line, if you’re familiar with psychedelics, have seen before. The Mystical Experience Questionnaire is a 30-item questionnaire that looks at various aspects of the psychedelic experience itself, which have been tied in part — maximum MEQ, has been tied to positive outcomes in depression trials. Maybe not a perfect one-to-one correlation, but are often indicative that if you get a high MEQ, you’re going to have a good chance of having positive outcomes, at least with things like psilocybin. So we’re following that.
And so the combined entity here will give us an information about the dose that we’re going to be taking into Phase II. So one dose that would be safe and — safe to the subjects, and then looking at those other measures as efficacy measures, maximizing them relative to the safety, making sure we don’t put the patients at risk, but we get a high as MEQ as we can.
Patrick Trucchio
What would lead to the enrollment of additional cohorts in this Phase I study? And would you know if you’re — when would you know if you’re going to enroll those cohorts? At what doses would those cohorts be enrolled?
Nathan Bryson
So we haven’t disclosed the doses, and I don’t want to get ahead of our Data Safety Committee, which is actually meeting this week to discuss the enrollment into cohort 5. We have an abundance of volunteers waiting to come into the trial. And as soon as we have the readout from the Data Safety Committee, those subjects — several of them have already been scheduled for screening, will be brought in for screening and then brought into the trial as quickly as possible to start cohort 5 if the Data Safety Committee says that they’re good to go. I have every assumption, every belief that, that would be the case, since we haven’t heard any significant safety readouts from the Data Safety Committee that would tell us no.
But they’ll have their own time to look at the data more in detail. Since it’s a blinded study, I don’t have access to everything. And I’ll let them do their readout and then we’ll report back to you.
As for cohort 6, again, that will still be a process. Once the 5 is over, we’ll go back to the data safety committee. If there’s an obvious end point reached in safety, then we’ll know where we are from a dose perspective. And then cohort 6, we would decide still voluntarily on our own part, whether we wanted to do something opportunistic like increasing the size of the cohorts or looking at a questionnaire that we hadn’t thought of or imply — used to date, then maybe we would consider something else. But that’s going to be — we’ll make those decisions when we get to finish cohort 5.
Patrick Trucchio
Yes. And then just 1 follow-up question around the regulatory environment. Discussed earlier is that this is developing in a positive way. So I’m wondering if you can elaborate on the level of engagement of regulators, with psychedelic drug developers and in particular, the openness of regulators to novel or differentiated mechanisms of action and advancing these compounds through development. And separately, if you could maybe comment on any learnings that emerged from the COMP360 pivotal trial design in terms of advancing RE-104 through Phase II and III studies in depression.
Greg Mayes
Yes. Great question, Patrick, and thanks for joining. It’s Greg speaking. I mean Look, I think — and I spoke about this in some of my opening remarks, I mean look, I think regulators are responding to the mental health crisis that exists in the United States and around the world. And that, coupled with the fact that there’s been nothing new and novel approved by the FDA for mental health conditions since SSRIs came in the fold 35 years ago. So what you’re seeing, I think, is a reaction to really what’s going on in the world around them. And they are now obviously working, designating a couple of companies with breakthrough designation status.
And I think I’ll leave the details to Nathan, but our view of the COMP360 rollout of its regulatory and pivotal trial path was that it’s reasonable. And from our perspective, the one thing you want is you don’t want any surprises. You want to know that there has been — what is the pathway that’s been sent? What are the guide marks? What are the — how are we going to proceed ultimately? And I think we have better guidance in a sense of that from the FDA. But Nathan, do you have any additional thoughts?
Nathan Bryson
No. I would only highlight that I think that a lot of the hesitancy, let’s say, in the past, and that was probably 20 years ago was the fact that the drugs weren’t being developed ethically by pharma companies and speaking to the FDA and getting their feedback and using that feedback appropriately. We’re doing that now. And if we can demonstrate the benefit risk of these drugs, and there’s some obvious benefits to not having chronic administrative SSRIs and not having chronic adverse events associated with them going to a new model. I think there’s all the reason that the FDA would consider these things seriously. So it’s a good place to be.
Patrick Trucchio
Yes, that’s helpful. Thank you so much.
Greg Mayes
Patrick have a great day. Thank you.
Operator
Thank you [Operator Instructions]. Our next question is from the line of Antonia Borovina with Bloom Burton. Please proceed.
Antonia Borovina
Hi, good morning. Thanks for taking my questions. My first one is just related to the earlier caller’s question with regards to the additional dosing cohorts in Phase I. So I just want to clarify, is this primarily being driven by the safety data and I guess, lack of adverse events you’re seeing with the first four dosing cohorts? Or are you seeing anything in the first four dosing cohorts that are suggesting that the drug isn’t behaving in humans the way you modeled?
Nathan Bryson
Hi, Antonia. Nice to have you on the call. No, no. When we’re doing a Phase I and as all Phase Is, you would do, you want to open up the largest safety window you can open up, right? If your drug is still demonstrating safety, you would like to go to the next level because you need to open up the possibility of going to, I’m going to say, the highest safe dose in your Phase II study. And so I would say it is driven by the lack of adverse safety events in our study.
I say that I’m waiting for the SRC to say that, the data review committee to say that this week. And if they say that, then we go forward. If they come back and say, no, you’ve probably reached a peak, then we’ll step back, we’ll look at the data and we’ll know where our upper-level dose is.
Greg Mayes
Yes, I’d like to just comment on too Antonia. I see the — and thanks for your question and joining the call. I actually see the potential for a fifth and maybe a sixth cohort as a huge opportunity. I think it should be viewed as a very positive sign from the company.
The study was essentially designed for the first four cohorts, but the opportunity that we have to press the dose further is a great thing for the company because we’re going to be spending a good amount of money on a Phase II study. And so for the management team to be able to move forward into the postpartum depression Phase II study in the second half of 2023, knowing that we did everything and that we’ve selected the best dose is great.
So again, I think this is — it’s a wonderful opportunity to ask the Safety Review Committee to move forward with a fifth cohort, maybe do a sixth cohort, and really assure ourselves that we’re on the right path, and we’re giving patients the right dose when we go to really see an effect in postpartum depression. So I’m really bullish on it. I think it’s great. And — but we will have obviously the first four cohorts of data available next quarter as well. So we’re moving forward with cautious optimism here.
Antonia Borovina
Okay. Great. And then my next question is just related to the potential Phase II study design. So I know that you haven’t had your meeting with the FDA yet. So obviously, the caveat there, but just wanted to get the company’s thinking. So would you base this Phase II study based off of what Sage has conducted? Or given the fact that this is a psychedelic trial, do you plan to incorporate any different elements to the study? And then is the current thinking to advance a single dose into Phase II? Or would you be looking at maybe two doses?
Nathan Bryson
Thank you. Good ones. I’ll say that a lot of this is not written in stone just yet. You’re right about the FDA. We do want their feedback on this. But we have the opportunity. We had a Scientific Advisory Report this weekend and discussed many of these things. So we’ve gotten lots and lots of feedback this weekend from our KOLs. And I think we need to digest that before we make any formal decisions. I can say our initial thought process was to go with the highest safe, tolerable dose and move into the study.
I think that there were challenges to that approach. And I think we should sit back and listen to what our KOLs had to say and decide appropriately. I would say that overall, the trial in my perspective, is sort of a hybrid between a TRD study and a PPD study with some aspects from both taken from Sage and taken from the design of Compass’ trial with a flavor to PPD. And I think you can guess on some of those. But I think we still want to wait and digest that internally before we start speaking too publicly about exactly what we want to do.
Antonia Borovina
Okay. And then just finally, with regards to TRD, this is your potential follow-on indication that, is the current thinking that you would wait for the PPD results before advancing the program? Or is it something that you could still potentially do concurrently?
Nathan Bryson
I think that’s a — it’s a question for both of us, I think, for both me and Greg. I think we’ll do it opportunistically. It does depend on financing and raises. It also depends — that will impact our ability to hire and get all the people we need to run two trials in parallel because that would be a ginormous undertaking. And we’re not currently staffed for that. So it’s something, I think, that will take up once we’ve had the financing, we’ll come back, step back and look not only at whether TRD is the most appropriate indication to do, but exactly the timing of that second indication. Am I getting that incorrect?
Greg Mayes
No, I think it’s right, Nathan. Yes. I think what, Antonia, you could expect in terms of a second indication after we’ve clearly anchored on a Phase II in PPD, and we are super excited about it. The feedback and enthusiasm from our key opinion leaders in this space is readily apparent. But what I’d like to do is — and as I try to lead companies like Reunion Neurosciences, let’s do one thing right at a time.
So when I think by the time we get PPD out the door and we’re dosing our first patient there, then we’ll be in a position to say, okay, and announce to the public and announce to analysts like yourself, where we’re headed. But let’s do — let’s take one step at a time. Let’s get the Phase II open in the United States. Let’s get patients moving forward in that, and then we’ll give you a direction in terms of what our next indication is. I mean, we do have to be cognizant of the size and the level of competition in treatment-resistant depression.
Do I think we could work there based upon our psilocybin-like properties? Absolutely. Do I think it’s the best spot for our money to be spent and maybe there’s some other niche indications within the spectrum of mental health disorders? There may be. So I’ve asked some of my key scientific and clinical leaders to really take a close look at that over the next few quarters while we ready PPD, and we’ll be in a position to let you know. So I’m super excited about it. I think the ambiguity in our answer should be viewed as a positive by all listening.
Antonia Borovina
Okay, great. That’s all for me. Thanks.
Greg Mayes
Thank you, Antonia. Have a great day.
Operator
Thank you. Our next question is from the line of Michael Okunewitch with Maxim. Please go ahead, proceed with your question.
Michael Okunewitch
Hey, guys. Thank you for taking my questions. So I guess, first, I’d like to just see if you could kind of frame the Phase I data for us a bit. And in particular, if you could discuss which properties in terms of PK profile and clearance from blood would be the most important for development in PPD given the particularities of that indication? And if this is different from what would make the drug optimal in something like treatment-resistant depression or other indications?
Nathan Bryson
Thanks for that, Mike. Right now, I think the key is — there are really two keys to RE-104. The first one is the short duration of the experience, what it was designed for. So in the pharmacokinetics, we’re going to be looking for not only that the DEQ keeps us under four hours, for example, but that we have a profile of elimination that would allow us to get back to breast feeding within a reasonable time frame.
Again, that’s something we won’t have to discuss the appropriateness with the FDA. But with a short enough half-life, maybe looking at something like a return after 48 hours with a manual pump and dump. So I think those would be key drivers for us, the half-life and the duration as the key drivers in the pharmacokinetics.
Michael Okunewitch
Thank you for that. And then I just like to see if you could touch on the RE200 series. In particular, how selective have you found it to be for 2A versus 2B? Because it seems like you’ve shifted towards a stronger tone on that with saying that it’s devoid of 2B agonism. So is this based on new information from your preclinical work? Or am I just reading too much into that?
Nathan Bryson
No, you’re absolutely reading that correctly. I have to be careful. It’s very difficult to take one phrase and describe a whole class of molecules that we’re making. But what we’re finding is, at least within a family that we’re able to sort of delineate from an IP perspective, are molecules that are actually antagonistic. Now when you’re talking about selectivity, I usually think of selectivity in terms of binding potency like how strongly they bind. But these things are binding quite strongly, but they’re antagonistic.
So that’s why the wording sounds a bit strange in that world, improving the selectivity of the agonism of the 2A. But on the 2B side, some of the molecules are weak binders and some of them are actually strong binders, but antagonistic. So they don’t create the agonism. We’re trying to avoid the agonism. That’s the biggest factor here. And the first question, I had actually said there were two points that I wanted to make about RE-104. The first one had to do with the pharmacokinetics. That’s obvious.
But I did want to make the point, intellectual property. The real point of — and that’s not something that’s coming out of the Phase I. It’s prior to the Phase I. It was already granted. I just wanted to highlight, don’t forget that the key aspects, I think, for the success of RE-104 are not only the pharmacokinetics, but the patentability of the molecule. Sorry about that.
Michael Okunewitch
Right. Yes, thank you for that. I just like to, maybe you could touch it, go a bit further on the 2B antagonism. And does that provide any potential for side effects?
Nathan Bryson
Always, there are always — you have to always look for your safety when you’re developing drugs. But a 2B antagonism in its own is not a negative. Atypical antidepressants like Abilify are driven in part by 2B antagonism. So it’s one of the primary antagonism, partial agonism but reduced 2B. So it is something that actually could be synergistic or beneficial within the construct of a serotonin 2A agonism.
Michael Okunewitch
All right. Thank you very much for taking my question and congratulations on the progress you have made this quarter.
Greg Mayes
Great, thanks Mike.
Operator
Thank you. There are no further questions at this time. I would like to turn the floor back over to Mr. Greg Mayes, President and CEO, for closing comments. Over to you.
Greg Mayes
Thank you. And thank you to our investors and analysts for the ongoing support. The work we are doing to advance our novel patent-protected psychedelic treatments at Reunion offers the potential to help a tremendous segment of our population in need of more effective mental health treatments. Reunion was just born in August. We have many great things ahead of us. Our Phase I study data readout in Q1 2023 and the opening of our Phase II study in PPD, all in 2023. With these milestones behind us and once they are satisfied, we are set up well to deliver a complete Phase II data package by the end of 2024 in PPD.
Beyond what we are going to do and when, most importantly, Reunion now has the ingredients that I believe are necessary for success. We have a professional team that has a successful track record in clinical stage drug development fully in place. We have IP that will protect your investment in additional clinical research and is necessary to lay the foundation for future collaborations and partnerships with large pharma and big biotech.
And our molecule 4-hydroxy DiPT is the only molecule of its type in development, and it’s uniquely engineered to produce a shorter-duration psychedelic experience that we believe will ultimately be preferred by patients, providers and payers. I look forward to personally sharing our Phase I data results in the first quarter of 2023. And I now ask the operator to please close the lines. Have a nice day.
Operator
Thank you. This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.
Be the first to comment