Herantis Pharma partners with Indivi to enable detection of early treatment effects in upcoming HER-096 Phase 2 trial in Parkinson’s disease

Herantis Pharma Plc – Press release

• Indivi’s digital biomarker platform is designed to enable earlier and more sensitive detection of treatment-related changes
• Improved sensitivity and reduced variability may support more efficient clinical studies, including shorter study duration and smaller patient cohorts

Espoo, Finland, May 19, 2026: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, announces a collaboration with Indivi, a Basel-based TechBio company focused on advancing precision medicine in neuroscience drug development, to integrate Indivi’s digital biomarker platform into Herantis’ upcoming Phase 2 proof-of-concept study of HER-096 in people living with Parkinson’s disease.

Indivi’s platform provides functional digital biomarkers derived from smartphone-based assessments of motor and cognitive function, enabling sensitive high-frequency multi-domain disease phenotyping that may support earlier detection of treatment-related changes compared to conventional clinical assessments.

Under the collaboration, Herantis Pharma will incorporate Indivi’s platform alongside conventional clinical assessments in its upcoming double-blind, placebo-controlled, randomized Phase 2 study of HER-096, with the aim of detecting early changes in motor and cognitive function following treatment.

Preparations for the proof-of-concept study are on track and are being further optimized for the integration of Indivi’s digital biomarker platform. Herantis expects to provide additional updates on the Phase 2 trial following completion of the study design.

Antti Vuolanto, CEO of Herantis Pharma, said: “Digital biomarkers have the potential to significantly improve the sensitivity and efficiency of clinical development in Parkinson’s disease. Following an evaluation of available digital health technology solutions, we selected Indivi based on the strength of its scientific capabilities, platform performance, and experience supporting neuroscience clinical studies with leading biotechnology and pharmaceutical companies. We believe the ability to sensitively detect early treatment-related changes in motor and cognitive function may become an important advantage in evaluating the therapeutic potential of HER-096. We are very pleased to collaborate with Indivi and look forward to working together to further strengthen the clinical evaluation of HER-096.”

Shibeshih Mitiku Belachew, Chief Medical Officer of Indivi, said: “We are excited to collaborate with Herantis on HER-096 program, a promising and differentiated investigational therapy for disease modification in people living with Parkinson’s disease. The mechanism of action of HER-096 is highly compelling, and we believe our digital biomarker platform is particularly well suited to capturing early symptomatic signals and treatment-related changes with greater sensitivity and precision than conventional assessments.”

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For more information, please contact:

Herantis Pharma:

Tone Kvåle, CFO Tel: +47 915 19576 Email: [email protected]

ICR Healthcare**:**

Sarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage Tel: +44 20 3709 5700 Email: [email protected]

Certified Advisor:

UB Corporate Finance Ltd Tel.: +358 9 25 380 225 E-mail: [email protected]

About Herantis Pharma Plc

Herantis Pharma Plc is a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease. The Company’s lead product, HER-096, is a first-in-class small peptide that combines the neuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF), with the convenience of subcutaneous administration. In a Phase 1b clinical trial, HER 096 was shown to be generally safe and well tolerated in Parkinson’s disease patients. Herantis plans to advance HER-096 into a Phase 2 clinical trial in 2026 to evaluate efficacy, safety and tolerability in early-stage Parkinson’s patients.

Herantis is listed on the Nasdaq First North Growth Market Finland.

Company website: www.herantis.com

About HER-096

Herantis Pharma is developing HER-096, a first-in-class drug candidate with the potential to stop the progression of Parkinson’s disease, repair striatal damage and significantly improve both an individual’s symptoms and quality of life.

HER-096 is a small peptide molecule based on the active site of and designed to mimic the activity of cerebral dopamine neurotrophic factor (CDNF), a protein known to promote neuronal cell survival and functional recovery.

HER-096’s multimodal mechanism of action targets key drivers of neurodegeneration in PD by modulation of the Unfolded Protein Response (UPR) pathway, reducing aggregation of the neurotoxic protein α-synuclein, and modulation of neuroinflammation. Combined with its demonstrated brain penetration, this enables HER-096 to protect dopamine neurons from further degeneration and supports their functional restoration.

About Indivi

Indivi is a Basel-based TechBio company advancing precision medicine in neuroscience drug development. Neurodegenerative diseases have historically low success rates, with high attrition during the transition from first-in-human to proof-of-concept studies, where conventional endpoints often lack sensitivity to detect early therapeutic effects. Indivi’s multi-modal deep phenotyping platform integrates digital measurement tools, including motor assessments and CoGames - a proprietary battery of gamified, user-adaptive cognitive assessments. These tools increase the signal-to-noise ratio of clinical endpoints, enabling more precise and sensitive detection of treatment effects.