Herantis Pharma Releases 2H And FY 2025 Report Today

(MENAFN- GlobeNewsWire - Nasdaq) Herantis Pharma Plc | Company Release | March 5, 2026 at 08:00:00 EET

Espoo, Finland, March 5, 2026: Herantis Pharma Plc ("Herantis") a clinical-stage company developing disease-modifying therapies to stop the progression of Parkinson's disease, releases today the Company's 2H and FY 2025 report. The full report is attached to this release and is also available on the Company's website: .

Commenting on the results, Antti Vuolanto, CEO of Herantis Pharma, said:“2025 was a year of significant progress for Herantis Pharma, highlighted by the positive topline data from our Phase 1b trial of HER-096 announced in October. The study met all primary and secondary endpoints, confirming safety and tolerability of HER-096, as well as its ability to cross the blood-brain barrier in people with Parkinson's disease.

“Post-period end, biomarker data from the Phase 1b study further strengthened these findings, providing important evidence of a biological response to HER-096 in people with Parkinson's disease. Drug exposure was associated with modulation of key disease-related pathways, consistent with expectations based on preclinical data. Collectively, these results reinforce the significant potential of the HER-096 program and support our ongoing preparations for a Phase 2 proof-of-concept study.

“We were delighted to recently announce the award of a non-dilutive EUR 8.0 million grant from Horizon Europe, providing further third-party validation of our approach and will make a meaningful contribution towards the execution of the study. Additionally, the completion of a EUR 4.2 million directed share issue has strengthened our balance sheet and provides flexibility as we prepare for the Phase 2 trial. I would like to take this opportunity to thank our existing and new investors, and our partners, for their invaluable support.”

Herantis will hold a webcast relating to the report and current operations today, Thursday, 5 March 2026, at 10:00 am EET (9:00 am CET). Questions can be submitted throughout the webcast event.

Please use the following link to register for the webcast:

Business highlights January – December 2025:

. Successful completion of a directed share issue raising EUR 5.2 million in February.

. The Board of Directors of Herantis decided on a new option rights program in May, under which, an aggregate of, up to 600,000 option rights may be issued to the CEO, management team members and other key personnel.

. In October, Herantis announced positive topline data for HER-096 in Phase 1b trial for people living with Parkinson's disease. The trial met all primary and secondary endpoints.

- Both repeated 200 mg and 300 mg doses of HER-096 were generally safe and well tolerated in people with Parkinson's disease (PD).

- The trial demonstrated a pharmacokinetic profile consistent with predictions based on the single-dose studies in healthy volunteers. Importantly, blood-brain barrier penetration was confirmed in people with Parkinson's disease.

- Data indicated a twice-weekly dosing regimen with 300 mg dose to be 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.

. Herantis completed a six-month preclinical Good Laboratory Practice (GLP) toxicology study for HER-096 in November. The study demonstrated a favorable safety and tolerability profile, well aligned with the previous pre-clinical and clinical data. These results provide further confidence in the compound's suitability for long-term administration and represent another important milestone on the path towards a Phase 2 clinical efficacy trial.

Events after the reporting period

. January 7, 2026: Herantis reported biomarker data from the Phase 1b clinical trial. The data showed clear evidence of biological response to HER-096 in people with Parkinson's disease.

- Biomarker data showed 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.

. February 11, 2026: Herantis successfully completed a directed share issue raising EUR 4.2 million.

. February 19, 2026: Herantis reported that it was leading a consortium that had been selected for, pending final negotiation, an EUR 8.0 million grant from the Horizon Europe 2025 Research and Innovation program, to support the execution of Herantis' Phase 2 trial of HER-096.

Key figures:

EUR thousands	July - December	Full Year
	2025	2024	2025	2024
Other operating income	43	575	178	1,562
Payroll and related expenses	806	722	1,921	1,488
Other operating expenses	2,678	2,124	4,652	5,101
Profit (loss) for the period	-3,419	-2,253	-6,620	-4,940
Cash flow from operating activities	-2,707	-3,510	-6,095	-6,545
	July - December	Full Year
	2025	2024	2025	2024
Equity ratio	-0,63	-0,08	-0,63	-0,08
Basic and diluted profit (loss) per share EUR	-0,14	-0,11	-0,28	-0,24
Number of shares at end of period	24,094,817	20,160,733	24,094,817	20,160,733
Average number of shares	24,094,817	20,160,733	23,634,279	20,160,733
EUR thousands			31.12.2025	31.12.2024
Cash and securities1)			2,597	2,135
Equity			-1,687	-243
Balance sheet total			2,668	2,571
1) 2025: Cash = 751' and Securities = 1,846' 2024: Cash = 635' and Securities = 1,500'

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

2025 Summary and Outlook for 2026

2025 represented a year of significant clinical progress for Herantis Pharma, with all activities completed on schedule. The Company completed its Phase 1b of HER-096 in people living with Parkinson's disease (PD), demonstrating that repeated 200 mg and 300 mg doses of HER-096 are generally safe and well tolerated in people with PD, with a favourable pharmacokinetic profile and blood-brain barrier penetration being confirmed. The subsequent Phase 1b biomarker data showed clear evidence of biological response to HER-096 exposure, 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. Together, these results derisk the future clinical development of HER-096 and provide a strong platform from which to advance to Phase 2, with the biomarker data informing dose selection and refinement of clinical endpoints, as well as guiding prioritization of biomarkers. The biomarker data will be presented at upcoming scientific conferences and submitted for publication in peer-reviewed scientific journals.

During the rest of 2026, the Company is focused on preparing for its Phase 2 proof-of-concept trial of HER-096, with plans for the study design underway, and is targeting initiation of the study following completion of the ongoing preparations. The Company will evaluate potential financing options including equity financing, non-dilutive funding or a partnership agreement.

For more information, please contact:

Herantis Pharma
Tone Kvåle, CFO
Tel: +47 915 19576
Email:...

ICR Healthcare
Sarah Elton-Farr, Stephanie Cuthbert, Phillip Marriage
Tel: +44 20 3709 5700
Email:...

Certified Advisor
UB Corporate Finance Ltd
Tel.: +358 9 25 380 225
E-mail:...

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:

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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