Analyst Comment

Herantis partners with Indivi in HER-096 Phase II trial

Summary

Herantis has partnered with Indivi to integrate a digital biomarker platform in the Phase II trial of the HER-096 drug candidate for Parkinson's disease.
Indivi's technology, which uses smartphone-based assessments, allows for more frequent and sensitive monitoring of motor and cognitive functions compared to traditional methods.
The use of digital tools is expected to enhance the study's ability to detect treatment effects, potentially facilitating a Phase III trial and marketing authorization.
Herantis plans to start the Phase II study during 2026, but additional funding is required.

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Translation: Original published in Finnish on 5/20/2026 at 6:56 am EEST.

Herantis announced on Tuesday that it had entered into a collaboration agreement with Switzerland-based Indivi for the integration of its digital biomarker platform in the upcoming Phase II study of the HER-096 drug candidate. The news is an anticipated step forward in trial design, as we have previously estimated that the company planned to use digital methods to monitor patients' symptoms. This technology can improve the study's sensitivity to detect potential treatment effects within a relatively short follow-up period.

Indivi's technology uses smartphone-based assessments of motor and cognitive function, enabling more frequent and sensitive symptom monitoring than traditional clinical methods. Parkinson's disease typically progresses slowly, making it challenging to demonstrate the drug's potential efficacy in a Phase II trial, which we estimate will last approximately 6–12 months. Incorporating digital tools into the upcoming study is indeed welcome because they can improve the study’s signal-to-noise ratio and help identify more acute treatment effects. In practice, we believe the tool increases the likelihood of identifying a potential treatment response, which could help facilitate the conduct and funding of a Phase III trial aimed at obtaining marketing authorization. Similar digital tools have already been utilized in drug development in this field, such as in Roche’s ongoing Phase III Parkinson’s study. Herantis aims to initiate the Phase II study during 2026, for which additional funding is still needed.

Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096 is a small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. HER-096 combines the mechanism of action of CDNF with subcutaneous administration. The Phase 1a clinical trial demonstrated a good safety and tolerability profile as well as blood-brain barrier penetration of subcutaneously administered HER-096. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.

Key Estimate Figures05.03

	2025	26e	27e
Revenue	0.0	0.0	0.0
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EBIT (adj.)	-6.4	-4.3	-7.4
EBIT-% (adj.)	-63,990.0 %	-43,499.8 %	-74,394.4 %
EPS (adj.)	-0.27	-0.13	-0.21
Dividend	0.00	0.00	0.00
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P/E (adj.)	neg.	neg.	neg.
EV/EBITDA	neg.	neg.	neg.