Herantis Pharma Plc | Company Release | March 6, 2025 at 08:00:00 EET

Herantis Pharma releases 2H and FY 2024 report today

" Herantis’ HER-096 program continued rapid progress during 2024: we achieved important partnerships with leading Parkinson’s charities, we started the Phase 1b clinical trial of HER-096, and the partnering discussions pharma industry have progressed with increasing interest towards HER-096. Obtaining financing of 3.6 million Euros from the two leading Parkinson’s charities to cover the costs of the Phase 1b trial, the Michael J. Fox Foundation and Parkinson’s UK, underlines the groundbreaking potential of HER-096. In the ongoing Phase 1b trial, HER-096 will be for the first time administered to people with Parkinson’s disease. Keeping in mind the promising results of the earlier CDNF Phase 1 trial, in which signs of both clinical and biological effects were seen in advanced Parkinson’s patients, we are now looking forward to the topline data expected in Q3 2025," said Antti Vuolanto, CEO of Herantis.

Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease, releases today the company’s 2H and Full Year 2024 report. The full report is attached to this release and is also available at the company’s website: www.herantis.com.

A webinar (in English) will be held today, March 6 at 14:30 EET (13:30 CET).

Please use the following link to register for this event: 

https://herantis.videosync.fi/q4-2024

After registering, you will receive a confirmation email containing information about joining the webcast. Questions can be submitted throughout the webcast event.

Business highlights January – December 2024:

• Herantis is conducting a Phase 1b clinical trial of HER-096, which main objective is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in subjects with Parkinson’s disease.
• Clinical trial application (CTA) approved in September.
• HER-096 dosing started in October.
• Successfully completion of the Part 1 of the Phase 1b clinical trial in November.
• Herantis received the second milestone payment of EUR 0.75 million from European Innovation Council in June. Herantis obtained an EUR 2.5 million European Innovation Council (EIC) Accelerator grant in 2023. Herantis received the first EUR 1.4 million payment tranche in 2023.
• Herantis announced early July that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Parkinson’s Virtual Biotech will together finance Herantis’ Phase 1b clinical trial of HER-096 in Parkinson’s disease and the on-going biomarker project, with research funding of EUR 3.6 million.
• The Board of Directors decided on a new employee option rights program in July. Under the new option rights program 2024 I, in aggregate up to 400,000 option rights entitling to shares were issued to the CEO, management team and other personnel.
• Structural rationale of HER-096 design was published in Nature Communications in September. The publication demonstrates that the neuroprotective activity of CDNF is mediated by its interaction with GRP78 protein providing the structural rationale of HER-096 design.

Events after the reporting period:

• On January 28, Herantis reported:
• Encouraging pharmacokinetic data of the Part 1 of the Phase 1b trial.
• First subject with Parkinson’s disease dosed in the Part 2 of the Phase 1b trial.
• Herantis successfully completed a directed share issue raising EUR 5.2 million on February 6.

Key figures:

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 for 2024 and outlook for 2025:

2024 milestones for HER-096:

• Phase 1b clinical trial application submitted (targeted 1H/2024)

– achieved May 20, 2024

• Phase 1b clinical trial application approved (targeted 2H/2024)

– achieved September 3, 2024

• First subject dosed in the HER-096 Phase 1b trial (targeted 2H/2024)

– achieved October 16, 2024

Herantis Pharma successfully completed the Part 1 of the Phase 1b clinical trial in November 2024, and started dosing of the first subject with Parkinson’s disease (Part 2) in January 2025. The goal is to present topline data from the Phase 1b clinical trial of HER-096 for Parkinson’s disease in Q3-2025.

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

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. 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. The primary aim of the ongoing Phase 1b clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease. The Phase 1a clinical trial, completed in late 2023, demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in healthy volunteers. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.

Company website: www.herantis.com

Forward-looking statements

This company 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.