Reunion Neuroscience Inc.

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00:31 Good morning everyone and welcome to Field Trip’s fiscal second quarter twenty twenty two financial results conference call. 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.

00:55 These results are outlined in the risk section of the filings and our disclosure materials. Any forward-looking statements should be considered in light of these factors.

Please also note a safe harbor, any outlook we present is as of today and management does not undertake any obligations to revise any forward-looking statements in the future. 01:15 Presenting today will be Joseph del Moral, Co-Founder and Chief Executive Officer; Ronan Levy, Co-Founder and Executive Chairman; and Donna Wong, Chief Financial Officer.

01:25 I will now turn the call over to Joseph to provide an update on Field Trip’s drug development pipeline.

01:32 Thank you, Kathleen, and welcome to everyone joining us this morning. I’m very proud of the progress the company has made in a short period of time in building two successful inter-related, but distinct businesses: Field Trip Discovery and Field Trip Health.

This is a testament to the hard work of our teams and the strategic vision of our board and management team to achieve this. I will discuss Field Trip Discovery and then turn the call over to Ronan to discuss Field Trip Health and our announcement with respect to reviewing our corporate structure.

02:01 During the quarter, we further progressed the development of our lead novel psychedelic compound FT-104 with the September announcement that the lead indications for FT-104 will be Treatment Resistant Depression or TRD and Post Partum Depression or PPD. Both represent areas of large unmet need.

It is estimated that approximately one hundred million people meet the diagnostic regimen for TRD, while PPD effect about ten percent to fifteen percent of all mothers of newborn with an estimated four hundred thousand diagnosed patients in the U.S. for a year.

02:34 There are few effective treatment options available for people suffering with TRD and those who are diagnosed have typically failed first and second line therapies. For PPD, the only currently approved therapy requires a significant time getting away from family and newborn about two to three days, while us levels [indiscernible] uptake inhibitors can take weeks for onset and only show limited efficacy.

02:58 The strategy of pursuing both indications enables us to achieve expected marketing approval more quickly for PPD, along with a larger potential total market with TRD subsequently. 03:10 FT-104 is progressing through preclinical studies with the in vivo portion completed, and final results from safety pharmacology and GLP toxicology being available in calendar Q4 twenty twenty one.

To date, GLP toxicology, cardiovascular, pulmonary, and neurological safety pharmacology studies, as well as genotoxicity potential, all continue to be encouraging and in line with expectation. 03:35 In addition, final investigational drug product manufacturing and key clinical start-up activities will be completed in calendar Q1 twenty twenty two positioning the company for trial initiation in the first half of twenty twenty two.

03:49 In parallel to the Phase one study, the company will prepare a detailed regulatory strategy that integrates developments in both PPD and TRD, which will define next steps in clinical developments. 04:01 Upon completion of phase one and calendar twenty twenty two the company anticipates opening an IND in the U.S.

with the intent to begin Phase 2a studies in the two indications. Lastly on FT-104, [indiscernible] patents are pending on FT-194’s structure formulation and use of treating a variety of central nervous system disorders.

04:23 We announced yesterday today that we are expanding the scope of our development pipeline with a new molecules termed the FT-200 group. This discovery effort is aimed at developing novel molecules with a structure of classical psychedelics, similar potency at the target serotonin 2A receptor the 5HT2A as FT-104 and psilocybin, but with reduced – were the absence of activity at the off target 5HT2B receptor which has been associated with the risks of cardiovascular toxicity.

04:54 The first molecule in the FT-200 group, was developed internally by our Chief Science Officer, Dr. Nathan Bryson.

Based on in vivo assay details, the first molecule in the group meets the above criteria and has in addition demonstrated improved selectivity for the 5HT2A receptor versus off target serotonin 5HT1A, 5HT2B, and 5HT2C receptors. 05:20 The aim of the work is that by reducing or eliminating 5HT2B activity it may allow molecules like those in the FT-200 group to be administered more frequently, such as more chronic or chronic intermittent administration or micro dosing strategies.

We continue to explore structural analogs within the FT-200 group to better define and optimize this new family of substances. 05:42 Understand our properties better and work towards identifying a lead candidate.

This is a very exciting time for fuel trip, as we further strengthen our position in the development of the next generation of psychedelic molecules. 05:54 I’ll now hand the call over to Ronan to provide an update on the clinics business and Field Trip’s strategic outlook.

06:00 Thanks Joseph and welcome everyone. As Joseph mentioned, we built two successful businesses.

You just heard him provide an update on Field Trip Discovery. I will provide an update on our best in class clinics.

We now have nine in operation and nine under construction or about to commence construction. 06:18 Last year, we only had two in operation.

We currently have six locations in the U.S., two in Canada with Vancouver opening shortly, and one in Amsterdam. Our Amsterdam facility began seeing patients in July twenty twenty one.

This is the first Field Trip Health Clinic focused on the therapeutic use of legal psilocybin truffles. 06:38 During the quarter, we continue to invest in our clinic infrastructure and entered into lease agreements for clinical locations in Dallas, Miami, and Scottsdale.

We're continuing to build on our well recognized brand in psychedelics. The company was featured in many top tier print and broadcast media during the quarter, including Forbes, Vox Media, Insider, People and others, generating nearly 2 billion total potential media impressions.

07:01 Field Trip’s brand presence and reach generates strong website traffic and patient interest in our ketamine-assisted therapy treatments offered at our clinics. Over the last year, we have built the infrastructure to support a rapidly clinic network and we continue to believe that demand for psychedelic assisted therapies will be robust as the research and awareness continues to advance.

07:22 Although we had expected to greater acceleration in revenues in the last quarter, the impact of COVID-nineteen and the Delta variant has kept patient growth below our expectations. 07:32 Through the operation of our first nine locations, we have greater clarity on how to move forward and have the team in place to get there and we've been working to optimize delivery of our treatment programs.

07:42 We are also revising our expansion plans to be in line of expected demand as the world continues to merge in a post-norm where we believe we are amongst of best positioned companies to harness the momentum behind the Psychedelic Renaissance. 07:55 In that regard, we have been also innovating new programs such as our KAP Co-op program, a program that enables eligible independent therapist to provide ketamine-assisted therapy in our clinics.

08:06 Under the KAP Co-op program, independent therapist who are experienced at providing Psychedelic assisted therapies or compete approved training programs are eligible to become a co-operative therapist with Field Trip. 08:18 These therapist will have access to our world-class centers for psychedelic therapies and other resources from Field Trip to provide cap to their own private practice clients as well as having access to our medical teams for the screening, prescribing, and administration academy.

Other [indiscernible] therapy including all preparation and integration therapy will be provided by the patient's therapist. 08:39 Additionally, we announced the launch of training programs besides designs to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to best-in-class training on ketamine-assisted therapy.

We will continue to leverage the data collection and insights generated from both our growing number of clinics, as well as from our KAP Co-op program to enable us to innovate new treatments, new offerings and increase operational efficiency. 09:03 We are very proud of how we have built Field Trip Health clinics business to be the leading platform in delivery of psychedelic therapies.

We have positioned ourselves to be in the fore front of our industry in establishing critical infrastructure in [indiscernible] therapies, and we're very excited about the future of Field Trip Health. 09:19 Moving next to a brief discussion about the strategic review of our corporate structure.

We have commenced a strategic review designed to ensure that each operating unit is best positioned, optionally resourced and focused to provide maximum long-term value to all stakeholders. 09:35 With FT-104 nearing the clinic, the expansion of discovery efforts around an FT-200 group and the growing number of opportunities for Field Trip Health Centers we believe it is the correct time to review all strategic options to ensure we continue to maximize the growth potential and value of each business unit.

09:52 We’ve engaged Bloom Burton Securities Inc. as our financial advisor in connection with the strategic review and we'll provide future updates on the process and as and when appropriate.

10:01 I will now turn the call over to Donna Wong, our CFO to discuss our financial results.

10:07 Thank you, Ronan, and good morning, everyone. As a reminder, all figures that I will be discussing are in Canadian dollars.

For our second fiscal quarter, the company earned patient service revenues of nine hundred and seven thousand, an increase of eighteen hundred and thirteen thousand or eight sixty percent over the comparative quarter ended September thirty, to twenty twenty, of ninety four thousand and an increase of forty thousand or five percent over the prior fiscal first quarter. 10:37 During the period, the company had seven clinics in operation versus only two at the same time last year.

Clinics generating revenue this year were located in Toronto, New York Santa Monica, Chicago, Atlanta, Houston and Amsterdam. The Amsterdam clinic began contributing revenues in September twenty twenty one.

11:00 In the comparative prior year period, only the New York and Toronto facilities were open. The modest quarter over quarter revenue increase from Q1 to Q2 was in part due to the COVID-nineteen Delta variant and seasonality as associated with the slower summer months.

Revenues in the first part of the third quarter indicate a clear upward trend as a result of recent process on its optimizations to accelerate patient onboarding and increased clinic capacity. 11:30 Moving on to a discussion of cost.

Total operating costs in the second fiscal quarter were fifteen point six million compared with three point eight million in the same period of the prior year. As we continue to invest in our drug development pipeline and best in class clinic infrastructure, our increased costs are reflective of this.

11:50 Within operating expenses, G and A or general and administration expenses of eight point nine million is our largest expenditure, which compares with two point one million in the same period of the prior year. The increase was primarily due to operations and medical office administration, which includes personnel relating to our existing clinics and the clinics under construction.

12:13 During the quarter, these expenses also included point six million in non-recurring costs, primarily related to the NASDAQ uplifting and one point three million dollars in recurring public company costs. Additionally, there was a non-cash component of one point five million associated with share based payments and depreciation and amortization.

12:34 Other operating costs include research and development at two point one million, patient services expenses of one point nine million and sales and marketing expenses of one point three million. Our R and D costs more than doubled from the same period of the prior year, which was primarily due to fees paid to a third party contract manufacturer or CMO and CRO, Contract Research Organization, to further FT-104 development and preclinical pipeline research.

13:04 Development of the chemistry, manufacturing and controls of the active ingredient FT-104 continues to progress as you just heard from Joseph. Net loss for the second fiscal quarter of the year of thirteen point zero million was primarily due to an increase in total operating costs as I just mentioned.

This was partially offset by a foreign exchange gain of one point nine million. This compares with a net loss of three point nine million in fiscal second quarter of the prior year.

The increase from the prior year, primarily reflects the company's focus on growing and scaling the business. 13:40 Turning now to the balance sheet, we are well capitalized.

At quarter-end, our unrestricted cash and cash equivalents, funds held in trust and short term investments totaled eighty seven point five million, compared to ninety nine point eight million at the end of the prior year or prior quarter. 13:58 Our healthy financial position will enable us to execute on our key strategic priorities and further our mission to bring psychedelic based treatments to patients in need.

Our last item before opening the call to your questions. We achieved a significant milestone on July twenty nine, twenty twenty one when Field Trip’s shares began trading on the NASDAQ.

That we were able to accomplish this with a testament of the rapid progress we have made in a short period of time. 14:22 The NASDAQ listing has increased our visibility in the investment community and improve trading liquidity for our shareholders.

This ends my prepared remarks. I'll now ask the operator to open the lines for Q and A.

15:12 Hi, good morning and thank you for taking my questions.

15:15 Good morning, Andrew.

15:18 Maybe just starting off with your chosen indications for your lead candidate, FT-104, you know PPD is an interesting choice, obviously not quite the same addressable market as TRD, but I think you mentioned a benefit of potentially a shorter time to approval. Could you discuss a little bit more about that and what makes you make that assessment?

15:48 Sure. For that, I'll hand the call over to Dr, Nathan Bryson.

15:52 Good morning, Andrew. How are you doing?

Yes. Don't forget that we're still considering TRD.

It's a very interesting market as well and has a sizable market. So, there's a lot of potential there too, but for PPD, we chose it because FT-104 is a fast acting drug and mother's need to response rapidly to the anti-depressant effect so they can get back to their children as quick as possible.

16:25 As for the overall timelines, we generally think of this, based on the developments that we're done at Sage Therapeutics. If you look at the pathway there, with a well-funded program, the PPD program was developed in about five years from start to finish.

That comes from the fact that this is not PPD itself is not a long term chronic indication, but really is more based on an event in life and overcoming that event and getting back to help. 17:00 And so, the overall timelines are not required to include long term chronic toxicity and safety, because you're thinking more in short term and getting to the short term outcomes very quickly.

And so the endpoints clinical studies in PPD have often been very short. Again, look to [indiscernible] as the benchmark, where the outcomes were typically at fourteen days or thirty days.

17:29 So, that's the reason that you see a shorter timeline in the development as well as the fact that these things can be looked at in terms of breakthrough through therapy. So, there’s additional incentive there at the FDA to get these products approved.

17:47 Interesting. Thanks for that color.

Maybe switching gears to new program, your FT-200, could you talk about, how do you see the opportunity here? Should we be thinking about completely new indications with the molecule coming out of that program?

Potentially larger addressable market here beyond the already large TRD opportunity and PPD shorten path to market or maybe could this be used in tandem with FT-104 to improve outcomes, given the lower toxicity potential and obviously, this is assuming everything goes well and gets approved.

18:35 Shall I go ahead with that one as well? Yes, I think it's really, really early in that development to be making any predictions right now.

I think what's really interesting is the fact that if you can reduce cardiovascular toxicity liability with serotonin agonist, you do open up a upgrade deal of potential to other markets because you open up a flexibility and dosing that you may not have with or other drugs, even if you're thinking about micro dosing there has been a constant concern about what this cardiovascular liability might be. 19:16 So, I think we'll wait a bit until we've developed these molecules.

We look a little bit better at the pharmacology off targets receptor interactions. And then we think about how those can best benefit the market in terms of which indication where that could work.

But right now, it's mainly targeting just reducing that to be component that cardiovascular liability which I think again, in terms of repeat dosing gives us more flexibility around what we want to do.

19:53 Thanks for that and maybe just one last one before I get back in the queue, transitioning to the strategic review. Could you talk a little bit about what prompted you to conduct this review?

How should we be thinking about this? Is this a consideration of maybe a divestment of one of the businesses?

And any color that you can provide on what you're seeing in the market as a result of this announcement?

20:23 Sure. Andrew.

As we mentioned, we believe we built two of the leading industries, leading businesses in the industry and so the quarter review is designed to make sure that each operating unit is really well positioned, it has the resources and the focus needed to provide long term value to all stakeholders. So, we're going to look at with Bloom Burton, look at all options ranging from no change to the current structure to adding additional assets or segments to the business to a separation of the business units with continued intercompany relationships.

20:58 So, we continue to maintain the synergies that we believe exist from having the two businesses. So, that’s kind of how I think about it, and how we're approaching it.

So, I think there is the potential in trust potential as to convert to a more traditional biopharma development stage company and a separate growth stage healthcare services business, but we're looking at all opportunities and all options right now.

21:31 Thank you for that color and taking my questions. I'll get back in the queue.

21:36 Thank you, Andrew.

21:43 Hi, thanks. Good morning.

Just first, if I could, I want to ask a follow-up on the Comp three sixty data that came out last week. I'm wondering what readthrough if any do you see from the Comp three sixty so in Phase 2b TRD trial to the FT-104 program in terms of potential safety and efficacy and potential trial design for the expected Phase 2 trial evaluating FT-104 and TRD?

22:11 Thanks Patrick. For that, I'll hand the call back over to Nathan.

22:15 Good morning, Patrick. The Compass data was very interesting.

It's great to see at least the very early positive signs of efficacy in the short term data. Some modest gains in remission data at six to twelve weeks.

So, I think that all pretends still positive outcome to future trials in this space. 22:45 But I think everybody is going to have to go back and learn more from this data and potentially redesign what they do going forward.

I think one of the highlights that's been seemed around the media sear in the past week or so has been the possibility of repeat dosing and when that repeat dosing might happen. And I think that points directly to our FT-200 group thinking of the possibility of low cardiovascular toxicity and the potential to have more flexible dosing.

23:22 We've been thinking about these kinds of things for some time. When we first set out to build our pipeline even FT-104 we sat back and said, are what are the shortcomings of the classical psychedelics and how can we address each one of them.

FT-104 was built to address I think a very practical aspect in terms of convenience and that would make it more accessible to patients and the FT-200 group is addressing that other aspect and I think that's going to help the whole field move forward around the cardiovascular safety. 23:56 I think that will help the whole field move forward.

And then as Compass goes maybe to their next Phase 2 or their Phase 3 trials. I think we're going to learn more from them as they design their trials and they publish their information about what that means in terms of how we're going to design our trials.

24:13 In the meantime, we're going to run our Phase 1, and by the time, we get there, hopefully, we'll have more information from that 2b trial and we'll be able to design better our Phase 2 studies.

24:25 Yeah. I do you have a few clarification questions on the timing of priority is for the FT-104 clinical development plan.

First, assuming all goes to plan in the Phase 1 study starts in the first half of twenty twenty two, would you anticipate having that data by the second half? And second, would you anticipate filing an IND for the Phase 2 program in the second half?

And finally, would the Phase 2 program include studies in TRD and PPD or would one indication be prioritized over the other potentially?

24:56 Yes. Good question.

Right now, with our timeline, we have suffered a couple of weeks, maybe few weeks to month, early months, short months of delay due to some COVID related issues and scheduling with our manufacturers and our clinical trials. So, that's why we sort of expanded the window on the start and completion of the trial.

But that said, we are still targeting. 25:25 We've actually already started most of the activities necessary for starting the clinical trial, the clinical drug is being prepared.

The toxicology program is finishing on time. The protocols and everything should be put into [ethics] [ph] before the end of Q1 at least that's our current scheduled program.

And we should actually be starting the clinical trial shortly thereafter with screening and actually recruitment activity starting right after the ethics approval at the end of the month or at the end of the quarter very early in the second quarter. At least, that's the plan.

26:01 If we’re not further delayed within that space, we should be filing the IND before the end of the year. We wanted to do that with a Phase 2 protocol in hand.

We have not yet decided exactly which indications going to go first, but TRD continues to be our lead program with PPD as our secondary. But a regulatory strategy review is currently ongoing we'll put that plan together and come back to you with more clarity on that in the near future.

26:34 That's helpful. And if I could just one on the clinics business.

Just on the revenues generated in the quarter, pretty robust results. I'm wondering if the magnitude of growth is expected to continue in the fourth quarter in twenty twenty two or would you expect an acceleration based on the disclosed build out of the clinic business that was outlined in the release and the regulatory filings?

26:56 We have, as we indicated in our press release, we've seen sort of clear upward trend quarter to date in revenue numbers, and that as a result of some of the process optimization that we've undertaken in existing clinics and the openings, the new clinics, so we do expect continued growth on revenues from the clinics in the next quarter and going forward as we build-out more clinics and the existing clinics keep going up there ramping curve. 27:29 And then we also learned a lot about how to run the clinics efficiently over the last year and a bit.

And so, we are now in the process of implementing some of those optimizations adding to the existing clinics and new clinics as we open them. And we expect to see those optimizations leading to get increased revenue growth as we go forward.

28:01 Great. Thank you very much.

28:03 Thanks Patrick.

28:13 Hi, congrats on continued growth both on the R and D side and the clinics. I'm just wondering, when you're looking ahead at your clinic operations, do you get visibility based on patient bookings?

And do you think you'll potentially have positioned to, kind of maybe put some KPIs out there or maybe give some backlog numbers to provide color on what the outlook looks like for some of these clinics and the patient flow through you expect or is that too much detail?

28:48 Not that it's too much detail, but it's more that, you know our focus is on eliminating backlogs and getting patients in from first contact to us into the clinics for their first dosing sessions as quickly as possible in the focus of many of our optimization efforts. So, we hope to not have significant backlog and be able to see patients quickly, because I'm not sure that metric would be particularly meaningful.

29:20 One thing that we do track internally, but I'm not sure, I don't think we'll start reporting on is, sort of, is around website traffic and leads and media impressions. We see that that has a correlation with patient flows and the clinics.

And so, I think we continue to be seen as the leader in the clinic space for psychedelic assisted therapies, and we can see that as we're in the media, as the mainstream, focuses on these types of therapies we do get increases on our website traffic and inquiries, which lead to increased bookings. So, we sort of see it coming a little bit in advance, but as I said we're trying to get to those patients in as quickly as possible.

30:06 That makes sense and thanks for the explanation there. And would it maybe be some sort of pre-screening process that your digital app offers or is there any other sort of points of visibility, whether it's before or after that you guys are implementing that may kind of lengthen your engagement just thinking off the Compass data on durability, obviously, there's more increased focus on potential repeat dosing, and I'm wondering how that affects your positioning on the clinic side?

30:40 For that, I'll hand the call over to Ronan to discuss our digital tools.

30:45 Certainly. I think it's amplified in light of the Compass data to the extent that we understand the results of them and what it suggests, but we've always been focused on building an ecosystem approach patient engagements of both of our digital tools trip and portal have been designed to maintain ongoing engagement with patients both from monitoring their ongoing mental health, but also providing them with additional tools whether that's information, meditations, videos, all that kind of stuff to support the benefits of the overall treatment program.

31:23 So, we don't have anything concrete to offering that, but that's always been part of the strategy in building those tools. And I think they will continue to play an instrumental role in terms of our patient engagement both with our ketamine-assisted therapy as well as psilocybin truffles in the Netherlands and as eventually, we moved closer to Phase two trials and beyond with the clinical trials as well, but that is all to be determined the future as it pertains to our clinical trials.

31:52 Perfect. Thank you for your time today.

Appreciate it.

31:55 Thanks Sepehr.

32:03 Good morning. Thanks for taking my questions.

A follow-up on the FT-200 program, I'm discussing some of the cardiovascular side effects. Are these like arrhythmias or could you give us just a little bit more detail on what those side effects are and how it's preventing you from getting into the micro dosing area?

32:22 Sorry. It was just a little [indiscernible] to me.

Could you repeat the question Bruce, there's was a fire truck going on behind us, so we couldn’t quite here it?

32:31 Sure. I'm sorry.

So with the FT-200 program, one of the objectives is to avoid the cardiovascular side effects. I'm wondering what the side effects are if they are arrythmias or something else?

And then if you can talk about how that enables the micro dosing program?

32:49 Oh sure. Yes.

Okay. It's pretty well known that the serotonin 2B receptor when agonized, that means when it's activated, actually can lead to cardiovascular valve hardening and is usually followed long term by a cardiovascular valve replacement.

And that was demonstrated with a drug. I think it was back in the nineties called Fenfluramine.

It's a very well-known drug that was taken off the market. It was used for weight loss in combination, it was called fen-phen.

33:32 That cardiovascular toxicity exists for most serotonin agonist in that when it agonizes the 2A, there's often off target activity at 2B and that off target activity can lead to that. Now, it all dependent on how much exposure a patient may receive from the drug.

So, it really depends on how frequently that drug is administered, the doses and things of that nature, but, so right now, I believe that in the space of psilocybin if it was given very, very frequently, such as maybe once a year or once every two years types of thing, there would not be any major toxicity problems here. 34:19 But if the drug was to be given every day then that level of exposure could create a sufficient risk that the FDA would be concerned and ask for us to confirm that the cardiovascular safety was there.

And so the two hundred program was designed to take that a component out of the psychedelic experience so that there would not be those questions. That's essentially the idea around the program.

And we have, I don't know that.

34:50 All right, very good. The other question I had was, you mentioned in the press release at the Toronto and the New York sites were the ones that were up and running the most continuously during the quarter, you had some COVID Delta variant impact on the other sites, I'm just curious for the sites where you were up and running, what were the same store metrics in terms of patient visits?

35:18 Thanks, Bruce. We don't report clinic level financial information or other metrics like that, and we probably won't start reporting on that until the business matures to a point where we think those metrics will be predictable enough to be instructive to our shareholders, but that said, we're seeing continuous improvement in the data and KPIs that we use to monitor the business and sort of the trends the benefits we're seeing from the optimization activity that we've undertaken in the last quarter are starting to show up in the numbers.

35:59 That’s where we are right now. Happy to answer, to give more color if you needed, but that's where we are on financials right now.

36:11 All right, good enough. Thank you for taking my questions.

36:15 Thanks, Bruce.

36:22 Hey guys this Michael Okunewitch on the line for Jason. Thanks for taking the question.

So, I'd like to follow-up on what a couple of previous callers asked relating to the Compass data, I think it's pretty clear. We saw a good dataset, but the magnitude is kind of what underperformed investors’ expectations.

36:43 Seems like there might have been a few factors contributing to that, but among them, it seems like the set and setting and psychological support were minimized for the purposes and design of this trial. So, with that in mind, I'd like to see if you could comment on what you found regarding the importance of proper psychological support experience psychiatrists, and the second setting in driving an optimal result for psychedelic-assisted psychotherapy.

37:17 Thanks for the call. I’ll hand it over to Nathan first to give some thoughts on that.

37:19 Good morning. I think the most information that we have on that would actually come from our ketamine clinics and the data we've been generating at the clinics.

As you know, we have a data collection tools that we can collect remote data from patients when they're at home. And after a ketamine session, we can continue to follow them or going to say a set of ketamine sessions.

37:52 We can continue to follow the progress of their outcomes over weeks and months. And that data is becoming very, very positive, which is showing us that if you can put the right set of parameters around the psychotherapy, the guidance, the preparation, you can get better outcomes than you can get with just ketamine type infusion treatments done even in the same paradigm.

38:22 So there are peer-review papers out there with six ketamine sessions in succession with a follow-on of the outcomes without psychotherapy and the outcomes are much shorter than what we're seeing currently in the clinic. I think that data is in our corporate presentation, if you want to go and take a look.

And we're seeing data I'm going to take symptom improvement that seemed to be maintained at least three months post treatment still in the mile range where you wouldn't necessarily be patient a re-booster session. 38:54 So, and that's significantly longer than what the least is in those peer reviewed papers that are very similar to what we do in the clinic except for the psychotherapy component.

So, I think that we're actually demonstrating with our clinics that the psychotherapy component is good for pushing those outcomes to much longer durations and resistance of resolution of symptoms.

39:20 Right. Thank you very much.

39:22 Yes, I would hope that that would flip over into the psychedelic with the [indiscernible] as well. So, I think that maybe there is a place for stronger psychotherapy and maybe that's something Compass is considering.

39:35 Yeah. Thank you.

Thank you. I'd also like to touch on the two hundred class and follow-up relating to the 5HT2A targeting, the CV toxicity associated with 2B, is pretty clearly an issue for peak dosing is likely, but could you talk about the potential benefit of also minimizing the 1A and 2C off target effect?

40:04 I'm probably not strong enough in pharmacology here to give you a really good answer, and I'm not sure that the pharmacology is well resolved in that respect. Most of these drugs often target multiple receptor systems in the brain and having clear answers to what 1A and 2A or a little bit of 1A and 2C to may add to a psychedelic experience or a depressive outcome is still something that is not a real good known factor right now.

40:44 All right. Thank you.

And then lastly, I'd like to see, if you could just provide a bit more color on the COVID effect to clinic revenue? Should we think about that as largely being localized to the newer clinics kind of preventing those from taking off in the same way we saw in New York and Toronto.

41:08 Yes. There’s been two effects really over the last quarter.

One is, COVID affecting patient demand for coming in for the one on one sessions where if you remember our protocol patients sit in the dosing room with the therapist. So, there are some patients, especially during the peak of the Delta variant that we're uncomfortable doing that on the one on one sessions.

But also during that quarter, we were ramping – trying to ramp up our group programs, which also suffered from COVID. 41:43 And one other factor that we had fully anticipated was just how much seasonality there would be?

It turns out that maybe not surprisingly, some patients chose not to embark on what is a pretty intensive three to four week program of psychotherapy and ketamine doses during July and August. And so, we saw some patients pushing out past summer months.

So, those are the combination of those two factors that I think sort of led to the growth that we saw in last quarter. 42:18 And as I mentioned before, I think we're encouraged by the size we're seeing quarter to date in the clinics and so, sort of looking forward to continuing increasing revenues going forward.

42:34 All right. Thank you very much for taking my question.

42:37 Thanks Michael.

42:45 Good morning, gentlemen. Just to expand on the Comp 360 observations, I mean, some hypothesis that there is a great deal of variability on the plasma levels of psilocybin following the administration of Comp 360.

Have you observed in preclinical studies that FT-104 could be potentially less variable?

43:17 What I can say from our pre-clinical studies which have been running in two species is that the plasma levels are very consistent. It's actually allowed us to run relative – I'm going to say relatively small trial in Phase one because of the good reproducibility and high consistency.

So that's a nice feature of FT-104 and that we're getting that result.

43:48 And secondly, when you thought about the FT-200 series, what sort of indications you had in mind?

43:59 Yes, I'll go ask and answered. It's really very, very early in this stage right now.

We've only got a few molecular candidates in the space that are actually demonstrating – that demonstrate the kind of profile we're looking for. But we still have to flush this out a lot more and define the structural activity relationships, be able to understand off target, safety potential safety issues or potential efficacy issues depending on whether how that plays out and then make our selection.

So, it's still a bit off for making that kind of projection of where it could be used. It just does gives us a lot more flexibility and how it would be used.

44:48 I see. And then, there was another question here.

I'll come back to you with that one offline. Thank you.

45:03 Thanks Elemer.

45:19 Hi, this is Bob Lyster. I wanted to just talk a little bit about the treatments that you offer in your clinics.

To my understanding, while, I'm sure you've studied it and thought about it, you're not using SPRAVATO or TMS, is there anything else that you're considering or close to or indeed do offer? And then in a related question, I'd like to ask if you could describe a little more the actual talking therapy or what kind of therapy you offer in-house along with the ketamine infusions.

45:56 Thanks, Bob. So, at clinics we’re offering ketamine psychotherapy right now.

You’re right, but that's the only offering that we offer in our North American clinics aside from in Amsterdam, we obviously offer psychedelic-assisted therapy. 46:16 Patients also have the opportunity to join ongoing therapy programs called our [indiscernible] program and group therapy programs that we hope continue to extend the benefit for the patients after they complete the six dosing sessions with academy.

But that's our focus right now. 46:36 And that's part of the strategic nature of the clinic in getting ready for MDMA and Psilocybin and other psychedelic drugs FT-104 in the future.

So, we've been focused on that developing – focus on developing the best way to combine psychedelic drug and psychedelic experience with supported psychotherapy. 46:59 So getting the psychotherapy piece, we developed a protocol, custom made for seeing patients with ketamine and it consists of two main parts.

One is behavioral activation and the second is motivational interviewing. So, these are techniques that our license psychotherapists are trained and used to help our patients.

47:28 And so, that's all held together with the protocol that takes into account the psychedelic experience and how different and important that experience can be to the patients and it's really not psychotherapy as normal. Having patients are having these really profound and often intense and meaningful experiences in the clinics and the psychotherapy is meant to support and take advantage of the – often the new insights and the news refrain mind, the patient finds themselves and following those types experiences and ready to build on that and have to build positive change for the patient going forward.

And that's what we [indiscernible] is part of the reason for these long lasting effects sourcing.

48:18 Thanks. It's very helpful.

48:20 Thank you, Bob.

48:31 Thank you, operator and thank you to our investors for the support and to all the analysts for your question, today. Psychedelic medicine in the industry is continuing to build momentum at a rapid pace as increased clinical data attest the value of these therapies.

48:50 We’ve been executing on our business plan [indiscernible] Field Trip into a leading technology therapy develop the company and I’m very pleased with the progress we have made in a short period of time. 48:59 Field Trip is well placed to leverage our strong business and brands take advantage of the emerging opportunities this presents.

With that, I'll ask the operator to close the lines.