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spk10: Greetings and welcome to Field Trip Second Quarter 2022 Earnings Results Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the former presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Kathleen Heaney, KCSA moderator. Please proceed.
spk01: Good morning, everyone, and welcome to FieldTrips Fiscal Second Quarter 2022 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. 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 that Safe Harbor, any outlook we present is as of today, and management does not undertake any obligation to revise any forward-looking statements in the future. 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. I will now turn the call over to Joseph to provide an update on Fieldtrip's drug development pipeline.
spk06: 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 interrelated but distinct businesses, Fieldtrip Discovery and Fieldtrip 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 Fieldtrip Discovery and then turn the call over to Ronan to discuss Fieldtrip Health and our announcement with respect to reviewing our corporate structure. During the quarter, we further progressed the development of our lead novel psychedelic compound, FT-104, with a September announcement that the lead indications for FT-104 will be treatment resistant depression, or TRD, and postpartum depression, or PPD. Both represent areas of large unmet need It is estimated that approximately 100 million people meet the diagnostic criteria for TRD, while PPD affects about 10 to 15% of all mothers of newborns, with an estimated 400,000 diagnosed patients in the U.S. for a year. There are a 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 commitment away from family and newborn, about two to three days, while off-label serotonin reuptake inhibitors can take weeks for onset and only show limited efficacy. 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. FG104 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 2021. 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 expectations. In addition, final investigational drug product manufacturing and key clinical startup activities will be completed in calendar Q1 2022, positioning the company for trial initiation in the first half of 2022. In parallel to the Phase 1 study, the company will prepare a detailed regulatory strategy that integrates developments in both PPD and TRD, which will define next steps in clinical development. While in completion of Phase 1 in calendar 2022, 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, USPTO and PCT patents are pending on FT-104's structure, formulation, and use in treating a variety of central nervous system disorders. We announced yesterday that we are expanding the scope of our development pipeline with a new group of molecules termed the FT-200 group. This discovery effort is aimed at developing novel molecules with a structure of classical psychedelics, similar in potency at the target serotonin 2A receptor, the 5-HT2A, as FT-104 and psilocybin, but with reduced or the absence of activity at the off-target 5-HT2B receptor, which has been associated with the risk of cardiovascular toxicity. The first molecule in the FT-200 group was developed internally by our Chief Science Officer, Dr. Nathan Bryce. 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 5-HT2A receptor versus off-target serotonin, 5-HT1A, 5-HT2B, and 5-HT2C receptors. The aim of the work is that by reducing or eliminating 5-HT2B activity, it may allow molecules like those in the FT200 group to be administered more frequently. such as more chronic or chronic intermittent administration or microdosing strategies. We continue to explore structural analogs within the FT200 group to better define and optimize this new family of substances, understand their properties better, and work towards identifying a lead candidate. This is a very exciting time for FieldTrip as we further strengthen our position in the development of the next generation of psychedelic molecules. I will now hand the call over to Ronan to provide an update on the clinic's business and FieldTrip's strategic outlook.
spk14: Thank you, Joseph, and welcome, everyone. As Joseph mentioned, we have built two successful businesses. You just heard him provide an update on field trip discovery. We'll provide an update on our best-in-class clinics. We now have nine in operation and nine under construction or about to commence construction. 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 2021. This is the first field trip health clinic focused on the therapeutic use of beagle psilocybin truffles. During the quarter, we continued to invest in our clinic infrastructure and entered into lease agreements for clinic locations in Dallas, Miami, and Scottsdale. We are 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. Fieldtrip's brand presence and reach has generated 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 scaling clinic network, and we continue to believe that demand for psychedelic-assisted therapies will be robust as the research and awareness continues to advance. Although we had expected a greater acceleration in revenues in the last quarter, the impact of COVID-19 and the Delta variant has kept patient growth below our expectations. 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. We are also revising our expansion plans to be in line with expected demand. As the world continues to merge in a post-COVID normal, we believe we are amongst the best positioned companies to harness the momentum behind the psychedelic renaissance. In that regard, we've been also innovating new programs such as our CAP co-op program, a program that enables eligible independent therapists to provide ketamine-assisted psychotherapy in our clinics. Under the CAP co-op program, independent therapists who are experienced at providing psychedelic-assisted therapies or who complete approved training programs are eligible to become a cooperative therapist with Fieldtrip. These therapists will have access to our world-class centers for psychedelic therapies and other resources from Fieldtrip to provide CAP to their own private practice clients, as well as having access to our medical teams for the screening, prescribing, and administration of ketamine. Other components of the therapy, including all preparation and integration therapy, will be provided by the patient's therapist. Additionally, we announced the launch of training programs designed to provide interested psychotherapists or other qualified mental health professionals and clinicians with access to 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 CAP co-op program to enable us to innovate new treatments, new offerings, and increase operational efficiency. We are very proud of how we have built Fieldtrip Health Clinic's business to be the leading platform in the delivery of psychedelic therapies. We have positioned ourselves to be at the forefront of our industry in establishing critical infrastructure for psychedelic therapy, and we're very excited about the future of Fieldtrip Health. 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, optimally resourced, and focused to provide maximum long-term value to all stakeholders. With FT-104 gearing the clinic, the expansion of discovery efforts around 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. We have engaged Bluebird Security, I think, as our financial advisor in connection with the strategic review, and we'll provide future updates on the process as and when appropriate. I'll now turn the call over to Donna Wong, our CFO, to discuss our financial results.
spk00: 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 $907,000, an increase of $1,813,000 or 860% over the comparative quarter ended September 30, 2020 of $94,000 and an increase of $40,000 or 5% over the prior fiscal first quarter. 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 2021. 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-19 Delta variant and seasonality 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 optimizations to accelerate patient onboarding and increase clinic capacity. Moving on to a discussion of cost. Total operating costs in the second fiscal quarter were $15.6 million compared with $3.8 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. Within operating expenses, G&A or general and administration expenses of $8.9 million is our largest expenditure, which compares with $2.1 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. During the quarter, these expenses also included 0.6 million in non-recurring costs, primarily related to the NASDAQ uplisting, and 1.3 million in recurring public company costs. Additionally, there was a non-cash component of 1.5 million associated with share-based payments and depreciation and amortization. Other operating costs include research and development at 2.1 million, patient services expenses of 1.9 million, and sales and marketing expenses of $1.3 million. Our R&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 CRR, contract research organization, to further FT-104 development and preclinical pipeline research. 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 $13.0 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 $1.9 million. This compares with a net loss of $3.9 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. 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 $87.5 million compared to $99.8 million at the end of the prior year, or prior quarter, excuse me. 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 29, 2021, when Fieldtrip's shares began trading on the NASDAQ. That we were able to accomplish this was a testament of the rapid progress we have made in a short period of time. The NASDAQ listing has increased our visibility in the investment community and improved trading liquidity for our shareholders. This ends my prepared remarks. I'll now ask the operator to open the lines for Q&A.
spk10: Thank you. At this time, we will conduct a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 at this time. One moment while we post our first question. Our first question comes from Andrew Parthenew with Stifel. Please proceed.
spk08: Hi, good morning, and thank you for taking my questions.
spk04: Morning, Andrew.
spk08: 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?
spk06: Sure. For that, I'll hand the call over to Dr. Nathan Bryson.
spk05: Good morning, Andrew. How are you doing? Yeah, 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 mothers need a response rapidly to the antidepressant effect so they can get back to their children as quick as possible. As for the overall timelines, we generally think of this based on the developments that were 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 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 health. 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 those short-term outcomes very quickly. And so the endpoints, And clinical studies in PPD have often been very short. Again, look to Xelresso as the benchmark, where the outcomes were typically at 14 days or 30 days. So that's the reason that you see shorter timelines in the development, as well as the fact that these things can be looked at in terms of breakthrough therapy. So there's additional incentives there at the FDA to get these products approved.
spk08: Interesting. Thanks for that color. Maybe switching gears to your new program here, FT200, 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? shortened path to market, or maybe, you know, 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.
spk05: Should I go ahead with that one as well? Yeah, I think it's really, really early in that development to be making any, you know, predictions right now. I think what's really interesting is the fact that if you can reduce cardiovascular toxicity liability with serotonin agonists, you do open up a great deal of potential to other markets because you open up a flexibility in dosing that you may not have with psilocybin or other drugs, even if you're thinking about drugs. microdosing, there has been a constant concern about what this cardiovascular liability might be. So, you know, I think we'll wait a bit until we've developed these molecules. We look a little bit better at pharmacology, off-target receptor interactions, and then we think about how those can best benefit the market in terms of which indications where that could work. But right now, it's mainly targeting just reducing that 2B component, that cardiovascular liability, which I think, again, in terms of repeat dosing, gives us more flexibility around what we want to do.
spk08: 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? Any color that you can provide on what you're seeing in the market as a result of this announcement?
spk06: Sure, Andrew. So as we mentioned, we believe we've built two of the leading industries, leading businesses in the industry. And so the corporate review is designed to make sure that each operating unit is really well positioned, has the resources and the focus needed to provide long-term value to all stakeholders. So we're going to look at, with Bloomberg, to 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 so that 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, and I'll stress potential, to convert to a more traditional biopharma development stage company and a separate growth stage health care services business. But we're looking at all opportunities and all options right now.
spk08: Thank you for that, Keller, and taking my questions. I'll get back in the queue.
spk04: Thank you, Andrew.
spk10: Our next question comes from Patrick Truccio with HC Wainwright. Please proceed.
spk12: Hi, thanks. Good morning. Just first, if I could, I want to ask a follow-up on the Comp360 data that came out last week. I'm wondering what read-through, if any, do you see from the Comp360 psilocybin phase 2B TRD trial to the FT-104 program in terms of, you know, potential safety and efficacy and potential trial design for the expected phase two trial evaluating FC-104 and TRD.
spk06: Thanks, Patrick. After that, I'll hand the call back over to you, Nathan.
spk05: Yeah, good morning, Patrick. The COMPASS data was very interesting. You know, 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 6 to 12 weeks. So I think that all portends still a positive outcome to future trials in this space. But I think everybody is going to have to go back and learn more from this data and potentially redesign what they're doing going forward. I think one of the highlights that's been seen around the media sphere 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 FT200 group, you know, thinking of the possibility of low cardiovascular toxicity and the potential to have more flexible dosing. We've been thinking about these kinds of things for some time. When we first set out to build our pipeline, even FT104, we sat back and said, 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 FT200 group is addressing that other aspect, and I think that's going to help the whole field move forward around the cardiovascular safety. I think that will help the whole field move forward. And then as Compass goes maybe to their next Phase II or their Phase III 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. In the meantime, you know, we're going to run our phase one, 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 two studies.
spk12: Yeah, I do have a few clarification questions on the timing and priorities for the FT-104 clinical development plan. First, assuming all goes to plan and the phase one study starts in the first half of 2022, would you anticipate having that data by the second half? And second, Would you anticipate filing an IND for the Phase II program in the second half? And finally, would the Phase II program include studies in TRD and PPD, or would one indication be prioritized over the other potentially?
spk05: Yeah, good question. You know, right now with our timeline, we have suffered a couple of weeks, maybe a few weeks a month, early months, short months, of delay due to some COVID related issues and scheduling with our manufacturers and and our clinical trials. So that's why we've sort of expanded the window on the start and completion of the trial. But that said, we are still targeting, we've actually already started most of the activities necessary for starting the clinical trial. The clinical trial is being prepared. The toxicology program is finishing on time. The protocols and everything should be put into ethics 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 activities starting right after the ethics approval at the end of the month or at the end of the quarter or very early in the second quarter. At least that's the plan. If all of that, 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 II protocol in hand. We have not yet decided exactly which indication is 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. And we'll put that plan together and come back to you with more clarity on that in the near future.
spk12: 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 2022, or would you expect an acceleration based on the disclosed build-out of the clinics business that was outlined in the release in the regulatory filing?
spk06: Yeah. We have, as we indicated in our press release, we've seen a sort of clear upward trend according to dates and revenue numbers, and that's as a result of some of the process optimization that we've undertaken in the 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 up more clinics and the existing clinics keep going up their ramping curve. And then we've 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 at each of the existing clinics and new clinics as we open them. And we expect to see those optimizations leading to good increased revenue growth as we go forward.
spk09: Great. Thank you very much.
spk04: Thank you, Patrick.
spk09: Our next question comes from Sefra Minochetri with Eight Capital. Please proceed.
spk13: Hi, congrats on the continued growth both on the R&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 a position 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?
spk06: Not that it's too much detail, but it's more that 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. That's been the focus of many of our optimization efforts. So, you know, we hope to not have significant backlogs and be able to see patients quickly. So I'm not sure that those, that metric would be particularly meaningful. 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 into 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 media 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 that we're trying to get those patients in as quickly as possible.
spk13: Oh, 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.
spk06: For that, I'll hand the call over to Roland to discuss our digital tools.
spk14: Certainly, you know, I think it's amplified in light of the Compass data to the extent that we understand the results of it and what it suggests. But we've always focused on building an ecosystem approach, patient engagement. So 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. We don't have anything concrete to offer in 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 therapies as well as psilocybin truffles in the Netherlands, and as eventually we move closer to Phase II trials and beyond with the clinical trials as well. But that is all to be determined in the future as it pertains to our clinical trials.
spk09: Perfect. Thank you for your time today. Appreciate it.
spk04: Thanks, Seth.
spk09: Our next question comes from Bruce Jackson with the Benchmark Company. Please proceed.
spk02: Good morning. Thanks for taking my questions. A follow-up on the FT200 program, you were 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 microdosing area?
spk14: It was just a little loud. It sounded fuzzy to me. Could you repeat the question, Bruce? There was a fire truck going on behind us, so we couldn't quite hear it.
spk02: Oh, sure. I'm sorry. So with the FT200 program, one of the objectives is to avoid the cardiovascular side effects. I'm wondering what those side effects are, if they're arrhythmias or something else. And then if you can talk about how that enables the microdosing program.
spk05: Oh, sure. Yeah. 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 90s, 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 fenfen. That cardiovascular toxicity exists for most serotonin agonists. 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 is 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. So right now, I believe that in the space of psilocybin, if it was given very, very infrequently, such as maybe once a year or once every two years types of thing, there would not be any major toxicity problems here. 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 200 program was designed to take that component out of the psychedelic experience so that there would not be those questions. That's essentially the idea around the program. And, you know, we have, I don't know, yeah.
spk02: All right, very good. The other question I had was you mentioned in the press release that the Toronto and the New York sites were the ones that were up and running the most continuously during the quarter, and 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?
spk06: 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 the 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 the business and sort of the trends, the benefits we're seeing from the optimization activities that we've undertaken in the last quarter are starting to show up in the numbers. That's kind of where we are right now. Happy to sort of answer, to give more color if you need it, but that's where we are on the global financials right now.
spk04: All right, good enough. Thank you for taking my questions.
spk09: Thanks, Bruce. Our next question comes from Jason McCarthy with Maxim.
spk10: Please proceed.
spk03: Hey, guys. This is Michael Chinowich on the line for Jason. Thanks for taking the question. Hi, Michael. 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 data set, but the magnitude is kind of what underperformed investors' expectations are. It 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, experienced psychiatrists, and the set and setting in driving an optimal result for psychedelic assisted psychotherapy.
spk06: Thanks for the call. I'll hand it over to Nathan first to give some thoughts on that.
spk05: Yeah, 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 tool so 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 I'm going to say a set of ketamine sessions. 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. So there are peer-reviewed 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 say symptom improvements that seem to be maintained at least three months post-treatment, still in the mild range where you wouldn't necessarily be giving patients a rebooster session. And that's significantly longer than what at 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 clinic that the psychotherapy component is good for pushing those outcomes to much longer durations and persistence of resolution of symptoms.
spk04: All right, thank you very much.
spk05: Yeah, I would hope that that would flip over into the psychedelic with the psilocybin as well. So I think that maybe there is a place for, you know, stronger psychotherapy and maybe that's something Compass is considering.
spk03: Yeah, thank you. Thank you. I'd also like to touch on the 200 class and follow up relating to the 5-HT2A targeting. The CV toxicity associated with 2B It's pretty clearly an issue for repeat dosing is likely, but could you talk about the potential benefit of also minimizing the 1A and 2C off target effect?
spk05: 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, clear answers to what 1A and 2A or a little bit of 1A and 2C may add to a psychedelic experience or a depressive outcome is still something that is not a real good known factor right now.
spk04: All right. Thank you.
spk03: Lastly, I'd like to see if we 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?
spk06: Yeah, 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 were uncomfortable doing that on the one-on-one sessions. But also, during that quarter, we were ramping up, trying to ramp up our group programs, which also suffered from COVID. And one, you know, Other factor that we hadn't fully anticipated was just how much seasonality there would be. It turns out that, you know, 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. The combination of those two factors, I think, led to the growth that we saw in the last quarter. As I mentioned before, I think we're encouraged by the signs we're seeing quarter to date in the clinics. We're looking forward to continuing increasing revenues going forward here.
spk04: Thank you very much for taking my question. Thanks, Michael.
spk09: Our next question comes from Elamir Piros with Roth Capital. Please proceed.
spk11: Good morning, gentlemen. Just to expand on the Comp360 observations, I mean, some hypothesizes that there is a great deal of variability on the plasma levels of psilocybin following the administration of Comp360. Have you observed in preclinical studies that FT-104 could be potentially less variable?
spk05: What I can say from our preclinical studies, which have been run in two species, is that the plasma levels are very consistent. It's actually allowed us to run, I'm going to say, a relatively small trial in phase one because of the good reproducibility and high consistency. So that's a nice feature of FT-104 is that we're getting that result.
spk11: And secondly, when you thought about the FT-200 series, what sort of indications you had in mind, Nathan?
spk05: I'll go ask and answer. It's really very, very early in this stage right now. We've only got a few molecular candidates in this space that are actually demonstrating the kind of profile we're looking for, but we still have to flesh this out a lot more. and define the structure activity relationships, be able to understand off-target potential safety issues or potential efficacy issues, depending on 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 give us a lot more flexibility in how it would be used.
spk11: I see. Then, let's see, there was another question here. I'll come back to you with that one offline. Thank you. Thanks, Oliver.
spk10: Once again, to ask a question, that's star one on your telephone keypad. Our next question comes from Robert Leister with Leister Watson Securities. Please proceed.
spk15: Hi, this is Bob Lister. I want 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?
spk06: Thanks, Bob. So at the clinics we're offering ketamine-assisted psychotherapy right now. You're right that that's the only offering that we offer in our North American clinics aside from, you know, in Amsterdam we obviously offer psilocybin-assisted psychotherapy. Patients also have the opportunity to join ongoing therapy programs called our And Beyond program and group therapy programs that we hope continue to extend the benefit for the patients after they complete the six dosing sessions with the ketamine. But that's our focus right now, and that's part of the strategic nature of the clinic and getting ready for MDMA and psilocybin and other psychedelic drugs, FT-104, in the future. So we've been focused on that, focused on developing the best way to combine psychedelic drug and psychedelic experience with supportive psychotherapy. So getting to 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 licensed psychotherapists are trained in and use to help our patients. And that's all held together with a protocol that takes into account the psychedelic experience and how different and important that experience can be to the patient. And it's really not psychotherapy as normal. Patients are having these really profound and often intense and meaningful experiences in the clinics, and the psychotherapy experience is meant to support and take advantage of often the new insights and the new sort of frame of mind that the patient finds themselves in following those types of experiences and really build on that and help to build positive change for the patient going forward. And that's what we theorize is part of the reason for these long-lasting effects that we're seeing.
spk04: Thanks. That's very helpful. Thank you, Bob.
spk10: Ladies and gentlemen, we have reached the end of the question and answer session. I would like to turn the call back to Ronan Levy for closing remarks.
spk04: Thank you.
spk14: Thank you, operator. Thank you to our investors for the support and to all the analysts for your questions today. Psychedelic medicine industry is continuing to build momentum at a rapid pace as increased clinical data attests to the value of these therapies. We've been executing on our business plan to build Fieldtrip into a leading psychedelic therapy development company, and I'm very pleased with the progress we have made in a short period of time. Fieldtrip is well-placed to leverage our strong business and brand to take advantage of the emerging opportunities this presents. With that, I'll ask the operator to close the lines.
spk10: Thank you, ladies and gentlemen. This does conclude today's teleconference. You may disconnect your lines at this time, and thank you for your participation, and have a great day.
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