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. 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 first half. Next slide, please. First and foremost, there may be some newcomers to the story, so short introduction on Faron and high-risk MDS.
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 U.S. and main EU countries. Faron's bexmarilimab is a first-in-class anti-Clever-1 antibody.
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 anti-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.
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 II-B 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 II-B readout.
But on top of that, we will also be delivering phase I/II data in a number of solid tumor indications. 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. So there is actually a lot of development ongoing. It's 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're showing here on the screen is some of these attempts still rely on targets that have unfortunately failed in this space, like CD47, BCL-2 inhibitors, and also kinase inhibitors.
But there is a nice fleet of new immunomodulating agents coming to this area, for example, 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. We need something truly disease-modifying, and we are leading this new era. Next slide, please. And 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'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.
But when we add bexmarilimab to azacitidine, 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. 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 the first time, one can expect historically 16%-17%. In recent trials, up to 20% complete remission rate, and that's ultimately what you want to achieve for these patients. Complete remission is cancer is gone and blood counts are back to normal. What we've seen in our open label phase I/II is a 45% CR rate, which is outstanding.
Still, survival is pretty mature in the frontline setting, but we have just recently reported the first data cut, and we will be presenting those in upcoming medical conferences. Now, in the last line setting, the relapse refractory setting where nothing seems to work, salvage treatment only usually brings five to six months of median survival. 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 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 II-B.
We are very happy with this partnership, and it has gone off to a good start. Then on the business development side, we have further strengthened our team with George Golumbeski joining our board. He brings decades of experience from business development across the industry. We are extremely happy with our team. Next slide, please. Recently, what's 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 BEAM-X is also progressing and currently in protocol development is the further relapse refractory MDS study with the City of Hope with oral HMA, the newcomer to the area. So rather vast pipeline producing a lot of new data for such a small company. Next slide, please. What can our audience and investors look for H2? As I said, we just did the first data cut for the survival readout in the frontline high-risk MDS population. It's 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 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, 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. We've 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.
Thank you, Juho. 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. 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 BEXERA 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 II 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.
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 II-B 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 first half 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.
Turning the events to the reporting periods after. On July 1, 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 August 3, 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 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.
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 off, 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. Questions please.
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? Are you still confident to have first patient in this year?
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 U.S.A., Europe, and U.K., have been submitted. So we are very well on track to deliver the first patient in.
Thank you. As a follow-up question for that, is there something that you can tell us about enrollment or expectations for the enrollment?
Again, we expect enrollment to be completed around beginning of August, allowing for then the CR to mature so that we will be doing the data cut and readout for November 2027.
Thank you. For the next question, what are the actual go or no-go milestones for BEXERA that investors should track?
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. For that readout to look out for, 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'll 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 our MDS, the last line population which have no options available, should accelerated approval be considered in that area?
But that's a separate discussion to be had with the FDA.
Thank you. With Parexel now on board, does that change the cost or timeline of BEXERA?
It doesn't 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're 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.
Thank you. Your cash runway guidance is until Q4 next year. What assumptions sit behind that, and what would move it?
Yes. Our cash runway—
Go ahead.
Based on the forecast, 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 enrollment, unplanned IIT support, or non-dilutive income, for example, from partnership, are examples of factors that could impact the cash runway.
Thank you. Then the next one. G&A expenses fell. Was this the result of cost savings program and tight budget control, or where did this reduction came from?
G&A in the first half of 2025 was impacted by EUR 1.3 million non-recurring consulting costs relating to our convertible bond. But beyond that, we have maintained discipline on our overall cost and our G&A spend in general, and we have not announced a formal named restructuring or saving plan.
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?
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. 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, 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. 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.
The last line results is actually what stands out here.
Thank you. How many patients have now been dosed with bexmarilimab in total, and does that population size support the safety profile?
Yes, it does, actually. Almost 300 patients have now been dosed with bexmarilimab, and the safety profile is very robust, solid, no surprises. It's constantly giving the same signal, so we are very happy with the safety profile. Again, close to 300 patients have been treated with the drug already.
Thank you. What's Faron's actual financial exposure to the IIT portfolio compared to BEXERA?
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 actual sponsored trial takes.
Thank you. Then one final question. What complete remission delta over AZA alone would you consider as a clear win?
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's what we're aiming for. We will be very happy, and again, a go, no go decision is if we improve the CR rate by 10%. Let's say if AZA is 16%, we are 26%. If AZA is 18%, we are 28%.
Thank you. That was the last final question.
Thank you, everybody. Thank you for joining the H1 webcast. We look forward to keeping you up to date on our progress. Again, data generation starts from here. Exciting times ahead. Have a good day.