Herantis Pharma Plc, Press release, 3 September 2024 at 11:30 EEST

Herantis Pharma announces approval of clinical trial application for a Phase 1b trial with HER-096 in Parkinson’s disease

• The primary objective is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease

Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease-modifying therapies for Parkinson’s disease is pleased to announce that the Competent Authorities have approved the clinical trial application (CTA) for a Phase 1b trial with HER-096 in Parkinson’s disease. The Phase 1b trial will be conducted in Finland.

“This is the first time we will be studying HER-096 in patients with Parkinson’s disease paving the way towards a Phase 2 clinical trial.”, said Antti Vuolanto, the CEO of Herantis Pharma. “We are pleased to advance the HER-096 program with the strong support from the two leading Parkinson’s charities The Michael J. Fox Foundation and Parkinson’s Virtual Biotech who are funding this Phase 1b trial demonstrating that we are in the forefront of the development of disease-modifying therapies for Parkinson’s disease.”

About Phase 1b clinical trial

The Phase 1b clinical study has two parts:

• In Part 1, up to 12 healthy volunteer subjects will be dosed with a single dose for assessment of pharmacokinetic properties of HER-096. The site in Turku, Finland will now start recruitment of healthy volunteer study subjects.
• In Part 2, up to 24 patients with Parkinson’s disease will be dosed for 4 week, 2 doses per week with either HER-096 or placebo to study the safety and tolerability of repeated subcutaneous doses of HER-096. The aim is also to evaluate selected biomarkers and discover and identify novel biomarkers in the Parkinson’s patients. The recruitment of patients will start after completing the Part 1 of the study.

More information about participation into the study can be found on the website (only in Finnish): osallistulaaketutkimukseen.fi/parkinsonin-tauti-laaketutkimus-c880/ 

About HER-096

HER-096 is an engineered peptidomimetic molecule designed to mimic the activity of CDNF, a protein that promotes cell survival and functional recovery of neurons. HER-096 modulates the Unfolded Protein Response (UPR) pathway, the regulation of which is essential in restoring the cell protein balance (proteostasis) and preventing the processes leading to, e.g., cytotoxic protein aggregation and neuronal cell death in the brain. In addition, HER-096 alleviates inflammation in the affected brain area. Thanks to its multimodal mechanism of action, Herantis’ HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.

For more information, please contact:

Tone Kvåle, CFO

Tel: +47 915 19576

Email: ir@herantis.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. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. It combines the compelling mechanism of action of CDNF with the convenience of subcutaneous administration. A Phase 1a clinical trial has demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in humans. The shares of Herantis are 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.