13.6 C
New York
Saturday, September 24, 2022

Field Trip Health Ltd. (FTRP) CEO Joseph Del Moral on Q3 2022 – Earnings Call Transcript


Title: Field Trip Health Ltd (NASDAQ:FTRP) Q3 2022 Earnings Conference Call February 16, 2022 8:30 AM ET

Company Participants

Joseph Del Moral – Co-Founder and Chief Executive Officer

Ronan Levy – Co-Founder and Executive Chairman

Donna Wong – Chief Financial Officer

Kathleen Heaney – KCSA Strategic Communications

Nathan Bryson – Chief Scientific Officer

Conference Call Participants

Andrew Partheniou – Stifel

Patrick Trucchio – HC Wainwright

Sepehr Manochehry – Eight Capital

David Martin – Bloom Burton

Elemer Piros – Roth Capital

Michael Okunewitch – Maxim Group

Operator

Greetings, and welcome to Field Trip Fiscal Third Quarter 2022 Earnings Results Conference Call. At this time, all participants are in listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Kathleen Heaney of KCSA. Please go ahead.

Kathleen Heaney

Good morning, everyone and welcome to Field Trip’s fiscal Third Quarter 2022 financial results conference call. Before we 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 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. 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 Field Trip, in particular, the discovery business.

Joseph Del Moral

Thank you, Kathleen, and welcome to everyone joining us this morning. Field Trip has continued to build its innovative drug research and development programs, as well as deliver high-quality patient services through its best-in-class clinic network. We are proud of the progress our team has made in developing Field Trip into a leading psychedelic assisted psychotherapy provider, and highly recognized brand at the forefront of the psychedelic medicine movement as we further our mission to deliver innovative treatments for patients in need. We are also particularly pleased to see a strong growth in patient revenues in the third fiscal quarter of 2022.

The Strategic Review of our corporate structure that we announced on the last earnings call is still underway. As a reminder, we commenced this review to ensure that each operating unit is best positioned, optimally resourced, and focused to provide maximum long-term value to all stakeholders. We will provide further updates as appropriate. Moving onto Field Trip Discovery, our drug development business. During the quarter, Field Trip Discovery progressed on the development of our lead novel psychedelic compound FT-104.

This work is advancing us closer to the development of FT-104 as a more convenient, consistent, and practical psychedelic treatment than is expected to be available through psilocybin and MDMA, should they be approved. FT-104 has the potential to change the lives of those suffering from post – partum depression and treatment resistant depression.

FT-104 is a prodrug of 4-HO-DiPT, a psychedelic substance identified by Alexander Shulgin as a fast-acting, intense psychedelic, providing us objective experience similar to psilocybin. FT-104 has improved to drug absorption, more reproducible pharmacokinetic profiles, and improved bio-availability relative to 4-HO-DiPT, making it potentially a superior drug candidate. During the quarter, the company expanded consideration for the Phase 1 trial sites to include Australia, in addition to the Netherlands, to mitigate against possible delays related to regional differences and reactions to the latest COVID surge.

As of January, the company finalized agreements with interested parties in Australia to pursue Phase 1 studies and site selection is nearly finalized. The company has received the results of its animal studies, which continue to be reviewed and tabulated. One additional pre -clinical study remains to be completed, and the company expects initiation of Phase 1 to commence on the timelines previously disclosed. We are currently targeting ethics submission before the end of the current calendar quarter. We will keep you apprised of our advancement into Phase 1. In early January, we received a notice of allowance for our patent application for claims-related to FT-104 and formerly known as Iso Pro s and [Indiscernible]. We continue to anticipate that the patent will be issued in Q2. On a separate note, we also progressed our early-stage research towards identifying a lead candidate in the FT-200 Group.

This group has provided potential candidates which are strong 5HT2C agonist, with improved selectivity relative to the serotonin 2B anti – target. Reducing off – target serotonin 2B receptor activity reduces the risk of cardiovascular toxicity, and so allowing for potentially safer medications that would have greater flexibility of dosing, such as allowing frequent or chronic dosing, including microdosing administration. We are initiating in vivo behavioral screening tests to determine the activity of these compounds in rodent models of depression. During the quarter, we also filed our first provisional patent application related to the FT-200 Group to protect new chemical compositions, potential formulations, and uses.

This is a very exciting time for Field Trip as we continue to lead the way in developing the next-generation of psychedelic treatments. I will now hand the call over to Ronan to provide an update on the clinics business.

Ronan Levy

Thank you, Joseph, and welcome everyone. In less than two years, we have grown Field Trip into a leading operator of psychedelic treatment centers with a well-recognized brand at the forefront of the psychedelic medicine music — movement. We provider — pride ourselves on delivering innovative and effective treatments to patients at our Field Trip Health Centers with our program showing success as reflected in patient testimonials and clinic data. Importantly, we continue to get better and more efficient as we take the learnings from the past 18 months, when we began opening clinics and apply them to all our locations.

We’ve been focused on improving the patient experience, while driving process improvements within our clinical operations. For example, we recently launched from the innovative teen treatment model, which has increased patient capacity within the clinic. We also launched a new digital screening tool to facilitate booking, which has decreased call center costs and improved conversion rates through some of our channels.

We are continuing to refine our service offers, offerings while driving operational excellence measures within our clinic network. And combined with our effective marketing activities, these measures have resulted in tracking new patients and driving revenue growth. To that end, we are pleased to report that the third quarter patient services revenues were up 50% sequentially, and more than 300% over the comparative period in the prior year. Vicki Reed who joined us as Chief Growth Officer during the quarter has also been instrumental in driving the improvements in the clinics business.

In addition, we’ve invested in our digital platform portal to allow Field Trip Health to communicate more efficiently with patients, collect data more easily, and make our processes more efficient. We anticipate that additional features will be released in the next quarter to allow for improved patient experience and additional client engagement through the portal. On the clinic front, we opened our Seattle location during the quarter. We also opened a clinic in Fredericton, New Brunswick, and most recently in Vancouver, British Columbia. Having best-in-class clinics has enabled us to look for additional ways to utilize them. To that end, we launched our site management organization, or SMO services in December.

The new offering enables companies and researchers developing psychedelic therapies to use our facilities and expertly trained medical and therapy teams to conduct clinical trials. The SMO services are led by Stefan Coty, who is our new Head of Quality. While still in the early stages, we are excited about this new opportunity. We’re also always trying to better serve our patients. and you may be aware Health Canada recently amended its special access program of the SAP, to enable access to psilocybin and MDMA through the SAP, and we’re pleased to announce that we assisted one of our patients to submit one of the first applications in Canada to the SAP.

The SAP provides physicians treating patients suffering serious or life-threatening conditions with the ability to request access to drugs that have not been approved for sale in Canada when conventional therapies have failed, are unsuitable, or are unavailable. As the largest provider of psychedelic assisted therapies in Canada, we are uniquely positioned to help Canadians access the SAP for psilocybin and MDMA. The clinics are an important vehicle for us in which we are able to build brand awareness, increase our market share, and continue to earn patient services revenue.

In that respect we are extremely pleased to report that according to Meltwater Field Trip alone has 58% of the share of voice in the psychedelics industry in the U.S. Share of voice is a metric that assesses brand awareness relative to all competitors and has a gauge of brand visibility. To conclude, I want to reiterate that we’re very focused on creating value for our shareholders, patients, and employees. I will now turn the call over to Donna Wong, CFO, to discuss our financial results.

Donna Wong

Thank you, Mark Ronan, and good morning, everyone. As a reminder, all figures that I will be discussing are in Canadian dollars. And the third fiscal quarter of 2022 corresponds to the three-month period ended December 31st, 2021. During the quarter, we earned patient services revenue of Can $ 1.4 million from our clinics. An increase of Can $ 1 million or 330% over the comparative quarter in the prior year. The San Diego clinic began generating revenues in December 2021. By contrast, third fiscal quarter 2021

patient services revenues were generated from three clinics. We are pleased with the 50% sequential increase in revenues.

This was due in part to the three additional clinics as compared to the prior quarter, as well as the steps the company has taken to further improve and drive business growth as Ronan has previously mentioned. For the nine-month period, revenue was $3.1 million, an increase of $2.7 million over the same period of the prior fiscal year. This reflects a significant increase in the number of clinics we had operating, 10 in the most recent quarter compared to three in the same period of the prior year. We expect to scale our revenue as the number of patients treated at our clinics continue to grow. Moving on now to a discussion of cost.

Total operating cost in the quarter were $15.6 million up from $5.9 million in the same period of the prior year and reflects our continued investments in growing and scaling our Drug Discovery business and clinics. General and Administration expenses of $9.1 million are our largest operating expenditures, and we’re up from $3 million in the same quarter of the prior year. The increase was primarily due to increased operating costs, reflecting a larger number of clinics opened in the quarter as compared to the prior year, as well as those under construction and an increase in public company related expenses.

G&A cost also including non-cash items comprised of share-based payments of $2.1 million and depreciation and amortization of $1 million. Other operating costs include patient services expenses of $2.5 million, research and development expenses of $1.4 million, and sales and marketing expenses of $1.1 million. Our R&D costs increased 44% over the prior year, primarily due to ramping up of development costs as we work to further progress our activities related to FT-104 and our FT-200 pipeline as you just heard from Joseph. Our marketing costs nearly doubled from the prior year as we increased paid social, search, and public relations expenditures to build patient interest in our brand.

This had the desired results as we saw steady growth in client acquisitions and patient services and validates the steps, we’ve undertaken to improve the business and drive efficiency. Net loss for the quarter of Can $ 14.9 million was primarily due to total operating costs of Can $ 15.6 million, which I just discussed, as well as a foreign exchange loss of Can $ 0.5 million. This compares with the net loss of Can $ 8.3 million in the same quarter of the prior year. The increase from the prior year primarily reflects the company’s focus on growing the business and continued investment in our drug development pipeline and clinic infrastructure, as well as our digital tools.

Turning next to the balance sheet, Field Trip remains well-capitalized. As of December 31st, 2021, we had unrestricted cash and cash equivalents, funds held in trust, and short term investments totaling $74.5 million. Our solid financial position enables us to continue executing upon our key strategic priorities and furthering our mission to bring innovative psychedelic -based treatments to patients in need. This ends the portion of our prepared remarks. I’ll now ask the operator to open the lines for the Q&A session.

Question-and-Answer Session

Operator

Thank you very much. At this time, we will be conducting our question-and-answer session. [Operator Instructions]. As a reminder, we ask that you limit to one question and one follow-up. If you have further question, please join the queue again. One moment please while we pull for questions. We have a first question from the line of Andrew Partheniou with Stifel. Please go ahead.

Andrew Partheniou

Hi, good morning. Thanks for taking my question.

Joseph Del Moral

Good morning, Andrew.

Andrew Partheniou

Could you provide any update, if possible, on the Strategic Review, where are you in the process and are you considering — have you moved forward on any considerations?

Joseph Del Moral

Yeah. We are pleased with the way the process is going. We are in the middle of the Strategic Review right now. We’re considering a number of different options in that Strategic Review as we’ve mentioned. We don’t have any further updates that we can share right now, but we will update when we have those.

Andrew Partheniou

All right, thanks for that. Maybe discussing on the FT-104 patent, you mentioned the prior art claim. Could you discuss a little bit of the background on that? What consequences, if any, of this may have? What options you have going forward and what makes you confident that you’re still be granted the composition of matter patents in Q2?

Joseph Del Moral

Mr. Andrew, for that, I’ll hand it over to Nathan Bryson.

Nathan Bryson

Good morning, Andrew. Right now, I think we like to keep that in-house. It’s with our legal counsel who is handling the issue. And I think we’ll get to you — we’ll get back to you fairly soon on that. We don’t expect this to hinder the granting process and we fully expect it to be granted before Q2 ’22.

Andrew Partheniou

Okay. I’ll get back in the queue.

Operator

Thank you. We have the next question from the line of Patrick Trucchio with HC Wainwright, please go ahead.

Patrick Trucchio

Thanks. Good morning. I’ve a couple of follow-up questions on FT-104. I guess the first is just can you tell us what additional studies such as neurotox cardiotox or additional potential — addiction potential studies could be necessary for FT-104 and if these studies could be needed as part of an IND filing for a Phase 2 program.

Joseph Del Moral

Sure, we actually did the neurotoxin and cardiotoxic as part of our package now and I’d say everything looks satisfactory for us to go forward. In most respect I — in all respects, the pre -clinical work that we’ve done so far is setting us up very well to start in our Phase 1. We’ve achieved an NAVEL and lowest non-adverse event dose. And so I think we’re poised to go. We will have additional non-clinical studies as we go past Phase I, as we start looking at specific indications. You can easily see that if we’re going to developing TPD, we’ll have to look at developmental and reproductive talks and things of that nature. Those are the kind of things we’ll have to look at as we go forward, but they’re not needed right now for Phase I with the single dose.

Patrick Trucchio

That’s helpful. And then can you tell us about your latest thoughts on potential Phase II trial design for TRD and or PPD, and in addition, should we expect, those studies could enroll simultaneously, or would one program such as TRD be prioritized? And if all goes to plan with your Phase I trial, when would be the earliest you’d anticipate starting the Phase II program?

Joseph Del Moral

Honestly, I think some of those questions are a little premature for us. We are stepping back. We’re finishing up, getting ready for the Phase 1 so really, we’re focused on that 100% right now. I’d say as soon as that’s up and running, we’ll set back and we’ll be working on those designs, and I think we could share a little bit more information with you then. I can’t say to which indication we developed first. I think that is still something that’s in discussions. And we — if we take the data to the FDA, that may also help clarify some of that. We’re looking at going to do a pre-IND as the Phase 1 is headed forward, and I think that will give us the information and will help make those selections and the N-help make those designs more efficient and tailored to what the agency is looking for

Patrick Trucchio

Thank you very much.

Operator

Thank you. We have next question from the line of Sepehr Manochehry with Eight Capital, please go ahead.

Sepehr Manochehry

Hi, and good morning. I — was great to hear you guys mention that you’ve already gone and now get through the SAP program, which seems like a transformative change for the space. So I’d love to gain some color on the workflow process there. Is that translated to incoming interest, or have you been more so mining your own data to assess patients that may qualify?

Joseph Del Moral

Thank you for the question. It’s — we have received a significant amount of inbound interest. I don’t have the numbers offhand from patients seeking treatment with psilocybin and MDMA. As you know, we currently provide psilocybin assisted psychotherapy at our clinic in the Netherlands. We have the protocols, we have well-trained therapists, we have the processes in place to be able to provide that sort of therapy, so I think we are well-positioned to help patients with these types of therapies in Canada, as well as it becomes hopefully more available. It’s early stages yet, but we’re in a good position to be administering these types of therapies for patients and yeah, to answer your question, we have had significant amount of inbound interest on both MDMA and Psilocybin therapy through the SAP program.

Sepehr Manochehry

Great. That’s really helpful. And just maybe, obviously, you guys have a reach across multiple jurisdictions. So, there’s jurisdiction-based differences in payers and payer mix. So just wanted to get maybe some rough understanding of your typical success rate that you see for reimbursements and if there are people being reimbursed for psychotherapy, if there’s more heavily weighted in certain jurisdictions versus others, at least for the psychotherapy component of your program.

Joseph Del Moral

Right. So, you’re — the way you phrased it is right. We do get — most patients get more reimbursement for the psychotherapy than they do for the ketamine dosing itself. In Canada, we tend to find I believe a higher percentage reimbursement in Canada than we do in the past, but in the U.S., patients also get reimbursement for the psychotherapy through out-of-network coverage if they have it, although I think it’s at a lower percentage than what we see in Canada right now.

Sepehr Manochehry

Okay. Could you characterize a ballpark of is there a typical window that you expect when you guys are putting filings through and the patients — do you characterize what the potential for reimbursement is when you speak to patients?

Joseph Del Moral

Well, we do as we create a super bill for the patient that breaks out the costs into the ketamine dosing versus the psychotherapy preparation integration sessions until they can see where the cost is split. It’s up — it’s around 55% or so, is the cycle therapy portion of the bill, and that’s the part that you get reimbursed — mostly get reimbursed on through their insurance providers. If you wanted to get into more detail on that, I have to — we have to get back to you so we can have a follow-up on that.

Sepehr Manochehry

Yeah, and there might be a KPI you guys maybe report moving forward as the kind of pair mix because that does helping form the outlook for the clinics business, certainly. But that’s how — yeah, I appreciate the insight on the diversion between Canada and U.S.

Joseph Del Moral

Thank you, Sep.

Operator

Thank you. We have next question from the line of David Martin with Bloom Burton, please go ahead.

David Martin

Yes, good morning. And so first question is the SAP Program, does that just provide access to treatment or does it pay for the patients to get the treatment?

Joseph Del Moral

It does not pay for the patients to get the treatment, so the patients will be paying for treatment. We’re still in the process of figuring out our own internal processes and how we’re going to deal with that — the financial aspect of this. So we’ll have more details on that as we progress further as the program develops. But that’s not — I don’t think it’s contemplated that they would get reimbursed for this through the government.

David Martin

Okay. And why not ketamine since that’s your main drug?

Joseph Del Moral

Ketamine is available as a — is available but Drug SAP is meant to give access to patients for drugs that are not currently approved for sale. We’ve tried all other options.

David Martin

Okay, got it. And then if you were using Spravato in the clinics, would there be more reimbursement available and if there would why the decision not to go the Spravato route so far?

Joseph Del Moral

That’s an area that we’ve looked at in some detail. Happy to have a more detailed conversation on it. It is a — SPRAVATO is an expensive product, and not everybody gets coverage from it. It’s also a medical question that our medical team is looking at, whether we can create the same sort of psychedelic experiences that we strive to create for our patients. So it’s one we’ve explored and continue to explore whether it would make sense to add it as an offering at the clinics, and today we haven’t decided to, but it’s — we’ll continue to look at.

David Martin

Okay. And if I could, just one more question. You had to get manufacturing and material prior to the Phase I starting. Is that still on schedule?

Joseph Del Moral

I’ll hand that over to you, Nathan (ph).

Nathan Bryson

Yes, that is.

David Martin

Okay, thank you.

Operator

Thank you. We have next question from the line of Elemer Piros with Roth Capital, please go ahead.

Elemer Piros

Yes. Good morning. Congratulations on the growth in the clinic business. And I just wanted to ask maybe couple of housekeeping questions. I’ve seen that quarter-over-quarter totally expenses were kept in check, roughly equal between second and third fiscal quarter. But some of the line items like occupancy costs, sales and marketing, and R&D actually declined. I was wondering if Donna you would be able to help us to project these numbers into the future, it’s just somewhat complicated here.

Joseph Del Moral

And that question over to Donna.

Donna Wong

Sorry, I was on mute. I guess what I would like to say is that the R&D numbers are going to be chunky depending on the specific statement of work that we have with the CROs and CMOs. So while you might have seen a slight decrease in Q3 over Q2 from an R&D perspective, you can expect to see those numbers to ramp over the next several quarters as we move into our Phase I clinical trials. And in terms of the decrease in Q over Q for our sales and marketing expenses, with the hiring of Vicki Reed as our Chief Growth Officer, we’ve started to take a detailed look at our different acquisition channels from a marketing perspective.

And so we’re refining our searches, our digital and paid searches. And so we’ve actually received — most of our leads are references through our digital acquisition channel and through organic growth, as opposed to paid search channels. So that’s why you see the decrease in sales and marketing as we are refining our business model and focusing on the clinics that we think that need more marketing and also changing the mix of the type of market sales and marketing services that are required. And I think from the occupancy cost, it’s based on IFRS 16 accounting, so that number there excludes the depreciation and amortization of the right-of-use assets. But if you look at the occupancy costs on a cash basis in terms of the leases that we have, you will see an increase. Does that explain that?

Elemer Piros

Yes, it does. And, Donna, would you please share the weighted average share count that was used, and also the shares outstanding by the end of December, please?

Donna Wong

Yes. So for the quarter, the weighted average share number that we used was $57.8 million on both basic and diluted basis.

Elemer Piros

Okay.

Donna Wong

Do you need it on the nine months end period?

Elemer Piros

No, and that’s okay.

Donna Wong

Okay.

Elemer Piros

But — and is this the share count by the end of December 31st as well?

Donna Wong

Yes, that is correct.

Elemer Piros

Okay. Thank you. And maybe just a general question about the site management organization services. What would you need to do some additional work that would qualify these sites, both in Canada and in the U.S. to conduct clinical trials there?

Joseph Del Moral

Elemer, we’ve been — so I know Stefan Coty came on as our Head of Quality. And she’s been working to help prepare sites for these types of trials. And so we’re fortunate that we already have the — most of the staffing needed at each of the clinics to conduct these types of clinical trials, so we’re in the process of putting together the SOPs, and back-office systems, and the insurance, and etc. setting all of that thing up, as well as in parallel to that, having discussions with potential partners who want to conduct trials at our clinics.

Elemer Piros

Thank you. And just a last question about the BFD 200 group. Are you thinking about potentially chronic administration, potentially microdosing? What sort of indications would you have in mind for that research effort?

Joseph Del Moral

I’ll hand that over to Nathan.

Nathan Bryson

It’s probably still a little bit early to make any [Indiscernible] statements on that, but yes, we are — it does open up the possibility of more frequent dosing without the risk of this cardio toxicity progression to take hold. We’ll still have to do additional work in animal model studies to look how we use this. But imagine, for example, that it could be a maintenance therapy post treatment with either ketamine or FT-104, where you could actually administer it once a week or even more frequently than not, if you were in the microdosing situation or even microdosing. So it’s that kind of concept, I think it could get more widespread use and more frequent use.

Elemer Piros

Thank you very much, Nathan. That was all for me.

Joseph Del Moral

Thank you, Elemer.

Operator

Thank you. [Operator Instructions] We have next question from the line of Jason McCarthy with Maxim Group. please go ahead.

Michael Okunewitch

Hey, guys. This is Michael Okunewitch on the line for Jason. Thank you for taking the question and congrats on the growth in the quarter. So I’d like to see, for the revenue growth, could you give a bit more color on the proportion of the growth that was from the two most mature clinics in New York and Toronto and how much of that came from the number of other clinics that you’ve opened. Is it largely driven by site and site or the addition of new sites which have started to gain traction?

Joseph Del Moral

I’ll let Donna provide any color she like on that, and I can add comments after.

Donna Wong

Hi. For the quarter we experienced growth across all our clinics, not just our Toronto and New York clinics.

Q Michael Okunewitch

Thank you very much.

Joseph Del Moral

Cool. A shift towards more organic growth from [Indiscernible] growth. That’s a result of the efforts of our very successful brand building and PR campaigns that we have. And really word of mouth and people coming through our clinics have often very positive experiences and they like to talk about it with their family and friends. And so we get a lot of word-of-mouth referrals as well now. So now you can see that a clinic with a larger base of clients such as our more established clinics, also get more organic word of mouth referrals.

So that’s — do you — the way we see the evolution of a clinic is it takes for more of an effort behind marketing and especially paid marketing in the early months of a clinic’s development to build the base out. And then as it has more and more clients and awareness built around it, we can reduce that and continue growing via organic means.

Michael Okunewitch

Thank you for that color. And then one more from me regarding the P1. Would you be looking at PK characteristics which would help indicate how long a PPD patient may have to give up breastfeeding and what sort of target you would have to meet to have a competitive advantage over standard of care, and that specific metric of clearance from bodily fluids.

Joseph Del Moral

Yeah, good question. We’ve already looked at most of the pharmacokinetics, at least in rodents. And I’d say the primary drug plus all metabolites are cleared within I’d say about four hours. And if we look at the half-life cycle, I think we can project most of the metabolites and the primary active molecule would be gone definitely within 12, so putting some safety margin on that, that might be 24. But those are hypothetical, you’re right.

We’ll confirm that through the human study, but the, I’m going to say the PK profile and the duration of the cycle activity experienced in a rodent does look to map very well with what is reported for the listed substance for hydrocopter being in the range of that two-to-three-hour window, which is what we see with the rodent. We think it’s going to map what we saw in the metabolism of the animals; we’re going to see with man. Beyond that, we’re going to have to confirm all that not just through pharmacokinetics, but through [Indiscernible] transfer studies.

Those can be run in animals at first and then we’ll capture milk in our PPD studies as we go forward. Either through a specific study or as part of our Phase 2 program, we’ll capture the milk and then do our analysis looking for our metabolized [Indiscernible] then confirm all that, and then build the story. But the pharmacokinetics and the wash up phonetics right now, look favorable for that. If I compare that to the standard of care, the current standard of care is either a chronic SSRIs which don’t work very well, take too long to kick in.

So, I pushed them aside because it’s the mother that needs help immediately. It’s not necessarily going to be happy with an SSRI that takes six to eight weeks to kick in. So, the other standard of care, which is the only other drug approved on the market is a Russel, which already the phase of treatment itself is three days. And then you must wait at least two weeks for the drug to wash out. So you’re looking at minimum of two weeks, if not more, that you’re going to have to deal with a washout. And then future drug from [Indiscernible] is a 14-day treatment with an additional two weeks on the back end of it, so you’re looking at nearly a month without breastfeeding.

Those kinds of things are not good for the bonding between the mother and the child especially if it’s necessary — wanted by the mother, and not being able to do it sometimes, that is a failure. So being able to get mothers back to their children very quickly for those that want to breastfeed is very important and I think FT-104 meets that. We just got to do the work.

Michael Okunewitch

Thank you very much.

Operator

Thank you. We have next question from the line of Andrew Partheniou with Stifel. Please go ahead.

Andrew Partheniou

Hi, thank you for taking my follow-up question, and I apologize if you mentioned this previously, I might have been disconnected, but could you talk or give a little bit more color about what triggered choosing the additional site for Phase I, and why was Australia the jurisdiction?

Joseph Del Moral

Both Australia and the Netherlands have very lean means of getting into Phase I. They’re still very rigorous, but the whole approval process relies highly on the investigators themselves. So from a selection standpoint, there’s not a lot of difference between the two, I will say there’s an additional benefit in Australia’s as there’s, like we have in Canada, a certain amount of financial reimbursement for using people — for working with people in the country. And that can be put back into the program. So it makes for some economical savings. But overall, part of the reason was just the fact that both of them could do on the same timeline.

Beyond that, we’ve had experience with the group in Australia before in previous slides and before Field Trip. And so we had comfort with the group that we’re looking at. And then the other factor that we were trying to weigh in was what was going on with the COVID situation and with Omicron high numbers in Europe and the site was having to shut down a couple of times, mainly because personnel who were getting sick and they didn’t have enough personnel to staff the system.

We looked at both sites and actually we felt that it was a little bit safer and better controlled in Australia. And so looking at the overall, it didn’t change anything to move to Australia, but gave us additional security and the additional comfort. We made that switch, we signed with a group, the site selection is I’m going to say pretty much finalized. We know where we’re going and we’re getting ready to submit our protocols to [Indiscernible], so we’re on our pathway to Phase one without actually having changed or have — without increasing the risks, we feel like we’ve reduced the risk.

Andrew Partheniou

Appreciate that extra color. Thank you.

Operator

Thank you. We have next question from the line of Patrick Trucchio with HC Wainwright. Please go ahead.

Patrick Trucchio

Hi, thanks for taking the follow-up. Just a few more on FT-104, just from the commentary in the release, which noted that as a prodrug FT-104 converts rapidly and completely after administration, and combined these properties resulted in improved drug absorption, more reproducible pharmacokinetic profile, and improved bioavailability, making it a superior drug candidate. I’m just wondering if you can further elaborate on the data that’s been generated to demonstrate those attributes, and if further details on that data is expected to be released at some point in the future?

Joseph Del Moral

Of course. I do think we’ll eventually publish the data we generated in animals so that you could see that. I don’t know what additional color I can give you. I know — for example, when we did pharmacokinetics in rodents, and this is in our presentation. When they administer FT-104 in the bloodstream, always see a small hydroxy DiPT. We don’t — we see very, very little of the FT-104. Now, when we do the Phase I in humans, we’ll be looking for both, obviously, we’ll design the trial to look for. But we know that it cleaves very fast.

We see that in vitro, we see that in vivo, and we can compare it to what happens in biological metrics that come from humans, and we can compare that to the rodents. And we see a very close comparison, maybe even more so than when we did pharmacokinetics and other higher species. So we’re very comfortable with the way it cleaves. We have some information from in vitro studies to know, what is the mechanism of cleavage and what promotes the cleavage within the biological matrix. At least we have some very strong suspicion, and we know, we can inhibit those things that cleave it.

We’ve got a very good description of what’s going on in terms of how FT-104 gets converted to oxidized DCPIP, gets into the system, and then all the pharmacokinetics that around the molecules, and then all the metabolisms. That’s part of that pre -clinical package that we’ve prepared. We’ve already shared it with some early — with the PI that would be running the study. They’re very comfortable with it. It’s very clear and quite complete. If that was all you were looking for, that’s about as far as I can go right now. We definitely will publish it sometime in the future.

Patrick Trucchio

Yes, that’s helpful. And then just as part of the Phase 1 program, I’m wondering if you would expect together additional data regarding a psychedelic experience itself. In addition to the length of the experience. And if so what are your expectations around that data?

Joseph Del Moral

Absolutely, we’re going to capture that. We’re going to use some of the standardized questionnaires that have been used with psychedelic substances in the past and maybe a slightened — slightly different ways, but very, very closely. Things like ASC and EQ, which has a standardized alternate space of consciousness, and the mystic will experience questionnaires which would have been related to outcomes in depression. So we’ll capture not only intensity of the experience, a little bit of the flavor nature of the experience, but also the duration. And so yeah, that’s totally going to be captured.

Recognize it’s going to be in healthy volunteers and volunteers who had some experience with psychoactive substances before, so they’ll likely be able to characterize it quite well. And then, we’ll use that as information to decide on our doses that we’ll go into Phase 2 with, obviously the experience at a patient might be slightly different than that in healthy adults, but we feel like that’s going to give us a very, very good window into the therapeutic doses that will be used in patients. It did for silicide, and I think it will for FT-104 since the pharmacology is very, very similar.

Patrick Trucchio

Got it. Thank you very much.

Operator

Thank you. We take the last question from the line of David Martin with Bloom Burton. Please go ahead.

David Martin

Thanks for taking the follow-up. What percent of the patients you treat are reimbursed right now, and what percent of those who seek treatment would you say have to walk away because there is no reimbursement for them. And are there steps you can take to increase coverage in addition to case-by-case efforts?

Joseph Del Moral

Thanks for the question, David. This is — it’s the second question on the care percentage of mix so maybe one that we’ll put some more focus on in our next quarter. But I don’t have the exact percentages so maybe we can follow up with you on that one. But I do know that it is private pay and cost is definitely one of the reasons why people not to proceed with the treatment. It’s one of the barriers and one that we’re hopeful that over time they’ll be increasing coverage. We’re seeing glimmers of that in different areas at average for military veterans in Canada already.

There are some signs of increased openness from employers and different group in the U.S. and people with different coverage plans. We see that or we’re starting to see that, but it’s already very still, but our hope is that over the next few years we’ll see greater percentage of people get coverage for these types of therapies. In terms of the exact mix right now it’s something that we can follow up with and look into those numbers for you.

David Martin

Okay. And I did have one last question linked to the last one. Will you use depression scales in the Phase I, because I know these are healthy volunteers, but everyone can potentially feel a little better. I know they’re not getting the psychotherapy associated with the drug, but would you apply a depression scale in the Phase I?

Joseph Del Moral

No. That wouldn’t be appropriate. A person that came in and actually had depression probably wouldn’t be considered healthy and allowed into the study, just from an exclusion standpoint. And if a person that came in as healthy, not depressed, numbers would be so low, there wouldn’t be room for calculation and fiscal analysis. So no, I don’t think that’s appropriate based on that.

David Martin

Okay, I didn’t think so, but thought I’d ask. Thanks.

Joseph Del Moral

Thank you, David.

Operator

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session, and I’d like to turn the call back to Ronan Levy for closing remarks. Over to you, sir.

Ronan Levy

Thank you, operator. And thank you to our investors for the support and to all the analysts for your questions today. The Field Trip team is proud of the business we have built as a leading psychedelic psych assisted psychotherapy provider and highly recognized brand at the forefront of the psychedelic medicine movement. We continue to execute upon our strategic priorities like building our innovative drug research and development pipeline, as well as delivering and helping patients through our best-in-class clinic network. With that, I’ll ask the operator to close the lines.

Operator

Thank you very much. Ladies and gentlemen, this concludes today’s conference call. You may now disconnect your lines at this time. Thank you for your participation.



Source link

Related Articles

Stay Connected

0FansLike
3,495FollowersFollow
0SubscribersSubscribe

Latest Articles