Herantis' Phase I trial achieved all its objectives

Translation: Original published in Finnish on 10/8/2025 at 7:25 am EET.

Herantis Pharma issued a press release on Tuesday evening regarding the main results of its clinical Phase Ib trial of HER-096, its drug candidate for Parkinson's disease. The study achieved all primary and secondary objectives set for it. The results thus clearly support moving to the next research phase and were also in line with previous data and our expectations. The company will hold a press conference on the results on Wednesday at 1 pm EEST. The event can be followed here. We will update our view by Thursday morning, once all information from the press conference is available. Based on our preliminary assessment, the stock's risk level decreases by one notch due to the positive results.

Trial objectives were met and there were no surprises

The primary objective of the study was to demonstrate the safety and tolerability of the drug candidate. According to Herantis, repeated doses of HER-096 were generally safe and well tolerated in patients with Parkinson's disease. The secondary objective was to determine the pharmacokinetics, i.e., the behavior of the drug in the body. The results confirmed that the drug effectively crosses the blood-brain barrier, meaning it reaches its target in the central nervous system. This is a critical feature for the drug's function, for which preliminary promising results were obtained earlier. According to the company, the concentrations achieved in the cerebrospinal fluid were at a level where pharmacological effects can be expected. In other words, the drug candidate reaches its target and remains there long enough for potential therapeutic effects to be achieved in the future. Regarding dosage, 300 mg/kg administered subcutaneously twice a week appears to have been selected as the best option for the next phase, according to the release. The trial was not designed to assess efficacy, so evidence in this regard will have to await the next phase.

Financing solution paves the way for the next clinical phase

According to the company, the results support the progression of HER-096 to a Phase II trial, which the company plans to initiate during 2026. We have already stated in our previous reports that the results support the continuation of the study. Reflecting this, in our H1’25 report, we had already raised the probability of Phase 1 success in our model to a rather high 75%. The results now obtained are thus in line with previously obtained results and our expectations. With good results, the risk profile of drug development will, in our view, decrease by one notch, although the overall risk level remains quite high. Herantis expects the entire study dataset, including exploratory biomarker results, to be completed by the end of 2025. These may provide additional information on the drug's behavior and effects, but in our opinion, the main results now published were the most important prerequisite for the project's continuation.

The next significant step for the company is securing funding for the Phase II trial. The company has previously stated that it aims to enter into a partnership agreement with a larger pharmaceutical company. In our view, the strong results now obtained support Herantis' negotiating position for a potential partnership agreement.