Herantis Pharma presents positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease

Herantis Pharma announces positive topline data for HER-096 in Phase 1b trial for people living with Parkinson’s disease

Trial meets all primary and secondary endpoints establishing a strong foundation to Phase 2

The clinical trial demonstrated that both repeated 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in Parkinson’s disease (PD) patients.
Results from the clinical trial demonstrated a pharmacokinetic profile consistent with predictions from the single-dose studies in healthy volunteers. Importantly, blood-brain barrier penetration was confirmed in Parkinson’s disease patients.
Data indicate that twice-weekly dosing regimen with 300 mg dose is suitable for a Phase 2 trial.
Phase 1b safety, tolerability, and pharmacokinetic data strongly support advancing HER-096 into a Phase 2 trial to assess efficacy.
The full dataset, including exploratory biomarker data, is expected before the end of 2025.
Herantis will hold a webcast on October 8^th, at 13:00 EEST. Link to the webcast: https://herantis.videosync.fi/phase-1b-data-readout

Espoo, Finland, 7 October 2025: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today announces 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. Based on these encouraging Phase 1b results, Herantis intends to advance HER-096 into a Phase 2 clinical trial during 2026 to evaluate the efficacy, safety and tolerability of HER-096 in early-stage Parkinson’s patients.

“The Phase 1b results combined with the previously reported clinical and preclinical data provide a good rationale for advancing HER-096 into a Phase 2 trial focused on efficacy. This is an important step forward for HER-096 as a very promising clinical-stage disease-modifying drug candidate addressing the unmet clinical need in Parkinson’s disease,” commented Anders Gersel Pedersen, M.D, Chairman of Herantis Scientific Advisory Board, formerly Director at Eli Lilly and Company, and EVP at Lundbeck.

“We are thrilled to achieve this important milestone, successfully meeting the trial’s primary and secondary endpoints. These results are a testament to our team’s expertise and dedication, demonstrating our ability to drive the development program forward efficiently. We sincerely thank the Parkinson’s patients participating in this trial, other contributors, and patient organizations, the Michael J. Fox Foundation and Parkinson’s UK, for their support and engagement in this study. We are now excited to advance this program to Phase 2 as we explore HER-096’s potential to become the first disease-modifying therapy for Parkinson’s disease,” said Antti Vuolanto, CEO of Herantis Pharma.

Topline data overview

Demonstrating safety and tolerability was the primary objective of the study. The repeated subcutaneous 200 mg and 300 mg doses of HER-096, two doses per week for four weeks, in Parkinson's disease patients were generally safe and well tolerated. The reported adverse events (AEs) were mainly mild and transient, mostly injection site reactions. One serious adverse event (SAE) was reported among placebo-treated patients. The safety and tolerability data supports moving HER-096 into a Phase 2 trial.
Studying the pharmacokinetic profile of HER-096 in both healthy volunteers and PD patients was the secondary objective of the study. The data demonstrates that both the 200 mg and 300 mg doses of HER-096 achieve sufficient maximum concentration and total exposure in cerebrospinal fluid (CSF) to reach the expected pharmacologically active levels, indicating strong blood-brain barrier crossing of HER-096 in PD patients. The pharmacokinetic data support the continuation to Phase 2 with subcutaneous administration of two injections per week.
Parkinson’s disease motor symptoms remained stable in both the active and placebo groups. Further interpretation of symptom data is limited by the short treatment and follow-up period and the small sample size, as the study was not designed to draw efficacy conclusions.
Herantis expects the full Phase 1b dataset, including all biomarker data, to be available before the end of 2025.

Webcast

Herantis management will host a webcast October 8^th, at 13:00 EEST. The webcast will be held in English, and there will be a Q&A session in the end of the webcast. The questions are asked to be submitted in English. Attendance to the webcast through this link: https://herantis.videosync.fi/phase-1b-data-readout

About the Phase 1b clinical trial
The Phase 1b clinical study consisted of two parts:

In Part 1, 12 healthy volunteer subjects were dosed with a single dose for additional assessment of pharmacokinetic properties of HER-096. Encouraging pharmacokinetic data from this part of the study were announced on 28 January 2025 here.
In Part 2, 24 patients with Parkinson’s disease were dosed for twice weekly over a four-week period with either HER-096 or placebo, to study the safety and tolerability of repeated subcutaneous doses of HER-096. The study includes an exploratory biomarker part, including both targeted and untargeted assessments, to evaluate biological responses to HER-096 dosing in humans.

This trial was funded by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Parkinson’s UK. It was conducted in Turku and Helsinki, Finland by the contract research organization Clinical Research Services Turku – CRST Oy.

The trial is registered at ClinicalTrials.gov here and at EU Clinical Trials here.

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.

For more information, please contact:

Herantis Pharma:
Antti Vuolanto, CEO
Tel: +358407517329

Tone Kvåle, CFO
Tel: +47 915 19576
Email: ir@herantis.com

ICR Healthcare:

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.

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