Alterity Therapeutics Limited (ATH) Earnings Call Transcript & Summary

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 devices 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 the 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. So I confirm that Notice of Meeting has been appropriately dispatched and that all shareholders and other persons entitled to receive the notice, received it in the notice period. The matters requiring consideration today are outlined in detail in the Notice of Meeting and the Notice of Meeting will be taken as read. All resolutions being considered today are ordinary resolutions and require 50% of the votes cast by shareholders in favor of the resolution to pass. Today's voting will be conducted by way of a poll on all the items of business -- 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, and if this were to happen, we should answer the questions in due course by e-mail 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 -- combined with the form 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 set out on the slide shown at each of the resolutions. And 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 to be published on the ASX and Alterity's website. Shareholders who have appointed the Chair of today's meeting as a proxy for their either voting against -- for or against, so voting for, against or at the discretion of each of the resolutions, and 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 1, the first resolution is to ratify the prior issue of shares under tranche 1 of the placement. I'll take the resolution as read. You'll see that on the screen, we have 184 million shares have the 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 has had good support and at the end of the meeting, we'll be able to resolve it 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 2 approves the issue of the shares under tranche 2 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, the 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. We can see there that at the moment is quite strong support. The next resolution is the approval of the issue of securities under the SPP. And so this resolution, resolution 4, 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 if the question is in relation to the placement on the SPP?

I think it's preferable to take these questions at the end of the resolutions.

Thank you. The next resolution -- and same routine, the final results will be announced on to 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, Director of the Company. We'll take the resolution as being read. We've got 184 million shares -- valid proxies received with 76% in favor and 24% against. But of course, these numbers are voted excluding the abstains. Are there any questions in relation to directors' participation?

There is. And probably appropriate at this time, questions come through from Dr. Peter [indiscernible] which of the directors are participating in and talking out loud, so Computershare can hear us as well as Dr. [indiscernible]. 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 perspectives which we just disclosed. Actually, no. It's in the Notice of Meeting.

No. It's been in the Notice of Meeting and it's [indiscernible] that we're seeking for approval which is correct and Lawrence [indiscernible] 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 [indiscernible] also sent notes to the Board ahead of the meeting. So I'm sure that we will first to be able to address those questions. Thank you very much. So that's the approval for Peter Marks' 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 to be 75% in favor of the resolution and 25% against. And -- and again, I'm going to say we're going to collect all 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 and 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 [indiscernible] questions verbally now.

Can you hear me?

Yes.

Sorry, this is all very clunky, the interface. So I have some questions about this. I'm -- worked extremely hard this year. So I didn't get time to look at this before this week. Yes. 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. So the tune that for each $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 may have this wrong, where you all invest $50,000 each for which as the options flow through, you end up getting about 0.5% of the company each. In contrast, I already own 1/3 of 1% of the company at the moment and under a scenario where the share placement plan is radically oversubscribed. So I get, say, a $4,000 right under the share purchase plan. Then I end up being diluted by about 60%. And 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 to the disadvantage of the retail shareholders.

Thanks, Peter. It's Lawrence Gozlan here, Chair of the meeting. I'll take the mix. So Peter, maybe if I work through the chronology of what actually happened. It was a very tough environment to raise capital last year -- this year and the company was faced with an existential sort of crisis, which is we need to raise funds to get to the end of our Phase II clinical trial. So the Board...

Let me just stop you there. Why did you need to raise funds to get to the end of the Phase II clinical trial? And 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 -- we haven't given guidance on our forward 12 months going forward. So -- 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. 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 [indiscernible] question.

What was the minimum amount of money you needed to raise, do 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 I just want to answer your first question. Your first question about the conflict of interest. So in a very difficult environment in which we were struggling to raise money. The investors who led the round, who set the price, who were the ones who negotiated the price. Once -- they actually were the ones who suggested that the directors participate. It was upon the advice of the investment bank and the investor for us to participate. When we -- 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 that's why -- and quite frankly, it's often considered a very good thing when directors are seeing reaching into their own pockets and putting money into the business.

Lawrence, if I may. Because I'm conscious, Peter, you've raised conflict of interest, and you're quite right. 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. If I can use my background as I guess, what I'm in here is Company Secretary, but I'm also a CFO for a number of listed biotech companies that have raised a lot of money during this past 12 months. I will tell you that the capital -- and we all sort of note the capital market has been hovered during this past 12 months, and it's not unusual for companies go out there. I'll say I've seen budgets where companies plan on raising $20 million to $40 million, maybe 2 amounts in $20 million. They eventually go to the market to raise $10 million and they come home with $4 million. There's nothing new there, right? This has been the market for the last 12 months. Our broker has -- we have been working with our brokers for a long period, and the company has been looking at the various alternative methods of capital for a good people 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 research and development milestones. So it's been a hard market to price. It's been a hard market to get money in. But with our advisers, 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. First off, we're only able to raise $1.3 million in our 15% capacity. So just structuring this deal, the way it is to say that it's the 2 tranche placement in the first instance says that we needed to extend beyond that existing 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 1 share versus those that have a lot of shares, and we've given the guidance 1 share an opportunity to buy $30,000 worth of shares. It's not been [indiscernible].

Okay. But I don't have 1 share. I have -- I don't have 1 share. I have many shares.

Phillip, can I just -- I would like to 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 what have you as to how much money is finally taken. If it is, I think hopefully, oversubscribed, we actually do have the ability to look after retail shareholders. So.

Can I get a clarification? Can I have a clarification on that because the press release said that you would limit it to $2 million strictly?

Yes. I need to say under the SPP, it's a legal restriction that we can't take more than this $2 million that's been mentioned there, and we can't take over $30,000 per shareholder -- 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, 1 of a better expression. So Peter, in all instance...

Hang on, just my concern is that especially how many retail shareholders are there in the company?

I haven't that number close to hand.

Thousands?

It's at about 5 -- it's actually about 5,000.

Yes. And of course, yes, Bank of New York as we speak the major shareholder representing the ADRs and ADSs.

Yes. Okay. So there's 5,000 shareholders. So it's not unreasonable given that the shares are trading 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 $30 million. 1,000 shareholders asking for $30,000 assuming that they're going to be scaled back. Is that a reasonable assumption?

No, I think it's a hypothetical and I don't think it's a reasonable assumption.

Not at all. That has less than 1% chance of actually happening.

I think you've ever seen an SPP with a take-up of more than a few percent to be honest.

Yes.

Yes.

Okay. What -- 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 basically. So if you're saying that there's a strict limit of $2 million on the SPP, what do you -- what can you do to help me, if it's massively oversubscribed.

So we'll introduce you to MST. 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, but happy to continue it offline.

So who am I actually talking to?

And this is Phillip.

Okay, Phillip. So you could introduce me to the broker and what -- and they could do the supplementary set placement or something on top of the -- of this deal or something.

No, I'm not making that undertaking, but I am not making the undertaking to introduce 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 eventually.

And if there is no shortfall?

If there's no shortfall, well, we look forward to another opportunity to encourage your investment.

In other words, I get f***ed over.

I didn't use those terms, and I wouldn't use those terms.

That's essentially the -- that's essentially the consequence. If there's a massive oversubscription, then I get diluted massively.

So Peter, that's true for any company that's listed on the securities, right?

That's not -- it'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. So I'd 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 majority of shareholders. So the very reason...

We are talking about the shareholders who voted?

Yes. Well, everybody had the chance to vote. Everybody had the opportunity to put in the floor...

Come on, that's the -- come on you know that's bananas. You know that.

Peter, we're descending into [indiscernible]. Please give it to...

I am just making the point. I am just making the point.

Peter is right. The shareholders have voted and the directors disclosed all their interests. And Peter, hopefully, the chronology of events we'll 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? And like in any market dynamics, it was supply and demand health environment, and they were the ones who set the price. And then at the last minute, it was the -- their request that the directors participate. So it wasn't -- that should, in a reasonable logic, reduce the accusation of any proprietary from directors. Now I think we've answered the question fully and happy to take this offline, we can move on.

I'd love to know why you didn't use that 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 3 minutes after the announcement, why wasn't held back? So you had the animal data to renegotiate the price. I mean there are many other questions I'm asking. I'm not satisfied at all that you've been doing this in the best of shareholders' interest. I have very limited faith in this board. But I'm happy to let it go. I'm happy to take up with Phillip offline afterwards, and I'm happy to be introduced to the brokers.

Thanks, Peter because the questions that we're answering specifically for the resolution. So we'll -- if there's no more questions on the resolutions, we'll move forward.

So we're going to put you on mute, Peter. Thank you. So Mr. Chair if I may. There is one other shareholder with a bunch of all questions, which are similar, slightly different. But I can just give those airplay quickly and close off. So it's from Kate [indiscernible], if I pronounced that correctly. One of the question is, is the SCT available to ADR and ADS holders. And the short answer I know is no. It's for Australian and New Zealand residents. We've got the [indiscernible] agreeing with [indiscernible] just previously and similar question. I think it's fair to ask why wasn't the capital raise after the monkey data was released and so she added is this why 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. So the capital raised 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 passing this on. It feels that the existing shareholders should have the option of buying more of the shares at the $0.35, not just $2 million of SPP and the request will also be referred to [indiscernible] MST and we'll pass those details on that [indiscernible] 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 Computershare representatives now and the online voting close now. The final results of the poll will be released on the ASX as soon as they are available and now I declare the meeting closed. I 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 going to 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. And 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 gate. And it's referred to as Parkinsonism because Parkinson's disease is the most common cause of this motor symptom -- motor syndrome. Next. Yes. But in addition to Parkinson's disease, there are other disorders that cause the same motor 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 and 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 an MSA and multiple other brain regions, there's increased iron in the brains of these patients in the areas of pathology. And this is the iron that we're very interested in. Next, so if you fast forward about 20 to 25 years, advanced MRI techniques have been measured so that you can actually measure iron in the brains of living patients. You don't have to rely on autopsy. And this is important for 2 reasons. As you can see at the tip of the orange arrow on the MRI scan, that dark red standing material is the increased iron that we are targeting. And this is important for 2 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 end point 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? The -- 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. And 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. So now I want to tell you about the primate data. And these are the data that were released in early December. And 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 using this or evaluating our drug candidate in a well-established model of Parkinson's disease. And this is in primates. And this is important because primates are closer to humans from a structure and a physiology standpoint. And what we've shown is that 434 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. And 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 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 8 weeks, at 12 weeks and then iron is measured at the end of the period of time at 12 to 14 weeks. The animals 1/3 received placebo or vehicle, it's also produced vehicle or 434 low dose or 434 in a high dose. Next slide. So these are the key data from the study. And you'll see on this slide that there's quite a bit of data. So bear with me for a moment while I orient you. These are 2 different sets of data. On the left are general motor skills and on the right is general behavior or functional measures. And what you see is the score of 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. And keep in mind that lower scores are better. Now next, next, there we go. So sort -- go back one. Yes. So as you see below on the graph, 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 in general motor performance and then on the right, we're looking at various behaviors that are much more relevant to human behavior such as 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 these data are so important is because we think this is what we -- 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. And in all of 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 the 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 2 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 has been very important as we had -- as it's really helped us design and derisk 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 2 studies -- the first 2 columns are the Phase II programs. The 201 study is the randomized, double-blind, placebo-controlled study that over enrolled. We enrolled about 75 patients at 20-odd sites around the world. Patients are receiving 12 months treatment with 2 dose levels of 434 for placebo. And the primary endpoint is the change in iron content as measured by brain MRI. The second Phase II study, the 202 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 434 a significant opportunity for -- sorry, 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 the appreciated effect that this is an oral drug that was easy to administer unlike many therapeutics being developed in this area, which are for -- which are infusion therapies. And 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 3 were completed in the last calendar year quarter of '23, 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 '25 or early -- by the end of '24 or early '25. 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 second -- in the first half of next year. Our development team has a strong track record with 3 FDA approvals under our belt at the FDA. And we look forward to the securities purchase plan, the SPP to commence in 2024 -- early '24. Thank you.

David, a couple of questions have come through if you're okay to answer those.

Sure.

The first 1 is what's happened to the monkeys after the completion of the trial.

Yes. Well, after animals like these are participated in the trial, they are humanely sacrificed to fully study the pathology and the potential benefit of the drug.

Rowan, you may have to repeat that question, we're off muted now, but you were mute halfway through your question.

Sorry, Sorry, Dave, there was a related question of why is the monkey data so important?

Right. So the monkey is important for a variety of reasons. Number one, monkey is 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 unlike a rodent brain. So that's from 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 -- we're targeting a monkey is -- it is a much more valuable model in terms of predicting the potential of the drug to work in the clinic. And the reason the data are so important is because -- the -- we have shown that we can lower -- we can lower the iron in the brain, in the areas of pathology in the brain of these animals and that 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 going to be much more valuable in predicting the potential efficacy of the drug in humans.

The last 2 questions you may have actually answered part of one, the how is reducing the iron help the patients and is the excess iron all over their body?

Yes. So that's an interesting one. So iron, as many of you may know, is important for many functions in life. So 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 neuron loss and where they have injury. So -- 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 the excess iron -- 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 the 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 look, I'll take this as last question. Is there likely to be more data released from monkey or tops? And if so, is there a time line 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 on 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.