Herantis H2’24 preview: Phase I clinical trial to be completed this year

Translation: Original published in Finnish on 3/4/2025 at 7:56 am EET.

Herantis will publish its H2 report on Thursday, March 6. The webcast starting at 2:30 pm (EET) can be viewed here. The company initiated a Phase Ib clinical trial in Parkinson's disease with HER-096 during the reporting period. Key results should be ready by Q3'25. After the review period, the company reported a directed 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 H2'24, we expect an operating result of -2.4 MEUR and earnings per share of -0.12 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. At the end of January, Herantis announced that the trial had progressed to the first patient with Parkinson's disease. The trial is on schedule and is expected to be completed in Q3'24.

Current funding sufficient to prepare for Phase II

As far as funding is concerned, Herantis received 3.6 MEUR research funding last summer to ensure the implementation 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. We have described the company's situation in more detail in our recent Initiation of coverage report.