Hello, everyone. Welcome to the Half-Year Report Conference Call for Faron Pharmaceuticals . Very excited to have you all on the call. We know there are quite a few of you still joining. We are excited to talk to you about the significant clinical and financial milestones that have been achieved in the first half of 2025 for Faron. We've got our corporate disclaimer, as we always do, included for your review. We've got our agenda. We have three presenters today. We have Dr. Juho Jalkanen, the CEO.
Hello, everyone.
We have Head of Clinical and Regulatory, Dr. Petri Bono.
Hello, everyone.
We have Yrjö Wichmann, who is the CFO.
Hello, everybody.
Each will be talking through a section of the presentation today. Then, as always, we will have a summary from Juho, and we will have a Q&A. Again, same drill as usual. For those of you who have joined before, go ahead and submit your questions. Those who are new, you can submit along the way. We will come back to a moderated Q&A toward the end of the session.
juicy stuff I know everybody's been waiting for. First of all, I'm going to start with this slide introducing some of the new people that may be on the line to our story, which is all about high-risk myelodysplastic syndrome, which is a rare form of leukemia, one of the deadliest cancers still known to man. No real new treatments for 20 years. We're here to serve that with bexmarilimab, we're going to call it BEX, the first-in-class anti-CLEVER-1 antibody. We've just completed our phase I/II study and reported at ASCO and EHA. We've just been to the FDA at an end-of-phase II meeting, and FDA is sending us into a registration phase II/III study in frontline, high-risk MDS. We're going to take you through that in more detail right here. That's why we also have<edited_transcript>Thank you, Julie. Great to have you all here.
It's been an exciting first half and a lot to report on. Before a conventional H1 report, let's go into a lot of the recent stuff that has been happening during the silent period, the juicy stuff I know everybody's been waiting for. First of all, I'm going to start with this slide introducing some of the new people that may be on the line to our story, which is all about high-risk myelodysplastic syndrome, which is a rare form of leukemia, one of the deadliest cancers still known to man. No real new treatments for 20 years. We're here to serve that with bexmarilimab, we're going to call it BEX, the first-in-class anti-CLEVER-1 antibody. We've just completed our phase I/II study and reported at ASCO and EHA.
We've just been to the FDA at an end-of-phase II meeting, and FDA is sending us into a registration phase II/III study in frontline, high-risk MDS. We're going to take you through that in more detail right here. That's why we also have our Chief Medical Officer. We've got asked a lot since the recent failure of, for example, venetoclax in the same space that since all the failures, how will a small company like Faron Pharmaceuticals be successful and be able to help out? It all comes down to the core biology of the disease and the core biology we are tackling with our drug. Next slide, please. I know this is a familiar slide to a lot of you. Again, let's just recap shortly. First of all, through targeting macrophages and monocytes with Bex, we ignite the immune system.
We enhance antigen presentation and T- cells against the cancer. In MDS, for example, the cancer cells are CLEVER-1 positive. They are basically macrophages gone wild. We're going to deprive the cancer of its main source of protection. This may actually be one of the root causes why this has been such a difficult disease to treat and conquer. Again, we're going to the root biology of the disease, depriving the cancer of its main source of protection. Next slide. What we also see compared to the other failed drugs in this space is this is a highly cytopenic patient population. These patients suffer from neutropenia, anemia, and a lot of these cancer drugs are very toxic and usually make this stuff worse. We actually don't make it worse. It looks like we're making it better.
What you see here is on the left, that's a cancer patient from the trial. That's their cell populations in the bone marrow. What you see actually after C3D28, meaning at the end of the third cycle of treatment, is you see growing populations of progenitor cells for erythrocytes. You see growing populations of progenitor cells for platelets and neutrophils. We're not adding to the toxicity. We're actually making a lot of this crucial, important stuff that's important to the patient and their well-being better and not worse like other attempts in this area have done. That's a key differentiator. Next slide, please. Again, just highlighting why we believe we'll make a difference here and our mode of action since it's multifunctional. Like I mentioned, we're going to activate the immune system. We're going to enhance antigen presentation and T cell activation against the cancer.
We're going to sensitize the blast cells, the cancer cells, to actually the toxic killing stuff, be it chemo or here azacitidine. Most importantly, it really looks like we're increasing the production of hematological cells, allowing hematological recovery to happen in these patients, which are usually deeply anemic, for example. Next slide, please. This is what I call nowadays the X Factor. Here you see in gray the other assets that have recently failed their phase III trials. In orange is our safety. This is safety parameters, especially hematological safety parameters from our phase I/II trial. You have to look at this from the biology of the disease. These patients suffer from severe cytopenias, meaning neutropenia, anemia. Usually, these toxic cancer drugs just make it worse. This frail population just cannot take it anymore. That's the main reason why a lot of these have failed.
Like I just showed, we're not likely to make it worse. We're actually even likely to make it better. That's seen through the lower box in orange there. If you look at what the standard care azacitidine had as neutropenia, 61% in its own registrational trial, while in our BEXMAB trial, adding bexmarilimab to AZA actually may even improve neutropenia. That's the differentiator. That's why we believe we will eventually be successful. This has actually led to a lot of these early responses we have seen to become deeper and deeper and more meaningful for the patient because of this hematological recovery. This takes time. For our drug to work, it takes time, but our results continue to improve. Petri Bono, our Chief Medical Officer, is going to take you through the results next.
Thank you, Juho. Next, the clinical regulatory update. This is the most recent data from our frontline patients treated in the BEXMAB trial with the combination of bexmarilimab plus azacitidine. As you can see here, the responses continue to deepen as the bone marrow recovers. What it actually means in numbers, earlier at the ASCO presentation and at the EHA presentation, we had a complete remission rate, CR rate, of 28%. It has now increased to 43% in the most recent August 1st, data cut. This 43% is one of the highest ever reported in the literature for these frontline high-risk MDS patients. This may still improve as the data matures. On the left side, you can see the waterfall plot analysis, which is showing the decline in the number of bone marrow blasts after patients have been treated with BEX plus azacitidine.
You can actually see that more than half of the patients do get a 100% reduction in the number of the bone marrow blasts. If we have a more thorough look according to the protocol-specified criteria, it's 43%, which means 9 out of 21 patients received the CR, but also other responses so that the overall response rate of this patient population is 81% in the most recent data cut. Of note, 35% of evaluable patients proceeded to stem cell transplant, the only curative treatment to the disease. This is also a very, very high number. Next slide, please. Based on these excellent phase II results, we submitted a briefing document to FDA and actually had very recently the end-of-phase II meeting with them. It was a very positive outcome from the meeting. The main outcome is shown here. First of all, clear path to registration.
FDA supported moving into a seamless, adaptive phase II/III trial design, enabling dose optimization and registration of study start in frontline high-risk MDS in Q2 2026. Frontline accelerated approval possibility already at the interim readout. FDA confirmed openness to this accelerated approval in the frontline setting, contingent on interim efficacy and overall survival data with CR and CR equivalent according to these new IWG 2023 criteria as agreed endpoints. All other trials earlier have used older criteria, typically the IWG 2006. These newer criteria are taking into account better clinically meaningful responses among the patients. Therefore, it's very important for the whole field that now for the first time in a prospective randomized setting, these new criteria will be used. Also, FDA importantly agreed on the use of CR and CR equivalent as the other primary endpoint of the study. The other primary endpoint will be overall survival.
Larger immediate label potential with entire high-risk MDS population. FDA advised focusing just on the frontline development with no expectation for separate randomized RR MDS program. Finally, very important what comes to the upcoming trials and also for the success of the phase three is that they aligned everything on our non-clinical questions in the briefing document. They confirmed that no changes are needed to the CMC or non-clinical plans, indicating solid foundational readiness. Actually, these were not discussed at the actual physical meeting as the preliminary response to the briefing document was already positive. Next slide, please. This is the registration study plan for the high-risk MDS trial per FDA. This is a seamless, adaptive phase 2/3 trial design with accelerated approval and resizing possibilities. These both improve the likelihood of success in this trial.
The running phase shown here on the left side of the slide includes randomization between placebo azacitidine versus bexmarilimab plus azacitidine and bexmarilimab with two different doses with 1 mg or 3 mg per Kg and 40 patients per each arm. After 120 patients have been enrolled, there will be an unguided analysis for the trial dose to be used in the next stage of the trial. Based on the PK/PD safety efficacy data as a company, we believe it's likely to be the three mg per kilo, but remains to be done in the running phase. Very importantly, after 120 patients, we will have randomized data showing the contribution of bexmarilimab to the efficacy of the treatment since the BEXMAB trial has been a single-arm study without randomization.
Also, importantly is that we do have an accelerated approval possibility based on the interim readout of the primary endpoint CR plus CR equivalent. Thereafter, there will be survival analysis. For that one also, there's an adaptive possibility to resize as is also in the earlier phase of the trial. Overall, this will be around 400 patients or slightly over 400 patient trial. Importantly, the 80 patients treated in the placebo plus with the dose that will continue in the phase III pod will be included in the final analysis. They will be included in the interim analysis, and they will be included within the 400 patients. Next slide, please. A little bit more in detail, what does this new response criteria mean and why it's important that it will be used in the upcoming trial? The most important is that it's patient-centric.
Those criteria take better patients into account and will improve the likelihood of success. It's important that, for example, the change in the hemoglobin threshold will improve the real-world relevance. If we compare on the left side, we can see the IWG 2006. There was only a CR category, but not a category called CR equivalent. What is the CR equivalent? It's worth going through since that's included in the primary endpoint of our upcoming trial. On the right side, you can see the difference between CR and CR equivalent. Patients who have at baseline, they have bone marrow blast count less than 5%, are unable to achieve CR response in the 2023 criteria. Therefore, the ones who have blast less than 5% on baseline, when they get also complete recovery of all three lineages of blood cells and also cytogenetic response, they are then called CR equivalent.
Since at MDS, it's actually around 25%, in some sources even 30% of the patients who have at baseline less than 5% blast, it's very important that these can also be counted into the full CR rate of the trial. This is enabled in the use of the 2023 criteria. Importantly, the FDA has also agreed that the use of these new criteria will improve the ability to identify the most promising treatments for patients. Next slide, please. Let Yrjö continue.
I will now run through the final results for the first half of 2025. Please take the next slide. We have continued to cost-efficiently deliver our program also during this first half. We ended the first half with a cash balance of EUR 13.5 million. We need to remember, of course, that we do have the second and third tranche of the height convertible loan facility still undrawn.
We had an operating loss roughly in the same level as last year, even though our activities were quite much larger this year. Our net loss remained roughly the same, and the net asset was minus EUR 16.7 million. The total R&D expenses grew by EUR 0.4 million, and it was roughly the amount that operating loss was larger than last year. Next slide, please. What we did in the first financial arrangements for the first half, overall, we can say that our financial position continued to be very strong during the first half. We did a EUR 12 million financing round in February, and that was actually quite strongly oversubscribed. In April, we entered into the EUR 35 million convertible bond arrangement where we repaid the IPF loan, which importantly also released the collateral of our intellectual property. That means we don't have any financial covenants anymore on the loans.
As mentioned, we still have two EUR 10 million tranches of the facility undrawn. The first EUR 10 million is fully at our discretion, so we can actually draw it down whenever we deem necessary. The second EUR 10 million requires both ours and [Heights'] consent. At the end of the period, we had roughly 112 million shares outstanding, and we still have 25,000 shares of authorization left granted by the AGM 2025. Those will be available until the end of June next year. Over to you, Juho.
Thank you, Yrjö. Now to the conventional reporting of H1 after the juicy first bit, especially those juicy finances. First of all, as you may remember, we've even strengthened our board and especially the management from a business development perspective. Colin Bond, former CFO of Sandoz, joined our board, a very experienced pharma person. Ralph Hughes, who actually had worked with us, some of you may know him from our previous webcast, was working on the commercial modeling for BEX and already quite well familiar with the commercial opportunity around MDS. We were lucky to get him to join the company, who has been of great value in our business development activities. Next slide. Quickly over the recent clinical stuff. As mentioned, we received orphans from both the FDA and EMA in the beginning of year- end. Just previously, we had completed enrollment in January.
Three months from getting every patient enrolled, we announced the positive phase II, but we got to present them in upcoming congresses in June 2025. As Petri mentioned, since then, the data has even become stronger and stronger over time. Next slide. For us, it was quite a surprise that we got oral presentations in all the major congresses in the area, the MDS symposium, ASCO, and EHA, while also getting the phase I results published in Lancet Hematology. I have to say, coming from an academic scientific background, that getting a royal flush like this is hardly impossible, but we were able to achieve that. Goes to the excitement in the scientific field around BEX and what we're doing. Next slide, please. This has just continued, and we weren't even expecting getting orals at the most prestigious immunology congress in the world. Also an oral at ESMO.
Basically, total surprise. As mentioned, we recently updated the efficacy towards the FDA meeting. Responses over time with hematological recovery just get better. What has happened in the population is that these composite CRs or near CRs become full-blown CRs per even the old 2006 criteria as the bone marrow recovers and all blood cell lines, be it red blood cells, white blood cells, or platelets, become normal again. This is what this drug can achieve, not like the other attempts in this area. Next slide, please. Actually, a bit of a surprise to us also that the U.S. Patent Office granted us an extension in patent life up to 2040. This new divisional patent actually is even broader, protecting us for treating Clever-1 positive cancers with BEX. This was a significant patent improvement as well.
As in August, Petri took you through, we had a very positive meeting with the FDA setting us into a registrational trial. I would like to conclude that H1, at least for us in the company and especially me, I think it's been a strong and steady stage of development. Now in H2, it's time for business. The great thing we've achieved here, and like many who have followed us, last year when I started as CEO, we first looked to finance the company, stabilize the company, make it healthy, well-functioning, and cost-efficient. We did that. We were doing good. We had no reason to believe why wouldn't the phase II eventually be successful. Let's get money and go all the way to end of phase II. That's where we have brought the company exactly according to plan.
Like Yrjö mentioned, now at the stage of end of phase II, we're still well financed with a nice reserve of cash in the bank. Next slide, please. We're entering the next stage of partnering discussions, and there's a lot on the table. There's a lot of options. I have to say what keeps me up at night is when I'm thinking of how to, with these all options and possibilities, regional deal, global deal, what is the right balance of not giving away too much, but also de-risking the development plan, but also maintaining shareholder value. As we here in the company believe, BEX is extremely valuable, and it's not only MDS. It has great potential also in a number of other cancers.
To help us navigate through this, we've actually signed up with a top-tier investment bank specialized in deal-making to sort it all through the options we have and to maximize shareholder value. Nothing slowing down from the clinical perspective either. Next, we will be going to EMA, MHRA, on the registrational study plan. There's still a number of patients in the ongoing BEXMAB trial. The BEXMAB trial will not be enrolling more. FDA said we've seen enough there. Move up, move ahead. There's a significant amount of patients still on the drug doing well, and we will look after them. There will be follow-up data also coming from the BEXMAB trial. The solid tumor stuff is progressing, like Petri mentioned, getting a big trial started, significant trial, there's a lot of bureaucracy. I'll let now Petri take you through on the progress we've been making on the solid tumor side.
Thank you, Juho. Let's get to the next slide, please. This is where I get also very, very excited. It's about our oncology pipeline. I joined the company a bit more than a year ago. In the Capital Market Day, I told about the plans also in the solid tumors. Here you can see how we are progressing there. Let's not mention too much about the BEXMAB. As you just heard, we just had the FDA meeting and the phase II meeting. We have the upcoming phase III preparations that are happening according to FDA's guidance. That's BEX plus AZA. Shown here in blue are the solid tumor trials. It's been shown not just by us, but also by external labs that there's nice synergy between chemo plus BEX, as well as anti-PD-1 antibody treatment and BEX. That's a good reason to combine BEX with these agents.
Of note, the safety profile of BECS is extremely good. In BEXMAB trial, only 36% of the patients had BEX-related adverse events. It's actually an ideal candidate to combine. I start with the first blue arrow there, BLAZE. That's the Royal Marsden lung melanoma trial for patients who have progressed despite anti-PD-1 therapy. There BEX is combined with anti-PD-1 antibody. We have edited approval for the study protocol. The first patient in is expected at the end of this year. The second one is a sarcoma trial, BEX trial that will be conducted in Spain and led by the Vall d'Hebron site in Barcelona. BEX will be combined with the standard of care in sarcomas, doxorubicin, frontline patients, metastatic patients. At the moment, we are finalizing the trial protocol. We expect first patient in H1 next year.
There's a new one that you have not heard earlier, and that' called FINPROVE. This is the first trial that will use CLEVER-1 positivity as a selection criteria or as an inclusion criteria to the trial. This will include metastatic breast cancer patients that will be treated with taxane plus bexmarilimab. Why taxane? Since colleagues at the Barts Cancer Center in London have shown that taxane plus anti-CLEVER-1 antibody treatment is synergistic. Therefore, we want to test that in the frontline chemo combo among metastatic breast cancer patients. For that, the first patient in is expected H1 next year. This FINPROVE trial, although it's an inclusion criteria to get enrolled to the trial. In the BLAZE and BEX trial, all the data that's coming will be also analyzed according to the CLEVER-1 expression level among the patients. Finally, the PD-1 basket trial, `we call it MATINS-02, is in planning.
We have made a decision that it will wait till we see initial efficacy readouts from the solid tumor IITs. For sure, company-sponsored BEX plus anti-PD-1 is there also on the list. Of note, the FINPROVE trial, the breast cancer trial, is a logical continuation for the MATINS trial where we saw very nice disease control among heavily treated metastatic breast cancer patients. In the MATINS trial, they had a median of eight lines of therapy for the metastatic disease. Based on that encouraging single-agent result, we will now jump into the frontline treatment of metastatic breast cancer patients together with the taxane. With this oncology pipeline, we can really be proud about the progress we've been making. Ethics approval in FINPROVE contract has been already signed and steady progress and the estimated timeline. My next milestones are there on the right in this slide.
With this one, we can move forward. That's the Q&A slide.
Excellent. Thank you to all of the presenters. Appreciate it very much. They are all on deck now in the hot seat to answer the Q&A. I'm going to let everyone know a lot of these questions were turned in by those of you who are on the line already. I want you to know that we absolutely are going to those questions first, but you can also submit more and they will be sent to me. Certainly a lot of excitement, not only with the current data, but with future potential. Number one question we almost always get, right guys, is about time to approval. When do we think, if we had a crystal ball, what would be our earliest time to approval that we could possibly plan for?
According to the industry standard, it takes 8 months-9 months to get the phase III trial running and do the enrollment phase. Based on that, as was shown also in one of the slides, there's a possibility for accelerated approval in 2028.
Excellent. Juho, one for you. The next most asked question, I believe, is about partners and partnering. Can you give us a little more detail on how those conversations are going, especially now with the trial results and the FDA meeting news?
Yes. This has kind of been the final missing piece of information, the FDA feedback, the clear study design. Now that this is cleared and knowing partners, and those of you who have followed, the clinical development plan has changed slightly, but no major significant change. Models will be updated and looking very good. This was the missing piece. Now we have it.
Excellent. Speaking of the trial and the study design, when will you be able to share more about the specifics on that design? This is a specific question. I'll just kind of group these together. Number of sites, geographies, anything more, Petri, that we can share on those fronts?
Yeah, we have started the preparations for the phase II protocol after the FDA meeting feedback. Already at this stage, I can tell that we are talking about most likely about 80, 90 sites in the U.S., in Europe, and also very likely at least in Japan. Of course, when we move forward with the preparations and finalizing also the protocol, and then also end up in the CRO selection, this will be more exactly defined. We are talking multicenter, multicontinental, large trial, which is needed to do a very high-quality randomized double-blinded trial.
Maybe just to close off on that, there's two quick questions about were there biomarkers discussed with the FDA and the handling of TP53 patients as a separate entity. Any more on that?
About the biomarker, we are shown in those meeting presentations that actually most all patients in practice, they express nicely CLEVER-1, these MDS patients. We don't see any differences in the responses according to the preliminary CLEVER-1 expression levels. That's why we didn't suggest to the FDA either that the biomarker would be needed. That's also in the briefing document, all the data, and they didn't want to discuss the possible need for a biomarker in higher risk MDS. About TP53, we briefly touched that in our briefing document and in the meeting. We have very nice efficacy both in TP53 mutants as well as wild type patients. There's no reason to restrict the trial just for the other patient population. For sure, it will be a stratification factor in the protocol so that the results then will be stratified according to the TP53 mutant.
Did we receive, it sounds like we received feedback from the FDA regarding the last refractory MDS. Is there any further feedback expected from them regarding that? Also, part two of this question is any benefit from project frontrunner now that approval has been granted for the first line? Kind of a group question.
Juho, do you want to take it?
Yeah, I can take it. We actually asked this same FDA. There was a good dialogue. There was a good vibe in the room. We asked the same question almost in these exact words to the FDA, and the FDA said, we don't expect to change anything else in the last refractory. You'll get the full population. Even now, possibly accelerated approval for the frontline when we last year thought the interim from the frontline could give RR actual approval. Now it's for the entire population. The FDA said, why would you do anything there?
That's great. Given such solid directional feedback from the FDA, do you see any risk that the EMA could take a different view than the FDA on applying the criteria for the endpoint evaluation, the new 2023 criteria, or any other elements of the trial? How are you feeling about that?
Patient centricity is extremely important to EMA. That's why I think they will go with this as well. OS has always been a mainstay for EMA. This randomized setting with OS and a patient-centric surrogate endpoint, I think we believe it will go down well. We will have to go and ask specifically that they're happy with this as well. We do not expect that they would see differently. Again, like Petri mentioned, this is one single beautiful randomized blinded gold standard. This is a gold standard study. The great thing about actually this study compared again to the past failures is it has these resizing elements and has its sneak peeks where we can adjust and the others didn't. Ultimately, we believe this increases our possibility to be successful.
Definitely learning from the past. Petri, for you, thoughts on the 1 mg dose? Do you see this as the potential final dose to be chosen following the run-in phase, or is it primarily intended to kind of satisfy the FDA requirements and build additional data around BEX? What are your thoughts there?
Based on the target engagement data that we have and also the efficacy data, we believe that 3 mg per Kg would be the dose in the phase II. I think FDA in their meeting feedback made a good point. The number of patients that have been treated with 1 mg per Kg. It has ben quite low. Based on Project Optimus, they are trying to find the lowest possible dose where you can get the efficacy and also a good safety profile. Based on that, it's understandable that they want us also to do some work still with the 1 mg per Kg. There is on the PK/PD data side such a difference that we believe that the 3 will be the winner. Of course, it's a randomized run-in phase. After treating 40 patients + 40 patients + 40 patients, we will then know.
Yeah.
Maybe to chime in here again, because having been with this story quite a long time, and we've looked at the dose quite substantially already in MATINSON. Three is our choice, and that's what we went to the FDA with. It was a bit of a surprise that they wanted one, because we had, by standards of drug development, ruled that out, that target coverage isn't sufficient for the dosing period. As the FDA duly pointed out, you do have some efficacy with one, and it looks like it's very safe. With the principle of going to the lowest possible efficient dose, they can apply for one, and better not argue on that with the FDA. We made them happy.
Exactly. Okay, let's stick with the U.S. for a minute. Has the situation in the U.S. changed the realistic monthly pricing, just kind of everything that's going on in the world over there? Previously, this was estimated at EUR 18,000-EUR 25,000 a month per patient. Has this changed? You know, anything evolved your thinking there?
For now, it hasn't. This attempt on drug pricing has been, again, tried like five times before and hasn't gone through. There is, again, public pressure on pricing in the U.S. What plays in our advantage and the stance the Trump administration has took, or where the pressure is, is that they would go to reference pricing. Looking in Europe, where pricing is done very well, it's like its own science on what the benefit the drug brings, it can be priced accordingly. The more benefit actually a drug brings, usually the price difference between the U.S. and Europe is the smallest. That's kind of where we are at. The likely benefit we would bring in hematological recovery, less transfusions, less infections, less hospitalizations, this looks like it will be a well-priced drug in Europe as well.
If we would just go with European pricing, it'd still be a great selling drug.
Yeah. A strong value proposition, right? That's, I think, this value-based medicine around the world in many regulatory bodies is a key focus. I knew someone would be able to sneak another partner question in. I'll go to that, and then we'll ask one about the pipeline and close out. When you're thinking about kind of de-risking and monetizing events in order to support clinical development of BEX, are the discussions exclusively on BEXMAB combination, or are potential partners interested in starting a new trial or a new therapeutic format using their own pipeline combination? All of the above? Where have the discussions taken you with the partners?
Almost all of the above. What I can mention is, has been of high interest, is our approach in AML. You know, there's a lot of drug development in AML. A lot of these companies play in AML. They want to do, because again, this works in AML, especially on the root cause of the disease again. Our positioning in AML, how to develop in this AML, has been brought up in a lot of these conversations.
All right. Two last questions related to pipeline. Sarcoma trial, the BEXMAB trial, what cytostatic medication is combined with BEX? Is it radiation? What stage of the disease are the patients in? All soft tissue sarcomas, including relapsed/ refractory GIST. Give us the scope of that one. A little more detail.
That's a good question. It's the standard of care chemotherapy that's been there for decades already. The drug is called doxorubicin. It's standard of care everywhere in the world. It's doxorubicin plus BEX. In terms of setting, it's the frontline treatment. It's the frontline trial in metastatic soft tissue sarcomas.
Excellent. Okay. Preclinical lymphoma study. Previous deadline was end of June, June 25. When will it be announced? Whether it will continue? If it continues, what's the aim? Is it data for meetings? Another announcement?
Yeah, that's well remembered. We had that preclinical stage, the lymphoma development path. We have definitely not forgotten that. We have done steady progress by analyzing patient samples more. At the moment, we are not yet at the stage where we could make a go/no-go decision whether to proceed with the lymphomas to a clinical trial. We will be there. We continue still to do some preclinical lab work. We're still talking about the largest group of lymphomas, those large cell diffuse large cell B- cell lymphomas. Hopefully, in future webcasts, more about that, but not yet ready to make a go decision with the preclinical data there.
Watch the space basically on that one. Excellent. Juho, close us out with a little bit more on this idea of options and optionality. You know how you've come along with this company and this compound for many, many years. As you said, given the outstanding, I've been in this business a long time to get, as you called it, the royal flush of all of those orals, as well as the Lancet publication. To have such a strong FDA meeting, finish us out with kind of a little bit more on what you mean by this idea of optionality and where you've landed and what you see as kind of the vision for where this might go.
Yeah, no, that's a great question. How I go about this, and again, it goes to the huge potential we believe BEX has, or I believe BEX has, but it's not just my belief. I go to physicians who treat patients with the drug and say, you like it? Is it good? How do you feel about it? Oh, yeah, it's great. I go to scientists who play with the drug in the lab. What does it do? Is it looking any good? Is this a good drug? I go to each and every one of our stakeholders, or be it our scientific officer, or be it, is this true? Do you believe in the drug? Everybody says, yes, it looks like a game-changing drug. I go, if that's the case, then why not drive it through the roof? There's only so much a small company like us can do.
We have that blue sky thinking, this huge potential, but this needs more muscle. This needs a lot of capital, and that needs to be brought in as well.
Excellent. Thank you, everyone, for the call. Very much appreciate the time. Appreciate those listening in. You can continue to submit questions. I know they're always willing to hear and share. Very much appreciate the time to the speakers and presenters. We'll see you on the next call. Thank you.
Thank you.
Thank you.
Thank you.
Bye, everyone.