Herantis Pharma Oyj

Good morning, everyone, and welcome to Herantis Pharma's webcast covering our results and key developments for the first half of 2026. Thank you for joining us today. My name is Antti Vuolanto. I'm the CEO of Herantis, joined today by CFO Tune Kuole and CMO Juha Savola. During the presentation, we will provide an update on our progress during the first half of the year, including the latest developments with HER96 and our plans going forward. We will also have a short discussion with our new chief medical officer Juha Saavola, who recently joined Herantis as we prepare for the next stage of HER96 clinical development. Following the presentation, we will have a Q&A session. You can submit questions at any time through the webcast dashboard. A recording of today's webcast will also be made available after the live broadcast. Before we get started, please take a moment to note the customary disclaimer shown on the screen. And with that, let's begin. So Herantis Pharma, we are a clinical stage public company developing disease modifying therapies for Parkinson's disease. And we are listed on the Nasdaq first North growth market here in Finland. Our lead asset HER96 is now ready to move forward to phase two efficacy trial. based on the very encouraging phase one data set. So we have evaluated ER96 in Parkinson's patients and in healthy volunteers. We have demonstrated favorable safety and tolerability profile. We have demonstrated efficient brain penetration and we also have a strong biomarker data set that suggests a biological response in Parkinson's patients and the response being consistent with the proposed mechanism of action. In addition to that, we are in a very special situation as we also have earlier biological validation with the CDNF cerebral dopamine neurotrophic factor, a neurotrophic factor biology in previous clinical and translational studies. So CDNF is a naturally occurring protein that protects and restores the function of dopaminergic neurons. And now with HER96, we can bring the same activity to the brain using very convenient subcutaneous administration. So we believe that we are in a very strong position when we now go towards the phase two efficacy trials. If I shortly summarize the different aspects providing a very strong foundation for the phase two development. First of all, we have significant unmet clinical need in Parkinson's disease. Currently, the patients can have symptomatic treatment addressing motor symptoms at the early stage of the disease or right after the diagnosis. However, no disease modifying drugs affecting the disease progression exist as of today. So there is large and growing market with high unmet clinical need. I will actually discuss that a bit further details shortly. The approach that we have with HER96, the mechanism of action derived from CDNF, is very broad mechanism addressing actually the very core disease biology. And this really puts us in a very specific proposal considering the other potentially disease modifying therapies in development. I will also discuss a little bit more about the competition or the situation in the disease modifying therapy space in Parkinson's disease. As already mentioned, the phase one data and the preceding preclinical data with HERD96 is very encouraging and very strong compared to the peers, considering the data set that leads to phase two. And we do have a very strong rationale for phase two, the specific design that we have being created and are still finalizing the clinical, the biomarker, the translational evidence provides that strong rationale that we will then test in phase two to show a patient benefit, the efficacy in phase two. I already mentioned about the unmet clinical need. So the current therapies are symptomatic therapies that only treat the motor symptoms, not the disease itself. And there are very severe non-motor symptoms that cannot be treated today. Even though at the early stage of the disease, many patients can have efficient symptomatic benefit from the current treatments, there are also a number of patients who either don't get the benefit or they may have significant side effects. And what is especially important is to know that the effectiveness of the current treatments decline over time when the underlying disease progresses so all the patients who are diagnosed with the Parkinson's disease they know that there will be the day when the current treatments are not efficiently enough supporting their quality of life and it will be compromised at some point of time and we want to make a change here and this is of course associated with huge huge potential considering the market size. So currently there are 10 or maybe 12 million patients suffering from Parkinson's disease globally. It is expected to over double until the year 2050 when approximately 25 million patients might be suffering from Parkinson's disease. And today the total economic impact or burden on Parkinson's globally today exceeds 250 billion US dollars. So we are talking about huge unmet clinical need, huge market. The therapeutic market currently is approximately 6 billion or 7 billion US dollars a year with these symptomatic treatments. we estimate that, and there are many estimates that say that it will at least double when the first disease modifying treatments will enter the market. And of course our ambition is to be there. And there is very strong pharma interest in disease modifying therapies in Parkinson's disease. For example, Roche, Eli Lilly, AbbVie, MSD, all of these large players have publicly said that they are really interested in this space So the opportunity is huge. And a short update about the current situation about the disease modifying therapies, where HER96 has a very strong position as based on the very broad mechanism addressing the core biology and the potential to protect and even restore the neuronal function. So despite of the huge unmet clinical need, the huge market, the treatment pipeline remains rather limited. And most of the competing programs, they focus on relatively narrow mechanisms. including immunotherapies against alpha-synuclein protein aggregates, kinase inhibition or lysosomal or GBA pathways. And also there are cell replacement therapies. Looking at phase three, there is one compound from Roche, which is alpha-synuclein immunotherapy going into phase three. It hasn't yet started, but it will be initiated rather soon. And in phase two, actually, there have been some news during the summertime. So there have been these genetic lysosomal targets, both from Biogen Denali and then a Portuguese company called Bial, which both have reported negative outcomes in the summertime and both of these companies have announced that they will discontinue the treatment, discontinue the development. Cell therapies has been discussed also in Finland in the newspapers, and that might be a promising technology. However, there are many challenges in the practicalities related to cell therapies. Cell therapies means that you grow neurons outside of the human body, then you implant them into the anatomical place with with a rather complicated surgery and then with the hope that the new neurons can be active at the site. And there are some promising results. However, it is most likely not very suitable to treat millions of Parkinson's patients or 250,000 new diagnosed cases in the US annually. So it can be a limited niche product, but it definitely cannot saturate the market. So based on this, when Heron96 will continue to phase two development, we are in a very good and very strong position among disease modification in Parkinson's disease. So we are planning for the phase two efficacy trial in early stage Parkinson's disease patients. This phase two efficacy proof of concept study aims to show improvement in motor symptoms using continuous objective monitoring of motor symptoms with sensitive digital devices. And with that, we have partnered with INDIVI, who, for example, provided the same platform for Biogen's LUMA trial with approximately 600 participants. We also will have clinical symptom assessments as a standard practice and also different brain imaging modalities as a measure of the disease modification. and of course we will exploit the great biomarker data that we've got from phase 1b and we will have selected fluid biomarkers to complement the data packets. The phase 2 trial itself will be randomized placebo-controlled double-blinded trial with two different parts. The first part will be nine months placebo-controlled part and then the next six months will be open label. So all the participants will get HER96 treatment. Approximately 100 early stage Parkinson's disease patients, and they will get two subcutaneous 300 milligram injections per week or placebo in the first part of the trial. And the preparations for this European study are underway. we already have very much advanced discussions with a number of clinical sites across different countries, Nordics and Middle Europe and Southern Europe to have sufficient number of sites to recruit the patients within. hopefully 12 months. So we expect to submit the clinical trial application by the end of this year, have the first patient in the protocol during the first half of next year, and the interim efficacy data readout early 2029, followed shortly after by the full data set of phase two. As announced earlier in the spring, we also had a discussion with FDA about our plans and their feedback supports the planned phase two development strategy. They considered the trial design appropriate for phase two. They didn't raise any concerns about the data package that we discussed with them. So basically the feedback supports submitting an IND. So potentially we could also have regulatory approval from FDA to conduct the phase two trial. So let's go to the business highlights of the first half of 2026. In January, we reported positive biomarker data that showed a very clear biological response to her 96 treatment in people living with Parkinson's disease. And the biological response was very much aligned with the expectations with the proposed mechanism of action. So improvements in proteostasis and mitochondrial function capacity. In February, we completed a directed share issue. We raised 4.2 million euros in that transaction. Further in February, we also announced that a consortium led by Herantis was selected to receive a 8 million euro grant to support the phase two trial of HER96. and the acronym of that EU project is HERMOD. So it covers part of the planned phase two trial that we are going to initiate later. In March, our chief scientific officer, Henri Huttunen, provided or delivered an oral presentation at ADPD 2026 Congress presenting the Phase 1b data. That was also a very important scientific milestone for the company. In May, we announced a collaboration with Indivi's digital biomarker platform for the phase two trial. And there, of course, the aim is to detect early treatment related changes in the phase two trial. In May further on, we received the positive feedback from FDA that I already discussed. In May further, we announced that we appointed the clinical CRO to support our phase two preparations and eventually the conduct of the trial. And then in June, we announced the appointment of of Dr. Juha Savola as our chief medical officer and he brings more than 25 years of global experience in drug development. Let's discuss this topic later when I have a chat with Juha. But let's dive now into the financing figures. So CFO Tune, please take the lead here.

Thank you for the introduction. The cost base, as you can see, remained flat compared to the same period last year. During the first half, we have spent our resources on the following core projects. We are preparing now for the phase two clinical trial, and we are continuing development and validation of the biomarkers. In addition, as Antti mentioned, we raised funds in February. So there was cost set aside for that. And of course, we are focusing a lot on investor relation and partnering activities. So that's also part of the resource spent. Next slide. So as you have heard today, we were selected for an 8 million Horizon Europe grant. And that's really positive. That's a kind of non dilutive funding important for us. Our cash position by the end of June ended at 3.5 million. The balance sheet, as such, also consisted of long-term debt that increased compared to the same period last year due to more funding from Michael J. Fox in Parkinson's UK. As you remember, they funded the full Phase 1b trial. Equity stood at minus 0.7 by the end of June, mentioned successful fundraising. And then, of course, in addition, just to say that we need to have more capital to launch the phase two clinical trial. And we are actively exploring different options, for instance, development partnership, equity financing and also more non-dilutive funding.

Tuna. And next we will have a short discussion with Juha, our chief medical officer. So Juha brings extensive experience from the pharmaceutical industry with a strong track record in clinical drug development and special expertise in neurology. And he joins, of course, Herantis now at a very important moment as we prepare for to advance HER96 into Phase 2 development. So Juha, welcome to Herantis. It's of course great to have you with us and here. Before we actually dive into Herantis and HER96, could you briefly tell our audience about your background and maybe highlight the experience that you believe have best prepared you for the role of Chief Medical Officer at Herantis?