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Biodexa Pharmaceuticals Plc (BDRX)

Q2 2020 Earnings Call· Thu, Sep 10, 2020

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Transcript

Tim Sparey

Operator

Good afternoon from Cardiff and welcome to the Midatech Pharma 2020 Interim Results Presentation. With me is Stephen Stamp; COO and CFO of the company who will run through the presentation. At the end of the presentation there will be a question-and-answer session. We've already received some questions, but if you would like to submit a question, please do click on the bottom link at the bottom of your screen at any time and those questions will be fed through to us. We'll endeavor to get through as many as we can, but apologies in advance if we do run out of time. And with that, I'll now hand over to Stephen, who will take you through the presentation. Stephen?

Stephen Stamp

Analyst

Thank you, Tim and good afternoon, everybody in the UK and good morning to those joining from the US. I am Stephen Stamp, CEO and CFO of Midatech and if you want to put a face to a name, I am in the middle of slide two surrounded by the brains of the organization. I have a dozen or so of slide today up which as Tim said would be happy any questions you may have submitted. Moving on to slide three, I should like to take this slide as read if I may, but I would encourage you to refer to our public findings both on the London Stock Exchange RNS in the UK and on SECs Edgar in the United States. So starting the presentation really on slide four, I would say that the first half of this year and year-to-date has been quite busy for the company and if I had to probably describe it as transitional a somewhat overused word, but I think actually appropriate for this company at this time. We've achieved some critical milestones which I'll review when we get on to the R&D [ph] slides, but most noticeable in the first half was the initiation by the board of a strategic review. That strategic review was triggered by a couple of things; one being the collapse in the capital markets in mid-February and alongside of that, the withdrawal of a perspective licensee that we had lined up for our project MTD201. Those two things as I said over the strategic review and that review immediately resulted in a couple of things. First of all the termination of further in-house of MTD201, there was no way we could see ourselves raising the $30 million or so in where we needed to complete that program.…

Unidentified Analyst

Analyst

Thank you very much, Stephen. We have received a number of questions from people who are participating in addition to the ones that I mentioned, we received ahead of the event. But if anybody does have any further questions, please do feel free to use the Submit question button. And those will be fed through to us. I will do my best to work through these. They're obviously by definition, not in any particular order. But we will look to try and answer everything that that has been submitted. There are a couple of common themes Stephen coming through. One of them is regard to timetables and do you have any expected or aspirational timelines to see either the existing collaborations come up, convert to formal development partnerships, and any idea that you can give listeners as to when they might be concluded their initial evaluation stages and moving on further?

Stephen Stamp

Analyst

Right, thank you, Tim. So, as I don't repeat myself, but one of the downsides maybe the only downside actually of a collaborative deal as opposed to the internal program is that the partner is more or less in charge of the timetable. It is the partner that will be doing the pre-IND enabling studies. And really, until you've done those and know that you have a product that is going to perform in the body as you would hope you will, according to target product profile, and there are no toxicology issues, which you wouldn't expect but you have to prove it. You haven't really achieved proof of concept. And until you achieve proof of concept, you're unlikely to get a multimillion dollar license fee out of a partner. So having said all of that, our target is to land our first licence fee in the first quarter of next year.

Unidentified Analyst

Analyst

Okay, thank you. You've mentioned obviously the relationship and the situation with Secura Bio. Obviously, there's very limited that we can say at this stage. But we have had a couple of questions. Is there any further update that you can give? Is there a formal process in train with them? Or is it just a wait and see?

Stephen Stamp

Analyst

So one of the options available to the company is to go to court and seek a declaratory judgment and have the license reinstated, if we win. We're advised that will take two possibly three years and cost $2 million, possibly $4 million. It seems like a heavy price to win something that already belongs to you. So we’re not persuaded that is the best use of the company's funds. So we will prefer a negotiated settlement if possible. We have invited Secura Bio to reconsider, they have chosen not to do that. So our options are becoming more limited to be honest. Having said all of that, the license agreement attaching to MTX110 by the panobinostat license is not particularly favorable to the company. And we could make an argument that actually the product is economically more valuable without the license, but it would mean delaying launch until the patents that expired. So, those are the sort of options that we’re weighing up now. In the meantime, we're able to proceed with the program because we were using panobinostat for research purposes.

Unidentified Analyst

Analyst

Thank you. Another theme that's come through in a number of questions is regarding the future of MTD201. Really, you've mentioned that partnerships are very much something that's being looked at. But is it an asset that the company will consider selling if the right offer was available?

Stephen Stamp

Analyst

Absolutely. So, MTD201 whilst we felt to get a licensee for it, as of yet anyway, it hasn't been a complete failure, because it has served a very useful purpose for demonstrating the characteristics and opportunities the Q-Sphera technology offers in humans, and that frankly is invaluable and without those data, I don't believe we'd have a cat and hills chance of getting a licensee for any of these other molecules that are working on because it very much is a proof-of-concept, proof-of-principle. So the short answer is yes, we would be very interested if somebody came forward with MTD201. But at this time, I don't think it's good use of the company's energy and resources to focus on that, we're better focusing on the newer opportunities, particularly the API's that have come to us asking us to work on their programs.

Unidentified Analyst

Analyst

Thank you. We've also had a couple of questions on strategy and what you've outlined in the presentation earlier. One, viewers made the comment that might take history of changing direction. Can you now confirm that this is the long-term strategy for the company? And if that is the case, why didn't pursue this sort of collaboration early partnering type strategy before now?

Stephen Stamp

Analyst

Yes, so I personally, I wasn't part of some of those earlier forays that the company made. So I can't talk exactly what the thinking behind that was, I think but potentially the company was looking to products that were closest to market which is an understandable aspiration and put all its efforts and energies and resources behind those products. The problem is that the closer you are to market in terms of Phase II, Phase III, the bigger the costs, and while these programs were going through the clinic, so the value of the company was declining and it became more and more difficult to raise the quantum of funds that you would need to get the product over the line. And then the pulling out of the licensee of MTD201, frankly was the final straw. So in my view, given this current size of the company and the access to resources that it has, this is probably the only feasible strategy. By that I mean, not doing clinical trials and partnering early that the company could pursue at this time. Having said that, if we're successful enough, when we get enough of these things over the line, and we get enough licenses and we get enough milestones, we could afford to start reaching further down the clinical path again and capturing more of the value. But as of today, this is the strategy and this is for the long-term, yes.

Unidentified Analyst

Analyst

Thank you. And a related question obviously, with the closure of Bilbao, how does the company plan to manufacture Q-Sphera products going forward?

Stephen Stamp

Analyst

That's an extremely good question. So the listeners will understand that Q-Sphera is a unique manufacturing process, which is what makes it so valuable and so differentiated from the traditional methods of PLGA manufacturing. So you can't go along to a CMO and say, print these tablet or make these tablets for me, all the technology, the knowhow is inside Midatech. So we’re in the process of lining-up some partnership agreements with well, that'd be one in the end but we’re talking to several CMOs, whereby we can take the smallest scale equipment that we salvage from Bilbao, we need to add one or two pieces to it and install that inside a CMO which will have GMP capability such that we can manufacture at least clinical trial scale and then it will be the partner that will take on the scale up to commercial manufacturing.

Unidentified Analyst

Analyst

Okay, thank you. One about the listings. Does the company intend to keep both the AIM and Nasdaq listings?

Stephen Stamp

Analyst

Yes, we do.

Unidentified Analyst

Analyst

Okay, thank you. It’s very clear. And we've had a few other questions coming that are not really don't fall under the previous sort of headings, but I'll just read them out in order. Emergex appears to be well funded and they're making progress with the T-cell vaccine development program. What are the implications for the MidaCore platform of this?

Stephen Stamp

Analyst

So Emergex is a private company, and as a private company, they don't have to disclose exactly what they're up to and what they're doing. I understand that they’re making good progress and they have a license to some of our gold-nanoparticle patents. There are very smart people in Emergex, some of whom were inventors in that whole gold-nanoparticle technology. So in some senses, they are the best people to take that technology forward. The license agreement that we have with them is a sort of traditional structure involves development milestones at certain stages and then back end royalties. So we're hopeful that they will be successful in what they do.

Unidentified Analyst

Analyst

Absolutely. Thank you. And one thing that has been mentioned in recent announcements is the situation with the EU regarding SME status, is there any update you can provide on that?

Stephen Stamp

Analyst

So the last submission we made to the EU was on the 1 of July, and we haven't heard back for them despite a number of prompts on our side. It is I have to tell you it’s quite frustrating Tim that Midatech isn't an SME by European definition. So I think the SME rules were put in place to prevent giant companies say Pfizer setting up a company subsidiary calling itself an SME and getting a grant. And that's understandable. On a particular date in 2019, CMS as a result of a license agreement that was put in place in February 2019 owned more than 50%, 51% in fact of Midatech and because of that, the European Union by the way, they're now down to 17%. But because of that the EU is choosing to regard CMS as a linked enterprise and therefore Midatech is part of the ex-CMS group. And therefore they're looking at the whole of CMS, which has got 2,000 employees and billions of dollars of revenue as part of the Midatech Group which is frankly ridiculous. And that that's our frustration. So we’re trying to persuade them to look through the black and whites of the rules and see the substance over the form here, but we're still waiting.

Unidentified Analyst

Analyst

Thank you. One listeners has commented that Midatech is a complex vehicle to analyze. Maybe just wondering if any of the company's advisors or any independent third-party had put together an assessment of the value of the group post the strategic review. And if not, are you anticipating anything maybe published in the coming months?

Stephen Stamp

Analyst

Yes, I'm not sure I would agree with the complex, well so we're certainly simpler than we were. As it happens, there have been two brokers today, one from each of our joint brokers, one of them pope has put together actually quite interesting valuation model. And they valued the company in three parts. One part is the Q-Sphera platform where they've sort of taken a shot at what a pro forma Q-Sphera product, and its revenues might look like. And then they've assumed I think there are going to be five of those over five years. And they've applied percentages of success to those various programs. And then they've separately valued MTX110. And then they've also knocked-off the sort of present value of the overhead and SG&A costs and come out with a valuation of about £65 million. So I would commend your readers to take a look at that because that sort of breaks the company up into nice manageable chunks and is pretty transparent some of the valuation.

Unidentified Analyst

Analyst

Thank you, very helpful. Well that concludes the questions that I've received to-date. If anybody does have a final question, you've got a few more seconds to submit it. And thank you very much, Stephen for that very insightful looking to the current situation of Midatech.

Stephen Stamp

Analyst

Thanks, Tim and thanks everybody for joining.