Key step achieved in advancing HER-096 towards Phase 2 efficacy trial
Espoo, Finland, 26 November 2025: Herantis Pharma Plc (“Herantis”), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today announces the successful completion of a six-month preclinical Good Laboratory Practice (GLP) toxicology study for its lead clinical asset, HER-096. The study demonstrated a favorable safety and tolerability profile, well aligned with the previous pre-clinical and clinical data. These results provide further confidence in the compound’s suitability for long-term administration and represent another important milestone on the path towards a Phase 2 clinical efficacy trial.
“The successful completion of this long-term toxicology study marks another important step forward for our HER-096 program”, said Henri Huttunen, CSO of Herantis Pharma. “Together with the positive results from our Phase 1b trial, we now have a comprehensive safety and pharmacokinetic dataset that provides a strong foundation for advancing HER-096 into Phase 2 clinical development. We are excited by the growing body of evidence for HER-096 as a potentially game-changing therapy that could become the first disease-modifying and neurorestorative treatment for Parkinson’s disease.”
The completion of the preclinical toxicology program also marks the final milestone of the EIC Accelerator Grant project, which began in 2023. The grant of EUR 2.5 million also enabled Herantis to advance its biomarker development program, the results of which have already been applied in exploratory biomarker analyses within the Phase 1b clinical trial.
Herantis recently (October 7, 2025) announced positive topline results from its Phase 1b trial of HER-096 in people living with Parkinson’s disease, with all primary and secondary endpoints met. Importantly, pharmacokinetic data were consistent with those observed in healthy volunteers, and efficient brain penetration was confirmed. Herantis expects to report the Phase 1b biomarker data by mid-January 2026, in advance of the JP Morgan Healthcare Conference week in San Francisco, where the Company’s management will be available for meetings.
Herantis plans to initiate a Phase 2 clinical trial in 2026 to evaluate the efficacy, safety, and tolerability of HER-096 in people with Parkinson’s disease.
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), an endogenous human 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.
Herantis has established a strong foundation of evidence in both preclinical and clinical settings. CDNF, has demonstrated robust neuroprotective and neurorestorative effects in preclinical models. In a Phase 1 clinical trial with intracranial CDNF conducted in 17 patients with moderately advanced Parkinson’s disease, encouraging signs of clinical improvements and biological responses were observed. To overcome the need for intracranial delivery required for CDNF, Herantis developed HER-096 that has shown compelling preclinical results, demonstrating the full neurorestorative potential of CDNF. Importantly, brain penetration of HER-096 has been confirmed in Parkinson’s patients at levels comparable to those associated with optimal efficacy in preclinical models, and the compound’s safety profile following subcutaneous administration has proven highly favorable.
For more information, please contact:
Herantis Pharma:
Antti Vuolanto, CEO
Tel: +358407517329
Tone Kvåle, CFO
Tel: +47 915 19576
Email: ir@herantis.com
Sarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage
Tel: +44 20 3709 5700
Email: herantispharma@icrhealthcare.com
Certified Advisor:
UB Corporate Finance Ltd
Tel.: +358 9 25 380 225
E-mail: ubcf@unitedbankers.fi
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
Forward-looking statements
This release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Herantis’ future financial position and results of operations, the Company’s strategy, objectives, future developments in the markets in which the Company participates or is seeking to participate or anticipated regulatory changes in the markets in which the Company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “potential,” “predict,” “projected,” “should” or “will” or the negative of such terms or other comparable terminology. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company’s actual results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release. Factors, including risks and uncertainties that could cause these differences include, but are not limited to risks associated with implementation of Herantis’ strategy, risks and uncertainties associated with the development and/or approval of Herantis’ drug candidates, ongoing and future clinical trials and expected trial results, the ability to commercialize drug candidates, technology changes and new products in Herantis’ potential market and industry, Herantis’ freedom to operate in respect of the products it develops (which freedom may be limited, e.g., by competitors’ patents), the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. In addition, even if Herantis’ historical results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, are consistent with the forward-looking statements contained in this company release, those results or developments may not be indicative of results or developments in subsequent periods.
