Well, it seems like most people are with us now. So welcome, my name is Tim Metcalfe. And with me today, I've got Stephen Stamp, who's CEO and CFO of Midatech Pharma. Unfortunately, Stephen is traveling on business at the moment, and where he is, the internet connection is not great. So unfortunately, we won't have video for Stephen today.

But he will run you through the presentation following the release of the company's interim results on Friday. And then, following the presentation, we'll have the opportunity for a question-and-answer session. Thank you very much to everybody who submitted questions in advance of the session, that's really appreciated.

But we do welcome questions during it. Unfortunately, given the number of people who are attending, it's not possible to go to individuals directly and ask them to unmute and put their questions to Stephen.

But if you would like to ask the question, please use the Q&A button at the bottom of your screen, type your question in, and I will go through those with Stephen at the end of the presentation, and we'll endeavor to answer as much as we can. So without further ado, I'll hand over to Stephen, to run you through the presentation.

Stephen?.

Thank you, Tim, and good afternoon, everybody. Let's start if we move Tim with Slide 2, and with your permission, I will take Slide 2 as read, other than to recommend that you read our public filings which can be accessed through website.

So, jumping to Slide 3, we have in front of us our summary profit and loss for the first-half of 2021, compared with the first-half of 2020. We had a nice bump in revenues. This was a result of our collaboration partnership, working on our Q-Sphera programs, more of that in a second.

But the most striking thing was that despite working on eight more projects in this half, actually our costs are pretty much half. And the reason for that is that the first-half of this year no longer reflects the costs of closing down Spain nor the operating costs of the Spanish operation.

So R&D was just about £2 million, admin costs £1.6 million for a total net loss of just over £3 million pounds or about £0.5 million a month, and that kind of reflects our ongoing run rate. So moving on to balance sheet, the balance sheet was similarly cleaned up this half year. All of the Spanish loans have now been repaid.

We took an impairment, if you may recall last year, about £11.3 million, I think it was for intangible assets. The only addition to the balance sheet is a new lease for our new headquarters and lab space in Cardiff, which has been capitalized in accordance with IFRS-16.

Cash on the balance sheet of the half year was £4.5 million, but we've raised another £9 million in July. So actually our current cash is more closer to £12 million, and that gives us a runway into the first quarter of 2023. Next slide, please.

So in the first-half of this year, we have managed to move our portfolio along both brexpiprazole and tacrolimus Q-Sphera internal programs have been moved from formulation into preclinical. We have preclinical data to show you for brexpiprazole.

Tacrolimus, we probably knew one more iteration of that program that dates we have are promising, but we need to refine that formulation one more time, I think. And 213, 214 and 216 are in collaboration with our partner. We've delivered proof-of-concept formulations for 214 and 216.

Our partners started in vivo animal testing with those formulations, and we should have data on those in the next few weeks. And 213, I'll update you on in a second. The other thing that moved is MTX110, two programs there. Our DIPG program is now moving into Phase II, and GBM program is moving into Phase I. And I’ll talk about that in a second too.

So nice progress in six months in our pipeline. So let's start with MTX110, you will recall this is MidaSolve technology applied to panobinostat to create a liquid form of panobinostat that can be injected via pump and catheter direct to tumor. We've been able to achieve concentrations of close to 100,000 times concentration.

You would compare it with what you would get taking the product already in tumor. So, we slightly moved this program around. We've decided to prioritize Glioblastoma Multiforme or GBM, mainly because it's much larger market potential. There are between 200,000 to 300,000 population diagnoses per annum.

And that equates to a sort of $3 to $5 billion market. Secondly, we were encouraged by the survival data we saw without our DIPG program, which we announced last October. If you remember, we showed that we were getting something like median survival of 26-months versus about 10-months in the literature.

But I should also say that was not a statistically significant result, because there were only seven patients enrolled in the study. However, we were encouraged by those data.

And what we've done, as illustrated here on the two charts on the slide at the top chart, reflects the much slower growth in tumor volume of our product, compared with control in vivo. That was in a single GBM cell line.

And then we repeated the experiment in vitro with four additional cell lines, and showed 100% cell death and looks to be therapeutically feasible concentrations of drug. So we've got some nice preclinical evidence. And we are working with our partners in the U.S. to set up a Phase I trial, which will begin recruiting in the next few months.

I haven't got anything to report in terms of the panobinostat license. You may recall that how our former partners secure a buyout terminated our license over a year ago now last, I think it was May, for reasons, claiming that we were liquidating the company.

They then sought to terminate again a second time in June this year, this time for material breach. The reason being, they were now alleging material breaches, that they are demanding a non-exclusive license to their IPs, they can compete with us. As you might expect, we've rejected that twice now. And so we wait to hear from them.

So moving on then to DIPG, we are in the process of setting up a Phase II study. We had a very productive meeting with FDA on pre-Phase II meeting. We are refining the protocol, based on the advice they gave us. And again, we expect to start recruiting for that trial in the not too distant future.

The challenges with this program are that there are very few patients. Obviously, this is ultra-orphan, only 1,000 patients a year, and finding patients which made the entry criteria to the study, and recruiting them is not easy.

And that's one of the reasons to be honest with you why we switch to GBM where there are many more patients available for entering the study. So, let's now talk about our Q-Sphera programs, and start with partner collaborations. 214 and 216 are small molecules and we delivered proof-of-concept formulations in June.

As I said, the partner is undertaking vivo studies and we should have data on those studies for both programs, either at the end of this month or early next month. As far as we know, they're progressing the plan. 213 is a large molecule. We presented data on that at the end of August.

And our partner has asked us to submit a proposal for an expanded research collaboration. And we're working that up now. And hopefully we'll have something to announce on that in the next couple of three weeks. So that's our partner collaborations. The first of our internal pipeline is brexpiprazole. And you've seen this chart before.

These are our in vivo pharmacokinetics study in rabbits. The blue line is our formulation of brexpiprazole. And you can see that we've got a nice therapeutic blood levels out through 91-days. And the orange line is a suspension of the immediate release product. And you can see there as you would expect the blood tail off quite quickly.

So, here we've developed a three month product, and as illustrated by Jansen’s latest offering in the antipsychotic market Hafyera. They're moving to a six month product and in fact the whole market is moving here to longer acting products. So our formulation of brexpiprazole in our opinion at least fits nicely with market trends. Good.

So let's move on now to talk about biologics. You might recall, we talked about this in our R&D update. They are notoriously difficult to formulate, because they are very large and very delicate molecules, easily denatured in the manufacturing process.

We always had an inkling that our process being printing and rather benign solvents, and no use of heat would have the potential to formulate a protein. And we focused on a monoclonal antibody, one of the larger proteins more than 150kDa. And actually, we were successful. And the three charts on Slide 13 illustrate that success.

So the charts on the left is immediate release product. And this was the starting material that we used. And as the concentration moves left to right on the chart, so the signal, which is a signal of inhibition declines.

And as the concentration gets higher and higher, so you get a lower -- you get greater and greater inhibition, which shows antigen binding of the monoclonal antibody. So what that tells us is that we had a good essay, and that it bound with increasing concentrations. So that was all good.

On the middle chart here, now what we did was we took that same protein, and heat treated it, so we basically killed it. And we got zero inhibition, which is kind of the result you would expect. We got positive control with the immediate release product of 100%. And in the Q-Sphera formulation with the protein we also got 100%.

So that also matched with what we would hope to see. And on the far right hand side, we've got a chart which shows the Q-Sphera formulation again, that increasing concentrations, showing increasing amounts of inhibition. So rather than 100%, we've got increasing amounts with and it sort of correlates. So all very good.

So you saw that chart before, the big news since the R&D update is that the Midatech team in Cardiff had been able to increase the drug loading threefold, since we started out with this process, which is fantastic news.

So that really is a big deal in terms of opening up the opportunities for Midatech in the large molecule protein space for our Q-Sphera technology, so delighted to announce that today. So let's summarize then the first-half, I hope you'd agree that we've got our costs under control.

We're down at £0.5 million a month burn rate, working on 10 programs across the company. And we've extended our cash runway to the first quarter of 2023. We're prioritizing the much larger GBM market for MTX110. To be honest, I have to say we're being a little bit disappointed with the response we've seen with our DIPG data last October.

Increasing survival from 10 to 26-months is no mean feat in the cancer world. And yeah, that didn't seem to be a lot of response to that, I suspect is because it's not a big market. GBM is a very large market.

And there has been something of a graveyard here for big pharma for various reasons, one of which is that many on most drugs don't cross the blood brain barrier. And of course, you'll recall with our catheter and pump system, we've dodged that. We can deliver drug straight to the tumor.

We also delivered in the first half two proof-of-concept formulations to our partner. And we've initiated a licensee search for our brexpiprazole products. We're using a European company called Lideri to help with that.

And they've already started work and I think they've reached out to more than 100 potential partners already, because we don't want 100 people interested, but we're hoping to create something of an auction there.

And then the really big news in the half year was the protein data with a monoclonal antibody, which offers very significant opportunities for our Q-Sphera platform. So, thank you for your time today. That's all I had to present. But I'm happy to take questions, Tim, when you're ready..

Well, thank you very much, Stephen. I have had a number of questions coming in as you've been presenting, I'm just going through those. A number of people have obviously focused on Q-Sphera and its use with large molecules, particularly proteins and monoclonal antibodies.

Could you talk a little bit more detail about some of the technical challenges that have been overcome in recent times, and some of those that you'll be looking to address in the next sort of 12-months?.

Sure. That's a very pertinent question. So the major challenge we think we have overcome, and that is to demonstrate that we can encapsulate the protein in Q-Sphera microspheres without denaturing it. The problem in most manufacturing processes is that the protein itself gets denatured.

The molecule gets smashed up, and then it doesn't do what it's supposed to do. So we've overcome that technical hurdle. So we can put a checkmark there. The next technical hurdle is to get the drug loading up to an appropriate level.

Obviously, if you can't deliver much drug in the Q-Sphera microsphere, then you're not going to have a three month product, you're going to have a three day product. And all I can tell you is that we're well on the way there, the team in Cardiff, as I said have increased that 3x.

So I'm going to give that a sort of a small checkmark, that piece is done. The next piece of challenge is dissolution, and specifically, coming up with an essay that we can measure the dissolution profile of the product over a period of time.

And the challenge here is that as the microspheres release drug into the dissolution medium, so the medium actually has the effect of denaturing the protein, so you can't measure it anymore. So we are working feverishly to come up with an assay that we can measure the dissolution of the product over a period of time in vitro.

We want to do that in vitro, because we can do much faster turnaround, and it's much quicker, obviously, much cheaper than doing it in vivo. And then the last thing that we need to work on is inject ability. We don't see any problems with that right now.

So we need a product which is sufficiently liquid and not this too viscous that it can go down a syringe needle, and into a patient without causing undue pain. So the four things that we've done, I think we've got sort of two and a half, maybe three done. And the one big thing to work on now as I say, the dissolution essay.

So does that cover the question you think?.

I think it does. And, yeah, I've had some questions that are sort of adjacent to that. And one we should ask is, the question was, were you disappointed with the termination of the Dr.

Reddy partnership? And was this due to the fact that their molecules weren't suitable for Q-Sphera? Or were there other reasons for the termination?.

You broke up there, but I think I got the gist of the question. So the Dr. Reddy molecule that gave us the work on was challenging from the get go, it’s the nature of the beast. And our suspicion is that they'd already tried to formulate it themselves, actually. They have a subsidiary company called OctoPlus.

And my belief anyway, is that they tried and OctoPlus tried to formulate it, it couldn't. So they shipped it off to us and lo and behold, we couldn't either. It's just the nature of the molecule itself, it wasn't well suited to PLGA microsphere formulation. So disappointing, yes, but it happens..

Absolutely. So the read across from that shouldn't be that it's putting a particular limitation on the use of Q-Sphera. This was just one particular use case that was challenging and it's not suitable for..

Yes..

Yeah. Obviously, there's potentially a huge market here with proteins, monoclonal antibodies and big pharma. You've got, obviously a focus on certain in-house programs and certain partnerships at the moment.

Is there a strategic desire to widen those number of partnerships to enter into sort of wider licensing deals, to try and get this technology to market potentially, in a far wider and quicker way?.

Sorry, you broke up again, there. That's alright, Tim. So our goal here is to maintain a balanced portfolio if we can. What we'd like to do is to have a small number of internal programs we work on. The reason for that is that we can determine the timelines ourselves within our available resources.

And ideally, we have the opportunity to create an auction, or some competitive pricing tension, at least, when we've delivered proof-of-concept. Having said that, it's also nice to have some partnered programs, because the partner pays for the development costs, but you're stuck with one customer.

So you don't have the opportunity to create an auction. And you're basically marching to that customer's timelines, and his resource capabilities. Now, most of the companies we talk to have more resources than we do. So that part isn't a problem. But, what big pharmas like, they switch up their strategies, they go to different places it happens.

So hence, we'd like to keep a balance..

No, that's absolutely understood. And obviously, with the recent funding, there are the funds there to do the in-house programs, as well as those that are financed by third parties..

Absolutely. And so the first quarter ‘23 cash runway number assumes a number of in-house programs..

Yes, and doesn't assume presumably significant license fees from third parties..

It assumes zero. Our advisors, we should always tread on the conservative side there..

Okay. Well, thank you for clarifying that. I've had a couple of questions relating to history and MTD201.

And whether that program is still something that you look at it, whether it has any value, other than really as a proof-of-concept for Q-Sphera? Or, have we genuinely moved on and the focus is now on this much wider and potentially significantly larger opportunity?.

So the data that we accumulated for entity 201, is good. And we have two Phase I trials. One was a PK trial compared with the Novartis product, and the other one compared intramuscular versus subcutaneous administration. And both gave us very nice data. And we tried long and hard to find a licensee for that product.

The reason for that was we couldn't take it any further ourselves. Because the product clearly was not going to be by equivalent to Novartis’s is Sandostatin. In my opinion, it was a much better product, much less into patient variability and inter batch variability associated with the Novartis product.

But I'm not even sure that product would be approved by today's standards. But the fact of the matter is Tim, we went far away to find a licensee, and we couldn't generate any interest. So we had to stop the program. If somebody wants to come forward, great. But we have to move on..

Yeah, absolutely. As you might expect on a session like this, obviously a number of existing shareholders here. I think I'm right in saying that I'm personally a shareholder. But everybody's a little disappointed at the moment with where the share price is.

And could you just share with us some of the things that you've been doing, and I'm obviously aware of, to generate further interest in the stock and the meetings that you've been having with institutions, for example, which while they're not yet reflected in the share price, hopefully will be in the future, just to reassure people that there is quite a lot going on behind the scenes that they don't see..

Yeah. So I have done many roadshows in the UK and the U.S. I've got more coming up. There's obviously a high interest in advance of announcing results. But I've got more coming up in the next couple of weeks. I'm planning on doing some investor conferences this autumn.

And I've been working with Edison to publish research on the company, which was also published, actually, on the day of the results on the last Friday. So, those are the things that have been happening. Obviously, that doesn't appear to have been a whole lot of positive reaction in share price..

No, not yet. But one's reassure everybody that there are a lot of efforts ongoing. You mentioned the Edison notes attendees have in….

Yes, and you're aware of some of those, Tim..

Personally, absolutely, I am. But I just want to get the message out too, because we're getting a number of questions on it. But if you haven't, any of the attendees haven't read the Edison research, it is readily available on their website.

So we'd encourage you to go to the Edison Research website and read that piece, because it's quite comprehensive, and hopefully fill in a little bit more of information. And I'm getting to the end of the questions that the people have been typing in. We do have a few more minutes.

We wanted to keep this session two a half an hour quick update, after the interims. But if anybody has got anything else, please try and type quickly. But if you do think of anything post the session, please do not hesitate to get in touch it at any time. I can be contacted on midatech@investor-focus.co.uk.

And we'll put any questions that you ask to Stephen and his colleagues and we'll endeavor to answer them. But rest assured, we are very keen to engage as much as we can with our current shareholders, and attract as many new ones as we possibly can. I can't see anybody typing rapidly on my screen at the moment.

So, Stephen, I think, your internet has managed to stay stable long enough. So, thank you very much..

Thank you..

Thank you very much to everybody who's joined us today. Much appreciated and really appreciate your support. So, thank you..

Absolutely. Thanks, all. And thanks, Tim..

Thank you..