Good morning, everybody, and welcome to the Faron Pharmaceuticals Annual Results webcast. My name is Juho Jalkanen, CEO of Faron Pharmaceuticals. So let's go over the results and outlook for 2025. Next slide, please. So as we're going to also be making forward-looking statements to 2025, here's the standard disclaimer. And then to the next slide, here with me today is also our Chief Financial Officer, Yrjö Wichmann. He's going to go over the actual financial results. I will then go over the events of 2024. And then at the end, there will be a Q&A session. Please submit your questions at any time during the webcast. Thank you. And I will now hand it over to Yrjö Wichmann to go over the financial results.
Hello, my name is Yrjö Wichmann. I'm the Chief Financial Officer of Faron. And I will briefly go through the financial results of 2024. Next slide, please. So during 2024, the cash position was strengthened with a combined transaction that raised EUR 35.5 million gross and also quite efficient cost savings. So the year ended with a EUR 9.5 million cash balance compared to around EUR 7 million last year, mainly contributed because of the combined transaction last spring. The loss for the period was roughly EUR 26 million, which was substantially lower than the previous year's years, around EUR 31 million. At the end of the year, we had the net assets were negative EUR 9.8 million compared to EUR 15.2 million previous year. At the end of the year, we had 104.6 million shares outstanding. And as mentioned, our financial position was significantly improved during 2024. Next slide, please.
After the closing of 2024, we did raise in February 2025 through a private placement a total of EUR 12 million. The placement was quite successful, and it was almost two times oversubscribed. And as a consequence of that, today we have 111.6 million shares outstanding. And there still remains a 12.1 million shares authorization granted by the AGM last year that is available until the end of June this year. And over to Juho.
Thank you, Yrjö. Now let's go over the events of last year. Next slide, please. First, the financing events. As many of you know, the capital markets in biotech have been bad for the last couple of years. Eventually, that also caught up with us, and we started the year hitting a minimum cash covenant required by our debt provider IPF Partners. We did immediate corrective measures, cutting cost, becoming very cost-efficient, and also securing bridge funding to bridge us to the substantial public and institutional offering that was completed in June. It was highly successful, and we at Faron were very pleased to finally have this offering also to the wider public. Next slide, please. Also, significant changes to the management over the course of the year were done. First of all, we want to thank our longstanding chairman, Frank Armstrong, and founder and CEO, Markku Jalkanen.
They stepped aside, and the new chairman became Tuomo Pätsi. Longstanding career in pharma, especially BMS Celgene. And I have to say, he is the man that brought azacitidine to the market, so he knows this field exceptionally well. Me and Yrjö, with you here today, are longstanding employees of the company but became CEO and CFO. Then, as the new CMO, we got, I would say, the leading clinical development oncologist, Petri Bono, the former chief of the Comprehensive Cancer Center of Helsinki, joining us to lead our development. Next slide, please. Together with Petri, we also made bold movements in renewing our scientific advisory board with absolutely top names in the field to position us for late-stage development. These are the people that run all the leading trials in oncology around the world. Next slide, please.
Then to the most important, what happened with bexmarilimab over the year of 2024? First of all, December 2023, we reported the phase one results at ASH. It was amazing results in phase one. We took bexmarilimab into phase two in relapsed/refractory MDS because that's where the biggest unmet need and desperate need for new medication is. We soon started seeing that the phase one results continued in phase two. We then made the decision to approach the FDA to already get advice on what should we put together after the phase two since the phase two was looking so positive. The FDA blessed us with a fast-track designation.
They also referred us to the Project FrontRunner in our development plan, stating that an open-label phase two could lead to accelerated approval in the relapsed/refractory setting while a confirmatory phase three study is run in the frontline setting of MDS. Later in the year, together with Petri and the scientific advisory board, we also announced our new plans in solid tumor development. Next slide, please. Then also later in the year, we made new openings and filed a patent on using soluble Clever-1 to inactivate T cells. This is especially handy in autoimmune diseases where you want to dampen T cells. So basically, this is the opposite we do in cancer. And autoimmune diseases, inflammation, it's a very hot field in pharma. And we believe Clever-1 biology is highly essential here as well.
Now we have the means to play the mode of action the other way around. That's a new clinical program we're entering into. Towards the end of the year, we reported further interim data again at ASH in December. The data even became stronger than before with an 80% response rate in relapsed/refractory MDS with a survival of 13.4 months while historically it's only five to six months. Outstanding clinical results. We were also blessed with an MHRA ILAP. Basically, what that means is a fast-track designation in the UK. Next slide, please. We've continued strong into 2025. We've completed the phase two enrollment as scheduled and now waiting for the top-line results. To tide us over the top-line results and upcoming activities, we did a further fundraise, as Yrjö described, which was almost two times oversubscribed.
Just now we also received an orphan designation from EMA. We're very well positioned into 2025. Perhaps we're going to go look at how 2025 looks moving forward. As mentioned, enrollment has now been completed and top-line results are awaited in April. The more detailed results will then be presented in the following major conferences. The following conferences are ASCO and EHA. It remains to be seen if we get a spot presenting there, but very likely. This data will be packaged for an end-of-phase two meeting with the FDA. We believe with this data we have breakthrough possibility. Later on in the year, survival data, follow-up data with duration and response will come from the phase two patients.
That will be very important data as we start talking with the FDA on what is needed for accelerated approval in our MDS with the phase two data. On top of all this clinical activity, we are very much looking forward to updating the market with upcoming business activities. It's a major year ahead of us. I would say one of the biggest years of all for the company. And then to the Q&A.
Thanks, Juho. First question, what would you consider to be positive data from the BEXMAB phase 2 top line readout? What's going to be reported and what are your expectations?
So we believe the data will continue pretty much as is, and that is overly positive. Basically, phase 2 is already positive. The data has been so strong, and we expect it to continue as previously reported. So in detail, we will be reporting around 20 frontline high-risk MDS patients and around 35 relapsed/refractory MDS patients. And the top line will mainly be the response rate. As mentioned, the follow-up data will build during the course of the year.
Can you talk about the planned regulatory pathway, so including the end-of-phase two meeting that you're going to schedule with the FDA? And then what would be a reasonable expectation to start thinking about a phase three trial? Are you already thinking about that trial design?
Yes, we're definitely thinking of that trial design and actually writing it as we speak. Major components of the upcoming FDA meeting will be deciding the final dose, which goes into registrational trials, and then the registrational trial design. So those are the major components of the upcoming end-of-phase 2 package. And once the FDA then approves the dose and approves the phase 3 design, it will then take around six to eight months. That's pretty industry standard. It's still pretty quick. It will take six to eight months to get the first patient into a phase 3 study. Those are roughly the timelines we're talking.
Do you believe that the current situation within the FDA could delay your timelines?
Yes, I have to admit that's a worry we have given what's happening in the U.S. We've heard a lot of people have been fired from the FDA or resigned due to the environment. This may cause delays, which have nothing to do with us, and we cannot do anything about them. That is a risk we face. But luckily, if I may say, usually indications like high-risk MDS indications that are highly deadly and big unmet needs, they're the least affected on delays in the FDA.
Next question, how are your pipeline plans affecting your cash spend?
Currently, at the moment, we're operating as we left off in 2024, but towards the end of the year, we will increase spend as we are putting together phase 3 and also starting proof of concept trials in solid tumors, so towards the end of the year, the spend will increase, but currently, we're operating as 2024.
Moving on to partnering, could you provide any updates about your partnering discussions to fund the phase three development of Bex and its commercialization? And would you consider hiring a chief commercial officer?
Yes, that's a very good question. So partnering discussions are highly active at the moment, and I'm sure we will be reporting on them during the course of this year. And yes, we're also looking to hire commercial resources internally. And that is not to commercialize the drug ourselves, but we ourselves, as a company, need experienced people at the table when these aspects are discussed as a part of partnering. So yes, in our hiring plans, there are also commercial people involved.
How many employees do you currently have, and how many do you plan to hire this year?
Currently, we have 25, and a couple of new employees are being onboarded. We will also be increasing the headcount a bit more. We're especially looking to hire people into manufacturing, clinical trials, of course. As mentioned, a very important aspect is commercial, but also hematology experience will be added to the company. Those are the major elements in our hiring plan.
Question about solid tumors. So what's the timing for the planned proof of concept studies, and how quickly could that enter the clinic?
So we're currently working very actively to get those started in the second half. I would believe the first patients could be treated in Q4. We're working hard to achieve that milestone.
What would be a good response rate or overall survival in those solid tumor trials?
That's a broad question because it really depends on the indication and setting, maybe just to give some flavor. For example, in checkpoint refractory melanoma, breakthrough designation has been achieved with 30% response rate. So that would be good in that setting. Also talking, for example, sarcoma, response rates have been notoriously low. 20%-30% response rate in sarcoma would be very good.
Then a financing question. So with the private placement in February, how should we be thinking about your financing strategy in 2025?
Yrjö, I saw you came off mute. Do you want to answer this question?
Yes, we are continuously looking at the alternative and different funding sources of funding, both equity and non-dilutive funding also, and the aim for 2025 is to expand the investor base to more international and especially sector-specialist investors.
And to that respect as well, we will be coming out with plans to the market as we're working on them currently. But over the course of the year, again, we will be coming out revealing our activities.
Are you still recruiting patients in CMML or MDS?
Yes, we are. So CMML is actively recruiting in BEXMAB. And then the current protocol allows us to build on our R/R MDS. And yes, that enrollment is open to make the dataset bigger for regulatory purposes. We believe the FDA will want to see, for example, more than 35 patients if thinking accelerated approval. So we can build under the current protocol up to 40 patients at first. Then we will have to see the FDA. But altogether, the current protocol will allow going up to around 50 patients.
Thanks very much. That's all the questions.
Thank you. If no further questions, we wish you all a very good day and an exciting year ahead of us.
Thank you also from my side.