Espoo, Finland, 21 August 2025: Herantis Pharma Plc ("Herantis"), a clinical-stage company developing disease-modifying therapies to stop Parkinson's disease, releases today the Company's 1H 2025 report. The full report is available at the Company's website: www.herantis.com.
Antti Vuolanto, CEO of Herantis, said: "We made significant clinical progress in the first half of 2025, advancing HER-096 through the Phase 1b study which is now approaching completion on schedule, a key milestone. We reported encouraging pharmacokinetic data from Part 1 of the study in healthy volunteers and completed the final patient visit in Part 2, which is evaluating HER-096 in individuals with Parkinson's disease. The upcoming topline data readout, expected by mid-October, will be an important inflection point for Herantis. While we are preparing for the Phase 2 study, the final design will be guided by the full Phase 1b dataset, which we anticipate will be available later this year. HER-096 has the potential to become the first disease-modifying treatment for Parkinson's disease, and we remain committed to bringing this transformative therapy to patients living with this devastating condition."
Herantis will hold a webcast related to the 1H report today, Thursday, 21 August at 10:00 EEST (9:00 CEST)
Please use the following link to register for the webcast: https://herantis.videosync.fi/q2-2025.
Questions can be submitted throughout the webcast event. A recording of the webinar will be made available on the Company's website.
Business highlights January - June 2025:
- Reported encouraging pharmacokinetic data in January from Part 1 of the HER-096 Phase 1b clinical study in healthy volunteers.
- First patient with Parkinson's disease was dosed in the Part 2 of the study in end of January.
- Successfully completed a directed share issue raising EUR 5.2 million on February 6.
- In May, successfully completed the first Parkinson's disease patient cohort in Part 2 of the Phase 1b trial evaluating the safety and tolerability of 200 mg doses of HER-096 vs placebo in patients with Parkinson's disease. Herantis subsequently received approval from the Data and Safety Monitoring Board to proceed to the final cohort.
- In May, the first patients were dosed in the final cohort of the Phase 1b clinical trial, evaluating the safety and tolerability of 300 mg doses of HER-096 vs placebo in patients with Parkinson's disease.
Events after the reporting period:
- Announced on 14 August that the last patient visit had been completed in the final cohort of the Phase 1b trial.
Key figures:
| EUR thousands | 1H 2025 | 1H 2024 | Full Year 2024 |
| Other operating income | 135 | 987 | 1 562 |
| Payroll and related expenses | 1 115 | 766 | 1 488 |
| Other operating expenses | 1 975 | 2 977 | 5 101 |
| Profit (loss) for the period | -3 201 | -2 687 | -4 940 |
| Cash flow from operating activities | -3 388 | -3 035 | -6 545 |
| 1H 2025 | 1H 2024 | Full Year 2024 | |
| Equity ratio % | 34,2 | 55,9 | -9,45 |
| Basic and diluted profit (loss) per share EUR | -0,13 | -0,13 | -0,24 |
| Number of shares at end of period | 24 094 817 | 20 160 733 | 20 160 733 |
| Average number of shares | 23 173 741 | 20 160 733 | 20 160 733 |
| EUR thousands | 30.06.2025 | 30.06.2024 | 31.12.2024 |
| Cash and securities1) | 4 559 | 3 489 | 2 135 |
| Equity | 1 749 | 2 040 | -243 |
| Balance sheet total | 5 112 | 3 648 | 2 571 |
| 1) 30.06.2025: Cash = 446 thousand EUR and Securities = 4 113 thousand EUR |
| 30.06.2024: Cash = 1 989 thousand EUR and Securities = 1 500 thousand EUR |
Formulas used to calculate key figures:
Equity ratio = Equity/balance sheet total,
Earnings per share = Profit for the period/average number of shares
Average number of shares = Weighted average number of shares. The number of shares weighted by the number of days each share has been outstanding during the review period
Summary and outlook for 2025:
The first half of 2025 represented a period of significant clinical progress for Herantis Pharma. The Company reported positive pharmacokinetic data for HER-096 in healthy volunteers and subsequently advanced its Phase 1b trial into two cohorts of Parkinson's disease patients. The final patient completed their last visit on 14 August 2025.
In February 2025, Herantis Pharma successfully completed a directed share issue, raising gross EUR 5.2 million, leaving the Company strongly positioned for its Phase 1b readout.
During the remainder of 2025, the Company is focused on analysing the data from its Phase 1b study of HER-096, and expects to present the topline data by mid-October 2025, with the full data readout expected before the end of the year. The Company will simultaneously continue its partnership discussions and preparations for the Phase 2 study of HER-096.
For more information, please contact:
Herantis Pharma:
Tone Kvåle, CFO
Tel: +47 915 19576
Email: ir@herantis.com
ICR Healthcare:
Mary-Jane Elliott, Sarah Elton-Farr, Stephanie Cuthbert
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. HER-096 is currently being evaluated in a Phase 1b clinical trial to assess the safety and tolerability of repeated subcutaneous dosing in patients with Parkinson's disease. The study builds on positive Phase 1a results, where HER-096 demonstrated a favourable safety and tolerability profile, and effective brain penetration in healthy volunteers.
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.
