Herantis Pharma plc

Herantis Pharma - Phase 1b biomarker data show clear evidence of biological response to HER-096 in people with Parkinson's disease

Herantis Pharma Plc – Company release

Inside information: Herantis Pharma – Phase 1b biomarker data show clear evidence of biological response to HER-096 in people with Parkinson's disease

• Biomarker data show that HER-096 modulates Parkinson’s disease-relevant pathways, consistent with preclinical data, and supporting further clinical development
• HER-096 exposure was associated with changes across key disease-related pathways, including proteostasis, mitochondrial function, and neuroinflammation, aligned with the expected mechanism of action and indicating disease-modifying potential
• Herantis will hold a webcast tomorrow, January 8^th at 12:00 EET (11:00 CET).
  
  

Link to the webcast: https://herantis.videosync.fi/phase-1b-biomarker-data

Espoo, Finland, 7 January 2026: Herantis Pharma Plc (“Herantis”), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson’s disease, today announces biomarker data from its Phase 1b trial of HER-096. The results show clear clinical evidence of biological response to HER-096 exposure in people with Parkinson’s disease, with a biomarker profile consistent with the expected mechanism of action of HER-096.

“Biomarker evidence supporting the expected mechanism of action of HER-096 in people with Parkinson’s disease marks a key development milestone for Herantis. These data de-risk the program for potential partners and investors, support readiness for a planned Phase 2 trial to evaluate clinical efficacy and provide guidance for dose selection. Together, they reinforce confidence in the long-term value of the program, and we look forward to discussing these exciting results with prospective pharma partners”, said Antti Vuolanto, CEO of Herantis Pharma.

“The Phase 1b biomarker data provide encouraging translational evidence that HER-096 drives biologically meaningful changes in people with Parkinson’s disease. The coordinated shifts we observed across multiple disease-relevant pathways, including proteostasis, mitochondrial function and neuroinflammation, are consistent with a disease-modifying mechanism and align with our preclinical findings. Consistent findings across different analyses and biological layers strengthen our confidence in the therapeutic rationale for HER-096 as development progresses to later-stage clinical trials”, said Henri Huttunen, CSO of Herantis Pharma.

The Phase 1b trial consisted of 24 patients with Parkinson’s disease, who received twice-weekly dosing of either HER-096 or placebo over a four-week period. The trial’s exploratory biomarker program assessed biological responses to HER-096 in humans, generating and analyzing more than 2.5 million datapoints.

• Untargeted biomarker analyses identified consistent, treatment-associated shifts in biomarkers linked to proteostasis, mitochondrial function and neuroinflammation – biologically relevant pathways to the Unfolded Protein Response and Parkinson’s disease – in response to HER-096 treatment.
• Alignment between targeted and untargeted biomarker datasets demonstrates modulation of biological pathways directly relevant to HER-096 mechanism of action, in line with the preclinical findings.

These exploratory biomarker findings support continued development of HER-096 and the planned Phase 2 trial to evaluate clinical efficacy. The data will inform dose selection and refinement of clinical endpoints for subsequent studies, as well as guiding prioritization of biomarkers for confirmation in future trials. The biomarker data will be presented at upcoming scientific conferences and submitted for publication in peer-reviewed scientific journals.

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.