FARON PHARMACEUTICALS OY — Call Transcript 2026

Good afternoon, Europe. Good morning, U.S.A. Welcome to the Faron Pharmaceuticals EHA 2026 webcast. My name is Juho Jalkanen, the Chief Executive Officer of Faron Pharmaceuticals. On to the next slide, please. Today, with great pleasure, we are happy to present what was presented over the weekend at European Hematology Association annual meeting in Stockholm, Sweden. Here presenting the actual data and in the Congress is Dr. Mika Kontro from Helsinki University Hospital, the Principal Investigator of the BEXMAB phase I/II trial. After that, as many of you may know and are eagerly waiting for the next phase IIb, our Chief Medical Officer, Dr. Petri Bono, will be presenting on how is the startup of the trial progressing. Before we go more deeper into the data and upcoming next trial, I would like to lay out a higher level big picture coming from. Next slide, please. As many of you may remember, ASH end of 2025 left the high-risk MDS field, I would say devastated after the phase III VERONA failure with Venetoclax. It left a vacuum in late-stage programs. What has actually since then happened is a plethora of upcoming new companies, even new drugs, to the field of high-risk MDS, which we are delighted to see. With the recent developments, though, we are happy to be in a lead position going further, and especially what still differentiates us from the crowd is our novel mode of action, having the possibility to really induce hematopoiesis and make the bone marrow healthier for these high-risk MDS patients. A lot of these different programs we're seeing, unfortunately, they are reruns of BCL-2 inhibitors, CD47 inhibitors, and kinase inhibitors. To mention and highlighting, nice to see also immune modulation, immunotherapy pickup in this field. Want to highlight the anti-galectin-9 from Galecto and the PI3K gamma inhibitor from Stelexis BioSciences. Those are good to be looking for in the future when it comes to immune modulation in high-risk MDS. This is the current state of the field, coming back from, I would say, maybe some depressed moods at ASH. At EHA, I think there is positive enthusiasm generating in the field and looking very much forward to these upcoming data readouts in the field that hopefully there will be something new for the high-risk MDS population. With these words and enthusiasm for the future, let's go see the latest from the BEXMAB trial reported on EHA. Next slide, and over to you, Dr. Kontro. Thank you, Juho. Can I have a first slide? Very briefly about the mode of action of Bexmarilimab. Basically, when monocytes and macrophages express Clever-1, it's kind of immunosuppressive molecule. Bexmarilimab is monoclonal antibody against Clever-1. When Clever-1 is inhibited in monocytes, it leads to enhanced immune activation. What we see in the patient samples, we see enhanced expression of antigen-presenting molecules, activation of T cells, and also activation of cytokines. Basically, these all make the monocytes more aggressive, and that may lead to better disease control. Actually, Clever-1 is also expressed on the myeloid blast cells, and there is emerging data that when we inhibit with Bexmarilimab Clever-1 on the blast cells, it may have an effect on the mitochondrial function of these cells and basically enhance the cell killing. Next slide, please. This is actually data that we showed at ESMO last fall. We actually observed that when we have good Clever-1 target engagement, we have more complete responses. Meaning that this shows good relationship between target engagement with bexmarilimab and response. As mentioned, the more target it engage, the better responses we have. Next slide, please. This is the overview of phase I, phase II BEXMAB trial. The trial recruited both treatment-naïve high-risk MDS patients. We had 20 patients or 21 patients, also the trial recruited HMA-failed high-risk MDS patient population. The trial was recruiting across 10 sites in U.S., U.K., and Finland. It was a combinational study with azacitidine, which is a hypomethylating agent. In the phase one, we evaluated three different dose levels, one, three, and six milligrams per kilogram. For phase II, we included patients with HMA-failed high-risk MDS and explored two dose levels. I want to underline on the right-hand side that actually very many of these patients that were included had a very high-risk disease as defined by IPSS-R, also TP53 mutations, which are commonly associated with very poor outcome, were highly prevalent in this patient population. When looking at treatment-naïve patient population, actually 57% of the patients were very high IPSS-M disease, which is currently more and more used for classification of the MDS. Next slide, please. This is the data from frontline patient population. In summary, we have observed a complete remission rate as per IWG 2006 criteria to be 45%, overall response rate extremely good, 85%. What we have already previously shown, the responses continued to be maintained with the AZA plus Bex combination, we have shown that there is high clearance of blast cells. We have also good response rate in TP53 mutated disease. At this meeting, we also reported the duration of complete remission, it's currently over 16 months, which is very encouraging in this patient population. Next slide, please. When looking at the data on HMA-failed MDS patient population, the overall response rate in this patient population is 64%, we still see good responses and duration of response. Next slide, please. Discussing briefly about the toxicity. In general, we can say that safety profile remains to be very promising. We have to remind ourselves that this patient population is rather fragile and elderly patient population, even though we haven't seen any Grade five Bex-related AEs in this patient population. Next slide, please. Adding a bit more granularity to the data. When looking at the most common treatment-related Adverse Events, it's mainly related in hematopoietic toxicity, which is quite common in this patient population. Next slide, please. When looking at Grade three or higher Adverse Events, basically a bit more serious Adverse Events, again, these are mainly based on hematopoietic toxicity. Febrile neutropenia was observed in 32.7% of the patients. Perhaps it's good to remind you that actually this was not just the frontline patient population, but also the HMA-failed patient population. In addition, the patients were not required to receive prophylactic antibiotic therapy as a study therapy. Next slide, please. Looking at some of the very interesting data that we actually presented first time at EHA meeting. This data comes from the patients that have been treated in the BEXMAB trial. On the left-hand side, you can see the data of the hematopoietic status of the patient. Basically, what we were capable of showing is that when the patient received AZA plus Bex combination, the number of or the proportion of hematopoietic progenitor cells is increasing, and this might be also relating to less transfusions and hematologic improvement. When looking at the right-hand side, we also observed that while the patients were receiving AZA plus Bex, we actually had a higher number of cytotoxic CD8 T cells, and quite interestingly, also a decrease of exhausted TIM-3 positive T cells. Next slide, please. This data was also presented first time at EHA. This is the patients that were evaluated at baseline and achieved response or not. We observed that there was higher proportion of both CD8 and CD4 central memory T cells, which actually can then be differentiated using Bexmarilimab plus Azacitidine. Interestingly also, we observed less terminal effector cytotoxic T cells in the patients that did not achieve treatment response. Basically, this shows that the patients that achieved CR had a best capacity to activate their T cell responses while receiving AZA plus Bex therapy. Next slide. Thank you, Mika. Very nice biomarker data. Really, I would say capturing and highlighting the effect of the Bex has on the immune system and activating the immune system and activating also hematopoiesis in this Again, very frail patients. Next up, over to our CMO, Dr. Bono, on where are we with starting the upcoming phase IIb. Thank you, Juho. Could I get the next slide, please? All right. Bexmarilimab, the randomized placebo control double-blinded phase IIb trial, schema shown here. First of all, population, newly diagnosed MDS patients with morphologically confirmed higher risk MDS and eligible for standard of care Azacitidine treatment and not eligible at time of screening to stem cell transplant. In the trial, patients will be randomized into three arms. Arm A, BEX 1 mg per kilo plus Azacitidine. Arm B, BEX 3 mg per kilo plus Azacitidine. Finally, arm C, placebo plus Azacitidine. Patients will be treated with BEX with weekly infusions, and patients who receive CR as their best response may proceed after three months to biweekly treatment or every other week infusion. That means why there is Q2-week if some way. Remember that usually Bex is given every week in the BEXMAB trial, but there's a possibility to move over to every two-week dosing. Primary analysis in the trial that will happen three months after last patient's first visit, and all the results will be stratified according to IPSS-M risk category that will be used in the trial and also according to baseline bone marrow blast count percentage and TP53 mutational status. Next slide, please. Where are we going currently with the trial preparations? We have earlier announced that Parexel has been selected as a CRO and actively working together with them. We are well underway with the trial preparations, and we are on track to really have the first patients enrolled to the trial already in early October. Protocol is ready. Protocol is signed. Informed consent forms are ready. Country selection and site feasibilities they have been done. First sites have already been qualified and are on track to be activated already in October. A study global PI, Professor Amer Zeidan from Yale, will be the global PI, then in EU, Mika Kontro will be the coordinating European PI and also Finland will be the reporting member state in EU. From U.K., the coordinating investigator will be Dr. Austin Kulasekararaj from King's London. Next slide, please. Here are the planned sites. If we start with the U.S. sites, the study will first be most likely enrolling first patient from U.S., although U.K. and our list is also very fast in opening. We will have here familiar sites from BEXMAB such as Yale, MD Anderson, City of Hope in California. In addition to that, University of Wisconsin, University of Colorado, Vanderbilt, Mass General for Boston, Dana-Farber/Harvard Cancer Center, as well as Moffitt Cancer Center in Tampa in Florida. In Europe, we will have countries Finland, Spain, Italy, France, and also Poland and Czech Republic. Not to forget, U.K., there will be sites also, four sites probably in U.K. Altogether, the planned number of sites is 35, and as a reminder, the study will have altogether 90 patients, 30 patients per arm, from these 35 sites. There's a nice geographical spread across Europe as well as across U.S. Next slide, please. Maybe then as a takeaway from the newest update of BEXMAB trial here at the end. Lots of interest in Mika's presentation. Data nicely maturing towards better with safety. We have earlier at ASH when we reported, we have in the frontline a bit longer than nine months median follow-up of the patients.Now we had bit more than 14 months median follow-up of the patients. Five months more follow-up, five months more time for safety evaluation. Safety profile remains actually numbers very similar to earlier, which is good news. The safety profile remains very good in this longer follow-up. The efficacy, strong response rates, strong CR rates, and very importantly, CR rate is 45% in the overall treatment line population, and 70% in TP53 mutants. Someone who may remember the ASH waterfall plot, there were a couple of changes also in the decline in the blast count changes, couple of deeper bars, as well as a bit higher number of 100% decline in the blast numbers. Finally, but very importantly, regulatory agencies take into account that not just the CR rates, but also duration of CR is important when considering approval of novel drugs, for example, in the treatment of higher risk MDS. The duration of CR has increased from earlier 12 months as reported at ASH to 16.1 months now reported by Mika Kontro at the EHA meeting. About a four-month improvement in the duration of CR. Importantly, as a summary, the phase IIb BEXERA trial preparations, they are on track and at the EHA meeting, lots of interest and engagement from principal investigators from both E.U. and U.S. We expect to have a rapid start for the trial. I think this was my last slide, and I give back to Juho. Yes. Thank you, Petri, opening up the Q&A as our investor relations starts getting in those questions. I have a couple to start with now that I have Mika here. We were actually so busy at the conference, didn't have proper time to discuss with Mika that how do you see now Bex in this field compared to others, and how much excitement? To me, it felt that this is the readout that everybody will be looking at in this field. How about you? Yeah. I tend to certainly agree. First of all, I think that what is a really good signal about the upcoming BEXERA trial is that basically all sites that were involved in the earlier BEXMAB trial are very eager to join, and I think that we have also, during the conference, had very good discussions that people are very interested in joining to the trial. With the current results and with the current CR and overall response rate, and also now with longer duration of response data, this is getting more and more interesting and very much looking forward to start also BEXERA here in Helsinki. Thank you. As you said, more and more interesting. Have to do another question for you, Mika. What I hear a lot and what I heard at the Congress is with this response rate in TP53 mutated, where usually response rate is very poor, should we focus solely on that? What's your answer? You perhaps know my answer already beforehand. I think that it actually would be very feasible option also to do and conduct a trial solely on TP53 mutated patient population due to the fact that there is no current available treatment options. All patients are receiving basically Azacitidine plus Venetoclax. Unfortunately, leads to responses. Part responses are quite short-lived. I certainly would be very keen to see the trial, perhaps separate trial to be conducted in that patient population as well. We do know that for FDA, the bar for approval of a compound that improves survival and response rate in TP53 mutated MDS, perhaps also in AML, would be highly valuable. Thank you. Yes, I totally agree. Maybe we will expand into that as our resources expand. My answer to that is we need further data before we just go do TP53 mutated. We will deliver this next Phase IIb. We will learn more, and if needed, we will focus and also, and even possibly solely on TP53 if that is the route. You learn always as you do and collect more data. I have one question to Petri before I let the audience go. You mentioned that there's been good engagement now putting together this trial, collecting the sites. What's it been like getting all these sites? How much work has that been? Of course, lot of work. It's nice that usually at least four times more feasibilities are sent out than actual wind up in the trial, for example, from U.S. 100% of the sites that have been approached, so they have been engaged and want to join our trial. Means that there's a lot of need for new treatments for the patients and the early experience from the existing sites. What the new sites have heard from presentations at various meetings have been positive, so they are eager to jump as a trial site and be part of the development story. Very good response from various PIs. Correct me if I'm wrong because I also get requests, is there already more that we can take along to the trial? We need to limit the trial sites. There would be clearly a lot more interest than how many sites we can open. Need to remember that this is a 90-patient trial, it is not very feasible to open a lot more sites. Okay. Thank you, Petri. Let's open the floor to the audience and questions. Thank you, Juho. The first question goes for Dr. Kontro. The median duration of complete remission is 16.1 months in frontline high-risk MDS. For treating this population today, how meaningful is the 16.1 months compared what's typically seen with azacitidine alone? Yeah, I think that's a great question, what we have thus far been seeing is that the responses have been, as mentioned, quite good. The duration of responses is also related to the fact that how many patients do respond. For example, Azacitidine, the response rate is approximately 25%-30%. Here for frontline patient population, we are looking at complete remission rate of 45%. We have got a better number of patients. For azacitidine, of course, most of the data is a bit outdated, but we are looking perhaps similar numbers with regards of survival instead of complete remission rate. If Petri actually could update on some of the latest data that you have been now going through regarding the duration of responses for AZA. Thank you. Yeah. It is. If you ask me, Mika, how I see the duration of CR, it is clearly shorter than what we have seen here, but of course, depends always compared to early phase trials or randomized control trials. But this 16 months compares very favorably to any studies with the CR duration report. Thank you. The next question. What's the signal that this combination is doing something that the standard of care doesn't? What's the value that Bex add? Maybe I'll go first from a layman perspective. Again, very scientific data presented at EHA and here in this webcast showing what is very important for these patients is that these again are very anemic, neutropenic patients, and the backbone regime of AZA adds to that. What we're seeing from a safety profile and now in the cells we were presenting here, that we actually do not make neutropenia or anemia worse than AZA would. It may even be that we make it even better, and this happens through the production of these new red and white blood cells. Maybe a more sophisticated answer from Dr. Kontro. Thanks, Juho. I think that one perhaps low-hanging fruit, in a sense, how to evaluate this is that what is the additional value of Bexmarilimab is the phase II or HMA failed patient population, which already have been receiving Azacitidine and have progressed while receiving therapy. For this patient population, as I showed previously, we see treatment responses. We see quite good overall survival in this patient population. Perhaps this is also one patient population that illustrates the additive value of Bexmarilimab on the top of Azacitidine. Petri, your view. Maybe to add on that, Mika is very right that RR MDS patient population is a good one to see the added benefit of Bex, but also like to highlight that the target engagement slide that Mika showed in the beginning, so that we have a very nice relationship that the higher target engagement, the higher response. The CR patients got the highest target engagement, and I think that's probably one of the best pieces of data in addition to that RR MDS patient population, what we can get without a randomized trial. Of course, the upcoming randomized trial will then give the definitive answer to the contribution and to the magnitude of contribution. Yeah, I personally like the target engagement slide really a lot in addition to the translational results that Mika showed, the increase in T cell infiltration and antigen presentation, of course, also. Yes, absolutely. Just like to comment for the benefit of the audience. In other words, the more Clever you block, the better response you get. Very nice to see. Next question. Thank you. Safety in an old and high-risk population is always a concern. How would you describe the tolerability so far? This I'll hand over to a practicing physician. Over to you, Dr. Kontro. Yeah. What we have actually been discussing also previously is that, as you mentioned, the patient population is rather fragile, very prone to the toxicities, and basically the toxicity profile is very similar to azacitidine therapy only. Of course, when interpreting this data, we have to remind ourselves that this is now from all patient population, all 55 patients, including de novo patients that haven't been treated before, and also patients with HMA-failed disease. Also, given the fact that what we have been discussing with other investigators in the investigators meetings, it really seems that, as mentioned, also the gut feeling is that the combination is quite well-tolerated and that this was also illustrated by the fact that we haven't had any bexmarilimab-related deaths in the trial. As mentioned, rather well-tolerated therapy option for these patients. Thank you. How do you plan to demonstrate the benefit of Bex regarding the duration of complete responses and overall survival if patients who undergo bone marrow transplant are censored from the follow-up? Dr. Bono? This is taken into account in the trial design, actually it follows exactly new guidance that FDA has provided for industry in the treatment of MDS. Patients who get a good response for the treatment are transferred to stem cell transplant will not be censored. This is how this is handled, and that's taken into account in the trial design. There's a lot of variation how these patients have been reported earlier in various trials, but now there's a clear FDA guidance that how we should do that, and we are following exactly that guidance. Thank you. You have described that Bexmarilimab is not just reducing cancer cells, but helping the body to produce healthy cells again. How important is this dual mode of action? Maybe I go first. To me, that is actually our, I would say, most important differentiator from other more cytotoxic treatments. For this population, this is an extremely valuable aspect of the drug. How about you, Dr. Kontro? Yeah, I agree. Really also looking very much for the randomized data on the topic, so that actually how much we achieve with combination of Bex to the Azacitidine. Do we have a good number of reduced red blood cells and platelet infusions? I think that will be very crucial for this, again, frail patient population. If we have that possibility that we need to transfuse patients less, it's a huge benefit for the patients and huge benefit also for quality of the life of these patients. Thank you. The final last questions. What are the key milestones between now and end of this year, and what should investors watch for this coming year? Petri, over to you. The key milestones are, of course, the launch of the new BEXERA trial, approval from regulatory agencies, submissions in time, and then first patient in in time, and really fast ramp-up of the patient enrollment. That's related to the BEXERA. Another milestone, at ASH meeting, a new updated efficacy will be for the first time told, for example, time to event endpoints in the frontline patient population. We plan to submit an abstract there and then to do a November data cut before the ASH meeting. Of course, not to forget solid tumor trials. We expect that there will be first patients also enrolled in those trials actually quite soon. Thank you, Petri. Then back to you, Juho. Okay. Thank you, everybody. That is a wrap. I would say super exciting times ahead for Bex, both in high-risk MDS and solid tumors, definitely for the high-risk MDS field. Very happy to see a lot of new attempts entering this field, more immunomodulating therapies into this field. I think they're highly needed, exciting times ahead for everybody. Thank you all, have a wonderful day

Speaker 1: Good afternoon, Europe. Good morning, U.S.A. Welcome to the Faron Pharmaceuticals EHA 2026 webcast. My name is Juho Jalkanen, the Chief Executive Officer of Faron Pharmaceuticals. On to the next slide, please. Today, with great pleasure, we are happy to present what was presented over the weekend at European Hematology Association annual meeting in Stockholm, Sweden. Here presenting the actual data and in the Congress is Dr. Mika Kontro from Helsinki University Hospital, the Principal Investigator of the BEXMAB phase I/II trial. After that, as many of you may know and are eagerly waiting for the next phase IIb, our Chief Medical Officer, Dr. Petri Bono, will be presenting on how is the startup of the trial progressing. Before we go more deeper into the data and upcoming next trial, I would like to lay out a higher level big picture coming from. Next slide, please. Good afternoon, Europe. good afternoon europe Good morning, U.S.A. good morning u.s.a Welcome to the Faron Pharmaceuticals EHA 2026 webcast. welcome to the faron pharmaceuticals eha 2026 webcast My name is Juho Jalkanen, the Chief Executive Officer of Faron Pharmaceuticals. my name is juho jalkanen the chief executive officer of faron pharmaceuticals On to the next slide, please. on to the next slide please Today, with great pleasure, we are happy to present what was presented over the weekend at European Hematology Association annual meeting in Stockholm, Sweden. today with great pleasure we are happy to present what was presented over the weekend at european hematology association annual meeting in stockholm sweden Here presenting the actual data and in the Congress is Dr. Mika Kontro from Helsinki University Hospital, the Principal Investigator of the BEXMAB phase I/II trial. here presenting the actual data and in the congress is dr mika kontro from helsinki university hospital the principal investigator of the bexmab phase i/ii trial After that, as many of you may know and are eagerly waiting for the next phase IIb, our Chief Medical Officer, Dr. Petri Bono, will be presenting on how is the startup of the trial progressing. after that as many of you may know and are eagerly waiting for the next phase iib our chief medical officer dr petri bono will be presenting on how is the startup of the trial progressing Before we go more deeper into the data and upcoming next trial, I would like to lay out a higher level big picture coming from. before we go more deeper into the data and upcoming next trial i would like to lay out a higher level big picture coming from Next slide, please. next slide please As many of you may remember, ASH end of 2025 left the high-risk MDS field, I would say devastated after the phase III VERONA failure with Venetoclax. It left a vacuum in late-stage programs. What has actually since then happened is a plethora of upcoming new companies, even new drugs, to the field of high-risk MDS, which we are delighted to see. With the recent developments, though, we are happy to be in a lead position going further, and especially what still differentiates us from the crowd is our novel mode of action, having the possibility to really induce hematopoiesis and make the bone marrow healthier for these high-risk MDS patients. A lot of these different programs we're seeing, unfortunately, they are reruns of BCL-2 inhibitors, CD47 inhibitors, and kinase inhibitors. To mention and highlighting, nice to see also immune modulation, immunotherapy pickup in this field. As many of you may remember, ASH end of 2025 left the high-risk MDS field, I would say devastated after the phase III VERONA failure with Venetoclax. as many of you may remember ash end of 2025 left the high-risk mds field i would say devastated after the phase iii verona failure with venetoclax It left a vacuum in late-stage programs. it left a vacuum in late-stage programs What has actually since then happened is a plethora of upcoming new companies, even new drugs, to the field of high-risk MDS, which we are delighted to see. what has actually since then happened is a plethora of upcoming new companies even new drugs to the field of high-risk mds which we are delighted to see With the recent developments, though, we are happy to be in a lead position going further, and especially what still differentiates us from the crowd is our novel mode of action, having the possibility to really induce hematopoiesis and make the bone marrow healthier for these high-risk MDS patients. with the recent developments though we are happy to be in a lead position going further and especially what still differentiates us from the crowd is our novel mode of action having the possibility to really induce hematopoiesis and make the bone marrow healthier for these high-risk mds patients A lot of these different programs we're seeing, unfortunately, they are reruns of BCL-2 inhibitors, CD47 inhibitors, and kinase inhibitors. a lot of these different programs we're seeing unfortunately they are reruns of bcl-2 inhibitors cd47 inhibitors and kinase inhibitors To mention and highlighting, nice to see also immune modulation, immunotherapy pickup in this field. to mention and highlighting nice to see also immune modulation immunotherapy pickup in this field Want to highlight the anti-galectin-9 from Galecto and the PI3K gamma inhibitor from Stelexis BioSciences. Those are good to be looking for in the future when it comes to immune modulation in high-risk MDS. This is the current state of the field, coming back from, I would say, maybe some depressed moods at ASH. At EHA, I think there is positive enthusiasm generating in the field and looking very much forward to these upcoming data readouts in the field that hopefully there will be something new for the high-risk MDS population. With these words and enthusiasm for the future, let's go see the latest from the BEXMAB trial reported on EHA. Next slide, and over to you, Dr. Kontro. Want to highlight the anti-galectin-9 from Galecto and the PI3K gamma inhibitor from Stelexis BioSciences. want to highlight the anti-galectin-9 from galecto and the pi3k gamma inhibitor from stelexis biosciences Those are good to be looking for in the future when it comes to immune modulation in high-risk MDS. those are good to be looking for in the future when it comes to immune modulation in high-risk mds This is the current state of the field, coming back from, I would say, maybe some depressed moods at ASH. this is the current state of the field coming back from i would say maybe some depressed moods at ash At EHA, I think there is positive enthusiasm generating in the field and looking very much forward to these upcoming data readouts in the field that hopefully there will be something new for the high-risk MDS population. at eha i think there is positive enthusiasm generating in the field and looking very much forward to these upcoming data readouts in the field that hopefully there will be something new for the high-risk mds population With these words and enthusiasm for the future, let's go see the latest from the BEXMAB trial reported on EHA. with these words and enthusiasm for the future let's go see the latest from the bexmab trial reported on eha Next slide, and over to you, Dr. Kontro. next slide and over to you dr kontro

Speaker 2: Thank you, Juho. Can I have a first slide? Very briefly about the mode of action of Bexmarilimab. Basically, when monocytes and macrophages express Clever-1, it's kind of immunosuppressive molecule. Bexmarilimab is monoclonal antibody against Clever-1. When Clever-1 is inhibited in monocytes, it leads to enhanced immune activation. What we see in the patient samples, we see enhanced expression of antigen-presenting molecules, activation of T cells, and also activation of cytokines. Basically, these all make the monocytes more aggressive, and that may lead to better disease control. Actually, Clever-1 is also expressed on the myeloid blast cells, and there is emerging data that when we inhibit with Bexmarilimab Clever-1 on the blast cells, it may have an effect on the mitochondrial function of these cells and basically enhance the cell killing. Next slide, please. This is actually data that we showed at ESMO last fall. Thank you, Juho. thank you juho Can I have a first slide? can i have a first slide Very briefly about the mode of action of Bexmarilimab. very briefly about the mode of action of bexmarilimab Basically, when monocytes and macrophages express Clever-1, it's kind of immunosuppressive molecule. basically when monocytes and macrophages express clever-1 it's kind of immunosuppressive molecule Bexmarilimab is monoclonal antibody against Clever-1. bexmarilimab is monoclonal antibody against clever-1 When Clever-1 is inhibited in monocytes, it leads to enhanced immune activation. when clever-1 is inhibited in monocytes it leads to enhanced immune activation What we see in the patient samples, we see enhanced expression of antigen-presenting molecules, activation of T cells, and also activation of cytokines. what we see in the patient samples we see enhanced expression of antigen-presenting molecules activation of t cells and also activation of cytokines Basically, these all make the monocytes more aggressive, and that may lead to better disease control. basically these all make the monocytes more aggressive and that may lead to better disease control Actually, Clever-1 is also expressed on the myeloid blast cells, and there is emerging data that when we inhibit with Bexmarilimab Clever-1 on the blast cells, it may have an effect on the mitochondrial function of these cells and basically enhance the cell killing. actually clever-1 is also expressed on the myeloid blast cells and there is emerging data that when we inhibit with bexmarilimab clever-1 on the blast cells it may have an effect on the mitochondrial function of these cells and basically enhance the cell killing Next slide, please. next slide please This is actually data that we showed at ESMO last fall. this is actually data that we showed at esmo last fall We actually observed that when we have good Clever-1 target engagement, we have more complete responses. Meaning that this shows good relationship between target engagement with bexmarilimab and response. As mentioned, the more target it engage, the better responses we have. Next slide, please. This is the overview of phase I, phase II BEXMAB trial. The trial recruited both treatment-naïve high-risk MDS patients. We had 20 patients or 21 patients, also the trial recruited HMA-failed high-risk MDS patient population. The trial was recruiting across 10 sites in U.S., U.K., and Finland. It was a combinational study with azacitidine, which is a hypomethylating agent. In the phase one, we evaluated three different dose levels, one, three, and six milligrams per kilogram. For phase II, we included patients with HMA-failed high-risk MDS and explored two dose levels. We actually observed that when we have good Clever-1 target engagement, we have more complete responses. we actually observed that when we have good clever-1 target engagement we have more complete responses Meaning that this shows good relationship between target engagement with bexmarilimab and response. meaning that this shows good relationship between target engagement with bexmarilimab and response As mentioned, the more target it engage, the better responses we have. as mentioned the more target it engage the better responses we have Next slide, please. next slide please This is the overview of phase I, phase II BEXMAB trial. this is the overview of phase i phase ii bexmab trial The trial recruited both treatment-naïve high-risk MDS patients. the trial recruited both treatment-naïve high-risk mds patients We had 20 patients or 21 patients, also the trial recruited HMA-failed high-risk MDS patient population. we had 20 patients or 21 patients also the trial recruited hma-failed high-risk mds patient population The trial was recruiting across 10 sites in U.S., U.K., and Finland. the trial was recruiting across 10 sites in u.s u.k and finland It was a combinational study with azacitidine, which is a hypomethylating agent. it was a combinational study with azacitidine which is a hypomethylating agent In the phase one, we evaluated three different dose levels, one, three, and six milligrams per kilogram. in the phase one we evaluated three different dose levels one three and six milligrams per kilogram For phase II, we included patients with HMA-failed high-risk MDS and explored two dose levels. for phase ii we included patients with hma-failed high-risk mds and explored two dose levels I want to underline on the right-hand side that actually very many of these patients that were included had a very high-risk disease as defined by IPSS-R, also TP53 mutations, which are commonly associated with very poor outcome, were highly prevalent in this patient population. When looking at treatment-naïve patient population, actually 57% of the patients were very high IPSS-M disease, which is currently more and more used for classification of the MDS. Next slide, please. This is the data from frontline patient population. In summary, we have observed a complete remission rate as per IWG 2006 criteria to be 45%, overall response rate extremely good, 85%. What we have already previously shown, the responses continued to be maintained with the AZA plus Bex combination, we have shown that there is high clearance of blast cells. We have also good response rate in TP53 mutated disease. I want to underline on the right-hand side that actually very many of these patients that were included had a very high-risk disease as defined by IPSS-R, also TP53 mutations, which are commonly associated with very poor outcome, were highly prevalent in this patient population. i want to underline on the right-hand side that actually very many of these patients that were included had a very high-risk disease as defined by ipss-r also tp53 mutations which are commonly associated with very poor outcome were highly prevalent in this patient population When looking at treatment-naïve patient population, actually 57% of the patients were very high IPSS-M disease, which is currently more and more used for classification of the MDS. when looking at treatment-naïve patient population actually 57% of the patients were very high ipss-m disease which is currently more and more used for classification of the mds Next slide, please. next slide please This is the data from frontline patient population. this is the data from frontline patient population In summary, we have observed a complete remission rate as per IWG 2006 criteria to be 45%, overall response rate extremely good, 85%. in summary we have observed a complete remission rate as per iwg 2006 criteria to be 45% overall response rate extremely good 85% What we have already previously shown, the responses continued to be maintained with the AZA plus Bex combination, we have shown that there is high clearance of blast cells. what we have already previously shown the responses continued to be maintained with the aza plus bex combination we have shown that there is high clearance of blast cells We have also good response rate in TP53 mutated disease. we have also good response rate in tp53 mutated disease At this meeting, we also reported the duration of complete remission, it's currently over 16 months, which is very encouraging in this patient population. Next slide, please. When looking at the data on HMA-failed MDS patient population, the overall response rate in this patient population is 64%, we still see good responses and duration of response. Next slide, please. Discussing briefly about the toxicity. In general, we can say that safety profile remains to be very promising. We have to remind ourselves that this patient population is rather fragile and elderly patient population, even though we haven't seen any Grade five Bex-related AEs in this patient population. Next slide, please. Adding a bit more granularity to the data. When looking at the most common treatment-related Adverse Events, it's mainly related in hematopoietic toxicity, which is quite common in this patient population. Next slide, please. At this meeting, we also reported the duration of complete remission, it's currently over 16 months, which is very encouraging in this patient population. at this meeting we also reported the duration of complete remission it's currently over 16 months which is very encouraging in this patient population Next slide, please. next slide please When looking at the data on HMA-failed MDS patient population, the overall response rate in this patient population is 64%, we still see good responses and duration of response. when looking at the data on hma-failed mds patient population the overall response rate in this patient population is 64% we still see good responses and duration of response Next slide, please. next slide please Discussing briefly about the toxicity. discussing briefly about the toxicity In general, we can say that safety profile remains to be very promising. in general we can say that safety profile remains to be very promising We have to remind ourselves that this patient population is rather fragile and elderly patient population, even though we haven't seen any Grade five Bex-related AEs in this patient population. we have to remind ourselves that this patient population is rather fragile and elderly patient population even though we haven't seen any grade five bex-related aes in this patient population Next slide, please. next slide please Adding a bit more granularity to the data. adding a bit more granularity to the data When looking at the most common treatment-related Adverse Events, it's mainly related in hematopoietic toxicity, which is quite common in this patient population. when looking at the most common treatment-related adverse events it's mainly related in hematopoietic toxicity which is quite common in this patient population Next slide, please. next slide please When looking at Grade three or higher Adverse Events, basically a bit more serious Adverse Events, again, these are mainly based on hematopoietic toxicity. Febrile neutropenia was observed in 32.7% of the patients. Perhaps it's good to remind you that actually this was not just the frontline patient population, but also the HMA-failed patient population. In addition, the patients were not required to receive prophylactic antibiotic therapy as a study therapy. Next slide, please. Looking at some of the very interesting data that we actually presented first time at EHA meeting. This data comes from the patients that have been treated in the BEXMAB trial. On the left-hand side, you can see the data of the hematopoietic status of the patient. When looking at Grade three or higher Adverse Events, basically a bit more serious Adverse Events, again, these are mainly based on hematopoietic toxicity. when looking at grade three or higher adverse events basically a bit more serious adverse events again these are mainly based on hematopoietic toxicity Febrile neutropenia was observed in 32.7% of the patients. febrile neutropenia was observed in 32.7% of the patients Perhaps it's good to remind you that actually this was not just the frontline patient population, but also the HMA-failed patient population. perhaps it's good to remind you that actually this was not just the frontline patient population but also the hma-failed patient population In addition, the patients were not required to receive prophylactic antibiotic therapy as a study therapy. in addition the patients were not required to receive prophylactic antibiotic therapy as a study therapy Next slide, please. next slide please Looking at some of the very interesting data that we actually presented first time at EHA meeting. looking at some of the very interesting data that we actually presented first time at eha meeting This data comes from the patients that have been treated in the BEXMAB trial. this data comes from the patients that have been treated in the bexmab trial On the left-hand side, you can see the data of the hematopoietic status of the patient. on the left-hand side you can see the data of the hematopoietic status of the patient Basically, what we were capable of showing is that when the patient received AZA plus Bex combination, the number of or the proportion of hematopoietic progenitor cells is increasing, and this might be also relating to less transfusions and hematologic improvement. When looking at the right-hand side, we also observed that while the patients were receiving AZA plus Bex, we actually had a higher number of cytotoxic CD8 T cells, and quite interestingly, also a decrease of exhausted TIM-3 positive T cells. Next slide, please. This data was also presented first time at EHA. This is the patients that were evaluated at baseline and achieved response or not. We observed that there was higher proportion of both CD8 and CD4 central memory T cells, which actually can then be differentiated using Bexmarilimab plus Azacitidine. Basically, what we were capable of showing is that when the patient received AZA plus Bex combination, the number of or the proportion of hematopoietic progenitor cells is increasing, and this might be also relating to less transfusions and hematologic improvement. basically what we were capable of showing is that when the patient received aza plus bex combination the number of or the proportion of hematopoietic progenitor cells is increasing and this might be also relating to less transfusions and hematologic improvement When looking at the right-hand side, we also observed that while the patients were receiving AZA plus Bex, we actually had a higher number of cytotoxic CD8 T cells, and quite interestingly, also a decrease of exhausted TIM-3 positive T cells. when looking at the right-hand side we also observed that while the patients were receiving aza plus bex we actually had a higher number of cytotoxic cd8 t cells and quite interestingly also a decrease of exhausted tim-3 positive t cells Next slide, please. next slide please This data was also presented first time at EHA. this data was also presented first time at eha This is the patients that were evaluated at baseline and achieved response or not. this is the patients that were evaluated at baseline and achieved response or not We observed that there was higher proportion of both CD8 and CD4 central memory T cells, which actually can then be differentiated using Bexmarilimab plus Azacitidine. we observed that there was higher proportion of both cd8 and cd4 central memory t cells which actually can then be differentiated using bexmarilimab plus azacitidine Interestingly also, we observed less terminal effector cytotoxic T cells in the patients that did not achieve treatment response. Basically, this shows that the patients that achieved CR had a best capacity to activate their T cell responses while receiving AZA plus Bex therapy. Next slide. Interestingly also, we observed less terminal effector cytotoxic T cells in the patients that did not achieve treatment response. interestingly also we observed less terminal effector cytotoxic t cells in the patients that did not achieve treatment response Basically, this shows that the patients that achieved CR had a best capacity to activate their T cell responses while receiving AZA plus Bex therapy. basically this shows that the patients that achieved cr had a best capacity to activate their t cell responses while receiving aza plus bex therapy Next slide. next slide

Speaker 1: Thank you, Mika. Very nice biomarker data. Really, I would say capturing and highlighting the effect of the Bex has on the immune system and activating the immune system and activating also hematopoiesis in this Again, very frail patients. Next up, over to our CMO, Dr. Bono, on where are we with starting the upcoming phase IIb. Thank you, Mika. thank you mika Very nice biomarker data. very nice biomarker data Really, I would say capturing and highlighting the effect of the Bex has on the immune system and activating the immune system and activating also hematopoiesis in this Again, very frail patients. really i would say capturing and highlighting the effect of the bex has on the immune system and activating the immune system and activating also hematopoiesis in this again very frail patients Next up, over to our CMO, Dr. Bono, on where are we with starting the upcoming phase IIb. next up over to our cmo dr bono on where are we with starting the upcoming phase iib

Speaker 3: Thank you, Juho. Could I get the next slide, please? All right. Bexmarilimab, the randomized placebo control double-blinded phase IIb trial, schema shown here. First of all, population, newly diagnosed MDS patients with morphologically confirmed higher risk MDS and eligible for standard of care Azacitidine treatment and not eligible at time of screening to stem cell transplant. In the trial, patients will be randomized into three arms. Arm A, BEX 1 mg per kilo plus Azacitidine. Arm B, BEX 3 mg per kilo plus Azacitidine. Finally, arm C, placebo plus Azacitidine. Patients will be treated with BEX with weekly infusions, and patients who receive CR as their best response may proceed after three months to biweekly treatment or every other week infusion. That means why there is Q2-week if some way. Thank you, Juho. thank you juho Could I get the next slide, please? could i get the next slide please All right. all right Bexmarilimab, the randomized placebo control double-blinded phase IIb trial, schema shown here. bexmarilimab the randomized placebo control double-blinded phase iib trial schema shown here First of all, population, newly diagnosed MDS patients with morphologically confirmed higher risk MDS and eligible for standard of care Azacitidine treatment and not eligible at time of screening to stem cell transplant. first of all population newly diagnosed mds patients with morphologically confirmed higher risk mds and eligible for standard of care azacitidine treatment and not eligible at time of screening to stem cell transplant In the trial, patients will be randomized into three arms. in the trial patients will be randomized into three arms Arm A, BEX 1 mg per kilo plus Azacitidine. arm a bex 1 mg per kilo plus azacitidine Arm B, BEX 3 mg per kilo plus Azacitidine. arm b bex 3 mg per kilo plus azacitidine Finally, arm C, placebo plus Azacitidine. finally arm c placebo plus azacitidine Patients will be treated with BEX with weekly infusions, and patients who receive CR as their best response may proceed after three months to biweekly treatment or every other week infusion. patients will be treated with bex with weekly infusions and patients who receive cr as their best response may proceed after three months to biweekly treatment or every other week infusion That means why there is Q2-week if some way. that means why there is q2-week if some way Remember that usually Bex is given every week in the BEXMAB trial, but there's a possibility to move over to every two-week dosing. Primary analysis in the trial that will happen three months after last patient's first visit, and all the results will be stratified according to IPSS-M risk category that will be used in the trial and also according to baseline bone marrow blast count percentage and TP53 mutational status. Next slide, please. Where are we going currently with the trial preparations? We have earlier announced that Parexel has been selected as a CRO and actively working together with them. We are well underway with the trial preparations, and we are on track to really have the first patients enrolled to the trial already in early October. Protocol is ready. Protocol is signed. Informed consent forms are ready. Country selection and site feasibilities they have been done. Remember that usually Bex is given every week in the BEXMAB trial, but there's a possibility to move over to every two-week dosing. remember that usually bex is given every week in the bexmab trial but there's a possibility to move over to every two-week dosing Primary analysis in the trial that will happen three months after last patient's first visit, and all the results will be stratified according to IPSS-M risk category that will be used in the trial and also according to baseline bone marrow blast count percentage and TP53 mutational status. primary analysis in the trial that will happen three months after last patient's first visit and all the results will be stratified according to ipss-m risk category that will be used in the trial and also according to baseline bone marrow blast count percentage and tp53 mutational status Next slide, please. next slide please Where are we going currently with the trial preparations? where are we going currently with the trial preparations We have earlier announced that Parexel has been selected as a CRO and actively working together with them. we have earlier announced that parexel has been selected as a cro and actively working together with them We are well underway with the trial preparations, and we are on track to really have the first patients enrolled to the trial already in early October. we are well underway with the trial preparations and we are on track to really have the first patients enrolled to the trial already in early october Protocol is ready. protocol is ready Protocol is signed. protocol is signed Informed consent forms are ready. informed consent forms are ready Country selection and site feasibilities they have been done. country selection and site feasibilities they have been done First sites have already been qualified and are on track to be activated already in October. A study global PI, Professor Amer Zeidan from Yale, will be the global PI, then in EU, Mika Kontro will be the coordinating European PI and also Finland will be the reporting member state in EU. From U.K., the coordinating investigator will be Dr. Austin Kulasekararaj from King's London. Next slide, please. Here are the planned sites. If we start with the U.S. sites, the study will first be most likely enrolling first patient from U.S., although U.K. and our list is also very fast in opening. We will have here familiar sites from BEXMAB such as Yale, MD Anderson, City of Hope in California. First sites have already been qualified and are on track to be activated already in October. first sites have already been qualified and are on track to be activated already in october A study global PI, Professor Amer Zeidan from Yale, will be the global PI, then in EU, Mika Kontro will be the coordinating European PI and also Finland will be the reporting member state in EU. a study global pi professor amer zeidan from yale will be the global pi then in eu mika kontro will be the coordinating european pi and also finland will be the reporting member state in eu From U.K., the coordinating investigator will be Dr. Austin Kulasekararaj from King's London. from u.k the coordinating investigator will be dr austin kulasekararaj from king's london Next slide, please. next slide please Here are the planned sites. If we start with the U.S. sites, the study will first be most likely enrolling first patient from U.S., although U.K. and our list is also very fast in opening. We will have here familiar sites from BEXMAB such as Yale, MD Anderson, City of Hope in California. here are the planned sites. if we start with the u.s. sites, the study will first be most likely enrolling first patient from u.s., although u.k. and our list is also very fast in opening. we will have here familiar sites from bexmab such as yale, md anderson, city of hope in california In addition to that, University of Wisconsin, University of Colorado, Vanderbilt, Mass General for Boston, Dana-Farber/Harvard Cancer Center, as well as Moffitt Cancer Center in Tampa in Florida. In Europe, we will have countries Finland, Spain, Italy, France, and also Poland and Czech Republic. Not to forget, U.K., there will be sites also, four sites probably in U.K. Altogether, the planned number of sites is 35, and as a reminder, the study will have altogether 90 patients, 30 patients per arm, from these 35 sites. There's a nice geographical spread across Europe as well as across U.S. Next slide, please. Maybe then as a takeaway from the newest update of BEXMAB trial here at the end. Lots of interest in Mika's presentation. In addition to that, University of Wisconsin, University of Colorado, Vanderbilt, Mass General for Boston, Dana-Farber/Harvard Cancer Center, as well as Moffitt Cancer Center in Tampa in Florida. in addition to that university of wisconsin university of colorado vanderbilt mass general for boston dana-farber/harvard cancer center as well as moffitt cancer center in tampa in florida In Europe, we will have countries Finland, Spain, Italy, France, and also Poland and Czech Republic. in europe we will have countries finland spain italy france and also poland and czech republic Not to forget, U.K., there will be sites also, four sites probably in U.K. not to forget u.k there will be sites also four sites probably in u.k Altogether, the planned number of sites is 35, and as a reminder, the study will have altogether 90 patients, 30 patients per arm, from these 35 sites. altogether the planned number of sites is 35 and as a reminder the study will have altogether 90 patients 30 patients per arm from these 35 sites There's a nice geographical spread across Europe as well as across U.S. there's a nice geographical spread across europe as well as across u.s Next slide, please. next slide please Maybe then as a takeaway from the newest update of BEXMAB trial here at the end. Lots of interest in Mika's presentation. maybe then as a takeaway from the newest update of bexmab trial here at the end. lots of interest in mika's presentation Data nicely maturing towards better with safety. We have earlier at ASH when we reported, we have in the frontline a bit longer than nine months median follow-up of the patients.Now we had bit more than 14 months median follow-up of the patients. Five months more follow-up, five months more time for safety evaluation. Safety profile remains actually numbers very similar to earlier, which is good news. The safety profile remains very good in this longer follow-up. The efficacy, strong response rates, strong CR rates, and very importantly, CR rate is 45% in the overall treatment line population, and 70% in TP53 mutants. Someone who may remember the ASH waterfall plot, there were a couple of changes also in the decline in the blast count changes, couple of deeper bars, as well as a bit higher number of 100% decline in the blast numbers. Data nicely maturing towards better with safety. We have earlier at ASH when we reported, we have in the frontline a bit longer than nine months median follow-up of the patients. data nicely maturing towards better with safety. we have earlier at ash when we reported we have in the frontline a bit longer than nine months median follow-up of the patients Now we had bit more than 14 months median follow-up of the patients. now we had bit more than 14 months median follow-up of the patients Five months more follow-up, five months more time for safety evaluation. five months more follow-up five months more time for safety evaluation Safety profile remains actually numbers very similar to earlier, which is good news. safety profile remains actually numbers very similar to earlier which is good news The safety profile remains very good in this longer follow-up. the safety profile remains very good in this longer follow-up The efficacy, strong response rates, strong CR rates, and very importantly, CR rate is 45% in the overall treatment line population, and 70% in TP53 mutants. the efficacy strong response rates strong cr rates and very importantly cr rate is 45% in the overall treatment line population and 70% in tp53 mutants Someone who may remember the ASH waterfall plot, there were a couple of changes also in the decline in the blast count changes, couple of deeper bars, as well as a bit higher number of 100% decline in the blast numbers. someone who may remember the ash waterfall plot there were a couple of changes also in the decline in the blast count changes couple of deeper bars as well as a bit higher number of 100% decline in the blast numbers Finally, but very importantly, regulatory agencies take into account that not just the CR rates, but also duration of CR is important when considering approval of novel drugs, for example, in the treatment of higher risk MDS. The duration of CR has increased from earlier 12 months as reported at ASH to 16.1 months now reported by Mika Kontro at the EHA meeting. About a four-month improvement in the duration of CR. Importantly, as a summary, the phase IIb BEXERA trial preparations, they are on track and at the EHA meeting, lots of interest and engagement from principal investigators from both E.U. and U.S. We expect to have a rapid start for the trial. I think this was my last slide, and I give back to Juho. Finally, but very importantly, regulatory agencies take into account that not just the CR rates, but also duration of CR is important when considering approval of novel drugs, for example, in the treatment of higher risk MDS. finally but very importantly regulatory agencies take into account that not just the cr rates but also duration of cr is important when considering approval of novel drugs for example in the treatment of higher risk mds The duration of CR has increased from earlier 12 months as reported at ASH to 16.1 months now reported by Mika Kontro at the EHA meeting. the duration of cr has increased from earlier 12 months as reported at ash to 16.1 months now reported by mika kontro at the eha meeting About a four-month improvement in the duration of CR. about a four-month improvement in the duration of cr Importantly, as a summary, the phase IIb BEXERA trial preparations, they are on track and at the EHA meeting, lots of interest and engagement from principal investigators from both E.U. and U.S. importantly as a summary the phase iib bexera trial preparations they are on track and at the eha meeting lots of interest and engagement from principal investigators from both e.u and u.s We expect to have a rapid start for the trial. we expect to have a rapid start for the trial I think this was my last slide, and I give back to Juho. i think this was my last slide and i give back to juho

Speaker 1: Yes. Thank you, Petri, opening up the Q&A as our investor relations starts getting in those questions. I have a couple to start with now that I have Mika here. We were actually so busy at the conference, didn't have proper time to discuss with Mika that how do you see now Bex in this field compared to others, and how much excitement? To me, it felt that this is the readout that everybody will be looking at in this field. How about you? Yes. yes Thank you, Petri, opening up the Q&A as our investor relations starts getting in those questions. thank you petri opening up the q&a as our investor relations starts getting in those questions I have a couple to start with now that I have Mika here. i have a couple to start with now that i have mika here We were actually so busy at the conference, didn't have proper time to discuss with Mika that how do you see now Bex in this field compared to others, and how much excitement? we were actually so busy at the conference didn't have proper time to discuss with mika that how do you see now bex in this field compared to others and how much excitement To me, it felt that this is the readout that everybody will be looking at in this field. to me it felt that this is the readout that everybody will be looking at in this field How about you? how about you

Speaker 2: Yeah. I tend to certainly agree. First of all, I think that what is a really good signal about the upcoming BEXERA trial is that basically all sites that were involved in the earlier BEXMAB trial are very eager to join, and I think that we have also, during the conference, had very good discussions that people are very interested in joining to the trial. With the current results and with the current CR and overall response rate, and also now with longer duration of response data, this is getting more and more interesting and very much looking forward to start also BEXERA here in Helsinki. Yeah. yeah I tend to certainly agree. i tend to certainly agree First of all, I think that what is a really good signal about the upcoming BEXERA trial is that basically all sites that were involved in the earlier BEXMAB trial are very eager to join, and I think that we have also, during the conference, had very good discussions that people are very interested in joining to the trial. first of all i think that what is a really good signal about the upcoming bexera trial is that basically all sites that were involved in the earlier bexmab trial are very eager to join and i think that we have also during the conference had very good discussions that people are very interested in joining to the trial With the current results and with the current CR and overall response rate, and also now with longer duration of response data, this is getting more and more interesting and very much looking forward to start also BEXERA here in Helsinki. with the current results and with the current cr and overall response rate and also now with longer duration of response data this is getting more and more interesting and very much looking forward to start also bexera here in helsinki

Speaker 1: Thank you. As you said, more and more interesting. Have to do another question for you, Mika. What I hear a lot and what I heard at the Congress is with this response rate in TP53 mutated, where usually response rate is very poor, should we focus solely on that? What's your answer? Thank you. thank you As you said, more and more interesting. as you said more and more interesting Have to do another question for you, Mika. have to do another question for you mika What I hear a lot and what I heard at the Congress is with this response rate in TP53 mutated, where usually response rate is very poor, should we focus solely on that? what i hear a lot and what i heard at the congress is with this response rate in tp53 mutated where usually response rate is very poor should we focus solely on that What's your answer? what's your answer

Speaker 2: You perhaps know my answer already beforehand. I think that it actually would be very feasible option also to do and conduct a trial solely on TP53 mutated patient population due to the fact that there is no current available treatment options. All patients are receiving basically Azacitidine plus Venetoclax. Unfortunately, leads to responses. Part responses are quite short-lived. I certainly would be very keen to see the trial, perhaps separate trial to be conducted in that patient population as well. We do know that for FDA, the bar for approval of a compound that improves survival and response rate in TP53 mutated MDS, perhaps also in AML, would be highly valuable. You perhaps know my answer already beforehand. you perhaps know my answer already beforehand I think that it actually would be very feasible option also to do and conduct a trial solely on TP53 mutated patient population due to the fact that there is no current available treatment options. i think that it actually would be very feasible option also to do and conduct a trial solely on tp53 mutated patient population due to the fact that there is no current available treatment options All patients are receiving basically Azacitidine plus Venetoclax. all patients are receiving basically azacitidine plus venetoclax Unfortunately, leads to responses. unfortunately leads to responses Part responses are quite short-lived. part responses are quite short-lived I certainly would be very keen to see the trial, perhaps separate trial to be conducted in that patient population as well. i certainly would be very keen to see the trial perhaps separate trial to be conducted in that patient population as well We do know that for FDA, the bar for approval of a compound that improves survival and response rate in TP53 mutated MDS, perhaps also in AML, would be highly valuable. we do know that for fda the bar for approval of a compound that improves survival and response rate in tp53 mutated mds perhaps also in aml would be highly valuable

Speaker 1: Thank you. Yes, I totally agree. Maybe we will expand into that as our resources expand. My answer to that is we need further data before we just go do TP53 mutated. We will deliver this next Phase IIb. We will learn more, and if needed, we will focus and also, and even possibly solely on TP53 if that is the route. You learn always as you do and collect more data. I have one question to Petri before I let the audience go. You mentioned that there's been good engagement now putting together this trial, collecting the sites. What's it been like getting all these sites? How much work has that been? Thank you. thank you Yes, I totally agree. yes i totally agree Maybe we will expand into that as our resources expand. maybe we will expand into that as our resources expand My answer to that is we need further data before we just go do TP53 mutated. my answer to that is we need further data before we just go do tp53 mutated We will deliver this next Phase IIb. we will deliver this next phase iib We will learn more, and if needed, we will focus and also, and even possibly solely on TP53 if that is the route. we will learn more and if needed we will focus and also and even possibly solely on tp53 if that is the route You learn always as you do and collect more data. you learn always as you do and collect more data I have one question to Petri before I let the audience go. i have one question to petri before i let the audience go You mentioned that there's been good engagement now putting together this trial, collecting the sites. you mentioned that there's been good engagement now putting together this trial collecting the sites What's it been like getting all these sites? what's it been like getting all these sites How much work has that been? how much work has that been

Speaker 3: Of course, lot of work. It's nice that usually at least four times more feasibilities are sent out than actual wind up in the trial, for example, from U.S. 100% of the sites that have been approached, so they have been engaged and want to join our trial. Means that there's a lot of need for new treatments for the patients and the early experience from the existing sites. What the new sites have heard from presentations at various meetings have been positive, so they are eager to jump as a trial site and be part of the development story. Very good response from various PIs. Of course, lot of work. of course lot of work It's nice that usually at least four times more feasibilities are sent out than actual wind up in the trial, for example, from U.S. 100% of the sites that have been approached, so they have been engaged and want to join our trial. it's nice that usually at least four times more feasibilities are sent out than actual wind up in the trial for example from u.s 100% of the sites that have been approached so they have been engaged and want to join our trial Means that there's a lot of need for new treatments for the patients and the early experience from the existing sites. means that there's a lot of need for new treatments for the patients and the early experience from the existing sites What the new sites have heard from presentations at various meetings have been positive, so they are eager to jump as a trial site and be part of the development story. what the new sites have heard from presentations at various meetings have been positive so they are eager to jump as a trial site and be part of the development story Very good response from various PIs. very good response from various pis

Speaker 1: Correct me if I'm wrong because I also get requests, is there already more that we can take along to the trial? Correct me if I'm wrong because I also get requests, is there already more that we can take along to the trial? correct me if i'm wrong because i also get requests is there already more that we can take along to the trial

Speaker 3: We need to limit the trial sites. There would be clearly a lot more interest than how many sites we can open. Need to remember that this is a 90-patient trial, it is not very feasible to open a lot more sites. We need to limit the trial sites. we need to limit the trial sites There would be clearly a lot more interest than how many sites we can open. there would be clearly a lot more interest than how many sites we can open Need to remember that this is a 90-patient trial, it is not very feasible to open a lot more sites. need to remember that this is a 90-patient trial it is not very feasible to open a lot more sites

Speaker 1: Okay. Thank you, Petri. Let's open the floor to the audience and questions. Okay. okay Thank you, Petri. thank you petri Let's open the floor to the audience and questions. let's open the floor to the audience and questions

Speaker 4: Thank you, Juho. The first question goes for Dr. Kontro. The median duration of complete remission is 16.1 months in frontline high-risk MDS. For treating this population today, how meaningful is the 16.1 months compared what's typically seen with azacitidine alone? Thank you, Juho. thank you juho The first question goes for Dr. Kontro. the first question goes for dr kontro The median duration of complete remission is 16.1 months in frontline high-risk MDS. the median duration of complete remission is 16.1 months in frontline high-risk mds For treating this population today, how meaningful is the 16.1 months compared what's typically seen with azacitidine alone? for treating this population today how meaningful is the 16.1 months compared what's typically seen with azacitidine alone

Speaker 2: Yeah, I think that's a great question, what we have thus far been seeing is that the responses have been, as mentioned, quite good. The duration of responses is also related to the fact that how many patients do respond. For example, Azacitidine, the response rate is approximately 25%-30%. Here for frontline patient population, we are looking at complete remission rate of 45%. We have got a better number of patients. For azacitidine, of course, most of the data is a bit outdated, but we are looking perhaps similar numbers with regards of survival instead of complete remission rate. If Petri actually could update on some of the latest data that you have been now going through regarding the duration of responses for AZA. Yeah, I think that's a great question, what we have thus far been seeing is that the responses have been, as mentioned, quite good. yeah i think that's a great question what we have thus far been seeing is that the responses have been as mentioned quite good The duration of responses is also related to the fact that how many patients do respond. the duration of responses is also related to the fact that how many patients do respond For example, Azacitidine, the response rate is approximately 25%-30%. for example azacitidine the response rate is approximately 25%-30% Here for frontline patient population, we are looking at complete remission rate of 45%. here for frontline patient population we are looking at complete remission rate of 45% We have got a better number of patients. we have got a better number of patients For azacitidine, of course, most of the data is a bit outdated, but we are looking perhaps similar numbers with regards of survival instead of complete remission rate. for azacitidine of course most of the data is a bit outdated but we are looking perhaps similar numbers with regards of survival instead of complete remission rate If Petri actually could update on some of the latest data that you have been now going through regarding the duration of responses for AZA. if petri actually could update on some of the latest data that you have been now going through regarding the duration of responses for aza

Speaker 4: Thank you. Thank you. thank you

Speaker 1: Yeah. Yeah. yeah

Speaker 3: It is. If you ask me, Mika, how I see the duration of CR, it is clearly shorter than what we have seen here, but of course, depends always compared to early phase trials or randomized control trials. But this 16 months compares very favorably to any studies with the CR duration report. It is. it is If you ask me, Mika, how I see the duration of CR, it is clearly shorter than what we have seen here, but of course, depends always compared to early phase trials or randomized control trials. if you ask me mika how i see the duration of cr it is clearly shorter than what we have seen here but of course depends always compared to early phase trials or randomized control trials But this 16 months compares very favorably to any studies with the CR duration report. but this 16 months compares very favorably to any studies with the cr duration report

Speaker 4: Thank you. The next question. What's the signal that this combination is doing something that the standard of care doesn't? What's the value that Bex add? Thank you. thank you The next question. the next question What's the signal that this combination is doing something that the standard of care doesn't? what's the signal that this combination is doing something that the standard of care doesn't What's the value that Bex add? what's the value that bex add

Speaker 1: Maybe I'll go first from a layman perspective. Again, very scientific data presented at EHA and here in this webcast showing what is very important for these patients is that these again are very anemic, neutropenic patients, and the backbone regime of AZA adds to that. What we're seeing from a safety profile and now in the cells we were presenting here, that we actually do not make neutropenia or anemia worse than AZA would. It may even be that we make it even better, and this happens through the production of these new red and white blood cells. Maybe a more sophisticated answer from Dr. Kontro. Maybe I'll go first from a layman perspective. maybe i'll go first from a layman perspective Again, very scientific data presented at EHA and here in this webcast showing what is very important for these patients is that these again are very anemic, neutropenic patients, and the backbone regime of AZA adds to that. again very scientific data presented at eha and here in this webcast showing what is very important for these patients is that these again are very anemic neutropenic patients and the backbone regime of aza adds to that What we're seeing from a safety profile and now in the cells we were presenting here, that we actually do not make neutropenia or anemia worse than AZA would. what we're seeing from a safety profile and now in the cells we were presenting here that we actually do not make neutropenia or anemia worse than aza would It may even be that we make it even better, and this happens through the production of these new red and white blood cells. it may even be that we make it even better and this happens through the production of these new red and white blood cells Maybe a more sophisticated answer from Dr. Kontro. maybe a more sophisticated answer from dr kontro

Speaker 2: Thanks, Juho. I think that one perhaps low-hanging fruit, in a sense, how to evaluate this is that what is the additional value of Bexmarilimab is the phase II or HMA failed patient population, which already have been receiving Azacitidine and have progressed while receiving therapy. For this patient population, as I showed previously, we see treatment responses. We see quite good overall survival in this patient population. Perhaps this is also one patient population that illustrates the additive value of Bexmarilimab on the top of Azacitidine. Thanks, Juho. thanks juho I think that one perhaps low-hanging fruit, in a sense, how to evaluate this is that what is the additional value of Bexmarilimab is the phase II or HMA failed patient population, which already have been receiving Azacitidine and have progressed while receiving therapy. i think that one perhaps low-hanging fruit in a sense how to evaluate this is that what is the additional value of bexmarilimab is the phase ii or hma failed patient population which already have been receiving azacitidine and have progressed while receiving therapy For this patient population, as I showed previously, we see treatment responses. for this patient population as i showed previously we see treatment responses We see quite good overall survival in this patient population. we see quite good overall survival in this patient population Perhaps this is also one patient population that illustrates the additive value of Bexmarilimab on the top of Azacitidine. perhaps this is also one patient population that illustrates the additive value of bexmarilimab on the top of azacitidine

Speaker 1: Petri, your view. Petri, your view. petri your view

Speaker 3: Maybe to add on that, Mika is very right that RR MDS patient population is a good one to see the added benefit of Bex, but also like to highlight that the target engagement slide that Mika showed in the beginning, so that we have a very nice relationship that the higher target engagement, the higher response. The CR patients got the highest target engagement, and I think that's probably one of the best pieces of data in addition to that RR MDS patient population, what we can get without a randomized trial. Of course, the upcoming randomized trial will then give the definitive answer to the contribution and to the magnitude of contribution. Yeah, I personally like the target engagement slide really a lot in addition to the translational results that Mika showed, the increase in T cell infiltration and antigen presentation, of course, also. Maybe to add on that, Mika is very right that RR MDS patient population is a good one to see the added benefit of Bex, but also like to highlight that the target engagement slide that Mika showed in the beginning, so that we have a very nice relationship that the higher target engagement, the higher response. maybe to add on that mika is very right that rr mds patient population is a good one to see the added benefit of bex but also like to highlight that the target engagement slide that mika showed in the beginning so that we have a very nice relationship that the higher target engagement the higher response The CR patients got the highest target engagement, and I think that's probably one of the best pieces of data in addition to that RR MDS patient population, what we can get without a randomized trial. the cr patients got the highest target engagement and i think that's probably one of the best pieces of data in addition to that rr mds patient population what we can get without a randomized trial Of course, the upcoming randomized trial will then give the definitive answer to the contribution and to the magnitude of contribution. of course the upcoming randomized trial will then give the definitive answer to the contribution and to the magnitude of contribution Yeah, I personally like the target engagement slide really a lot in addition to the translational results that Mika showed, the increase in T cell infiltration and antigen presentation, of course, also. yeah i personally like the target engagement slide really a lot in addition to the translational results that mika showed the increase in t cell infiltration and antigen presentation of course also

Speaker 1: Yes, absolutely. Just like to comment for the benefit of the audience. In other words, the more Clever you block, the better response you get. Very nice to see. Next question. Yes, absolutely. yes absolutely Just like to comment for the benefit of the audience. just like to comment for the benefit of the audience In other words, the more Clever you block, the better response you get. in other words the more clever you block the better response you get Very nice to see. very nice to see Next question. next question

Speaker 4: Thank you. Safety in an old and high-risk population is always a concern. How would you describe the tolerability so far? Thank you. thank you Safety in an old and high-risk population is always a concern. safety in an old and high-risk population is always a concern How would you describe the tolerability so far? how would you describe the tolerability so far

Speaker 1: This I'll hand over to a practicing physician. Over to you, Dr. Kontro. This I'll hand over to a practicing physician. this i'll hand over to a practicing physician Over to you, Dr. Kontro. over to you dr kontro

Speaker 2: Yeah. What we have actually been discussing also previously is that, as you mentioned, the patient population is rather fragile, very prone to the toxicities, and basically the toxicity profile is very similar to azacitidine therapy only. Of course, when interpreting this data, we have to remind ourselves that this is now from all patient population, all 55 patients, including de novo patients that haven't been treated before, and also patients with HMA-failed disease. Also, given the fact that what we have been discussing with other investigators in the investigators meetings, it really seems that, as mentioned, also the gut feeling is that the combination is quite well-tolerated and that this was also illustrated by the fact that we haven't had any bexmarilimab-related deaths in the trial. As mentioned, rather well-tolerated therapy option for these patients. Yeah. yeah What we have actually been discussing also previously is that, as you mentioned, the patient population is rather fragile, very prone to the toxicities, and basically the toxicity profile is very similar to azacitidine therapy only. what we have actually been discussing also previously is that as you mentioned the patient population is rather fragile very prone to the toxicities and basically the toxicity profile is very similar to azacitidine therapy only Of course, when interpreting this data, we have to remind ourselves that this is now from all patient population, all 55 patients, including de novo patients that haven't been treated before, and also patients with HMA-failed disease. of course when interpreting this data we have to remind ourselves that this is now from all patient population all 55 patients including de novo patients that haven't been treated before and also patients with hma-failed disease Also, given the fact that what we have been discussing with other investigators in the investigators meetings, it really seems that, as mentioned, also the gut feeling is that the combination is quite well-tolerated and that this was also illustrated by the fact that we haven't had any bexmarilimab-related deaths in the trial. also given the fact that what we have been discussing with other investigators in the investigators meetings it really seems that as mentioned also the gut feeling is that the combination is quite well-tolerated and that this was also illustrated by the fact that we haven't had any bexmarilimab-related deaths in the trial As mentioned, rather well-tolerated therapy option for these patients. as mentioned rather well-tolerated therapy option for these patients

Speaker 4: Thank you. How do you plan to demonstrate the benefit of Bex regarding the duration of complete responses and overall survival if patients who undergo bone marrow transplant are censored from the follow-up? Thank you. thank you How do you plan to demonstrate the benefit of Bex regarding the duration of complete responses and overall survival if patients who undergo bone marrow transplant are censored from the follow-up? how do you plan to demonstrate the benefit of bex regarding the duration of complete responses and overall survival if patients who undergo bone marrow transplant are censored from the follow-up

Speaker 1: Dr. Bono? Dr. Bono? dr bono

Speaker 3: This is taken into account in the trial design, actually it follows exactly new guidance that FDA has provided for industry in the treatment of MDS. Patients who get a good response for the treatment are transferred to stem cell transplant will not be censored. This is how this is handled, and that's taken into account in the trial design. There's a lot of variation how these patients have been reported earlier in various trials, but now there's a clear FDA guidance that how we should do that, and we are following exactly that guidance. This is taken into account in the trial design, actually it follows exactly new guidance that FDA has provided for industry in the treatment of MDS. this is taken into account in the trial design actually it follows exactly new guidance that fda has provided for industry in the treatment of mds Patients who get a good response for the treatment are transferred to stem cell transplant will not be censored. patients who get a good response for the treatment are transferred to stem cell transplant will not be censored This is how this is handled, and that's taken into account in the trial design. this is how this is handled and that's taken into account in the trial design There's a lot of variation how these patients have been reported earlier in various trials, but now there's a clear FDA guidance that how we should do that, and we are following exactly that guidance. there's a lot of variation how these patients have been reported earlier in various trials but now there's a clear fda guidance that how we should do that and we are following exactly that guidance

Speaker 4: Thank you. You have described that Bexmarilimab is not just reducing cancer cells, but helping the body to produce healthy cells again. How important is this dual mode of action? Thank you. thank you You have described that Bexmarilimab is not just reducing cancer cells, but helping the body to produce healthy cells again. you have described that bexmarilimab is not just reducing cancer cells but helping the body to produce healthy cells again How important is this dual mode of action? how important is this dual mode of action

Speaker 1: Maybe I go first. To me, that is actually our, I would say, most important differentiator from other more cytotoxic treatments. For this population, this is an extremely valuable aspect of the drug. How about you, Dr. Kontro? Maybe I go first. maybe i go first To me, that is actually our, I would say, most important differentiator from other more cytotoxic treatments. to me that is actually our i would say most important differentiator from other more cytotoxic treatments For this population, this is an extremely valuable aspect of the drug. for this population this is an extremely valuable aspect of the drug How about you, Dr. Kontro? how about you dr kontro

Speaker 2: Yeah, I agree. Really also looking very much for the randomized data on the topic, so that actually how much we achieve with combination of Bex to the Azacitidine. Do we have a good number of reduced red blood cells and platelet infusions? I think that will be very crucial for this, again, frail patient population. If we have that possibility that we need to transfuse patients less, it's a huge benefit for the patients and huge benefit also for quality of the life of these patients. Yeah, I agree. yeah i agree Really also looking very much for the randomized data on the topic, so that actually how much we achieve with combination of Bex to the Azacitidine. really also looking very much for the randomized data on the topic so that actually how much we achieve with combination of bex to the azacitidine Do we have a good number of reduced red blood cells and platelet infusions? do we have a good number of reduced red blood cells and platelet infusions I think that will be very crucial for this, again, frail patient population. i think that will be very crucial for this again frail patient population If we have that possibility that we need to transfuse patients less, it's a huge benefit for the patients and huge benefit also for quality of the life of these patients. if we have that possibility that we need to transfuse patients less it's a huge benefit for the patients and huge benefit also for quality of the life of these patients

Speaker 4: Thank you. The final last questions. What are the key milestones between now and end of this year, and what should investors watch for this coming year? Thank you. thank you The final last questions. the final last questions What are the key milestones between now and end of this year, and what should investors watch for this coming year? what are the key milestones between now and end of this year and what should investors watch for this coming year

Speaker 1: Petri, over to you. Petri, over to you. petri over to you

Speaker 3: The key milestones are, of course, the launch of the new BEXERA trial, approval from regulatory agencies, submissions in time, and then first patient in in time, and really fast ramp-up of the patient enrollment. That's related to the BEXERA. Another milestone, at ASH meeting, a new updated efficacy will be for the first time told, for example, time to event endpoints in the frontline patient population. We plan to submit an abstract there and then to do a November data cut before the ASH meeting. Of course, not to forget solid tumor trials. We expect that there will be first patients also enrolled in those trials actually quite soon. The key milestones are, of course, the launch of the new BEXERA trial, approval from regulatory agencies, submissions in time, and then first patient in in time, and really fast ramp-up of the patient enrollment. the key milestones are of course the launch of the new bexera trial approval from regulatory agencies submissions in time and then first patient in in time and really fast ramp-up of the patient enrollment That's related to the BEXERA. that's related to the bexera Another milestone, at ASH meeting, a new updated efficacy will be for the first time told, for example, time to event endpoints in the frontline patient population. another milestone at ash meeting a new updated efficacy will be for the first time told for example time to event endpoints in the frontline patient population We plan to submit an abstract there and then to do a November data cut before the ASH meeting. we plan to submit an abstract there and then to do a november data cut before the ash meeting Of course, not to forget solid tumor trials. of course not to forget solid tumor trials We expect that there will be first patients also enrolled in those trials actually quite soon. we expect that there will be first patients also enrolled in those trials actually quite soon

Speaker 4: Thank you, Petri. Then back to you, Juho. Thank you, Petri. thank you petri Then back to you, Juho. then back to you juho

Speaker 1: Okay. Thank you, everybody. That is a wrap. I would say super exciting times ahead for Bex, both in high-risk MDS and solid tumors, definitely for the high-risk MDS field. Very happy to see a lot of new attempts entering this field, more immunomodulating therapies into this field. I think they're highly needed, exciting times ahead for everybody. Thank you all, have a wonderful day Okay. okay Thank you, everybody. thank you everybody That is a wrap. that is a wrap I would say super exciting times ahead for Bex, both in high-risk MDS and solid tumors, definitely for the high-risk MDS field. i would say super exciting times ahead for bex both in high-risk mds and solid tumors definitely for the high-risk mds field Very happy to see a lot of new attempts entering this field, more immunomodulating therapies into this field. very happy to see a lot of new attempts entering this field more immunomodulating therapies into this field I think they're highly needed, exciting times ahead for everybody. i think they're highly needed exciting times ahead for everybody Thank you all, have a wonderful day thank you all have a wonderful day