Translation: Original published in Finnish on 11/6/2026 at 7:45 am EET.

On Thursday, Herantis published an update on its plans and preparations for the upcoming Phase 2 trial of its drug candidate HER-096. Preparations for the trial are proceeding according to previous plans and timelines. Recent progress includes scaling up production and developing an improved drug product. A new study on the smartphone-based digital motor score (DMS) used by Herantis was recently published, reinforcing existing evidence of the method’s effectiveness in measuring the symptoms of Parkinson’s disease. The method was already part of Herantis’ plan, and it improves the likelihood of detecting a potential treatment response in the upcoming study. This is also supported by a blinded, controlled follow-up period slightly longer than originally planned. Overall, the company says the study timeline and funding requirement are unchanged. With preparations on track, the release does not change our view. Near-term milestones include submitting the clinical trial application by the end of the year, enrolling the first patient in H1'27, and securing the remaining funding needed for the study.

Digital measure supports efficacy assessment

The Phase 2 HERMOD study evaluates the tolerability, safety, and preliminary efficacy of Herantis’ drug candidate HER-096 over a 15-month dosing period (nine months double-blind and placebo-controlled, followed by six months open-label). The Phase 1 study in 2023–2025 already confirmed good short-term tolerability and the expected behavior of the drug in the body. In the HERMOD trial, the primary efficacy endpoint is the Digital Motor Score (DMS), a smartphone-based measure developed by Indivi. According to the press release, recent analyses show the measure to be ~2.5 times more sensitive to disease progression than conventional clinical assessments, which can reduce the number of patients needed to detect the same treatment effect by an estimated 80%. Parkinson’s disease typically progresses slowly, and in our view, statistically verifying a disease-modifying effect with conventional methods in a 15-month study of ~100 patients would be uncertain. Detecting an efficacy signal is also critical, as we believe statistically significant results in this study are central to the candidate’s further development. Using a digital biomarker thus allows Herantis to run a cheaper and shorter Phase 2 study while still offering a realistic chance of demonstrating an efficacy signal.

Preparations progressing toward trial start next year

Alongside the clinical trial design, Herantis has also made progress in drug substance manufacturing and drug product development. The company has scaled up HER-096 production from hundreds of grams in Phase 1 to multi-kilogram scale, while lowering unit costs. The drug product has also been improved so that the 300 mg dose, estimated to be optimal based on the full Phase 1 trial, can be administered as a single subcutaneous injection. This improves patient convenience and supports the drug’s potential future commercial profile. The study timeline is unchanged: the clinical trial application is to be submitted by the end of 2026, with the first patients expected to receive treatment in H1'27. Conducting the trial still requires securing the remaining funding. We believe the company will primarily seek non-dilutive financing, such as a licensing agreement or foundation grants. Equity financing is also an option, and in our view a moderately likely one. We discussed the financial position in more detail in our recent comment on the H1 report.

Long-term work on treating neurodegenerative diseases

Herantis’ HER-096 has been developed as a disease-modifying drug candidate for Parkinson’s disease. Current medications only treat the symptoms of the disease, so if successful, the candidate could significantly change the treatment of Parkinson’s disease. Given its mechanism of action, HER-096 could also be a potential drug candidate for other neurodegenerative diseases, such as Alzheimer’s disease. For now, however, Herantis’ clinical program focuses purely on Parkinson’s disease.

The upcoming Phase 2 study is designed to high standards and will yield valuable data on the properties of HER-096 on its completion in 2029. Obtaining marketing authorization will then require an even larger and presumably longer Phase 3 study. If the results are favorable, we estimate that marketing authorization could be obtained in 2034. In the longer term, we estimate HER-096’s peak sales potential at ~6 BEUR (detailed calculations in our extensive report and company reports). This estimate is subject to significant uncertainty in both directions, as the commercial potential ultimately depends on many variables, such as the drug’s safety and efficacy, its pricing, and the number of eligible patients. We estimate the probability of marketing authorization at ~15% based on historical success rates in the industry. We have previously written about the probabilities of drug development success in general terms here. The most uncertain phase in drug development is typically Phase 2, where the efficacy signal must be strong enough to justify a pivotal Phase 3 study.