Half Year 2026 Herantis Pharma Oyj Earnings Call

August 20, 2026

Speaker #1: 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.

Antti Vuolanto: Good morning, everyone, and welcome to Herantis Pharma's webcast covering our results and key developments for the H1 2026. Thank you for joining us today. My name is Antti Vuolanto. I am the CEO of Herantis. I am joined today by CFO, Tone Kvåle, and CMO, Juha Savola. During the presentation, we will provide an update on our progress during the H1 of the year, including the latest developments with HER-096 and our plans going forward. We will also have a short discussion with our new Chief Medical Officer, Juha Savola, who recently joined Herantis as we prepare for the next stage of HER-096 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.

Antti Vuolanto: Good morning, everyone, and welcome to Herantis Pharma's webcast covering our results and key developments for the H1 of 2026. Thank you for joining us today. My name is Antti Vuolanto. I am the CEO of Herantis. I am joined today by CFO, Tone Kvåle, and CMO, Juha Savola. During the presentation, we will provide an update on our progress during the H1 of the year, including the latest developments with HER-096 and our plans going forward. We will also have a short discussion with our new Chief Medical Officer, Juha Savola, who recently joined Herantis as we prepare for the next stage of HER-096 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.

Speaker #1: 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 HER-096 and our plans going forward.

Speaker #1: We will also have a short discussion with our new Chief Medical Officer, Juha Savola, who recently joined Herantis as we prepare for the next stage of HER-096 clinical development.

Speaker #1: 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.

Speaker #1: Before we get started, please take a moment to note the customary disclaimer shown on the screen. And with that, let's begin. Herantis Pharma is a clinical-stage public company developing disease-modifying therapies for Parkinson's disease.

Antti Vuolanto: Before we get started, please take a moment to note the customary disclaimer shown on the screen. With that, let's begin. 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, HER-096, is now ready to move forward to phase II efficacy trial based on the very encouraging phase I data set. We have evaluated HER-096 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.

Speaker #1: We are listed on the NASDAQ First North Growth Market here in Finland. Our lead asset, HER-096, is now ready to move forward to the Phase 2 efficacy trial.

Speaker #1: Based on the very encouraging Phase 1 data set, we have evaluated HER-096 in Parkinson's patients and in healthy volunteers. We have demonstrated favorable safety and tolerability profiles.

Speaker #1: We have demonstrated efficient brain penetration, and we also have a strong biomarker dataset that suggests a biological response in Parkinson's patients, with the response being consistent with the proposed mechanism of action.

Speaker #1: In addition to that, we are in a very special situation, as we also have earlier biological validation with the cNDF—cerebral dopamine neurotrophic factor—a neurotrophic factor biology in previous clinical and translational studies.

Antti Vuolanto: 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. CDNF is a naturally occurring protein that protects and restores the function of dopaminergic neurons. Now with HER-096, we can bring the same activity to the brain using very convenient subcutaneous administration. We believe that we are in a very strong position when we now go towards the phase II efficacy trials. If I shortly summarize the different aspects providing a very strong foundation for the phase II 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.

Speaker #1: So, CDNF is a naturally occurring protein that protects and restores the function of dopaminergic neurons. And now, with HER-096, we can bring the same activity to the brain using very convenient subcutaneous administration.

Speaker #1: So, we believe that we are in a very strong position as we now move towards the phase two efficacy trials. To briefly summarize, there are several aspects providing a very strong foundation for the phase two development.

Speaker #1: First of all, we have a significant unmet clinical need in Parkinson's disease. Currently, patients can have symptomatic treatment addressing motor symptoms at the early stage of the disease or right after the diagnosis.

Speaker #1: However, no disease-modifying drugs affecting the disease progression exist as of today. So, there is a large and growing market with high unmet clinical need. I will actually discuss that in a bit further detail shortly.

Antti Vuolanto: However, no disease-modifying drugs affecting the disease progression exist as of today. 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 HER-096, the mechanism of action derived from CDNF, is very broad mechanism addressing actually the very core disease biology. 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 I data and the preceding preclinical data with HER-096 is very encouraging and very strong compared to the peers, considering the data set that leads to phase II.

Speaker #1: The approach that we have with HER-096, the mechanism of action derived from CDNF, is a very broad mechanism addressing actually the very core disease biology.

Speaker #1: And this really puts us in a very specific position, 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.

Speaker #1: As already mentioned, the Phase 1 data and the preceding preclinical data with HER96 are very encouraging and very strong compared to the peers, considering the dataset that leads to Phase 2.

Speaker #1: And we do have a very strong rationale for phase two. The specific design that we have created and are still finalizing—the clinical and the biomarker translational evidence—provides that strong rationale that we will then test in phase two to show a patient benefit.

Antti Vuolanto: We do have a very strong rationale for phase II, 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 II to show a patient benefit, the efficacy in phase II. I already mentioned about the unmet clinical need. The current therapies are symptomatic therapies that only treat the motor symptoms, not the disease itself. 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.

Speaker #1: The efficacy in phase two. I already mentioned the unmet clinical need. Currently, therapies are symptomatic therapies that only treat the motor symptoms, not the disease itself.

Speaker #1: 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 symptomatic benefit, or they may have significant side effects.

Speaker #1: And what is especially important is to know that the effectiveness of the current treatments declines over time when the underlying disease progresses. So all the patients who are diagnosed with Parkinson's disease, they know that there will be a day when the current treatments are not efficiently enough supporting their quality of life.

Antti Vuolanto: What is especially important is to know that the effectiveness of the current treatments decline over time when the underlying disease progresses. All the patients who are diagnosed with 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. This is, of course, associated with huge potential considering the market size. 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. Today, the total economic impact of burden on Parkinson's globally today exceeds $250 billion US dollars. We are talking about huge unmet clinical need, huge market.

Speaker #1: And it will be compromised at some point in time. And we want to make a change here. This is, of course, associated with huge potential considering the market size.

Speaker #1: So currently, there are 10 or maybe 12 million patients suffering from Parkinson's disease globally. It is expected to more than double by the year 2050, when approximately 25 million patients might be suffering from Parkinson's disease.

Speaker #1: And today, the total economic impact or burden on Parkinson's globally exceeds $250 billion. So we are talking about a huge unmet clinical need—huge market.

Speaker #1: 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.

Antti Vuolanto: 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. Of course, our ambition is to be there. There is very strong pharma interest in disease-modifying therapies in Parkinson's disease. For example, Roche, Eli Lilly and Company, AbbVie, MSD, all of these large players have publicly said that they are really interested in this space. The opportunity is huge. A short update about the current situation about the disease-modifying therapies, where HER-096 has a very strong position based on the very broad mechanism addressing the core biology and the potential to protect and even restore the neuronal function.

Speaker #1: 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.

Speaker #1: So, the opportunity is huge. And a short update about the current situation with disease-modifying therapies, where HER-096 has a very strong position, as it is based on a very broad mechanism addressing the core biology and the potential to protect and even restore neuronal function.

Speaker #1: So, despite the huge unmet clinical need and the huge market, the treatment pipeline remains rather limited. Many or most of the competing programs focus on relatively narrow mechanisms, including immunotherapies against alpha-synuclein protein aggregates, kinase inhibition, or lysosomal or GBA pathways.

Antti Vuolanto: Despite of the huge unmet clinical need, the huge market, the treatment pipeline remains rather limited. 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. Also there are cell replacement therapies. Looking at phase III, there is one compound from Roche, which is alpha-synuclein immunotherapy going into phase III. It hasn't yet started, but it will be initiated rather soon. In phase II, actually, there have been some news during the summertime. 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 development. Cell therapies has been discussed also in Finland in the newspapers, and that might be a promising technology.

Speaker #1: And also, there are cell replacement therapies. Looking at phase three, there is one compound from Roche, which is an alpha-synuclein immunotherapy going into phase three.

Speaker #1: 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 this company called Bial.

Speaker #1: Both have reported negative outcomes in the summertime, and both of these companies have announced that they will discontinue the treatment—discontinue the development.

Speaker #1: Cell therapies have 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.

Antti Vuolanto: 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 a rather complicated surgery, and then with the hope that the new neurons can be active at the site. 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. It can be a limited niche product, but it definitely cannot saturate the market. Based on this, when HER-096 will continue the phase II development, we are in a very good and very strong position among disease modification in Parkinson's disease. We are planning for the phase II efficacy trial in early-stage Parkinson's disease patients.

Speaker #1: Cell therapies means that you grow neurons outside of the human body, then you implant them into the anatomical place with a rather complicated surgery.

Speaker #1: And then with the hope that the new neurons can be active at the site. There are some promising results. However, it is most likely not very suitable to treat millions of Parkinson's patients or 250,000 newly diagnosed cases in the U.S. annually.

Speaker #1: So, it can be a limited niche product, but it definitely cannot saturate the market. So, based on this, when Herantis' HER-096 goes on to continue in phase two development, we are in a very good and very strong position among disease modification in Parkinson's disease.

Speaker #1: So we are planning for the Phase 2 efficacy trial in early-stage Parkinson's disease patients. This Phase 2 efficacy proof-of-concept study aims to show improvement in motor symptoms using continuous, objective monitoring of motor symptoms with sensitive digital devices, and for that we have partnered with Indevi, who, for example, provided the same platform for the Biogen Luma trial with approximately 600 participants.

Antti Vuolanto: This phase II efficacy proof of concept study aims to show improvement in motor symptoms using continuous objective monitoring of motor symptoms with sensitive digital devices. 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. Of course, we will exploit the great biomarker data that we've got from phase Ib and with biomarkers to complement the data package. The phase II trial itself will be a randomized, placebo-controlled, double-blinded trial with two different parts. The first part will be a nine-month placebo-controlled part, and then the next six months will be open label, so all the participants will get HER-096 treatment.

Speaker #1: 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.

Speaker #1: With biomarkers to complement the data packets, the phase two trial itself will be a randomized, placebo-controlled, double-blinded trial with two different parts. The first part will be a nine-month, placebo-controlled part, and then the next six months will be open-label, so all the participants will get HER-096 treatment.

Speaker #1: Approximately 100 early-stage Parkinson's disease patients, and they will receive two subcutaneous 300-milligram injections per week or placebo in the first part of the trial.

Antti Vuolanto: Approximately 100 early-stage Parkinson's disease patients, and they will get two subcutaneous 300 milligram injections per week or a placebo in the first part of the trial. The preparations for this European study are underway, and 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. We expect to submit the Clinical Trial Application by the end of this year. Have the first patient in the protocol during the first H1 of next year, and the interim efficacy data readout early 2029, followed shortly after by the full data set of phase II. As announced earlier in the spring, we also had a discussion with FDA about our plans, and their feedback supports the planned phase II development strategy.

Speaker #1: And the preparations for this European study are underway, and we already have very advanced discussions with a number of clinical sites across different countries—the Nordics, Middle Europe, and Southern Europe—to have a sufficient number of sites to recruit the patients within, hopefully, 12 months.

Speaker #1: 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 interim efficacy data readout early 2029, followed shortly after by the full data set of Phase Two.

Speaker #1: As announced earlier in the spring, we also had a discussion with the FDA about our plans, and their feedback supports the planned Phase II development strategy.

Speaker #1: They considered the trial design appropriate for Phase 2. 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, in a way, have regulatory approval from the FDA to conduct the Phase 2 trial.

Antti Vuolanto: They considered the trial design appropriate for phase II. They didn't raise any concerns about the data package that we discussed with them. Basically, the feedback supports submitting an IND. Potentially we could also in a way have regulatory approval from FDA to conduct the phase II trial. Let's go to the business highlights of the first H1 of 2026. In January, we reported positive biomarker data that showed a very clear biological response to HER-096 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 EUR 4.2 million in that transaction.

Speaker #1: 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-096 treatment in people living with Parkinson's disease.

Speaker #1: And the biological response was very much aligned with the expectations for the proposed mechanism of action—so, improvements in proteostasis and mitochondrial functional capacity.

Speaker #1: In February, we completed a directed share issue. We raised €4.2 million in that transaction. Further, in February we also announced that a consortium led by Herantis was selected to receive an €8 million grant to support the Phase Two trial of HER96.

Antti Vuolanto: Further in February, we also announced that a consortium led by Herantis was selected to receive an EUR 8 million grant to support the phase II trial of HER-096. The acronym of that EU project is HERMON. It covers part of the planned phase II trial that we are going to initiate later. In March, our Chief Scientific Officer, Henri Huttunen, delivered an oral presentation at AD/PD 2026 Congress, presenting the phase Ib 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 II trial. There, of course, the aim is to detect early treatment-related changes in the phase II trial. In May, further on, we received the positive feedback from FDA that I already discussed.

Speaker #1: And the acronym of that EU project is HERMON. So it covers part of the planned phase 2 trial that we are going to initiate later.

Speaker #1: In March, our Chief Scientific Officer, Henry Huttunen, delivered an oral presentation at the ADPD 2026 Congress, presenting the Phase 1b data. That was also a very important scientific milestone for the company.

Speaker #1: In May, we announced a collaboration with Indevi's digital biomarker platform for the Phase 2 trial. The aim there, of course, is to detect early treatment-related changes in the Phase 2 trial.

Speaker #1: In May, further on, we received the positive feedback from FDA that I already discussed. In May, furthermore, we announced that we appointed the clinical CRO to support our Phase 2 preparations and eventually the conduct of the trial.

Antti Vuolanto: In May further, we announced that we appointed the clinical CRO to support our phase II preparations and eventually the conduct of the trial. In June, we announced the appointment of Dr. Juha Savola as our Chief Medical Officer. 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. Let's dive now into the financing figures. CFO Tone, please take the lead here.

Speaker #1: And then in June, we announced the appointment of Dr. Juha Savola as our Chief Medical Officer, and he brings more than 25 years of global experience in drug development.

Speaker #1: Let's discuss this topic later when I have a chat with Juha. But let's dive now into the financing figures. So, CFO Tuune, please take the lead.

Speaker #1: Here.

Tone Kvåle: Yeah, thank you for the introduction. The cost base, as you can see, remained flat compared to the same period last year. During H1, we have spent our resources on the following core projects. We are preparing now for the phase II 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. Of course, we are focusing a lot on investor relation and partnering activities, so that's also part of the resource spent. Next slide. As you have heard today, we were selected for an EUR 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 EUR 3.5 million.

Speaker #2: Yeah, 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.

Speaker #2: We are preparing now for the phase 2 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.

Speaker #2: And of course, we are focusing a lot on investor relations and partnering activities, so that's also a part of the resources spent. Next slide.

Speaker #2: 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, which is important for us.

Speaker #2: Our cash position at the end of June stood at €3.5 million. The balance sheet also included long-term debt, which increased compared to the same period last year due to additional funding from Michael J.

Tone Kvåle: 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 The Michael J. Fox Foundation and Parkinson's UK. As you remember, they funded the full phase Ib trial. Equity stood at minus EUR 0.7 million by the end of June. I mentioned successful fundraising. In addition, just to say that we need to have more capital to launch the phase II clinical trial, and we are actively exploring different options, for instance, development partnership, equity financing, and also more non-dilutive funding.

Speaker #2: Fox and Parkinson UK, as you remember, they funded the full Phase 1b trial. Equity stood at minus 0.7 by the end of June.

Speaker #2: 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. We are actively exploring different options, for instance, development partnership, equity financing, and also more non-dilutive funding.

Speaker #1: Thank you, Tuune. Next, we will have a short discussion with Juha, our Chief Medical Officer. Juha brings extensive experience from the pharmaceutical industry.

Antti Vuolanto: Thank you, Tone. Next, we will have a short discussion with Juha, our Chief Medical Officer. Juha brings extensive experience from the pharmaceutical industry, with a strong track record in clinical drug development and special expertise in neurology. He joins, of course, Herantis now at a very important moment as we prepare to advance HER-096 into phase II development. Juha, welcome to Herantis. It's of course great to have you with us and here. Before we actually dive into Herantis and HER-096, 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?

Speaker #1: 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 to advance HER-096 into Phase 2 development.

Speaker #1: So Juha, welcome to Herantis. It's, of course, great to have you with us and here. Before we actually dive into Herantis and HER-096, could you briefly tell our audience about your background and maybe highlight the experiences that you believe have best prepared you for the role of Chief Medical Officer at Herantis?

Speaker #3: Sure. Thanks, Antti. And thanks, everybody. Good to be here. Exciting moment. Exciting moment for Herantis, and really proud to be part of making things move forward.

Juha Savola: Sure. Thanks, Antti, and thanks everybody. Good to be here. Exciting moment for Herantis, and really proud to be part of making things moving forward. I have worked, as you said, quite many years in the field. Many of those being responsible and leading clinical development in neurology, and some other therapeutic areas. Parkinson's disease has been the field where I have done actually most of the clinical research. I actually joined Herantis from retirement. Before stepping out from pharmaceutical drug development, I worked in my last role five years in Philadelphia, USA in Spark Therapeutics, which is a gene therapy company, and we had developed the very first gene therapy for treatment of genetic blindness. In that role, we started a therapy for treatment of another rare disease with neurological consequences, and that's Huntington's disease. We were thinking about and planning forward moving a Parkinson's disease compound.

Speaker #3: I have worked, as you said, quite many years in the field. Many of those years I have been responsible for and leading clinical development in neurology and some other therapeutic areas. But Parkinson's disease has been the field where I have actually done most of the clinical research.

Speaker #3: I actually joined Herantis from retirement. But before stepping out from pharmaceutical drug development, I worked in my last role for five years in Philadelphia, USA, at Spark Therapeutics, which is a gene therapy company, and we had developed the very first gene therapy for treatment of genetic blindness.

Speaker #3: In that role, we started a therapy for treatment of another rare disease with neurological consequences, and that's Huntington's disease. We were thinking about and planning forward, moving a Parkinson's disease compound.

Speaker #3: So I would say that these years in business have kept me very excited about Parkinson's disease and very determined in finding better solutions for patients.

Juha Savola: I would say that these years in business have kept me very excited about Parkinson's disease and very desperate in finding better solutions for patients. All these years have led me to fine-tune what might be most optimal way of designing a study to address that unmet need. In my roles working especially with the rare diseases, I learned to appreciate the value of single subject in the study, and that I think is important thinking at Herantis. We can't recruit many patients and just believe in masses of data providing the future for the program development. We need to be smart. We need to make every patient count in the study, and that will be the best feedback we can give to the patients and scientific community.

Speaker #3: All these years have let me fine-tune what might be the most optimal way of designing a study to address that unmet need. In my roles, working especially with rare diseases, I learned to appreciate the value of a single subject in the study.

Speaker #3: And that, I think, is important thinking. Herantis—we can't pay, we can't recruit many patients, and just believe in masses of data providing the future for the program development.

Juha Savola: We can't recruit many patients and just believe in masses of data providing the future for the program development. We need to be smart. We need to make every patient count in the study, and that will be the best feedback we can give to the patients and scientific community. Yes, I think my background in the field of neurological diseases, different modalities, and really opportunity to provide something meaningful to patients is making my life very exciting.

Speaker #3: We need to be smart. We need to make every patient count in the study, and that will be the best feedback we can give to the patients and the scientific community.

Speaker #3: So yes, I think my background in the field of neurological diseases, different modalities, and really the opportunity to provide something meaningful to patients is making my life very exciting.

Juha Savola: Yes, I think my background in the field of neurological diseases, different modalities, and really opportunity to provide something meaningful to patients is making my life very exciting.

Speaker #1: Very good. With that quite impressive background, what is it in HER-096 and Herantis that has convinced you to join? And you said that you had retired, but then you wanted to come back to an operational role.

Antti Vuolanto: Very good. With that quite impressive background, what in HER-096 and Herantis has convinced you to join? You said that you had retired, but then you wanted to come back to operational role. What is that compelling thing that you see in HER-096? Maybe also compared to other approaches that are currently being evaluated in Parkinson's disease.

Speaker #1: So, what is that compelling thing that you see in HER-096? Maybe also compared to other approaches that are currently being evaluated in Parkinson's disease.

Speaker #3: Well, there are two things—if not three, even. First of all, the very concept of HER-096, which is attractive for me, is that it is not, as you pointed out, a single mechanism of action.

Juha Savola: Well, there are two things, if not three even. First of all, the very concept of HER-096 which is attractive for me is that it is not, as you pointed out, it is not a single mechanism of action. It is targeted mechanism of action, but it is playing across the pathology of Parkinson's disease, which is important. I think this is important scientifically in comparison to many very focused, laser-focused biology. That biological non-specificity is important for disease like Parkinson's disease therapy. What was exceptional when I listened and watched your data readout when you had your phase I data out, I was impressed that in phase I you actually had a signal that this experimental drug is actually biologically active.

Speaker #3: It is a targeted mechanism of action, but it is playing across the pathology of Parkinson's disease, which is important. And I think this is important scientifically, in comparison to many very focused, laser-focused biology approaches.

Speaker #3: So that biological non-specificity is important for diseases like Parkinson's disease therapy. What was exceptional when I listened and watched your data readout, when you had your phase one data out, I was impressed that in phase one you actually had a signal that the drug, this experimental drug, is actually biologically active. Everything I saw at that moment, and later on as I have had access to the books, is building on that story; we didn’t find any surprises there.

Juha Savola: Everything I saw at that moment and later on as I have been accessed to the books, is building on that story that we didn't find any surprises there. We actually got a signal that the hypothesis built on preclinical animal studies appear to be valid for humans, and that's a jump start. That made me excited. Of course this motivation, what Herantis has is exceptional. Shortly after speaking with you and other colleagues in Herantis, I felt there is a spirit spot on in this company.

Speaker #3: We actually got a signal that the hypothesis built on preclinical animal studies appears to be valid for humans. And that's a jumpstart, and that made me excited.

Speaker #3: And of course, this motivation that Herantis has is exceptional, and shortly after speaking with you and other colleagues at Herantis, I felt there is a spirit spot on in this company.

Speaker #1: Very good. And that leads to the next item that I had in mind. So, you have now spent your first two months at Herantis, and with the team.

Antti Vuolanto: Very good. That leads to the next item that I had in mind. You have now spent two first months at Herantis and the team. What has mostly impressed you about Herantis as a company or our great team? At least I would say the great team, but maybe you will.

Speaker #1: So what has mostly impressed you about Herantis as a company? Or our great team, at least? I would say the great team, but maybe you will.

Speaker #3: Well, can't deny that. As I said, Herantis is showing, is living every moment. I see it, I feel it when I am with Herantis.

Juha Savola: Well, can't deny that. As I said, Herantis is showing, is living every moment. I see it, I feel it when I am with Herantis, seeing the people. Everybody is engaged. Everybody wants to make impact on the lives of Parkinson's patients and their families. Everybody knows what we are doing and why we are doing it, and the level of engagement and commitment is very tangible. So it is, and there's a good humor in the company, and it's a perfect place to work.

Speaker #3: Seeing the people, everybody is engaged. Everybody wants to make an impact on the lives of Parkinson's patients and their families. Everyone knows what we are doing and why we are doing it.

Speaker #3: And the level of engagement and commitment is very tangible. There is a good sense of humor in the company, and it's a perfect place to work.

Speaker #1: Well, that sounds very good. Of course, in the years as CEO, you have seen the full body of evidence that we have built. Now, within the first two months of your engagement with Herantis—

Antti Vuolanto: Well, that sounds very good, of course, in the ears of the CEO. Well, you have seen the full body of evidence that we have built now within the first two months of your engagement with Herantis. What is in a way the most encouraging? You said that the broad mechanism of action, but if you consider the dataset that we have, what is convincing you that yes, we are going in the right direction considering the long track of evidence that we have built from the CDNF preclinical to HER-096 phase I data?

Speaker #1: What is, in a way, the most encouraging? You said that the broad mechanism of action is positive, but if you consider the data set that we have, what is convincing you that, yes, we are going in the right direction?

Speaker #1: Considering the long track of evidence that we have built from the CDNF preclinical to HER-096 phase one data, so.

Speaker #3: Well, it's good at the very basic mechanism of action. The evidence Herantis has built around CDNF first, and then later on HER-096, is very compelling in the field of any modalities I am aware of in competing products.

Juha Savola: Well, let's go to the very basic mechanism of action. The evidence Herantis has built around CDNF first and then later on HER-096 is very compelling in the field of any modalities I am aware of competing products. There is an opportunity for neurorestorative, meaning this drug might make cells behave better, and they might catch up, and they might be finally something which is doing more than simply providing less reduction in clinical progress. That would be fantastic for these patients. I can see that kind of glimmer of hope coming from these cell culture studies in our animal studies. So that was the first thing, which was my attraction when I was going through the documentation I had access to. The preclinical package has been well thought out, well planned, well executed, impressive.

Speaker #3: There is an opportunity for neurorestorative—meaning this drug might make cells behave better, and they might catch up, and there might finally be something that is doing more than simply providing less reduction in clinical progress.

Speaker #3: And that would be fantastic for these patients. I can see that glimmer of hope coming from these cell culture studies and our animal studies. So, that was the first thing which attracted me when I was going through the documentation we had.

Juha Savola: I can see that kind of glimmer of hope coming from these cell culture studies in our animal studies. So that was the first thing, which was my attraction when I was going through the documentation I had access to. The preclinical package has been well thought out, well planned, well executed, impressive. Then on top of that, as I mentioned, our human data is building up on that story, and it makes me very hopeful that we are able to create something which is standing out in the crowd. This what we are doing really will make an impact for patients.

Speaker #3: I had access to the preclinical patches package. It has been well thought out, well planned, and well executed—impressive. And then, on top of that, as I mentioned, our human data is building up on that story, and it makes me very hopeful that we are able to create something which is standing out in the crowd. What we are doing really will make an impact for patients.

Juha Savola: Then on top of that, as I mentioned, our human data is building up on that story, and it makes me very hopeful that we are able to create something which is standing out in the crowd. This what we are doing really will make an impact for patients.

Speaker #1: Right. And now, as we prepare for phase two, what do you see as the most important elements of the study design so that we can maximize the chances of success, which is, of course, very critical?

Antti Vuolanto: Right. As we prepare for phase II, what do you see as the most important elements of the study design so that we can maximize the chances of success, which is, of course, very critical? The phase II is the critical step towards commercialization.

Speaker #1: The Phase 2 is the critical step towards commercialization.

Speaker #3: It is a critical step for any company. The principle is 'kill early.' We need to have a study which tells us if we need to stop this, treat the concept, and not invest anything, because it would likely be wasted money. Or, we need to have evidence and a signal that there is continued reason to believe in the compound.

Juha Savola: It is critical step for any company. The principle is kill early. We need to have a study which is telling us if we need to stop the concept and not invest anything of that because it would be likely wasted money, or we need to have evidence, a signal that there is continued reason in believing in the compound. This is the very solid stepping stone for us to move forward. The design has to be creative. The design has to be smart in a way that we are able, as I said, use every subject in the study to build up understanding if this drug is doing what we are expecting it to do and we hope it would be doing. So finding right elements for measuring the biological therapeutic benefit is important.

Speaker #3: And this is the very solid stepping stone for us to move forward. And the design has to be creative, the design has to be smart—and smart in a way that we are able, as I said, to use every subject in the study to build up understanding if this drug is doing what we are expecting it to do.

Speaker #3: And we hope it would be doing. So, finding the right elements for measuring the biological therapeutic benefit is important. For that, I think your choice of building up initial efficacy demonstration on smartphone is smart, obviously.

Juha Savola: For that, I think your choice of building up initial efficacy demonstration on a smartphone is smart, obviously, because it is so much more sensitive to detecting the subtle moment disorder symptom severity. It will be also more sensitive than traditional measures detecting if there is potential treatment benefit. So I believe that the compound is safe. That is based on phase I data is probably not a question anymore. The question is now what handle we can get. Parkinson's disease is not easy from that perspective. We are so much dependent on the Parkinson's subject behavior and what we can measure and how we can measure and quantify that disturbance. I think that is the tricky part in early patient populations.

Speaker #3: And because it's so much more sensitive to detecting these subtle movement disorder symptom severities, it will also be more sensitive than traditional measures in detecting if there's potential treatment benefit.

Speaker #3: So I believe that the compound is safe. That's based on phase one data—it's probably not a question anymore. The question is now what handle we can get. Parkinson's disease is not easy from that perspective.

Speaker #3: We are so much dependent on the Parkinson's subject behavior and what we can measure, and how we can measure and quantify that disturbance, and I think that's the tricky part in early patient populations.

Speaker #1: Yes. And taking a bit broader view, looking ahead, how would you define success for HER-096, considering the Parkinson's patients, and maybe also for Herantis?

Antti Vuolanto: Yes. A bit broader view looking ahead, how you would define a success for HER-096 considering the Parkinson's patients and maybe also Herantis? Considering phase II and beyond, what you could foresee here?

Speaker #1: So, considering Phase Two and beyond, what could you foresee here?

Speaker #3: What I can foresee is interesting. There is a potential that we are able to demonstrate potentially therapeutic benefit in this phase two study. We do everything we can to build a protocol where we are maximizing the probability of picking up the signal of therapeutic potential.

Juha Savola: What I can foresee is interesting. There is a potential that we are able to demonstrate potentially therapeutic benefit in this phase II study. We do everything we can to build a protocol where we are maximizing probability of picking up the signal of therapeutic potential. Without that, there is no path forward with this compound, and it is even our call and our ethical duty to the patient community out there to be honest with the data and see if there is a reason or not to continue developing.

Speaker #3: Without that, there is no path forward with this compound. And it is even our call and our ethical duty to the patient community out there to be honest with the data and see if there is a reason or not to continue development, if we are picking up the signal, if this study will be a sufficient stepping stone in developing this drug forward and should be ready for confirmatory phase three studies. There, we are truly demonstrating that it is benefiting the patients and their observations—how the disease is impacting their daily activities—can be documented and can be demonstrated. And then, with those data, the product can be taken to global markets.

Juha Savola: If we are picking up the signal, if this study will be a sufficient another stepping stone in developing this drug forward and should be ready for confirmatory phase III studies where we are truly demonstrating that it is benefiting the patients and their observations how the disease is impacting their daily activities can be documented and can be demonstrated, and then with those data, the product can be taken to global markets. Obviously, that confirmatory phase III program is beyond our reach. It does require global player. So for Herantis, these data are critical for licensing partner identification for the patient community. It is important additional flicker of hope that there is something will come up to benefit them. You mentioned that there are lots of activities going on in Parkinson's pipeline. That is good for patients. That is so important because there have been so many disappointing years.

Speaker #3: Obviously, that confirmatory Phase 3 program is beyond our reach. It does require a global player, so for Herantis, these data are critical for licensing partner identification. For the patient community, it's an important additional flicker of hope that something will come up to benefit them.

Juha Savola: So for Herantis, these data are critical for licensing partner identification for the patient community. It is important additional flicker of hope that there is something will come up to benefit them. You mentioned that there are lots of activities going on in Parkinson's pipeline. That is good for patients. That is so important because there have been so many disappointing years. Nothing really important has been introduced over couple of decades in Parkinson's field, and that is sad for anybody who is living with the disease.

Speaker #3: You mentioned that there are lots of activities going on in the Parkinson's pipeline that is good for patients. That is so important because there have been so many disappointing years. Nothing really important has been introduced over a couple of decades in the Parkinson's field, and that's sad for anybody who is living with the disease.

Juha Savola: Nothing really important has been introduced over couple of decades in Parkinson's field, and that is sad for anybody who is living with the disease.

Speaker #1: Yes, all right. With these words, let's continue with the Q&A session.

Antti Vuolanto: Yes. All right. With these words, let's continue with the Q&A session.

Speaker #2: Yes, and we have received many questions, but there is still room for more. So, what is the rationale for pursuing an FDA submission alongside the European CTA during Phase 2?

Tone Kvåle: Yes, and we have received many questions, but there is still room for more. What is the rationale for pursuing an FDA submission alongside the European CTA during phase II?

Speaker #1: That's, of course, a very good question. We are planning a European study. However, having the FDA’s blessing, as you will, would act as an external validation for the program.

Antti Vuolanto: That is of course a very good question. We are planning a European study. However, having FDA's blessing, as you will, would act as an external validation for the program. Juha, would you have any other view from the big pharma standpoint as you come from there?

Speaker #1: Would you have any other view from the Big Pharma standpoint, as you come from there?

Speaker #3: For them, it is important that FDA has both, and these pharma partners who we would be approaching need US clinical research conducted as well. And for that, it's a six-month prep work done already by us, so that when they got our data, we can have—and well, I'm saying we probably—we have a joint meeting with the FDA, and then phase three plans can be nailed down and the program can move forward.

Juha Savola: For them, it is important that FDA has both in these pharma partners who we would be approaching. They need US clinical research conducted as well. For that, it is a 6-month prep work done already by us so that when they got our data, we can have, and I am saying we, probably we have a joint meeting with the FDA, and then phase III plans can be nailed down and the program can move forward. It is a huge shortening of the wide space in development. It will be paid back to the licensing partner, and of course, market time will be much earlier.

Speaker #3: So, it's a huge shortening of the white space in development. So it will be paid back to the licensing partner, and of course, market time will be much earlier.

Speaker #1: Very good.

Antti Vuolanto: Very good.

Speaker #2: Next, what are the key milestones investors should expect over the next 12 months?

Tone Kvåle: Next, what are the key milestones investors should expect over the next 12 months?

Speaker #1: Yeah. Of course, as we already mentioned during the webcast, we are now preparing for the phase two. And there, of course, important milestones are to submit the clinical trial application by the end of the year, start the actual clinical trial patient treatments in the first half of next year, and, of course, before that we need to secure the resourcing of the phase two. As you mentioned already, too, we are in discussions with pharma related to partnering, we are in discussions with investors, and also non-dilutive financing.

Antti Vuolanto: Yeah. Of course, as we already mentioned during the webcast, we are now preparing for the phase II, and there, of course, important milestones are to submit the Clinical Trial Application by the end of the year, start the actual clinical trial patient treatments H1 of next year. And of course, before that, we need to secure the resourcing of the phase II with, as you mentioned already, Tone, we are in discussions with pharma related to partnering. We are in discussions with investors and also non-dilutive financing. And, of course, we are very confident that the timelines that we have communicated, they will hold, and we have a very good kickstart for the phase II program.

Speaker #1: And of course, we are very confident that the timelines we have communicated will hold, and we have a very good kickstart for the Phase 2 program.

Speaker #2: Yeah, good. In previous communication, you have referred to the upcoming phase 2a study, and it's now being called a phase 2. What has changed, and do you need more money for this?

Tone Kvåle: Yeah. Good. In previous communication, you have referred to the upcoming phase IIa study, and it is now being called a phase II. What has changed, and do you need more money for this?

Speaker #1: Yes, this is a very good question again. It's a tiny letter, an 'A', but it might have a certain meaning and, of course, claiming phase 2a or phase 2 is not a regulatory label—it's more like the company communication label.

Antti Vuolanto: Yes. This is a very good question. Again, it is a tiny letter, an A, but it might have a certain meaning. And of course, claiming phase IIa or phase II is not a regulatory label. It is more like the company communication label. And this is actually one thing that Juha actually brought with him, his big pharma view on how we should define items. So maybe, Juha, you could provide the rationale why you believe that phase II is the right wording and what does it mean for the phase III.

Speaker #1: And this is actually one thing that you have actually brought with you—it's a big pharma view on how we should define items. So maybe you could provide the rationale for why you believe that phase two is the right wording and what it means for phase three?

Speaker #3: Yes. To me, it was clear when I saw it after seeing our phase 1b data, our phase 1 data providing evidence of mechanism—proof of mechanism—and therefore I don't need to redo that in many patients.

Juha Savola: Yes. To me, it was clear when I saw it after seeing our phase I-B data, our phase I data providing evidence of proof of mechanism. I do not need to redo that in many patients. I want to design a study and want us to do and commit to conducting a study which is ready to build up understanding whether we can or we should not continue in the confirmatory study. With this number of patients we are considering, we should be able to support progressing into pivotal program.

Speaker #3: I want to design a study, and I want us to do and commit to conducting a study which is ready to build up understanding of whether we can, or we should not, continue into the confirmatory study.

Speaker #3: And with this number of patients we are considering, we should be able to support progressing into the pivotal program.

Speaker #1: And I can also confirm that there is no extra resources money required. So it's maybe a branding and labeling item, not as such a design item for the trial.

Antti Vuolanto: I can also confirm that there is no extra resources money required. So it is maybe a branding and labeling item, not as such

Antti Vuolanto: I can also confirm that there is no extra resources money required. So it is maybe a branding and labeling item, not as such a design item for the trial.

Tone Kvåle: Yeah

Antti Vuolanto: a design item for the trial.

Speaker #2: Yeah. Can you update us on the status of your other indications beyond Parkinson's disease? Are you doing any preclinical studies on those programs?

Tone Kvåle: Yep. Can you update us on the status of all your other indications beyond Parkinson's disease? Are you doing any preclinical studies on those programs?

Speaker #1: That's a very good question, and based, of course, on what we have disclosed earlier, we have almost fully concentrated on Parkinson's disease, and we have not divided our resources into other indications too heavily.

Antti Vuolanto: That's a very good question, and based, of course, on what we have disclosed earlier, we have almost fully concentrated on Parkinson's disease, and we have not divided our resources into other indications too heavily. However, I can mention that, yes, we have, for example, filed a patent application in a non-CNS indication earlier this year. We haven't disclosed what that indication is, and of course, there is no decisions to invest in that program. Our ambition is currently to secure that we can continue to phase II development, and then once the resources are there, we, of course, would like to invest more on the other indications. Of course, the mechanism of action really must support going also beyond Parkinson's disease. That's, of course, also the ambition of the company at the right point of time going forward.

Speaker #1: However, I can mention that, yes, we have, for example, filed a patent application in a non-CNS indication earlier this year. We haven't disclosed what that indication is, and, of course, there are no decisions to invest in that program.

Speaker #1: Our ambition is currently to ensure that we can continue to phase two development, and then, once the resources are there, we, of course, would like to invest more in the other indications, as the mechanism of action really must support going also beyond Parkinson's disease, and that's, of course, also the ambition of the company.

Speaker #1: At the right point in time. Going forward.

Tone Kvåle: Referring to the phase II trial, the upcoming one, can you define early state with some symptoms and Finland, and is it this? Can North Finland also be involved in clinical tests? How do we apply for the testing group?

Speaker #2: Referring to the Phase Two trial, the upcoming one, can you define early stage, with some symptoms, in Finland? And is it—can North Finland also be involved in clinical tests?

Speaker #2: How do we apply for the testing group?

Speaker #1: Yes. Maybe you could comment on this. How is the practicality?

Antti Vuolanto: Yes, maybe Juha, you could comment on this, how the practicality is practiced.

Juha Savola: Yes. Thank you. It's a good question. We do use only clinical assessment to define if somebody is early with their disease progression or more advanced. That is well established in clinical research of Parkinson's disease. We are looking subjects who are not long time ago diagnosed, but we are looking for subjects who are quite recently diagnosed. That is one way of identifying right patient population. That's important so that we are not having very diverse group of people with different stages of disease. Now, what investigators, what sites, and geographical access we are looking is first of all driven by identifying sites and investigators, doctors who are experts in this field of clinical research. That is not really putting a pin on a map and say, we need to do it here. We do it there if there's an expert of the sort we need.

Speaker #3: Yes, thank you. That's a good question. We do use only clinical assessment to define if somebody is early in the disease progression or more advanced.

Speaker #3: That is well established in clinical research of Parkinson's disease. We are looking for subjects who were not diagnosed a long time ago, but we are looking for subjects who are quite recently diagnosed. That is one way of identifying the right patient population, and that's important.

Speaker #3: So that we are not having a very diverse group of people with different stages of disease. Now, what investigators, what sites and geographical access we are looking at is first of all driven by identifying sites and investigators—doctors—who are experts in this field of clinical research.

Speaker #3: And that is not really putting a pin on a map and saying we need to do it here. We do it there if there’s an expert of the sort we need.

Speaker #3: But we, as a sponsor, have many mechanisms in our repertoire which we can use to facilitate if somebody lives in the northern part of Finland and our investigators are in the southern part of Finland, then how we facilitate that back-and-forth movement.

Juha Savola: But we, as a sponsor, we have many mechanisms in our repertoire which we can use to facilitate if somebody lives in northern part of Finland and our investigator is in the southern part of Finland, then how we facilitate that back and forth movement. It will be a logistical challenge in a country like Finland, which is very long country. So it is going to be unfair when it comes to geography.

Speaker #3: But it will be a logistical challenge in a country like Finland, which is a very long country. So it is going to be unfair when it comes to geography.

Speaker #1: And maybe I'll continue a bit. So, in practice, we are now planning to submit the clinical trial application, and once we get the approval, then we can activate the patient recruitment activities. Herantis, as a sponsor, does not recruit the patients directly.

Antti Vuolanto: And maybe I will continue a bit. So in practice, we are now planning to submit the Clinical Trial Application, and once we get the approval, then we can activate the patient recruitment activities. Herantis as a sponsor does not recruit the patients directly, so it will be the clinical sites who will actually recruit the patients. And of course, we as a sponsor will also publish guides how to conduct the investigators and how to get involved into the trial. But this will be informed the patient community as soon as we have all the required information available.

Speaker #1: So, it will be the clinical sites who will actually recruit the patients, and of course, we as a sponsor will also publish guides on how to conduct the investigators and how to get involved in the trial.

Speaker #1: But this will be informed to the patient community as soon as we have all the required information available.

Speaker #3: Very important addition. Thank you.

Juha Savola: Very important addition. Thank you.

Speaker #2: Yeah. What is the expected cost for the phase two study, and what additional financing is needed until its completion and results are known?

Tone Kvåle: Yeah. What is the expected cost for the phase II study? And what additional financing is needed until its completion and results will be known?

Speaker #1: Yes. As already earlier disclosed, the trial cost lands somewhere around €20 million, and the total financing need of the company is around €30 to €35 million, from which we have secured that €8 million EU non-dilutive grant. And a reminder that we do have a commitment from the EIC fund for equity investments, and based on the term sheet that we signed in 2023, they can have up to one-third of equity financing.

Antti Vuolanto: Yes. As already earlier disclosed, the trial cost lands somewhere around EUR 20 million, and the total financing need of the company is around EUR 30 to 35 million, from which we have secured that 8 million EU grant, non-dilutive EU grant. A reminder that we do have a commitment from EIC Fund for equity investments. Based on the term sheet that we signed 2023, they can have up to one third of equity finances if we go through that route. Of course, once we go a bit further with the resourcing of the phase II trial, we will definitely inform the market in due course about any development on that side.

Speaker #1: If we go through that route, and of course, once we go a bit further with the resourcing of the phase two trial, we will definitely inform the market in due course about any developments on that side.

Speaker #2: Good morning. Thanks for the presentation, and congratulations on the progress. Developments so far this year have been encouraging. Can you share how discussions have evolved since the start of the year?

Tone Kvåle: Good morning. Thanks for the presentation and congratulations with the progress. Development so far this year have been encouraging. Can you share how discussions have been evolved since the start of the year? Would you prefer outcome be to secure a partner before phase II starts, or will you retain greater ownership through the proof of concept readout?

Speaker #2: Would your preferred outcome be to secure a partner before Phase II starts, or would you retain greater ownership through the proof of concept without one?

Speaker #1: A very good question. And that's also, of course, the thing that the company and the board of directors are continuously assessing—what makes sense, what are the options. As we have quite openly communicated, we have had very intimate discussions with several both global and, maybe, more regional partners over the years.

Antti Vuolanto: A very good question, and that is of course, the thing that the company and the board of directors are continuously assessing what makes sense, what are the options. As we have quite openly communicated, we have had very intimate discussions with several, both global and maybe more regional partners over the years. As already mentioned, we will inform the market in due course when there are any developments. But of course, the question is correct that we need to consider the ownership retainment, and relate it to phase II and what actually builds the biggest value for our shareholders. That is of course, something that we want to secure that in the longer term, our shareholders gets the best value, which would be aligned with the value of HER-096 and the value for the patients. So everything is in the same basket.

Speaker #1: And as already mentioned, we will inform the market in due course when there are any developments. But, of course, the question is correct that we need to consider the ownership retainment related to Phase Two, and what actually builds the biggest value for our shareholders. And that's, of course, something that we want to secure—that in the longer term, our shareholders get the best value.

Speaker #1: Which would be aligned with the value of HER-096 and the value for the patients, so everything is in the same basket.

Speaker #2: Should we expect a material step up in R&D and cash burn through the next half year, and also into 2027, as manufacturing, regulatory, and site activities accelerate?

Tone Kvåle: Should we expect a material step up in R&D and cash burn through the next H2 and also into 2027 as manufacturing, regulatory, and site activities accelerate?

Speaker #1: Yes, definitely, that's a valid point. So, when we approach and start the Phase 2 trial, of course the R&D expenses will increase. But as Tune already mentioned during the presentation, to activate the Phase 2 we need to secure more resources for that.

Antti Vuolanto: Yes, definitely, that's a valid point. When we approach and start the phase II trial, of course, the R&D expenses will increase. But as Tone already mentioned during the presentation, to activate the phase II, we need to secure more resources for that. Just follow the news flow, that will explain what are the next steps and how we ramp up with the phase II execution.

Speaker #1: So just follow the news flow, and that will explain what the next steps are and how we ramp up with the Phase 2 execution.

Speaker #2: Yeah. With the discontinuation of the Biogen-Denali program in early-stage Parkinson's disease, from your perspective, what are the key differences between that program and HERO96?

Tone Kvåle: Yeah, with the discontinuation of Biogen/Denali's program in early stage Parkinson's disease, from your perspective, what are the key differences between the program and HER-096? Does the program failure, if anything, reinforce your approach based on a biomarker-supported mechanism and a more sensitive digital primary endpoint?

Speaker #2: Does the program failure, if anything, reinforce your approach based on a biomarker-supported mechanism and a more sensitive digital primary endpoint?

Speaker #1: Yeah. First of all, the Biogen-Denali mechanism was very, very different from what we have at Herantis. Their approach was targeting a specific kinase target, which is expressed actually in a fraction of patients, but in this trial they wanted to treat idiopathic, so all comers in a way.

Antti Vuolanto: Yeah, first of all, the Biogen/Denali mechanism was very, very different from what we have at Herantis. Their approach was targeting a specific target, a kinase target, which is expressed actually in a fraction of patients. But in this trial, they wanted to treat idiopathic, so all comers in a way. They showed in the trial that on that broad patient population, it wasn't efficacious with the study set-up that they built. Considering our mechanism of action, which is very broadly addressing the core biology of Parkinson's disease, it's very different. What was the second part of the question?

Speaker #1: And they showed in the trial that, on that broad patient population, it wasn't efficacious with the study setup that they built. And considering our mechanism of action, which is very broadly addressing the core biology of Parkinson's disease, it's very different.

Speaker #1: What was the second part of the question?

Speaker #2: Does the program failure refer to that, or does it in any way reinforce your approach based on a biomarker-supported mechanism and more sensitive digital primary endpoints?

Tone Kvåle: Does the program failure, referring to that, if anything, reinforce your approach based on biomarker-supported mechanism and a more sensitive digital primary endpoint?

Speaker #1: I wouldn't say that the failure itself had an impact on our plans. But of course, it means that there is less competition, and we are stepping more visibly across the different approaches for Parkinson's disease modification.

Antti Vuolanto: I wouldn't say that the failure itself had an impact on our plans, but of course, it means that there is less competition, and we are stepping more visible across the different approaches for Parkinson's disease modification. Would you have any additions here?

Speaker #1: Would you have any additions here?

Speaker #3: Yes. I would like to emphasize even this laser-focused mechanism of action that they had, and how they selected the patient population based on publicly available information.

Juha Savola: Yes. I would like to emphasize even this laser-focused mechanism of action, what they had and how they selected the patient population based on publicly available information. Need to remind that we have very little information of the details of the study. Interestingly, Denali wants to continue in this genetically identified subpopulations. So it is telling me that there is something still which we don't understand from the data, and they might. I agree with you, their outcome is not informing us on our risk profile moving forward. It is informing us that you can implement a smartphone-based data collection in a quite substantially big phase II study. So at least one technical learning, which is supporting our decision making, is coming from that study.

Speaker #3: We need to remind that we have very little information about the details of the study. And interestingly, Denali wants to continue in these genetically identified subpopulations.

Speaker #3: So it is telling me that there is something still which we don't understand from the data. They might. I agree with you—their outcome is not informing us on our risk profile moving forward.

Speaker #3: It is informing us that you can implement a smartphone-based data collection in a quite substantially big phase two study. So, at least one technical learning which is supporting our decision-making is coming from that study.

Speaker #1: And actually, combining those data together with published data from Roche helps us to define the statistical power behind the selected patient population and the number of patients.

Antti Vuolanto: Actually continuing that, those data together with published data from Roche helps us to define the statistical power behind the selected patient population and the number of patients. So it will help us in the phase II conduct and reinforce the probability of success for us.

Speaker #1: So it will help us in the Phase 2 conduct and reinforce the probability of success for us.

Speaker #2: Yes. From your comments, if all goes to plan, what is the timeline toward a Phase 3 trial?

Tone Kvåle: Yes. From your comments, if all goes to plan, what is the timeline towards a phase III trial?

Speaker #1: Yes. So basically, as I explained earlier today, we expect to have the interim efficacy readout in early 2029. That, of course, could already potentially trigger discussions with regulatory authorities.

Antti Vuolanto: Yes. Basically, as I explained earlier today, we expect to have the interim efficacy readout early 2029, and that, of course, would already potentially trigger discussions with regulatory authorities during 2029 or early 2030, which would mean that we would, of course, want to initiate the pivotal phase III program maybe within a year or even less time from the end of the phase II trial. Then, of course, depending on the results, we need to, together with the regulatory authorities, discuss what is the right setup for the pivotal program, the length, the number of patients. It really depends on the data that we will be able to get from phase II. But now we do have the visibility already to the pivotal program, at least some shape and form. Any additions, Juha?

Speaker #1: During 2026, or 2029, or early 2030—which would mean that we would, of course, want to initiate the pivotal Phase 3 program maybe within a year, or even less time, from the end of the Phase 2 trial.

Speaker #1: And then, of course, depending on the results, we need to, together with the regulatory authorities, discuss what is the right setup for the pivotal program—the length, the number of patients really depends on the data that we will be able to get from Phase Two.

Speaker #1: But now we do have visibility already into the pivotal program, at least in some shape and form. Any additions you have?

Speaker #3: And now, coming back to Pick Pharma—where timelines are not always met, and these so-called white spaces between phase transitions are not always so critical.

Juha Savola: Coming back from big pharma, where timelines are not always in this so-called wide space between phase transitions, it is not always so critical. It is very difficult for us to control that, and they might go through their committees and spend time in planning and replanning. So it is difficult for us to predict when the market is. But what are the timelines you just referred to? Those are achievable.

Speaker #3: It is very difficult for us to control that, and they might go through the committees and spend time in planning and re-planning, so it is difficult for us to predict when the market is.

Speaker #3: But what are the timelines you just referred to? Those are achievable. They are achievable, and 2030 immediately after that should be doable. It does require that a few of the stars align.

Antti Vuolanto: Yes.

Juha Savola: They are achievable, and 2030, immediately after that, should be doable. It does require that a few of the stars align. There has to be compelling data coming from this study. There has to be a strong committed partner, which is, of course, important decision-making for us as well, and that they have the motivation to keep going with the pace we have started.

Speaker #3: There has to be compelling data coming from this study. There has to be a strong, committed partner, which is, of course, important in decision-making for us as well.

Speaker #3: And that they have the motivation to keep going at the pace we have started.

Speaker #2: Yes, I think that concludes the Q&A session. It's going to be a very busy second half of this year, and I guess we are looking forward to updating the market about the progress.

Tone Kvåle: Yes, I think that concludes the Q&A session. It is going to be a very busy H2 of this year. I guess we are looking forward to updating the market about the progress. Do you have any closing remarks?

Speaker #2: Do you have any closing remarks?

Speaker #1: Yes. So thank you for spending the time with us. I hope that there was a big audience who were there for almost the full hour, which is, I think, the record length for the first half webinars.

Antti Vuolanto: Yes. Thank you all for spending us the time. I hope that there is a big audience who were there almost the full hour, which is, I think, the record length for the H1 webinars. Of course, the discussion with Juha and the many questions from the audience, relevant questions there, we were really happy to answer these questions. I hope you all a very nice August, late summer, and please keep tuned about the news about Herantis as we go forward to very exciting moment in Herantis, but also overall for the whole Parkinson's community. Thank you for watching.

Speaker #1: Of course, the discussion with Juha and the many questions from the audience were relevant questions. There, we were really happy to answer these questions. So I hope you all have a very nice August, late summer, and please stay tuned for news about Herantis as we go forward to a very exciting moment in Herantis, but also overall for the whole Parkinson's community.

Speaker #1: So thank you for watching.

Juha Savola: Thank you.

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Half Year 2026 Herantis Pharma Oyj Earnings Call

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