Herantis H1'25 preview: Clinical Phase I nearing completion

Source: Inderes

Translation: Original published in Finnish on 8/19/2025 at 7:47 am EEST.

Herantis will publish its H1 report on Thursday, August 21, at 8.00 am (EEST). The webcast starts at 10 am and can be viewed here. The company initiated a Phase Ib clinical study in Parkinson's disease with the investigational drug HER-096 in H2 last year. The first results are expected to be completed in the coming weeks, and the full study data will be released by the end of the year. During the review period, the company announced a directed share issue, which was in line with our expectations. The current funding should be sufficient to complete Phase Ib, prepare for Phase II and advance partnering negotiations. For H1'25, we expect an operating result of -2.1 MEUR and earnings per share of -0.10 EUR.

Phase I Parkinson's disease trial matures this year

In late 2023, Herantis completed a Phase Ia study showing that HER-096, an investigational drug in development for Parkinson's disease, crosses the blood-brain barrier. This means that HER-096 is reaching its intended target in the central nervous system. There were also no tolerability concerns, which helped reduce the risk associated with development and paved the way for further development of the candidate. In H2'24, a Phase Ib trial was initiated with the primary objective of evaluating the safety and tolerability of subcutaneously administered HER-096 in healthy volunteers and Parkinson's disease patients. Herantis recently announced that the final patient visit for the study had been completed on schedule. First results can be expected at the turn of September-October and a full analysis of the results by the end of the year. Results have been promising so far. Based on the data so far, it appears that the company would have no obstacles to moving to Phase II in terms of results. However, more robust conclusions can only be drawn towards the end of the year, when further results become available for assessment.

Current funding sufficient to prepare for Phase II

Regarding financing, Herantis received 3.6 MEUR in research funding last summer, which ensures the execution of Phase Ib. The company also announced a directed issue of 5.2 MEUR in February, which was almost fully in line with our expectations. With the funding secured, the company will prepare for the Phase II trial and advance partnering negotiations to fund future trials.

High-potential, high-risk drug development company

Herantis is developing HER-096 as a disease-modifying treatment for Parkinson's disease. The development is at an early clinical stage, so there is a high risk of market entry and it will take time to conduct the necessary studies. There are currently no drugs on the market that affect the progression of the disease, so the commercial opportunity to offset the risk is significant. In terms of its mechanism of action, HER-096 may also have potential for the treatment of other neurodegenerative diseases. No information is currently available regarding potential clinical study programs for these.