Q2 2026 Faron Pharmaceuticals Oy Earnings Release
Juho Jalkanen: Hello everyone. Welcome to the Faron Pharmaceuticals half-year report webcast. Apologies for the technical issues in the beginning, but I think we're now up and running and happy to be here with you. Next slide, please. As a biotech, classically, we will be making forward-looking statements, so our standard disclaimer. Next slide, please. For today's agenda, I will be taking you through the past key events and also the future outlook. Then our Chief Financial Officer, Jurriaan Dekkers, will be presenting the actual financial results, followed by a Q&A session. Next slide, please. Okay, let's go to the key events of the H1. Next slide, please. First and foremost, there may be some newcomers to the story, so short introduction on Faron and high-risk MDS.
Juho Jalkanen: Hello everyone. Welcome to the Faron Pharmaceuticals Half-year Report Webcast. Apologies for the technical issues in the beginning, but I think we're now up and running and happy to be here with you. Next slide, please. As a biotech, classically, we will be making forward-looking statements, so our standard disclaimer. Next slide, please. For today's agenda, I will be taking you through the past key events and also the future outlook. Then our Chief Financial Officer, Jurriaan Dekkers, will be presenting the actual financial results, followed by a Q&A session. Next slide, please. Okay, let's go to the key events of the H1. Next slide, please. First and foremost, there may be some newcomers to the story, so short introduction on Faron and high-risk MDS.
Speaker #1: Hello, everyone. Welcome to the Faron Pharmaceuticals half-year report webcast. Apologies for the technical issues at the beginning, but I think we're now up and running and happy to be here.
Speaker #1: With you. Next slide, please. As a biotech, classically, we will be making forward-looking statements, so our standard disclaimer: next slide, please. For today's agenda, I will be taking you through the past key events and also the future outlook.
Speaker #1: Then our Chief Financial Officer, Jurian Teckers, will be presenting the actual financial results, followed by a Q&A session. Next slide, please. Okay, let's go to the key events of the first half.
Speaker #1: Next slide, please. First and foremost, there may be some newcomers to the story, so a short introduction on Faron and high-risk MDS. First of all, Faron is a clinical-stage immunotherapy company with proven efficacy in Phase 2 that we can overcome treatment resistance in some very difficult cancers.
Juho Jalkanen: First of all, Faron is a clinical stage immunotherapy company with proven efficacy in phase II that we can overcome treatment resistance in some very difficult cancers. Our lead focus is in high-risk myelodysplastic syndrome, HR-MDS. It is a lethal form of leukemia causing severe anemia, severe infections, and bleeding, and without any new treatments for the past 20 years. It is currently treated with a chemotherapy-like regime named hypomethylating agents. The problem with hypomethylating is that majority do not get a proper response, and eventually, basically everybody relapses and there is no approved second-line therapy. This is an orphan indication, but the market opportunity is significant with 40,000 new patients each year in the US and main EU countries. Faron's bexmarilimab is a first-in-class anti-CLEVER-1 antibody.
Juho Jalkanen: First of all, Faron is a clinical stage immunotherapy company with proven efficacy in phase II that we can overcome treatment resistance in some very difficult cancers. Our lead focus is in high-risk myelodysplastic syndrome, HR-MDS. It is a lethal form of leukemia causing severe anemia, severe infections, and bleeding, and without any new treatments for the past 20 years. It is currently treated with a chemotherapy-like regime named hypomethylating agents. The problem with hypomethylating is that majority do not get a proper response, and eventually, basically everybody relapses and there is no approved second-line therapy. This is an orphan indication, but the market opportunity is significant with 40,000 new patients each year in the US and main EU countries. Faron's bexmarilimab is a first-in-class anti-CLEVER-1 antibody.
Speaker #1: Our lead focus is in high-risk myelodysplastic syndrome, HRMDS. It is a lethal form of leukemia, causing severe anemia, severe infections, and bleeding, and there have been no new treatments for the past 20 years.
Speaker #1: It is currently treated with a chemotherapy-like regimen named hypomethylating agents. The problem with hypomethylating agents is that the majority do not get a proper response, and eventually, basically everybody relapses, and there is no approved second-line therapy.
Speaker #1: This is an orphan indication, but the market opportunity is significant, with 40,000 new patients each year in the US and main EU countries. Faron's pexmarilimab is a first-in-class anti-Clever-1 antibody.
Speaker #1: It is one of the rare drugs that has actually shown that it can improve cancer cell killing while also inducing the production of healthy blood cells in the bone marrow.
Juho Jalkanen: It is one of the rare drugs that has actually shown that it can improve cancer cell killing while also inducing the production of healthy blood cells in the bone marrow. This is key for deep and durable responses and sustainable benefit for patients. So let's have a look at what this drug does. Next slide, please. Again, first-in-class CLEVER-1 antibody. Number one, we activate the immune system through activating monocytes and macrophages. Number two, MDS is a cancer of the macrophage population. So all the cancer cells named blast are CLEVER-1 positive. So in the context of MDS, we're not just activating the immune system, we're also depriving a cancer of its main source of protection, and this is likely why we're seeing such good results.
Juho Jalkanen: It is one of the rare drugs that has actually shown that it can improve cancer cell killing while also inducing the production of healthy blood cells in the bone marrow. This is key for deep and durable responses and sustainable benefit for patients. So let's have a look at what this drug does. Next slide, please. Again, first-in-class CLEVER-1 antibody. Number one, we activate the immune system through activating monocytes and macrophages. Number two, MDS is a cancer of the macrophage population. So all the cancer cells named blast are CLEVER-1 positive. So in the context of MDS, we're not just activating the immune system, we're also depriving a cancer of its main source of protection, and this is likely why we're seeing such good results.
Speaker #1: And this is key for deep and durable responses, and sustainable benefit for patients. So, let's have a look at what this drug does. Next slide, please.
Speaker #1: Again, first-in-class anti-Clever-1 antibody. Number one, we activate the immune system through activating monocytes and macrophages. And now, number two, MDS is a cancer of the macrophage population.
Speaker #1: So, all the cancer cells, named blasts, are Clever-1 positive. So, in the context of MDS, we're not just activating the immune system; we're also depriving cancer of its main source of protection, and this is likely why we're seeing such good results.
Speaker #1: We believe we are one of the first drugs to tackle the core biology of MDS, which makes it such a difficult disease to treat.
Juho Jalkanen: We believe we are one of the first drugs to tackle the core biology of MDS, which makes it such a difficult disease to treat. Next slide, please. So what has recently happened? We have completed a Phase I/II open label study. Follow-up data has continued to come, and it's been strong, confirming sustainable benefit for patients. Meanwhile, in the area of high-risk MDS, there has unfortunately been a lot of Phase III failures. But these come with important learnings, which we have now taken into consideration, and they have guided us to put together a Phase IIb study in frontline high-risk MDS. Based on that, we have completed one of the biggest financial rounds in Finland for biotechs, EUR 40 million raised through a rights issue, and now we are funded to deliver this Phase IIb readout.
Juho Jalkanen: We believe we are one of the first drugs to tackle the core biology of MDS, which makes it such a difficult disease to treat. Next slide, please. So what has recently happened? We have completed a Phase I/II open label study. Follow-up data has continued to come, and it's been strong, confirming sustainable benefit for patients. Meanwhile, in the area of high-risk MDS, there has unfortunately been a lot of Phase III failures. But these come with important learnings, which we have now taken into consideration, and they have guided us to put together a Phase IIb study in frontline high-risk MDS. Based on that, we have completed one of the biggest financial rounds in Finland for biotechs, EUR 40 million raised through a rights issue, and now we are funded to deliver this Phase IIb readout.
Speaker #1: Next slide, please. So, what has recently happened? We have completed a Phase 1/2 open-label study. Follow-up data has continued to come in, and it's been strong, confirming sustainable benefit for patients.
Speaker #1: Meanwhile, in the area of high-risk MDS, there has unfortunately been a lot of phase 3 failures, but these come with important learnings, which we have now taken into consideration, and they have guided us to put together a phase 2b study in front-line high-risk MDS.
Speaker #1: Based on that, we have completed one of the biggest financial rounds in Finland for biotechs—€40 million raised through a rights issue—and now we are funded to deliver this phase 2b readout. But on top of that, we will also be delivering phase 1/2 data in a number of solid tumor indications.
Juho Jalkanen: But on top of that, we will also be delivering phase I/II data in a number of solid tumor indications. Truly exciting times ahead. Next slide, please. I would like to take this moment to look at the landscape of high-risk MDS. The absolute vacuum of new treatment options has brought a lot of pharma companies into this area. There is actually a lot of development ongoing. It is primarily early stage, so actually we have now evolved as one of the leading candidates in this space, and especially a leading candidate when it comes to disease-modifying agents. What we are showing here on the screen is some of these attempts still rely on targets that have unfortunately failed in this space, like CD47, BCL2 inhibitors, and also kinase inhibitors. There is a nice fleet of new immunomodulating agents coming to this area.
Juho Jalkanen: But on top of that, we will also be delivering phase I/II data in a number of solid tumor indications. Truly exciting times ahead. Next slide, please. I would like to take this moment to look at the landscape of high-risk MDS. The absolute vacuum of new treatment options has brought a lot of pharma companies into this area. There is actually a lot of development ongoing. It is primarily early stage, so actually we have now evolved as one of the leading candidates in this space, and especially a leading candidate when it comes to disease-modifying agents. What we are showing here on the screen is some of these attempts still rely on targets that have unfortunately failed in this space, like CD47, BCL2 inhibitors, and also kinase inhibitors. There is a nice fleet of new immunomodulating agents coming to this area.
Speaker #1: So, truly exciting times ahead. Next slide, please. I would like to take this moment to look at the landscape of high-risk MDS. The absolute vacuum of new treatment options has brought a lot of pharma companies into this area.
Speaker #1: So, there is actually a lot of development ongoing. It's primarily early stage, so we have now evolved as one of the leading candidates in this space.
Speaker #1: And especially a leading candidate when it comes to disease-modifying agents. What we're showing here on the screen is that some of these attempts still rely on targets that have unfortunately failed in this space, like CD47, BCL2 inhibitors, and also kinase inhibitors.
Speaker #1: But there is a nice fleet of new immunomodulating agents coming to this area. For example, a galectin-9 inhibitor or a PI3K gamma inhibitor. So I would say now, finally, the area, the field of MDS have understood that we cannot continue giving toxic, cytopenic drugs to these patients.
Juho Jalkanen: For example, galectin-9 inhibitor or a PI3K gamma inhibitor. I would say now finally, the area, the field of MDS have understood that we cannot continue giving toxic cytopenic drugs to these patients. We need something truly disease-modifying, and we are leading this new era. Next slide, please. What really makes our drug, bexmarilimab, different, and I would say special, is what we showed is the mode of action and then the safety profile that comes with the mode of action. Again, we are not a cytotoxic agent causing anemia and neutropenia. Actually, it looks like we are making it better. Here in this slide, in gray, you can see what is expected from a safety profile for the market-leading HMA, azacitidine. When we add bexmarilimab to azacitidine, we are not actually increasing these safety issues.
Juho Jalkanen: For example, galectin-9 inhibitor or a PI3K gamma inhibitor. I would say now finally, the area, the field of MDS have understood that we cannot continue giving toxic cytopenic drugs to these patients. We need something truly disease-modifying, and we are leading this new era. Next slide, please. What really makes our drug, bexmarilimab, different, and I would say special, is what we showed is the mode of action and then the safety profile that comes with the mode of action. Again, we are not a cytotoxic agent causing anemia and neutropenia. Actually, it looks like we are making it better. Here in this slide, in gray, you can see what is expected from a safety profile for the market-leading HMA, azacitidine. When we add bexmarilimab to azacitidine, we are not actually increasing these safety issues.
Speaker #1: We need something truly disease-modifying, and we are leading this new era. Next slide, please. And what really makes our drug pexmarilimab different, and I would say special, is what we showed is the mode of action and then the safety profile that comes with the mode of action.
Speaker #1: We, again, we're not a cytotoxic agent causing anemia and neutropenia. Actually, it looks like we are making it better. So here in this slide, in gray, you can see what is expected from a safety profile for the market-leading HMA, azacitidine.
Speaker #1: But when we add pexmarilimab to ACE cytidine, we're not actually increasing these safety issues. We're actually making them better, because we are, again, one of the rare—possibly only—drugs that improves cancer cell killing while also inducing the production of healthy blood cells.
Juho Jalkanen: We are actually making them better because we are, again, one of the rare, possibly only drugs that improves cancer cell killing while also inducing the production of healthy blood cells. Next slide, please. That was the safety, and this is the efficacy. What are we looking at here? In the frontline, where patients see azacitidine also the first time, one can expect historically 16% to 17%, in recent trials up to 20% complete remission rate, and that is ultimately what you want to achieve for these patients. Complete remission is cancer is gone and blood counts are back to normal. What we have seen in our open-label phase I/II is a 45% CR rate, which is outstanding. Still, survival is pretty immature in the frontline setting, but we have just recently reported the first data cut, and we will be presenting those in upcoming medical conferences.
Juho Jalkanen: We are actually making them better because we are, again, one of the rare, possibly only drugs that improves cancer cell killing while also inducing the production of healthy blood cells. Next slide, please. That was the safety, and this is the efficacy. What are we looking at here? In the frontline, where patients see azacitidine also the first time, one can expect historically 16% to 17%, in recent trials up to 20% complete remission rate, and that is ultimately what you want to achieve for these patients. Complete remission is cancer is gone and blood counts are back to normal. What we have seen in our open-label phase I/II is a 45% CR rate, which is outstanding. Still, survival is pretty immature in the frontline setting, but we have just recently reported the first data cut, and we will be presenting those in upcoming medical conferences.
Speaker #1: Next slide, please. So that was the safety, and this is the efficacy. What are we looking at here? In the frontline, where patients see azacitidine also for the first time, one can expect historically 16% to 17%, and in recent trials up to 20% complete remission rate.
Speaker #1: And that's ultimately what you want to achieve for these patients. Complete remission is, the cancer is gone and blood counts are back to normal. What we've seen in our open-label Phase 1/2 is a 45% CR rate, which is outstanding.
Speaker #1: Still, survival is pretty mature in the front-line setting, but we have just recently reported the first data cut, and we will be presenting those at upcoming medical conferences.
Speaker #1: Now, in the last lines, and in the relapsing, refractory setting where nothing seems to work, salvage treatment usually only brings five to six months of median survival.
Juho Jalkanen: Now, in the last line setting, the relapsed/refractory setting where nothing seems to work, salvage treatment only usually brings 5 to 6 months of median survival. We are expecting to double that. Again, sustainable benefit for patients. Next slide, please. We are entering late-stage development. We have further strengthened our team during H1. Chief Technical Officer, Mr. Heikki Jouttijärvi, has started with decades of experience bringing drugs to market from a supply chain and manufacturing perspective. Just as important as the clinical trials are, is the manufacturing of the drug and preparing it for Marketing approval. We have partnered up with Parexel, a world-leading global contract research organization, to deliver the phase IIb. We are very happy with this partnership, and it has gone off to a good start. On the business development side, we have further strengthened our team with George Golumbeski joining our board.
Juho Jalkanen: Now, in the last line setting, the relapsed/refractory setting where nothing seems to work, salvage treatment only usually brings 5 to 6 months of median survival. We are expecting to double that. Again, sustainable benefit for patients. Next slide, please. We are entering late-stage development. We have further strengthened our team during H1. Chief Technical Officer, Mr. Heikki Jouttijärvi, has started with decades of experience bringing drugs to market from a supply chain and manufacturing perspective. Just as important as the clinical trials are, is the manufacturing of the drug and preparing it for Marketing approval. We have partnered up with Parexel, a world-leading global contract research organization, to deliver the phase IIb. We are very happy with this partnership, and it has gone off to a good start. On the business development side, we have further strengthened our team with George Golumbeski joining our board.
Speaker #1: We are expecting to double that. So again, sustainable benefit for patients. Next slide, please. So, we're entering late-stage development. We have further strengthened our team during H1. Chief Technical Officer, Mr. Heikki Jouti, has started.
Speaker #1: We have decades of experience bringing drugs to market from a supply chain and manufacturing perspective. Just as important as the clinical trials are, is the manufacturing of the drug and preparing it for marketing approval.
Speaker #1: We have partnered up with Paracel, a world-leading global contract research organization, to deliver the Phase 2B. We are very happy with this partnership, and it has gotten off to a good start.
Speaker #1: Then, on the business development side, we have further strengthened our team with George Golumbevsky joining our Board. He brings decades of experience from business development across the industry.
Juho Jalkanen: He brings decades of experience from business development across the industry. We are extremely happy with our team. Next slide, please. Recently, what is now coming up then? We have announced that the BLAZE study in checkpoint refractory lung and melanoma has gained regulatory approval. Also, the BEXAR study in soft tissue sarcoma has gained regulatory approval. The FINPROVE study in breast cancer will not be proceeding. It will require a standalone study, and we are focusing our resources on our main MDS program instead on putting together a standalone study for breast cancer. AML study BEXMAB is also progressing, and currently in protocol development is the further relapsed refractory MDS study with the City of Hope with oral HMA, the newcomer to the area. Rather vast pipeline producing a lot of new data for such a small company. Next slide, please.
Juho Jalkanen: He brings decades of experience from business development across the industry. We are extremely happy with our team. Next slide, please. Recently, what is now coming up then? We have announced that the BLAZE study in checkpoint refractory lung and melanoma has gained regulatory approval. Also, the BEXAR study in soft tissue sarcoma has gained regulatory approval. The FINPROVE study in breast cancer will not be proceeding. It will require a standalone study, and we are focusing our resources on our main MDS program instead on putting together a standalone study for breast cancer. AML study BEXMAB is also progressing, and currently in protocol development is the further relapsed refractory MDS study with the City of Hope with oral HMA, the newcomer to the area. Rather vast pipeline producing a lot of new data for such a small company. Next slide, please.
Speaker #1: We are extremely happy with our team. Next slide, please. So, recently, what's now coming up then? We have announced that the BLASE study in checkpoint refractory lung and melanoma has gained regulatory approval, and also the Bexar study in soft tissue sarcoma has gained regulatory approval. The FINPROOF study in breast cancer will not be proceeding; it will require a standalone study, and we are focusing our resources on our main MDS program instead of putting together a standalone study for breast cancer.
Speaker #1: The AML study, BeamX, is also progressing and currently in protocol development is the further relapsed/refractory MDS study with City of Hope with oral HMA.
Speaker #1: The newcomer to the area. So, a rather vast pipeline producing a lot of new data for such a small company. Next slide, please. But what can our audience and investors look for in H2?
Juho Jalkanen: What can our audience and investors look for H2? As said, we just did the first data cut for the survival readout in the frontline high-risk MDS population. It is trending good. We will report further follow-up data in upcoming conferences, and this is why this data cut was performed. Also, in upcoming major conference, we will be reporting actual, more mature, further data from the first in-human BEXMAB in solid tumor trial, and also how our trials progress in solid tumors. The scientific foundation of CLEVER-1 continues to strengthen and broaden during the second half. Next slide, please. What can one anticipate further from a news flow? There will now in H2 be a series of first patient in announcements from a number of these trials. There will be further follow-up data from our existing trials.
Juho Jalkanen: What can our audience and investors look for H2? As said, we just did the first data cut for the survival readout in the frontline high-risk MDS population. It is trending good. We will report further follow-up data in upcoming conferences, and this is why this data cut was performed. Also, in upcoming major conference, we will be reporting actual, more mature, further data from the first in-human BEXMAB in solid tumor trial, and also how our trials progress in solid tumors. The scientific foundation of CLEVER-1 continues to strengthen and broaden during the second half. Next slide, please. What can one anticipate further from a news flow? There will now in H2 be a series of first patient in announcements from a number of these trials. There will be further follow-up data from our existing trials.
Speaker #1: So, as said, we just did the first data cut for the survival readout in the front-line, high-risk MDS population. It’s trending well. We will report further follow-up data at upcoming conferences, and this is why this data cut was performed.
Speaker #1: Also, in an upcoming major conference, we will be reporting actual, more mature, further data from the first-in-human MATINS solid tumor trial, and also how our trials progress in solid tumors.
Speaker #1: So, the scientific foundation of Clever One continues to strengthen and broaden during the second half. Next slide, please. So, what can one anticipate further from a news flow?
Speaker #1: There will now, in H2, be a series of first-patient-in announcements from a number of these trials. There will also be further follow-up data from our existing trials.
Speaker #1: But then comes the most exciting year, 2027, when a lot of this data will be coming out from these trials. So very exciting times ahead.
Juho Jalkanen: Then comes the most exciting year, 2027, when a lot of this data will be coming out from these trials. Very exciting times ahead. We have worked extremely hard during H1 to get these trials starting, and now they are starting. I couldn't be more excited. Next slide, please. Next we will give the floor to our Chief Financial Officer, Jurriaan, to talk about the financial results.
Juho Jalkanen: Then comes the most exciting year, 2027, when a lot of this data will be coming out from these trials. Very exciting times ahead. We have worked extremely hard during H1 to get these trials starting, and now they are starting. I couldn't be more excited. Next slide, please. Next we will give the floor to our Chief Financial Officer, Jurriaan, to talk about the financial results.
Speaker #1: We've worked extremely hard during H1 to get these trials starting. Now they are starting, and I couldn't be more excited. Next slide, please. So next, we will give the floor to our Chief Financial Officer, Yurian, to talk about the financial results.
Speaker #2: Thank you. I'll present our financial results for the first half of 2026. The first six months of the year have been transformational for Faron from a financial perspective.
Jurriaan Dekkers: Thank you, Juho. I will present our financial results for the first half of 2026. The first six months of the year have been transformational for Faron from a financial perspective. We significantly strengthened our balance sheet through the successful completion of a fully covered rights issue, providing the resources needed to execute our clinical development strategy and advance BEX into its next major milestones. Our financial performance reflects continued disciplined cost management while maintaining strong focus on value-generating clinical activities. Most importantly, we now have the funding necessary to support the phase IIb BEXERA clinical trial and also support our IITs and reach key data readouts expected in 2027. Next slide, please. During the first half of 2026, we substantially strengthened our financial position through the successful completion of our rights offering. The transaction generated gross proceeds of approximately EUR 40 million and net proceeds of approximately EUR 32.8 million.
Jurriaan Dekkers: Thank you, Juho. I will present our financial results for the first half of 2026. The first six months of the year have been transformational for Faron from a financial perspective. We significantly strengthened our balance sheet through the successful completion of a fully covered rights issue, providing the resources needed to execute our clinical development strategy and advance BEX into its next major milestones. Our financial performance reflects continued disciplined cost management while maintaining strong focus on value-generating clinical activities. Most importantly, we now have the funding necessary to support the phase IIb BEXERA clinical trial and also support our IITs and reach key data readouts expected in 2027. Next slide, please.
Speaker #2: We significantly strengthened our balance sheet through the successful completion of a fully covered rights issue, providing the resources needed to execute our clinical development strategy.
Speaker #2: And advanced BEX into its next major milestones. Our financial performance reflects continued, disciplined cost management while maintaining strong focus on value-generating clinical activities. Most importantly, we now have the funding necessary to support the Phase 2 BEXERA clinical trial and also support our IITs, and reach key data readouts expected in 2027.
Speaker #2: Next slide, please. During the first half of 2026, we substantially strengthened our financial position through the successful completion of our rights offering. The transaction generated gross proceeds of approximately €40 million and net proceeds of approximately €32.8 million.
Jurriaan Dekkers: During the first half of 2026, we substantially strengthened our financial position through the successful completion of our rights offering. The transaction generated gross proceeds of approximately EUR 40 million and net proceeds of approximately EUR 32.8 million. As a result, our cash position increased to EUR 32 million at the end of June 2026, compared with EUR 13.5 million at the same time last year. Importantly, we are now funded through the expected Phase 2b BEXERA readout in 2027 and several other important milestones across our development program. Operating loss for the period was EUR 11.1 million, broadly in line with the EUR 11.8 million operating loss reported in the H1 of 2025.
Speaker #2: As a result, our cash position increased to €32 million at the end of June 2026, compared with €13.5 million at the same time last year.
Jurriaan Dekkers: As a result, our cash position increased to EUR 32 million at the end of June 2026, compared with EUR 13.5 million at the same time last year. Importantly, we are now funded through the expected Phase 2b BEXERA readout in 2027 and several other important milestones across our development program. Operating loss for the period was EUR 11.1 million, broadly in line with the EUR 11.8 million operating loss reported in the H1 of 2025. This reflects our continuous focus on responsible capital allocation while advancing our clinical development program. Our balance sheet has also improved significantly with net assets of EUR 11.6 million at the end of June 2026, compared with negative net assets of EUR 16.7 million one year earlier. Overall, we believe these results demonstrate both financial discipline and our ability to secure the capital required to execute on a strategy and create long-term shareholder value. Next slide, please.
Speaker #2: Importantly, we are now funded through the expected Phase II BEXERA readout in 2027, and several other important milestones across our development program. Operating loss for the period was €11.1 million, broadly in line with the €11.8 million operating loss reported in the first half of 2025.
Speaker #2: This reflects our continuous focus on responsible capital allocation and advancing our clinical development program. Our balance sheet has also improved significantly, with net assets of €11.6 million at the end of June 2026, compared with negative net assets of €16.7 million one year earlier.
Jurriaan Dekkers: This reflects our continuous focus on responsible capital allocation while advancing our clinical development program. Our balance sheet has also improved significantly with net assets of EUR 11.6 million at the end of June 2026, compared with negative net assets of EUR 16.7 million one year earlier. Overall, we believe these results demonstrate both financial discipline and our ability to secure the capital required to execute on a strategy and create long-term shareholder value. Next slide, please.
Speaker #2: Overall, we believe these results demonstrate both financial discipline and our ability to secure the capital required to execute on our strategy and create long-term shareholder value.
Speaker #2: Next slide, please. Turning to the events in the reporting period thereafter: On the 1st of July, the Board confirmed the grant of approximately 2.2 million options under the Company 2026 Share Option Plan.
Jurriaan Dekkers: Turning to events after the reporting periods. On 1 July, the board confirmed the grant of approximately 2.2 million options under the company 2026 share option plan. These awards are intended to support employee retention and align incentives with long-term shareholder value creation. On 3 August, the company approved the exercise of 3.6 million special rights. This was completed in connection with the scheduled amortization payment of the first and second tranche convertible bonds. As of August 2026, Faron had 227.8 million ordinary shares outstanding, of which 25 million shares were held in treasury. In summary, Faron enters the H2 of 2026 with a strengthened capital position, funding secured through the key value inflection points, and a clear focus on delivering the next important clinical milestones for BEX.
Jurriaan Dekkers: Turning to events after the reporting periods. On 1 July, the board confirmed the grant of approximately 2.2 million options under the company 2026 share option plan. These awards are intended to support employee retention and align incentives with long-term shareholder value creation. On 3 August, the company approved the exercise of 3.6 million special rights. This was completed in connection with the scheduled amortization payment of the first and second tranche convertible bonds. As of August 2026, Faron had 227.8 million ordinary shares outstanding, of which 25 million shares were held in treasury. In summary, Faron enters the H2 of 2026 with a strengthened capital position, funding secured through the key value inflection points, and a clear focus on delivering the next important clinical milestones for BEX.
Speaker #2: These awards are intended to support employee retention and align incentives with long-term shareholder value creation. On the 3rd of August, the company approved the exercise of 3.6 million special rights.
Speaker #2: This was completed in connection with the scheduled amortization payment of the first and second tranche convertible bonds. As of August 2026, Faron had 227.8 million ordinary shares outstanding, of which 25 million shares were held in treasury.
Speaker #2: So, in summary, Faron enters the second half of 2026 with a strengthened capital position, funding secured through the key value inflection points, and a clear focus on delivering the next important clinical milestones for BEX.
Speaker #1: Thank you, Yurian. Then to some key conclusions before Q&A. Next slide, please. So, we just want to recap. First of all, large underserved market opportunity in high-risk MDS.
Juho Jalkanen: Thank you, Jurriaan. Then to some key conclusions before Q&A. Next slide, please. We just want to recap. First of all, large underserved market opportunity in high-risk MDS with best-in-class efficacy seen to date, with actually one of the worst of most severe populations reported. This is thanks to, I would say, our unique differentiated mode of action and safety profile, which is exactly what these patients need. This gives us an open window to be the leading asset in development for high-risk MDS, and we are funded to deliver the next significant catalyst. Thank you. Next slide, and questions, please.
Juho Jalkanen: Thank you, Jurriaan. Then to some key conclusions before Q&A. Next slide, please. We just want to recap. First of all, large underserved market opportunity in high-risk MDS with best-in-class efficacy seen to date, with actually one of the worst of most severe populations reported. This is thanks to, I would say, our unique differentiated mode of action and safety profile, which is exactly what these patients need. This gives us an open window to be the leading asset in development for high-risk MDS, and we are funded to deliver the next significant catalyst. Thank you. Next slide, and questions, please.
Speaker #1: With best-in-class efficacy seen to date, with actually one of the worst, most severe populations reported. And this is thanks to, I would say, our unique, differentiated mode of action and safety profile, which is exactly what these patients need.
Speaker #1: This gives us an open window to be the leading asset in development for high-risk MDS, and we are funded to deliver the next significant catalyst.
Speaker #1: Thank you. Next slide. Any questions, please?
Speaker #3: Thank you for the excellent presentation. Let's go to the first question. BEXERA hasn't started yet. What's actually left to do before the first patient is in?
Operator: Thank you for the excellent presentation. Let's go for the first question. BEXERA hasn't started yet. What's actually left to do before first patient is in, and are you still confident to have first patient in this year?
[Company Representative] (Faron Pharmaceuticals): Thank you for the excellent presentation. Let's go for the first question. BEXERA hasn't started yet. What's actually left to do before first patient is in, and are you still confident to have first patient in this year?
Speaker #3: And are you still confident to have the first patient in this year?
Speaker #1: We are very confident. We are well on track. We have completed country and site selection and feasibility. All regulatory submissions to the regions—being USA, Europe, and UK—have been submitted.
Juho Jalkanen: We are very confident. We are well on track. We have completed country and site selection and feasibility. All regulatory submissions to the regions, being USA, Europe, and UK, have been submitted. We are very well on track to deliver the first patient in.
Juho Jalkanen: We are very confident. We are well on track. We have completed country and site selection and feasibility. All regulatory submissions to the regions, being USA, Europe, and UK, have been submitted. We are very well on track to deliver the first patient in.
Speaker #1: So we are very well on track to deliver the first patient in.
Speaker #3: Thank you. And as a follow-up question to that, is there something you can tell us about enrollment or expectations for enrollment?
Operator: Thank you. As a follow-up question for that, is there something that you can tell us about enrollment or expectations for the enrollment?
[Company Representative] (Faron Pharmaceuticals): Thank you. As a follow-up question for that, is there something that you can tell us about enrollment or expectations for the enrollment?
Speaker #1: Again, we expect enrollment to be completed around the beginning of August, allowing for the CR to mature so that we will be doing the data cut and readout for November 27.
Juho Jalkanen: Again, we expect enrollment to be completed around beginning of August, allowing for the CR to mature so that we will be doing the data cut and readout for 27 November.
Juho Jalkanen: Again, we expect enrollment to be completed around beginning of August, allowing for the CR to mature so that we will be doing the data cut and readout for 27 November.
Speaker #3: Thank you. Then, for the next question: what are the actual goal or no-go milestones for Bexera that investors should track?
Operator: Thank you. For the next question, what are the actual go or no-go milestones for BEXERA that investors should track?
[Company Representative] (Faron Pharmaceuticals): Thank you. For the next question, what are the actual go or no-go milestones for BEXERA that investors should track?
Speaker #1: So BEXERA itself is a very compact, straightforward study. So there will be no interim; it's the actual readout that will be coming in late 2027.
Juho Jalkanen: BEXERA itself is a very compact, straightforward study, so there will be no interim. It is the actual readout that will be coming in late 2027. For that readout to look out for and the no-go, go decisions are based on the primary endpoint CR readout. Then with the CR readout, that will give us insight on the effect size, how big is the effect size against the comparator single-agent AZA. The most important information from that will be the size of the phase III then. Also, then very importantly, we will be confirming the phase III endpoint with the FDA at that moment, and also depending on the effect size, again, how high is our CR rate compared to the control CR rate is the question that should RR MDS, the last line population which have no options available, should Accelerated Approval be considered in that area.
Juho Jalkanen: BEXERA itself is a very compact, straightforward study, so there will be no interim. It is the actual readout that will be coming in late 2027. For that readout to look out for and the no-go, go decisions are based on the primary endpoint CR readout. Then with the CR readout, that will give us insight on the effect size, how big is the effect size against the comparator single-agent AZA. The most important information from that will be the size of the phase III then. Also, then very importantly, we will be confirming the phase III endpoint with the FDA at that moment, and also depending on the effect size, again, how high is our CR rate compared to the control CR rate is the question that should RR MDS, the last line population which have no options available, should Accelerated Approval be considered in that area.
Speaker #1: For that readout, look out for the go and no-go decisions, which are based on the primary endpoint CR readout. Then, with the CR readout, that will give us insight on the effect size—how big is the effect size against the comparator, single-agent ASA.
Speaker #1: So, the most important information from that will be the size of the phase three, then. Also, then very importantly, will be confirming the phase three endpoint with the FDA at that moment.
Speaker #1: And also, depending on the effect size—again, how high is the RCR rate compared to the control CR rate—there is the question of whether RRMDS, the last-line population with no options available, should have accelerated approval considered in that area.
Speaker #1: But that's a separate discussion to be had with the FDA.
Juho Jalkanen: That is a separate discussion to be had with the FDA.
Juho Jalkanen: That is a separate discussion to be had with the FDA.
Speaker #3: Thank you. With Parexel now on board, does that change the cost or timeline of BEXERA?
Operator: Thank you. With Parexel now on board, does that change the cost or timeline of BEXERA?
[Company Representative] (Faron Pharmaceuticals): Thank you. With Parexel now on board, does that change the cost or timeline of BEXERA?
Speaker #1: It doesn't change the cost. Actually, we have I cannot elaborate too much, but if we have a risk sharing based agreement where with a certain amount of money, we are aiming to hit the enrollment and readout.
Juho Jalkanen: It does not change the cost. Actually, we have, I cannot elaborate too much, but we have a risk-sharing based agreement where with a certain amount of money, we are aiming to hit the enrollment and readout, so we are in a sense, in a way capping it. Again, with a large global organization like Parexel, we believe in fast delivery, fast and strong delivery. Again, we will be on time and on cost.
Juho Jalkanen: It does not change the cost. Actually, we have, I cannot elaborate too much, but we have a risk-sharing based agreement where with a certain amount of money, we are aiming to hit the enrollment and readout, so we are in a sense, in a way capping it. Again, with a large global organization like Parexel, we believe in fast delivery, fast and strong delivery. Again, we will be on time and on cost.
Speaker #1: So we're, in a sense, in a way, capping it. And again, with a large global organization like Parexel, we believe in fast delivery—fast and strong delivery.
Speaker #1: So we, again, will be on time and on cost.
Speaker #3: Thank you. Your cash runway guidance is until Q4 next year. What assumptions sit behind that, and what would move it?
Operator: Thank you. Your cash runway guidance is until Q4 next year. What assumptions sit behind that and what would move it?
[Company Representative] (Faron Pharmaceuticals): Thank you. Your cash runway guidance is until Q4 next year. What assumptions sit behind that and what would move it?
Speaker #2: Yeah, so I guess one I guess one based on the forecast, the current forecast of management of our clinical trial expenditure. So principally our BEXERA cost.
Jurriaan Dekkers: Yes. Our cash runway
Jurriaan Dekkers: Yes. Our cash runway
Juho Jalkanen: Go ahead, please, go ahead.
Juho Jalkanen: Go ahead, please, go ahead.
Jurriaan Dekkers: based on the current forecast of management of our clinical trial expenditure, so principally our BEXERA cost, our operating cost, and the expected timing of the cash flows. Good to know that our cash runway does not assume any additional cash flow from new financing income from potential partnerships and related milestone payments. Faster than planned BEXERA enrollments, unplanned IT support or non-dilutive income, for example, from partnership, are examples of factors that could impact the cash runway.
Jurriaan Dekkers: based on the current forecast of management of our clinical trial expenditure, so principally our BEXERA cost, our operating cost, and the expected timing of the cash flows. Good to know that our cash runway does not assume any additional cash flow from new financing income from potential partnerships and related milestone payments. Faster than planned BEXERA enrollments, unplanned IT support or non-dilutive income, for example, from partnership, are examples of factors that could impact the cash runway.
Speaker #2: Our operating cost and the expected timing of the cash flows. And good to know that our cash runway does not assume any additional cash flow from new financing, income from potential partnerships, and related milestone payments.
Speaker #2: And faster than planned BEXERA enrollment, unplanned IoT support, or non-dilutive income, for example from a partnership, are examples of factors that could impact the cash runway.
Speaker #3: Thank you. Then the next one. Q&A expenses fell. Was this a result of the cost savings program and tight budget control, or where did this reduction come from?
Operator: Thank you. Then the next one. G&A expenses fell. Was this a result of cost savings program and tight budget control, or where did this reduction came from?
[Company Representative] (Faron Pharmaceuticals): Thank you. Then the next one. G&A expenses fell. Was this a result of cost savings program and tight budget control, or where did this reduction came from?
Jurriaan Dekkers: Well, G&A in the H1 of 2025 was impacted by EUR 1.3 million non-recurring consulting costs relating to our convertible bonds. Beyond that, we've maintained discipline on our overall cost and our G&A spend in general, and we haven't announced a formal named restructuring or saving plan.
Jurriaan Dekkers: Well, G&A in the H1 of 2025 was impacted by EUR 1.3 million non-recurring consulting costs relating to our convertible bonds. Beyond that, we've maintained discipline on our overall cost and our G&A spend in general, and we haven't announced a formal named restructuring or saving plan.
Speaker #2: Yeah, Gina, in the first half of 2025, we were impacted by €1.3 million in non-recurring consulting costs related to our convertible bonds. But beyond that, we've maintained discipline on our overall costs and our G&A spend in general.
Speaker #2: And we haven't announced a formal name for the restructuring or savings plan.
Speaker #3: Thank you. The BEXMAP frontline data shows an 85% response rate, a 45% complete remission rate, and 16 months of duration for complete response. Why should investors trust that this holds up in a randomized trial?
Operator: Thank you. The BEXMAB frontline data shows 85% response rate, 45% complete remission rate, and 60 months of duration for complete response. Why should investors trust that this holds up in a randomized trial?
[Company Representative] (Faron Pharmaceuticals): Thank you. The BEXMAB frontline data shows 85% response rate, 45% complete remission rate, and 60 months of duration for complete response. Why should investors trust that this holds up in a randomized trial?
Speaker #1: It is again me. As a physician scientist, what is very convincing to us and our investigators is what we see happen in the bone marrow of these patients.
Juho Jalkanen: It is, again, me as a physician scientist, what is very convincing to us and our investigators is what we see happen in the bone marrow of these patients. Again, not just killing cancer, but actually enhancing the production of healthy blood cells. Majority of these patients becoming transfusion-independent, majority of these patients achieving MRD negativity, so no minimal residual disease, no disease to be measured, blood counts back to normal. Again, it is very convincing, but actually the most convincing thing, again, what we believe and our investigators believe is the most important thing is the last line efficacy and the last line survival benefit. It is, again, some of the strongest data seen in this, and not that many of these drugs that have been trialed in high-risk MDS actually had that good last line results.
Juho Jalkanen: It is, again, me as a physician scientist, what is very convincing to us and our investigators is what we see happen in the bone marrow of these patients. Again, not just killing cancer, but actually enhancing the production of healthy blood cells. Majority of these patients becoming transfusion-independent, majority of these patients achieving MRD negativity, so no minimal residual disease, no disease to be measured, blood counts back to normal. Again, it is very convincing, but actually the most convincing thing, again, what we believe and our investigators believe is the most important thing is the last line efficacy and the last line survival benefit. It is, again, some of the strongest data seen in this, and not that many of these drugs that have been trialed in high-risk MDS actually had that good last line results.
Speaker #1: So again, not just killing cancer, but actually enhancing the production of healthy blood cells majority of these patients becoming transfusion independent majority of these patients achieving MRD negativity.
Speaker #1: So, no minimal residual disease, no disease to be measured, blood counts back to normal. Again, it is very convincing. But actually, the most convincing thing—and what we believe, and our investigators believe, is the most important—is the last-line efficacy.
Speaker #1: And the last-line survival benefit—so it is again some of the strongest data seen in this. And not that many of these drugs that have been trialed in high-risk MDS actually had that good last-line results.
Speaker #1: So, the last line of results is actually what stands out here.
Juho Jalkanen: The last line results is actually what stands out here.
Juho Jalkanen: The last line results is actually what stands out here.
Speaker #3: Thank you. How many patients have now been dosed with BEX in total, and does that population size support the safety profile?
Operator: Thank you. How many patients have now been dosed with BEX in total, and does that population size support the safety profile?
[Company Representative] (Faron Pharmaceuticals): Thank you. How many patients have now been dosed with BEX in total, and does that population size support the safety profile?
Speaker #1: Yes, it does, actually. So, almost 300 patients have now been dosed with BEX, and the safety profile is very robust—solid, no surprises.
Juho Jalkanen: Yes, it does actually. Almost 300 patients have now been dosed with BEX, and the safety profile is very robust, solid, no surprises. It is constantly giving the same signal. We are very happy with the safety profile. Again, close to 300 patients have been treated with the drug already.
Juho Jalkanen: Yes, it does actually. Almost 300 patients have now been dosed with BEX, and the safety profile is very robust, solid, no surprises. It is constantly giving the same signal. We are very happy with the safety profile. Again, close to 300 patients have been treated with the drug already.
Speaker #1: It's constantly giving the same signal, so we are very happy with the safety profile. And again, close to 300 patients have been treated with the drug already.
Speaker #3: Thank you. What is Faron's actual financial exposure to the IIT portfolio compared to BEXMAB?
Operator: Thank you. What is Faron's actual financial exposure to the IIT portfolio compared to BEXERA?
[Company Representative] (Faron Pharmaceuticals): Thank you. What is Faron's actual financial exposure to the IIT portfolio compared to BEXERA?
Speaker #1: It is actually very minimal. So the far majority of our finances goes to the MDS program, the lead program. To give a ballpark, basically these IITs take one-tenth of what an actual sponsored trial takes.
Juho Jalkanen: It is actually very minimal. The far majority of our finances goes to the MDS program, the lead program. To give a ballpark, basically these IITs take one-tenth of what actual sponsored trial takes.
Juho Jalkanen: It is actually very minimal. The far majority of our finances goes to the MDS program, the lead program. To give a ballpark, basically these IITs take one-tenth of what actual sponsored trial takes.
Speaker #3: Thank you. Then one final question: What complete remission delta over ASA alone would you consider as a clear win?
Operator: Thank you. Then one final question. What complete remission delta over AZA alone would you consider as a clear win?
[Company Representative] (Faron Pharmaceuticals): Thank you. Then one final question. What complete remission delta over AZA alone would you consider as a clear win?
Juho Jalkanen: A 10% improvement. Based on the current data, what we would like to see and which would be amazing, that we double the CR rate. That would be, again, absolutely amazing. That is what we are aiming for. We will be very happy, and again, a go, no-go decision is if we improve the CR rate by 10%. Let us say if AZA is 16%, we are 26%. If AZA is 18%, we are 28%.
Juho Jalkanen: A 10% improvement. Based on the current data, what we would like to see and which would be amazing, that we double the CR rate. That would be, again, absolutely amazing. That is what we are aiming for. We will be very happy, and again, a go, no-go decision is if we improve the CR rate by 10%. Let us say if AZA is 16%, we are 26%. If AZA is 18%, we are 28%.
Speaker #1: At 10% improvement. So, based on the current data, what we would like to see, and which would be amazing, is that we double the CR rate.
Speaker #1: But that would be, again, absolutely amazing. That's what we're aiming for, but we would be very happy—and again, our go/no-go decision is if we improve the CR rate by 10%.
Speaker #1: So, let's say if ASA is 16, we are 26. If ASA is 18, we are 28.
Speaker #3: Thank you. That was the last final question.
Operator: Thank you, Tapaswa. Last final question.
[Company Representative] (Faron Pharmaceuticals): Thank you, Tapaswa. Last final question.
Speaker #1: Thank you, everybody. Thank you for joining the H1 webcast. We look forward to keeping you up to date on our progress, and again, data generation starts from here.
Juho Jalkanen: Thank you, everybody. Thank you for joining the H1 webcast. We look forward to keeping you up to date on our progress. Data generation starts from here. Exciting times ahead. Have a good day.
Juho Jalkanen: Thank you, everybody. Thank you for joining the H1 webcast. We look forward to keeping you up to date on our progress. Data generation starts from here. Exciting times ahead. Have a good day.

