Hello, everyone. Welcome to the Faron Pharmaceuticals annual results webcast for 2025.

My name is Juho Jalkanen, the CEO of the company. Here with me today our new CFO, Jurriaan.

Hi. My name is Jurriaan Dekkers.

I started as CFO on the 1st of December 2025, replacing Yrjö who decided to retire by the end of March this year. I've been working in different global, regional, and local finance roles over the last 25 years with a focus on healthcare and biotech.

My last role was at ProQR Therapeutics, CFO of a Dutch-based, Nasdaq-listed company. Before that, I've been working at AstraZeneca, CFO in the Netherlands, but also for Astellas Pharma and DaVita Medical Group.

Together with my wife, I have two daughters, and I enjoy sailing a lot.

Thank you, Jurriaan. All right, everybody.

Great to be here with you today. I think we have some fabulous results to go over for the past year.

We will be making forward-looking statements also into the future, our basic disclaimer. On today's agenda, I'll be taking you first on the main events of the year.

Jurriaan will cover the financial results, and then into the outlook and Q&A. First of all, '25 has been a remarkable year for us, putting us in a leading position in the treatment of high-risk MDS.

We have delivered outstanding clinical results in both frontline and last-line populations with deep and durable complete remissions and transfusion independence. This translates to significant, long-lasting patient benefit.

Actually, looking back at our dataset, we have been treating a very severely ill population with a high risk score, even highlighting these results further. Meanwhile, unfortunately, some of our competitors in this space have unfortunately failed, making us now a leading candidate for this indication.

In the second half of this year, we had a successful end-of-Phase 2 meeting with the FDA setting us moving into a Phase 2/3 trial in the frontline setting. Ultimately, what the FDA wants us to answer is bex plus aza against aza and placebo in a blinded manner, the ultimate test for a drug for approval.

With our differentiated biology and despite the setbacks in the field, with our differentiated development plan which we will go through in more detail, we believe we are positioned for success. We have been doing this all with a solid cash position, even repaying our IPF debt facility in a challenging equity market for biotechs.

Truly a strong year of performance in some challenging times. Talking about flying the airplane, we have been building the airplane while we fly it, strengthening both our board and management team.

As Jurriaan mentioned, we want to thank our longtime CFO, a true Faronian, Mr. Yrjö Wichmann, who actually will be here with us today handling the Q&A, and welcoming Jurriaan in his position.

Then we've strengthened the management board and our BD team with Wraith Hughes, former Pfizer, Mundipharma, and PharmaVentures, and to our board, an absolutely marvelous chap, Colin Bond, a big heavyweight. Truly a great team taking the company further.

Let's then go in more detail on the events, especially the clinical and regulatory events of the year. We started the year in January by completing the enrollment of the BEXMAB Phase 1/2 open-label trial, then received orphans from EMA and FDA.

Fast track had already been given previous year. After completing enrollment, some 3 months later you start seeing the responses.

Topline was reported in April and then presented back-to-back in oral sessions at ASCO and EHA. Last-line response rate 63%, survival at 13.4 months; frontline response rate 72% and CR rate at 28%.

We actually hit exactly our mark cuz at this similar stage our closest competitor venetoclax, a BCL-2 inhibitor, had 75% ORR and 29% CR before moving into their Phase 3 trial. What we actually saw over the year is that already at EHA, there's more happening in the new frontline population: ORR increased first, but later on our CR, complete remission, kept on increasing.

We saw the responses deepen. We saw the bone marrow become healthy.

It started producing more blood cells. What we actually witnessed over the year was a truly disease-modifying drug with bex, and at the end of the year, our CR landed at 45%, pretty exceptional, and the duration of CR being over 12 months and counting.

The majority of patients also became transfusion-independent, which is a very important factor in this indication. Meanwhile, as mentioned unfortunately, venetoclax failed in their Phase 3 effort due to multiple reasons.

We have taken these learnings and now are mitigating the risk of these learnings going further. This is comparing our data to what has been trialed or what could one expect from aza.

The upper part, our CR rate again 45% with good duration, and previous failures magrolimab, venetoclax, sabatolimab, they were at this point with their Phase 1bs or Phase 1/2s seeing CRs from 28 to 33% basically. They went mainly directly into a big Phase 3 trial after that.

We are not now taking that approach. Then on the lower part, just want to also highlight our last-line survival, which truly stands out, and usually if you can make it in last line, you can make it anywhere.

As mentioned, other drugs in development moved directly with this level of margin compared to aza into their frontline trials against single-agent aza. Have a look at our margin.

We're still not making that step thanks to the recent learnings. Instead, what we're going for is a Phase 2b in blue here of 90 patients.

We are still going to do two doses by the request of the FDA, even going one dose lower to 1 mg per kg, our chosen dose already being 3 mg per kg. That's what we're aiming for, and that is a significant de-risking step for entire program, and ultimately a very important step also to answer the question of what is the contribution of each agent in this combination treatment.

That could possibly address FDA's question and we could open the dialogue also for the relapsed/refractory population where there is nothing available, that when they should be available to getting this treatment combo. Then to the financial results and over to you, Jurriaan.

Thank you, Juho. We ended the year with a cash position of €12.3 million, which is slightly higher than the 9.5 at the end of 2024.

This is mainly driven by the successful raise of €12 million in February 2025 through a private placement, but also the combination of the convertible bond arrangement for up to €35 million in April '25. The first tranche of that convertible bond was drawn in April '25 and partly used to repay the IPF loan.

The second tranche was drawn in December '25 for the amount of €10 million. We ended the year with a loss of €27.3 million and net assets of -€18.5 million.

At the end of the year, we had 114.4 million shares outstanding. A couple of highlights I want to share about 2026: In January and February '26, the company approved the subscriptions based on the special rights in connection with the amortization of the first and second tranche bonds.

In February, we announced the plan for the rights offering of approximately €40 million to strengthen our capital structure and drive our lead asset, bex, to key milestones. In addition, the company may conduct a directed share issue.

Early this week, on the 2nd of March, the EGM authorized the board to resolve on the issuance of a maximum of 80 million new shares. On the 3rd of March, yesterday, the company had 119.5 million shares outstanding.

Thank you, Jurriaan. Building on our hard work and success in 2025, what do we plan to do next?

As Jurriaan already alluded to, we plan to go for more. We plan to raise 40 million to deliver that Phase 2b gold standard randomized trial showing bex plus aza against aza alone.

Further, physicians in the field of MDS, especially relapsed/refractory MDS, feel that it is clear that the benefit in last line comes from bex. They want to produce more data in this, led by City of Hope, there will be a trial producing also more data for regulatory purposes in the last-line setting.

With these excellent results we have been seeing, there is a lot of interest among physicians to investigate bex further in a number of indications. We have what we call investigator-initiated trials, IITs.

It means a physician wants to test in the patients they see the drug. This is a very cost-efficient way to generate good data, and we're looking at indications from soft tissue sarcoma to breast cancer, melanoma, lung cancer, and AML.

We will come back later this spring to give you more details on these upcoming trials. Just to mention, a lot of these are all in regulatory submission looking to get first patient in still the first half this year.

A strong set of deliverables. This is the anticipated newsflow, and a company our size, our resources producing this wave of data I say is amazing.

This is what we're going for cuz as often mentioned in the past, we believe bex is not only a drug for MDS, but it is a drug to overcome treatment resistance where macrophages are the problem of cancer spread and metastasis. A very busy schedule ahead for us and our team.

Just to wrap up, the concluding slide highlighting the essentials. This is what I call the fact sheet: high-risk myelodysplastic syndrome, absolutely deadly form of leukemia, remains a profound need, nothing really out there.

Now we seem to be in leading position. Let's go for it.

We have shown some of the best results so far in this indication. We have shown the best efficacy among the drugs in development for this indication in one of the worst populations reported.

Now we have what we believe is the best possible development plan to mitigate all known and possibly even unknown risk. What we're offering is a considerable value inflection with not a crazy amount of money to deliver the Phase 2 in frontline high-risk MDS as well as a number of new indications to prove that bex works.

Thank you. Over to Q&A then.

I can share that we are progressing well, and we will announce more in due course.

There's multiple reasons for still running a trial in the last-line setting. Ultimately, I feel most important is there's nothing really out there, a trial as such gives a possibility for last-line patients to receive bex plus aza, hopefully getting benefit at that point, so that is, for me and I think for the physicians, one of the most important things.

Then discussing with the physicians, especially at ASH, they see that it is very clear that the benefit in last line comes from bex. We actually did discuss with the investigators who are putting together the trial that would they consider having a control arm of investigator's choice, which actually would increase the meaning or the power from a regulatory perspective of this dataset.

They actually felt that that's even unethical considering that bex and aza is available, they didn't even consider it ethical giving investigator's choice or best supportive care in comparison. Ultimately, actually it's not about aza, they're planning to run it with oral HMAs.

What the physicians in the US are saying that oral HMAs are getting more and more ground, they're likely to become the new standard of care instead of aza. Actually, for us as a company looking to become the new standard-of-care agent with HMAs, it is also very important to generate data with these oral, new HMAs.

Then

We are looking into that closely. We believe the readout is positioned where we will have, I would say, the far majority, everybody should be at their CR at the time of the readout, cuz again it's going to be a very important readout, let's not take it too early.

Then

In MDS, everybody is basically Clever-1 positive, there really doesn't seem to be a need for patient selection. We're not running a diagnostic with it, but there are very interesting subpopulations, as mentioned in the question, for example the TP53-mutated where we had an astonishing CR of 70%, 7-0.

That's an interesting population where really nothing works. Then there's another very interesting subpopulation, which is what the field calls, low blast count patients, meaning that there's not a lot of those blasts or cancer cells to be killed.

We actually seem to work very well in this population, which is seen as a very difficult population cuz cancer-killing drugs don't really benefit in this population, but we, as a disease-modifying agent, really seem to work in this difficult population. This is why, actually, this Phase 2 part of the Phase 2/3 is very important, that we could look into then doing the final Phase 3 in a specific subpopulation, be it, for example, the low blast count population or the TP53 population, cuz actually then you could get an even more cost-efficient, smaller Phase 3 in a subpopulation and get approval with a very limited Phase 3.

Cuz ultimately, you want your first approval. We have already shown that this is still an all-comer drug, but seems to work very well in these subpopulations.

Go for a first approval, go for it quick. It will be used in this entire population.

Excellent question. Now with substantially longer follow-up, we're not seeing anything more in the safety signals, it's remained constant, nothing new even you're long on the treatment.

Then still, as seen already in this population, the most frequent adverse event is neutropenia and severe neutropenia. It comes with the disease and aza usually makes it worse, but to give light and understanding on it, what we're seeing actually with bex plus aza that severe Grade 3 to 4 neutropenia is around 34%, and even with single-agent aza it's been around 60%.

Crazy enough, it looks like the bex-aza combination is improving the safety profile of aza, and this actually will be then possibly proven in the randomized dataset planned next. If that is true, that's going to be truly amazing, but there is a biological rationale for this cuz we are inducing hematopoiesis in these patients and making neutropenia and anemia better.

Based on the current status of the process, we are comfortable we can extend our cash runway by more than 12 months until the readout of the Phase 2. The company continuously evaluates all available resources for funding to be able to act in case needed, but more information will be given in due course.

Then

Excellent question. As seen with previous agents, let's say aza alone would be 17% CR, an increase of 10% to that, to 27, 28%, is seen as positive, and this is what led the others to move into a Phase 3.

Those was open-label datasets compared to historical comparison. We will now have a randomized dataset real time.

That is the comfort level of moving into Phase 3 and announcing positive, let's take the aza 17% CR to 27. Ultimately, what we're going to go for, doubling the CR, cuz then the Phase 2 dataset would have sufficient power to have some very interesting and meaningful regulatory discussions.

We're looking to double it, let's give an example how we're actually powering it is that aza would be 17 and we would be 35 in CR.

During '26, especially that we get first patients in in the solid tumor trials, of course our offering that is planned, that is one big major event coming very soon, then that we get also the first patient in into the Phase 2 in high-risk MDS, and then towards the end of the year these IITs are going to be open-label again. Can't really say yet when data will come or will be reported, but they will be open-label, they will be reporting data more constantly while we wait for the readout of the actual frontline randomized MDS trial.

Thank you, everyone. Have a great day.

Thank you.