- FDA considered the planned HER-096 Phase 2a study design appropriate
- Study design finalized; approximately 100 patients to be enrolled
- More than 50% of Phase 2 funding secured or identified
Espoo, Finland, 2 June 2026: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson's disease, today provides an update on preparations for the Phase 2a proof-of-concept efficacy study of HER-096, its lead candidate for the treatment of Parkinson's disease, ahead of its webcast being hosted later today at 13.00 EEST (12:00 CEST).
Herantis recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned clinical development of HER-096. The FDA raised no concerns regarding the Company's chemistry, manufacturing and controls (CMC) information or preclinical data package and confirmed that, based on the current data package, Herantis would be in a position to activate U.S. clinical sites should an Investigational New Drug (IND) application be submitted. The FDA considered the Phase 2a trial design appropriate for the current stage of development and discussions also included the endpoint strategy for future clinical studies.
The Phase 2a study is designed to evaluate the efficacy, safety and tolerability of HER-096 in patients with early-stage Parkinson's disease and is expected to provide the first evidence of its potential to deliver meaningful clinical benefit in patients. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 100 newly diagnosed Parkinson's disease patients who are not receiving symptomatic medication across multiple sites in Europe. Patients will receive twice-weekly subcutaneous dosing of HER-096 or placebo for six months, followed by a six-month open-label extension. The study will use a Digital Motor Score (DMS) as its primary endpoint, complemented by established clinical assessments, imaging and biomarker analyses. The integration of Indivi's digital biomarker platform is intended to provide objective and continuous assessments of disease progression and treatment response.
Herantis has appointed CTC Clinical Trial Consultants AB (CTC) as the clinical CRO to support the execution of the Phase 2a study. CTC brings extensive experience in Parkinson's disease clinical trials and will support study start-up, site management and operational execution across participating study centers.
Herantis has already secured significant support for the program through the previously announced €8 million Horizon Europe grant and the potential for further investment from the European Innovation Council (EIC) Fund. Over 50% of the funding required to execute the Phase 2 study has been secured or identified. The Company continues to evaluate financing alternatives to support advancement into Phase 2, including strategic partnerships, equity financing and non-dilutive funding.
Antti Vuolanto, CEO of Herantis Pharma, said: "The successful outcome of our FDA meeting is an important milestone as we advance HER-096 towards Phase 2 development. Together with our positive Phase 1b data, encouraging biomarker findings and Horizon Europe grant support, the FDA feedback strengthens our confidence in the program and our development strategy. With the study design now finalized and our CRO partner selected, we have taken a significant step towards initiating the Phase 2a proof-of-concept efficacy study. We look forward to initiating the study and generating data that will further evaluate HER-096's potential as a disease-modifying treatment for Parkinson's disease."
Webcast details
Herantis' management team will host a webcast today, Tuesday 2 June 2026, at 13.00 EEST (12.00 CEST), during which the Company will provide further details on the study design, the FDA feedback and recent corporate developments.
Attendees are invited to pre-register and join the online event using the following link: https://herantis.videosync.fi/update-on-phase-2-preparation
Questions can be submitted throughout the webcast event and a recording will be available on the Company's website following the event.
For more information, please contact:
Herantis Pharma Plc
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
Email: 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 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.
