ReNeuron Team plc (OTCPK:RNUGF) Q1 2023 Income Convention Name Would possibly 25, 2023 4:30 AM ET
Corporate Contributors
Iain Ross – Government Chairman
John Hawkins – CFO
Randolph Corteling – Leader Clinical Officer
Convention Name Contributors
Operator
Team plc Investor Presentation. [Operator Instructions] The corporate might not be able to respond to each query won right through the assembly itself. On the other hand, the corporate will assessment all questions submitted as of late and put up responses the place it is suitable to take action. Ahead of we start, I might love to publish the next ballot.
I might now like handy over to Government Chairman, Iain Ross. Excellent morning to you.
Iain Ross
Excellent morning, everyone. I see from the display, now we have were given numerous attendees. And we are in point of fact happy to come up with an replace on our initial effects. The primary web page talks about growing a treasured and differentiated drug supply platform. And you are going to recall, originally of the 12 months, that we made it very transparent that that is the place we are going to focal point. And that’s the reason the place we are going to produce knowledge. And so what we need to do that morning, is solely to take you thru our presentation, you are going to have all learn the announcement this morning.
And I should be truthful, there is no longer an enormous quantity to let you know, as a result of we’re in reality doing what we stated we’d do originally of the 12 months is that we’re operating exhausting to supply the information. And I will be able to say to you that we are heading in the right direction to be generating knowledge throughout the subsequent 2 to three months. And from that knowledge, we are hoping, we can conclude numerous discussions which can be already in growth. So simply shifting during the disclaimer, which everyone I am certain is learn intimately.
Transferring on to the primary slide. The tale for ReNeuron may be very easy. Now we have vanguard science. And I imagine that drug supply isn’t simple. If it was once simple, then most of the other modalities which can be in the market would have succeeded. However in actual fact, it’s a must to in reality tailor issues to the place you need to ship the specific shipment within the frame. And we imagine that our supply platform in point of fact offers us that flexibility, that it isn’t simply sufficient to have an exosome, you need to have the correct kind of exosome with the intention to ship the correct kind of payload to a selected goal within the frame.
And now we have endured over the past, specifically over the past 6 months, now we have endured to broaden our platform. And I imagine that our proprietary stem cells generation differentiates us from the competition. And we imagine that we can produce knowledge to turn that. Now we have reduce the group all the way down to focal point very in particular at the construction of the exosome generation platform.
Now we have 23 people now and we cut back the headcount via about 40%. Now we have Randolph, who is sitting beside me right here, who’s supported via a very good Clinical Advisory Board. However Randolph, after all, was once the person who at the start began the exosome analysis in ReNeuron numerous years in the past, and we had been very fortunate for him to rejoin it.
We have now additionally appointed Simon Dew, as CBO, who has a large number of revel in in doing explicit offers with exosomes. And so the opposite factor I might say is that it is in point of fact vital, it is all really well to have a excellent supply generation, however you might have in an effort to manufacture, and you’ve got in an effort to manufacture at scale. And that’s the reason the only factor that ReNeuron surely has a large number of revel in on. And the very last thing to mention this is now we have a robust development to state and we’re submitting patents as we proceed to move ahead.
So if I transfer to the following slide, and simply take a look at probably the most operational highlights, and via the best way, I have had numerous questions that had been pre-submitted, so I am going to check out and resolution a few of the ones questions as we move alongside. However originally, we’re specializing in [indiscernible]. We did proof-of-concept research remaining 12 months, remaining calendar 12 months in in vitro. And to be completely truthful, that was once no longer sufficient to persuade folks to both spend money on the corporate or move right into a collaboration with us.
Now we have endured to do extra in vitro paintings. So now we have broadened our experience in that space, however the true query is doing in vivo paintings. And that’s what we set out originally of the 12 months that we can do in vivo paintings to offer knowledge to give a boost to the importing of a shipment, the supply of that shipment relating to via distribution and the frame, and in addition the unloading of that shipment on the explicit web site and to turn some capability. We are doing that. We are on target.
I have had an enormous collection of questions pronouncing when are you going to offer us knowledge? We are going to give knowledge when now we have that knowledge. And we are very fascinated by what we are seeing as we transfer ahead with our exterior advisors, and in addition the corporations which can be operating with us. However in this day and age, we should not have that knowledge in a sort that in reality we will be able to provide. However we did say originally of the 12 months that we’d do this inside of the second one and 1/3 quarter and we are on target to do this.
Now we have modified the management. Mainly I am now complete time operating the industry. John has stepped as much as CFO; Randolph is the CSO; and Suzanne Hancock is in control of our operations and we had been joined via Simon Dew. Stefano, the Chairman of the Clinical Advisory Board has revised that Board and taken in some actual professionals in that space. And simply sooner than anyone requested me, is that costing us cash? No, it isn’t costing us cash. It is individuals who need to paintings with us as a result of they are enthusiastic about our platform. So operationally, now we have moved ahead. John, possibly you need to hide the price range?
John Hawkins
Sure. Hi, everyone. Sure, as, Ian discussed, in January, we undertook a restructuring of the industry to realign our assets against the validation of CustomEX. We’re very a lot specializing in holding money. The money is the shareholders cash, and we are most effective spending it the place we expect we will be able to reach the utmost payback. This — the restructure ended in a 40% relief in headcount and a decreasing of variable prices. That leads to relief, the underlying price base has enabled us to keep our money, such that on the thirty first of March, we had money of $7.2 million, which is which is forward of marketplace expectation, and the runway extending into 2024.
So you’ll see there, I may not move into element at the pieces at the slide, you’ll see our earnings was once up somewhat. You’ll see our price base did cut back fairly considerably at the prior 12 months, and that that led into the relief within the loss for the 12 months. K, in order that was once that was once all.
Iain Ross
So simply sooner than we transfer to thoughts off, who is going to hide probably the most questions that now we have had relating to the science, and the place we’re with generating the information, it is price pronouncing there are collection of questions are coming in pronouncing the place are we with industrial partnerships? We’re precisely the place we need to be. We’re surroundings the ones up. We’re speaking to folks. Simon is widely travelling and speaking to firms and pronouncing, if we produce this information, will you in reality input into an settlement with us? Now it is really easy for them to mention sure, however clearly, the information would be the check. And in order that’s the place we are in point of fact targeted in this day and age is generating that knowledge, and the use of shareholders budget judiciously.
So possibly we transfer to Randolph and you’ll let us know how you might be getting up.
Randolph Corteling
Nice. Thanks, Ian. In order Ian discussed, we’re growing that next-generation drug supply platform. And we are doing that via harnessing the herbal functions of exosomes, stem cellular derived exosomes, as a result of they’ve a herbal skill to triumph over probably the most obstacles round present supply platforms. For example, protection, viral vectors were plagued via negative effects. Additionally they are restricted at the sort and the dimensions of the shipment they bring, and lipid nanoparticles be afflicted by successfully turning in their shipment. And they all in point of fact be afflicted by a restricted or a small quantity of focused on.
On the other hand, whilst you take a look at a stem cellular exosomes, those exosomes are protected. They’re naturally happening nanoparticles that evade the immune detection. This opens up the potential of repeat management. They have got wide applicability with regards to turning in other bio — bioactive cargoes. We have now proven that they are able to concurrently ship proteins in addition to nucleic acids. However the important thing factor for our platform, and the important factor is that they are able to goal recipient cellular sorts via other floor proteins on them and so they do that via converting the place that — the place the cellular of foundation is. So in point of fact, the exosome cellular supply is a very powerful attention when focused drug supply.
And now we have already proven this in vitro. So the remaining one year, now we have proven — as Ian discussed, now we have proven this categorically in vitro, that in reality beginning at the left hand aspect of our slide, we display that there are other exosomes that experience other kind of like cellular markers, so distinctive cellular floor markers. While you put those other exosomes on other cellular sorts, so taking a look on the center graph right here at the slide, you’ll display that via hanging those on other recipient cellular sorts, such things as epithelial cells, endothelial cells and neuronal cells, and evaluating them with a HEK 293-derived exosome, you’ll see a vital growth in supply from 10 to 20-fold growth.
That uptake, we then took that one step additional at the proper hand aspect and checked out whether or not that uptake of exosomes that particular focused on of exosomes in reality relates and is a part of the supply of the shipment and what you’ll see at the proper hand aspect there, the crimson line illustrates the fluorescently classified siRNA dropped at via a HEK 293. And the 2 strains above illustrate an as much as 6-fold growth in that supply. So now we have proven that we will be able to goal and ship cargoes in vitro.
So this is the reason now we have evolved the CustomEX platform, a customizable exosomes platform made up of a couple of manufacturer cellular strains, which enable other exosome applicants to be decided on for his or her skill to focus on explicit cellular sorts. At the left hand aspect, we display what the usual approaches via a lot of our competition the use of a unmarried cellular line providing you with a unmarried end result, a unmarried exosome candidate, however one dimension suits all method.
While within the blue field, you notice what ReNeuron has with their CustomEX platform. They have got a couple of conditionally immortalized manufacturer cellular strains. So we recently have 4 neuronal stem cellular strains, and 3 non-neuronal stem cellular strains, which may also be selected relying on their explicit focused on skill. Nevertheless it does not prevent there. We even have an precipitated pluripotent stem cellular strains. So if that exosome candidate does not exist, we will be able to make new present — new strains, which is able to goal other areas of the frame. So you’ll select the exosome that you want to in keeping with tissue focused on each off and on goal results, the way it delivers, and paired with probably the most engineering and loading functions, we will be able to display that we will be able to ship this shipment in vitro.
However it isn’t simply the cellular strains this is important to our platform. What may be important and what in reality differentiates us from many of us within the business is our generation, which permits us to stably produce cells and the exosomes to a scale this is clinically related. And this generation is named ReNeuron’s conditionally immortalization [ph] generation. It permits — stem cells tends to modify in tradition. However what [indiscernible] can do via this generation is in reality regulate the proliferation of those stem cells.
So via including — via genetically engineering the cellular strains, we will be able to now upload a small molecule which permits us to modify on cellular proliferation or transfer off proliferation, which assists in keeping the cellular sort very — that the phenotype maintained over a couple of other pathologies, so now we have a strong manufacturer cellular strains. This procedure is absolutely certified to GMP and tightly regulated with strict unencumber standards is there for scalable, we will be able to then produce the cells and therefore the other exosomes are commercially related scales. And the exosomes are strong and protected. The generation is not transferred into the exosomes, and now we have lately received protection knowledge for the cells with 10 years in [indiscernible].
So principally, what now we have carried out over the past kind of calendar 12 months is in reality now we have already proven that our exosomes, our CustomEX platform can ship a variety of biologically energetic cargoes. As I stated, now we have proven with nucleic acids, but additionally with proteins. Now we have proven that they are able to goal recipient cells via the skin markers in vitro, relying on the place the ones exosomes got here from. So no longer all exosomes are the similar, and it in point of fact displays that you want a list of exosomes in an effort to goal other spaces. And so what now we have carried out is the whole lot to this point as of late, now we have proven that we will be able to do that in vitro. The keys subsequent level is to turn this in vivo.
And my remaining slide in point of fact displays us what’s ongoing and as discussed — as Ian discussed in brief sooner than, that the remaining 6 months now we have been thinking about taking a look at that ongoing in vivo validation. So the important thing issues that we’re appearing at the moment is that we’re to show in vivo demonstration that our exosomes can goal tissues and cells in vivo with that other functions of the ones other exosome applicants.
We need to ascertain the protection profile of our property and principally display that we — this then opens up repeat management, show a transparent benefit of the stem cellular derived exosomes that CustomEX platform over the HEK based totally platform that one dimension suits all. After which after all show that focused and functionability — that useful supply in vivo of a healing payload.
Iain Ross
So what we are taking a look at, take a look at the objectives coming this is we are going to proceed to do what we stated we’d do. And that’s to in reality broaden the platform, produce knowledge to make sure and validate that platform, to then take that knowledge and use that during the ones discussions and taking a look relating to partnering licensing discussions. We even have plans, how we will be able to take issues ahead thereafter. We’re taking a look at non-diluted investment, and the collection of questions is pronouncing, are you going to wish extra money? In fact, we are going to want extra money. However we’re dedicated to doing that thru collaborations and partnerships.
If the information is shocking, and we imagine it is within the pursuits of the shareholders to additional make investments, we can come to the shareholders. However my view is that partnering is the best way that we take this ahead. And now we have numerous discussions ongoing. Individuals are asking the place we’re with our collaborations. We’re so thinking about generating knowledge, Simon is speaking to all the ones folks updating them precisely once we imagine or have knowledge that can be related to them. And we can take the ones discussions ahead.
I feel additionally it is vital to emphasise individuals are coming to us now. It wasn’t the opposite direction round a 12 months or so in the past, it was once we had been going out touting our platform. Now that individuals are coming and asking is when now we have the information we are to peer. And I am telling you, a few of these individuals are afraid of enormous teams. So I imagine that during abstract that we’re taking a look after your cash, which I feel is in point of fact vital. We are the use of it very judiciously. Now we have a list of various cellular strains, so we will be able to have a list of several types of exosomes. We’re generating the information, and we’re progressing the ones third-party discussions. I might very a lot hope within the subsequent 2 to three months, we can make numerous bulletins alongside the ones strains.
Sure, any individual has simply requested us about our ideas on Codiak ? I’ve to mention that we had been very just about Codiak. We are very sorry to peer what in reality came about to them. However that may be a case of the place they in point of fact had been having a bet the farm at the healing pipeline. We haven’t any aim of happening the healing pipeline. We can paintings with companions, we can paintings and resolve their issues, supply issues. So sure, Codiak have long gone. However there are a selection of different exosome firms in the market. And sure, we do communicate to them, as a result of they will neatly have generation that which is able to reinforce our scenario or is complimentary to us. And we are proceeding to speak to everyone.
Is there some other explicit questions? Sorry, I am simply taking a look down the record. Are there any competition doing this paintings? We are not conscious about any competition the use of the generation that we’re. There has a tendency to be an excessively a lot a view is like one dimension suits all. And we simply do not imagine the information is in the market to give a boost to that. And so we’re going face to face, and once we are generating this information, we aren’t simply generating knowledge to mention we will be able to do that, we’re in reality generating knowledge to distinguish [indiscernible].
Oh, any individual stated they labored with me at Celltech. They usually play golfing with me. That is very attention-grabbing. What’s the part lifetime of the exosomes?
Randolph Corteling
The ones research are ongoing at the moment, so we’re doing the bio-distribution research at the moment. That is this kind of the query that we’re answering that focused skill — are excreted all of a sudden. However clearly, should you get focused supply, that may not be the case. So that is very a lot kind of like within the package deal coming ahead, which may have that knowledge within the subsequent 2 to three months.
Iain Ross
Anyone has requested a query about probably the most legacy property, in regards to the retinitis pigmentosa. Now we have principally performed down the legacy property. So any upside we get from that can be a good. However the query was once, have we been beneath CDA with any possible a part of the retinitis pigmentosa? The solution is sure.
What timetable are we taking a look at relating to to begin attaining worth? That is a in point of fact excellent query. As a result of we in point of fact must create some worth this 12 months, this calendar 12 months. And we imagine that we’re doing that in keeping with the information and the partnership discussions that we have ongoing.
Anyone stated resolution the pre-submitted questions. Neatly, now we have a number of pre-submitted questions. So do you simply need to take a look spherical off and notice if there is any science, what was once there?
Randolph Corteling
Sure. One of the crucial questions requested in regards to the — [indiscernible] inherent variation within the exosome populations made from cellular strains? That is completely proper. There may be. And now we have proven that. We have now proven that during our preclinical. Every cellular line produces a singular exosome that has distinct focused on skills. So that is what our platform does, it has a list of various exosomes, from production from batch to batch, that is the place we’re considerably other from others. Now we have the conditionally immortalization of the ones stem cellular strains, because of this from batch to batch, we get no longer most effective scale, however prime levels of consistency. In order that was once one thing that we replied ourselves originally. And we’re satisfied that we’ve got an excessively strong product.
Iain Ross
K.
Randolph Corteling
Sure.
Iain Ross
So the opposite questions I used to be requested, and any individual has simply requested, do you assume ReNeuron goes to move bust? No, ReNeuron isn’t going to move bust. We are very assured that we’re principally turning in at the promise that we laid on originally of the 12 months. Anyone else has requested is, is there going to be a bidding conflict to happen for ReNeuron? I very a lot hope so. However I do not hope it isn’t for the following 2 or 3 years. As a result of clearly, if you wish to bidding extra [ph], you need to do it from the next worth than this.
What do I feel is truthful worth for the [indiscernible] with the industry? Neatly, you’ll pass judgement on it via the percentage worth as of late. What do I feel is truthful worth, surely now we have noticed the analyst document as such about $35 million I feel.
John Hawkins
Sure, $35 million
Iain Ross
In my opinion, I’ve to mention, having been concerned within the business for 40 years, I imagine that we produce some knowledge, and we get a validating partnership, I feel we can see the price of the corporate rocket lovely briefly. As a result of exosomes are right here, they’re naturally happening and they’re conscious about turning in medicine. And that’s the reason the largest problem within the pharmaceutical business. It isn’t such a lot the horny science in generating the unique molecule. It is in reality about getting that molecule having the ability to manufacture to scale and having the ability to goal it. And I imagine that we’ve got skilled, and we will have knowledge, proving the exosomes can be elementary as issues move ahead. [Indiscernible] questions.
Randolph Corteling
Sure, there is every other pre-submitted query for me. The query says, do you want to turn differentiation towards your competition with the intention to transfer ahead together with your companions doing in vivo trials? In the event you display excellent efficacy, however no longer essentially awesome to the contest, would this nonetheless provide a chance? And thank you for the query. You are completely proper. This does nonetheless open a chance. I stated on my first slide, that there are vital problems with the present supply platforms relating to protection, efficacy, and focused on. All 3 of the ones are in reality a part of our exosome platform. So we should not have to overcome the HEK 293, however we imagine that we will be able to, and that’s what we are making an attempt to reach.
John Hawkins
So there is a query arise, what is the present price base of the corporate put up the workforce explanation had been? The best way I guess to provide an explanation for, with out any longer budget, the money on the finish of March will take us into quarter 2024. Our forecast assumes some further investment and that takes us thru into center of 2024. And PwC have labored with us for the audit and so they’re ok with the ones assumptions. So that they challenged us, however I feel I don’t [indiscernible] that query.
Iain Ross
Do we be capable of lift financing if required in those occasions, not like what came about to with 4D firms are discovering [indiscernible] unattainable to boost recently. However I am additionally Chairman of different firms and I’ve to mention you might be completely proper. It is a in point of fact difficult setting. And the one factor that may transfer the dial this is generating forged knowledge. And that’s the reason why we took the verdict originally of the 12 months to supply the in vivo knowledge. I do not fake it is going to be simple. However we imagine we will be able to do non-dilutive investment thru partnerships. And if we need to move to the shareholders, then we need to move to the shareholders with a completely compelling tale. However we don’t have any plans to do this at this level.
And [indiscernible] what are the possibilities of the present ReNeuron technique no longer understanding? Neatly, that is an ideal query. Sciences is unpredictable. I’ve to mention, each week we take a seat down, and we assessment the place we’re with the information technology. And in this day and age, it is going extraordinarily neatly. So we took a principally a calculated chance originally of the 12 months to position all our efforts in the back of the improvement of the exosome platform. And I imagine that that chance is been minimized, and that we can in reality make it. However there is at all times a possibility it does not paintings. However probably the most good things about speaking to 3rd events is we’re taking a look at all times at other applied sciences that may make stronger us, and who is aware of the place a few of the ones discussions might be able to lead. However there is not any level at my age sitting right here operating in an organization, at the foundation of it isn’t going to paintings, it is going to paintings.
Any further questions? What is the largest chance pending for us? Neatly, the largest chance is that the information does not reside as much as what we imagine it is going to. And so that may be a chance. However we’re managing chance as we move ahead. For [indiscernible] I don’t see that every one firms — any individual has simply congratulating us for being clear. I feel we should be clear with you. This corporate has spent some huge cash over time. And so what we are pronouncing is that we’re taking a look after your money now and we are seeking to spend it properly, I will be able to guarantee you, if we run into an issue, we can prevent spending the cash. We aren’t within the industry of simply retaining the corporate going. We’re within the industry of in reality attaining the milestones that we set out to reach.
Any further questions? After the information is won [indiscernible] how lengthy will it take? That is a in point of fact excellent query. So one can not suppose that the minute we get the information that may signal offers. Large Pharma is excellent at retaining you putting on. And that’s the reason why Simon is in the market now speaking about it, and ensuring that there’s some aggressive pastime in what we are doing. And we are additionally, as I stated previous, more than happy that individuals are coming to us and asking us how we are getting on. And so we are very open with them. We are telling them what we are doing. However we aren’t revealing the information till we’re completely satisfied this is forged knowledge. Too many firms move out with knowledge, which is in vitro and early.
When will the in vivo knowledge that has been mentioned grow to be to be had? What research are being carried out?
Randolph Corteling
John, a few research which have been carried out?
John Hawkins
Sure, surely. So sure, probably the most key research is that heads up comparability with the vintage one dimension suits all. Taking a look at protection, via distribution, and the important thing factor is tissue and cell focused on, all are being carried out in parallel in this day and age, and can feed out within the subsequent 2 to three months.
Iain Ross
And I feel that is the query, we are nonetheless on time to do within the subsequent 2 to three months. The questions coming in. Simply checking the pre-submitted ones. Anyone is looking if I am seeing any indicators of growth within the capital elevating marketplace? No, I am not in reality in this day and age. It is very difficult in the market.
Are you in quest of to procure any of the IP of different property of Codiak Biosciences which is present process reorganization beneath Bankruptcy 11? Sure, now we have been taking a look at that. However sadly, it’s a must to understand that I have simply stated to you that we are going to spend your cash judiciously. And while I am certain there is issues throughout the Codiak portfolio that we’d fairly like to procure, I feel you would not thank me if I used to be in the market spending cash purchasing any individual else’s IP. No longer in this day and age. We need to stand via what now we have were given and imagine in what now we have were given.
Are you able to supply an replace at the construction of CTX in China? This is progressing. And we can cause milestones in monetary 12 months ’24? Neatly, I am not going to sit down right here and make forecasts, however principally the connection with Fosun is in reality progressing. Anything?
Randolph Corteling
In fact, I have were given one right here at the pre-submitted. Are you able to ascertain that the regulatory government are ok with using exosomes as carriers, for instance, pre-existing therapeutics? Completely. We have now spoken about probably the most different firms, Codiak, they do have a medical trial — did have a medical trial doing precisely that. Taking a look on the enhancements for turning in a preexisting healing and simply making improvements to the protection of that shipment. So very a lot throughout the scope of the CustomEX platform as neatly. Any further questions, John?
No, I feel this is it. So in abstract, I feel what you have got may be very targeted corporate. Now we have an excessively targeted platform, which we imagine has software in an effort to ship numerous other cargoes. And that’s the reason as a result of now we have principally were given a CustomEX platform. We have now were given a excellent a professional group, and that group were operating in combination for fairly a while. Randolph has come again and has in point of fact put power into the exosome program. We imagine we will be able to ship for you, and we are taking a look ahead to having additional updates later within the 12 months.
Unidentified Corporate Consultant
Ian, John, Randolph, thanks very a lot certainly for updating traders as of late. May just I please ask traders to not shut this consultation, as you are going to now be routinely redirected to offer a comments so that the control group can higher perceive your perspectives and expectancies. This will likely most effective take a couple of moments to finish and I am certain can be a great deal valued via the corporate.
On behalf of the control group for ReNeuron Team plc, we want to thanks for attending as of late’s presentation. That concludes as of late’s assembly. Excellent morning. See you.
Query-and-Solution Consultation
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