Morning, ladies and gentlemen. Warm welcome to the 2021 annual general meeting of PYC Therapeutics Limited. A warm welcome to those in the room and to those who are attending remotely. We've got a good attendance at today's meeting, probably a record for us. My name is Alan Tribe, and I am the Chairman of the company, and I'm joined here in the room by our CEO, Rohan Hockings, and Company Secretary, Kevin Hart. Remotely, we're joined by our U.S. non-executive directors, Mike Rosenblatt and Jason Haddock. Sam Nasseri, a U.S. director, tenders his apologies for not being able to attend today's meeting. Sam is not seeking re-election at this annual general meeting and therefore will be stepping down as a director at the end of the meeting.
I'd like to take this opportunity to thank Sam for his contribution as a director of the company, and particularly acknowledge the great progress that has been made in the U.S. under his guidance. The team that Sam has built has been formally set up in the JLABS innovation hub in San Diego, and that group has quickly reached critical mass and are now driving the company's technology towards clinical development. I'd like to thank him for his efforts and his achievements during his tenure. For the record, I'm advised that there is a quorum present, and I therefore declare the meeting open. Now, the format for today's meeting will be as follows. The first part will be the presentation of my chairman's address, and then we will attend to the formal business of the meeting.
At the conclusion of the formal business, the meeting will be closed, and following that, CEO Rohan Hockings will give an update of the company's progress and future outlook. A copy of the notice convening this meeting has previously been made available to all shareholders and sets out in detail the nature and purpose of the resolutions to be considered at today's meeting. I propose to take that notice of meeting as read. First up then, my chairman's address. It's been another year of significant progress for the company. You will hear later from CEO Rohan Hockings, details of the most exciting recent results and plans for the future. In my view, these results mark a major milestone in the development of the company.
At this important time, I think it's worth reflecting on where the company has come from in the context of where we're going to. In broad terms, developments to date have progressed along the following lines. Approximately three years ago, PYC's principal asset was its drug delivery platform based upon cell-penetrating peptides. At that time, the issue for the company was, while it had a drug delivery capability, it had no drugs to deliver. An important strategic decision was made at that time, and that led to PYC commencing the development of drugs in-house. The decision was made to focus on eye diseases, as this is considered to be the target most appropriate for a company the size of PYC with limited resources. The company then expanded by recruiting a team with drug development capabilities led by Sue Fletcher.
Based upon RNA technology, a pipeline of drugs has been developed, all targeted in the eye. Of these, three should offer treatment for disorders for which there is currently none. All of these drugs currently use the same baseline technology, and this confers significant advance, advantages in advancing their progress. For example, the most recent results are relevant to all of those drug candidates. This pipeline of drugs will now move steadily towards clinical trials in humans and then ultimately release for the benefit of patients. However, it's important to remember that drug delivery, the drug delivery platform has the potential for a much wider range of applications. Some of these are being studied in-house at the moment, such as the central nervous system and the kidney.
There is also considerable opportunity for PYC to work with other organizations that have developed drugs which could benefit from this drug delivery technology. Today we're at a point where both the drug delivery platform and the first of its drug candidates, which is a treatment for Retinitis Pigmentosa 11, they've both been validated in trials in non-human primates. The next step after completion of GLP studies is to submit an application to the U.S. Food and Drug Administration for approval to commence clinical trials in humans. The validation of the drug delivery platform has significance not only for the in-house drugs being developed but also for collaboration with other organizations within the pharmaceutical sector. Discussions will continue to progress with parties who show interest in using this technology. Drug development takes time, and there are no shortcuts.
PYC has diligently continued to develop both its drug delivery platform and its pipeline of drug candidates over the past year. The prospect of being able to bring drugs to market, especially for patients who have no treatment available today, is a major achievement. Providing remedies to those sufferers who need them will also lead the company to future growth and commercial success. This year, the PYC team has expanded through the opening of its office in the U.S., and I would like to acknowledge the hard work of my talented colleagues, both in Australia and the U.S., who have achieved so much this year. This relatively small team has delivered remarkable results through considerable effort and dedication. As in previous years, I look forward with considerable optimism to continued progress by the company on its path to in-human clinical trials and beyond.
Now moving into the formal business of the meeting, I'll just read out the proxies that we've received. The company has received valid proxies from 108 shareholders, being a total of, we've got many hundreds of millions numbers here, so with your indulgence, I might just abbreviate them to the hundreds of millions and just to keep it shorter. We've received proxies from shareholders holding a total of 802,926,000. That's right. Yes, shares representing 25% of the issued capital of the company. After each resolution is displayed on the screen, I will invite questions from the floor, and I'll be limiting questions to the motion being considered. Opportunity will be provided for shareholders to ask questions on the resolutions.
I would ask that you state your name for the record when you address the meeting. If a question is asked, which in my opinion does not relate to the motion which is before the meeting, I will rule the question inadmissible, in that unlikely event. In my capacity as chairman, I will today call on a poll, for a poll on each of the resolutions rather than a vote by show of hands. The poll will be taken once we've all been through all of the resolutions, and ballot papers were given to eligible shareholders at the time of registration. I will ask you to complete these. The poll will be taken, results of which will be announced to the ASX market later today. I will further explain the procedure for the poll at that time.
Note that each shareholder at the meeting can only vote for his or her personal shareholding at this time, and only proxies lodged with the company up to 48 hours before this meeting can be counted in the vote. They're the rules. We will now proceed with the business of the meeting. The first item on the agenda is the consideration of the financial statements, the directors' statement, the report, and the auditor's report for the financial year ending thirtieth June, two thousand and twenty-one, all of which have been made available to shareholders in accordance with the requirements of the Corporations Act. The company's auditors, PricewaterhouseCoopers, are represented here today by Adam Thompson. Welcome, Adam. In accordance with the requirements of the Corporations Act, he is available to address appropriate questions or comments from shareholders on this agenda item.
Let me ask, are there any questions or comments in relation to the reports under consideration? Very well. There is no requirement for a vote on this item of business, so we'll proceed to the second item of business. Resolution one is adoption of the remuneration report. The Corporations Act requires that 25% of the valid votes cast be against adoption of the company's remuneration report at two consecutive annual general meetings, then shareholders of the company will be required to vote on whether to hold a meeting of shareholders within 90 days from the second annual general meeting, at which all directors, with the exception of the managing director, will offer themselves for re-election.
Further details, including key management personnel, which includes directors' voting prohibitions and the voting of undirected proxies, are included in the notice of annual general meeting dated 18th of October, 2021. The remuneration report is set out in the annual report. In accordance with legislation, the vote on the resolution is advisory only and does not bind the directors of the company. However, the board will take the outcome of the vote into consideration when reviewing remuneration practices and policies of the company. Thank you. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. It should be noted that on the remuneration resolution, less than 0.5% of the votes cast are voting against the remuneration resolution, and therefore the majority in favor. You can see those proxy numbers displayed at the moment.
I won't read them out because of those big numbers. If you're happy with that, I'm happy to if some people would like me to. Very good. Okay. The resolution reads that the remuneration report for the year ended 30th June 2021 be adopted by the company. I now formally move the motion that resolution one be put to the meeting in the form set out in the notice of the meeting. Is there any discussion on this resolution? Very well. In my capacity as Chairman, I call for a poll on this resolution, and this poll will be taken once all of the resolutions contained in the notice of meeting have been formally put to the meeting. Resolution two relates to the re-election of me as a director.
For the purposes of considering this resolution, I will hand over chairmanship of the meeting to my colleague, fellow director, Rohan Hockings. Rohan.
Thanks, Alan. Agenda item number three and Resolution two of the meeting is the re-election of Mr. Alan Tribe. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. The resolution reads that Mr. Alan Tribe be re-elected as a director. I now formally move the motion that Resolution two be put to the meeting in the form set out in the notice of meeting. Is there any discussion on this resolution? A poll on this resolution will be taken once all of the resolutions contained in the notice of meeting have been formally put to the meeting. I hand the chair back to Alan.
Thank you, Rohan. Agenda item number four, the re-election of Dr. Michael Rosenblatt as a director. I refer shareholders to the screen displaying the resolution in full and the valid proxy results. The resolution reads that Dr. Michael Rosenblatt be re-elected as a director. I now formally move that Resolution th be put to the meeting in the form set out in the notice of the meeting. Is there any discussion on this resolution? Very well. In my capacity as chairman, I call for a poll on this resolution. This poll will be taken once all of the resolutions contained in the notice of meeting have been formally put to the meeting. Agenda item number five, re-election of U.S. director Jason Haddock. I now refer shareholders to the screen displaying the resolution in full and the valid proxy results. The resolution reads that Mr.
Jason Haddock be re-elected as a director. I now formally move that resolution four be put to the meeting in the form set out in the notice of meeting. Is there any discussion on this resolution? In my capacity as chairman, I call for a poll on this resolution. This poll will be taken once all of the resolutions contained in the notice of meeting have been formally put to the meeting. Resolution five, approval of change of auditor. I now refer shareholders to the screen displaying. Thanks, Rohan. The resolution in full and the valid proxy results.
The resolution reads that for the purposes of Section 327B (1)(b) of the Corporations Act 2001, and for all other purposes, PricewaterhouseCoopers, having been nominated by a shareholder and having consented in writing to act as auditors of the company, be appointed as auditors of the company. I now formally move the motion that Resolution five be put to the meeting in the form set out in the notice of meeting. Is there any discussion on this resolution? In my capacity as chairman, I call for a poll on this resolution. The poll will be taken again once all of the resolutions contained in the notice of meeting have been formally put to the meeting.
Okay, it's now time to take the polls on Resolutions one -five , and a representative from Automic Share Registry will act as the returning officer. Recent changes to the Corporations Act have changed the law in relation to the obligations of proxies to vote where a poll is called on any resolution. If the proxy is the chair of the meeting at which the resolution is voted on, the proxy must vote on a poll and must vote as directed. If the proxy is not the chair of the meeting, the proxy need not vote on the poll, but if the proxy does so, the proxy must vote as directed. If you're a proxyholder with open votes, you may vote as you wish. You've all been handed a ballot paper for the poll on registration this morning.
The resolution upon which the poll is being taken is to be set out on the ballot paper by you. That is resolutions one- five. You should record your vote by placing a cross in either for or against square on the paper. You should also print on the ballot paper your name if you're a shareholder or the name of the shareholder whose proxy representative or attorney you are. If you hold multiple proxies, please state this, and we will complete the information from the proxies. Okay, let's get underway with the poll then. Thank you. Well done. Thank you. Thank you. It's probably worth pointing out to shareholders that the way we're going to run today's meeting is that we will close the formal part of the meeting, and then there will be a presentation by our CEO, Rohan Hockings.
I've already outlined that. At the closure of the meeting, our U.S. directors will leave us. They have a very onerous time difference from Perth, and I'm sure their beds are looking very attractive at this time of the evening. We'll let them leave us at the closure of the formal part of the meeting. I now open the meeting to members to ask any questions that they may have at this point. Does any shareholder have any questions or comments? Very good. Thank you. Ladies and gentlemen, that concludes the business of the meeting. Thank you again for your attendance. I now formally declare the meeting closed. Thank you to our U.S. directors for their attendance, and we'll now move the presentation by a...
to move to the presentation by our CEO, Rohan Hockings. Before doing that, I'd like to say that the next part of the presentation is probably not as dry as the first part, so I'm sure you'll enjoy it a bit more. Thank you very much.
Thanks very much, Alan. [audio distortion] Before I begin the presentation today, I wanted to just say two thank yous. Firstly, to the staff, many of whom have joined us here today, and many more who are online as well. Your commitment to good science, patient impact, and your company is an inspiration, and I know that the efforts that you have engaged in throughout the course of the year have been quite considerable. I think far greater than many people understand. We're also joined by our U.S. colleagues who bring a new capability to take our technology closer to clinical development than we've ever been before. We are learning a lot from them, and we are very grateful for their contribution as well.
I'd also like to thank the board of directors and in particular, our Chairman, Alan Tribe, for your continued support throughout the course of the year. I feel particularly well supported in my role. I have learned a great deal from Alan and continue to do so, and I'm very grateful to be on the journey with you. Thank you to both of those two groups. I'd like to advise everyone that from this point on, the meeting is going to be recorded, so it's a requirement to let you all know that the audio will now be recorded for the benefit of shareholders who were not able to make it to the formal part of the meeting. If you just bear with me for a moment.
Recording in progress. Recording stopped.
I'm just gonna make sure it's recording to the cloud.
Recording in progress.
I think everyone is now quite familiar with the overarching drug development process. I wanted to spend a little bit of time today going into topics that we haven't touched on in a great deal of detail before. The first one of which is our portfolio development strategy as a company, and that really sets the framing for the next two points that I'd like to discuss, which are the body of data that is now coming to hand, starting with the results from the dose-range finding studies in the non-GLP data from earlier this week, and give everyone a chance to ask any questions so that we have a common understanding of that. That really sets out, and Alan touched on it in his presentation as well, the platform through which we can scale the technology rapidly.
We'll have a discussion not just of the implications of those results for the RP11 program, but also for the platform as a whole. We're going to look forward to the next stage of development because the investment proposition in the company is evolving rapidly and is increasingly driven by our prospects of success in clinical development. There's some very important differences between what the industry as a whole is doing in drug development as compared to what PYC is doing, and I think it's important for shareholders to understand those. I'm also very happy for people to ask questions as we go through. If you'd like to have a discussion, please feel free to ask a question at the end of each slide that is presented.
In terms of where we start the drug development process at PYC, it very much looks to patients and an unmet need. At the right-hand side of that drug development pathway that we have outlined on the board here. We're looking for high-value target markets. In value, that's value in a patient impact sense as well as a commercial sense. What we're looking for is the ability to meaningfully change someone's life. If you can do that, you create a compelling commercial proposition. I think it's particularly worthwhile for those of you who are unfamiliar with Orphan Drug Pricing to point out that the industry as a whole has specifically set out to incentivize drug developers to create medicines for rare diseases.
The reason for that is, while individually rare, collectively rare diseases are very common. 7% of the population suffer from a rare disease, and there is an intentional decision that has been made in the U.S., in particular under the Orphan Drug Act, to incentivize the development of medicines for these patient populations. What you see is the median drug pricing for orphan indications creeping up towards $200,000 per patient per annum, which means that with a patient population of 5,000 or more, you're looking at a target market in excess of $1 billion per annum. Significant markets, and that's a very conscious decision that has been made by the regulatory authorities in the industry in the U.S. We are particularly interested in those indications.
As Alan mentioned before, as a small company, we like to play at the safer end of the spectrum because of the significant risks involved in the drug development pathway. The second benefit of focusing on unmet needs is that they confer the potential for a more rapid path to market. Many of you will be familiar with the traditional three phases of clinical trials before you reach market. There's an opportunity in rare diseases where there's a genuine unmet need to condense that into two clinical trials. That is another significant advantage for us, in particular with respect to time to market. The two areas that I want to touch on today with a particular focus are this point here, points three and four, the high propensity for success associated with genetic medicines.
We're going to go into that in quite a little bit of detail shortly, so I'm not going to dwell on it now. The next one is the implications of these historical results that have just come through earlier this week, leveraging the readouts that we are getting in the lead program for the benefit of the platform technology, in particular for programs two, three, four, and five that are progressing through an ocular development, if you are keeping the target tissue constant, you are really drawing the advantages of the proof of concept that's coming from that lead indication. Finally, if those are the first three drugs in the pipeline, as those progress towards first in human trials, we are also validating our delivery technology.
In that context, we are encouraged to look to the broader unmet need in the ophthalmology space and looking at the leading causes of blindness globally and seeing whether or not we can move into the patient populations that are not 5,000 patients, but five million patients that we can reach. That is another part of the portfolio strategy that you will see an increasing focus on from the company. In particular, I think in the very near term, we will be looking to address the more prevalent or common indications that cause blindness globally. I wanted to give everyone an opportunity to ask any questions that they had in relation to the results that were released earlier this week.
It's a very significant milestone for the company, and so I've just recapitulated here the graphic from the announcement that went out to market that displays the results, and to talk you through the way that the company designed the results and how these compare to our expectations. It's important that we don't preempt in any way a regulatory determination of the interpretation of these results, because ultimately it is the regulatory authority who decides what the true meaning of the outcomes are and how they will inform the in-human dosing. If you think about the two objectives of the study, however, we set out to achieve two things. Firstly, to establish that we had one clear tolerated dose in these dose escalation studies, and also one clear non-tolerated dose.
This is so that we get the resolution around where that transition zone between tolerated and non-tolerated occurs, so that we can design appropriately the GLP or Good Laboratory Practice studies that are to ensue. We get that detailed resolution on what that maximum tolerated dose is before we get into the human trials. If you asked us at the start of these studies, what would a perfect outcome look like? It would look very close to what you see on the board in front of you, with the exception of this one number down here. If that one had been in this column over here, that would have been a perfect scorecard.
Thinking about the first objective, what you see here is in the six eyes that were dosed with the test article, 100% of those eyes had no findings of adverse tolerability at the conclusion of the study. That checks objective number one. Objective number two, if you look to the highest dose that was intended to find adverse tolerability, you can see adverse tolerability established in each one of those eyes. Those are the two primary objectives of the study met.
In the context of having already achieved those outcomes, it would have been a perfect result for us to have had the mid-dose and the high dose both showing no adverse tolerability, which would have informed us that the window between no adverse tolerability and adverse tolerability is somewhere between these two doses, and it gives us exceedingly sharp resolution around where we need to look in those GLP studies. There's this one finding here that is the slight slip-up to the perfect result that we were hoping for. Other than that, I think it is a highly successful study that does everything that we need it to do to guide the progression into the GLP studies. Are there any questions in relation to the NHP findings? Sorry, you're talking about the gap between the mid-dose?
It's a fairly constant multiple if you look throughout them as a 3x escalation across each one of the dose groups. That's how the study was designed from the outset. That's intentional. Yeah. I think that's the issue that we don't want to get too deep into because ultimately that's for the regulator to decide, and we won't even be having that conversation until we've completed the GLP study. Really what we were looking to do here is guide the design of those GLP studies, and it will be the GLP studies that then inform the IND submission to the FDA that drives that conversation. Yeah, that's right. It's supposed to be a balance between the value of the monkey life and the cost of the studies.
On the other side, giving us a sufficient number of eyes to give us a true indication of the outcomes that we're seeing. I think that that's the balance there that we have struck. As you mentioned, it's really just an indicative finding before we progress into the GLP studies that give you the definitive resolution that we're looking for.
[audio distortion]
The intention is to use the non-GLP studies to inform the design of the GLP. You'll see a change in the design in terms of the doses that we go into those studies in. The other big difference between them is it's a longer study in the GLP context, and it's a repeat dose study rather than a single dose study. Those will be the differences between the two.
[audio distortion]
No. I think that will be the intention behind the GLP studies to work out, is that result that we're seeing here a result that is due to the test article or is it due to some other feature that does not relate to the test article itself? Look, in the interpretation, I mean, you can see that the significant majority of the eyes in that group did not manifest an adverse finding. Yes, something unusual has happened there, and we need to understand more about what that is, and that will be the purpose of the GLP studies. It's not. Actually, it's two primates who are both dosed in both eyes and two primates who are dosed in one eye with the other eye serving as a control. I think I've got the study design appropriate there. Geez, we're getting detailed here on the NHPs.
[audio distortion]
I hope the people online are following Mike with these questions, but the result was actually in a primate that had only one eye dosed.
[audio distortion]
The intention behind the dose escalation and that threefold increase that we're looking at is to ensure that we had, as we described before, we wanted at least one tolerated dose. That would have been acceptable for us to have had just one, but obviously the more that you get, the higher that the maximum tolerated dose is, the greater the potential window between the maximum tolerated dose and the minimum effective dose. That's what we are effectively looking for there. We didn't have a detailed discussion about, you know, what would PAR be beforehand, but this is probably at the upper end of the expectation.
[audio distortion]
I think it. Look, it is possible to speculate, albeit we don't want to, and I don't think we need to because we have the progression into the GLP studies and the ability to select additional doses around those dose levels with greater detail that should provide the resolution that we need to satisfy the regulator that we have a maximum tolerated dose that is well-defined.
[audio distortion]
If you look at the underneath in the explanations of the ASX announcement, you'll look at the different parameters that were observed throughout the course of the study. There's an in-life portion of the study where the animals are monitored at multiple time points throughout the course of study.
Then at the end of the study, on the sacrifice of the animals, there is a histopathology analysis done that looks at the individual cellular level in the back of the eye of those animals, and also looks at a bunch of other features as well. Looking at the systemic implications of the drug as well. If there is any finding that is adverse on any one of those dimensions, it is recorded as an adverse finding in this column. It's quite possible or an underlying susceptibility in that particular animal. There's a bunch of things that it could be, but it could also be due to the test article, and so we will find a definitive answer to those questions through the course of the GLP studies. What? We're still going?
It's supposed to be a period that is long enough after the administration of the test article to observe any adverse findings. It's a fairly standard design of a non-GLP study for an intravitreal route of administration.
[audio distortion]
Yeah. I think, I mean, if you're looking at it here, and this has been pointed out before, we're looking at a three times multiple between the different doses. Given that we now have the benefit of these outcomes to inform the design of the GLPs, you should see greater resolution around the different doses that we are expecting to be the maximum tolerated dose, and you will see the full picture of those outcomes and not be required to interpret one variable in isolation as we are in these studies. That's the.
Glenn mentioned it in his comment in the announcement as well, the evolution and the building layer by layer of the data that goes in support of the submission to the FDA. I'm gonna be very happy to leave the NHP studies behind us at this point. If there are no further questions, we'll keep moving ahead with portfolio strategy. Yeah. Okay. We'll take that on board. Thank you. Yeah, if you can get a roving mic. You'll need to turn those on, Carol.
[audio distortion]
Alan touched on, before the platform read-through of these outcomes, and I think it's important for people to understand that we are developing an RNA therapeutic modality that is made up of a delivery technology and then the RNA therapeutic itself. They are what we call a conjugate. They are joined together.
There's a lot of common features that are shared between the different drugs in our pipeline. Great degree of similarity between the delivery technology and the backbone chemistry that's used in the antisense oligonucleotide or the RNA therapeutic is common across those drugs. What changes is the sequence of the nucleotides that form the antisense strand. From that commonality, what we get in this context is a significant degree of read-through into programs two, three, four, and five from the readout that we have available to us in the lead program. You can see the particular importance of those results.
The other thing that we are able to do now is when we are doing our early stage toxicity and tolerability assessments in small animal models and in cells, we can link and benchmark the outcomes that we are seeing in the subsequent programs to what we're seeing in the RP11 program. It's a very important piece of information because we can use the comparison between that co-lead molecule and the one that we are assessing in those earlier stage studies to get a very good insight as to what is likely to happen when we progress into the non-human primates. In that, you see what we talk about as the platform read-through for this stage of development.
These programs here effectively have a significant piece of the puzzle in this stage of development answered for them, meaning it's a very important readout for our platform technology as a whole. The second point that I made before, and you see here, as we move through this IND-enabling course to the IND submission, the Investigational New Drug submission next year, increasingly the investment proposition of the company is changing from a bet on that platform technology, the ability to establish the safety of the molecule in the non-clinical setting coupled with the efficacy in the non-clinical setting, to efficacy and safety in a clinical setting, so the results of the first in human trials.
That's particularly important because we're going to go into some more detail shortly around what that journey looks like from the start of the phase I or the first-in-human studies to the New Drug Application that also goes to the FDA at the end of those clinical studies in the context of genetic medicines. Those medicines that we spoke about that form the core of PYC's portfolio, one, two, three here that you see are monogenic diseases, and this is critical. We'll come back to why that is very shortly. If there's one thing that you take away from today's presentation, it should be this sentence here. Drugs targeting monogenic diseases are more than five times more likely to be approved. That's from first-in-human to market.
The reason for that is the biological validity of the targets that have been chosen, and we spoke about this at the outset when we look at the unmet need and the genetic validation of the target. If you have got a complex disease process where there are many drivers of that phenotype or the adverse outcomes in that patient, the ability to understand what is going on and correct it is more complex than if you have a single genetic mutation that is manifesting at the protein level, whereby if you correct the gene expression profile, you in theory should rescue everything that happens from downstream from that protein in terms of the function of that cell, and therefore the implications for the patient.
This is a fundamental distinction in the drug development pathway for genetic medicines companies and is something that defines PYC's future as we progress into first in human studies. Any questions in relation to this? The other thing that's critical here, as mentioned in the title, is in the context of high quality non-clinical models, and I think many of you are familiar with the process of developing the patient-derived models. Because these are human genetic medicines, we are particularly interested in the performance of our therapeutic molecule in the context of a human genetic background.
We have the great advantage of being able to take the skin sample from the patients who have these diseases, reverse differentiate that into a stem cell, and then differentiate that into all of the cell types that exist in the eye and use that to assess our the efficacy of our therapeutic compounds. That gives us very strong conviction that we have got a therapeutic that is likely to make a significant impact in humans. We've really spoken about what's happening in the ocular portfolio and haven't touched in any great detail on the other areas of interest to PYC, and that's because we have an awful lot going on within our organization as a whole at the minute. There's a great deal of excitement coming in relation to the central nervous system in particular. This is a feature of our conversations with the U.S. markets.
There's a great degree of interest in central nervous system disorders. We've also got some very encouraging early data around the distribution of our molecules and the high-value cells that we can reach in the kidneys. That is encouraging in terms of the development pathway for potential therapeutics in that context as well. In terms of the platform, generally, we have a number of bodies of work that are invested in taking this one forward. One looks at going back to the peptide libraries for receptor binding domains that upon systemic delivery of the drug will target particular organs and particular cells within those organs. Others look at the ability to combine technologies for the delivery of larger molecules, so you're all familiar with the lipid nanoparticle shell that surrounds many of the COVID vaccinations.
Combinations between the lipid nanoparticles with peptides embedded in the surface to be able to deliver different therapeutic payloads to the antisense oligonucleotides that we're currently working on. There's a huge body of work that has gone into development, not just of the ocular pipeline. Things are really moving quickly in the context of the ocular space, and that's great because when we used to talk about the platform technology but not have an example of how that manifested in a product, that was the only interest that investors had. It's fantastic that you have this technology, but where's the product? We have the benefit of having multiple products that are progressing towards clinical development in the ocular space. That should not take away from the fact that we have a platform technology that can be scaled across many other indications.
Hopefully, you've got a sense of the portfolio strategy in the context of the eye itself. The majority of indications that we're pursuing here and the cornerstone indications are blinding eye diseases that are caused by monogenic causes or mutations. The validation of the delivery technology in the non-GLP studies and subsequently the GLP studies that are about to begin in the first quarter of next year will allow us to move into the highest areas of unmet need in the eye, so the two most common causes of blinding eye disease. You won't have to wait very long to hear some exciting progress that we are making on that front.
We are then looking to see whether or not we can recapitulate the competitive advantages that we have seen in the eye, so the privileged access to the retina that we have, the depth, breadth, and evenness of drug distribution in the central nervous system, and in particular, linking the cell types that we are distributing into or that we can reach the inside of to the diseases that are occurring in those cell types and the engineering of drugs to rescue the problem that is occurring within those cells. A very similar process is happening in the context of the kidney, but with the added complexity of using a systemic route of administration. We have a significant interest in scaling our platform as well. It's a really action-packed 2022 that we have lined up.
Even just looking at the immediate operational plans for what we need to deliver by the end of Q1, I can see some whitening faces throughout the back row seats at this point as a consequence of that. It's a very, very exciting time for the organization, but also quite an exhausting one if you are inside the company. Any questions on our outlook? If you just switch the power button on at the bottom there, Tony. Mike, how many stockbrokers does it take to turn on a microphone?
I was gonna ask about the last three years.
Mm-hmm.
If you have the RP11 drug, and if those clinical trials take 2 years, when do you ever run that?
So-
To repeat the question, just in case some of us are asking, when do you commence clinical trials?
Yeah, I might repeat it just into the microphone, so the benefit of those online. The question comes in relation to the RP11 program, when we anticipate initiating the clinical trials and also when those clinical trials may have concluded such that we will have a drug in market, assuming that they are successful. The answer is twofold. There will be two sets of clinical trials that are initiated next year, all going well. The first trial will be initiated in the first quarter of next year, and that's what we call a natural history or an observational study. What we are looking for there is the ability to monitor patients who have RP11 to have a look at what the baseline progression of their disease looks like in the absence of treatment.
What that provides us with is a benchmark against which to compare the rate of decline in those patients in contrast to the patients in the interventional clinical trial to establish the difference in the course of the disease. We'll be looking at initiating the first clinical trial in Q1 of next year, albeit I think the greater interest from the shareholder perspective is in the interventional clinical trial that is scheduled to initiate in Q4 of next year. We are looking at the IND submission in Q3 on the back of successful completion of the GLP studies, engagement with the US regulator, and then they have a period of several weeks to turn around the response to the IND, which would enable progression into the first in-human studies.
In terms of the answer as to when that could potentially yield a therapeutic end market, I'll take that one on notice because we're in the process of doing the detailed design of the clinical trial protocols, and it will be informed by how long those clinical trials take and the extent to which we can possibly overlap the phase II/III clinical trial with the phase I/II in the context of an early finding of efficacy of the drug in the context of a clean safety profile. I'll come back to you on that one, Tony.
Are you able to identify the top three central nervous system?
Yes, I think we can. Sorry, the question for those online is: Are we able to identify the indications of interest in the central nervous system, so the specific diseases that we are interested in pursuing for CNS disease? I think it's actually very helpful to have had the portfolio strategy conversation here, because if you think about the basis for the programs, the indications that we've selected in that context, the monogenic diseases, the same feature of those monogenic diseases applies in the CNS. We are interested in monogenic diseases, but the area of, I think, greatest passion to our CNS scientists is neurodegenerative disorders.
We have previously articulated that the two pathways that we are most interested in this context, is the autophagy pathway, so the cell's ability to remove the garbage from inside the cell, the garbage disposal system, and also the neuroinflammatory response that is triggered by protein accumulation disorders, so protein aggregation diseases. We're looking at the far more common diseases in that context, diseases such as Alzheimer's disease, for the CNS portfolio. In many respects, we invert the paradigm of the ocular space. We're willing to take the higher-risk bets because we've got the safer end of the spectrum progressing in the ocular portfolio. That encourages us to swing for the fences in the context of the CNS pipeline.
We're looking at both the more prevalent indications where there's a large unmet need due to a lack of effective drugs available on market today. That's not at the expense of rather we're looking at in parallel the monogenic or rarer disorders that have got that higher propensity for clinical success.
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Mm-hmm. It's not other two. We're looking at pathways. The pathways are common across the different indications. ALS would be another one that we'd be interested in, Parkinson's disease, the most prevalent indications in the CNS that cause pathology that has not got an effective therapy. Any other questions?
Very well. As we move towards clinical trials, but a rough number, the level of confidence that we're getting more steps as we go forward. One assumes you don't go to the clinical trial and go, "Well, we'll give this a crack. You know, we might be successful. We might be not.
Mm-hmm.
What sort of level of confidence is something you?
For the benefit of those online, the question is the extent to which the company can gain conviction from the work that's been done to date with respect to the likely outcomes in the clinical trials. I think I can certainly understand from a shareholder perspective. I mean, basically, that informs your valuation model, right?
Yeah.
Yeah. I completely understand. If you think about, firstly, the two sources from which you may gain that evidence and the encouragement that, hey, we're on a really good path here. One comes from factors that are agnostic to our drug. They relate much more to the indication selection, and that's why I'm really keen to impress upon people the greater than 5 x propensity for success in the clinic for drugs that are in, targeted directly towards diseases that are monogenic in nature. I think you should take great comfort from that factor. A 5x scaling factor is probably the most significant piece of evidence that you're going to get.
Then the other one relates to what is the quality of the body of work that's been done with that molecule in the non-clinical setting to encourage us that we've got the conviction that it's going to work. Here in the eye, in particular, we benefit from the availability of these retina-in-a-dish models. The drug development landscape is evolving. We have not had for very long the ability to generate a model from a patient that recapitulates the human eye with the genetic indication that we're looking at. You, you'll be familiar with the non-clinical development pathways, basically broken down into patient-derived models and animal models to assess the efficacy of the drug. The problem with the animal models is that they don't always fully recapitulate the human disease process.
Even if you see success in the animal model, you're often limited in the extent to which you can infer that's going to guide success in clinical development. This is why we focus so heavily on the generation of the patient-derived models. Because we've got precision or genetic medicines, we're much more interested in the context of, against the human genetic background, do we know how and why the cells that come from those patients are manifesting the disease that they are? Can we see in the non-clinical studies that we are able to correct those deficits?
If you go back and look at the data pack in support of the RP11 program in particular, but also the ADOA program that sits underneath it, the OPA1 program, you get some very encouraging results that we are likely to see a successful outcome in clinical development. The million-dollar question, there's a whole bunch of very interesting literature. Just get on Google and start having a look, but have a look in particular at monogenic protein replacement therapies. That's exactly what we're after. We think our technology fits best in the context of a disease process that is known as a haploinsufficiency, so not having enough of a target protein. In the context of a sensitive cell, sensitive organ and cell types within it, that if you overexpress the protein that's missing, you also induce a disease phenotype.
What we're looking for is that very subtle upregulation to get us back to the physiological levels. Usually what's happening in a haploinsufficiency is you've lost one copy of the gene. You've got one copy that's working, but you're basically down 50% on the amount of the protein that you should have. If we can restore that back to physiological levels, that's the specific indication that has got one of the highest success rates in clinical development. Over and above the 5 x increase for the monogenic disorders. If you put all of these pieces of information together, it starts to look very exciting. But look, it's always difficult to say exactly what do we look at in terms of the success rates in clinical development. Which is why it's nice to have a portfolio of therapies.
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That's a good question. The question for the benefit of those online is when do we expect the monkey trials for the CNS programs to begin? The answer is twofold. Firstly, we will go into rats before we go into monkeys, and the rat studies are about to be initiated now. I'm looking at Vanya, who's not giving me anything in terms of cues to answer specifically, but those studies are about to begin, and I, from looking at the discussion on whether or not we'll get the results late this year, I think it looks like it's tipped over into early in the new year because we don't want to leave the samples at risk of the logistics shutdown across the Christmas window. Rats via intrathecal injection. It'll be an administration in the same route that we anticipate going into humans.
That will be very insightful to have a look at what's the cellular level distribution within the rats, because other groups have seen that you get a very similar profile in the non-human primate and into humans as well. An early indication, I think will come in Q1. The progression into the non-human primate models with the reporter oligo, so an oligonucleotide, that gives us a readout of which cells we got into, but is not itself the therapeutic, is scheduled to begin in Q1. Maybe Q2 for results on that front as well. That will be very interesting. It's a bit like, a bit like what's happened in the context of the ocular disorders. What we're doing is we're pulling down the safety tolerability profile. That's the platform implications that Alan spoke about from the RP11 drug.
There's a whole bunch of work that goes on in the context of these patient-derived models in particular or human cellular models that enable us to work out what's the efficacy of that molecule. That work is running in parallel across all of the different pathways that we've spoken about. If you couple those two together, the efficacy profile that we're seeing in those models, and that will progress in the more common indications that you were asking the question on the diseases in the CNS that we're interested in. There, the availability of animal models is a little bit greater than what we see in the rare ocular disorders.
We'll move across into the in vivo therapeutic models in the animals at the same time as getting the reporter readout from the large animal that will tell you both in the most toxicologically relevant species, whether or not the drug has got an acceptable safety profile, and in the species that's most similar to the human, what the drug distribution profile looks like in terms of getting to the cells in which that actual disease is occurring. It's you're always trying to piece the puzzle together and then launch the program in totality on the back of that. It's the strength of that evidence that then informs how likely we are to succeed in the clinic. Exactly. We're. We will almost.
We've got multiple different oligo development programs in place, targeting different pathways that we know are of very high value in the CNS. We will look at the distribution profile that we get in the rats and the non-human primates and prioritize those that the delivery technology naturally gets us to. We'll deal with the challenge of tuning the distribution later by making changes to the delivery technology. We're going to go after the ones that are immediately amenable to progression on a prioritized basis, which is why it's nice to have these bodies of work running in parallel, which is why the team need to work so hard in the intervening period, so that we've got choice and that we can inform a review of the strategic direction at that point in time. Everyone happy with the rapidly scalable platform technology?
If you look at the comments of Bob Langer, who's a luminary in the field at the STAT Hearts and Minds, what he looks for in a biotechnology company, it's the platform. It's the scalability of the underlying technology. I think the great benefit that we've got of the RNA therapeutic modality in particular is the front end of the development pathway is rapid. It's very, very fast for antisense oligos. I see some skepticism from Emily in the audience. Would you like to come down and explain, Emily, what you're thinking there? No. Yes, it's not as fast, I think, as some of the literature suggests. Some of the literature suggests you can go from identification of the putative antisense strand to your therapeutic within a window of six months. We have not found that to be the case.
I think that's a little bit aggressive, but it's certainly a lot faster than the conventional drug discovery pathway. In particular, when you're coupling, and this is critical, again, mainly in the blinding eye diseases, because this is where we have got the greatest data, courtesy of our colleagues in the U.S. who are rapidly building out the case for this modality. If you couple the information that you are getting in this part of the chain with the efficacy signals in programs two, three, four and five, you start to get significant conviction that you have got a molecule that's going to start clinical trials, because that's the first question, right?
It's from that point in time when you've got that conviction, it's all right, now how do we build out the evidence that we think this is really going to work when we get into clinical development? That's the work that is being done in those subsequent programs now, with the killer experiment that we're looking for in non-clinical development. Just in summary, to bring it all together, it's a platform technology, and I think everyone has a good understanding of that now. The really nice thing for us at this stage is that we have got a pathway to a top line. I'll come back to you on exactly when it is, Tony, the drugs are anticipated to enter market.
Remember, the key here is that they start clinical trials first, because if you've got a first in class molecule that goes through the IND process, and you've got an appropriately designed clinical trial, that should, if it is successful, be the first drug to market. It provides a gold standard against which the standard of care then needs to be compared. It secures your path into that market. In the context of genetic medicines that have got that five times higher prospect of success, that's a real feature that should excite shareholders now. Whatever number you're punching in into your assumptions on that risk-adjusted net present value model, you're gonna come out with an outcome that is far larger than the market capitalization at this point in time.
It's on the back of multiple programs that we've got progressing into the clinic across a number of different target tissues, but you can see why we have that focus on blinding eye diseases. I think we've covered the final page just to really knit it all together. What's gonna happen in 2022, well, we've become a clinical stage company, and that's really important to us as an organization. Firstly, it means that we are impacting on patient lives, and that is a fundamental driver for the team and one of the very big reasons why we have the level of commitment and the willingness to work so hard that we see within our organization. It's also important to shareholders because it caps off that evolution and the value proposition from evaluation in the non-clinical setting.
Now the driver is success in clinical development. I think really excitingly for us, we are trying to use the genetic insights to drive a very calculated transition from the orphan indications into the non-orphan indications. I'm looking at Dulcie and Janvi now. It's bioinformatics. It's the use of very clever assessment of large data sets to work out, okay, we're not gonna get the five times uplift because these are much more complex disease processes, but how can we really build out a high-quality body of evidence to support the specific target that we are choosing in that pathway? Why is our drug going to be better than other companies that are involved in the space? How can we make sure that we are maximizing the impact that we're going to have for those patients? Finally, we're scaling a platform technology.
As we mentioned before, there's a lot of interest in the U.S. in the central nervous system. There's less interest in blinding eye diseases. It's a more niche and bespoke market. There's less interest again in orphan blinding eye diseases, for the reason being that the $1-$2 billion markets are considered relatively small by the majority of the industry in that context. I don't think it's anything for us to worry about. I think actually that's a great thing for us. It also is, I think, highly rewarding to think that we have got the first available disease-modifying therapy for these patients. That's really impactful. We also do want to get across into those non-orphan indications. We want to reach the five million-10 million patients rather than just the 5,000, and that path is really coming together very quickly.
I don't think that you will even need to wait until 2022 to get the first insight in that regard. A very exciting window for us as we approach the end of the year. Tony?
We have more questions.
Yeah, we're open for more questions. Yeah, we are.
I think this time last year we set up an office in America. The main objective there was to engage, enable us to attract. Also, to start to populate our share registry with American investors because they understand biotechnology. Australians don't really. Now it's clear to me that we are well engaged with the FDA, but unfortunately, we haven't got any validation at this stage from American investors. I was just wondering whether or not you could give us an idea as to currently how the board sees things, if there's any change in strategy now that maybe we've identified that's harder than we thought it was going to be twelve months ago, and whether or not a U.S. listing is perhaps going to be deferred for a period of time just to focus more on Australian institutions, all those sorts of things.
Just remember I've got to synthesize this question for the benefit of the audience online, Tony. I think if I can summarize the question that's come from the audience, it relates to the establishment of the U.S. office and the objectives that we set out at that time. If you wind back to what was communicated publicly, Alan, our intentions of getting over there, one was to establish the infrastructure on the ground that had access to the skill sets that we don't have here in Australia and for those guys to drive the U.S. regulatory engagement. I think Tony in the question has acknowledged the great progress that's been made there. I think Glenn and the team have done a fantastic job in that regard.
That was the core objective, make sure that we've got an efficient path for these drugs to get into first in human studies. Objectives number two and three were. Gabriella, would you mind just not defacing the company's materials in the public forum? I don't think Gabriella shares our conviction that we're gonna hit the clinic next year. The other two objectives were investor relations, so to engage the U.S. life sciences institutions, because I think you're right, I think the Australian market looks for a lead from those institutions. Then the final one was business development. To be closer to the pharmaceutical companies that may look to partner with us on the journey, either of developing our own drugs or, as Alan mentioned, using our delivery technology to take their therapeutics forward inside cells.
I think you're right. We haven't made as much progress in terms of the IR and the BD front as we have on the regulatory engagement, and if you gave me a choice, that's the way around that I'd have it. The making sure that we are progressing as a company towards our translational objectives, that was the core focus of what we were going to do. The reception of the U.S. life science investors has been very strong. We've had engagement through Kagan, our chief business officer, and Sam over in the U.S. with probably more than 50 life sciences specialist funds and the top-tier life sciences specialist funds as well. I think there's a very strong recognition of the value of what the company has.
I think one of the challenges that we faced is those companies, those institutional investors won't buy on market. We're having two very different conversations than. One with the ASX retail investor, largely retail investor, and one with a very sophisticated life sciences specialist investor, and they both have very different investment objectives. The way that they enter their shareholding in the company is also quite different. I think, as you know, the company has also, as we made that commitment to funding the company's future, we gave the company the capital, a multi-year cash runway, to make it selective, the timing and the terms on which we moved across to those capital markets.
I think the other complexity that we have realized and probably appreciated more, as you pointed out in the question after the fact, is that the management of the two markets across the window period where we envisage that we are potentially sourcing capital from both markets and possibly even have a listing in both markets, is going to be more complex than we had first thought. We are still going to need to do a lot of work in terms of engaging Australian investors and Australian generalist investors. I think that will be made easier by the presence of a life sciences fund on the register, but I don't think we have fully thought through how we are going to go about supporting those dual pathways of communication and the combined aspiration that we have across them.
On the business development front, it's interesting, and I think it is worthwhile pointing out to the Australian investors, most of what the Australian investor wants in terms of a partnership deal and the validation that brings is not wanted by the U.S. investor. They don't want to see it happen. They want you to own the entirety of your drug pipeline and 100% ownership of the assets within it. Unless you do a very well-structured deal with a pharmaceutical company that does not give away the core asset that you are looking to develop and allow them to get it too cheaply, they are much more interested in undertaking a due diligence on the basis of the data that you are putting in front of them. Their preference is very strongly that you have not out-licensed or sold a shareholding in those assets.
While I understand why the Australian market are interested in it's the polar opposite of the outcome that the U.S. market are looking for. Just run me through the question again, Mike, before I paraphrase it. Yeah. That's a good question. I understand it now. The question relates to, and there's a particular interest in the central nervous system pipeline, and whether or not that principle of the U.S. investors wanting whole ownership of the assets applies where another company is developing the RNA therapeutic or the precision medicine, and that may be improved by PYC's delivery technology.
I think then that the investor would be understanding of the fact that if the IP around the RNA therapeutic is already wrapped up and they've chosen a target and an indication that is very attractive, and they've got a good body of evidence in the non-clinical setting that is in support of that molecule, that's when they would be open to seeing us do a delivery deal. I think actually, a really good example of it is the Ionis-Bicycle deal. Ionis are the oligo company, Bicycle are a peptide company. Ionis have paid, I think it was $50 million upfront for a license to a peptide that targets the transferrin receptor to get across the blood-brain barrier, and with a big back end on that deal as well.
That's an example of exactly the type of deal that you are speaking about. Yes, I think we're very much open to that. I guess more what I'm saying is if... Remember we've got the RNA drug design capability in-house as well. If we've developed, designed, developed the molecule ourselves, I think the interest is in keeping that in-house and not farming out a share too cheaply to a party just for the validation that that party brings. They're very comfortable with the data, the U.S. investors. You know, they are very comfortable to back their judgment and their assessment of the data itself, so they don't look for the external views on validation in the same way that the Australian market does.
The question is in relation to the cash runway and where across the pathway that we are currently funded for do we need to look to visit the capital markets. I think the headline message is no time soon. We've got a multi-year cash runway. We're the beneficiaries in Australia of the R&D rebate, so it's a very capital-intensive environment. The company is in the best cash position that it's been in in an awfully long time. That's against the backdrop of costs obviously go up the further in development that you go into, but we don't have any near-term pressure on us in terms of the capital markets visitation.
I think if you look at what we're trying to achieve in the context of the presentation that we've just given, there are a couple of milestones that are really critical to the U.S. investors that I think can help us change the valuation paradigm, and so that's what we're looking to drive towards. Even if you think through the aspiration just between now and the middle of next year, we will be very close to starting. We will have started one clinical trial in the observational study, so technically made the transition to a clinical-stage company, but I think people are more interested in the interventional study. You'll be a couple of months away from submission of the IND and initiation of those first-in-human studies, and then you get a really high degree of conviction.
Once you've wrapped up the non-GLP studies and you've started the GLP studies, you really know that you're going to go at that point in time. We will also have engaged the regulator. I think there's an open question in terms of regulatory engagement ensuring a smooth path forward. The pre-IND meeting with the FDA will have occurred, and that gives us a window to really drive the efficacy signal. Remember we spoke about, okay, that's in the lead program, but if you're pulling through all that data to have a read-through benefit to programs two, three, four and five, what else can we do in terms of getting that efficacy signal fully developed so that we start getting those programs valued as well? We don't have those programs valued at the minute. In the market capitalization, we don't have the platform valued either.
We've got that challenging task now of running those two different conversations, one to an audience in Australia that's very different to the conversations that we're having in the U.S. It becomes a lot easier the more the data matures. Again, the layering of the data. We're getting very close now to the point of having the full non-clinical validation of the technology. That will be a much stronger point to go to the capital markets from. I think no time soon is the headline message there.
Are there any significant competitors to PYC?
Yes. The question relates to, are there any significant competitors to PYC? Yes. This is the single strongest trend in the pharmaceutical industry, the push towards precision medicines and getting large molecules inside of cells. There are competitors everywhere. There are competitors in stealth mode that we know nothing about. There are competitors who are public and well advanced. There are competitors in the RNA therapeutic space who are going after the same indications that we are. Competitors in the DNA therapeutic space that will cut our lunch if they can as well. That's great for patients, right, to have the choice. I think that's when it comes down to your strategy and how well have you chosen the indications that you are going after.
From competitors within the RNA therapeutic space, you get a lot of protection conferred by the IP around the oligo sequence itself, because that's your composition of matter claim to that drug. What we try and do when we look at the targets that we're going after is we make a very broad claim of all of the different sequences that we could use, and then we sharpen and sharpen and sharpen that data around the lead candidate that does exactly what we want it to do. That's the lead selection phase in the drug development that we spoke about previously. That gives us a big differential. Then the nature of the indications that we've chosen and their suitability for RNA therapeutics. This is the link back to the haploinsufficiencies that we spoke about before.
If you think about the lead program, the primary competitor for us in Retinitis Pigmentosa Type 11 is Biogen. A significantly sized U.S. pharmaceutical company who are using an adeno-associated virus to deliver another copy of the PRPF31 gene, the gene that's deficient in this indication. We haven't heard a lot about that program recently, and I suspect that's due to a couple of reasons. Firstly, AAV, the delivery technology there, has had some very well-publicized difficulties in clinical development, safety issues around intravitreal administration.
The way that they have to administer the drug, instead of just an injection into the center of the eye itself and allowing the drug to distribute everywhere within the retina, they have to go all the way through the eye and tear the retina off its posterior pole, and you only get a very limited distribution of the drug. The problem is you get an uneven transfection of the cells that sit around that area. Some of the cells express 10 times as much of the target protein, and some still express none because they haven't had the drug successfully delivered. The ones that express 10 x often are subject to a disease phenotype and stuff. That will induce a disease process because you've got too much of the protein being expressed.
That gives us a lot of conviction in the RP11 program. In the context of the OPA1 program, Stoke Therapeutics, another RNA therapeutics company, have got a program, a naked oligonucleotide, so they don't have the benefit of the facilitated delivery. We have a competitor in that domain who look like they are progressing that asset into clinical development, and that one is probably a lot more relevant for us. The competitive advantage that we have there is the delivery technology itself. Certainly what we're seeing in the non-clinical assessment is a very clear articulation of the differences conferred by facilitated delivery in the target cells. It's much more potent. Well, that was a good workout. Yeah. All right. If there are no further questions, I'll thank everyone very much for their attendance. Thank you again to the staff and to the board.
Apparently there's morning tea outside as well. Please join us. I would encourage all of the scientists who are here, stick around and have a conversation about the great work that you are doing with the shareholders. Ask any hard questions that you've been saving in the back pocket of these guys. Thanks very much to everyone online.