Q1 2024 Pharmala Biotech Holdings Inc Earnings Call
Operator: www.microsoft.com www.microsoft.com www.microsoft.com You have joined the meeting as an attendee and will be muted throughout the meeting. And with me is Shane Morris, our COO.
Okay.
[music].
You have joined the meeting as an attendee and will be muted throughout the meeting and with me is Shane Morris our CFO, we're going to talk about some of the recent developments in the company, we're going to take some questions. I think this webinar is going to go for between 30 and 45 minutes here. It's been about 15 minutes talking about some of the some of the major moves that we've.
Speaker 1: We're going to talk about some of the recent developments in the company, and we're going to take some questions. I think this webinar is going to go for between 30 and 45 minutes.
Speaker 1: We're going to spend about 15 minutes talking about some of the major moves that we've made as a company in the last week, two weeks, and some of the things that are coming up in the next little while. And then we'll take a whole bunch of questions from folks, because I know that there are a lot out there. If you want, you can start submitting your questions through the webinar function, and we will get to them as soon as we've done our piece and talked about our stuff.
Made as a company in Alaska.
The week two weeks.
Some of the things that are coming up in the next little while and then we will take a whole bunch of questions from folks. So I know that theres a lot out there.
If you want you can start submitting your questions through the web and a function and we will get to them as soon as a as soon as we've we've done our piece and talked about our stuff.
Speaker 1: So maybe I'll kick it off, Shane, you want to talk a little bit about the controlled substance license from Aligot, because I think that's a big piece for us. I know we've been working on it for a long time. Maybe I'll just let you talk about that a little bit, because that was that was your big project. Yes, certainly, it was a big team effort.
So maybe I'll kick it off Shane you want to talk a little bit about the controlled substance license it from algar, because I think that's it.
It's a big piece for US I know, we've been working on it for a long time, maybe I'll just let you talk about that a little bit because that was that was your big project.
Yes, certainly it was a big team effort.
We obtained.
License very recently and it was really a first.
Shane Morris: We obtained the license very recently, and it was really a first for Health Canada in a way that you have to remember on the MDMA side, this definitely does not have a DIN, which is a Drug Identification Number, and it was certainly something, a product that was needed, especially in the Special Access Program. And as a result, leveraging the relatively recent changes in Health Canada's regulatory elements around the Special Access Program, we were then able to obtain, essentially, what we call a dealer's license. At that point, it allows us to be able to talk to prescribers, and interact more in the value chain than would normally be allowed with a controlled substance like MDMA. Certainly, it has opened up some avenues for us in a very novel way to have those discussions here in Canada specifically, but it also allows, it gives some credence to us internationally as well to be licensed by Health Canada.
<unk> kind of in a way that you have to remember on the <unk> side definitely does not have.
<unk>, which is drug identification number.
It was.
Certainly something.
The products that was needed, especially in the special access program.
As a result.
Leveraging their relatively recent changes in health Canada's regulatory elements around special access program. We were then able to.
Obtained a <unk>.
Essentially what we call it the theaters license at that point it allows us to be able to.
Talk to prescribers.
More.
In the value chain.
Already the livelihood of controlled substance like MMA.
Certainly.
It has opened up some avenues for us.
Novel way to have those discussions here.
Here in Canada, specifically, but it also lives it get.
Some credence to us internationally as well to be licensed by health, Canada and hats off to help kind of has to be said.
Shane Morris: And hats off to Health Canada, it has to be said. I'm often very critical of Health Canada as an ex-bureaucrat, but certainly they saw the need for this for patients. They put a patient-first approach and worked with us on this issue, and that was certainly something I think that will go a long way to helping patients in need of this requirement for MDMA treatment. Yeah, I mean, look, we often say that we're a regulatory-first organization, but I think it's fair to say that hasn't stopped us from criticizing some of the things that Health Canada has done in the past. But really, hats off to them, like a really collaborative relationship, really open to sort of new ideas and new ways of doing things. And that's rare for regulators.
Im also very critical health, Canada as an.
And X P aircrafts, but certainly.
They saw the need for this for patients they put a patient floored patient first approach.
And work with US on this issue and that was certainly something I think that will go a long way to helping patients that need to have this requirement for MDMA treatment.
Yes, I mean look we often say that we're a regulatory first organization, but I think it's fair to say that hasn't stopped us from criticizing some of the things that health, Canada has done in the past, but but really hats off to them like really collaboratively.
Relationship really open to sort of new ideas and new ways of doing things.
It's rare for our regulators, so I think really full credit to health Canada.
Speaker 1: So I think, really full credit to Health Canada on this and how they've been approaching psychedelics over the last year and a half. Yeah, certainly seeing some changes in attitude and certainly some, like I say, nice and refreshing to see a patient-first approach. Totally.
This and how they've been approaching psychedelics over the last over the last year and Youre in a half.
Certainly seeing some changes in attitudes and certainly some apps like I say nice and refreshing to see a patient first approach here totally.
Speaker 1: The other major thing that happened just this Monday was we released our Q1 financials. And for the first time in the company's history, we managed to show a profit. But I can't I can't know 100% because there are a lot of private companies, of course, as well, who don't release their financials.
The other major thing that happened just this Monday was we released our Q1 financials and for the first time in the company's history.
We managed to show a profit.
I can't I can't know, 100% because theres a lot of private companies of course, as well, who don't released their financials, but as far as we know at this time first psychedelics company to show a profit in any quarter.
Shane Morris: But as far as we know, at this time, it's the first psychedelics company to show a profit in any quarter. So we're pretty proud about that. Yeah, I think certainly it has been an interesting quarter, a lot of heavy lifting in relation to putting together the value chain and making sure that it's executed well across the board. We certainly, you know, just on the financials, I think certainly we're looking at a market that is quite slow, I think it's fair to say that we're building across the board, and certainly there's a lot of work to be done on that Yeah, yeah, look, I think for all the investors out there, you know, I want to set expectations at the right level, right? Like, it's still a very young industry, we're still a very young company. We're, you know, barely three years old. And so it's going to be choppy, right? You know, I don't think anybody should expect that it's just going to be like, you know, a steep trajectory rise into infinity.
So we're pretty proud about that.
Yes, I think certainly it has been a.
An interesting quarter and a lot of heavy lifting in relation to putting together the value chain and making sure that it is executed well across the board.
We certainly just on the on the on the financials I think certainly we're looking at.
A market that is quite slow I think it's fair to say that we're building across the board and certainly theres a lot of work to be done in upfront yet.
Yeah look I think for all the investors out there I want to set expectations that the right level right. It's still a very young industry, we're still very young company.
We're barely three years old.
And so it's going to be choppy right.
Anybody should expect that it's going to be like.
A steep trajectory rise.
Into infinity.
Speaker 1: But we've seen a lot of great progress, including, you know, I think just last week, the first MDMA dose that was prescribed in Australia, which is another really positive sign. I mean, we're not just a Canadian company. We also do work with Cortexa, our joint venture with Vitro Health in Australia. And so having that first patient dose is also really critical. I will say, because I promised that I would say this, the dose that was prescribed came out of inventory that we manufactured for an organization called Mind Medicine Australia, which is a charity. But they provided the dose and the training to the clinic in question, which is Monarch Clinics. And so that's how that sort of all came together.
But we've seen like a lot of great progress, including.
Just last week, the first MDMA dose that was prescribed in Australia, which is another really positive sign I mean, we're not just the Canadian company. We also do work with <unk>, our joint venture with <unk> Health in Australia.
That first patient dose is also really critical I will say because because I promised that I would say it is.
The dose that was prescribed.
Came out of inventory that we manufactured for an organization called mine Medicine, Australia, and my Medicine, Australia as a charity, but they provided the dose and the training to the clinic in question, which is monarch clinics.
And so that's how that sort of all came together.
Shane Morris: And the other thing, Shane has been really run off his feet, I think, as our operations lead, in that, you know, there's not a lot of folks who sort of say that they're going to do stuff, but there's not a lot of folks who actually do it. So Shane, do you want to talk a little bit about what we've seen in the market out there? Yeah, certainly, you know, as a small company, we're very conscious of making sure that we're not overextended on any part of what we do from an operational perspective, be it manufacturing active ingredients, i.e., the API of MDMA, all the way to making sure we have enough capsules completed and ready to go and to be able to supply into a demand plan that we understand.
And the other thing Shane has been really runoff as feed I think.
Our operations lead in that there's.
Theres not a lot of there's a lot of folks who sort of say that theyre going to do stuff, but there's not a lot of folks who actually execute.
So Sean do you want to talk a little bit about what we've seen in the market out there yes.
Yes, certainly.
As a small company, we're very conscious of making sure that we're not overextended on any part of what we do from an operational perspective be it manufacturing.
The active ingredient <unk>.
You may all the way to making sure we have enough capsules complete.
Ready to go.
Supply into the demand plan that we understand however.
Shane Morris: However, as this is a very new market, a very new value chain, and a lot of people in different jurisdictions with different regulatory requirements are looking to move on this, it doesn't, and I'm going to be very selfish about this, it doesn't help me from a demand planning perspective. If we're not making Nike here, and we know, you know, okay, we're going to increase our production by one quarter, we could have huge percentages and swings in relation to demand.
As this is a very new market very new value chain.
A lot of people in different jurisdictions with different regulatory requirements are looking to move on this it doesn't.
To be very selfish about this it doesn't help me from a demand planning perspective, we're not making Nike here and we know we're going to increase our production by one quarter, we could have huge percentages and swings in relation to demand. So we're trying to manage that well.
Shane Morris: So we're trying to manage that well. Certainly, I think we've done a good job of that. What we're seeing, though, putting pressure on that is where people have been promised.
Certainly I think we've done a good tell the tops out with what we're seeing though putting pressure on that is where people have been promised.
Shane Morris: So, for example, in other jurisdictions, they've been promised product to be able to start their either clinical trials or their, you know, actual clinical use in the market. And certainly, you know, they seem to have been left wanting for product on a correct timeline because this is difficult, you know, to manage your production for anybody. But it's nice to see that we're being able to step in and help those in certain circumstances, again, putting a patient first approach. But obviously, it puts demands on myself and the team here in relation to understanding the man planning and getting it right. Because you want to allocate resources correctly.
For example in other jurisdictions that could cost product to be able to start to either clinical trials are there.
Actual clinical use in market.
Certainly.
They seem to have been left wanting for product.
Correct timeline, because this is difficult.
To manage here.
Production for anybody.
It's nice to see that we're being able to step in and help those in certain circumstances again, putting a patient first approach.
Obviously it puts demand.
Myself and the team here in relation to understanding the amount of planning and getting it right because you want to allocate resources correctly.
Speaker 1: Yeah, absolutely. And Shane and his team have done a really, really good job. And, frankly, it's a bit of a tough environment, just trying to roll with the punches and make sure to get materials to patients. Ultimately, this is all about patients. One of my sort of annoyances in this industry is how little we hear about patients and the patient experience. But it is really, really important to keep, you know, patients centered in everything that we do. And it's something that we talk about all the time because, ultimately, that's what we're doing here, right?
Absolutely and Shane and his team have done a really really good job in and frankly like a bit of a tough environment, just trying to roll with the punches and make sure to get materials to patients. Ultimately this is all about patients.
One of my sort of annoyances in this industry is how little we hear about the patient and the patient experience, but really really important to keep patient centered in everything that we do and it's something that firm. Although we talk about all the time because ultimately that's what we're doing here right like we're generating materials that are going to be used.
Speaker 1: Like we're generating materials that are going to be used to treat patients, and hopefully, help patients. And then, and then, of course, you know, the sort of convergence of all this is moving towards a model where, now, with our controlled substances license and with the inventory that we've generated, we can actually gather data in a really, really cost-effective way. And I don't know that a lot of people have sort of understood this yet, but one of the really, really cool things that is going on right now in this space is that you have something that doesn't really happen very often.
To treat patients hopefully help patients.
And then and then of course, the sort of the convergence of all of this is moving towards <unk>.
A model, where now with our controlled substances license and with the inventory that we've generated we can actually gather data and are really really cost effective manner and I don't know that a lot of people have sort of.
Understood. This yet, but one of the really really cool things that is going on right. Now in this space is you have something it doesn't really happen very often you have a drug which is not yet approved although we'll talk about what's going on with maps and the United States in the approval process, there, but in Canada, and Australia, as an unapproved drug but the government.
Speaker 1: You have a drug that is not yet approved, although we'll talk about what's going on with MAPS in the United States and the approval process there. But in Canada and Australia, there's an unapproved drug, but the government has seen the clinical evidence and has seen the patient need and has authorized some amount of use, whether through an authorized prescriber or through special access here in Canada. And late last year, we announced a partnership with the University of Calgary to gather that real-world evidence and package it together into data. And so that is, you know, in many ways, that is, I don't, I don't want to say it's equivalent to a phase three clinical trial, it is, it is, an alternate data gathering step, but it's much more cost-effective because not only are we gathering this data, but now It's not like a clinical trial. You don't have controls.
Has seen the clinical evidence and have seen the patient need and has authorized some amount of use whether through authorized prescriber or through special access here in Canada and late last year, we announced a partnership with the University of Calgary to gather that real world evidence and to package it together into a data package.
And so that is in many ways that is that.
I don't want to say its equivalent to a phase III clinical trial. It is it is a an alternate data gathering step, but it's much more cost effective because not only are we gathering this data and now we can talk to prescribers with our controlled substances license.
But but this is very very valuable data about how these these treatments rollout in the real world.
And the real worlds messy right, it's not like a clinical trial you don't have controls.
Speaker 1: You know, we did a webinar last year and one of the, I don't know if you were listening in on that one, Shane, but one of the clinicians on that webinar basically said, oh yeah, we did a treatment, and we did a virtual one. And as far as I know, that's the first time that MDMA has ever been administered through a virtual therapy session. It's never happened in clinical.
We did a webinar last year and one of the I don't know if you were listening in on that one train, but what are the clinicians on that webinar basically said Oh, yes, we did a treatment and we did it virtually and as far as I know that's the first time that MDMA has ever been administered through a virtual therapy session that has never happened in clinical trial.
Speaker 1: So gathering that data on how this works in the real world is hugely, hugely important, but it also means that we can gather that data and we can submit it to regulators, which is, you know, that's huge, it's important. It also has a huge benefit for helping us at the forefront of this treatment with this molecule to be able to obtain that data and lessons from prescribers here in Canada. I think that's gonna be vitally important as we interact with prescribers in Australia and elsewhere in the world, being able to take data and lessons learned from prescribers here in Australia under the SAP program and apply them to people in particular with PTSD and understand how this operates and understand the prescriber's perspective on this. I think it will be, you know, pretty cutting-edge data gathering and pretty cutting-edge treatment information. Yeah, absolutely.
Gathering that data on how this world's out in the real world is hugely hugely important but it also means that we can gather that data and we can submitted to regulators which is.
That's huge.
It also has a huge benefit for <unk>.
Helping us at the forefront of this treatment with this molecule to be able to obtained up data.
Lessons from prescribers here in Canada, I think thats going to be vitally important as we interact with prescribers, Australia elsewhere in the world.
Being able to be.
In a position to take that and lessons learned from prescribers here in Australia, and the SAP program.
And our clients to people, particularly with PTSD and understand how this operates on a standard prescribers perspective on this I think it will be.
Pretty cutting edge.
Got it got them pretty cutting edge.
That treatment.
Information.
Speaker 1: So for anyone listening in, if you'd like to ask questions, you can ask them during the Q&A. We're going to get started on the questions in just a few minutes. I did want to just sort of preface the Q&A portion with some of the milestones that we anticipate seeing in the next couple of months. So, as I think most people are aware, Lycos Therapeutics, which was previously known as MAPS Public Benefit Corporation, submitted their full new drug application to the Food and Drug Administration in the U.S. And, frankly, in the next couple of weeks, we should see from FDA an indication of when they expect to have So FDA has a choice between fast tracking this, and that would be a six-month review period, or the regular track, which is a 10-month review period. And we're gonna find out what's gonna happen there relatively quickly.
So for anyone listening in if you'd like to ask questions. You can ask them through the Q&A, we're going to get started on the questions in just a few minutes.
I did want to just sort of.
The Q&A portion with some of the milestones that we anticipate seeing in the next couple of months. So as I think most people are aware lycos therapeutics, which was previously known as maps public benefit Corporation in December they submitted their full new drug application to the food and drug administration in the U S and frankly in the next couple of.
Weeks, we should see from FDA and indication of when they expect it to have an answer on that application. So FDA has a choice between fast tracking this and that would be six months.
Review period or the regular track, which is a 10 month review period, and we're going to find out what's going to happen there relatively quickly, but there's lots of really good progress all over the world now obviously, we mentioned the MDMA treatment that happened in Australia recently.
Speaker 1: But, you know, there's lots of really good progress all over the world now. Obviously, we mentioned the MDMA treatment that happened in Australia recently. Clarion Clinics, which is one of our customers, recently announced they have now been authorized to start issuing prescribed prescriptions under the authorized prescriber scheme.
Clarian clinics, which is one of our customers.
We announced that they've now been authorized to start issuing prescribed prescriptions under the authorized prescriber scheme and then in April the EU is hosting a large forum.
Speaker 1: And then in April, the EU is hosting a large forum for regulators and trade groups on psychedelics and psychedelic medicine, and the regulations around it. So lots of really interesting and good progress on that happening all over the world. So with that, I mean, the really point of this webinar is to give everyone out there a chance to ask their questions; please do write them in the chat. And I'm going to ask our friend Conway to start reading out some of these questions, and Shannon, I'll answer them as they come in. Absolutely. The first one is coming from us from an anonymous user.
For regulators and trade groups on.
Gadhelic psychedelic medicine, the regulations around it so lots of really interesting and good progress on that.
Happening really all over the world.
So with that I mean, the really the point of this webinar is to give everyone out there a chance to ask their questions. Please do write them in the chat.
And I'm going to ask our friend Conway to start reading out some of these questions and Shannon and I will answer them as they come in.
Absolutely. The first one is coming from someone anonymously you there I am curious about the onshore manufacturing in Australia. If it has commenced.
Speaker 1: I'm curious about onshore manufacturing in Australia, if it has commenced. So we have not yet commenced onshore manufacturing in Australia, but we anticipate starting that in the next couple of months. As you'll recall, the terms of the JV were structured so that at first, Cortexa could get our inventory, the previously manufactured inventory from Parmala, and then could move into manufacturing as the market need sort of developed in other ways. There are a lot of really good reasons to manufacture in Australia. One of the biggest being, I say this endlessly, but I'll keep saying it. Export is really hard.
So we have not yet commenced entre manufacturer in Australia, but we anticipate starting that in the next couple of months.
As Youll recall the terms of the JV was structured so that at first cortex that could get our inventory.
<unk> manufacturing inventory from Formula and then could move into into.
<unk> as the market need sort of developed in Australia.
A lot of really good reasons to manufacture in Australia, one of the biggest being.
I say this endlessly, but I'll keep saying it.
Import export is really hard.
Shane Morris: And we put a lot of pressure on Shane to land a lot of deliveries over the last couple of months, and he's done a brilliant job at it. But you know, outsourcing that manufacturing lowers our costs, it brings us closer to the customer, closer to the patient again. Patient-centric. And so I think that's really, really critical, um, Shane, anything else you want to mention about that? Yeah, I think it should be remembered that there have been products sent, our products sent to Australia, so finished product and also API. So we feel that we're in a very good position to supply in the next couple of months as Australian patients come online with our product. We have obviously done a lot of work in setting up for onshore manufacturing in Australia. We've done the audit assessments to where we need to be. We understand the systems and the processes and the quality requirements very well. So from that perspective, I think, you know, they're ready, you know, pretty much ready to go in the grand scheme of things.
We've put a lot of pressure on chain to land a lot of deliveries over the last couple of months and he has done a brilliant job at it but onshoring that manufacturing and lowers our costs. It brings us closer to the customer closer to the patient again patient centric.
And so I think thats really really critical.
Jean anything else you want to mention about that.
It should be remembered that.
Terry.
Has being product sent our product center, Australia sell finished products and also <unk>.
So.
We feel that we're in a very good position to supply and in the next couple of months as Australia patients come online.
Product.
We have obviously done a lot of work and setting up for onshore manufacturing in Australia, we've done.
The audits assessments are need to be.
Understand the systems and the processes and the quality requirements very well so from that perspective I think.
They are ready.
Pretty much ready to go in the Grand scheme of things.
Speaker 1: But I'm pretty confident that there is enough product, finished product, in Australia right now to help, you know, support the first number of months, at least, considering the rate of rollout that we're seeing. Remember, we've just seen one happen in Australia. So certainly, I think we're in a very good position and our partners in Cortex are delighted not only to have a finished product but API on hand to start manufacturing whenever it's required, and I just see that there's another question here around whether we will need to import more material for Cortexa or whether they have enough. Well, look, we will do what is necessary to make sure that we don't run out of product. So if we need to import more to Australia, we will.
But I'm pretty confident that.
There is enough products finished product in.
Australia right now to help.
Supports.
Number of months at least considering the rate of rollout that we're seeing where everyone's have seen one.
Happen in Australia. So certainly I think we're in very good position in our partners and cortex are delighted not only to have finished product, but API on hand to start manufacturing whenever it's required.
And I just see that there was another question on here around whether we will need to import more material corporate tax or whether they have enough.
Look.
We will do what is necessary to make sure that.
We don't run out of product. So if we need to import more to Australia, we will.
Speaker 1: I think we've been very, very clear that it's our preference to just get to manufacturing in Australia, but the biggest priority at the end of the day is making sure that there are no patients, deserving patients who are missing out on treatments because of inventory bottlenecks. So if we need to import, we will, with the goal, of course, of getting manufacturing going as a major priority. Again, demand planning is a challenge for everybody in the space.
I think we've been very very clear that it is our preference to just get to manufacturing in Australia, but the biggest priority at the end of the day is making sure that there are not patients deserving patients who are who are missing out on treatments because of.
Inventory bottlenecks so.
If we need to import we will.
With the goal of course of getting manufacturing going is a major priority for US again to mine planning is a challenge for everybody in the space No one knows.
Shane Morris: No one knows how big and how quick the ramp-up will be, but we're, I believe, very well positioned in Australia right now with both finished product and API ingredient, MDMA powder, essentially, to encapsulate whenever we feel fit. So we've done a good job at managing both the reliability of supply for demand, which is unknown at this point. We've obviously planned it out in some degree, but we feel very confident that there won't be any patients left wanting in Australia for our product at any time in the near future or in the longer term once we decide to pull the trigger, or Cortex decides to pull the trigger on manufacturing. Conway, do you want to take us to the next question?
How big and how quick the ramp up will be but were I believe very well positioned in Australia right now with both the finished product.
API.
Ingredients.
DMA tighter essentially to encapsulate whenever we feel fit so we've done a.
A good job managing both the reliability of the map.
Supply, Florida demand, which is unknown at this point.
<unk> planned to some degree, but we feel very confident that.
There won't be any patients left wanting in Australia for our product.
Anytime.
In near future or in the longer term once we decide to pull the trigger or Texas decide to pull the trigger on manufacturing.
Yes.
Con way do you want to take us to the next question absolutely disciplined with regards to the our trial in Calgary.
Conway: Absolutely. This one is in regards to their trial in Calgary. Has that, or is her heart's trial begun?
That <unk> begun.
Speaker 1: Yeah, so the answer is yes. We've been treating, you know, a number of patients every month since May of last year, or I should say, we haven't been treating them. We've been providing the drug for the treatment of patients since May of last year. So there's been a number of patients that have gone through one or two dosages. I don't know that anybody's done all three doses in the protocol yet
Yes, so the answer is yes.
We've been treating a number of patients every month since may of <unk>.
I should say, we haven't been treating them, we've been providing drug for.
For the treatment of patients since may of last year. So there's been a number of patients that have gone through one or two dosages I don't know that anybody has done all three doses in the protocol yet.
Shane Morris: But, but yeah, we've started data gathering. And really, I think a big priority for us now that we have our controlled substances license is starting to talk to prescribers, starting to talk to clinicians, and really making them aware of what this type of therapy is all about and what they can expect. And, you know, what potential benefits might exist for patients, with the goal, obviously, of trying to increase the number of patients if they are deserving, in the opinion of the clinicians, and they meet the qualifications for the special access program. I would also add that it's vitally important that people realize that this is a clinical trial that is run by the University of Calgary, essentially. We are obviously partners in the process.
But but yes, we've started data gathering and really I think a big priority for US now that we have are controlled substances license is starting to talk to prescribers starting to talk to clinicians and really making them aware of what this type of therapy is all about what they can expect.
And what potential benefits might exist for patients with the with the goal obviously is trying to increase the number of patients.
If they are deserving in the opinion of the clinicians and they meet the qualifications for the special access program.
I would also add I think it's vitally important that people realize statistic clinical trial that is.
Run by the University of Calgary essentially.
We obviously are partners in the process, but at the end of the day.
Shane Morris: But at the end of the day, we certainly won't be interacting with the prescribers as part of that research. It's really between, you know, understanding, getting an insight into the prescriber's processes and opinions, and you know how it worked for them as a prescriber and how did they see improvements for the University of Calgary to bring that to publication and to release those results at the end of the day.
We certainly.
Won't be interacting with key prescribers as part of that.
Research, it's really between.
Understanding.
Getting an insight into the prescribers.
Processes.
Openings.
How it worked for them that's a prescriber.
Im sorry.
How did they see improvements for university of Calgary to bring that to publication to release those results at the end of the day.
Shane Morris: I think it's vitally important that that gap between the prescribers and any drug manufacturers is well maintained. Yeah, we don't hold patient data within PharmaLA for a very good reason. We have pharmacovigilance agreements, so if there are any adverse events, of course, the drug product manufacturer, we are obligated to get that information submitted to Health Canada where it is deemed appropriate. But on confidential patient information, we don't
I think it's vitally important to top.
GAAP between.
To prescribers and any drug manufacturers.
Well contained.
We don't hold patient data within for Mueller.
For very good reason, we have pharmacovigilance agreement. So if theres any adverse events of course, the drug product manufacturer. We are obligated to get that information submitted to health, Canada, where it is deemed appropriate but.
But on confidential patient information, we don't hold it and that's part of the reason why we're working with University of Calgary.
Speaker 1: And that's part of the reason why we're working with the University of Calgary to gather that data. And they're very well equipped for it. Leah Mayo, who's the lead researcher there, Dr. Leah Mayo, I actually just saw her this morning because I am in Calgary right now.
Out of that data.
And they are very well equipped for it Lia Mayo was the lead researcher their doctor the email.
I actually just sorry, this morning, I am in Calgary right now.
Speaker 1: And she's a brilliant researcher. She knows exactly how to do this properly, safely, and correctly. And so really, the job for us is just to make sure that there's supply for patients and then let the University of Calgary researchers do their work. Next question.
And she's a brilliant researcher she knows exactly how to do this properly safely correctly.
So really the job for US is just make sure that their supply for patients and then let the university of Calgary researchers do their work.
Next question.
Speaker 1: How will we fund the clinical trials? We talked about this a lot, right? So for the University of Calgary, that's an observational trial; it's not a clinical trial. So for that, you know, we're not funding that in any way. For our own novel molecules, we, we are definitely looking at a whole bunch of different funding opportunities for that. We have actually completed the design of the ALA002 clinical trial.
How will we fund the clinical trials.
We've talked about this a lot right. So for University of Calgary, That's an observational trials on a clinical trial so for that.
Funding that in any way.
For our own novel molecules. We we are definitely looking at a whole bunch of different funding mechanisms we.
We have actually completed the design of the 002 clinical trial.
Speaker 1: We worked with a researcher named Adam Guastella over at the University of Sydney, also in Australia, to develop that protocol, and it is complete. In terms of funding, I think there are two ways to do this. The first way is, you know, just raise a bunch of money and do it. Do you know what I mean? Hire the people, pay the University of Sydney or whatever clinical trial site we decide on, and just do the trial. That's fine.
We worked with a researcher.
Adam <unk> over at the University of Sydney also in Australia.
To develop that protocol and it is complete in terms of funding and even people theres two ways to do this the first way is just raised a bunch of money and do it maybe and hire the people pay the university of Sydney or whatever clinical trials site, we decided on and just do the trial.
That's fine there are some drawbacks to it though and one of them quite frankly is we are a small team and we're not specialized in clinical research where specialized in preclinical research harpreet and her team do a lot of preclinical where specialized in drug discovery and drug design, we're not specialized in clinical research and so.
Speaker 1: There are some drawbacks to it, though, and one of them, quite frankly, is that we're a small team and we're not specialized in clinical research. We're specialized in preclinical research. Harpreet and her team do a lot of preclinical research
Speaker 1: We're specialized in drug discovery and drug design, but we are not specialized in clinical research. And so building that capacity in-house is challenging and expensive.
Building that capacity in house.
It is challenging and expensive.
Speaker 1: The other option, which we're pursuing very aggressively, is out-licensing with large pharmaceutical companies. And in the pharma industry, this happens all the time. So, you know, you develop a new drug, you get it to a point where it's ready to go for phase two, and then you seek partners with significant experience in clinical trial management design, and you basically work out a licensing deal with that company to do that work. And I can't go into details about what's going on on that front. What I can say is that Harpreet and I have been working diligently.
The other option, which we're pursuing very aggressively is out licensing with large pharma companies and in the pharma industry. This happens all the time.
So you develop a new drug you get it to a point where its ready to go for phase two and then you seek partners with significant experience in clinical trial management design.
And you basically work at a licensing deal with that company to do that work.
And I can't I can't go into details about what's going on on that front, but I can say is heartbeat and I have been working diligently.
Speaker 1: You know, I think it's public knowledge that we were at the JP Morgan Conference in San Francisco just last month, meeting with representatives of the pharmaceutical industry. So, you know, if I had my choice, I would pick that option, you know, stay in our lane, continue to specialize in what we are very, very good at, and work with, you know, folks who are very, very good at what they do to accomplish that. It was awesome.
I think it's public knowledge that we were at the JP Morgan Conference in San Francisco, just last month meeting with representatives of the pharmaceutical industry. So if I had my choice I would pick that option.
Anr Lane continue to specialize in what we are very very good at.
And work with.
Folks who are very very good in what they do to accomplish those trials.
Okay.
Speaker 1: I'm going to tie in two questions together. What other benefits does the Health Canada license allow Formala Biotech to explore? And how many other companies have a similar license in Canada? Okay, do you want me to take that, Nick? Yeah, I'll take it.
To tie two questions together, what other benefits does help.
The health, Canada license allow from Allah biotech to explore and how many other companies have a similar license in Canada.
Okay.
Nick.
Take care all taken a reverse.
Shane Morris: I'll take it in reverse. So basically, the license that we obtained, there are many organizations that have a similar dealer's license. However, the license itself has to be specified. Once you're dealing with a controlled substance, you actually have to specify on the license the specific molecule that you're working with. So while someone could have a dealer's license, there are very few, I believe, that would have MDMA listed on their license. Now, you can also, once you have a license, apply to Health Canada to add a substance, a controlled substance, to your license, but there's a set of requirements that go with that, so it's not necessarily a numbers game in relation to how many licenses there are that are similar, but the conditions and the license. What are the benefits?
<unk>.
So basically the license that we obtained there are many.
Organization.
Similar to either license. However, the license itself has to be specified.
Once youre getting on controlled substance you actually have to specify on the license.
<unk>.
Molecule that youre working with so now while.
While someone could hover theaters license Theres very few are you believed out with hubs.
<unk> listed under license now you can also once you have a license you can apply to health Canada too.
The substance of controlled substance to year license, but there's a set of requirements that are.
That go with that.
So.
It's not necessary.
<unk> game or I should say, how many licenses there are similar but it's what is permitted within that license Aida conditions under license.
What are the benefits certainly as we've outlined.
Shane Morris: Certainly, as we've outlined, the benefits range from being able to proactively, you know, cell, that definition of selling is interacting with other appropriately licensed individuals, organizations, being able to work with people who, you know, doctors or prescribers, hospitals, etc., allows us to be in a much stronger position to be involved in clinical research as well. Certainly, there are, you know, options around Section 56s that it opens So, I think that, you know, really what it does is it puts us on the right footing to be able to continue growing and understanding patient needs. Absolutely. And again, like, you know, you'll hear me say this a lot, but, you know, keeping patient-centered is really critical in all this. At the end of the day, there's no more persuasive argument in favor of, you know, continued regulatory change and movement in this space than positive patient outcomes. And so we just have to we have to do everything we can to keep that front. Bombay.
But the benefits ranged from being able to.
Sure.
Proactively.
Cell Act.
The definition of selling is interacting with other appropriately.
Licensed individuals' are conversations being able to work with.
People, who.
Doctors prescribers hospitals et cetera allows us to be much stronger position to be involved in clinical research as well.
And really there is.
Options around section 56 is that it opens up as well so I think it.
Really.
Does is it puts us on the right footing to be able to continue growing.
Understanding the patient needs.
And again, you'll hear me say this a lot, but keeping patient centered is really critical and all this at the end of the day. There is no more persuasive argument in favor of continued regulatory change and movement in this space than positive patient outcomes and.
And so we just have to we have to do everything we can to keep that front and center.
Conway: Awesome. I'm going to lump some questions in together. Do we have any talks with pharma companies on ALA? And will trials for ALA start in the first quarter?
Awesome.
Lumpkin questions and together do we have any talks with pharma companies on.
And.
We will trial for early start in the first quarter.
Speaker 1: Uh, so I can't guarantee that the trials will start in the first quarter. There's, you know, there's lots of work that goes into a clinical trial. We're doing the best that we can to move this forward, but I think everyone who's sort of aware of this space has seen timelines slip for like every single company out there. And in terms of funding those trials, as I said, our goal is to work with large pharma to outlicense some of our novel IP assets and to make sure that we are going into these trials with partners. And so, you know, if I am given a choice between, you know, waiting for a few more months and landing a really great partner, or just trying to go at ourselves just to hit an arbitrary timeline, I think the best outcomes for shareholders, for the company, and for patients are to work with, you know, the best possible partner. And for us, I think we've proven that we are capable of doing that.
So I cant guarantee that the trials will start in the first quarter. There is there's lots of work that goes into a clinical trial. We're doing the best that we can to move this forward, but I think everyone who's sort of aware of this space has seen timeline slipped four like every single company out there.
And in terms of funding those trials as I said, our goal is to work with large pharma to out license.
Some of our novel IP assets.
To make sure that we are going into these trials with partners and so.
If I am given the choice between.
Waiting for a few more months and landing a really great partner or just trying to go it ourselves just to hit an arbitrary timeline I think the best outcomes for shareholders for the company and for patients is to work with the best possible partners and.
For Us I think we've proven that we are capable of doing that cortex is a great case study and a best in class market entry with the best possible partners done on a great timeline.
Speaker 1: You know, Cortexa is a great case study of a best-in-class market entry with the best possible partners done on a great timeline. And so this is a different type of commercial transaction, but that's the kind of success that we want to replicate.
And so this is a different type of commercial transaction, but that's the kind of success that we want to replicate.
Speaker 1: On the topic of partnerships, can you elaborate on an eventual partnership you are still pursuing? And what about a partnership with Otsuka? Is that another one? So I can't.
On the top of the partnerships can you elaborate on an eventual partnership you are still pursuing and what about our partnership with Otsuka is another question.
Speaker 1: One of the requirements of a non-disclosure agreement is that you can't talk about any non-disclosure agreement. No, look, we're talking to a whole range of partners. We're working hard. I'm not going to comment on any specific companies. I'm not going to comment on any specific deals.
So I can't.
Now one of the one of the requirements of a non disclosure agreement as you can't talk about any Nondisclosure agreement I don't know look.
We're talking to a whole range of partners, we're working hard I'm not going to comment on any specific companies not going to comment on any specific deals I think you guys know what the goals are for the business. We've elaborated those very very clearly and we're pursuing those goals.
Speaker 1: I think you guys know what the goals are for the business. We've defined those very, very clearly, and we're pursuing those goals.
Awesome.
Speaker 1: Based on the successful Q1 financials, are we seeing similar trends for demand or greater in Q2? Anything you can elaborate on operations increasing capacity would be appreciated, um again uh you know one of the requirements for a publicly traded company is we can't talk about financials until they're released to the broader market so i'm not going to talk about like broad trends i'm not going to talk about what's going to happen in the next quarter financials what i will say is uh and i said this earlier on the webinar i think you know set expectations at the right level it's an early it's early days in this industry right first mdma treatment in australia just happened, So it's gonna take some time for things to sort of level out and stabilize.
Based on the successful Q1 financials are we seeing similar trends for demand or greater in Q2 anything you can elaborate on operations increasing capacity would be appreciated.
Again.
One of the requirements for a publicly traded company as we can't talk about financials until they are released to the broader market. So I'm not going to talk about like broad trends I'm not going to talk about what's going to happen in the next quarter financials, but I will say is.
I said this earlier on the webinar I think set expectations at the right level. It's early it's early days in this industry right first MDMA treatment in Australia, just happens so it's going to take some time for things to sort of level out and stabilize it's going to be choppy, but the goal as long as we all keep that goal in mind is to increase.
Speaker 1: It's gonna be choppy, but the goal, as long as we all keep that goal in mind, is to increase our capacity, increase our throughput, increase the number of patients that are benefiting from these types of treatments. And as long as we do that, and I think we have, right? I think the numbers that we've released show that we have, I think everyone's gonna be very, very pleased with the results. Shane, anything you want to add?
Our capacity increase our throughput increase the number of patients that are benefiting from these types of treatments and as long as we do that and we I think we have right I think the number that we've released show that we have.
I think everyone's going to be very very pleased with the results Shayne anything you want on that certainly.
Shane Morris: Certainly, I think we, maybe the questioner hadn't heard the start of the call. I think, you know, from a demand plan perspective, I think you're seeing it be not very clear on when and how demand is going to hit. So we're trying to manage our resources accordingly and correctly. The worst situation you want to be in is to have, you know you know 3x too many the capsules on hand that we would want to have and then going you know they essentially go expiring uh so then you've got you know capital wrapped up in uh inventory which is it's not good application so we're trying very very hard to uh understand what the question is asking is looking at demand plan uh certainly uh i think it's interesting just from a timing perspective as you said nick there's just being the first um prescription australia but there is a real you know clear intent for the australian market in particular to want to be successful as a whole you've seen just the closing uh very recently in the last number of days of the tga's consultation on the quality standards required that they will put in place for uh so far than an mdma uh so certainly we've been involved in those discussions uh so you know that hasn't even been established yet uh in australia so just uh you know i think to reiterate nick's point um we don't have a crystal ball we're not making nikes where we can have 30 years of uh understanding of where demand is going to you know the trends and demands i think we're looking at opportunities and we're making sure we're rightly positioned rightly placed and we will and executing in a manner that will ensure that we are well positioned to take advantage of all the opportunities that exist around the world on you know in this space, Yeah, there's a number of questions in the chat about other markets beyond Canada, Australia and the United States to open up. And maybe I'll address all of them sort of altogether.
I think we maybe the questionnaire hadn't heard you started the call I think.
From a demand planning perspective, I think you're seeing it.
Not very clear.
When and how demand is going to hit so we're we're trying to manage our resources accordingly and correctly. The worst situation do you want to be in is to have.
No.
Three X too many the capsules on hand that we would want to have in them going.
Essentially expiring.
You've got capital wrapped up in inventory, which is not good application. So we're trying very very hard to understand what the question is asking is looking at the math.
Certainly I think it's interesting just from a timing perspective as you said think theres just being the first.
Prescription Australia, but there is a clear.
Clear intent is for the Australian market in particular to want to be successful as a whole you've seen just to closing.
Very recently in the last number of days of the <unk> consultation on the quality standards required start they will put in place for.
Nm DMA. So certainly we've been involved in those discussions.
No.
It hasnt even been established yet.
Australia, So just.
I think to reiterate mikes point.
We don't have a crystal ball, we're not making nike's, where we can have 30 years of understanding of where demand is going to.
The trends in the bonds I think we're looking at opportunities.
Sure, we're rightly positioned rightly placed.
And we will.
Executing in a manner that will ensure we are well positioned to take advantage of all the opportunities that exist around the world.
In this space.
Yes, there's a number of questions on the chat about other markets beyond Canada, Australia, and the United States to open up maybe I'll address all of them sort of altogether.
Speaker 1: So, we don't know in advance if a government is going to change its minds on regulation. But we do engage heavily with a number of governments because this is part of the work that we do, right? Like, you know, in addition to my work with Pharmala, I'm the board chair for SCICAN, which is the Trade Association for Psychedelics Companies in Canada. I already mentioned that there is a major meeting happening in the EU to talk about psychedelics regulation in April. We obviously, as SCICAN, very much hope to participate in that. I'm certainly planning to be in Amsterdam for that meeting, if they allow industry reputation or representation, which I believe that they will. But broadly speaking, you know, some of the countries that we've talked about in the past, Brazil is very interesting, the EU, the UK, and each of these countries has its own regulatory systems, each has its own sort of advocacy groups within those countries. But right now, our focus is, you know, we know that we can enter a new market if we need to. We did it in Australia; we can do it again.
So.
We don't know in advance if the government is going to change their minds on regulation.
We do engage heavily with a number of governments because this is part of the work that we do right.
In addition to my work with <unk> and the board Chair for <unk>, which is the trade Association for Psychedelics companies in Canada, I already mentioned that there is.
A major meeting happening at the EU to talk about psychedelics regulation in April.
We obviously have sight can we very much hope to participate in that and certainly planning to be in Amsterdam for that meeting if they allow industry reputation overrepresentation, which I believe that they will.
But broadly speaking you know some of the countries that we've talked about in the past, Brazil is very interesting the EU the U K.
In each of these countries have their own regulatory systems, each has their own sort of advocate groups within those countries, but right now our focus is.
We know that we can enter new market, if we need to we did it in Australia, we could do it again, our focus is on growing the markets in those countries, which already allow for the use of these molecules and Thats right now, Canada, and Australia, where we're at.
Speaker 1: Our focus is on growing the markets in those countries which already allow for the use of these molecules. And that's right now, Canada and Australia, where we are. And regulatory change takes time. Look at any other sector you want. I've been hearing for... 10 years, well, nearly 8 years now, that the legalization of cannabis in Germany is going to happen any day soon. So obviously, you want to manage your expectations around regulatory change because it's subject to a whole host of political pressures; nothing's ever completely guaranteed in this space. So again, I think we're positioning ourselves in a way where we can actually expand markets that we know exist, that are solid, that we have partners in, and that we certainly want to get our product into the hands of prescribers and patients so that we can get that data feedback from different Yeah Yeah, that's exactly right.
And regulatory change takes time.
Look at any other sector you want wetter.
<unk> been hearing for.
10 years eight years now.
Legalization of cannabis in Germany is going to happen any day. Soon so obviously you want to manage your expectations from a brand regulatory change because it's subject to a whole host of.
Political.
Pressures.
Nothing's ever completely guaranteed in this space. So again I think we're positioning ourselves in a way where we can actually.
Spot markets that we know exist.
Our solid.
We have partners in them that we certainly want to be.
Get our product into the hands of prescribers and patients. So that we can get tapped out or feedback from different markets as quick as possible.
Yeah, that's exactly right. There's also a number of questions about FDA FDA timelines on the maps approval and then our sort of work in the United States. So I'll remind everyone that last year, our materials are linear MDMA capsules.
Speaker 1: There are also a number of questions about FDA, FDA timelines for MAPS approval, and then our sort of work in the United States. So I'll remind everyone that last year our materials, our Lineo MDMA capsules, were accepted by the US FDA for use in clinical trials in the United States. So we already supply clinical trials in the US, and we will continue to do so as clinical trials come online. I don't think that the clinical trial space with MDMA is over; we're not there yet. There are a lot of clinical trials in the pipeline, including just recently the VA, the Veterans Affairs Administration in the United States recently announced a large grant funding envelope for research on PTSD with MDMA.
<unk> accepted by the U S FDA for use in clinical trials in the United States. So we already supply clinical trials in the U S and we will continue to do so as clinical trials come online I don't think that the clinical trial space with MDMA is over.
There yet there is a lot of clinical trials in the pipeline, including just recently the VA. The Veterans Affairs administration in the United States recently announced a large grant funding envelope for research on PTSD with MDMA. So obviously, we would love to participate in that and loved to be suppliers for that.
Speaker 1: So obviously, we would love to participate in that and love to be suppliers for that research when those grants are awarded because they haven't even been awarded yet. Grant timelines take a long time. For anyone who has been around in academia, it's like, it's the long haul, it's a slog.
For that research when those grants are awarded because they haven't even been awarded yet.
Grant timeline to take a long time for anyone who has been around in academia.
It's like it's a long long, it's a long haul to slog.
Speaker 1: I think we've proven that we're very, very successful in working with researchers. And to Shane's previous point, developing that reputation of customer service for our research customers is critical. There's always gonna be somebody who pops up who says like, I'm gonna do this, I'm gonna do it quick. Don't worry, I'll do it quick and cheap.
But we've I think we've proven that we've been very very successful in working with researchers.
And to <unk> previous point developing that reputation of customer service for our research customers.
Is critical.
Theres always going to be somebody who pops up who says like I'm going to do this I'm going to do a quick don't worry I'll do a quick and cheap.
Speaker 1: But what we've seen a lot of the time is those people pop up, and then they say they're gonna do stuff, and then they don't do it. And then researchers are left scrambling. Cortex is speaking to a researcher in Australia right now who basically had a deal in place for supply, and then that supply fell through, and they've been waiting for a full year to start their clinical trial. And so you can imagine the cost involved in keeping researchers just sitting around and waiting. So a lot of the work that Shane does now is sort of jumping into those discussions and trying to very quickly sort of alleviate that demand and make sure that we actually land the material and get that research going.
But what we've seen a lot of the time as those people pop up and then they say theyre going to do stuff and then they don't execute.
And then researchers are left scrambling.
Cortex is speaking to a researcher in Australia, right now, who basically like how to deal in place for supply.
And then that supply fell through and they've been waiting for a full year to start their clinical trial and so you can imagine the cost involved in keeping researchers just sitting around and waiting.
So a lot of the work the chain does now is sort of hopping into those discussions and trying to very quickly sort of alleviate that demand.
And make sure that we actually land material and get that research going.
In terms of the maps.
Speaker 1: In terms of MAPS approval, as I've said, in the next couple of weeks, we're gonna hear from FDA on what the timeline is, six months to 10 months. But keep in mind, it's actually gonna be a little bit longer than that. Usually, during the new drug application process, they're going to come back to the sponsor company with questions. And each time they ask a question, it's like speed chess. You stop the clock, and you sit, and you know they don't count time waiting for a response as time towards their application deadline.
Approval as I have said in the next couple of weeks, we're going to hear from FDA on what what the timeline is six months to 10 months keep in mind is actually going to be a little bit longer than that usually during the new drug application process theyre going to come back to the sponsor company with questions and each time. They ask the question. It's like it's like speed chess they stop the clock.
You sit in.
They don't count time waiting for a response as time towards their application deadlines and so.
Speaker 1: And so, you know, if they say six months, maybe eight, if they say 10 months, maybe 12, sometimes longer, it was very, very difficult for us to predict in advance how the regulators were going to react to this. I do think it's positive that MAPS has a breakthrough therapy designation because, if you look at the historical record, most drugs are not approved, but FDA has approved actually slightly more than 50% of all the drugs submitted that have breakthrough therapy designations. So, sort of, the wind is in our sails from that. Conway, any other questions you want to read out for us? Absolutely not. This user is curious how or if the numinous mass steel will affect Pharmala or the industry as a whole. I don't know, it's really hard to say.
If they say six months, maybe eight if they say 10 months, maybe 12 <unk>.
Sometimes longer.
It was very very difficult for us to predict in advance how the regulators are going to react to this I do think it's positive that maps has a breakthrough therapy designation because if you look at the historical record.
Most drugs are not approved but FDA has approved actually had slightly more than 50% of all the drugs submitted that have breakthrough therapy designation, so sort of a wind is in our sales from that perspective.
Conway any other questions you want to read out for us absolutely.
Just curious how or if the numinous map deal will affect formula or the industry as a whole.
I don't know really hard to say.
Speaker 1: I will say, you know, we speak to Numinus often. Numinus not only works with MAPS, they are also an SAP provider in Canada, and we've provided materials for a number of SAPs that Numinus has done at their clinic site. So, I hope to continue working with them as they move forward. I'm glad to see that they got funding, because that's really, really important. Glad to see some money flowing back into the sector because, you know, as with most of these things, a rising tide does lift all ships. From Lucas, a projection on how many patients we are expecting in 2024 and 2025. Geez, Lucas, I wish I knew that.
I will say, we speak to new minutes often.
Numinous not only does work with maps. They also are an SAP provider in Canada, and we've provided materials for a number of Sap's numinous has done at their clinic site. So hope to continue working with them as they as they move forward glad to see that they got funding because that's really really important glad to see some money flowing back into the sector.
I think.
As with most of these things a rising tide does lift all ships.
Awesome.
From Lucas our protection on how many patients we are expecting in 2024 and 2025.
Jeez Lucas our winter demand.
I wish I view that.
Speaker 1: That would make our lives a lot easier. Yeah, absolutely. OK, if we knew that, my job would be, you know, super easy. We're basically ensuring that along our value chain, no matter what the number of patients we have or that we get happy to access, we will be in a position to supply the value chain at the right points at the right times for the right regulatory systems. So whether that's FEP in Canada here or not, we're well positioned to find that out. And we do that on an ongoing basis. We have Australia.
That would make our lives a lot easier.
Absolutely.
If we knew that my job would be.
Super easy.
We're basically ensuring along our value chain no matter, what the number of patients we have.
We can be able to access we will be in a position to supply the value chain at the right points at the right times.
Florida right.
Regulatory systems, so weathered ups.
S&P in Canada here.
We're well positioned.
Despite that I would do that on an ongoing basis.
We have Australia, we're now well established we got products.
Shane Morris: We're now well established. We've got product on the ground in various formats. We can pull the trigger on manufacturing if we see demands start to ramp up, or we can export what we have products here available within probably four or six weeks.
Underground various formats.
We can pull the trigger on manufacturing.
Demand, if we see demand start to ramp up or we can export while we have products here available within probably.
Four to six weeks, we can move product pretty quickly.
Shane Morris: We can move product pretty quickly. So we're certainly well positioned to be able to answer your question. Well, you know, we do our own estimates, we have ranges, and we're trying to do this in a logical manner and make sure that we don't overspend or underspend to service those patients. Absolutely.
So, we're certainly well positioned to be able to answer your question.
Wow.
We do our own estimates we have ranges, we're trying to do this in a logical manner.
Make sure that.
We don't overspend or understand to service those patients absolutely.
Speaker 1: I think that's going to be the last question; maybe we'll get two more in, but there's a question about how we're educating therapists and what tools we're providing to them to streamline their processes. And on that, I will mention again, the Controlled Substance License we are granted does offer us some more tools in speaking with clinicians and providers. There are other groups working on this as well. For example, MAPS Canada, which is not the same organization as MAPS in the United States. It is a charity here in Canada, so MAPS Canada recently released an SAP guide.
I think this is going to be the last question, maybe we will get two more in but there's a question about how we're educating therapists and what tools, we're providing to them to streamline their processes.
And SAP.
And on that.
I will mention again the controlled substance licenses were granted does offer some more tools and speaking with.
Clinicians providers.
There are other groups working on this as well so maps, Canada, which is not the same organization as maps in the United States. It is a charity here in Canada. So maps, Canada recently released an SAP guide and one of the things we were really gratified to see in that guide was for Molla biotech was listed as the only provider for MDMA for SAP.
Speaker 1: And one of the things we were really gratified to see in that guide was that Pharmala Biotech was listed as the only provider of MDMA for SAP available today. And we are working on in-house tools to help clinicians make their applications and educate them about the nature of these treatments. All of those tools have to be held very, very closely by us, right? We don't want to breach the terms of our license. And so those aren't available to the general public. Those are available solely for practitioners who are licensed.
<unk> today.
And we are working on in house tools to help clinicians make their applications and educate them about the nature of these treatments that all of those tools have to be held very very closely by US right. We don't want to breach the terms of our of our license and so those arent available to the general public those are available solely for practitioners who are licensed.
<unk>.
Speaker 1: But yeah, we're actively working to try and improve education and the availability of information for those clinicians who do want to work with these molecules, and let's see, what about... Do you want to touch on the Israel one, considering? Yeah, so for those who don't know, I'm Jewish. I don't think it's a secret. Certainly, I haven't kept it a secret.
But yes, we are actively working to try and improve.
The education and the availability of information for those clinicians who do want to work with these molecules.
And let's see.
What about <unk>.
Do you want to touch on the Israel alone considering.
Yeah.
So.
Look.
For those who don't know Jewish.
I don't think Thats, a secret certainly I havent kept it a secret.
Speaker 1: So the situation in the Middle East is definitely sort of front and center in my mind. There's a lot of work being done right now to attempt group therapy for folks who were victims of the October 7th attacks in Israel. I'm sorry to say, but there's just like a ton of PTSD right now. There were hugely traumatic events.
So the situation in the middle East is definitely sort of front.
<unk> Center in my mind.
There's a lot of work being done right now to attend.
<unk> therapy for <unk>.
For folks who were victims in the October 7th attacks in Israel.
I'm, sorry to say, but there's just a ton of PTSD right now they were hugely traumatic events. There is hugely traumatic events going on in Gaza right now as well right.
Speaker 1: There are hugely traumatic events going on in Gaza right now as well, right? And regardless of anything else, we don't pick and choose. Trauma is trauma, and patients are patients, but we are in discussions with a number of groups in Israel. If we can help in any way, we've made clear that we're available to help, and, you know, as those discussions come to fruition, we'll be able to comment more publicly, but I think, you know, there is a lot of work to be done. Very, very difficult to work with these types of controlled molecules in functionally like war zones, right? Not that all of Israel is a war zone, but, you know, there is an ongoing war in the Middle East and now in several parts of the Middle East.
And regardless of anything else, we don't we don't pick and choose.
Rama is trauma and patients or patients.
But we are in discussion with a number of groups in Israel. If we can help in any way.
Made clear that we are available to help.
And.
So those discussions come to fruition.
We had more profitability.
A lot of a lot of work to be done very very difficult to work with these types of control molecules.
Functionally like war zones right.
Not that all of Israel as a war zone, but.
There is an ongoing war in the middle East and now in several parts of the Middle East. We also had a number of discussions with groups in Ukraine.
Speaker 1: We also had a number of discussions with groups in Ukraine at the start of that conflict, but, you know, I'll be blunt. I would not want to be accused of, you know, taking advantage of a conflict like that, right? Like, that's not the goal of the company. That's not what we're setting out to do.
At the start of that conflict.
But.
I'll be I'll be blunt I would not want to be accused of.
Taking advantage of a conflict like that right.
It's not the goal of the company that's not what we're setting out to do so these these types of initiatives they have to be sort of driven by folks in those countries.
Speaker 1: So, these types of initiatives have to be sort of driven by folks in those countries, and, you know, we're happy to help. We would like to help. I think that there's a ton of good that we can do in places like Ukraine or Israel or Gaza, but those have to be initiatives that local governments sort of decide to embark upon, and then we are there as a supplier and, of course, like, happy to provide products on a low or no cost basis to do that kind of good work. I think we have pretty unique insights into Israel, in particular. You know, I was there over the New Year and into the New Year.
And we're happy to help we would like to help I think that there is a ton of good that we can do in places like Ukraine, or Israel or Gaza, but those have to be initiatives that local governments sort of.
Decide to embark upon and then we are there as a supplier and of course like happy to provide product on a low or no cost basis to do that kind of bid work I think we have.
Pretty unique insights into Israel in particular.
I was there.
New year and into the new year.
Shane Morris: Certainly, you know, I have a lot of contacts personally and family-wise into the healthcare system in Israel. So, we're watching the space, but I think we're also, as Nick said, very conscious of the fact that, you know, those kinds of treatments and systems, support structures, et cetera, really need to come from within the country, not any pharmaceutical company outside. Absolutely. And with that, I think we're gonna end things here. I know that there are a number of other questions.
Certainly.
We have a lot of contacts personally and salary wise into the healthcare system in Israel. So we're watching this space, but I think we're also as Nick said, we're very conscious of the fact that.
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Those kinds of treatments and systems support structures et cetera, really need to come from within.
Within the country not any pharmaceutical company outside the country.
Yeah.
And with that I think we're going to we're going to end things here I know that there are a number of other questions. As always you can reach out to us at investor that from all of the FCA and send us your questions.
Speaker 1: As always, you can reach out to us at investors@farmala.ca and send us your questions. Like on this webinar, I can't promise that we're gonna be able to answer them all, but we do really, really try to keep an ongoing conversation going with our investors. We do try to keep you guys apprised of things that are going on with the company and in the market. So, thank you for your time. Thank you for your attention. Thanks for joining us. And we hope to be speaking to you soon. Goodbye.
Like on this webinar I can't promise, we are going to be able to answer them, all but we do really really try to keep.
Keep an ongoing conversation going with our investors and we do try to keep you guys apprised of things that are going on with the company and broadly in the market. So thank you for your time. Thank you for your attention and thanks for joining us and we hope to be speaking to you soon.
Goodbye.