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Redx Pharma PLC
LSE:REDX

Watchlist Manager
Redx Pharma PLC
LSE:REDX
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Price: 15 GBX 31.58% Market Closed
Updated: May 7, 2024

Earnings Call Transcript

Earnings Call Transcript
2022-Q2

from 0
Operator

Good day, ladies and gentlemen, and welcome to Redx's webcast covering the company's interim results for the 6 months ended 31st of March 2022. [Operator Instructions] I will now hand over to Rachel Curtis Gravesen to open the call.

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Rachel Gravesen

Good morning and good afternoon. Thank you for joining us today. The call to discuss Redx's interim results for the 6 months ended 31st of March 2022. I'm Rachel Curtis Gravesen. And in a moment, I'll hand over to Redx's Chief Executive Officer, Lisa Mary Anson; our Chief Financial Officer for the company, Peter Collum; and the Chief Scientific Officer, Richard Armer, who will all present the progress made during the period by the company. After the presentation, we'll hold a Q&A session and Dr. Jane Robertson, who's the company's Chief Medical Officer, will also participate in that session together with the other presenters. If you're on the phone, you'll be able to ask your questions live and the operator will explain the procedure of how you can do that before the start of the session. If you're on the webcast, you can also ask questions at any time during the presentation. There are written questions. How you do that is you click the Ask a Question button at the bottom left-hand corner of the screen below the webcast player window. At that point though, I'd like you to move to the next slide, please. And because before we begin, I'd like to draw your attention to the disclaimer on this slide, Slide 2, and remind you that any statements made during this call, that are not historical statements, will be forward-looking statements, and as such, they will be subject to risks and uncertainties, which, if they materialize, could materially affect Redx's share price. So with that, I'd like to hand over the call now to the CEO of Redx, Lisa Anson. Thanks, Lisa.

L
Lisa Mary Anson
executive

Fantastic. Thank you, Rachel, and good morning, good afternoon, everyone. It's a pleasure to be here presenting Redx's interim results. So the agenda today, we're going to talk through the progress that we've made during the first half of 2022 to the 31st of March. We're going to cover the portfolio, both our clinical stage assets and our discovery pipeline. Richard and I will both present on that. And then Pete, our CFO, is going to cover the financials and the outlook. So on this slide, let me just start with -- on the next slide, with a quick reminder of Redx as a company. So as you're aware, we are a discovery company. We discover and develop novel small molecule targeted medicines in the areas of cancer and fibrotic disease. Our aim is generally to progress these molecules to clinical proof of concepts, and we are delighted to have 2 clinical stage assets that are wholly owned that were discovered in-house, as well as our core strength, which is our world-class discovery engine, driven by an exceptional team of medicinal scientists. The quality and credibility of our approach is actually further endorsed by a number of significant partnerships. As you're probably aware, our out-licensing deals, which we'll comment on, with AstraZeneca and also with Jazz Pharmaceuticals. We do now believe that we are extremely well positioned with the momentum in our pipeline that we're going to talk about today as well as the financing, which we will cover today, to pursue our pipeline to key value inflection points towards the end of next year. So let me start with that as an introduction on the next slide to summarize the progress over the period. And I'm very pleased to report that we have made progress across all aspects of our business. And I think that's a real strength of this set of results. So firstly, if we look at the clinically -- the clinical assets that are wholly owned, so our lead clinical programs, we have made strong progress on both of these. So with 004, which you'll recall is our wholly owned PORCUPINE inhibitor, we have, for the first time, started Phase II trials as Redx as an organization. So this is -- that was a key milestone for us. And we have 2 Phase II trials underway in hard-to-treat Wnt-ligand driven tumors. Both of these trials, PORCUPINE and PORCUPINE2, are ongoing. And our key focus at the moment is to drive recruitment of those 2 trials. For our second clinical stage asset is 007, which you'll recall is our ROCK inhibitor. And the key milestone in the period was that we reported the data from our Phase I study on 007, which showed excellent safety and pharmacokinetic profile. And this was data we actually presented at the Lung Disease Drug Development Summit back in March. As a result of this data, we are now preparing to take 007 into a Phase II study. So I'm sure you'll agree really strong progress on both assets. Importantly, what we believe is our third pillar of our company, the third area of investment, our discovery engine has made really strong progress also in the period. And Richard will talk us through a new development candidate we have nominated RXC008. But we have also progressed another new program that we announced in January, our Discoidin Domain Receptor program, which has moved on to lead optimization. We're very excited about the potential for that as well. And to further underline this progress in our discovery engine, I'd just like to mention that although partnered with Jazz Pharmaceuticals post period, our Pan-RAF program did indeed receive IND clearance. And when Jazz starts that clinical program shortly, that will be the fifth asset from the Redx discovery portfolio that has made into the clinic, which I think is an enviable track record for any biotech and certainly one of our size. And the final momentum is really around strengthening our balance sheet, which provides us runway through to the end of 2023. So post period, we had a successful fund raise that Pete will go into. But I'd also like to underline that we have received non-diluted finance of GBP 19 million during the period and a further GBP 5 million post period, which I think serves to underline the really strong progress made on our partnered programs, underlining the scientific strength of Redx, but also the ability to strike strong commercial partnerships that generate meaningful financial contributions. So turning to the next slide. We have our pipeline as it stands today. I think you can see the progress that I've mentioned during the period. So 004 in Phase II, 007 assets about to start Phase II and then the progress in the discovery engines, which is targeted to deliver. Our external target, we've stated a number of times, remains 3 INDs by 2025. And I think you'll agree, we've made strong progress towards that with the nomination of 008. And then down at the bottom, the partnered programs, all 3 of which, as I just mentioned, have contributed with milestones in the period. And just one note post period on the Jazz collaboration on the MAPK pathway. Post period, we have recently confirmed with Jazz that we will progress one of the target programs towards IND. And on the second target, we have agreed that we will discontinue due to our pipeline prioritization by Jazz given the evolving competitive landscape. So a slight amendment to the bottom of the pipeline there with one of the programs now continuing to IND and one of the programs being discontinued. So with those general remarks, let me just make a few more specific points about RXC004. As a reminder, on the next slide, so this is our clinically validated PORCUPINE inhibitor and our lead oncology program. Why do we like this program so much? Four key reasons, we like Wnt because it is a well-established and critical driver of cancer. So we know that this is a key pathway. PORCUPINE sits upstream on this pathway, and it blocks both the canonical and noncanonical aspects. So we think that's really important in terms of driving efficacy. So that's the first reason we like PORCUPINE as a target. Second reason, you'll recall is that there is a clear patient population of Wnt-ligand driven tumors. That's either through a genetic mutation or indeed through the nature of the tumor type, so biliary cancer being the example where it's majority driven by these Wnt-ligand pathway. So this clear population is the second reason we like this. Thirdly, we've now seen a therapeutic window. So we believe we can drive this forward into therapeutic use. That's why we've moved forward into Phase II. And the final reason we really like the target is because there is both a direct tumor action and this immune evasion actions. This dual mechanism of action, which we think provides for potentially a very useful therapeutic option and indeed allows for both monotherapy and combination use with immunotherapy agents. So you'll recall that we have started both PORCUPINE and PORCUPINE2 in Phase II with this program, and I'll cover that shortly. But firstly, let me just remind you of the data that we presented on this asset on the next slide. So we presented this at ESMO last September. And this is the data that supports -- if you could move to the next slide. This is the data that supports our decision to move into Phase II. So we have 2 key conclusions really from this data. You will see the different subtypes that we have presented the Wnt-ligand dependent population on the right-hand side of the slide. And this really shows where we would expect to see activity and indeed did see activity. And that is why we are selecting for Wnt-ligand driven patients in our Phase II program. So that was the first key learning where we saw the activity monotherapy in these very hard-to-treat and, remember, late-stage patients. And the second key finding from this Phase I study was we looked at the tolerability and found a therapeutic window. We decided to take forward the 2-milligram dose from this data based on the overall safety, pharmacokinetic and efficacy profile. And that is the dose that we've taken forward into Phase II for monotherapy. On the next slide, you can see just the schematic of our Phase II program, which, as I mentioned, is ongoing. So there are 2 key trials, PORCUPINE, which is a trial in metastatic colorectal cancer, in the MSS setting. So this is a setting recall that PD1 inhibitors do not work, and we'll be looking at both the monotherapy and the combination in this setting. The combination arm is not yet started. That is slated to start in the second half of this year as soon as we have identified the combination dose from the ongoing Phase I study. On the right-hand side of the slide is the PORCUPINE2 study. So this is a study in pancreatic cancer monotherapy for selected patients, unselected biliary cancer, recalling that this is a Wnt-ligand driven tumor so we've chosen not to select patients for that. And we have added now a combination arm in biliary cancer that again, we will propose to start in the second half of this year as soon as we have a combination dose identified. And I think the combination arms here underline that we have demonstrated preclinically this effect with 004 by blocking. The Wnt pathway can restore the ability of the immune system to fight the tumor, giving rise to this intriguing dual mechanism of action, both direct on the tumor and the immune enhancing effect, which we would like to see the full potential of in these cohorts of a Phase II study. We expect top line data from these 2 studies to read out starting from the first half of next year and reading out through next year. So very exciting progress for 004. Now let me turn to our second clinical program briefly. This is 007 on the next slide, which is our selective ROCK2 inhibitor and again, a wholly owned program. Now ROCK you'll recall is recognized as a novel point in the cell signaling pathway associated with fibrosis. And we know that if you target both forms -- isoforms of ROCK, ROCK1 and ROCK2, you can induce a systemically -- systemic hypertension, which is clinically significant. And that, therefore, has historically limited the systemic use of ROCK inhibitors. By obtaining selectivity just of ROCK2, we have managed to overcome this challenge, and the Redx molecule is highly selective for ROCK2 over ROCK1. And this challenging chemistry also means that there is, therefore, limited competition for selective ROCK2 inhibitors whilst overcoming that historic challenge of the hypertension. We know that this is a clinically validated target with FDA approval of the first ROCK2-selected inhibitor last year, and we are very excited by the data that we see preclinically in IPF. We know that ROCK is heavily outweighed in IPF and disease tissue, and that is our chosen setting now for clinical proof of concept, very high unmet need area in terms of medium survival is poor, high number of patients, about 170,000 and a significant market with some standard of care treatments that have limitations. So we believe a high unmet need. We have now completed our Phase I safety study of this molecule and that's what we reported during the period. Before I share that -- remind you of that data, let me just take a moment to reflect on why we chose IPF. On the next slide, on the left-hand side of the slide, you can see the data in a preclinical animal model. On the right-hand side, you can see some data that we have looked at from the human tissue. So we have tested 007 in quite a wide range of models preclinically. The one on the left is the industry standard IPF therapeutic model of lung fibrosis induced by bleomycin challenge. And we have shown really strong reduction of fibrosis and collagen deposition in the lungs. And on the right-hand side, we have shown in humans actually in-human precision-cut lung slices derived from post-transplant IPF lung tissue, we have seen strong modulation of the inflammatory and fibrotic gene signals. So we're very confident with what we've seen preclinically in both animal and human models. And together with the data about the upregulation of ROCK2 in IPF, that has led us to move forward with IPF as our chosen proof-of-concept setting for 007. And on the next slide, just a quick reminder of the data that we presented during the period. This is our Phase I data now reported for RXC007, which shows this strong safety and pharmacokinetic profile in healthy volunteers. You can see the linear profile. We have a very good range of exposure. We've seen everything that we would like to see in terms of safety and pharmacokinetics. And on this basis, both in the single dose, we have also run a multi-dose cohort of 50 milligrams BID with no clinically meaningful adverse events. And therefore, we are now moving forward rapidly to take this into a Phase IIa study in IPF patients. And just on the next slide, we'll give you the outline of that study that we are going to start in the second half of this year. Based on quite a number of industry learnings and looking at other programs, we have decided to take a staged approach to IPF development, and we will take an initial 12-week randomized placebo-controlled Phase II study to assess the doses in a number of dose cohorts, but to look at early efficacy signs as well as safety and tolerability. But very importantly, to try and understand the disease biomarker and engagement data both with and without standard of care, so we can really understand the potential and move forward then rapidly in the full 12-month efficacy studies at speed, having understood the doses and the target engagement. So we're excited to take this program now forward into IPF. And as I mentioned, we expect to start this study in the second half of this year. So that gives you a flavor of the very strong clinical progress that we have made over this period with both of our lead assets, RXC004 and 007. And as I mentioned, the progress in the period has also been in our research pipeline or our discovery engine. And I'd now like to hand over to our Chief Scientific Officer, Richard Armer, who's going to cover our newly nominated development candidate on the next slide. So Richard, over to you.

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Richard Armer
executive

Thanks, Lisa. So RXC008 was nominated in our latest antifibrosis drug candidate in March this year. It's a very potent and orally active ROCK1/2 inhibitor for the treatment of fibrostenosis associated with Crohn's disease. Fibrostenotic Crohn's disease is the buildup of fibrous tissue in the gastrointestinal tract, which can lead to strictures or blockages, infects approximately 50% of Crohn's patients within 10 years of their first diagnosis. Existing treatments are limited to expensive surgical interventions such as balloon plasty, strictureplasty or resection of the disease tissue, and there are no approved pharmaceutical agents for this indication, making RXC008 the potential first-in-class agent. RXC008 worth potential cardiovascular side effects of systemic ROCK1/2 inhibition are being restricted to activity in the GI tract and have shown good antifibrotic effects in disease models by inhibiting these key enzymes and fibrosis signaling. IND-enabling work is now underway to facilitate Phase I first-in-man study to start late in 2023. The next 2 slides, I'll share some of the preclinical data. Next slide, please. So this study shows the therapeutic effects of RXC008 on preformed gastrointestinal fibrosis in the adoptive T cell transfer model, which is a model that is believed to be make the human disease situation well. We can see that RXC008 dosed orally at 10 milligrams per kilogram once daily reduces tissue damage and strongly inhibits fibrosis, whereas the potent anti P40 monoclonal antibody anti-inflammatory agent does not impact the fibrosis as is the case in clinical use. Next slide, please. RXC008 also shows strong antifibrotic effects in the chemically induced DSS GI fibrosis model when dosed prophylactically at 10 milligrams per kilogram orally once daily. Importantly, in this study carried out with Ghent University, we are also able to look at the inhibition of fibrosis with RXC008, noninvasive MRI scans, which we also aim to use translationally in our clinical trials going forward. I'll now pass over to Pete for the financials.

P
Peter Collum
executive

Thanks, Richard. So on the next slide, on the financial front, we are in a strong cash position, given our March cash balance of GBP 31.6 million plus. As Lisa mentioned, the proceeds from our post-period financing of GBP 34.3 million gross, which brought in GBP 33.5 million net of expenses. And that resulted in a post-financing cash balance of GBP 59.7 million estimated or about USD 73.4 million. And so this cash balance funds Redx through calendar year '23, which is strategically important because as you've heard from both Lisa and Richard, we have multiple important proof-of-concept data readouts for both 004 and 007 as well as advancing 008 to IND, all within that period. So we have multiple value inflection points that are now fully funded. Regarding the financing, I do want to point out a few key highlights that we think are especially significant given the difficult state of the public biotech equity markets, as we're all aware. First, we had really strong support from all of our existing institutional investors, which included Redmile, Sofinnova, Polar Capital and Platinum. And this really underscores the value of having such strong and supportive investors as shareholders to weather really tough markets that we're in right now. Secondly, we were able to add to that shareholder list by bringing in a new specialist life science investor, Invus, which is particularly tough to do in the current market environment as most funds are only supporting their own portfolio companies. So very happy to have Invus join us. And last, we were able to price this offering at the market, which actually represented a premium over the previous financing that we did in December of 2020, particularly unique given most of our peers have traded well below their December 2020 levels. And importantly, we also continue to trigger milestone payments from our partnered programs, which are a complementary form of non-dilutive cash into the company. Most recently, as Lisa mentioned, post period, we triggered a $5 million milestone from Jazz from our Pan-RAF program IND clearance, which when it starts Phase I officially will represent the fifth program to enter the clinic to come from Redx's own discovery engine. And that milestone comes on the heels of $19 million in milestones from those partnerships that we received during the interim period. On the next slide, a little more detail on the interim financials. As we said the last time, during the fiscal '21 results conference call, our R&D line item -- line does continue to grow, which reflects the continued advancement of our own pipeline with multiple Phase II studies ongoing and more early-stage programs progressing as well. And we expect that R&D expense line to continue growing in future periods as that pipeline advancement continues. I will also point out that there was a jump in the contract liabilities line from GBP 4.3 million to GBP 11 million, and that just reflects the fact that we had some milestones triggered during the period that are not immediately recognized as revenue. And over time, that contract liabilities line will be reduced as those payments do get recognized as revenue based on progress for those related projects. And lastly, on this slide, the total loss for the period clearly continues to be driven by R&D. However, it was lower by about GBP 3 million compared to the prior period, and that was due to the increased partnership revenue during the first half of this year that offset that expense. And on the next slide, we'll cover some of the milestones over the next 18 months. As you've heard throughout the presentation, we have made significant headway with our wholly-owned assets entering Phase II, our discovery engine continuing to produce promising development candidates, as well as our partnered programs also reaching significant milestones and resulting in financial milestone payments. Over the next 18 months, as you see on this slide, we expect that momentum to continue across our portfolio with multiple potential value inflection events expected, including the top line data readouts for the proof-of-concept studies for both 004 and 007, as well as the progression of 008 to IND submission, which again highlights the strategic importance of this financing, which together with our current cash balance will fund the company through these important milestones throughout 2023. So probably needless to say, our team is very excited about all that we have on our horizon for the next 1.5 years. And I think with that, we will open it up for questions.

Operator

[Operator Instructions] We will take our first question from Stephen Willey of Stifel.

S
Stephen Willey
analyst

Congratulations on the progress. Just a couple of questions on the Phase IIa IPF trial. Just curious, how frequently will you be assessing lung function during the 3-month treatment period? And will there be just a single HR CT scan that will be conducted at the end of the 3-month dosing period? And then I just have a follow-up as well.

L
Lisa Mary Anson
executive

Yes. Thanks, Stephen. I'm going to ask Jane Robertson, our CMO, to pick that question up, please. Jane?

J
Jane Robertson
executive

Yes, we'll be assessing lung function with a sort of centrally assessed assessment of forced vital capacity, FVC, and also the DLCO. We will be doing imaging and a number of other sort of imaging endpoints to assess quantitative lung fibrosis. That will be done, yes, at the beginning and at the end of the 3-month period.

S
Stephen Willey
analyst

Okay. And then I know that there's an opportunity for patients to continue in, I guess, what is an extension protocol based upon whether or not they have disease progression after 3 months. How are you defining disease progression in this study? Is there some threshold decrement in lung function that you need to see? Is there some evidence on an HR CT scan that needs to be met? I would just be curious how that definition is holding up clinically?

J
Jane Robertson
executive

Yes. I mean that continuation will be at the discretion of the investigator, and it will be very much around the whole status of the patient, both in terms of safety and evidence of clinical activity or lack of progression. There isn't actually a defined progression criteria for that in the protocol. And clearly, if their patients do continue, we will continue doing assessments of lung function and imaging as well.

S
Stephen Willey
analyst

Okay. So that will be investigator assessed. That's helpful. And then maybe just one last quick question for Peter. Does the cash runway guidance contemplate any additional non-dilutive capital that could be secured through the achievement of various milestones from partnerships? Or is that just cash on hand that gets you to year-end '23?

P
Peter Collum
executive

It's mostly cash on hand, Steve, existing cash plus the proceeds from the raise. There is a small piece of milestone assumption that we use on a risk-adjusted basis. So we typically only include it if we have high level of confidence. But yes, there's a small piece of that.

Operator

[Operator Instructions] We have our next question from Franc Gregori of Trinity Delta.

F
Francesco Gregori
analyst

I'm sorry to say, Pete, because I dropped out just as you were talking. So you were talking about these impressive fund raise and that you've got the runway through to end '23. So maybe you've covered this. But could you tell me what exactly these monies will fund in terms of the clinical programs that they will allow to complete?

P
Peter Collum
executive

Yes. Franc, thanks for the question. I think if you think about the picture on the prior slide, the last slide that we spoke to really kind of tells the story of use of proceeds. Starting with the 004 Phase II study. So we fund PORCUPINE and PORCUPINE2 through their readouts, which we'll be reading out throughout 2023, as we said. It also funds us through the Phase IIa study for 007 in IPF, which again, we'll be reading out we expect towards the end of 2023. And then lastly, sort of collectively, what we're referring to as the research engine. So getting 008 to IND by the end of the year as well as funding advancement of our numerous research-stage portfolio, which we have not identified all of the targets that we have in progress. But we're obviously still continuing to move those programs forward as well.

F
Francesco Gregori
analyst

Can I ask on a more general note, and I guess this is directed to Lisa. If you had more funds available, would there be anything that you would do differently to help improve outcomes or speed up progress or maybe diversify a little?

L
Lisa Mary Anson
executive

Thanks for the question, Franc. I mean, I think you can see that we've just presented kind of really strong progress on all fronts. So I believe as Redx, we have an ambitious plan. We are an ambitious team. We're getting a very strong success rate. And I think job #1 is to make sure that we deliver the programs and the plans that we've got. And therefore, the fundraising that we've done was targeted, as Pete's just alluded to, to make sure those key Phase II programs and the discovery engine were funded to the plan that we wanted. So I think that's a very good position to be in. Having said that, I think you'll see from the nature of the targets that we've got. So with 007, for example, with ROCK, there is a lot beyond IPF potentially in that molecule. So we could potentially expand the number of indications that we're looking at. We're already doing some work with the Garvan Institute in Australia looking at potential other fibrotic indications. There's areas like systemic sclerosis, so other areas where we would be particularly interested to look at ROCK so we could potentially accelerate some of those programs once we see our efficacy signal. And likewise, with PORCUPINE, we already have quite a number of hard-to-treat tumors in our setting because we really want to understand the full potential of that molecule in our proof-of-concept study, but we know that Wnt is a significant driver of many tumors. So I think probably the most obvious area of future expansion will be to grow those clinical programs and really get the full potential of these molecules that we've got in-house and they're wholly owned. But I think right now -- and that plays to a little bit extending the runway beyond 2023. We've got quite a significant clinical program marked in for 2023, as you'll see. So I think further money would go to either expanding those programs and certainly extending the runway for the company beyond that. And you could see something like 008 where we would be ready to go into a Phase I study at the end of next year. And obviously, that would be subject to additional funding.

F
Francesco Gregori
analyst

Thank you, Lisa, very clear. And again, well done. You've done fantastically well.

L
Lisa Mary Anson
executive

Thanks, Franc. Are there other questions on the line?

Operator

We have no further questions on the line at this time. [Operator Instructions]

L
Lisa Mary Anson
executive

Perhaps to just turn to Rachel and see if there's been anything coming on the chats on the webcast.

R
Rachel Gravesen

Yes, we've got quite a few, so -- and some of them have been answered already, so apologies if I don't ask those because they have already been answered. But there's one that's come in from Lala Gregorek from Trinity Delta, who asked this is about the milestones. You've received a significant amount of milestones from partners over the last 9 months. So we're talking about monetary milestones. Looking to the future, can you comment on the milestones that are likely to come over the next 12 months and then the following 12 months. So perhaps you could expand Pete, on what you just said about the actual monetary milestones. If you can give any color.

P
Peter Collum
executive

Yes. And thanks, Lala, for the question. We don't, and we actually can't really give specific guidance on milestones, and that's primarily because we don't control the development of those programs. That said, we do have 3 active partnerships ongoing and advancing with a large amount of bio box potential remaining behind them. So we do expect that over time, and we measure that in years, not months, they will continue to produce milestones that are meaningful on a cumulative basis as they advance. And generally speaking, since now 2 out of the 3 programs are clinical stage, at least when the Pan-RAF starts dosing in Phase I and II of the 3 will be clinical stage, you would expect that those milestones start to become a bit more spaced out than they have historically just given the longer duration of those clinical trials and reaching the next milestone versus earlier stage development. So I think that's about as specific as we can get. So hopefully, I've answered the question, Lala.

R
Rachel Gravesen

Yes, that's great. And there's a follow-up as well about RXC008. Does this have the potential to be highly differentiated? You seem very keen that when you said, Richard. So can you say a bit about what excites you most about this asset and the indication that it addresses why you think that's interesting?

R
Richard Armer
executive

Yes, sure. I mean it's totally differentiated. It can be a potentially first-in-class here. So there are no agents currently, pharmaceutical agents that treat this disease. It's really debilitating part of Crohn's disease. When we speak to key opinion leaders, they are really, really keen to see something coming through from this indication. We've had a lot of anti-inflammatory agents coming through over the past 10, 15 years, which will really help manage flares and et cetera, and the inflammatory aspects of the disease. But none of those have impacted on the fibrosis and people still are getting hospitalized. 50% of these patients get hospitalized within 10 years of diagnosis to have surgical intervention for their fibrotic disease. So this really could be a game changer, I think, and we're really excited about this.

R
Rachel Gravesen

Great. There's actually -- sorry, I'm just reading as you're answering that, Richard, and there are some follow-up questions for that in terms of the discovery engine. You've given us a clear view. This comes from Panmure, Mike Mitchell. You've given us a clear view on expected progress towards the clinical development of 008, which you were just explaining. What's the sort of intensive investment over the next 18 months or so that's going to be focused on that versus other programs and other projects that maybe you haven't publicly named? And connected to that, there's a clear view on currently partnered programs, what should Panmure be thinking about in terms of near or midterm opportunities for partnering from that discovery engine?

R
Richard Armer
executive

Sure. I'll take the science and I'll leave Lisa to do the partnering aspects. So we got -- obviously now RXC008 is nominated that we move forward into towards the clinic that we go through a standard set of chemistry or scale of material manufacturing, which then allows us to do regulatory toxicology studies, formulation to the clinic, et cetera. So all that is on the way right now. And that takes roughly towards the end of next year when we'll be able to start that clinical trial. So that's all really readily mapped out. For the other programs, obviously, we mentioned our Discoidin Domain Receptor program, which is doing really well in the optimization. So we're looking forward to that moving towards a potential candidate nomination. And then behind that, we've got obviously undisclosed programs, which are ranging from hit identification through to lead optimization in both fibrosis and oncology. So we've got a very nice full pipeline coming up behind that. So...

L
Lisa Mary Anson
executive

Thanks, Richard. And just to finish off that question, I mean, we do think about the business, as I mentioned at the beginning, there's 3 investment pillars. So very much the RXC004 program. The second pillar is RXC007. And our discovery engine is very much our third investment pillar. So it's a very significant investment. It's our lifeline in terms of fueling the pipeline. Remember, we do have an internally sourced pipeline, which I think is one of the key characteristics of Redx as a company. And so that third pillar that Richard has alluded to, with both DDR and RXC008, we have a target, an external target, that we stated a number of times of 3 new INDs by 2025. So that's what we're looking for from that. So you can imagine that RXC008 maybe one of those if it goes through its IND program by the end of next year, I would be looking to possibly DDR to come through in that time frame and then some of the other programs in that discovery engine. So I think that gives you a sense of the investment in that discovery engine. And yes, I mean, in terms of partnership, we're always talking. I think it's a continual conversation with large pharma or potential partners about our programs. We think it's very important to keep that sort of dialogue moving on all our assets. So we understand where people's interests are, what is particularly helpful to them if they were to look for a partnering deal, and we know, therefore, who are the parties who might be interested at any one stage. And I think we have a goal to continue to move assets forward through to clinical proof of concept. But we will always look at partnering and make sure that we can actually deliver on the portfolio that we've got. And we are in a fortunate position at the moment of having a strong progress, as we've outlined. Obviously, we did a couple of deals a few years ago where we felt we weren't able to take all of the assets forward internally with the right level of funding. That has proved to have been a very good strategy from where we were 3 years ago. At this point in time, we will evaluate all of the options on our assets as we go forward and make the right decision. So we're not going to commit to any particular strategy for any particular assets, but we will assure you that we continue to look at partnering options. And where it makes sense, that may well be something we bring to the table.

R
Rachel Gravesen

Thanks, Lisa. There's a question coming about on the clinical pipeline from Max Herrmann at Stifel. What should we expect from the results of the 004 Phase II studies with PD-1, particularly given both treatment arms will receive 004?

L
Lisa Mary Anson
executive

Thanks, Max. So maybe that's one I would ask, Jane, perhaps you'd like to comment on that question.

J
Jane Robertson
executive

Yes. I mean I think for the PD-1 combination arm, as you say, this is an open-label study, and it's just a single arm in combination. The reason we're able to interpret that data is that we know that in MSS colorectal cancer, nivolumab really has no effect. We will have the single-arm monotherapy arm also in the study. So I think we're really attributing any additional effect that we see in that combination to the synergistic effect of those compounds together, which is what we've seen in the preclinical models.

R
Rachel Gravesen

Great. There's one financial one actually, it's more directed to Pete, but maybe, Lisa, you want to start and then hand over to Pete. Given the current macro environment, was it difficult to get this fund raise across the line? And do you have more long-term objectives now? I mean, I know we heard from Lisa earlier, but what are the sort of more longer term objectives? And is there a potential more fundraising in the future?

P
Peter Collum
executive

Yes, I can start out. So was it difficult? No, not at all. Easy to chuckle now given it's behind us. But I think we all realize the macro environment has had a real impact on the biotech equity markets. And I think safe to say that any biotech out there raising money right now is going to have some difficulty, which really highlights the significance of what we were able to do. I think the good news is that for us, it was tough due to market reasons and not Redx reasons. As I said earlier, it's tough right now to get all of your existing investors to participate in a fund raise. And I think across the board right now, that's not a foregone conclusion in this environment, and we certainly did not take that for granted. And we're really fortunate to have really supportive group of institutions behind us that believes in the Redx team and our strategy and our assets. And as I said before, that's Redmile, Sofinnova, Polar and Platinum. And I think the value of those relationships really becomes even more evident in tough markets. And I'd say it's even more difficult right now to attract new investors, which is why we're extremely pleased to have Invus join the register in this round, and they're really well-known, high-quality life sciences investor. And we did have some other smaller investors come into the raise as well. And so all in all, we think having this group of investors come into the fund raise plus the fact that we priced at premium, which I mentioned earlier, is really a great outcome in this difficult market environment, and it's a real kind of stamp of validation of Redx and what we're doing from the market. In terms of the second half of the question about longer term objectives, I'd say our key long-term goals remain to continue expanding the base of high-quality, long-term minded shareholders to continue enhancing our access to capital and to continue improving the liquidity and trading profile so that ideally, when we do have positive data events and successful execution, it is appropriately reflected in the share price in our valuation, so that our shareholders can get the benefit of that in terms of a great return on their investment. Otherwise, what's the point of being public. I think we took a good step in that direction with this financing, adding Invus, as well as some of the other smaller investors to the group. And we will look to continue to do that in the future.

R
Rachel Gravesen

I think that's probably the last one from the webcast. So I'll hand it back to you, Lisa.

L
Lisa Mary Anson
executive

Thanks, Rachel. Can I just check in with the operator, there's nothing else comes through on the phone lines?

Operator

We have no questions registered on the phone lines.

L
Lisa Mary Anson
executive

Okay. So with that, it just remains for me to underline that we are very pleased with the progress that we've reported today in the first half in terms of all fronts of the company, the clinical pipeline, the discovery pipeline and indeed the financing. We're excited as a team to work together to progress that and to continue to work on our strategy. And so we really appreciate you joining us today and your interest in the company and your questions. And thank you for your time. And with that, I will close today's call. Thank you very much.

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2022