Good morning, ladies and gentlemen, and welcome to the Extraordinary General Meeting of Alterity Therapeutics, whether you're joining us in person or by webcast. My name is Lawrence Gozlan, and I'm a Non-Executive Director of the company. I'm joining you from Melbourne. Our Chairman, Geoffrey Kempler, is unable to attend today, and I will act as Chair of the meeting. For those attending in person, can I please ask you to place your electronic device on silent? I'm advised that the notice of meeting has been properly dispatched and that a quorum of members is present. Accordingly, I declare the meeting formally open, and thank you for your attendance today. I'm pleased to introduce my fellow directors, Mr. Peter Marks, Non-Executive Director and Chair of the Remuneration Committee, Mr. Brian Meltzer, Non-Executive Director and Chair of the Audit Committee.
Also present is the team from the company's share registry, Computershare, who will assist in polling votes, and Company Secretary, Phillip Hains. For today's meeting, we will first consider the formal business and the resolutions of the meeting and consider any questions on the resolution. We will then hear from the Chief Executive Officer, Dr. David Stamler, via Zoom from San Francisco. We will now move to the formal business of today's meeting, and I hand over to Phillip Hains, Company Secretary.
Thank you very much, Lawrence. I confirm that notice of meeting has been appropriately dispatched, and that all shareholders and other persons entitled to receive the notice have received it in the notice period. The matters requiring consideration today are outlined in the notice in detail in the notice of meeting, and the notice of meeting we take as read. All resolutions being considered today are ordinary resolutions and require 50% of the votes cast by shareholders in favor of the resolutions to pass. Today's voting will be conducted by way of a poll on all of the business items, and if you have not already voted or if you wish to change your vote, please submit your proxy cards to Computershare representatives at the end of the meeting.
The online polling is now open and will close at the completion of the formal part of today's meeting. For shareholders and proxy holders attending by webcast, you may submit your questions at any time via the Q&A icon and submit or change your vote via the vote icon. Please note that your questions will be addressed at the relevant times in the meeting. Please also note that questions may be amalgamated together if we receive multiple questions on the same topic. And finally, due to time constraints, we may run out of time to answer all of the questions. If this were to happen, we should answer the questions in due course by email or by posting on the company's website. Shareholders who have already submitted their proxy form will automatically have their voting instructions captured.
Polling outcomes will be combined with the proxy votes for, and compiled at the forum at the end of the meeting, and the ASX will be informed after the meeting of the outcomes of each of the resolutions. Proxy votes submitted prior to the meeting will be sent out, will be set out on the slide shown at each of the resolutions. For context, Alterity currently has approximately 2.8 billion shares on issue. Proxies cast during the meeting will be counted after the end of the meeting, and the results will be published on the ASX and ASX, and Alterity's website. Shareholders have appointed, will appoint the Chair of today's meeting as proxy for their, either voting against, for or against, sorry, voting for, against, or at the discretion for each of the resolutions.
As indicated on the proxy form and in the notice of meeting, the chair intends to vote all discretionary or undirected proxies in favor of each of the resolutions. So, Resolution one. The first resolution is to ratify the prior issue of shares under tranche one of the placement. I'll take the resolution as read. You'll see that up on the screen we have 184 million valid proxies have been received, of which 84% are in favor of the resolution, including those undirected proxies, and 16% against. It looks like it's had good support, and at the end of the meeting, we'll be able to resolve if that's passed or not. Are there any questions in relation to this resolution?
No, there are no questions on this resolution.
Thank you very much. The next resolution is for the approval of the share issue. Resolution two approves the issue of the shares under tranche two of the placement. I'll take the resolution as read, and we can see that again, we've got 181.6 million shares. Valid proxies have been received, 78% of which are in favor of the resolution, 22% against the resolution. Are there any questions in relation to this resolution?
There are no questions on this resolution.
Thank you very much. Again, final results will be shown after the meeting on the ASX. The next resolution is for the issue of options. I'll take the resolution as being read. Again, we've got 180-odd million valid proxies have been received, with 78% in favor and 22% against. Are there any questions in relation to this resolution? There is a question in relation to resolutions. We may come back at the end of the meeting, we'll aggregate them. Thank you very much. But we can see there that at the moment, it's got quite strong support. The next resolution is the approval of the issue of securities under the SPP. And so this resolution, Resolution Four, we again, we've got 183 million valid proxies received, with 76% in favor and 24% against.
Is there another question in relation to this, or are we aggregating it to questions in relation to the placement and the SPP?
I think it's appropriate we'll take these questions at the end of the resolutions.
Thank you. The next resolution, and same routine, the final results will be announced onto the ASX at the end of the meeting or in the afternoon. The next resolution is the approval of participation of a director. And so this is the approval of participation by Mr. Peter Marks, the director of the company. We'll take the resolution as being read. We've got 184 million shares of valid proxies received, with 76% in favor and 24% against. Of course, these numbers are quoted excluding the abstains. Are there any questions in relation to the director's participation?
There is probably appropriate at this time. Questions come through from Dr. Peter Seebohm, which of the directors are participating in and talking aloud, so Computershare can hear us, as well as Dr. Seebohm. His request, his question seems to be cut off. I'm presuming which directors are participating in the placement.
My recollection is it's outlined in the, actually, it's outlined in the prospectus, which just disclosed. Actually, no.
No.
It's been in the notice of meeting.
It's in the notice.
It's the three resolutions that we're seeking for approval. Which is correct.
And Lawrence, the three directors seeking approval. He's also asked, he'd like to ask some questions verbally. And I know that requires Computershare in a moment to be able to do that, possibly after we finish the next couple of resolutions.
Yes, and we note that Dr. Peter Seebohm also sent notes to the Board ahead of the meeting, so I'm sure we'll be well versed to be able to address those questions. Thank you very much. So that's the approval for Peter Marks's participation. The next resolution is for Brian Meltzer to participate in the placement. We'll take the resolution as read. We've got 184 million shares, almost 185 million valid proxies received, with 75% in favor of the resolution and 25% against. And again, I'm going to say we're going to collect all of the questions to be addressed at the end of the various resolutions. Thank you. Next resolution is for Lawrence Gozlan to participate in the placement.
We'll take the resolution as read, with 184 million valid proxies received, and 75% in favor, 25% against. Questions will be aggregated to the end of the resolutions, which we're just about there. The final proxy or poll results will be released to the market after the meetings. And so, Rowan, if you're able to aggregate the questions succinctly.
Sure. So actually, to Computershare, if possible, could we take Dr. Peter Seebohm's questions verbally now?
We'll bring him into the chat.
Can you hear me?
Yes.
Can you hear me?
Yes.
You can hear me? Great.
Yes. Yes.
Sorry, this is all very clunky, the interface. So I have some questions about this. I worked extremely hard this year, so I didn't get time to look at this before this week.
Can you hear me?
Yeah. So, I didn't get the chance to look at this before this week, but I've been doing some calculations, and I've been looking at it. And as I see it, I have a serious concern, and the concern. The easiest way to frame this is to point out that as directors, you're on both sides of this transaction.
In that you have an incentive to do a deal that's highly beneficial for the purchasing parties in this transaction to the tune that for each AUD 50,000 you invest, and unfortunately, I haven't done the calculations to see what it is, you end up picking up, if you don't, under the scenario I've worked through, roughly, is one where, and I, I may have this wrong, where you all invest AUD 50,000 each, for which as the auction flows through, you end up getting about 0.5% of the company each.
In contrast, I already own 0.33% of the company at the moment, and under a scenario where the share placement plan is radically oversubscribed, so I get, say, an AUD 4,000 r ight under the Share Purchase Plan, then I end up being diluted by about 60%. I think that I would like to know what the board has done to manage the conflict of interest over the fact that you are sitting on both sides of this transaction, and this transaction seems to be extremely favorable to the members of the board and to the disadvantage of the retail shareholders.
Thanks, Peter. It's Lawrence Gozlan here, Chair of the meeting. I'll take the meeting. So Peter, maybe if I work through the chronology of what actually happened. It was a very tough environment to raise capital-
Mm-hmm.
last year, this year.
Yeah.
The company was faced with an existential sort of, sort of crisis, which is we need to raise funds to get to the end of our phase II clinical trial. So,
Let me just, stop with that. Why did you need to raise funds to get to the end of the phase II clinical trial?
Okay, well, so,
How much did you need? And how much do you need to get to the end of the trial?
I'll get to that in a sec. So we haven't given guidance on our forward twelve months, that's going forward, so,
Mm.
But the board was faced with a position which would have led to a going concern from the auditors, and hence we needed to raise capital. Okay? And that's probably the extent to which I can say publicly, because the company hasn't formally given any guidance. That's on your,
What was the minimum amount of money you needed to raise?
Yeah.
To not raise concerns from the auditors and to finish the clinical trial?
We raised it so that it wouldn't, we raised the amount that would not bring a going concern. So,
What, how much money do you need to raise?
Peter, I just want to answer your first question, your first question about the conflict of interest. So in a very difficult environment in which,
Mm.
We were struggling to raise money, the in,
Yeah.
The investors who led the round, who set the price, who were the ones who negotiated the price.
Yeah.
They actually were the ones who suggested that the directors participate. It was upon the advice of the investment bank.
Yeah.
And the lead investor for us to participate.
Mm.
When the price was determined and the options were determined, there was no director was going to invest. That was a last-minute squeeze that the investors put on us. And so,
Mm-hmm.
That's why, a nd, quite rightly, it's often considered a very good thing when directors are seen reaching into their own pockets and putting money into the business.
Mm-hmm.
Lawrence, if I may interrupt.
Yeah, please.
Because I'm conscious, Peter, you've raised conflict of interest, and you're quite right. You know, Lawrence is there, and he's a participant in the placement, so there's a question about whether Lawrence should be speaking to this particular question.
Mm.
If I can use my background as, I guess, what I'm in here is Company Secretary, but I'm also CFO for a number of listed biotech companies that have raised a lot of money during these past 12 months.
Yeah.
I will tell you that the capital, and we all sort of know, the capital market is, has been horrid during this past 12 months, and it's not unusual.
Yeah.
Companies go out there. I'll say, I've seen budgets where companies plan on raising AUD 20 million-AUD 40 million, maybe two amounts of AUD 20 million. They eventually go to the market to raise AUD 10 million, and they come home with AUD 4 million.
Mm.
There's nothing new there, right? This has been the market for the last 12 months.
Mm.
Our broker, we've been working with our broker for a long period, and the company's been looking at the various alternative methods of capital for a good period, certainly for the last 12 months. At the end of the day, it was resolved that this pricing would get an amount of money into the bank to ensure that the company would be able to live a fairly frugal life while it meets its work, its research and development milestones.
Mm-hmm.
So it's, you know, it, it's been a hard, it's been a hard market to price. It's been a hard market to get money in, but with our advisors, this is the way it's been agreed to go. It wasn't done without a lot of consideration. And to get the directors to participate is seen as being a positive within the market and has been well received by many in the market.
Mm.
First up, you know, we're only able to raise AUD 1.3 million in our 15% capacity. So, you know,
Mm.
Just structuring this deal the way it is, to say that it's a two-tranche placement in the first instance, says that we need to-
Mm.
Extend beyond our 15% capacity. Secondly, we need to ensure that we give our shareholders an opportunity to top up, and that's why the SPP position has been placed there. Third, we need to consider the structure of the share register to see how many shareholders only have one share versus those that have a lot of shares. And we've given the guy with one share an opportunity to buy AUD 30,000 worth of shares. It's not been an easy-
I don't, I don't have one share. I have, I don't have one share. I have a million shares.
The, the-
Yes.
Phil, Philip, can I just make the point that, I think, didn't we, in the prospectus, include the right to accept overs in the SPP? So it will be at the board's review or what have you, as to how much money is finally taken. So if it is, you know, I think hopefully oversubscribed, we actually do have the ability to look after retail shareholders.
So, so,
Can I just get a clarification? Can I have a clarification on that? Because the press release said that you would limit it to AUD 2 million, strictly.
Yes, I need to say, under the SPP, it's a legal restriction that we can't take more than this AUD 2 million that's been mentioned there, and we can't take over,
Okay
AUD 30,000 per shareholder.
Good. Yeah.
Eligible shareholder. So there are restrictions if it should fall short, and if sophisticated investors were to approach the MST as the broker, then they may be able to participate in any shortfall, want of a better expression. So Peter,
Hang on, hang on. But, but, but hang on. My concern is that, s o say, how many retail shareholders are there in the company?
I haven't got that number close to hand.
Well, just, is it 1,000?
No, it's 20,000.
It's actually about 5,000.
Yes.
Okay. Yeah, right.
Of course, yeah, Bank of New York is the major shareholder representing the ADRs and ADS.
Yeah. Okay. So there's 5,000 shareholders, so it's not unreasonable given that the shares are trading at, at twice the offer price at the moment. It's not unreasonable that the, share placement would be massively oversubscribed, and you might have offers for AUD 30 million. 1,000 shareholders asking for AUD 30,000.
So,
Assuming that they're going to be cut, scaled back. Is that, is that a reasonable assumption?
No.
I think it's a hypothetical, but I don't think it's a reasonable assumption.
Not at all.
Okay. All right.
That, that has less than 1% chance of actually that happening.
Mm-hmm.
I don't think I've ever seen an SPP with a take-up of more than, you know, a few percent, to be honest.
Yeah.
Yeah.
Okay. So my concern, right? So if the SPP isn't oversubscribed, then I'm happy. Right? I'm fine. My concern is that if the SPP is oversubscribed, massively oversubscribed, then I get completely screwed.
It,
Basically. So if you're saying that there's a strict limit of AUD 2 million on the SPP, what do you, w hat can you do to help me?
We'll introduce you to MST.
If it's massively oversubscribed.
So,
Sorry.
So Peter, we can introduce you to the brokers at MST. Other than that, I would say that at this stage, I would say that we've canvassed this question quite extensively in this meeting, and I'm going to propose that we call the question to a close, and we hand over to David to do his presentation.
Yeah.
But happy to continue it offline, yeah?
So, who am I actually talking to?
In this instance, it's Phillip.
Okay. Phillip. Okay, Phillip. Right. So you could introduce me to the broker, and they could do a supplementary separate placement or something on top of this deal or something?
No. No, I'm not making that undertaking, but I am making the undertaking to introduce you to the broker, and we'll be able to work with the numbers, and we'll be able to include you in any plans for any shortfall that may, may eventuate.
If there's no shortfall?
If there's no shortfall, we'll, you know, look forward to another opportunity to encourage your investment.
In other words, I get fucked over.
I didn't use those terms, and I wouldn't use those terms.
But that's essentially the,
Well,
That's essentially the consequence. If there's a massive oversubscription, then I get diluted massively.
So, but Peter, that's true for any company that's listed on the securities, right? That's not,
That's not true. But it's not true for the directors who participated on the wholesale side of the deal.
The shareholders just had a chance to reject the directors' participation.
Yeah.
So be very clear that you talk about the conflict of being on both sides. The directors who are participating have just had their participation endorsed by a, you know, majority of shareholders. So the very reason.
Majority of the shareholders who voted? Yes.
Well, but everybody had the chance to vote. Everybody had the opportunity to,
Come on, you know, that's banal.
Well, Peter, we're descending into squalor.
I'm not. I'm just making the point.
Yeah.
Making the point.
Peter's right. The shareholders have voted, and the directors disclosed all their interests. And Peter, hopefully, the chronology of events will satisfy your question. Specifically, that this was at the request of the investors who participated in the placement, who they were the ones who set the price, right?
Mm-hmm.
And like in any market dynamic, right? It was supply and demand.
But it,
Tough environment.
Yeah, but it would be in your interest,
And then at the last minute, it was their request that the directors participate. So it wasn't, t hat should, in a reasonable corporate logic, reduce the accusation of any impropriety from directors. Now, I think we've answered the question fully, and happy to take this offline. We can move on.
So,
Okay. Well, I'm, y eah, I'd love to know why you didn't use the at the market facility. I'd love to know why there wasn't a contingency put in on the basis of the animal data that came in three minutes after the announcement, why wasn't it held back till you had the animal data to read up, re-negotiate the price? I mean, there are a million other questions to ask. I'm not satisfied at all that you've been doing this in the best of shareholders' interests. I have very limited faith in this board, but I'm happy to let it go. I'm happy to take it up with Phillip offline afterwards, and I'm happy to be introduced to the brokers.
Thanks, Peter. Because the questions that we're answering are specifically for the resolution, so we'll, well, if there's no more questions on the resolutions, we'll move forward.
We're gonna put you on mute, Peter. Thank you.
Okay, sure.
Mr. Chair, if I may?
Yeah.
There's one other shareholder with a bunch of four questions which are similar, slightly different. If I could just give those airplay quickly.
Sure.
And close off. So it's from Kate Schroeder, if I've pronounced that correctly. One question is, Is the SPP available to ADR and ADS holders? And the short answer I know is no.
Correct.
It's for Australian and New Zealand residents.
That's correct.
They've got a question, a comment, agreeing with Dr. Cohen just previously. And similar question, I think it's fair to ask: Why wasn't the capital raised after the monkey data was released and associated? Is this why the CFO resigned?
Right. So the CFO resignation had nothing to do with the monkey data being released. And I don't think that relates to any of the resolutions. But the capital raising question was simply because it's not the directors' duties to predict what's going to happen in the market, and we have to raise money when there's interest from investors.
Sure. Probably more of a comment, just for passing this on, feels that the existing shareholders should have the option of buying more of the shares at AUD 0.35, not just AUD 2 million of the SPP. The request will also be referred to Phillip and MST, and I'll pass those details on. That captures those questions, and there haven't been any other questions received online.
Excellent. Thank you. All right. Well, I think that concludes the formal business of the meeting. Please submit your proxy forms to the Computershare representatives now, and the online voting will close now. The final results of the poll will be released on the ASX as soon as they're available. I now declare the meeting closed. I'll hand over to Dr. David Stamler to provide an update on the company's activities. Thank you, David.
Well, thank you, Lawrence. And good morning to everyone in Australia, and afternoon and evening to those in the United States. I am happy to give you an update on the recent data that we've presented, and to give you a brief clinical update. These are our forward-looking statements. Next slide. So as referenced in the earlier part of the meeting, there was recently some primate data that was released to the market in December when it was presented at a conference. And I look forward to sharing those data with you because they're very exciting, and I think they do help us support our clinical approach. I'm also gonna give you an update on our clinical programs and then touch briefly on our milestones expected in 2024. Next slide.
So a brief refresher. We will be addressing and discussing Parkinsonian disorders. Parkinsonian disorders get their name from patients having Parkinsonism, which is the motor symptoms that we've all seen in friends or family members, and that's the slow movement, the stiffness, or the shuffling gait. And it's referred to as Parkinsonism because Parkinson's disease is the most common cause of this motor symptom or motor syndrome. Next. Yes, but in addition to Parkinson's disease, there are other disorders that cause the same motor symptom syndrome, one of which is referred to as MSA or Multiple System Atrophy, and others. MSA is a rare disease without approved therapy, and it is an orphan.
We have Orphan Drug Designation for this disease, which is our lead indication. Now, before we go on and talk a little bit about some of the animal data, I just want to refresh that Parkinson's disease and MSA do have similar underlying pathology. Next slide. So these are data that come from a study of human brains in patients who ultimately succumb to their either Parkinson's disease on the left or MSA, Multiple System Atrophy, on the right. And the patients are reflected in blue. The patients or the healthy controls are in green. And we see that in Parkinson's disease on the left and in MSA, in multiple other brain regions, there's increased iron in the brains of these patients in the areas of pathology.
This is the iron that we're very interested in. Next. So, if you fast-forward about 20-25 years, advanced MRI techniques have been measured so that you can actually measure iron in the brains of living patients, so you don't have to rely on autopsy. And this is important, for two reasons. As you can see at the tip of the orange arrow on the MRI scan, that dark red staining material is the increased iron that we are targeting. And this is important for two reasons, because we're using this type of scanning to identify patients to come into our clinical trials, number one, and number two, it represents a key endpoint, in our, clinical trials to demonstrate that the drug is actually engaging with the target, the excess iron, and that we can lower it. Next.
Now, what is this excess iron actually doing? What you see in the picture there is, on the left is a cartoon of an important protein that is referred to as alpha-synuclein. And that's a protein that is present in all neurons, and it's really important for nerves to communicate with one another. In the setting of increased iron, this protein actually forms clumps and can't function properly. The excess iron is also a root cause of oxidative stress, which then ultimately damages other structures within cells. And if you look at the cartoon on the right side of the slide, you see this vicious cycle where the iron imbalance causes oxidative stress, inflammation, and then the protein clumping that I was just telling you about. Next slide.
So to tie this all together, what we're really trying to do with our therapy is to bind that excess iron within the areas of pathology that I showed you. To reduce the clumping of this protein, called alpha-synuclein, and reduce the oxidative stress, thereby rescuing normal neuronal function. And in doing this, just by binding this iron, our goal is to modify the course of disease and slow the disease progression, something that many companies are searching for with very different strategies. Next slide. So I'd now like to tell you a little bit about our lead drug candidate, ATH434, which is designed to modify the course of disease. ATH434 redistributes excess iron and reduces that alpha-synuclein clumping in the brain.
It is an oral agent, which makes it easy to use for patients, and we've shown that it is readily absorbed and reaches the site of action, in man, at concentrations that are consistent with efficacy from numerous animal studies that I'm going to show you in a moment. This drug has the potential to treat various Parkinsonian disorders. As I showed you on an earlier slide, it can treat Parkinson's disease, potentially because of the increased iron, and it also has the potential to treat MSA. Regarding development approach, we have discussed our development approach, at length, with various regulatory authorities, the U.S. FDA, as well as the European Medicines Agency. Next. Now I want to tell you about the primate data, and these are the data that were released in early December.
These data are really exciting because they do validate the clinical approach that we are taking. Now, before I show you the data, just a little bit of background. We're evaluating our drug candidate in a well-established model of Parkinson's disease, and this is in primates. This is important because primates are closer to humans from a structure and a physiology standpoint. What we've shown is that ATH434 improves the motor skills and the general behavior in these animals that had experimentally induced Parkinson's disease. We also showed, importantly, that the favorable impact on symptoms in these animals was associated with lower brain iron in the areas of pathology. That's something that is quite important because that's what we've seen in other patients with these diseases.
Now, 434 treatment also increased levels of a protein marker called synaptophysin, which is something that reflects improved connectivity between neurons. And that's something that's in our poster posted at our website. I'm not going to go through those data for reasons of time, but again, very important supportive data about why these monkey data are so helpful. And overall, I think the conclusion is that the data from this this monkey trial improves our confidence regarding our ongoing studies and the promise of 434 for its use in Parkinson's disease. Next slide. So here's the study design from the monkey study. After the animals are trained, and excuse me. One moment.
So after disease onset is induced, experimentally, animals then undergo baseline assessment, where a motor assessment is performed. And then this is repeated, at eight weeks, at 12 weeks, and then iron is measured at the end of the period of time, at 12-14 weeks. The animals receive placebo or vehicle, it's also referred to as vehicle, or 434 low dose or 434, at a high dose. Next slide. So these are, these are the key data from the study, and you'll see on, on this slide, that there's quite a bit of data, so bear with me for a moment while I orient you. These are two different sets of data. On the left are general motor skills, and on the right is general behavior or functional measures.
What you see is the score at baseline on the left side of each graph, and then the score after 12 months, or sorry, after 12 weeks of treatment on the right side of each graph. Keep in mind that lower scores are better. Now, next. Next. There we go. Go back one. Yeah. So as you see below on the graphs, the orange areas highlighting what we're actually looking at. So we're actually looking at fine motor skills and various behaviors such as eating and general motor performance. Then on the right, we're looking at various behaviors that are much more relevant to human behavior, such as a response to food, appearance, posture, and balance.
So these, what's important about this primate model is that these animals bear much more greater resemblance to humans in terms of how their behavior and how their function can be assessed. Now, what you see now, looking at the graph, is that the lines in blue, which are the active treatments with 434, either low dose or high dose, that those animals are improving from baseline to week 12 on both the general motor scores as well as the general behavior. And then next. And that those animals that had the improvement in their behavior and their motor performance had the lowest iron levels.
So the reason that these data are so important is because we think this is what we're, what we'd like to see with the activity of the drug, in that all monkeys had improved motor and behavior scores, as well as lowered iron. Next slide. Now, the study that I just showed you is on the bottom of the slide, but this reinforces the various data that's been accumulated over the last several years with 434. Where we've looked at it in various models of Parkinson's disease, as well as MSA, as indicated on the table.
In all these studies, we've shown that we can reduce brain iron, reduce alpha-synuclein, the clumping of that alpha-synuclein, and improve the connectivity or the number of neurons as well, with the important clinical observation of improved motor performance. And this is important because we've seen this in a diversity of animals as well as animal models. Next. All right, so let's turn to the clinical development briefly. Next slide. This is a summary of our ongoing trials at the moment. The first two are our phase II studies in MSA. The first study, the 201 study, is in early-stage patients. The 202 study, which is the biomarker study, that I'll tell you more about in a moment, is in more advanced patients. We are concluding our natural history study called bioMUSE.
This study's been very important as it's really helped us design and de-risk the design of the phase II program. And then lastly, I just told you about the animal study in Parkinson's disease that was supported by the Michael J. Fox Foundation. Next slide. So regarding clinical development, this is a summary of the ongoing trials. The first two studies, the first two columns are the phase II programs. The ATH201 study is the randomized, double-blind, placebo-controlled study that over-enrolled, we enrolled about 75 patients at 20 sites around the world. Patients are receiving 12 months treatment with two dose levels of ATH434 or placebo, and the primary endpoint is the change in iron content as measured by brain MRI.
The second phase II study, the ATH202 study, is a single-arm study, open label, basically assessing the same primary endpoint, change in brain iron, on MRI. And again, patients will be treated for 12 months. In both of these studies, we will be examining the clinical endpoints necessary to demonstrate patient improvement. Next slide. From a commercial standpoint, not only is ATH434 a significant opportunity, s orry, is not only important for improving patients, but it represents a significant commercial opportunity. These data were based on a survey of 30 U.S. neurologists, who demonstrated that there was a strong intent to prescribe.
They clearly recognized the substantial unmet need in treating these patients, and they appreciated the fact that this was an oral drug that was easy to administer, unlike many therapeutics being developed in this area, which are infusion therapies. Based on relatively conservative estimates of the performance of the drug, using contemporary prevalence and estimated sales. We estimate peak sales to be approximately $1.1 billion in the United States for MSA alone. Next slide. So the milestones you see on the slide, the first three were completed in the last calendar year quarter of 2023. Most recently with the data from the primate model.
The open label data, we expect will read out in the first half of next year. And then the double-blind trial, the 201 study, we expect, will conclude. The complete treatment will complete in November, and then we'll bring those data in, as soon as possible thereafter, either by the end of 2025 or early, by the end of 2024 or early 2025. The next slide. So in summary, the new primate data that I shared with you does validate the clinical strategy that we are undertaking, with our lead indication. We have achieved all our clinical and corporate milestones in 2023. ATH434 is a drug candidate that is novel and can target various Parkinsonian disorders.
Our lead indication, MSA, is progressing nicely in the clinic with completed enrollment in the double-blind study, as well as ongoing conduct of the open label study, the 202 study, with preliminary data expected in the first half of next year. Our development team has a strong track record with three FDA approvals under our belt at the FDA, and we look forward to the share purchase plan, the SPP, to commence in 2024, early 2024. Thank you.
David, a couple of questions have come through, if you're okay to answer those?
Oh, sure.
The first one is: What's happened to the monkeys after the completion of the trial?
Yes. Well, after animals like these participate in the trial, you know, they are humanely sacrificed to fully study the pathology and the potential benefit of the drug.
Data.
Rowan, you may have to repeat that question. We're off, we're off mute now, but you were on mute part way through your question.
Sorry. Sorry, David. There was a related question, w hy is the monkey data so important?
Right. So the monkey is important for a variety of reasons. Number one, monkeys neuroanatomically are much closer to humans than other animal models, which are typically used in drug development, such as mice or rats. So their neuroanatomy is much closer, their physiology is much closer, and it's a larger brain, you know, unlike a rodent brain. So that's from an, like an anatomical standpoint. From a behavioral standpoint, monkeys exhibit behaviors and learning and skills that are much closer to humans than we see in rodents. And that's why we can assess such sophisticated levels of behavior as well as motor performance.
So for all those reasons, the fact that we can, w e're targeting a monkey. It is a much more valuable model in terms of predicting the potential of the drug to work in the clinic. The reason the data are so important is because we have shown that we can lower the iron in the brain, in the areas of pathology, in the brain of these animals. And those animals that had the greatest motor performance actually had the greatest reduction in iron.
So what the data from the study is essentially doing is providing a bridge from some of our earlier work in rodents to a higher order animal, like the monkey, which we think is gonna be much more valuable in predicting the potential efficacy of the drug in humans.
Okay, the last, t here's two questions. You may have actually answered part of one, but how does reducing the iron help the patients, and is the excess iron all over their body?
Yeah. So that's an interesting one. So iron, as many of you may know, is important for many functions in life. So, you know, for energy production or enzyme activity, or even for transporting oxygen and blood. So these patients don't have excess brain iron. They only have selective increases in iron in the brain. And it's not throughout the brain, it's only in certain areas where they have, you know, neuron loss and where they have injury. So what we're actually doing is we're targeting the excess iron that's just increased in the areas of their brain. We're not targeting iron elsewhere in their body. And the goal is by targeting this excess iron, we're actually removing the source of ongoing injury.
The excess iron does lead to oxidative stress, as I mentioned in my presentation. The excess iron does lead to neuron loss. It does lead to this protein, this important protein for nerve cells to communicate, causes it to clump. So by restoring the normal iron balance in the brain, we're actually returning things to the native state, so that neurons can communicate with one another more readily, and so that neurologic function can be preserved, and so that individual's quality of life can be preserved. So that's the overall goal, and what we're targeting by targeting this excess iron.
Sure. And I'll take this as last question. Is there likely to be more data released from monkey autopsies? And if so, is there a timeline for that?
We don't, I don't believe we have any additional data to release. We may publish the data in greater detail in a full publication, which is often the case. This was presented at a Parkinson's disease conference in poster form, which is at our website, but the full data set will be presented in greater detail in a full publication.
Excellent, David. Thank you for your presentation, and thank you to all shareholders, for your ongoing support of Alterity. With that, we'll end the meeting.